The Effects of Improvisational Music Therapy on Joint Attention Behaviors in Autistic Children: A Randomized Controlled Study

ERIC Educational Resources Information Center

Kim, Jinah; Wigram, Tony; Gold, Christian

2008-01-01

The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism. It was a randomized controlled study employing a single subject comparison design in two different conditions, improvisational music therapy and play sessions with toys, and using standardized…

Outcome-Based Evaluation of a Social Skills Program Using Art Therapy and Group Therapy for Children on the Autism Spectrum

ERIC Educational Resources Information Center

Epp, Kathleen Marie

2008-01-01

There is a paucity of literature on social skills therapy for students on the autism spectrum, revealing an urgent need for additional research. Past research has focused on the use of small groups or single-case study designs. The present study examines the effectiveness of a social skills therapy program for school-age children ages 11 through…

Art Therapy Teaching as Performance Art

ERIC Educational Resources Information Center

Moon, Bruce L.

2012-01-01

This viewpoint asserts that art therapy education is a form of performance art. By designing class sessions as performance artworks, art therapy educators can help their students become more fully immersed in their studies. This view also can be extended to conceptualizing each semester--and the entire art therapy curriculum--as a complex and…

Interdisciplinary Concepts for Design and Implementation of Mixed Reality Interactive Neurorehabilitation Systems for Stroke

PubMed Central

Lehrer, Nicole; Duff, Margaret; Venkataraman, Vinay; Turaga, Pavan; Ingalls, Todd; Rymer, W. Zev; Wolf, Steven L.; Rikakis, Thanassis

2015-01-01

Interactive neurorehabilitation (INR) systems provide therapy that can evaluate and deliver feedback on a patient's movement computationally. There are currently many approaches to INR design and implementation, without a clear indication of which methods to utilize best. This article presents key interactive computing, motor learning, and media arts concepts utilized by an interdisciplinary group to develop adaptive, mixed reality INR systems for upper extremity therapy of patients with stroke. Two INR systems are used as examples to show how the concepts can be applied within: (1) a small-scale INR clinical study that achieved integrated improvement of movement quality and functionality through continuously supervised therapy and (2) a pilot study that achieved improvement of clinical scores with minimal supervision. The notion is proposed that some of the successful approaches developed and tested within these systems can form the basis of a scalable design methodology for other INR systems. A coherent approach to INR design is needed to facilitate the use of the systems by physical therapists, increase the number of successful INR studies, and generate rich clinical data that can inform the development of best practices for use of INR in physical therapy. PMID:25425694

Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

PubMed

Felker, G Michael; Ahmad, Tariq; Anstrom, Kevin J; Adams, Kirkwood F; Cooper, Lawton S; Ezekowitz, Justin A; Fiuzat, Mona; Houston-Miller, Nancy; Januzzi, James L; Leifer, Eric S; Mark, Daniel B; Desvigne-Nickens, Patrice; Paynter, Gayle; Piña, Ileana L; Whellan, David J; O'Connor, Christopher M

2014-10-01

The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of <1,000 pg/ml compared with usual care in high-risk patients with systolic heart failure (HF). Elevations in natriuretic peptide (NP) levels provide key prognostic information in patients with HF. Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs, and observational data show that decreases in NP levels over time are associated with favorable outcomes. Results from smaller prospective, randomized studies of this strategy thus far have been mixed, and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF. GUIDE-IT is a prospective, randomized, controlled, unblinded, multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF (left ventricular ejection fraction ≤40%) to either usual care (optimized guideline-recommended therapy) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of <1,000 pg/ml. Patients in either arm of the study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months. The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF. Secondary endpoints include time to cardiovascular death and all-cause mortality, cumulative mortality, health-related quality of life, resource use, cost-effectiveness, and safety. The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality, hospitalization, quality of life, and medical resource use. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A Phase I/II adaptive design for heterogeneous groups with application to a stereotactic body radiation therapy trial.

PubMed

Wages, Nolan A; Read, Paul W; Petroni, Gina R

2015-01-01

Dose-finding studies that aim to evaluate the safety of single agents are becoming less common, and advances in clinical research have complicated the paradigm of dose finding in oncology. A class of more complex problems, such as targeted agents, combination therapies and stratification of patients by clinical or genetic characteristics, has created the need to adapt early-phase trial design to the specific type of drug being investigated and the corresponding endpoints. In this article, we describe the implementation of an adaptive design based on a continual reassessment method for heterogeneous groups, modified to coincide with the objectives of a Phase I/II trial of stereotactic body radiation therapy in patients with painful osseous metastatic disease. Operating characteristics of the Institutional Review Board approved design are demonstrated under various possible true scenarios via simulation studies. Copyright © 2015 John Wiley & Sons, Ltd.

Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A): study protocol

PubMed Central

2012-01-01

Background Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week) affects outcome of therapy, and to determine cost-effectiveness. Methods/Design Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity) or three sessions (high-intensity) per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS) and parents (Social Responsiveness Scale, SRS) before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency. Discussion Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session frequency for therapy outcome. Trial Registration Current Controlled Trials ISRCTN78923965. PMID:22221670

[The effect of a group therapy for the offenders of family violence].

PubMed

Hyun, Mi Yeul

2008-06-01

The purpose of this study was to evaluate the contribution of group therapy to the improvement of self-esteem, anger, stress coping and communication of those who were violent in to family. The research design was a one-group- pretest-posttest design in quasi-experimental research, and the period of this study was from March to October, 2005. Participants were 14 offenders who were ordered to be counseled according to 'the special exemption law for punishing domestic violence.' Group therapy was applied once a week for 8 weeks. Results were collected by using a questionnaire for self-esteem, anger, stress coping and communication. In the data analysis, Wilcoxon signed test with SPSS/WIN 12.0 program was used. The scores of self-esteem and communication showed statistically significant improvement from pre to post therapy. However, the scores of anger and stress coping were not significantly changed from pre to post therapy. This group therapy was effective in improving the self-esteem and communication in offenders of family violence.

Active Music Therapy and Physical Improvements From Rehabilitation for Neurological Conditions.

PubMed

Kogutek, Demian Leandro; Holmes, Jeffrey David; Grahn, Jessica Adrienne; Lutz, Sara G; Ready, Emily

2016-01-01

Context • A variety of rehabilitation-based interventions are currently available for individuals with physical impairments resulting from neurological conditions, including physiotherapy, occupational therapy, and speech language pathology. Many individuals find participation in those therapies to be challenging. Alternative therapies have emerged as beneficial adjunctive treatments for individuals undergoing neurological rehabilitation, including music therapy (MT). Objective • The study intended to identify and collate systematically the evidence on MT interventions that address physical improvements in a rehabilitative setting. Design • The research team performed a literature review, searching electronic databases from their inception to April 2014, including Embase, CINAHL, PubMed, Scopus, and ProQuest. The review included original studies that examined the use of active MT as an intervention that promotes physical improvements for adults >18 y of age. Articles were excluded if the studies focused primarily on psychosocial, emotional, or spiritual therapeutic goals. The review identified the studies' outcome measures for different populations and the MT approaches and interventions and obtained a general description of the clinical sessions, such as the frequency and duration of the therapy, interventions performed, sessions designs, populations, equipment used, and credentials of the therapists. Results • Eleven studies identified 2 major categories for the delivery of MT sessions: individual and group. One study included group sessions, and 10 studies included individual sessions. The studies included a total of 290 participants, 32 in the group MT, and 258 in the individual MT. The one study that used group therapy was based on active MT improvisation. For the individual therapy, 2 studies had investigated therapeutic instrument music performance and 8 used music-supported therapy. Conclusions • The findings of the review suggested that active MT can improve motor skills and should be considered as a potential adjunctive treatment.

[Balneotherapy and spa therapy of rheumatic diseases in Turkey: a systematic review].

PubMed

Karagülle, M Z; Karagülle, M

2004-02-01

Turkey has a lot of thermal and mineral springs and is looking back on a still vivid tradition of spa therapy and balneotherapy, applied especially for the treatment of rheumatic diseases. This tradition is predominantly empiric and intuitive, however, it has assumed some important aspects of modern balneotherapeutic methods as well. This article is aimed at presenting the characteristics of traditional and modern balneological and spa therapy forms in Turkey. The studies which have been conducted between 1990 and 2000 in different spas in Turkey on the efficacy and effectiveness of spa therapy and balneotherapy for rheumatic diseases have been searched and analyzed independent of their design. A descriptive evaluation of the studies was carried out. A total of 15 published studies have been found and analyzed. The investigations have been carried out in 8 different spa resorts in Turkey. In these studies the effectiveness and efficacy of different balneological and spa therapies on a variety of rheumatic diseases (from osteoarthritis to fibromyalgia and from rheumatoid arthritis to low back pain) could be shown. Nearly all studied balneotherapeutic modalities were applied as bathing cures. Only in one study peloid therapy was applied. Balneotherapeutic therapy was applied in a modern and traditional way, and both open and stationary spa therapy forms were used at the same time. The review has shown the effectiveness of the investigated spa therapy and balneotherapy forms. It could be concluded that nearly all forms of spa therapy and balneotherapy used for the treatment of rheumatic diseases in Turkey are effective. A definitive conclusion, however, is not possible because of the heterogeneity of the study designs, methodological flaws, and the publication bias. In future good quality randomized controlled trials are needed. Copyright 2004 S. Karger GmbH, Freiburg

[Design and study of parallel computing environment of Monte Carlo simulation for particle therapy planning using a public cloud-computing infrastructure].

PubMed

Yokohama, Noriya

2013-07-01

This report was aimed at structuring the design of architectures and studying performance measurement of a parallel computing environment using a Monte Carlo simulation for particle therapy using a high performance computing (HPC) instance within a public cloud-computing infrastructure. Performance measurements showed an approximately 28 times faster speed than seen with single-thread architecture, combined with improved stability. A study of methods of optimizing the system operations also indicated lower cost.

An Investigative Study of the Perceptions of Nationally Certified Massage Practitioners toward Entry Level Web Based Massage Therapy Curriculum Designs

ERIC Educational Resources Information Center

Vlahos, Efthimios

2011-01-01

This descriptive study examines the current status of online education in massage therapy with respect to the development of web based curriculums. Participants are drawn from the public listing of the National Certification Board for Therapeutic Massage and Bodywork (NCBTMB). The Online Curriculum Survey in Massage Therapy is used as an…

Differential Effects of Emotion-Focused Therapy and Psychoeducation in Facilitating Forgiveness and Letting Go of Emotional Injuries

ERIC Educational Resources Information Center

Greenberg, Leslie J.; Warwar, Serine H.; Malcolm, Wanda M.

2008-01-01

This study compared the effectiveness of emotion-focused therapy (EFT) involving gestalt empty-chair dialogue in the treatment of individuals who were emotionally injured by a significant other with therapy in a psychoeducation group designed to deal with these injuries. In addition, this study examined aspects of the emotional process of…

75 FR 67987 - Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-04

...] Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability AGENCY: Food and Drug... availability of a document entitled ``Guidance for Industry: Cellular Therapy for Cardiac Disease'' dated... treatment of cardiac disease with recommendations on the design of preclinical and clinical studies and on...

Structure of the physical therapy benefit in a typical Blue Cross Blue Shield preferred provider organization plan available in the individual insurance market in 2011.

PubMed

Sandstrom, Robert W; Lehman, Jedd; Hahn, Lee; Ballard, Andrew

2013-10-01

The Affordable Care Act of 2010 establishes American Health Benefit Exchanges. The benefit design of insurance plans in state health insurance exchanges will be based on the structure of existing small-employer-sponsored plans. The purpose of this study was to describe the structure of the physical therapy benefit in a typical Blue Cross Blue Shield (BCBS) preferred provider organization (PPO) health insurance plan available in the individual insurance market in 2011. A cross-sectional survey design was used. The physical therapy benefit within 39 BCBS PPO plans in 2011 was studied for a standard consumer with a standard budget. First, whether physical therapy was a benefit in the plan was determined. If so, then the structure of the benefit was described in terms of whether the physical therapy benefit was a stand-alone benefit or part of a combined-discipline benefit and whether a visit or financial limit was placed on the physical therapy benefit. Physical therapy was included in all BCBS plans that were studied. Ninety-three percent of plans combined physical therapy with other disciplines. Two thirds of plans placed a limit on the number of visits covered. The results of the study are limited to 1 standard consumer, 1 association of insurance companies, 1 form of insurance (a PPO), and 1 PPO plan in each of the 39 states that were studied. Physical therapy is a covered benefit in a typical BCBS PPO health insurance plan. Physical therapy most often is combined with other therapy disciplines, and the number of covered visits is limited in two thirds of plans.

Cognitive-Behavioral Therapy for HIV Medication Adherence and Depression

ERIC Educational Resources Information Center

Safren, Steven A.; Hendriksen, Ellen S.; Mayer, Kenneth H.; Mimiaga, Matthew J.; Pickard, Robert; Otto, Michael W.

2004-01-01

For patients with HIV, depression is a common, distressing condition that can interfere with a critical self-care behavior--adherence to antiretroviral therapy. The present study describes a cognitive-behavioral treatment designed to integrate cognitive-behavioral therapy for depression with our previously tested approach to improving adherence to…

Exercise therapy and other types of physical therapy for patients with neuromuscular diseases: a systematic review.

PubMed

Cup, Edith H; Pieterse, Allan J; Ten Broek-Pastoor, Jessica M; Munneke, Marten; van Engelen, Baziel G; Hendricks, Henk T; van der Wilt, Gert J; Oostendorp, Rob A

2007-11-01

To summarize and critically appraise the available evidence on exercise therapy and other types of physical therapies for patients with neuromuscular diseases (NMD). Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews, Medline, CINAHL, EMBASE (Rehabilitation and Physical Medicine), and reference lists of reviews and articles. Randomized clinical trials (RCTs), controlled clinical trials (CCTs), and other designs were included. Study participants had to have any of the following types of NMD: motoneuron diseases, disorders of the motor nerve roots or peripheral nerves, neuromuscular transmission disorders, or muscle diseases. All types of exercise therapy and other physical therapy modalities were included. Outcome measures had to be at the level of body functions, activities, or participation according to the definitions of the International Classification of Functioning, Disability and Health (ICF). Two reviewers independently decided on inclusion or exclusion of articles and rated the methodologic quality of the studies included. All RCTs, CCTs, and other designs only if of sufficient methodologic quality were included in a best evidence synthesis. A level of evidence was attributed for each subgroup of NMD and each type of intervention. Initially 58 studies were included: 12 RCTs, 5 CCTs, and 41 other designs. After methodologic assessment, 19 other designs were excluded from further analysis. There is level II evidence ("likely to be effective") for strengthening exercises in combination with aerobic exercises for patients with muscle disorders. Level III evidence ("indications of effectiveness") was found for aerobic exercises in patients with muscle disorders and for the combination of muscle strengthening and aerobic exercises in a heterogeneous group of muscle disorders. Finally, there is level III evidence for breathing exercises for patients with myasthenia gravis and for patients with myotonic muscular dystrophy. Adverse effects of exercise therapy were negligible. The available evidence is limited, but relevant for clinicians. Future studies should be preferably multicentered, and use an international classification of the variables of exercise therapy and an ICF core set for NMD in order to improve comparability of results.

Use of music during physical therapy intervention for an infant with Erb's palsy: a single-subject design.

PubMed

Rahlin, Mary; Cech, Donna; Rheault, Wendy; Stoecker, Judith

2007-01-01

Evidence supporting the use of music during pediatric physical therapy intervention is limited. The purpose of this single-subject design was to evaluate the effects of music on patient progress, the amount of crying during therapy, and parent satisfaction with physical therapy services. The subject was an infant girl with Erb's palsy who participated in this study from age 8 months to age 20 months. An A-B-A withdrawal single-subject design was used. The patient's progress was assessed by using the T.I.M.E. The amount of crying was documented in the Crying Log. A parent satisfaction questionnaire was administered three times over the course of the study. The subject's progress in the music intervention period increased on three of five primary subtests of the T.I.M.E. The amount of crying decreased and parent satisfaction increased when music was played during therapy. Music may be used by pediatric physical therapists to decrease the patient's crying, increase parent satisfaction, and possibly to increase the child's rate of progress. Further research conducted with a group of infants and toddlers may help generalize these findings to a wider patient population.

[Effects of heat therapy using a far infrared rays heating element for dysmenorrhea in high school girls].

PubMed

Hong, Yeon Ran

2011-02-01

The purpose of this study was designed to identify the effects of heat therapy on dysmenorrhea, heat being provided using a far infrared rays heating element. The research design for the study was a non-equivalent control group quasi-experimental design. Participants were 22 students for the experimental group, and 26 students for the control group. Data were analyzed using SAS WIN 9.1 program. The experimental group had significantly lower mean scores for menstrual pain, dysmenorrhea, and blood pressure than those in the control group. However, no significant differences were found between two groups for pulse, respiration, and temperature. These findings show that thermotherapy was effective for reduction of menstrual pain, dysmenorrhea, and B/P. Therefore, this therapy could be used as a nursing intervention for students with dysmenorrhea.

Two is better than one; toward a rational design of combinatorial therapy.

PubMed

Chen, Sheng-Hong; Lahav, Galit

2016-12-01

Drug combination is an appealing strategy for combating the heterogeneity of tumors and evolution of drug resistance. However, the rationale underlying combinatorial therapy is often not well established due to lack of understandings of the specific pathways responding to the drugs, and their temporal dynamics following each treatment. Here we present several emerging trends in harnessing properties of biological systems for the optimal design of drug combinations, including the type of drugs, specific concentration, sequence of addition and the temporal schedule of treatments. We highlight recent studies showing different approaches for efficient design of drug combinations including single-cell signaling dynamics, adaption and pathway crosstalk. Finally, we discuss novel and feasible approaches that can facilitate the optimal design of combinatorial therapy. Copyright © 2016 Elsevier Ltd. All rights reserved.

Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: The Qatar Study

PubMed Central

Abdul-Ghani, Muhammad; Migahid, Osama; Megahed, Ayman; Adams, John; Triplitt, Curtis; DeFronzo, Ralph A.; Zirie, Mahmoud; Jayyousi, Amin

2017-01-01

OBJECTIVE The Qatar Study was designed to examine the efficacy of combination therapy with exenatide plus pioglitazone versus basal/bolus insulin in patients with long-standing poorly controlled type 2 diabetes mellitus (T2DM) on metformin plus a sulfonylurea. RESEARCH DESIGN AND METHODS The study randomized 231 patients with poorly controlled (HbA1c >7.5%, 58 mmol/mol) T2DM on a sulfonylurea plus metformin to receive 1) pioglitazone plus weekly exenatide (combination therapy) or 2) basal plus prandial insulin (insulin therapy) to maintain HbA1c <7.0% (53 mmol/mol). RESULTS After a mean follow-up of 12 months, combination therapy caused a robust decrease in HbA1c from 10.0 ± 0.6% (86 ± 5.2 mmol/mol) at baseline to 6.1 ± 0.1% (43 ± 0.7 mmol/mol) compared with 7.1 ± 0.1% (54 ± 0.8 mmol/mol) in subjects receiving insulin therapy. Combination therapy was effective in lowering the HbA1c independent of sex, ethnicity, BMI, or baseline HbA1c. Subjects in the insulin therapy group experienced significantly greater weight gain and a threefold higher rate of hypoglycemia than patients in the combination therapy group. CONCLUSIONS Combination exenatide/pioglitazone therapy is a very effective and safe therapeutic option in patients with long-standing poorly controlled T2DM on metformin plus a sulfonylurea. PMID:28096223

Outcomes of an Acceptance and Commitment Therapy-Based Skills Training Group for Students with High-Functioning Autism Spectrum Disorder: A Quasi-Experimental Pilot Study

ERIC Educational Resources Information Center

Pahnke, Johan; Lundgren, Tobias; Hursti, Timo; Hirvikoski, Tatja

2014-01-01

Autism spectrum disorder is characterized by social impairments and behavioural inflexibility. In this pilot study, the feasibility and outcomes of a 6-week acceptance and commitment therapy-based skills training group were evaluated in a special school setting using a quasi-experimental design (acceptance and commitment therapy/school classes as…

The Effect of Music Therapy Services on Classroom Behaviours of Newly Arrived Refugee Students in Australia--A Pilot Study

ERIC Educational Resources Information Center

Baker, Felicity; Jones, Carolyn

2006-01-01

This pilot study examined the effects of a short-term music therapy program on the classroom behaviours of newly arrived refugee students who were attending an intensive "English as a Second Language" secondary school. A cross-over design with two five-week intervention periods was employed with group music therapy sessions conducted one…

Enhancing treatment fidelity in psychotherapy research: novel approach to measure the components of cognitive behavioural therapy for relapse prevention in first-episode psychosis.

PubMed

Alvarez-Jimenez, Mario; Wade, Darryl; Cotton, Sue; Gee, Donna; Pearce, Tracey; Crisp, Kingsley; McGorry, Patrick D; Gleeson, John F

2008-12-01

Establishing treatment fidelity is one of the most important aspects of psychotherapy research. Treatment fidelity refers to the methodological strategies used to examine and enhance the reliability and validity of psychotherapy. This study sought to develop and evaluate a measure specifically designed to assess fidelity to the different therapeutic components (i.e. therapy phases) of the individual intervention of a psychotherapy clinical trial (the EPISODE II trial). A representative sample of sessions stratified by therapy phase was assessed using a specifically developed fidelity measure (Relapse Prevention Therapy-Fidelity Scale, RPT-FS). Each RPT-FS subscale was designed to include a different component/phase of therapy and its major therapeutic ingredients. The measure was found to be reliable and had good internal consistency. The RPT-FS discriminated, almost perfectly, between therapy phases. The analysis of the therapeutic strategies implemented during the intervention indicated that treatment fidelity was good throughout therapy phases. While therapists primarily engaged in interventions from the appropriate therapeutic phase, flexibility in therapy was evident. This study described the development of a brief, reliable and internally consistent measure to determine both treatment fidelity and the therapy components implemented throughout the intervention. This methodology can be potentially useful to determine those components related to therapeutic change.

Autism spectrum disorder and pet therapy.

PubMed

Siewertsen, Caitlin M; French, Emma D; Teramoto, Masaru

2015-01-01

Autism Spectrum Disorder (ASD) encompasses a wide range of social and mental afflictions that are difficult to treat. Due to a lack of established treatments for ASD, alternative therapies have been the primary form of intervention. One of these alternatives is pet therapy, a field that has experienced growing interest and has recently accumulated studies that investigate its efficacy. This article reviews and summarizes that effectiveness as well as the findings and limitations associated with pet therapy for ASD. The majority of research on ASD and pet therapy has examined children and has primarily used dogs and horses for therapy. Studies have shown positive effects for the therapy, including high satisfaction rates among the participants' families. Major limitations of studies in the current literature include the lack of control groups and small sample sizes. Future research should incorporate better study designs and large samples to validate pet therapy as an appropriate treatment for ASD.

Effectiveness of Solution-Focused Brief Therapy: A Systematic Qualitative Review of Controlled Outcome Studies

ERIC Educational Resources Information Center

Gingerich, Wallace J.; Peterson, Lance T.

2013-01-01

Objective: We review all available controlled outcome studies of solution-focused brief therapy (SFBT) to evaluate evidence of its effectiveness. Method: Forty-three studies were located and key data abstracted on problem, setting, SFBT intervention, design characteristics, and outcomes. Results: Thirty-two (74%) of the studies reported…

Relative Effectiveness of Operant Conditioning and Play Therapy in Childhood Schizophrenia

ERIC Educational Resources Information Center

Ney, Philip G.; And Others

1971-01-01

An experimental study designed to examine the relative effectiveness of operant conditioning and play therapy in improving the communication and social functioning of psychotic children was presented and discussed. (Author)

Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design.

PubMed

Lal, Rohit; Bourayou, Nawel; Hillerdal, Gunnar; Nicolson, Marianne; Vikstrom, Anders; Lorenzo, Maria; D'yachkova, Yulia; Barriga, Susana; Visseren-Grul, Carla

2013-10-03

Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting. Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0-1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m(2) every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients' quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011. This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home-based chemotherapy. The study design requires unusual methodology and specific logistics to address outcomes relevant to the home-delivery approach. This article presents a study design that offers a novel and reproducible model for home-based chemotherapy, and provides an up-to-date overview of the literature regarding this type of treatment. ClinicalTrials.gov: NCT01473563.

Experiential Learning in Occupational Therapy: Can It Enhance Readiness for Clinical Practice?

ERIC Educational Resources Information Center

Knecht-Sabres, Lisa Jean

2013-01-01

This mixed method study examined the effectiveness of experiential learning opportunities near the end of the occupational therapy students' didactic education. A pretest/posttest design with a gain score approach was used to determine whether there was a significant improvement in the occupational therapy students' self-perception of their…

Effect of Audiovisual Distraction on Distress and Oxygenation Status in Children Receiving Aerosol Therapy.

PubMed

Shinta Devi, Ni Luh Putu; Nurhaeni, Nani; Hayati, Happy

Aerosol therapy, a treatment for children with disorders of the respiratory system, often causes distress, especially in young children. Distress during aerosol therapy can decrease the effectiveness of the treatment. This study aimed to determine the effect of audiovisual distraction on distress levels and oxygenation status (measured by oxygen saturation and respiratory frequency) in children who receive aerosol therapy for disorders of the respiratory system. A quasi-experimental design was employed, specifically a non-equivalent control group, pre-test-post-test design. The study sample consisted of 38 children who were divided into 2 groups (control and intervention), each group consisting of 19 children. The results of this study showed that there were significant differences in distress scores between the control group and the intervention group (p = .0001). There were also significant differences in the mean value changes in oxygenation status before and after intervention between the control and intervention groups. These findings could be used to prevent distress and increase oxygenation status in children who receive aerosol therapy.

Biomimetics in the design of a robotic exoskeleton for upper limb therapy

NASA Astrophysics Data System (ADS)

Baniqued, Paul Dominick E.; Dungao, Jade R.; Manguerra, Michael V.; Baldovino, Renann G.; Abad, Alexander C.; Bugtai, Nilo T.

2018-02-01

Current methodologies in designing robotic exoskeletons for upper limb therapy simplify the complex requirements of the human anatomy. As a result, such devices tend to compromise safety and biocompatibility with the intended user. However, a new design methodology uses biological analogues as inspiration to address these technical issues. This approach follows that of biomimetics, a design principle that uses the extraction and transfer of useful information from natural morphologies and processes to solve technical design issues. In this study, a biomimetic approach in the design of a 5-degree-of-freedom robotic exoskeleton for upper limb therapy was performed. A review of biomimetics was first discussed along with its current contribution to the design of rehabilitation robots. With a proposed methodological framework, the design for an upper limb robotic exoskeleton was generated using CATIA software. The design was inspired by the morphology of the bones and the muscle force transmission of the upper limbs. Finally, a full design assembly presented had integrated features extracted from the biological analogue. The successful execution of a biomimetic design methodology made a case in providing safer and more biocompatible robots for rehabilitation.

The TOPSHOCK study: Effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial

PubMed Central

2011-01-01

Background Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. Methods/design The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. Discussion The TOPSHOCK study is the first randomised controlled trial that directly compares the effectiveness of focused shockwave therapy and radial shockwave therapy, both in combination with eccentric decline squat training, for treating patellar tendinopathy. Trial registration Trial registration number NTR2774. PMID:21989041

Psychological therapy for psychogenic amnesia: Successful treatment in a single case study.

PubMed

Cassel, Anneli; Humphreys, Kate

2016-01-01

Psychogenic amnesia is widely understood to be a memory impairment of psychological origin that occurs as a response to severe stress. However, there is a paucity of evidence regarding the effectiveness of psychological therapy approaches in the treatment of this disorder. The current article describes a single case, "Ben", who was treated with formulation-driven psychological therapy using techniques drawn from cognitive behavioural therapy (CBT) and acceptance and commitment therapy (ACT) for psychogenic amnesia. Before treatment, Ben exhibited isolated retrograde and anterograde memory impairments. He received 12 therapy sessions that targeted experiential avoidance followed by two review sessions, six weeks and five months later. Ben's retrograde and anterograde memory impairments improved following therapy to return to within the "average" to "superior" ranges, which were maintained at follow-up. Further experimental single case study designs and larger group studies are required to advance the understanding of the effectiveness and efficacy of psychological therapy for psychogenic amnesia.

Does continuous positive airway pressure reduce aldosterone levels in patients with obstructive sleep apnea?

PubMed

Yang, Si-Jiu; Jiang, Xing-Tang; Zhang, Xiao-Bin; Yin, Xiao-Wen; Deng, Wei-Xian

2016-09-01

Aldosterone is associated with the development of obstructive sleep apnea (OSA) and cardiovascular diseases. Continuous positive airway pressure (CPAP) is an effective treatment for OSA, but the impact of CPAP therapy on aldosterone levels in patients with OSA remains unclear. To address this issue, a meta-analysis was conducted to evaluate the effects of CPAP therapy on serum aldosterone levels in OSA. Two reviewers independently searched PubMed, Cochrane library, Embase, and Web of Science before March 2015. Information on characteristics of subjects, study design, and pre- and post-CPAP treatment of serum aldosterone was extracted for analysis. Standardized mean difference (SMD) was calculated to estimate the treatment effects of CPAP therapy. A total of 5 studies involving 329 patients were pooled into this meta-analysis, including 3 observational studies and 2 randomized controlled studies. Results indicated significantly decreased aldosterone levels after CPAP therapy (SMD = -0.236, 95 % confidence interval (CI) = -0.45 to -0.02, z = 2.12, p = 0.034). This meta-analysis suggested that CPAP therapy was associated with a decrease in serum aldosterone in patients with OSA. Further large-scale, well-designed interventional investigations are needed to clarify this issue.

Patient positioning and ventilator-associated pneumonia.

PubMed

Hess, Dean R

2005-07-01

Rotational beds, prone position, and semi-recumbent position have been proposed as procedures to prevent ventilator-associated pneumonia (VAP). Rotational therapy uses a special bed designed to turn continuously, or nearly continuously, the patient from side to side; specific designs include kinetic therapy and continuous lateral rotation therapy. A meta-analysis of studies evaluating the effect of rotational bed therapy shows a decrease in the risk of pneumonia but no effect on mortality. Two studies reported a lower risk of VAP in patients placed in a prone position, with no effect on mortality. Studies using radiolabeled enteral feeding solutions in mechanically ventilated patients have reported that aspiration of gastric contents occurs to a greater degree when patients are in the supine position, compared with the semirecumbent position. One study reported a lower rate of VAP in patients randomized to semi-recumbent compared to supine position. Although each of the techniques discussed in this paper has been shown to reduce the risk of VAP, none has been shown to affect mortality. The available evidence suggests that semi-recumbent position should be used routinely, rotational therapy should be considered in selected patients, and prone position should not be used as a technique to reduce the risk of VAP.

Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD.

PubMed

Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

2016-01-01

Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design.

Examination of Student Outcomes in Play Therapy: A Qualitative Case Study Design

ERIC Educational Resources Information Center

Dillman Taylor, Dalena L.; Blount, Ashley J.; Bloom, Zachary

2017-01-01

Outcome research examining the effectiveness of teaching methods in counselor education is sparse. The researchers conducted a qualitative investigation utilizing an instrumental case study to examine the influence of a constructivist-developmental format on a play therapy counseling course in a large CACREP accredited university in the…

Cultivating cohort studies for observational translational research.

PubMed

Ransohoff, David F

2013-04-01

"Discovery" research about molecular markers for diagnosis, prognosis, or prediction of response to therapy has frequently produced results that were not reproducible in subsequent studies. What are the reasons, and can observational cohorts be cultivated to provide strong and reliable answers to those questions? Experimental Selected examples are used to illustrate: (i) what features of research design provide strength and reliability in observational studies about markers of diagnosis, prognosis, and response to therapy? (ii) How can those design features be cultivated in existing observational cohorts, for example, within randomized controlled clinical trial (RCT), other existing observational research studies, or practice settings like health maintenance organization (HMOs)? Examples include a study of RNA expression profiles of tumor tissue to predict prognosis of breast cancer, a study of serum proteomics profiles to diagnose ovarian cancer, and a study of stool-based DNA assays to screen for colon cancer. Strengths and weaknesses of observational study design features are discussed, along with lessons about how features that help assure strength might be "cultivated" in the future. By considering these examples and others, it may be possible to develop a process of "cultivating cohorts" in ongoing RCTs, observational cohort studies, and practice settings like HMOs that have strong features of study design. Such an effort could produce sources of data and specimens to reliably answer questions about the use of molecular markers in diagnosis, prognosis, and response to therapy.

User Experience of Cognitive Behavioral Therapy Apps for Depression: An Analysis of App Functionality and User Reviews.

PubMed

Stawarz, Katarzyna; Preist, Chris; Tallon, Debbie; Wiles, Nicola; Coyle, David

2018-06-06

Hundreds of mental health apps are available to the general public. With increasing pressures on health care systems, they offer a potential way for people to support their mental health and well-being. However, although many are highly rated by users, few are evidence-based. Equally, our understanding of what makes apps engaging and valuable to users is limited. The aim of this paper was to analyze functionality and user opinions of mobile apps purporting to support cognitive behavioral therapy for depression and to explore key factors that have an impact on user experience and support engagement. We systematically identified apps described as being based on cognitive behavioral therapy for depression. We then conducted 2 studies. In the first, we analyzed the therapeutic functionality of apps. This corroborated existing work on apps' fidelity to cognitive behavioral therapy theory, but we also extended prior work by examining features designed to support user engagement. Engagement features found in cognitive behavioral therapy apps for depression were compared with those found in a larger group of apps that support mental well-being in a more general sense. Our second study involved a more detailed examination of user experience, through a thematic analysis of publicly available user reviews of cognitive behavioral therapy apps for depression. We identified 31 apps that purport to be based on cognitive behavioral therapy for depression. Functionality analysis (study 1) showed that they offered an eclectic mix of features, including many not based on cognitive behavioral therapy practice. Cognitive behavioral therapy apps used less varied engagement features compared with 253 other mental well-being apps. The analysis of 1287 user reviews of cognitive behavioral therapy apps for depression (study 2) showed that apps are used in a wide range of contexts, both replacing and augmenting therapy, and allowing users to play an active role in supporting their mental health and well-being. Users, including health professionals, valued and used apps that incorporated both core cognitive behavioral therapy and non-cognitive behavioral therapy elements, but concerns were also expressed regarding the unsupervised use of apps. Positivity was seen as important to engagement, for example, in the context of automatic thoughts, users expressed a preference to capture not just negative but also positive ones. Privacy, security, and trust were crucial to the user experience. Cognitive behavioral therapy apps for depression need to improve with respect to incorporating evidence-based cognitive behavioral therapy elements. Equally, a positive user experience is dependent on other design factors, including consideration of varying contexts of use. App designers should be able to clearly identify the therapeutic basis of their apps, but they should also draw on evidence-based strategies to support a positive and engaging user experience. The most effective apps are likely to strike a balance between evidence-based cognitive behavioral therapy strategies and evidence-based design strategies, including the possibility of eclectic therapeutic techniques. ©Katarzyna Stawarz, Chris Preist, Debbie Tallon, Nicola Wiles, David Coyle. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.06.2018.

Perceptions among Occupational and Physical Therapy Students of a Nontraditional Methodology for Teaching Laboratory Gross Anatomy

ERIC Educational Resources Information Center

Thomas, K. Jackson; Denham, Bryan E.; Dinolfo, John D.

2011-01-01

This pilot study was designed to assess the perceptions of physical therapy (PT) and occupational therapy (OT) students regarding the use of computer-assisted pedagogy and prosection-oriented communications in the laboratory component of a human anatomy course at a comprehensive health sciences university in the southeastern United States. The…

Modeling Signaling Networks to Advance New Cancer Therapies.

PubMed

Saez-Rodriguez, Julio; MacNamara, Aidan; Cook, Simon

2015-01-01

Cell signaling pathways control cells' responses to their environment through an intricate network of proteins and small molecules partitioned by intracellular structures, such as the cytoskeleton and nucleus. Our understanding of these pathways has been revised recently with the advent of more advanced experimental techniques; no longer are signaling pathways viewed as linear cascades of information flowing from membrane-bound receptors to the nucleus. Instead, such pathways must be understood in the context of networks, and studying such networks requires an integration of computational and experimental approaches. This understanding is becoming more important in designing novel therapies for diseases such as cancer. Using the MAPK (mitogen-activated protein kinase) and PI3K (class I phosphoinositide-3' kinase) pathways as case studies of cellular signaling, we give an overview of these pathways and their functions. We then describe, using a number of case studies, how computational modeling has aided in understanding these pathways' deregulation in cancer, and how such understanding can be used to optimally tailor current therapies or help design new therapies against cancer.

Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis.

PubMed

Gauthier, Lynne V; Kane, Chelsea; Borstad, Alexandra; Strahl, Nancy; Uswatte, Gitendra; Taub, Edward; Morris, David; Hall, Alli; Arakelian, Melissa; Mark, Victor

2017-06-08

Constraint-Induced Movement therapy (CI therapy) is shown to reduce disability, increase use of the more affected arm/hand, and promote brain plasticity for individuals with upper extremity hemiparesis post-stroke. Randomized controlled trials consistently demonstrate that CI therapy is superior to other rehabilitation paradigms, yet it is available to only a small minority of the estimated 1.2 million chronic stroke survivors with upper extremity disability. The current study aims to establish the comparative effectiveness of a novel, patient-centered approach to rehabilitation utilizing newly developed, inexpensive, and commercially available gaming technology to disseminate CI therapy to underserved individuals. Video game delivery of CI therapy will be compared against traditional clinic-based CI therapy and standard upper extremity rehabilitation. Additionally, individual factors that differentially influence response to one treatment versus another will be examined. This protocol outlines a multi-site, randomized controlled trial with parallel group design. Two hundred twenty four adults with chronic hemiparesis post-stroke will be recruited at four sites. Participants are randomized to one of four study groups: (1) traditional clinic-based CI therapy, (2) therapist-as-consultant video game CI therapy, (3) therapist-as-consultant video game CI therapy with additional therapist contact via telerehabilitation/video consultation, and (4) standard upper extremity rehabilitation. After 6-month follow-up, individuals assigned to the standard upper extremity rehabilitation condition crossover to stand-alone video game CI therapy preceded by a therapist consultation. All interventions are delivered over a period of three weeks. Primary outcome measures include motor improvement as measured by the Wolf Motor Function Test (WMFT), quality of arm use for daily activities as measured by Motor Activity Log (MAL), and quality of life as measured by the Quality of Life in Neurological Disorders (NeuroQOL). This multi-site RCT is designed to determine comparative effectiveness of in-home technology-based delivery of CI therapy versus standard upper extremity rehabilitation and in-clinic CI therapy. The study design also enables evaluation of the effect of therapist contact time on treatment outcomes within a therapist-as-consultant model of gaming and technology-based rehabilitation. Clinicaltrials.gov, NCT02631850 .

‘Dignity therapy’, a promising intervention in palliative care: A comprehensive systematic literature review

PubMed Central

Martínez, Marina; Arantzamendi, María; Belar, Alazne; Carrasco, José Miguel; Carvajal, Ana; Rullán, María; Centeno, Carlos

2016-01-01

Background: Dignity therapy is psychotherapy to relieve psychological and existential distress in patients at the end of life. Little is known about its effect. Aim: To analyse the outcomes of dignity therapy in patients with advanced life-threatening diseases. Design: Systematic review was conducted. Three authors extracted data of the articles and evaluated quality using Critical Appraisal Skills Programme. Data were synthesized, considering study objectives. Data sources: PubMed, CINAHL, Cochrane Library and PsycINFO. The years searched were 2002 (year of dignity therapy development) to January 2016. ‘Dignity therapy’ was used as search term. Studies with patients with advanced life-threatening diseases were included. Results: Of 121 studies, 28 were included. Quality of studies is high. Results were grouped into effectiveness, satisfaction, suitability and feasibility, and adaptability to different diseases and cultures. Two of five randomized control trials applied dignity therapy to patients with high levels of baseline psychological distress. One showed statistically significant decrease on patients’ anxiety and depression scores over time. The other showed statistical decrease on anxiety scores pre–post dignity therapy, not on depression. Nonrandomized studies suggested statistically significant improvements in existential and psychosocial measurements. Patients, relatives and professionals perceived it improved end-of-life experience. Conclusion: Evidence suggests that dignity therapy is beneficial. One randomized controlled trial with patients with high levels of psychological distress shows DT efficacy in anxiety and depression scores. Other design studies report beneficial outcomes in terms of end-of-life experience. Further research should understand how dignity therapy functions to establish a means for measuring its impact and assessing whether high level of distress patients can benefit most from this therapy. PMID:27566756

Design and Implementation of an Interactive Website for Pediatric Voice Therapy-The Concept of In-Between Care: A Telehealth Model.

PubMed

Doarn, Charles R; Zacharias, Stephanie; Keck, Casey Stewart; Tabangin, Meredith; DeAlarcon, Alessandro; Kelchner, Lisa

2018-06-05

This article describes the design and implementation of a web-based portal developed to provide supported home practice between weekly voice therapy sessions delivered through telehealth to children with voice disorders. This in-between care consisted of supported home practice that was remotely monitored by speech-language pathologists (SLPs). A web-based voice therapy portal (VTP) was developed as a platform so participants could complete voice therapy home practice by an interdisciplinary team of SLPs (specialized in pediatric voice therapy), telehealth specialists, biomedical informaticians, and interface designers. The VTP was subsequently field tested in a group of children with voice disorders, participating in a larger telehealth study. Building the VTP for supported home practice for pediatric voice therapy was challenging, but successful. Key interactive features of the final site included 11 vocal hygiene questions, traditional voice therapy exercises grouped into levels, audio/visual voice therapy demonstrations, a store-and-retrieval system for voice samples, message/chat function, written guidelines for weekly therapy exercises, and questionnaires for parents to complete after each therapy session. Ten participants (9-14 years of age) diagnosed with a voice disorder were enrolled for eight weekly telehealth voice therapy sessions with follow-up in-between care provided using the VTP. The development and implementation of the VTP as a novel platform for the delivery of voice therapy home practice sessions were effective. We found that a versatile individual, who can work with all project staff (speak the language of both SLPs and information technologists), is essential to the development process. Once the website was established, participants and SLPs effectively utilized the web-based VTP. They found it feasible and useful for needed in-between care and reinforcement of therapeutic exercises.

Striving for Effectiveness in the Treatment of Adolescent Depression: Cognitive Behavior Therapy for Multisite Community Intervention

ERIC Educational Resources Information Center

Curry, John F.; Wells, Karen C.

2005-01-01

The Treatment for Adolescents With Depression Study (TADS) was designed to compare the relative and combined effectiveness of cognitive behavior therapy (CBT) and fluoxetine, each of which had demonstrated efficacy in carefully controlled single-site studies. Models of CBT from these efficacy studies served as the foundation for the TADS…

Music therapy and musical stimulation in the context of prematurity: A narrative literature review from 2010-2015.

PubMed

Palazzi, Ambra; Nunes, Camila Canani; Piccinini, Cesar Augusto

2018-01-01

To examine empirical studies of musical stimulation and music therapy carried out with preterm infants and their parents published from 2010-2015. Prematurity constitutes a global health problem that can impact the development of the preterm infant and the well-being of the parents. Music-based interventions may benefit the infant, parents and their relationship. In our review, we distinguished between musical stimulation and music therapy, as we found no previous studies that had made this distinction. This is a narrative literature review. A search was undertaken in PubMed, PsycINFO and LILACS using the terms "music," "music therapy," "singing," "prematurity" and "preterm." Thirty studies were included and analysed according to the following categories: (i) aims of the study, (ii) participants, (iii) design, (iv) type of intervention, (v) assessment and measures and (vi) main results. The vast majority of the studies focused on the preterm infants and used an experimental design. Few studies carried out family-centred interventions, despite this having been noted as an important factor in effective interventions. Musical stimulation studies used more recorded music, whereas music therapy studies used more individualised interventions with live music. Both musical stimulation and music therapy demonstrated significant effects on preterm infants and their parents. However, compared to musical stimulation studies, interventions performed by music therapists provided more individualised care and tended to show greater effects on infants' physiological and behavioural responses. Our review showed that music therapy interventions may provide individualised, effective and family-centred care. There is a significant need for these types of interventions in the neonatal intensive care unit (NICU). © 2017 John Wiley & Sons Ltd.

Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.

PubMed

Bradt, Joke

2012-01-01

Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.

Editorial--Avoiding Unethical Helicobacter pylori Clinical Trials: Susceptibility-Based Studies and Probiotics as Adjuvants.

PubMed

Graham, David Y

2015-10-01

As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g., in a population with known clarithromycin resistance) is unethical. As susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance >0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies, and studies of adjuvants and probiotics. However, the journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors, we provide examples and suggestions regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. © 2015 John Wiley & Sons Ltd.

BEAM DYNAMICS STUDIES FOR A COMPACT CARBON ION LINAC FOR THERAPY

DOE Office of Scientific and Technical Information (OSTI.GOV)

Plastun, A.; Mustapha, B.; Nassiri, A.

2016-05-01

Feasibility of an Advanced Compact Carbon Ion Linac (ACCIL) for hadron therapy is being studied at Argonne National Laboratory in collaboration with RadiaBeam Technologies. The 45-meter long linac is designed to deliver 109 carbon ions per second with variable energy from 45 MeV/u to 450 MeV/u. S-band structure provides the acceleration in this range. The carbon beam energy can be adjusted from pulse to pulse, making 3D tumor scanning straightforward and fast. Front end accelerating structures such as RFQ, DTL and coupled DTL are designed to operate at lower frequencies. The design of the linac was accompanied with extensive end-to-endmore » beam dynamics studies which are presented in this paper.« less

Ethical considerations of neuro-oncology trial design in the era of precision medicine.

PubMed

Gupta, Saksham; Smith, Timothy R; Broekman, Marike L

2017-08-01

The field of oncology is currently undergoing a paradigm shift. Advances in the understanding of tumor biology and in tumor sequencing technology have contributed to the shift towards precision medicine, the therapeutic framework of targeting the individual oncogenic changes each tumor harbors. The success of precision medicine therapies, such as targeted kinase inhibitors and immunotherapies, in other cancers have motivated studies in brain cancers. The high specificity and cost of these therapies also encourage a shift in clinical trial design away from randomized control trials towards smaller, more exclusive early phase clinical trials. While these new trials advance the clinical application of increasingly precise and individualized therapies, their design brings ethical challenges . We review the pertinent ethical considerations for clinical trials of precision medicine in neuro-oncology and discuss methods to protect patients in this new era of trial design.

Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder.

PubMed

Geretsegger, Monika; Holck, Ulla; Bieleninik, Łucja; Gold, Christian

2016-01-01

To conduct generalizable, rigorously designed, adequately powered trials investigating music therapy and other complex interventions, it is essential that study procedures are feasible and acceptable for participants. To date, only limited evidence on feasibility of trial designs and strategies to facilitate study implementation is available in the music therapy literature. Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety, document concomitant treatment, and report consistency of individuals' trends over time in chosen outcome measures. Children with ASD aged between 4 years, 0 months, and 6 years, 11 months, were randomly assigned to one of three conditions: one (low intensity) vs. three weekly IMT sessions (high intensity) for five months vs. standard care. Feasibility was evaluated by examining recruitment, implementation of study conditions, assessment procedures, blinding, and retention; we also evaluated safety, concomitant treatment, and consistency of changes in standardized scales completed by blinded assessors and parents before and 5 months after randomization. Within this subsample (n = 15), recruitment rates, session attendance in the high-intensity condition, and consistency between outcome measures were lower than expected. Session attendance in the low-intensity and control conditions, treatment fidelity, measurement completion, blinding, retention, and safety met a priori thresholds for feasibility. By discussing strategies to improve recruitment and to minimize potential burden on study participants, referrers, and researchers, this study helps build knowledge about designing and implementing trials successfully. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Editorial - Avoiding unethical Helicobacter pylori clinical trials: Susceptibility-based studies and probiotics as adjuvants

PubMed Central

Graham, David Y.

2016-01-01

As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g. in a population with known clarithromycin resistance) is unethical. Since susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance greater than 0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies and of adjuvants and probiotics. However, the Journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors we provide examples and suggestion regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. PMID:26123529

Musical stairs: the impact of audio feedback during stair-climbing physical therapies for children.

PubMed

Khan, Ajmal; Biddiss, Elaine

2015-05-01

Enhanced biofeedback during rehabilitation therapies has the potential to provide a therapeutic environment optimally designed for neuroplasticity. This study investigates the impact of audio feedback on the achievement of a targeted therapeutic goal, namely, use of reciprocal steps. Stair-climbing therapy sessions conducted with and without audio feedback were compared in a randomized AB/BA cross-over study design. Seventeen children, aged 4-7 years, with various diagnoses participated. Reports from the participants, therapists, and a blinded observer were collected to evaluate achievement of the therapeutic goal, motivation and enjoyment during the therapy sessions. Audio feedback resulted in a 5.7% increase (p = 0.007) in reciprocal steps. Levels of participant enjoyment increased significantly (p = 0.031) and motivation was reported by child participants and therapists to be greater when audio feedback was provided. These positive results indicate that audio feedback may influence the achievement of therapeutic goals and promote enjoyment and motivation in young patients engaged in rehabilitation therapies. This study lays the groundwork for future research to determine the long term effects of audio feedback on functional outcomes of therapy. Stair-climbing is an important mobility skill for promoting independence and activities of daily life and is a key component of rehabilitation therapies for physically disabled children. Provision of audio feedback during stair-climbing therapies for young children may increase their achievement of a targeted therapeutic goal (i.e., use of reciprocal steps). Children's motivation and enjoyment of the stair-climbing therapy was enhanced when audio feedback was provided.

Reduced stress and improved physical functional ability in elderly with mental health problems following a horticultural therapy program.

PubMed

Han, Ah-Reum; Park, Sin-Ae; Ahn, Byung-Eun

2018-06-01

This study aimed to determine the effects of a plant cultivation-based horticultural therapy program for elderly people with mental health problems. Pre- and post-test design with experimental and control groups. Twenty-eight elderly Korean people with mental health problems participated from April to June 2017 at a farm located in Suwon, South Korea. The participants were randomly assigned to either the control (n = 14) or horticultural therapy group (n = 14); the latter participated in once-weekly sessions of a previously designed 10-session horticultural therapy program. The pre-test occurred 1 week before starting the horticultural therapy program. The post-test was completed within 1 week after finishing the final program session. Cortisol levels were measured in saliva samples collected from both groups. The Senior Fitness Test was used to assess physical functional ability in both groups. In the horticultural therapy group, the cortisol levels decreased significantly from before to after the horticultural therapy program, and the post-test scores for six subtests of the Senior Fitness Test improved significantly. No significant improvements were seen in either measure in the control group. This study demonstrates the potential ability of horticultural therapy to improve the stress levels and physical functional abilities of elderly people with mental health problems. In future studies, it would be interesting to verify the long-term effects of this horticultural therapy program and to compare its effects with regard to sex, age, and various mental symptoms. Copyright © 2018 Elsevier Ltd. All rights reserved.

Music therapy as a non-pharmacological treatment for epilepsy.

PubMed

Liao, Huan; Jiang, Guohui; Wang, Xuefeng

2015-01-01

Epilepsy is one of the most common neurological diseases. Currently, the primary methods of treatment include pharmacological and surgical treatment. However, approximately one-third of patients exhibit refractory epilepsy. Therefore, a novel approach to epilepsy treatment is necessary. Several studies have confirmed that music therapy can be effective at reducing seizures and epileptiform discharges, thus providing a new option for clinicians in the treatment of epilepsy. Although the underlying mechanism of music therapy is unknown, it may be related to resonance, mirror neurons, dopamine pathways and parasympathetic activation. Large sample, multicenter, randomized double-blind and more effectively designed studies are needed for future music therapy studies.

Osteoporosis therapies: evidence from health-care databases and observational population studies.

PubMed

Silverman, Stuart L

2010-11-01

Osteoporosis is a well-recognized disease with severe consequences if left untreated. Randomized controlled trials are the most rigorous method for determining the efficacy and safety of therapies. Nevertheless, randomized controlled trials underrepresent the real-world patient population and are costly in both time and money. Modern technology has enabled researchers to use information gathered from large health-care or medical-claims databases to assess the practical utilization of available therapies in appropriate patients. Observational database studies lack randomization but, if carefully designed and successfully completed, can provide valuable information that complements results obtained from randomized controlled trials and extends our knowledge to real-world clinical patients. Randomized controlled trials comparing fracture outcomes among osteoporosis therapies are difficult to perform. In this regard, large observational database studies could be useful in identifying clinically important differences among therapeutic options. Database studies can also provide important information with regard to osteoporosis prevalence, health economics, and compliance and persistence with treatment. This article describes the strengths and limitations of both randomized controlled trials and observational database studies, discusses considerations for observational study design, and reviews a wealth of information generated by database studies in the field of osteoporosis.

Group Therapy for Improving Self-Esteem and Social Functioning of College Students with ADHD

ERIC Educational Resources Information Center

Shaikh, Ayesha

2018-01-01

The present study examined the effectiveness of interpersonal group therapy designed to improve self-esteem and social functioning in college students with Attention-Deficit/Hyperactivity Disorder (ADHD). Participants with documented ADHD diagnoses completed self-report measures of self-esteem and social functioning at the initiation of the study,…

Efficacy of Parent-Child Interaction Therapy with Chinese ADHD Children: Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.

2017-01-01

Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…

What Cognitive Behavioral Techniques Do Therapists Report Using when Delivering Cognitive Behavioral Therapy for the Eating Disorders?

ERIC Educational Resources Information Center

Waller, Glenn; Stringer, Hannah; Meyer, Caroline

2012-01-01

Objective: Clinicians commonly "drift" away from using proven therapeutic techniques. This study examined the degree to which such drift occurs among cognitive behavioral therapy (CBT) clinicians working with a specific clinical population--adults with eating disorders. Method: The study used a correlational design. The participants were…

Group Therapy Goals: A Comparison of Group Therapy Providers and Male Inmates

ERIC Educational Resources Information Center

Morgan, Robert D.; Garland, J. Travis; Rozycki, Alicia T.; Reich, Darcy A.; Wilson, Scott

2005-01-01

This study was designed to identify important process and content goals from the perspective of inmates and compare these goals to the goals identified by group therapists in a previous study conducted by Winterowd, Morgan, and Ferrell (2001). Utilizing survey data from 156 incarcerated adult males, an initial confirmatory factor analysis…

Self-Administered Cued Naming Therapy: A Single-Participant Investigation of a Computer-Based Therapy Program Replicated in Four Cases

ERIC Educational Resources Information Center

Ramsberger, Gail; Marie, Basem

2007-01-01

Purpose: This study examined the benefits of a self-administered, clinician-guided, computer-based, cued naming therapy. Results of intense and nonintense treatment schedules were compared. Method: A single-participant design with multiple baselines across behaviors and varied treatment intensity for 2 trained lists was replicated over 4…

Identification of potential neuromotor mechanisms of manual therapy in patients with musculoskeletal disablement: rationale and description of a clinical trial

PubMed Central

Fisher, Beth E; Davenport, Todd E; Kulig, Kornelia; Wu, Allan D

2009-01-01

Background Many health care practitioners use a variety of hands-on treatments to improve symptoms and disablement in patients with musculoskeletal pathology. Research to date indirectly suggests a potentially broad effect of manual therapy on the neuromotor processing of functional behavior within the supraspinal central nervous system (CNS) in a manner that may be independent of modification at the level of local spinal circuits. However, the effect of treatment speed, as well as the specific mechanism and locus of CNS changes, remain unclear. Methods/Design We developed a placebo-controlled, randomized study to test the hypothesis that manual therapy procedures directed to the talocrural joint in individuals with post-acute ankle sprain induce a change in corticospinal excitability that is relevant to improve the performance of lower extremity functional behavior. Discussion This study is designed to identify potential neuromotor changes associated with manual therapy procedures directed to the appendicular skeleton, compare the relative effect of treatment speed on potential neuromotor effects of manual therapy procedures, and determine the behavioral relevance of potential neuromotor effects of manual therapy procedures. Trial Registration identifier NCT00847769. PMID:19460169

Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004).

PubMed

Morin, Charles M; Bootzin, Richard R; Buysse, Daniel J; Edinger, Jack D; Espie, Colin A; Lichstein, Kenneth L

2006-11-01

Recognition that psychological and behavioral factors play an important role in insomnia has led to increased interest in therapies targeting these factors. A review paper published in 1999 summarized the evidence regarding the efficacy of psychological and behavioral treatments for persistent insomnia. The present review provides an update of the evidence published since the original paper. As with the original paper, this review was conducted by a task force commissioned by the American Academy of Sleep Medicine in order to update its practice parameters on psychological and behavioral therapies for insomnia. A systematic review was conducted on 37 treatment studies (N = 2246 subjects/patients) published between 1998 and 2004 inclusively and identified through Psyclnfo and Medline searches. Each study was systematically reviewed with a standard coding sheet and the following information was extracted: Study design, sample (number of participants, age, gender), diagnosis, type of treatments and controls, primary and secondary outcome measures, and main findings. Criteria for inclusion of a study were as follows: (a) the main sleep diagnosis was insomnia (primary or comorbid), (b) at least 1 treatment condition was psychological or behavioral in content, (c) the study design was a randomized controlled trial, a nonrandomized group design, a clinical case series or a single subject experimental design with a minimum of 10 subjects, and (d) the study included at least 1 of the following as dependent variables: sleep onset latency, number and/or duration of awakenings, total sleep time, sleep efficiency, or sleep quality. Psychological and behavioral therapies produced reliable changes in several sleep parameters of individuals with either primary insomnia or insomnia associated with medical and psychiatric disorders. Nine studies documented the benefits of insomnia treatment in older adults or for facilitating discontinuation of medication among chronic hypnotic users. Sleep improvements achieved with treatment were well sustained over time; however, with the exception of reduced psychological symptoms/ distress, there was limited evidence that improved sleep led to clinically meaningful changes in other indices of morbidity (e.g., daytime fatigue). Five treatments met criteria for empirically-supported psychological treatments for insomnia: Stimulus control therapy, relaxation, paradoxical intention, sleep restriction, and cognitive-behavior therapy. These updated findings provide additional evidence in support of the original review's conclusions as to the efficacy and generalizability of psychological and behavioral therapies for persistent insomnia. Nonetheless, further research is needed to develop therapies that would optimize outcomes and reduce morbidity, as would studies of treatment mechanisms, mediators, and moderators of outcomes. Effectiveness studies are also needed to validate those therapies when implemented in clinical settings (primary care), by non-sleep specialists. There is also a need to disseminate more effectively the available evidence in support of psychological and behavioral interventions to health-care practitioners working on the front line.

Impact of exchanges and client-therapist alliance in online-text psychotherapy.

PubMed

Reynolds, D'Arcy J; Stiles, William B; Bailer, A John; Hughes, Michael R

2013-05-01

The impact of exchanges and client-therapist alliance of online therapy text exchanges were compared to previously published results in face-to-face therapy, and the moderating effects of four participant factors found significant in previously published face-to-face studies were investigated using statistical mixed-effect modeling analytic techniques. Therapists (N=30) and clients (N=30) engaged in online therapy were recruited from private practitioner sites, e-clinics, online counseling centers, and mental-health-related discussion boards. In a naturalistic design, they each visited an online site weekly and completed the standard impact and alliance questionnaires for at least 6 weeks. Results indicated that the impact of exchanges and client-therapist alliance in text therapy was similar to, but in some respects more positive than, previous evaluations of face-to-face therapy. The significance of participant factors previously found to influence impact and alliance in face-to-face therapy (client symptom severity, social support, therapist theoretical orientation, and therapist experience) was not replicated, except that therapists with the more symptomatic clients rated their text exchanges as less smooth and comfortable. Although its small size and naturalistic design impose limitations on sensitivity and generalizability, this study provides some insights into treatment impact and the alliance in online therapy.

The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence

PubMed Central

Boyde, Constance; Linden, Ulrike; Boehm, Katja

2012-01-01

Background: Music therapy is one of the oldest forms of creative art therapy and has been shown to have effects in different clinical and therapeutic settings, such as schizophrenia, pain, cardiovascular parameters, and dementia. This article provides an overview of some of the recent findings in this field and also reports two single case vignettes that offer insight into day-to-day applications of clinical music therapy. Material and Methods: For the collection of clinical studies of music therapy in oncology, the databases AMED, CAIRSS, EMBASE, MEDLINE, PsychINFO, and PSYNDEX were searched with the terms “Study OR Trial” AND “Music Therapy” AND “Cancer OR Oncolog$.” Studies were analyzed with respect to their design, setting and interventions, indications, patients, and outcomes. In addition, two case vignettes present the application of music therapy for a child with leukemia and an adult patient with breast cancer. Results: We found a total of 12 clinical studies conducted between 2001 and 2011 comprised of a total of 922 patients. Eight studies had a randomized controlled design, and four studies were conducted in the field of pediatric oncology. Studies reported heterogeneous results on short-term improvements in patients' mood and relaxation and reduced exhaustion and anxiety as well as in coping with the disease and cancer-related pain. Case descriptions showed similar effects in expressing emotions, opening up new goals, and turning the mind toward a healthy process and away form a disease-centered focus. Conclusion: The use of music therapy in the integrative treatment of cancer patients is a therapeutic option whose salutogenetic potential is shown in many case studies such as those presented here. Study results, however, did not draw a conclusive picture of the overall effect of music therapy. In addition to further clinical trials, the evidence mosaic should be complemented with qualitative studies, single case descriptions, and basic research. PMID:27257528

Research lessons learned: occupational therapy with culturally diverse mothers of premature infants.

PubMed

Reid, Denise T; Chiu, Teresa M L

2011-06-01

Evaluation studies of the effectiveness of home-based occupational therapy are scarce but are needed to justify the impact of occupational therapy intervention. When the intervention is for persons from diverse cultural backgrounds, additional research challenges arise. To share lessons learned in conducting home-based occupational therapy research with Canadian, and immigrant South Asian and Chinese mothers of premature infants in a large Canadian city. Lessons learned were to implement a culturally sensitive recruitment process, change the research design to include more interviews and focus groups, and be aware of the need for culturally appropriate instruments. Researchers need to be sensitized to the Western cultural values upon which most research designs and instrumentation are constructed. Involvement of a culturally diverse research team, openness to feedback, adaptability, and critical reflection on what is important to the cultural groups are among the suggestions for researchers planning home-based occupational therapy research with culturally diverse populations.

Progresses towards safe and efficient gene therapy vectors.

PubMed

Chira, Sergiu; Jackson, Carlo S; Oprea, Iulian; Ozturk, Ferhat; Pepper, Michael S; Diaconu, Iulia; Braicu, Cornelia; Raduly, Lajos-Zsolt; Calin, George A; Berindan-Neagoe, Ioana

2015-10-13

The emergence of genetic engineering at the beginning of the 1970's opened the era of biomedical technologies, which aims to improve human health using genetic manipulation techniques in a clinical context. Gene therapy represents an innovating and appealing strategy for treatment of human diseases, which utilizes vehicles or vectors for delivering therapeutic genes into the patients' body. However, a few past unsuccessful events that negatively marked the beginning of gene therapy resulted in the need for further studies regarding the design and biology of gene therapy vectors, so that this innovating treatment approach can successfully move from bench to bedside. In this paper, we review the major gene delivery vectors and recent improvements made in their design meant to overcome the issues that commonly arise with the use of gene therapy vectors. At the end of the manuscript, we summarized the main advantages and disadvantages of common gene therapy vectors and we discuss possible future directions for potential therapeutic vectors.

Progresses towards safe and efficient gene therapy vectors

PubMed Central

Chira, Sergiu; Jackson, Carlo S.; Oprea, Iulian; Ozturk, Ferhat; Pepper, Michael S.; Diaconu, Iulia; Braicu, Cornelia; Raduly, Lajos-Zsolt; Calin, George A.; Berindan-Neagoe, Ioana

2015-01-01

The emergence of genetic engineering at the beginning of the 1970′s opened the era of biomedical technologies, which aims to improve human health using genetic manipulation techniques in a clinical context. Gene therapy represents an innovating and appealing strategy for treatment of human diseases, which utilizes vehicles or vectors for delivering therapeutic genes into the patients' body. However, a few past unsuccessful events that negatively marked the beginning of gene therapy resulted in the need for further studies regarding the design and biology of gene therapy vectors, so that this innovating treatment approach can successfully move from bench to bedside. In this paper, we review the major gene delivery vectors and recent improvements made in their design meant to overcome the issues that commonly arise with the use of gene therapy vectors. At the end of the manuscript, we summarized the main advantages and disadvantages of common gene therapy vectors and we discuss possible future directions for potential therapeutic vectors. PMID:26362400

Postoperative physical therapy program for latissimus dorsi and teres major tendons transfer to rotator cuff in children with obstetrical brachial plexus injury.

PubMed

Safoury, Yasser A; Eldesoky, Mohamed T; Abutaleb, Enas E; Atteya, Mohamed R; Gabr, Ahmed M

2017-04-01

The transfer of latissimus dorsi and teres major tendons to rotator cuff have been developed to rebalance the muscular dysfunction and improve shoulder range of motion in children with obstetrical brachial plexus palsy (OBPP). No previous study reported the ideal postoperative physical therapy program for these cases. The aim of the present study was to design appropriate postoperative physical therapy (PT) program after latissimus dorsi and teres major tendons transfer to rotator cuff in OBPP to improve upper limb function. Time series design. The patients were recruited from outpatient clinic of Kasr EL Aini Hospital, Cairo, Egypt. Forty seven OBPP infants (4.64±1.21 years with a range of 2.5 to 7 years, 21male and26 female) were allocated to one group. All patients had functional limitation in the involved arm due to muscle paralysis and contracture. Twenty-five patients had C5-C6 nerve root lesions while 22 had C5-C6-C7 nerve root lesions. The children underwent the surgical procedures of the transfer of latissimus dorsi and teres major tendons to rotator cuff. After the surgery the children participated in a designed physical therapy program for 6 months. Active shoulder abduction, flexion and external rotation range of motion (ROM) were assessed by electrogoniometer, and functional assessments were measured using the modified Mallet scale. All measurements were taken preoperative, 6 weeks, 3 months, and 6 months postoperatively after the application of the designed PT program. Repeated measure analysis of variance (ANOVA) followed by Bonferroni post-hoc test were used to show the improvement in all measured variables. Analysis revealed that shoulder abduction, flexion and external rotation ROM and shoulder function measured by modified Mallet scale were significantly improved (P<0.0001) after the designed postoperative PT program. It can be concluded that the combination treatment of surgical procedure and the postoperative physical therapy program seem to be effective in improving shoulder and arm functions in children with OBPP. This study describes a detailed physical therapy program after latissimus dorsi and teres major tendons transfer to rotator cuff in OBPP.

Petting away pre-exam stress: The effect of therapy dog sessions on student well-being.

PubMed

Ward-Griffin, Emma; Klaiber, Patrick; Collins, Hanne K; Owens, Rhea L; Coren, Stanley; Chen, Frances S

2018-03-12

Recently, many universities have implemented programmes in which therapy dogs and their handlers visit college campuses. Despite the immense popularity of therapy dog sessions, few randomized studies have empirically tested the efficacy of such programmes. The present study evaluates the efficacy of such a therapy dog programme in improving the well-being of university students. This research incorporates two components: (a) a pre/post within-subjects design, in which 246 participants completed a brief questionnaire immediately before and after a therapy dog session and (b) an experimental design with a delayed-treatment control group, in which all participants completed baseline measures and follow-up measures approximately 10 hr later. Only participants in the experimental condition experienced the therapy dog session in between the baseline and follow-up measures. Analyses of pre/post data revealed that the therapy dog sessions had strong immediate benefits, significantly reducing stress and increasing happiness and energy levels. In addition, participants in the experimental group reported a greater improvement in negative affect, perceived social support, and perceived stress compared with those in the delayed-treatment control group. Our results suggest that single, drop-in, therapy dog sessions have large and immediate effects on students' well-being, but also that the effects after several hours are small. Copyright © 2018 John Wiley & Sons, Ltd.

Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design

PubMed Central

2013-01-01

Background Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting. Methods Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0–1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m2 every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients’ quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011. Discussion This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home-based chemotherapy. The study design requires unusual methodology and specific logistics to address outcomes relevant to the home-delivery approach. This article presents a study design that offers a novel and reproducible model for home-based chemotherapy, and provides an up-to-date overview of the literature regarding this type of treatment. Trial registration ClinicalTrials.gov: NCT01473563 PMID:24090033

Perioperative and maintenance therapy following first-line therapy as paradigms for drug discovery in urothelial carcinoma

PubMed Central

Hoffman-Censits, Jean; Wong, Yu-Ning

2015-01-01

Perioperative chemotherapy given to increase the chance of cure for localized disease, and maintenance therapy for metastatic disease, represent distinct aspects of the urothelial cancer disease treatment spectrum. The ability to access both pre and post chemotherapy tissue in the neoadjuvant setting provides important opportunities for translational research to test novel therapies and identify predictors of response to therapy. The maintenance setting may be more complex and study design and endpoints need to be determined based on the candidate drugs mechanism of action and toxicity. PMID:25987535

An evaluation of NCRP report 151--radiation shielding design for radiotherapy facilities, and a feasibility study for 6 MV open-door treatments in an existing high-energy radiation therapy bunker

NASA Astrophysics Data System (ADS)

Kildea, John

This thesis describes a study of shielding design techniques used for radiation therapy facilities that employ megavoltage linear accelerators. Specifically, an evaluation of the shielding design formalism described in NCRP report 151 was undertaken and a feasibility study for open-door 6 MV radiation therapy treatments in existing 6 MV, 18 MV treatment rooms at the Montreal General Hospital (MGH) was conducted. To evaluate the shielding design formalism of NCRP 151, barrier-attenuated equivalent doses were measured for several of the treatment rooms at the MGH and compared with expectations from NCRP 151 calculations. It was found that, while the insight and recommendations of NCRP 151 are very valuable, its dose predictions are not always correct. As such, the NCRP 151 methodology is best used in conjunction with physical measurements. The feasibility study for 6 MV open-door treatments made use of the NCRP 151 formalism, together with physical measurements for realistic 6 MV workloads. The results suggest that, dosimetrically, 6 MV open door treatments are feasible. A conservative estimate for the increased dose at the door arising from such treatments is 0.1 mSv, with a 1/8 occupancy factor, as recommended in NCRP 151, included.

Grounded theory in music therapy research.

PubMed

O'Callaghan, Clare

2012-01-01

Grounded theory is one of the most common methodologies used in constructivist (qualitative) music therapy research. Researchers use the term "grounded theory" when denoting varying research designs and theoretical outcomes. This may be challenging for novice researchers when considering whether grounded theory is appropriate for their research phenomena. This paper examines grounded theory within music therapy research. Grounded theory is briefly described, including some of its "contested" ideas. A literature search was conducted using the descriptor "music therapy and grounded theory" in Pubmed, CINAHL PsychlNFO, SCOPUS, ERIC (CSA), Web of Science databases, and a music therapy monograph series. A descriptive analysis was performed on the uncovered studies to examine researched phenomena, grounded theory methods used, and how findings were presented, Thirty music therapy research projects were found in refereed journals and monographs from 1993 to "in press." The Strauss and Corbin approach to grounded theory dominates the field. Descriptors to signify grounded theory components in the studies greatly varied. Researchers have used partial or complete grounded theory methods to examine clients', family members', staff, music therapy "overhearers," music therapists', and students' experiences, as well as music therapy creative products and professional views, issues, and literature. Seven grounded theories were offered. It is suggested that grounded theory researchers clarify what and who inspired their design, why partial grounded theory methods were used (when relevant), and their ontology. By elucidating assumptions underpinning the data collection, analysis, and findings' contribution, researchers will continue to improve music therapy research using grounded theory methods.

Enhanced Exercise Therapy in Parkinson’s disease: A comparative effectiveness trial

PubMed Central

Ridgel, Angela L.; Walter, Benjamin L.; Tatsuoka, Curtis; Walter, Ellen M.; Colón-Zimmermann, Kari; Welter, Elisabeth; Sajatovic, Martha

2015-01-01

Objectives Exercise can improve motor function in people with Parkinson’s disease but depression reduces the motivation to participate in regular exercise. The aim of this study was to develop a novel Enhanced Exercise Therapy program that uses manual-driven guided exercise and peer-facilitated psychoeducation for individuals with Parkinson’s disease and depression. Design 24 week randomized controlled design. Methods Thirty individuals were randomized to Enhanced Exercise Therapy or self-guided therapy, and evaluated at baseline, 12-weeks and at 24-weeks. Enhanced Exercise Therapy included group exercise and group psychoeducation for 12 weeks. Between 13–24 weeks, individuals had access to the fitness facility but group sessions were not held. Self-guided therapy included written guidelines for a self-paced exercise program and psychoeducation. Primary outcome measures included the number of exercise sessions and International Physical Activity Questionnaire score. Secondary measures included resting heart rate, supine blood pressure, estimated VO2max and incidence of orthostatic hypotension. Results Twenty four individuals completed the study (80% retention) and both groups attended similar number of exercise sessions. There were no significant changes in cardiovascular fitness measures but there was a significant increase in the amount of physical activity in the Enhanced Exercise Therapy group and a decrease in the self-guided therapy group during the post-intervention period. Conclusions Enhanced exercise therapy appears to promote engagement in an exercise program and more physical activity, even after group sessions were concluded in individuals with Parkinson’s disease and depression. PMID:25709055

WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

PubMed Central

Voigt-Radloff, Sebastian; Graff, Maud; Leonhart, Rainer; Schornstein, Katrin; Vernooij-Dassen, Myrra; Olde-Rikkert, Marcel; Huell, Michael

2009-01-01

Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. Methods/Design A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion. Discussion The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment. The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform. PMID:19799779

Intensive behavioral therapy for agoraphobia.

PubMed

Knuts, Inge J E; Esquivel, Gabriel; Overbeek, Thea; Schruers, Koen R J

2015-03-15

We investigated the efficacy of an intensive 1-week behavioral therapy program focusing on agoraphobia for panic disorder patients with agoraphobia (PDA). The study design was a case-control study. Main outcome measure was the agoraphobia score of the Fear Questionnaire (FQ-AGO). The outcomes on the FQ-AGO of a 1-week intensive therapy (96 patients) and a twice-weekly therapy (98 patients) were compared. Agoraphobia improved significantly in both groups, 1 week and 3 months after therapy. Effect size for changes in the 1-week intensive therapy on the FQ-AGO was 0.75. Limitations are use of antidepressants, no placebo group, and no long term follow-up. Behavioral therapy for agoraphobia can be shortened significantly if intensified without affecting therapy outcome, thus allowing patients a more rapid return to work and resumption of daily activities. Copyright © 2014 Elsevier B.V. All rights reserved.

Design of clinical trials of gene therapy in Parkinson disease.

PubMed

Lewis, Travis B; Standaert, David G

2008-01-01

No current therapy for Parkinson disease has been shown to slow or reverse the progressive course of the disease. As a departure from traditional treatments, gene therapy approaches provide a new hope for realizing this long-sought goal; but before they can be widely employed for use in patients, they must first be submitted to the rigorous safety and efficacy standards of the clinical trial. Some of the challenges of gene therapy clinical trial design are similar to those in studies of conventional pharmacological agents and include addressing the heterogeneity of the disease, the need for clinical and surrogate endpoints, and the issue of distinguishing "symptomatic" from "neuroprotective" effects. Gene therapy trials also raise the issues of the risks of viral therapy, issues of dose-response, the need for sham surgery, and the long duration of risks and benefits. We conclude that the most feasible designs are for those treatments that are expected to produce a rapid improvement in directly observable symptoms. Trials of agents which are expected to produce only a slowing of progression and not a reversal of the disease course are likely to take much longer and will require the development of methods to assess quality of life and other non-motor aspects of the disease.

Therapy of the burnout syndrome.

PubMed

Korczak, Dieter; Wastian, Monika; Schneider, Michael

2012-01-01

The prevalence, diagnostics and therapy of the burnout syndrome are increasingly discussed in the public. The unclear definition and diagnostics of the burnout syndrome are scientifically criticized. There are several therapies with unclear evidence for the treatment of burnout in existence. The health technology assessment (HTA) report deals with the question of usage and efficacy of different burnout therapies. For the years 2006 to 2011, a systematic literature research was done in 31 electronic databases (e.g. EMBASE, MEDLINE, PsycINFO). Important inclusion criteria are burnout, therapeutic intervention and treatment outcome. 17 studies meet the inclusion criteria and are regarded for the HTA report. The studies are very heterogeneous (sample size, type of intervention, measuring method, level of evidence). Due to their study design (e.g. four reviews, eight randomized controlled trials) the studies have a comparable high evidence: three times 1A, five times 1B, one time 2A, two times 2B and six times 4. 13 of the 17 studies are dealing with the efficacy of psychotherapy and psychosocial interventions for the reduction of burnout (partly in combination with other techniques). Cognitive behaviour therapy leads to the improvement of emotional exhaustion in the majority of the studies. The evidence is inconsistent for the efficacy of stress management and music therapy. Two studies regarding the efficacy of Qigong therapy do not deliver a distinct result. One study proves the efficacy of roots of Rhodiola rosea (evidence level 1B). Physical therapy is only in one study separately examined and does not show a better result than standard therapy. Despite the number of studies with high evidence the results for the efficacy of burnout therapies are preliminary and do have only limited reach. The authors of the studies complain about the low number of skilled studies for the therapy of burnout. Furthermore, they point to the insufficient evaluation of the therapy studies and the need for further research. Some authors report the effects of considerable natural recovering. Numerous limitations affect the quality of the results. Intervention contents and duration, study design and study size are very diverse and do not permit direct comparison. Most of the samples are small by size with low statistical power, long-term follow-ups are missing. Comorbidities and parallel utilized therapies are insufficient documented or controlled. Most of the studies use the Maslach Burnout Inventory (MBI) as diagnostic or outcome-tool, but with different cut-off-points. It should be noticed that the validity of the MBI as diagnostic tool is not proved. Ethical, juridical and social determining factors are not covered or discussed in the studies. The efficacy of therapies for the treatment of the burnout syndrome is insufficient investigated. Only for cognitive behavioural therapy (CBT) exists an adequate number of studies which prove its efficacy. Big long-term experimental studies are missing which compare the efficacy of the single therapies and evaluate their evidence. The natural recovering without any therapy needs further research. Additionally, it has to be examined to what extent therapies and their possible effects are thwarted by the conditions of the working place and the working conditions.

The Role of Occupational Therapy in Promoting Playfulness, Parent Competence, and Social Participation in Early Childhood Playgroups: A Pretest Posttest Design

ERIC Educational Resources Information Center

Fabrizi, Sarah; Hubbell, Kristin

2017-01-01

This study examined the effects of an inclusive, community-based playgroup intervention on parent and child outcomes. The role of occupational therapy as part of a team of providers in early childhood was also explored. Caregiver-child dyads (n = 36) were enrolled in one of three playgroup conditions (control, occupational therapy support, and…

An optimal stratified Simon two-stage design.

PubMed

Parashar, Deepak; Bowden, Jack; Starr, Colin; Wernisch, Lorenz; Mander, Adrian

2016-07-01

In Phase II oncology trials, therapies are increasingly being evaluated for their effectiveness in specific populations of interest. Such targeted trials require designs that allow for stratification based on the participants' molecular characterisation. A targeted design proposed by Jones and Holmgren (JH) Jones CL, Holmgren E: 'An adaptive Simon two-stage design for phase 2 studies of targeted therapies', Contemporary Clinical Trials 28 (2007) 654-661.determines whether a drug only has activity in a disease sub-population or in the wider disease population. Their adaptive design uses results from a single interim analysis to decide whether to enrich the study population with a subgroup or not; it is based on two parallel Simon two-stage designs. We study the JH design in detail and extend it by providing a few alternative ways to control the familywise error rate, in the weak sense as well as the strong sense. We also introduce a novel optimal design by minimising the expected sample size. Our extended design contributes to the much needed framework for conducting Phase II trials in stratified medicine. © 2016 The Authors Pharmaceutical Statistics Published by John Wiley & Sons Ltd. © 2016 The Authors Pharmaceutical Statistics Published by John Wiley & Sons Ltd.

Design of an instrument to measure the quality of care in Physical Therapy.

PubMed

Cavalheiro, Leny Vieira; Eid, Raquel Afonso Caserta; Talerman, Claudia; Prado, Cristiane do; Gobbi, Fátima Cristina Martorano; Andreoli, Paola Bruno de Araujo

2015-01-01

To design an instrument composed of domains that would demonstrate physical therapy activities and generate a consistent index to represent the quality of care in physical therapy. The methodology Lean Six Sigma was used to design the tool. The discussion involved seven different management groups staff. By means of brainstorming and Cause & Effect Matrix, we set up the process map. Five requirements composed the quality of care index in physical therapy, after application of the tool called Cause & Effect Matrix. The following requirements were assessed: physical therapist performance, care outcome indicator, adherence to physical therapy protocols, measure whether the prognosis and treatment outcome was achieved and Infrastructure. The proposed design allowed evaluating several items related to physical therapy service, enabling customization, reproducibility and benchmarking with other organizations. For management, this index provides the opportunity to identify areas for improvement and the strengths of the team and process of physical therapy care.

"Thank You, Sorry, Love" (TSL) Therapy with North Korean Refugee Women: A Pilot Study

ERIC Educational Resources Information Center

Kim, Hee Jin; Kim, Jae Yop; Kim, Dong Goo

2016-01-01

Objectives: This study was designed to evaluate the effectiveness of The "Thank You, Sorry, Love" (TSL) family therapy program in potentially improving the marital relationships and health of North Korean refugee women. Methods: The participants included 12 married North Korean female refugees in their 20s to 40s. Using a blinded…

Supervised Study Guide for Physical Therapy Aide (079.378). Texas Trade and Industrial Education Series.

ERIC Educational Resources Information Center

Jordan, Georgia S.; Dunn, Florence

This study guide for the physical therapy aide, as one of a series designed to present related technical instruction to students in trade and industrial education, is intended for use under the direct supervision of a vocational instructor or instructor-coordinator. Developed by a materials specialist, this document contains a separate answer…

The Ecological Transition to Auditory-Verbal Therapy: Experiences of Parents Whose Children Use Cochlear Implants

ERIC Educational Resources Information Center

Neuss, Deirdre

2006-01-01

This Canadian study reports on the experiences of parents whose children use cochlear implants and on their perspectives prior to and following the transition to Auditory-Verbal therapy. A qualitative case study design, framed in social-ecological theory, guided this research. Data collection procedures included a family information questionnaire,…

A Brief Cognitive Behavioural Therapy Psychoeducational Group for Chinese People with Chronic Illnesses: An Evaluation Study

ERIC Educational Resources Information Center

Wong, Daniel F. K.; Ip, Priscilla S. Y.; Lee, Kim Man

2017-01-01

This pilot study attempted to examine the effectiveness of a brief cognitive behavioural therapy (CBT) psychoeducational group for Chinese people with chronic illness in Hong Kong. It adopted a single group design, and 52 participants joined the group. A questionnaire with three outcome measures, measuring general mental health, quality of life…

Effects of a live educational music therapy intervention on acute psychiatric inpatients' perceived social support and trust in the therapist: a four-group randomized effectiveness study.

PubMed

Silverman, Michael J

2014-01-01

Social support is associated with enhanced illness management and recovery in persons with mental illness, making it an important topic addressed through acute inpatient psychoeducational programs. In addition, trust in the therapist may mediate clinical outcomes in this patient population. To date, few studies have examined the effect of music-based psychoeducational programs on these variables. The purpose of this study was to isolate and examine the component parts of a live educational music therapy intervention, and its effect on acute psychiatric inpatients' perceived social support from significant others, family, and friends and trust in the therapist. This study also explored whether trust in therapist varied across conditions, but did not examine it as a mediator for social support. Participants (N = 96) were cluster-randomized in a single-session posttest-only design to one of four conditions: live educational music therapy, recorded educational music therapy, education without music, or recreational music therapy without education. Conditions were designed to isolate the following intervention components: live vs. recorded music, educational vs. non-educational content, and music vs. nonmusic modality. Dependent measures were assessed post intervention via established self-report instruments evaluating perceived social support and trust in the therapist. There were no significant between-group differences for social support or trust in therapist total scores. However, subscale score analyses revealed two significant between-group differences: (a) participants in the Live Educational Music Therapy condition reported significantly higher perceived therapist competence compared with the Recorded Educational Music Therapy condition; (b) participants in the Live Educational Music Therapy condition reported significantly higher perceived support from friends compared with the Recreational Music Therapy condition. Live educational music therapy may be a way to heighten psychiatric inpatients' perceived social support concerning friends and perceptions of the therapist's competence. The current results demonstrated differences between live and recorded music therapy in psychiatric music therapy and provide empirical support for competent musicianship. Implications for clinical practice, limitations, and suggestions for future research are included. © the American Music Therapy Association 2014. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Facilitators and Barriers to Learning in Occupational Therapy Fieldwork Education: Student Perspectives.

PubMed

Grenier, Marie-Lyne

2015-01-01

The purpose of this study was to gain a comprehensive understanding of the facilitators of and barriers to learning within occupational therapy fieldwork education from the perspective of both Canadian and American students. A qualitative study using an online open survey format was conducted to gather data from 29 occupational therapy students regarding their fieldwork experiences. An inductive grounded theory approach to content analysis was used. Individual, environmental, educational, and institutional facilitators of and barriers to learning within occupational therapy fieldwork education were identified. This study's findings suggest that learning within fieldwork education is a highly individual and dynamic process that is influenced by numerous factors. The new information generated by this study has the potential to positively affect the future design and implementation of fieldwork education. Copyright © 2015 by the American Occupational Therapy Association, Inc.

Longitudinal trends in use and costs of targeted therapies for common cancers in Taiwan: a retrospective observational study

PubMed Central

Hsu, Jason C; Lu, Christine Y

2016-01-01

Objectives Some targeted therapies have improved survival and overall quality of cancer care generally, but these increasingly expensive medicines have led to increases in pharmaceutical expenditure. This study examined trends in use and expenditures of antineoplastic agents in Taiwan, and estimated market shares by prescription volume and costs of targeted therapies over time. We also determined which cancer types accounted for the highest use of targeted therapies. Design This is a retrospective observational study focusing on the utilisation of targeted therapies for treatment of cancer. Setting The monthly claims data for antineoplastic agents were retrieved from Taiwan's National Health Insurance Research Database (2009–2012). Main outcome measures We calculated market shares by prescription volume and costs for each class of antineoplastic agent by cancer type. Using a time series design with Autoregressive Integrated Moving Average (ARIMA) models, we estimated trends in use and costs of targeted therapies. Results Among all antineoplastic agents, use of targeted therapies grew from 6.24% in 2009 to 12.29% in 2012, but their costs rose from 26.16% to 41.57% in that time. Monoclonal antibodies and protein kinase inhibitors contributed the most (respectively, 23.84% and 16.12% of costs for antineoplastic agents in 2012). During 2009–2012, lung (44.64% of use; 28.26% of costs), female breast (16.49% of use; 27.18% of costs) and colorectal (12.11% of use; 13.16% of costs) cancers accounted for the highest use of targeted therapies. Conclusions In Taiwan, targeted therapies are increasingly used for different cancers, representing a substantial economic burden. It is important to establish mechanisms to monitor their use and outcomes. PMID:27266775

Modelling Ecological Cognitive Rehabilitation Therapies for Building Virtual Environments in Brain Injury.

PubMed

Martínez-Moreno, J M; Sánchez-González, P; Luna, M; Roig, T; Tormos, J M; Gómez, E J

2016-01-01

Brain Injury (BI) has become one of the most common causes of neurological disability in developed countries. Cognitive disorders result in a loss of independence and patients' quality of life. Cognitive rehabilitation aims to promote patients' skills to achieve their highest degree of personal autonomy. New technologies such as virtual reality or interactive video allow developing rehabilitation therapies based on reproducible Activities of Daily Living (ADLs), increasing the ecological validity of the therapy. However, the lack of frameworks to formalize and represent the definition of this kind of therapies can be a barrier for widespread use of interactive virtual environments in clinical routine. To provide neuropsychologists with a methodology and an instrument to design and evaluate cognitive rehabilitation therapeutic interventions strategies based on ADLs performed in interactive virtual environments. The proposed methodology is used to model therapeutic interventions during virtual ADLs considering cognitive deficit, expected abnormal interactions and therapeutic hypotheses. It allows identifying abnormal behavioural patterns and designing interventions strategies in order to achieve errorless-based rehabilitation. An ADL case study ('buying bread') is defined according to the guidelines established by the ADL intervention model. This case study is developed, as a proof of principle, using interactive video technology and is used to assess the feasibility of the proposed methodology in the definition of therapeutic intervention procedures. The proposed methodology provides neuropsychologists with an instrument to design and evaluate ADL-based therapeutic intervention strategies, attending to solve actual limitation of virtual scenarios, to be use for ecological rehabilitation of cognitive deficit in daily clinical practice. The developed case study proves the potential of the methodology to design therapeutic interventions strategies; however our current work is devoted to designing more experiments in order to present more evidence about its values.

Quality evaluation of Persian nutrition and diet therapy websites.

PubMed

Gholizadeh, Zahra; Papi, Ahmad; Ashrafi-Rizi, Hasan; Shahrzadi, Leila; Hasanzadeh, Akbar

2017-01-01

Nowadays websites are among the most important information sources used by most people. With the spread of websites, especially those related to health issues, the number of their visitors also increases, more than half of which are about nutritional information. Therefore, quality analysis of nutrition and diet therapy websites is of outmost importance. This study aims to evaluate the quality of Persian nutrition and diet therapy websites. The current work is a survey study and uses an applied study method. The statistical population consists of 51 Persian websites about nutrition and diet therapy and census method was used in order to study them. Data gathering was done using a checklist and with direct visit to each website. Descriptive and analytical statistics were used to analyse the gathered data with the help of SPSS 21 software. Findings showed that content (66.7%), organization (82.4%), user friendly interfaces (52.9%) and total quality (70.6%) of most websites had a mediocre score while the design score for most of the websites (70.6%) was acceptable also organizational websites had better design, organization and quality compared to private websites. The three websites with the highest general quality score were the websites of "Novel Diet Therapy," "Behsite" and "Dr. BehdadiPour" (jointly) and "Dr. Kermani" respectively. Also in the dimension of content the factors of goal, relevance and credibility, in the dimension of design the factors of color, text and sound, pictures and videos, in the dimension of organization the factors of stability and indexing and in the dimension of user friendliness the factors of confidentiality, credibility and personalization had the highest scores. The results showed that the design score was higher than other scores. Also the general quality score of the websites was mediocre and was not desirable. Also websites didn't have suitable scores in every factor. Since most people search the internet for nutritional and diet therapy information, the creators of these websites should endeavor to fix the shortcomings of their websites and increase the quality of their websites in several different areas.

Quality evaluation of Persian nutrition and diet therapy websites

PubMed Central

Gholizadeh, Zahra; Papi, Ahmad; Ashrafi-rizi, Hasan; Shahrzadi, Leila; Hasanzadeh, Akbar

2017-01-01

INTRODUCTION: Nowadays websites are among the most important information sources used by most people. With the spread of websites, especially those related to health issues, the number of their visitors also increases, more than half of which are about nutritional information. Therefore, quality analysis of nutrition and diet therapy websites is of outmost importance. This study aims to evaluate the quality of Persian nutrition and diet therapy websites. METHODS: The current work is a survey study and uses an applied study method. The statistical population consists of 51 Persian websites about nutrition and diet therapy and census method was used in order to study them. Data gathering was done using a checklist and with direct visit to each website. Descriptive and analytical statistics were used to analyse the gathered data with the help of SPSS 21 software. RESULTS: Findings showed that content (66.7%), organization (82.4%), user friendly interfaces (52.9%) and total quality (70.6%) of most websites had a mediocre score while the design score for most of the websites (70.6%) was acceptable also organizational websites had better design, organization and quality compared to private websites. The three websites with the highest general quality score were the websites of “Novel Diet Therapy,” “Behsite” and “Dr. BehdadiPour” (jointly) and “Dr. Kermani” respectively. Also in the dimension of content the factors of goal, relevance and credibility, in the dimension of design the factors of color, text and sound, pictures and videos, in the dimension of organization the factors of stability and indexing and in the dimension of user friendliness the factors of confidentiality, credibility and personalization had the highest scores. CONCLUSION: The results showed that the design score was higher than other scores. Also the general quality score of the websites was mediocre and was not desirable. Also websites didn’t have suitable scores in every factor. Since most people search the internet for nutritional and diet therapy information, the creators of these websites should endeavor to fix the shortcomings of their websites and increase the quality of their websites in several different areas. PMID:28616415

Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A): study protocol.

PubMed

Geretsegger, Monika; Holck, Ulla; Gold, Christian

2012-01-05

Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week) affects outcome of therapy, and to determine cost-effectiveness. Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity) or three sessions (high-intensity) per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS) and parents (Social Responsiveness Scale, SRS) before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency. Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session frequency for therapy outcome. Current Controlled Trials ISRCTN78923965.

Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design.

PubMed

Cully, Jeffrey A; Armento, Maria E A; Mott, Juliette; Nadorff, Michael R; Naik, Aanand D; Stanley, Melinda A; Sorocco, Kristen H; Kunik, Mark E; Petersen, Nancy J; Kauth, Michael R

2012-07-11

Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n = 200) or usual care (n = 120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity. Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice. NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772.

A cMUT probe for ultrasound-guided focused ultrasound targeted therapy.

PubMed

Gross, Dominique; Coutier, Caroline; Legros, Mathieu; Bouakaz, Ayache; Certon, Dominique

2015-06-01

Ultrasound-mediated targeted therapy represents a promising strategy in the arsenal of modern therapy. Capacitive micromachined ultrasonic transducer (cMUT) technology could overcome some difficulties encountered by traditional piezoelectric transducers. In this study, we report on the design, fabrication, and characterization of an ultrasound-guided focused ultrasound (USgFUS) cMUT probe dedicated to preclinical evaluation of targeted therapy (hyperthermia, thermosensitive liposomes activation, and sonoporation) at low frequency (1 MHz) with simultaneous ultrasonic imaging and guidance (15 to 20 MHz). The probe embeds two types of cMUT arrays to perform the modalities of targeted therapy and imaging respectively. The wafer-bonding process flow employed for the manufacturing of the cMUTs is reported. One of its main features is the possibility of implementing two different gap heights on the same wafer. All the design and characterization steps of the devices are described and discussed, starting from the array design up to the first in vitro measurements: optical (microscopy) and electrical (impedance) measurements, arrays' electroacoustic responses, focused pressure field mapping (maximum peak-to-peak pressure = 2.5 MPa), and the first B-scan image of a wire-target phantom.

The efficacy of problem solving therapy to reduce post stroke emotional distress in younger (18-65) stroke survivors.

PubMed

Chalmers, Charlotte; Leathem, Janet; Bennett, Simon; McNaughton, Harry; Mahawish, Karim

2017-11-26

To investigate the efficacy of problem solving therapy for reducing the emotional distress experienced by younger stroke survivors. A non-randomized waitlist controlled design was used to compare outcome measures for the treatment group and a waitlist control group at baseline and post-waitlist/post-therapy. After the waitlist group received problem solving therapy an analysis was completed on the pooled outcome measures at baseline, post-treatment, and three-month follow-up. Changes on outcome measures between baseline and post-treatment (n = 13) were not significantly different between the two groups, treatment (n = 13), and the waitlist control group (n = 16) (between-subject design). The pooled data (n = 28) indicated that receiving problem solving therapy significantly reduced participants levels of depression and anxiety and increased quality of life levels from baseline to follow up (within-subject design), however, methodological limitations, such as the lack of a control group reduce the validity of this finding. The between-subject results suggest that there was no significant difference between those that received problem solving therapy and a waitlist control group between baseline and post-waitlist/post-therapy. The within-subject design suggests that problem solving therapy may be beneficial for younger stroke survivors when they are given some time to learn and implement the skills into their day to day life. However, additional research with a control group is required to investigate this further. This study provides limited evidence for the provision of support groups for younger stroke survivors post stroke, however, it remains unclear about what type of support this should be. Implications for Rehabilitation Problem solving therapy is no more effective for reducing post stroke distress than a wait-list control group. Problem solving therapy may be perceived as helpful and enjoyable by younger stroke survivors. Younger stroke survivors may use the skills learnt from problem solving therapy to solve problems in their day to day lives. Younger stroke survivors may benefit from age appropriate psychological support; however, future research is needed to determine what type of support this should be.

Proton Therapy Dose Characterization and Verification

DTIC Science & Technology

2016-10-01

than recommended as these patients are on a separate UPENN research study where dose maximum accepted was 6700 cGy. 15... Research Protection Office. 8.0 Data Handling and Record Keeping All patients must have a signed Informed Consent Form and an On - study (confirmation...this award. Phase 1 concentrated on designing and building a Multi-leaf collimator for use in proton therapy. Phase 2 focused on studying the

Occupational therapy articles in serial publications: an analysis of sources.

PubMed Central

Reed, K L

1988-01-01

This study was designed to locate and document serial literature on occupational therapy published since 1900. Emphasis is placed on finding articles on occupational therapy or by occupational therapists from sources other than those normally associated with the professional journals. Multiple sources were used including print indexes, online databases, occupational therapy bibliographies, and tables of contents or yearly indexes. Almost 7,000 articles were identified, not including those published in foreign journals. Occupational therapy publications have increased steadily since 1900, with the most rapid increase during the 1970s and 1980s when five new occupational therapy journals were initiated. Suggestions for formulating search strategies are included. PMID:3285932

Spinal Manipulative Therapy and Sports Performance Enhancement: A Systematic Review.

PubMed

Botelho, Marcelo B; Alvarenga, Bruno A P; Molina, Nícolly; Ribas, Marcos; Baptista, Abrahão F

2017-09-01

The purpose of this study was to review the literature regarding the relationship between spinal manipulative therapy (SMT) and sports performance. PubMed and Embase databases were searched for original studies published up to July 2016. Inclusion criteria were if SMT has been applied to athletes and if any sports performance-related outcome was measured. Of the 581 potential studies, 7 clinical trials were selected. Most studies had adequate quality (≥6/11) when assessed by the PEDro scale. None of those studies assessed performance at an event or competition. Four studies revealed improvement in a sports performance test after SMT. Meta-analysis could not be performed because of the wide differences in methodologies, design, and outcomes measured. Spinal manipulative therapy influences a wide range of neurophysiological parameters that could be associated with sports performance. Of the 3 studies where SMT did not improve test performance, 2 used SMT not for therapeutic correction of a dysfunctional vertebral joint but to an arbitrary previously set joint. Although 4 of 7 studies showed that SMT improved sports performance tests, the evidence is still weak to support its use. Spinal manipulative therapy may be a promising approach for performance enhancement that should be investigated with more consistent methodologic designs. Copyright © 2017. Published by Elsevier Inc.

A bibliometric analysis of statistical terms used in American Physical Therapy Association journals (2011-2012): evidence for educating physical therapists.

PubMed

Tilson, Julie K; Marshall, Katie; Tam, Jodi J; Fetters, Linda

2016-04-22

A primary barrier to the implementation of evidence based practice (EBP) in physical therapy is therapists' limited ability to understand and interpret statistics. Physical therapists demonstrate limited skills and report low self-efficacy for interpreting results of statistical procedures. While standards for physical therapist education include statistics, little empirical evidence is available to inform what should constitute such curricula. The purpose of this study was to conduct a census of the statistical terms and study designs used in physical therapy literature and to use the results to make recommendations for curricular development in physical therapist education. We conducted a bibliometric analysis of 14 peer-reviewed journals associated with the American Physical Therapy Association over 12 months (Oct 2011-Sept 2012). Trained raters recorded every statistical term appearing in identified systematic reviews, primary research reports, and case series and case reports. Investigator-reported study design was also recorded. Terms representing the same statistical test or concept were combined into a single, representative term. Cumulative percentage was used to identify the most common representative statistical terms. Common representative terms were organized into eight categories to inform curricular design. Of 485 articles reviewed, 391 met the inclusion criteria. These 391 articles used 532 different terms which were combined into 321 representative terms; 13.1 (sd = 8.0) terms per article. Eighty-one representative terms constituted 90% of all representative term occurrences. Of the remaining 240 representative terms, 105 (44%) were used in only one article. The most common study design was prospective cohort (32.5%). Physical therapy literature contains a large number of statistical terms and concepts for readers to navigate. However, in the year sampled, 81 representative terms accounted for 90% of all occurrences. These "common representative terms" can be used to inform curricula to promote physical therapists' skills, competency, and confidence in interpreting statistics in their professional literature. We make specific recommendations for curriculum development informed by our findings.

Integrative Therapies for Low Back Pain That Include Complementary and Alternative Medicine Care: A Systematic Review

PubMed Central

Rose, Kevin; Kadar, Gena E.

2014-01-01

Study Design: Systematic review of the literature. Objective: To evaluate whether an integrated approach that includes different Complementary and Alternative Medicine (CAM) therapies combined or CAM therapies combined with conventional medical care is more effective for the management of low back pain (LBP) than single modalities alone. Summary of Background Data: LBP is one of the leading causes of disability worldwide, yet its optimal management is still unresolved. Methods: The PRISMA Statement guidelines were followed. The Cochrane Back Review Group scale was used to rate the quality of the studies found. Results: Twenty-one studies were found that met the inclusion criteria. The CAM modalities used in the studies included spinal manipulative therapy, acupuncture, exercise therapy, physiotherapy, massage therapy, and a topical ointment. Twenty studies included acupuncture and/or spinal manipulative therapy. Nine high quality studies showed that integrative care was clinically effective for the management of LBP. Spinal manipulative therapy combined with exercise therapy and acupuncture combined with conventional medical care or with exercise therapy appears to be promising approaches to the management of chronic cases of LBP. Conclusions: There is support in the literature for integrated CAM and conventional medical therapy for the management of chronic LBP. Further research into the integrated management of LBP is clearly needed to provide better guidance for patients and clinicians. PMID:25568825

Quantitative comparison of cognitive behavioral therapy and music therapy research: a methodological best-practices analysis to guide future investigation for adult psychiatric patients.

PubMed

Silverman, Michael J

2008-01-01

While the music therapy profession is relatively young and small in size, it can treat a variety of clinical populations and has established a diverse research base. However, although the profession originated working with persons diagnosed with mental illnesses, there is a considerable lack of quantitative research concerning the effects of music therapy with this population. Music therapy clinicians and researchers have reported on this lack of evidence and the difficulty in conducting psychosocial research on their interventions (Choi, 1997; Silverman, 2003a). While published studies have provided suggestions for future research, no studies have provided detailed propositions for the methodology and design of meticulous high quality randomized controlled psychiatric music therapy research. How do other psychotherapies accomplish their databases and could the music therapy field borrow from their rigorous "methodological best practices" to strengthen its own literature base? Therefore, as the National Institutes of Mental Health state the treatment of choice for evidence-based psychotherapy is cognitive behavioral therapy (CBT), aspects of this psychotherapy's literature base were analyzed. The purpose of this literature analysis was to (a) analyze and identify components of high-quality quantitative CBT research for adult psychiatric consumers, (b) analyze and identify the variables and other elements of existing quantitative psychiatric music therapy research for adult consumers, and (c) compare the two data sets to identify the best methodological designs and variables for future quantitative music therapy research with the mental health population. A table analyzing randomized and thoroughly controlled studies involving the use of CBT for persons with severe mental illnesses is included to determine chief components of high-quality experimental research designs and implementation of quantitative clinical research. The table also shows the same analyzed components for existing quantitative psychiatric music therapy research with adult consumers, thus highlighting potential areas and elements for future investigations. A second table depicts a number of potential dependent measures and their sources to be evaluated in future music therapy studies. A third table providing suggestions for future research is derived from a synthesis of the tables and is included to guide researchers and encourage the advancement and expansion of the current literature base. The body of the paper is a discussion of the results of the literature analysis derived from the tables, meta-analyses, and reviews of literature. It is hoped that this report will lead to the addition of future high-quality quantitative research to the psychiatric music therapy literature base and thus provide evidence-based services to as many persons with mental illnesses as possible.

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.

PubMed

Hwang, Thomas J; Franklin, Jessica M; Chen, Christopher T; Lauffenburger, Julie C; Gyawali, Bishal; Kesselheim, Aaron S; Darrow, Jonathan J

2018-04-24

Purpose The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non-breakthrough-designated cancer drugs approved by the US Food and Drug Administration (FDA). Methods We studied all new cancer drugs approved by the FDA between January 2012 and December 2017. Regulatory and therapeutic characteristics (time to FDA approval, pivotal trial efficacy end point, novelty of mechanism of action) were compared between breakthrough-designated and non-breakthrough-designated cancer drugs. Random-effects meta-regression was used to assess the association between breakthrough therapy designation and hazard ratios for progression-free survival (PFS), response rates (RRs) for solid tumors, serious adverse events, and deaths not attributed to disease progression. Results Between 2012 and 2017, the FDA approved 58 new cancer drugs, 25 (43%) of which received breakthrough therapy designation. The median time to first FDA approval was 5.2 years for breakthrough-designated drugs versus 7.1 years for non-breakthrough-designated drugs (difference, 1.9 years; P = .01). There were no statistically significant differences between breakthrough-designated and non-breakthrough-designated drugs in median PFS gains (8.6 v 4.0 months; P = .11), hazard ratios for PFS (0.43 v 0.51; P = .28), or RRs for solid tumors (37% v 39%; P = .74). Breakthrough therapy-designated drugs were not more likely to act via a novel mechanism of action (36% v 39%; P = 1.00). Rates of deaths (6% v 4%; P = .99) and serious adverse events (38% v 36%; P = 0.93) were also similar in breakthrough-designated and non-breakthrough-designated drugs. Conclusion Breakthrough-designated cancer drugs were associated with faster times to approval, but there was no evidence that these drugs provide improvements in safety or novelty; nor was there a statistically significant efficacy advantage when compared with non-breakthrough-designated drugs.

Recommendations for Benchmarking Preclinical Studies of Nanomedicines.

PubMed

Dawidczyk, Charlene M; Russell, Luisa M; Searson, Peter C

2015-10-01

Nanoparticle-based delivery systems provide new opportunities to overcome the limitations associated with traditional small-molecule drug therapy for cancer and to achieve both therapeutic and diagnostic functions in the same platform. Preclinical trials are generally designed to assess therapeutic potential and not to optimize the design of the delivery platform. Consequently, progress in developing design rules for cancer nanomedicines has been slow, hindering progress in the field. Despite the large number of preclinical trials, several factors restrict comparison and benchmarking of different platforms, including variability in experimental design, reporting of results, and the lack of quantitative data. To solve this problem, we review the variables involved in the design of preclinical trials and propose a protocol for benchmarking that we recommend be included in in vivo preclinical studies of drug-delivery platforms for cancer therapy. This strategy will contribute to building the scientific knowledge base that enables development of design rules and accelerates the translation of new technologies. ©2015 American Association for Cancer Research.

Perspective: Recommendations for benchmarking pre-clinical studies of nanomedicines

PubMed Central

Dawidczyk, Charlene M.; Russell, Luisa M.; Searson, Peter C.

2015-01-01

Nanoparticle-based delivery systems provide new opportunities to overcome the limitations associated with traditional small molecule drug therapy for cancer, and to achieve both therapeutic and diagnostic functions in the same platform. Pre-clinical trials are generally designed to assess therapeutic potential and not to optimize the design of the delivery platform. Consequently, progress in developing design rules for cancer nanomedicines has been slow, hindering progress in the field. Despite the large number of pre-clinical trials, several factors restrict comparison and benchmarking of different platforms, including variability in experimental design, reporting of results, and the lack of quantitative data. To solve this problem, we review the variables involved in the design of pre-clinical trials and propose a protocol for benchmarking that we recommend be included in in vivo pre-clinical studies of drug delivery platforms for cancer therapy. This strategy will contribute to building the scientific knowledge base that enables development of design rules and accelerates the translation of new technologies. PMID:26249177

In vivo selective cancer-tracking gadolinium eradicator as new-generation photodynamic therapy agent

PubMed Central

Zhang, Tao; Lan, Rongfeng; Chan, Chi-Fai; Law, Ga-Lai; Wong, Wai-Kwok; Wong, Ka-Leung

2014-01-01

In this work, we demonstrate a modality of photodynamic therapy (PDT) through the design of our truly dual-functional—PDT and imaging—gadolinium complex (Gd-N), which can target cancer cells specifically. In the light of our design, the PDT drug can specifically localize on the anionic cell membrane of cancer cells in which its laser-excited photoemission signal can be monitored without triggering the phototoxic generation of reactive oxygen species—singlet oxygen—before due excitation. Comprehensive in vitro and in vivo studies had been conducted for the substantiation of the effectiveness of Gd-N as such a tumor-selective PDT photosensitizer. This treatment modality does initiate a new direction in the development of “precision medicine” in line with stem cell and gene therapies as tools in cancer therapy. PMID:25453097

Pharmacological enhancement of drug cue extinction learning: translational challenges

PubMed Central

Kantak, K.M.; Nic Dhonnchadha, B.Á.

2010-01-01

Augmentation of cue exposure (extinction) therapy with cognitive-enhancing pharmacotherapy may constitute a rational strategy for the clinical management of drug relapse. While certain success has been reported for this form of therapy in anxiety disorders, in this article we highlight several obstacles that may undermine the efficacy of exposure therapy for substance use disorders. We also review translational studies that have evaluated the facilitative effects of the cognitive enhancer D-cycloserine on extinction targeting drug-related cues. Finally, important considerations for the design and implementation of future studies evaluating exposure therapy combined with pharmacotherapy for substance use disorders are discussed. PMID:21272016

Diketopyrrolopyrrole-based carbon dots for photodynamic therapy.

PubMed

He, Haozhe; Zheng, Xiaohua; Liu, Shi; Zheng, Min; Xie, Zhigang; Wang, Yong; Yu, Meng; Shuai, Xintao

2018-06-01

The development of a simple and straightforward strategy to synthesize multifunctional carbon dots for photodynamic therapy (PDT) has been an emerging focus. In this work, diketopyrrolopyrrole-based fluorescent carbon dots (DPP CDs) were designed and synthesized through a facile one-pot hydrothermal method by using diketopyrrolopyrrole (DPP) and chitosan (CTS) as raw materials. DPP CDs not only maintained the ability of DPP to generate singlet oxygen (1O2) but also have excellent hydrophilic properties and outstanding biocompatibility. In vitro and in vivo experiments demonstrated that DPP CDs greatly inhibited the growth of tumor cells under laser irradiation (540 nm). This study highlights the potential of the rational design of CDs for efficient cancer therapy.

A Comparison of Psychoanalytic Therapy and Cognitive Behavioral Therapy for Anxiety (Panic/Agoraphobia) and Personality Disorders (APD Study): Presentation of the RCT Study Design.

PubMed

Benecke, Cord; Huber, Dorothea; Staats, Hermann; Zimmermann, Johannes; Henkel, Miriam; Deserno, Heinrich; Wiegand-Grefe, Silke; Schauenburg, Henning

2016-09-01

Anxiety disorders, most notably panic disorders and agoraphobia, are common mental disorders, and there is a high comorbidity with personality disorders. Randomized controlled trails addressing this highly relevant group of patients are missing. The multicenter Anxiety and Personality Disorders (APD) study investigates 200 patients with panic disorder and/or agoraphobia with comorbid personality disorder in a randomized control-group comparison of psychoanalytic therapy (PT) and cognitive behavioral therapy (CBT), including 100 patients in each group. Each patient will be examined over a period of six years, regardless of the duration of the individual treatment. The main issues that are addressed in this study are the comparison of the efficacy of PT and CBT in this special patient population, the comparison of the sustainability of the effects of PT and CBT, the comparison of the long-term cost-benefit-ratios of PT and CBT as well as the investigation of prescriptive patient characteristics for individualized treatment recommendations (differential indication). The APD study compares efficacy, sustainability, and cost-benefit-ratios of CBT and PT for anxiety plus personality disorders in a randomized controlled trail. The study design meets the requirements for an efficacy study for PT, which were recently defined. Current Controlled Trials ISRCTN12449681.

Examining Students' Self-Perceived Competence and Comfort in an Experiential Play Therapy Counseling Course: A Single Group Pretest-Posttest Investigation

ERIC Educational Resources Information Center

Flasch, Paulina; Taylor, Dalena; Clauber, Rikke Nynne; Robinson, Edward, III

2017-01-01

The current study utilized a single-group pretest-posttest design to evaluate students' self-perceived competence and comfort of using a variety of play therapy techniques and interventions with a range of client populations as a result of taking a one-week intensive course in Play Therapy. In an effort to conduct course evaluation and explore…

Occupational Therapy Students' Perceptions of Spirituality in Training.

PubMed

Mthembu, Thuli Godfrey; Ahmed, Firdous; Nkuna, Thembi; Yaca, Khalipha

2015-12-01

Spirituality is recognized as an essential and integral component of a holistic approach in occupational therapy practice. However, little is known about occupational therapy students' perceptions regarding spirituality in learning context. This study used qualitative exploratory, descriptive design to explore the occupational therapy students' perceptions about spirituality in training. Using purposive sampling, four semi-structured interviews were conducted with two students, a lecturer and an occupational therapist. In addition, two focus groups were conducted with students in order to collect data. Data collected were audio-taped; transcribed and thematic analysis was used to identify themes. The analysis resulted in emergence of four themes: "Unique to every individual," "Spirituality in occupational therapy," "To be or not to be taught," and "The Real world." Participants perceived spirituality as an individually experienced. The study contributes to the body of knowledge base of occupational therapy education regarding spirituality. However, there is a need for guidelines to integrate spirituality in occupational therapy training.

The Effects of Music Therapy on the Physiological Response of Asthmatic Children Receiving Inhalation Therapy.

PubMed

Roslita, Riau; Nurhaeni, Nani; Wanda, Dessie

The clinical manifestation of asthma in children can interfere with their daily activities. Music therapy may become one of the alternative approaches to making children feel comfortable during inhalation therapy. The aim of the study was to identify the effects of music therapy on the physiological response of asthmatic preschool and school-age children receiving inhalation therapy. This study used a quasi-experimental, nonequivalent control group with a pre-test-post-test design. The 44 respondents consisted of preschool and school-age children assigned to intervention and control groups. The results showed a significant difference in average oxygen saturation, heart rate, and respiratory rate between the control and intervention groups before and after intervention (p < α; α = .05). Music therapy can be used as a nursing intervention to improve the physiological response of children with breathing problems.

A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study).

PubMed

Flik, Carla E; van Rood, Yanda R; Laan, Wijnand; Smout, André Jpm; Weusten, Bas Lam; Whorwell, Peter J; de Wit, Niek J

2011-12-20

Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. ISRCTN: ISRCTN22888906.

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

PubMed

Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L

2017-08-01

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

A data-driven approach for evaluating multi-modal therapy in traumatic brain injury

PubMed Central

Haefeli, Jenny; Ferguson, Adam R.; Bingham, Deborah; Orr, Adrienne; Won, Seok Joon; Lam, Tina I.; Shi, Jian; Hawley, Sarah; Liu, Jialing; Swanson, Raymond A.; Massa, Stephen M.

2017-01-01

Combination therapies targeting multiple recovery mechanisms have the potential for additive or synergistic effects, but experimental design and analyses of multimodal therapeutic trials are challenging. To address this problem, we developed a data-driven approach to integrate and analyze raw source data from separate pre-clinical studies and evaluated interactions between four treatments following traumatic brain injury. Histologic and behavioral outcomes were measured in 202 rats treated with combinations of an anti-inflammatory agent (minocycline), a neurotrophic agent (LM11A-31), and physical therapy consisting of assisted exercise with or without botulinum toxin-induced limb constraint. Data was curated and analyzed in a linked workflow involving non-linear principal component analysis followed by hypothesis testing with a linear mixed model. Results revealed significant benefits of the neurotrophic agent LM11A-31 on learning and memory outcomes after traumatic brain injury. In addition, modulations of LM11A-31 effects by co-administration of minocycline and by the type of physical therapy applied reached statistical significance. These results suggest a combinatorial effect of drug and physical therapy interventions that was not evident by univariate analysis. The study designs and analytic techniques applied here form a structured, unbiased, internally validated workflow that may be applied to other combinatorial studies, both in animals and humans. PMID:28205533

A data-driven approach for evaluating multi-modal therapy in traumatic brain injury.

PubMed

Haefeli, Jenny; Ferguson, Adam R; Bingham, Deborah; Orr, Adrienne; Won, Seok Joon; Lam, Tina I; Shi, Jian; Hawley, Sarah; Liu, Jialing; Swanson, Raymond A; Massa, Stephen M

2017-02-16

Combination therapies targeting multiple recovery mechanisms have the potential for additive or synergistic effects, but experimental design and analyses of multimodal therapeutic trials are challenging. To address this problem, we developed a data-driven approach to integrate and analyze raw source data from separate pre-clinical studies and evaluated interactions between four treatments following traumatic brain injury. Histologic and behavioral outcomes were measured in 202 rats treated with combinations of an anti-inflammatory agent (minocycline), a neurotrophic agent (LM11A-31), and physical therapy consisting of assisted exercise with or without botulinum toxin-induced limb constraint. Data was curated and analyzed in a linked workflow involving non-linear principal component analysis followed by hypothesis testing with a linear mixed model. Results revealed significant benefits of the neurotrophic agent LM11A-31 on learning and memory outcomes after traumatic brain injury. In addition, modulations of LM11A-31 effects by co-administration of minocycline and by the type of physical therapy applied reached statistical significance. These results suggest a combinatorial effect of drug and physical therapy interventions that was not evident by univariate analysis. The study designs and analytic techniques applied here form a structured, unbiased, internally validated workflow that may be applied to other combinatorial studies, both in animals and humans.

The Effectiveness of Art Therapy in Reducing Internalizing and Externalizing Problems of Female Adolescents.

PubMed

Bazargan, Yasaman; Pakdaman, Shahla

2016-01-01

The internalizing and externalizing problems relating to childhood and adolescent have always been significant. Because there is special considerations in establishing communication with them and hence, the therapeutic methods for these problems must take into account these considerations. As establishing a therapeutic relationship is an important component of effective counseling, it seems that art therapy may help alleviate these problems. The purpose of this study is to determine the effectiveness of art therapy in reducing internalizing and externalizing problems of adolescent girls (14 - 18 years old). This is a semi-experimental study carried out in the form of a pre-test/post-test design with control group. The population of this study includes female students of Gole Laleh School of Art in district 3 of Tehran, Iran, out of which 30 students with internalizing problems and 30 individuals with externalizing problems were selected through targeted sampling. Students were randomly assigned to control and experimental groups. Experimental groups participated in 6 painting sessions designed based on Art therapy theories and previous studies. The material used for diagnosis of the problems in posttest and pretest was an Achenbach self-assessment form. Data were analyzed using a mixed analysis of variance (ANOVA). Our results showed that Art therapy significantly reduced internalizing problems (F = 17.61, P < 0.001); however, its effect in reducing externalizing problems was not significant (F = 3.93, P = 0.06). Art therapy as a practical therapeutic method can be used to improve internalizing problems. To reduce externalizing problems, more sessions may be needed. Thus, future studies are required to insure these findings.

Recruitment of Participants to a Clinical Trial of Botanical Therapy for Benign Prostatic Hyperplasia

PubMed Central

Foster, Harris E.; McVary, Kevin T.; Meleth, Sreelatha; Stavris, Karen; Downey, Joe; Kusek, John W.

2011-01-01

Abstract Objectives The timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy. Design CAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS. Subjects The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS. Results The target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms. Conclusions Successful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated study population. PMID:21554128

Methodology for a trial of brain-centered versus anticholinergic therapy in women with urgency urinary incontinence.

PubMed

Komesu, Yuko M; Rogers, Rebecca G; Sapien, Robert E; Schrader, Ronald M; Simmerman-Sierra, Timothy; Mayer, Andrew R; Ketai, Loren H

2017-06-01

We describe the rationale and methodology for a study comparing mind-body treatment and pharmacotherapy in women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy, a mind-body intervention, will be at least as effective as pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups. We describe the development and design challenges of a study comparing the efficacy of hypnotherapy and conventional pharmacotherapy in the treatment of UUI. The study randomizes women to either of these treatments, and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a noninferiority test (alpha = 0.025, beta = 0.20), after considering dropout subjects and subjects lost to follow-up, indicated that approximately 150 woman would be required to test the hypothesis that hypnotherapy is not inferior to pharmacotherapy within a 5 % noninferiority margin. The study will also evaluate fMRI changes in a subset of participants before and after therapy. Challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, and confronting the reality that trials are time-consuming for participants who have to make appropriate accommodations in their schedule. Study enrollment began in March 2013 and is ongoing. We describe the design of a randomized controlled trial comparing mind-body therapy and pharmacotherapy in the treatment of UUI and the challenges encountered in its implementation.

Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE)" study: a double-blind randomised controlled multicenter clinical trial

PubMed Central

2011-01-01

Background Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux. Methods/design The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE) study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study. Discussion The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol. Trial registration number ClinicalTrials (NCT): NCT01031667 PMID:21226953

Movement-Based VR Gameplay Therapy For A Child With Cerebral Palsy.

PubMed

Stansfield, Sharon; Dennis, Carole; Larin, Hélène; Gallagher, Courtney

2015-01-01

This paper presents a single-subject feasibility study of a motion-based VR game designed to provide benefits similar to constraint-induced movement therapy for children with cerebral palsy, while providing a more enjoyable experience. The game was designed to encourage the child to perform the desired therapeutic movements by allowing him to interact with the game using only his more-affected arm. The study used an AB design: Performance across baseline and intervention phases was assessed to determine whether the intervention resulted in changes to repeated measures. Results of the study showed that compared with baseline measurements done prior to his game experience, the participant's post-intervention performance showed improvement in speed of reach, dissociated movement, and bilateral integration of upper extremities in functional tasks. The child's mother, as well as one of his therapists, reported better performance outside of the study environment as well.

Challenges for Preclinical Investigations of Human Biofield Modalities

PubMed Central

Gronowicz, Gloria; Bengston, William

2015-01-01

Preclinical models for studying the effects of the human biofield have great potential to advance our understanding of human biofield modalities, which include external qigong, Johrei, Reiki, therapeutic touch, healing touch, polarity therapy, pranic healing, and other practices. A short history of Western biofield studies using preclinical models is presented and demonstrates numerous and consistent examples of human biofields significantly affecting biological systems both in vitro and in vivo. Methodological issues arising from these studies and practical solutions in experimental design are presented. Important questions still left unanswered with preclinical models include variable reproducibility, dosing, intentionality of the practitioner, best preclinical systems, and mechanisms. Input from the biofield practitioners in the experimental design is critical to improving experimental outcomes; however, the development of standard criteria for uniformity of practice and for inclusion of multiple practitioners is needed. Research in human biofield studies involving preclinical models promises a better understanding of the mechanisms underlying the efficacy of biofield therapies and will be important in guiding clinical protocols and integrating treatments with conventional medical therapies. PMID:26665042

78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

... and Gene Therapy Products; Extension of Comment Period AGENCY: Food and Drug Administration, HHS...: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' that... sponsors of Investigational New Drug Applications for cellular therapy (CT) and gene therapy (GT) products...

Design of an instrument to measure the quality of care in Physical Therapy

PubMed Central

Cavalheiro, Leny Vieira; Eid, Raquel Afonso Caserta; Talerman, Claudia; do Prado, Cristiane; Gobbi, Fátima Cristina Martorano; Andreoli, Paola Bruno de Araujo

2015-01-01

ABSTRACT Objective: To design an instrument composed of domains that would demonstrate physical therapy activities and generate a consistent index to represent the quality of care in physical therapy. Methods: The methodology Lean Six Sigma was used to design the tool. The discussion involved seven different management groups staff. By means of brainstorming and Cause & Effect Matrix, we set up the process map. Results: Five requirements composed the quality of care index in physical therapy, after application of the tool called Cause & Effect Matrix. The following requirements were assessed: physical therapist performance, care outcome indicator, adherence to physical therapy protocols, measure whether the prognosis and treatment outcome was achieved and Infrastructure. Conclusion: The proposed design allowed evaluating several items related to physical therapy service, enabling customization, reproducibility and benchmarking with other organizations. For management, this index provides the opportunity to identify areas for improvement and the strengths of the team and process of physical therapy care. PMID:26154548

Parents' Perspectives on Surf Therapy for Children with Disabilities

ERIC Educational Resources Information Center

Moore, Adam M.; Clapham, Emily D.; Deeney, Theresa A.

2018-01-01

This qualitative study was designed to understand parents' perceptions of their children's participation in an inclusive surf therapy programme in the United States. Ten parents and one caregiver were interviewed about theirs and their children's experience in the surf programme. Parent discussions centred on the child, parent/caregiver,…

Cognitive Therapy and Assertive Training in the Treatment of Depression in Women.

ERIC Educational Resources Information Center

LaPointe, Karen A.

Little empirical study has been done on the efficacy of the variety of psychological approaches used to treat depression. The author reviews theoretical points of view: psychoanalytic, cognitive and behavioral, and constructs an experimental design to compare the relative effectiveness of cognitive therapy, assertiveness training and insight…

Emotional Intelligence (EI): A Therapy for Higher Education Students

ERIC Educational Resources Information Center

Machera, Robert P.; Machera, Precious C.

2017-01-01

This study investigates the need to design and develop emotional intelligence curriculum for students in higher education. Emotional intelligence curriculum may be used as a therapy that provides skills to manage high emotions faced by generation "Y", on a day-to-day basis. Generation "Y" is emotionally challenged with: drug…

Development of an Attitudes towards Complementary Therapies Scale for Psychologists

ERIC Educational Resources Information Center

Wilson, Lee-Ann; White, Katherine M.

2007-01-01

This study designed and tested a scale to measure psychologists' attitudes towards complementary and alternative therapies. The scale, derived from existing measures for medical professionals, was tested on a sample of psychology students (N = 163) using an online survey. The data were factor analysed and three correlated subscales were…

Problem-Solving Therapy for Depression in Adults: A Systematic Review

ERIC Educational Resources Information Center

Gellis, Zvi D.; Kenaley, Bonnie

2008-01-01

Objectives: This article presents a systematic review of the evidence on problem-solving therapy (PST) for depressive disorders in noninstitutionalized adults. Method: Intervention studies using randomized controlled designs are included and methodological quality is assessed using a standard set of criteria from the Cochrane Collaborative Review…

Early Attrition among Suicidal Clients

ERIC Educational Resources Information Center

Surgenor, P. W. G.; Meehan, V.; Moore, A.

2016-01-01

The study aimed to identify the level of suicidal ideation in early attrition clients and their reasons for the early termination of their therapy. The cross-sectional design involved early attrition clients (C[subscript A]) who withdrew from therapy before their second session (n = 61), and continuing clients who (C[subscript C]) progressed…

Examining the Influence of Occupational Therapy and Its Effectiveness in Long-Term Care on Dementia Patients Through Ontology-Based Clustering

NASA Astrophysics Data System (ADS)

Fang, Kwoting; Change, Chingwei; Yuliao, Miao; Chi, Yenping

Over the past decade, the number of long-term care (LTC) residents has increased, and many have accepted treatments such as medication, rehabilitation and occupational therapy. This study discusses the effectiveness of occupational therapy when given to dementia patients of different contexts. The results of this study showed that patients of a good condition in the first stage present a more positive attitude towards participation in the occupational therapy designed by the institution; therefore, they have a greater chance of their condition improving or remaining the same. However, patients of an average condition have a more passive attitude towards taking part in any therapy; therefore, they have a greater chance of their condition deteriorating. In conclusion, occupational therapy has an effect on all kinds of patients.

Feasibility, Acceptability, and Potential Effectiveness of Dignity Therapy for People with Motor Neurone Disease

PubMed Central

Bentley, Brenda; O'Connor, Moira; Kane, Robert; Breen, Lauren J.

2014-01-01

Background Motor neurone disease (MND) practice guidelines suggest developing interventions that will promote hope, meaning, and dignity to alleviate psychological distress, but very little research has been done. This study begins to address this need by exploring the use of dignity therapy with people with MND. Dignity therapy is a brief psychotherapy that promotes hope, meaning and dignity, and enhances the end of life for people with advanced cancer. The aims of this study are to assess the feasibility, acceptability, and potential effectiveness of dignity therapy for people with MND. Methods/design This cross-sectional feasibility study used a one-group pre-test post-test design with 29 people diagnosed with MND. Study participants completed the following self-report questionnaires: Herth Hope Index, FACIT-sp, Patient Dignity Inventory, ALS Assessment Questionnaire, ALS Cognitive Behavioural Screen, and a demographic and health history questionnaire. Acceptability was measured with a 25-item feedback questionnaire. Feasibility was assessed by examining the length of time taken to complete dignity therapy and how symptoms common in MND affected the intervention. Generalised linear mixed models and reliable change scores were used to analyse the data. Results There were no significant pre-test post-test changes for hopefulness, spirituality or dignity on the group level, but there were changes in hopefulness on the individual level. The results of the feedback questionnaire indicates dignity therapy is highly acceptable to people with MND, who report benefits similar to those in the international randomised controlled trial on dignity therapy, a population who primarily had end-stage cancer. Benefits include better family relationships, improved sense of self and greater acceptance. Dignity therapy with people with MND is feasible if the therapist can overcome time and communication difficulties. Conclusions Dignity therapy for people with MND is feasible and acceptable. Further research is warranted to explore its ability to diminish distress. Trial Registration www.anzctr.org.au ACTRN12611000410954 PMID:24816742

The integration of occupational therapy into primary care: a multiple case study design

PubMed Central

2013-01-01

Background For over two decades occupational therapists have been encouraged to enhance their roles within primary care and focus on health promotion and prevention activities. While there is a clear fit between occupational therapy and primary care, there have been few practice examples, despite a growing body of evidence to support the role. In 2010, the province of Ontario, Canada provided funding to include occupational therapists as members of Family Health Teams, an interprofessional model of primary care. The integration of occupational therapists into this model of primary care is one of the first large scale initiatives of its kind in North America. The objective of the study was to examine how occupational therapy services are being integrated into primary care teams and understand the structures supporting the integration. Methods A multiple case study design was used to provide an in-depth description of the integration of occupational therapy. Four Family Health Teams with occupational therapists as part of the team were identified. Data collection included in-depth interviews, document analyses, and questionnaires. Results Each Family Health Team had a unique organizational structure that contributed to the integration of occupational therapy. Communication, trust and understanding of occupational therapy were key elements in the integration of occupational therapy into Family Health Teams, and were supported by a number of strategies including co-location, electronic medical records and team meetings. An understanding of occupational therapy was critical for integration into the team and physicians were less likely to understand the occupational therapy role than other health providers. Conclusion With an increased emphasis on interprofessional primary care, new professions will be integrated into primary healthcare teams. The study found that explicit strategies and structures are required to facilitate the integration of a new professional group. An understanding of professional roles, trust and communication are foundations for interprofessional collaborative practice. PMID:23679667

Gamification in Physical Therapy: More Than Using Games.

PubMed

Janssen, Joep; Verschuren, Olaf; Renger, Willem Jan; Ermers, Jose; Ketelaar, Marjolijn; van Ee, Raymond

2017-01-01

The implementation of computer games in physical therapy is motivated by characteristics such as attractiveness, motivation, and engagement, but these do not guarantee the intended therapeutic effect of the interventions. Yet, these characteristics are important variables in physical therapy interventions because they involve reward-related dopaminergic systems in the brain that are known to facilitate learning through long-term potentiation of neural connections. In this perspective we propose a way to apply game design approaches to therapy development by "designing" therapy sessions in such a way as to trigger physical and cognitive behavioral patterns required for treatment and neurological recovery. We also advocate that improving game knowledge among therapists and improving communication between therapists and game designers may lead to a novel avenue in designing applied games with specific therapeutic input, thereby making gamification in therapy a realistic and promising future that may optimize clinical practice.

How do eHealth Programs for Adolescents With Depression Work? A Realist Review of Persuasive System Design Components in Internet-Based Psychological Therapies

PubMed Central

McGrath, Patrick J

2017-01-01

Background Major depressive disorders are common among adolescents and can impact all aspects of their daily life. Traditional therapies, cognitive behavioral therapy (CBT), and interpersonal psychotherapy (IPT) have been delivered face-to-face. However, Internet-based (online) delivery of these therapies is emerging as an option for adolescents. Internet-based CBT and IPT involve therapeutic content, interaction between the user and the system, and different technological features embedded into the online program (eg, multimedia). Studies of Internet-based CBT and IPT for adolescent depression differ on all three aspects, and variable, positive therapy effects have been reported. A better understanding of the treatment conditions that influence therapy outcomes is important to designing and evaluating these novel therapies. Objective Our aim was to examine the technological and program delivery features of Internet-based CBT and IPT for adolescent depression and to document their potential relation to treatment outcomes and program use. Methods We performed a realist synthesis. We started with an extensive search of published and gray literature. We included intervention studies that evaluated Internet-based CBT or IPT for adolescent depression. We included mixed-methods and qualitative studies, theoretical papers, and policy/implementation documents if they included a focus on how Internet-based psychological therapy is proposed to work for adolescents with depression/depressive symptoms. We used the Mixed-Methods Appraisal Tool to assess the methodological quality of studies. We used the Persuasive System Design (PSD) model as a framework for data extraction and analysis to examine how Internet-based CBT and IPT, as technology-based systems, influence the attitudes and behaviors of system users. PSD components described for the therapies were linked to reported outcomes using a cross-case comparison method and thematic synthesis. Results We identified 19 Internet-based CBT programs in 59 documents. Of those, 71% (42/59) were of moderate to high quality. The PSD features surface credibility (competent “look and feel”), dialogue support (online program + in-person support), liking and similarity (esthetics and content appeal to adolescent users), the reduction and tunneling of therapeutic content (reducing online content into simple tasks, guiding users), and use of self-monitoring were present in therapies that resulted in improved therapy engagement, satisfaction, and adherence, as well as symptom and functional impairments. Conclusions When incorporated into Internet-based CBT for adolescent depression, PSD features may improve adolescent adherence, satisfaction, and depression-related outcomes. Testing of these features using hypothesis-driven dismantling approaches is recommended to advance our understanding of how these features contribute to therapy effectiveness. PMID:28793983

Neurobiological mechanisms of exercise and psychotherapy in depression: The SPeED study-Rationale, design, and methodological issues.

PubMed

Heinzel, Stephan; Rapp, Michael A; Fydrich, Thomas; Ströhle, Andreas; Terán, Christina; Kallies, Gunnar; Schwefel, Melanie; Heissel, Andreas

2018-02-01

Even though cognitive behavioral therapy has become a relatively effective treatment for major depressive disorder and cognitive behavioral therapy-related changes of dysfunctional neural activations were shown in recent studies, remission rates still remain at an insufficient level. Therefore, the implementation of effective augmentation strategies is needed. In recent meta-analyses, exercise therapy (especially endurance exercise) was reported to be an effective intervention in major depressive disorder. Despite these findings, underlying mechanisms of the antidepressant effect of exercise especially in combination with cognitive behavioral therapy have rarely been studied to date and an investigation of its neural underpinnings is lacking. A better understanding of the psychological and neural mechanisms of exercise and cognitive behavioral therapy would be important for developing optimal treatment strategies in depression. The SPeED study (Sport/Exercise Therapy and Psychotherapy-evaluating treatment Effects in Depressive patients) is a randomized controlled trial to investigate underlying physiological, neurobiological, and psychological mechanisms of the augmentation of cognitive behavioral therapy with endurance exercise. It is investigated if a preceding endurance exercise program will enhance the effect of a subsequent cognitive behavioral therapy. This study will include 105 patients diagnosed with a mild or moderate depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.). The participants are randomized into one of three groups: a high-intensive or a low-intensive endurance exercise group or a waiting list control group. After the exercise program/waiting period, all patients receive an outpatient cognitive behavioral therapy treatment according to a standardized therapy manual. At four measurement points, major depressive disorder symptoms (Beck Depression Inventory, Hamilton Rating Scale for Depression), (neuro)biological measures (neural activations during working memory, monetary incentive delay task, and emotion regulation, as well as cortisol levels and brain-derived neurotrophic factor), neuropsychological test performance, and questionnaires (psychological needs, self-efficacy, and quality of life) are assessed. In this article, we report the design of the SPeED study and refer to important methodological issues such as including both high- and low-intensity endurance exercise groups to allow the investigation of dose-response effects and physiological components of the therapy effects. The main aims of this research project are to study effects of endurance exercise and cognitive behavioral therapy on depressive symptoms and to investigate underlying physiological and neurobiological mechanisms of these effects. Results may provide important implications for the development of effective treatment strategies in major depressive disorder, specifically concerning the augmentation of cognitive behavioral therapy by endurance exercise.

Design and Rationale of the LAPLACE-TIMI 57 Trial: A Phase II, Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of a Monoclonal Antibody Inhibitor of PCSK9 in Subjects With Hypercholesterolemia on Background Statin Therapy

PubMed Central

Kohli, Payal; Desai, Nihar R.; Giugliano, Robert P.; Kim, Jae B.; Somaratne, Ransi; Huang, Fannie; Knusel, Beat; McDonald, Shannon; Abrahamsen, Timothy; Wasserman, Scott M.; Scott, Robert; Sabatine, Marc S.

2013-01-01

Lowering low-density lipoprotein cholesterol (LDL-C) is a cornerstone for the prevention of atherosclerotic heart disease, improving clinical outcomes and reducing vascular mortality in patients with hypercholesterolemia. The clinical benefits of LDL-C reduction appear to extend even to patients starting with LDL-C as low as 60–80 mg/dL prior to initiating therapy. Statins are the first-line agents for treating hypercholesterolemia and are effective in reducing LDL-C, but many patients are unable to achieve their optimal lipid targets despite intensive statin therapy. Therefore, there has been a strong impetus for the development of novel pharmacologic agents designed to lower LDL-C further in patients already on statin therapy. Genetic mutations resulting in altered cholesterol homeostasis provide valuable information regarding novel approaches for treating hypercholesterolemia. To that end, mutations in proprotein convertase subtilisin/kexin type 9 (PCSK9) were linked to altered levels of LDL-C, illustrating this protein’s role in lipid metabolism. PCSK9 promotes degradation of the LDL receptor, preventing its transport back to the cell surface and thereby increasing circulating LDL-C. Conversely, inhibition of PCSK9 can profoundly decrease circulating LDL-C, and thus is an attractive new target for LDL-C–lowering therapy. AMG 145 is a fully human monoclonal immunoglobulin G2 antibody that binds specifically to human PCSK9 and inhibits its interaction with the low-density lipoprotein receptor. In this manuscript, we describe the rationale and design of LDL-C Assessment with PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy–Thrombolysis In Myocardial Infarction 57 (LAPLACE-TIMI 57; NCT01380730), a 12-week, randomized, double-blind, dose-ranging, placebo-controlled study designed to assess the safety and efficacy of AMG 145 when added to statin therapy in patients with hypercholesterolemia. PMID:22714699

Evaluation of electrical aversion therapy for inappropriate sexual behaviour after traumatic brain injury: a single case experimental design study

PubMed Central

ter Mors, Bert Jan; van Heugten, Caroline M; van Harten, Peter N

2012-01-01

Inappropriate sexual behaviour after acquired brain injury is a severe complication. Evidence for effective treatment is not available. Electrical aversion therapy (EAT) is a behavioural therapeutic option used in persons with intellectual disabilities, which might be suitable for brain-injured individuals for whom other therapies are not effective. The effect of EAT in brain injury has not been investigated previously. A single case experimental design was used. In an ABBA (baseline-treatment-treatment-withdrawal) design the frequency of the target behaviour (ie, inappropriate sexual behaviour) in a 40-year-old man was measured daily. A total of 551 measurements were recorded. A significant reduction of the target behaviour was seen after the first treatment phase (baseline 12.18 (2.59) vs 3.15 (3.19) mean target behaviours daily); this reduction remained stable over time. We conclude that EAT was effective in this patient with inappropriate sexual behaviour due to severe brain injury. EAT can therefore be considered in therapy resistant inappropriate sexual behaviour in brain-injured patients. PMID:22922913

Evaluation of electrical aversion therapy for inappropriate sexual behaviour after traumatic brain injury: a single case experimental design study.

PubMed

Ter Mors, Bert Jan; van Heugten, Caroline M; van Harten, Peter N

2012-08-24

Inappropriate sexual behaviour after acquired brain injury is a severe complication. Evidence for effective treatment is not available. Electrical aversion therapy (EAT) is a behavioural therapeutic option used in persons with intellectual disabilities, which might be suitable for brain-injured individuals for whom other therapies are not effective. The effect of EAT in brain injury has not been investigated previously. A single case experimental design was used. In an ABBA (baseline-treatment-treatment-withdrawal) design the frequency of the target behaviour (ie, inappropriate sexual behaviour) in a 40-year-old man was measured daily. A total of 551 measurements were recorded. A significant reduction of the target behaviour was seen after the first treatment phase (baseline 12.18 (2.59) vs 3.15 (3.19) mean target behaviours daily); this reduction remained stable over time. We conclude that EAT was effective in this patient with inappropriate sexual behaviour due to severe brain injury. EAT can therefore be considered in therapy resistant inappropriate sexual behaviour in brain-injured patients.

Comorbidity ascertainment from the ESRD Medical Evidence Report and Medicare claims around dialysis initiation: a comparison using US Renal Data System data.

PubMed

Krishnan, Mahesh; Weinhandl, Eric D; Jackson, Scott; Gilbertson, David T; Lacson, Eduardo

2015-11-01

The end-stage renal disease Medical Evidence Report serves as a source of comorbid condition data for risk adjustment of quality metrics. We sought to compare comorbid condition data in the Medical Evidence Report around dialysis therapy initiation with diagnosis codes in Medicare claims. Observational cohort study using US Renal Data System data. Medicare-enrolled elderly (≥66 years) patients who initiated maintenance dialysis therapy July 1 to December 31, 2007, 2008, or 2009. 12 comorbid conditions ascertained from claims during the 6 months before dialysis therapy initiation, the Medical Evidence Report, and claims during the 3 months after dialysis therapy initiation. None. Comorbid condition prevalence according to claims before dialysis therapy initiation generally exceeded prevalence according to the Medical Evidence Report. The κ statistics for comorbid condition designations other than diabetes ranged from 0.06 to 0.43. Discordance of designations was associated with age, race, sex, and end-stage renal disease Network. During 23,930 patient-years of follow-up from 4 to 12 months after dialysis therapy initiation (8,930 deaths), designations from claims during the 3 months after initiation better discriminated risk of death than designations from the Medical Evidence Report (C statistics of 0.674 vs 0.616). Between the Medical Evidence Report and claims, standardized mortality ratios changed by >10% for more than half the dialysis facilities. Neither the Medical Evidence Report nor diagnosis codes in claims constitute a gold standard of comorbid condition data; results may not apply to nonelderly patients or patients without Medicare coverage. Discordance of comorbid condition designations from the Medical Evidence Report and claims around dialysis therapy initiation was substantial and significantly associated with patient characteristics, including location. These patterns may engender bias in risk-adjusted quality metrics. In lieu of the Medical Evidence Report, claims during the 3 months after dialysis therapy initiation may constitute a useful source of comorbid condition data. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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

PubMed Central

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

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

PubMed

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

2015-11-01

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.

New directions in the rational design of electrical and magnetic seizure therapies: individualized Low Amplitude Seizure Therapy (iLAST) and Magnetic Seizure Therapy (MST).

PubMed

Radman, Thomas; Lisanby, Sarah H

2017-04-01

Electroconvulsive therapy remains a key treatment option for severe cases of depression, but undesirable side-effects continue to limit its use. Innovations in the design of novel seizure therapies seek to improve its risk benefit ratio through enhanced control of the focality of stimulation. The design of seizure therapies with increased spatial precision is motivated by avoiding stimulation of deep brain structures implicated in memory retention, including the hippocampus. The development of two innovations in seizure therapy-individualized low-amplitude seizure therapy (iLAST) and magnetic seizure therapy (MST), are detailed. iLAST is a method of seizure titration involving reducing current spread in the brain by titrating current amplitude from the traditional fixed amplitudes. MST, which can be used in conjunction with iLAST dosing methods, involves the use of magnetic stimulation to reduce shunting and spreading of current by the scalp occurring during electrical stimulation. Evidence is presented on the rationale for increasing the focality of ECT in hopes of preserving its effectiveness, while reducing cognitive side-effects. Finally, the value of electric field and neural modelling is illustrated to explain observed clinical effects of modifications to ECT technique, and their utility in the rational design of the next generation of seizure therapies.

[The influence of general magnetic therapy on the psychological status of the patients presenting with osteoarthrosis].

PubMed

Degtiarev, V K; Aleksandrov, A V; Nenasheva, N V; Cherkashina, I V; Nikitin, M V

2013-01-01

The present study was designed to estimate the influence of general magnetic therapy on the psychical conditions of 151 patients presenting with degenerative joint diseases including osteoarthritis (OA). It was shown that the application of general magnetic therapy for the rehabilitative treatment of osteoarthrosis promotes the improvement of the psycho-emotional state of the patients. It is concluded that prescription of general magnetic therapy to the patients with OA suffering from serious psycho-emotional disorders brings about beneficial changes in their anxiety- and depression-related personality traits.

Rhodiola rosea therapy for major depressive disorder: a study protocol for a randomized, double-blind, placebo- controlled trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Xie, Sharon X; Amsterdam, Jay D.

2014-01-01

Background Rhodiola rosea (R. rosea), a botanical of both western and traditional Chinese medicine, has been used as a folk remedy for improving stamina and reducing stress. However, few controlled clinical trials have examined the safety and efficacy of R. rosea for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of R. rosea in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design. Methods / Design Subjects with MDD not receiving antidepressant therapy will be randomized to either R. rosea extract 340–1,360 mg daily; sertraline 50–200 mg daily, or placebo for 12 weeks. The primary outcome measure will be change over time in the mean 17-item Hamilton Depression Rating score. Secondary outcome measures will include safety and quality of life ratings. Statistical procedures will include mixed-effects models to assess efficacy for primary and secondary outcomes. Discussion This study will provide valuable preliminary information on the safety and efficacy data of R. rosea versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with R. rosea to determine its safety and efficacy in MDD. PMID:25610752

77 FR 18251 - Development of Animal Models of Pregnancy To Address Medical Countermeasures for Influenza in the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-27

... during pregnancy. Specifically, this workshop will address experimental design issues in selecting the... countermeasures, including influenza therapies, that may be used during pregnancy; and (3) experimental design... pharmacokinetic studies, and (3) additional issues in experimental design. Background information on the public...

The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan.

PubMed

Delaney, Anthony P; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

2013-09-01

The Australasian Resuscitation in Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the emergency department with severe sepsis. In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and before completion of the two related international studies. Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and conforms to current best practice in conducting clinical trials.

The efficacy of cognitive behavioral therapy for Chinese people: A meta-analysis.

PubMed

Ng, Ting Kin; Wong, Daniel Fu Keung

2018-07-01

Over the past decade, cognitive behavioral therapy has been applied to an increasingly wider range of disorders and problems in Chinese societies. However, no meta-analysis has been conducted to synthesize the studies on cognitive behavioral therapy for Chinese clients. The purpose of this meta-analytic study was to examine the overall efficacy of cognitive behavioral therapy for Chinese people. A literature search was conducted using electronic databases, including Web of Science, PsycINFO and PubMed. Pooled mean effect sizes were calculated using the random-effects model. The literature search identified 55 studies with 6763 Chinese participants. The overall short-term effect of cognitive behavioral therapy on the primary outcome was medium in size. Effect sizes were medium for anxiety, depression/well-being and caregiving stress and small for psychotic symptoms and addictive behaviors. The effects of cognitive behavioral therapy on process variables, dysfunctional thoughts and coping, were in the small range. The overall longer-term effect of cognitive behavioral therapy on the primary outcome was medium in size. Moderator analyses showed that the short-term effect was stronger for culturally adapted cognitive behavioral therapy than for unadapted cognitive behavioral therapy. Type of primary outcome, type of control group, recruitment method, study design, the format of delivery and region were found to moderate the efficacy of cognitive behavioral therapy. The findings of this study provide evidence for the overall efficacy of cognitive behavioral therapy for Chinese people and the benefit of cultural adaptation of cognitive behavioral therapy to Chinese culture.

The value of normalization: Group therapy for individuals with brain injury.

PubMed

von Mensenkampff, Barbara; Ward, Marcia; Kelly, Grace; Cadogan, Sam; Fawsit, Feargus; Lowe, Niamh

2015-01-01

This paper reports on a client-driven therapy group designed to help clients actively process changes and equip them with the psychological skills necessary to facilitate rehabilitation. This is an exploratory mixed methods research design based in clinical practice. This study documents results from five therapy groups, each group consisting of 2-hour sessions over an average of 6 weeks with a review session 6 weeks later. Forty-five clients (13 female, 32 male, average age = 40.54, SD = 11.87) with brain injury attended the group with Headway psychological services, Cork. Clients' pre- and post-measures of functioning were gathered to assess the potential therapeutic benefits. Thematic analysis was used to evaluate the qualitative data. Results illustrate a number of benefits to the participants, including normalizing effects, helping with acceptance, finding a new identity and positive mental health changes. Findings are encouraging and help to validate the effectiveness of group therapy as an intervention tool.

CHIP: Facilitating Interprofessional and Culturally Competent Patient Care Through Experiential Learning in China.

PubMed

Mu, Keli; Peck, Kirk; Jensen, Lou; Bracciano, Al; Carrico, Cathy; Feldhacker, Diana

2016-12-01

Health care professionals have advocated for educating culturally competent practitioners. Immersion in international experiences has an impact on student cultural competency and interprofessional development. The China Honors Interprofessional Program (CHIP) at a university in the Midwest is designed to increase students' cultural competency and interprofessional development. From 2009 to 2013, a total of 25 professional students including twelve occupational therapy students, ten physical therapy students and three nursing students were enrolled in the programme. Using a one group pre and posttest research design, this study evaluated the impact of CHIP on the participating students. Both quantitative and qualitative data were collected in the study. Findings of the study revealed that CHIP has impact on students' cultural competency and professional development including gaining appreciation and understanding of the contributions of other healthcare professionals and knowledge and skills in team work. The findings of the study suggested that international immersion experience such as CHIP is an important way to increase students' cultural competency and interprofessional knowledge and skills. Limitations of the study included the small sample in the study, indirect outcome measures and the possible celling effect of the instruments of the study. Future research studies should include a larger and more representative sample, direct outcome measures such as behaviour observation and more rigorous design such as prospective experimental comparison group design. Future research should also examine the long-term effects of international experience on the professional development of occupational therapy students. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Gleaning Insights from Fecal Microbiota Transplantation and Probiotic Studies for the Rational Design of Combination Microbial Therapies

PubMed Central

Hudson, Lauren E.; Anderson, Sarah E.; Corbett, Anita H.

2016-01-01

SUMMARY Beneficial microorganisms hold promise for the treatment of numerous gastrointestinal diseases. The transfer of whole microbiota via fecal transplantation has already been shown to ameliorate the severity of diseases such as Clostridium difficile infection, inflammatory bowel disease, and others. However, the exact mechanisms of fecal microbiota transplant efficacy and the particular strains conferring this benefit are still unclear. Rationally designed combinations of microbial preparations may enable more efficient and effective treatment approaches tailored to particular diseases. Here we use an infectious disease, C. difficile infection, and an inflammatory disorder, the inflammatory bowel disease ulcerative colitis, as examples to facilitate the discussion of how microbial therapy might be rationally designed for specific gastrointestinal diseases. Fecal microbiota transplantation has already shown some efficacy in the treatment of both these disorders; detailed comparisons of studies evaluating commensal and probiotic organisms in the context of these disparate gastrointestinal diseases may shed light on potential protective mechanisms and elucidate how future microbial therapies can be tailored to particular diseases. PMID:27856521

Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale.

PubMed

Charles, David; Tolleson, Christopher; Davis, Thomas L; Gill, Chandler E; Molinari, Anna L; Bliton, Mark J; Tramontana, Michael G; Salomon, Ronald M; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T; Neimat, Joseph S; Konrad, Peter E

2012-01-01

Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease.

Pilot Study Assessing the Feasibility of Applying Bilateral Subthalamic Nucleus Deep Brain Stimulation in Very Early Stage Parkinson's Disease: Study design and rationale

PubMed Central

Charles, David; Tolleson, Christopher; Davis, Thomas L.; Gill, Chandler E.; Molinari, Anna L.; Bliton, Mark J.; Tramontana, Michael G.; Salomon, Ronald M.; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T.; Neimat, Joseph S.; Konrad, Peter E.

2014-01-01

Background Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. Objective We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. Methods We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Results Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. Conclusions This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease. PMID:23938229

The effect of positive group psychotherapy on self-esteem and state anger among adolescents at Korean immigrant churches.

PubMed

Lee, Eun Jin

2015-04-01

The aim of the current study was to describe participants' experiences and examine the effects of group therapy on self-esteem and state anger among the adolescent children of immigrants in the US. A quasi-experimental design and qualitative and quantitative methods were used. Group therapy was conducted for 8weeks. Thirty-three adolescents took part in the study. Quantitative results revealed that group therapy improved self-esteem (t=2.222. p<.05) but not state anger. However, qualitative results suggested that group therapy helped improve interpersonal relationships and communication skills, the forgiveness of others, and the management of anger. Furthermore, group therapy utilizing positive psychology strategies improved self-esteem, interpersonal relationships, and communication skills. Copyright © 2014 Elsevier Inc. All rights reserved.

Developing the Medication Reminder Mobile Application "Seeb".

PubMed

Saghaeiannejad-Isfahani, Sakineh; Ehteshami, Asghar; Savari, Ebtesam; Samimi, Ali

2017-06-01

Today, the structure of comprehensive health care emphasizes self-care more than therapy. Medication therapy is a strong instrument for therapy received through the health setting, especially in medication area. Error in medication administration has produced different problems and they cost billions of dollars every year. Regarding mobile phone extensions, we developed a local medication reminder mobile application called "Seeb" as a suitable solution for decreasing medication errors for Iranians. We conducted a mixed methods study in three Phases: 1) Comparative study of existing mobile applications; 2) developed its object-oriented model; 3) Developed the initial version of "Seeb" that was approved for production. This application was designed for the appropriate medication administration including time and dosages through: recording patient and medication data; scheduling patients' medication; and reporting medication administration on progress. "Seeb" has been designed in compliance with Iranian health information technologists and pharmacists requirements. It is expected to reduce medication error and improve patient adherence to medical prescriptions.

Effectiveness of integrative and instrumental reminiscence therapies on depression symptoms reduction in institutionalized older adults: an empirical study.

PubMed

Karimi, H; Dolatshahee, B; Momeni, K; Khodabakhshi, A; Rezaei, M; Kamrani, A A

2010-09-01

Reminiscence therapy is a psychological intervention which is specifically designed to address issues of particular relevance to older adults, such as depression. The latest approach to the research on therapeutic utility of reminiscence is gaining popularity among researchers and practitioners, and has yielded promising results. Specifying different types of reminiscence is a crucial component of the approach. The aim of this study was to examine the therapeutic effectiveness of integrative and instrumental types of reminiscence for the treatment of depression in institutionalized older adults dwelling in a nursing home. The study employed a three-group pre-post-test design with random allocation to instrumental or integrative reminiscence or an active social discussion control condition. Twenty-nine institutionalized older adults (12 men and 17 women) with depressive symptoms varying from mild to severe constituted the sample. The interventions were implemented in a short-form group format. Analysis of changes from pre-test to post-test revealed that integrative reminiscence therapy led to statistically significant reduction in symptoms of depression in contrast with the control group. Although instrumental reminiscence therapy also reduced depressive symptoms, this improvement was not statistically significant compared to the control group. This study provides additional support for the effectiveness of integrative reminiscence therapy as an intervention for depressed older adults living in residential care settings. This study also provides support for the hypothesis that certain types of reminiscence produce their own specific effects.

Adjunctive use of the diode laser in non-surgical periodontal therapy: exploring the controversy.

PubMed

Porteous, Mary Sornborger; Rowe, Dorothy J

2014-04-01

Despite the controversy regarding clinical efficacy, dental hygienists use the diode laser as an adjunct to non-surgical periodontal therapy. The technique to maximize successful laser therapy outcome is controversial as well. The purpose of this review is to explore the scientific foundation of the controversy surrounding the use of the diode laser as an adjunct to non-surgical periodontal therapy. Further, this paper addresses the weaknesses in study design, the heterogeneity of methodology in the published clinical studies, especially the laser parameters, and how these issues impact the collective clinical and microbial data, and thus conclusions regarding clinical efficacy. Evaluation of the literature identifies possible mechanisms that could contribute to the varied, often conflicting results among laser studies that are the foundation of the controversy surrounding clinical efficacy. These mechanisms include current paradigms of periodontal biofilm behavior, tissue response to laser therapy being dependent on tissue type and health, and that the successful therapeutic treatment window is specific to the target tissue, biofilm composition, laser wavelength, and laser energy delivered. Lastly, this paper discusses laser parameters used in the various clinical studies, and how their diversity contributes to the controversy. Although this review does not establish clinical efficacy, it does reveal the scientific foundation of the controversy and the need for standardized, well designed randomized controlled clinical trials to develop specific guidelines for using the laser as an adjunct to non-surgical periodontal therapy. Using evidence-based laser guidelines would allow dental hygienists to provide more effective non-surgical periodontal care.

Attitudes and Beliefs of Working and Work-Disabled People with Chronic Pain Prescribed Long-Term Opioids.

PubMed

Robinson, James P; Dansie, Elizabeth J; Wilson, Hilary D; Rapp, Suzanne; Turk, Dennis C

2015-07-01

This study was designed to gain insight into the apparent contradiction between the perspectives of researchers and policy makers, who have questioned the efficacy and safety of chronic opioid therapy for non-cancer pain patients, and the patients themselves, who often indicate that the therapy has value. A convenience sample of 54 patients on chronic opioid therapy was studied. Participants completed a questionnaire specifically designed for the study, and also several standard instruments that addressed functional interference, emotional functioning, and possible misuse of opioids. Their treating physicians rated the participants on the severity of their disability and the success of their opioid therapy. Although participants reported significant ongoing pain, they gave positive global ratings to their opioid therapy, and reported little concern about addiction or side effects of opioids. They strongly endorsed the beliefs that opioids helped them control their pain and allowed them to participate in important activities such as work. They expressed the belief that their pain would be severe if they did not have access to opioids, and reported negative experiences with tapering or discontinuing opioids in the past. Work-disabled participants reported higher levels of affective distress, catastrophizing, and functional interference than working participants, and were judged by their physicians to be relatively less successful in managing their pain. The results of this study suggest several tentative hypotheses about why patients on chronic opioid therapy value opioids, and identified several areas for systematic investigation in the future. © 2015 American Academy of Pain Medicine.

Methodology for a Trial of Brain-Centered versus Anti-cholinergic Therapy for Women with Urgency Urinary Incontinence

PubMed Central

Komesu, Yuko M.; Ketai, Loren H.; Sapien, Robert E.; Rogers, Rebecca G.; Schrader, Ronald M.; Simmerman-Sierra, Timothy; Mayer, Andrew R.

2016-01-01

Introduction This paper describes the rationale and methodology a study which investigates mind-body treatment versus pharmacotherapy for women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy a mind-body intervention, will be at least as effective pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups. Methods The purpose of this manuscript is to recount the development and design challenges of a study evaluating the efficacy of hypnotherapy compared to conventional pharmacotherapy in UUI treatment. The study randomizes women to either of these treatments and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a non-inferiority test (alpha=.025, beta=0.20), after considering drop-out/loss to follow-up, indicated approximately 150 woman would be required to test the hypothesis that hypnotherapy is non-inferior to pharmacotherapy within a 5% non-inferiority margin. The study will also evaluate fMRI change in a subset of participants before and after therapy. Study challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, confronting the reality that trials are time-consuming for participants and making appropriate accommodations. Results Study enrollment began March 2013 and is ongoing. Conclusions This manuscript details the design a of randomized controlled trial (RCT) comparing mind-body therapy to medications in treatment of UUI and describes the challenges encountered in its planning. PMID:27752750

Incidence, management and outcomes of cardiovascular insufficiency in critically ill term and late preterm newborn infants

PubMed Central

Fernandez, Erika; Watterberg, Kristi L.; Faix, Roger G.; Yoder, Bradley A.; Walsh, Michele C.; Lacy, Conra Backstrom; Osborne, Karen A.; Das, Abhik; Kendrick, Douglas E.; Stoll, Barbara J.; Poindexter, Brenda B.; Laptook, Abbot R.; Kennedy, Kathleen A.; Schibler, Kurt; Bell, Edward F.; Van Meurs, Krisa P.; Frantz, Ivan D.; Goldberg, Ronald N.; Shankaran, Seetha; Carlo, Waldemar A.; Ehrenkranz, Richard A.; Sánchez, Pablo J.; Higgins, Rosemary D.

2014-01-01

Objective To characterize the incidence, management and short term outcomes of cardiovascular insufficiency (CVI) in mechanically ventilated newborns, evaluating 4 separate pre-specified definitions. Study Design Multicenter, prospective cohort study of infants ≥34 weeks gestational age (GA) and on mechanical ventilation during the first 72 hours. CVI was prospectively defined as either (1) mean arterial pressure (MAP)

Parent-Child Interaction Therapy in a Community Setting: Examining Outcomes, Attrition, and Treatment Setting

ERIC Educational Resources Information Center

Lanier, Paul; Kohl, Patrica L.; Benz, Joan; Swinger, Dawn; Moussette, Pam; Drake, Brett

2011-01-01

Objectives: The purpose of this study was to evaluate Parent-Child Interaction Therapy (PCIT) deployed in a community setting comparing in-home with the standard office-based intervention. Child behavior, parent stress, parent functioning, and attrition were examined. Methods: Using a quasi-experimental design, standardized measures at three time…

Gestalt Therapy in a Social Psychiatric Setting: The 'Oil & Water' Solution.

ERIC Educational Resources Information Center

Neill, R. B.

1979-01-01

In this case study of a residential treatment center for emotionally disturbed adolescents, evaluative data demonstrated that Gestalt Therapy was neither designed nor intended for use in an institutional setting with severely disturbed young adolescents, with people of lower socioeconomic status or of low verbal skill and intelligence. (Author/SJL)

Art Therapy, Men and the Expressivity Gap

ERIC Educational Resources Information Center

Trombetta, Robert

2007-01-01

Men as a discrete subject group and the gender-based nuances of their visual expression is a relatively unexplored art therapy research topic. The author describes a study designed to investigate the lived experience of a male subject in communicating about an episode of major depression, through both verbal communication and associations to…

Cognitive Behavioral Therapy for Anxiety in Children with Autism Spectrum Disorders: A Randomized, Controlled Trial

ERIC Educational Resources Information Center

Wood, Jeffrey J.; Drahota, Amy; Sze, Karen; Har, Kim; Chiu, Angela; Langer, David A.

2009-01-01

Background: Children with autism spectrum disorders often present with comorbid anxiety disorders that cause significant functional impairment. This study tested a modular cognitive behavioral therapy (CBT) program for children with this profile. A standard CBT program was augmented with multiple treatment components designed to accommodate or…

42 CFR 413.106 - Reasonable cost of physical and other therapy services furnished under arrangements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... provider or other organization had such services been performed by such person in an employment... of therapy, to therapists working full time in an employment relationship. (2) Fringe benefit and... that the study designs, questionnaires and instructions, as well as the resultant survey data for...

AUTOGENIC THERAPY IN TENSION HEADACHE

PubMed Central

Amruthraj, Brunda; Mishra, H.; Kumaraiah, V.

1987-01-01

SUMMARY Ten subjects diagnosed as Psychalgia were taken for study. A multiple baseline design was adapted and clients were subjected to 30 sessions of autogenic training. They were assessed using physiological (EMG and thermal change) and behavioural measures (Visual analogue scale and behavioural symptom checklist). Findings revealed autogenic therapy to be effective in reducing tension headache. PMID:21927245

Parkinson's Disease Gene Therapy: Success by Design Meets Failure by Efficacy

PubMed Central

Bartus, Raymond T; Weinberg, Marc S; Samulski, R. Jude

2014-01-01

Over the past decade, nine gene therapy clinical trials for Parkinson's disease (PD) have been initiated and completed. Starting with considerable optimism at the initiation of each trial, none of the programs has yet borne sufficiently robust clinical efficacy or found a clear path toward regulatory approval. Despite the immediately disappointing nature of the efficacy outcomes in these trials, the clinical data garnered from the individual studies nonetheless represent tangible and significant progress for the gene therapy field. Collectively, the clinical trials demonstrate that we have overcome the major safety hurdles previously suppressing central nervous system (CNS) gene therapy, for none produced any evidence of untoward risk or harm after administration of various vector-delivery systems. More importantly, these studies also demonstrated controlled, highly persistent generation of biologically active proteins targeted to structures deep in the human brain. Therefore, a renewed, focused emphasis must be placed on advancing clinical efficacy by improving clinical trial design, patient selection and outcome measures, developing more predictive animal models to support clinical testing, carefully performing retrospective analyses, and most importantly moving forward—beyond our past limits. PMID:24356252

02A. Design, Methods, and Outcomes for Recent Clinical Trials Utilizing Ayurvedic Medicine, Yoga, and Meditation

PubMed Central

Saper, Robert; Vinjamury, Sivarama; Elder, Charles

2013-01-01

Focus Area: Integrative Approaches to Care The panel discussants will present on the outcomes of four recent pragmatic trials covering the spectrum of Ayurvedic medicine, yoga, and meditation as therapeutic approaches for both acute and chronic conditions. The presenters will discuss: (1) a pilot study of a whole-systems Ayurveda and Yoga Therapy intervention for obesity; (2) a comparative effectiveness randomized controlled trial of hatha yoga, physical therapy, and education for non-specific chronic low back pain in low-income minority populations; (3) an investigation of the therapeutic usefulness of Shirodhara (Ayurvedic oil dripping therapy) as a treatment for insomnia; and (4) a discussion of the evidence base supporting implementation of meditation interventions in schools and workplace settings. Discussants will present information on study designs, research methodology, and outcome measure selection to highlight special considerations in conducting research on whole medical systems that use multi-target therapies and focus on patient-centered outcomes. Ayurvedic medicine and yoga are characterized by low-cost, noninvasive interventions that can be usefully offered as part of an integrative medicine therapeutic approach.

Multimodal therapy of word retrieval disorder due to phonological encoding dysfunction.

PubMed

Weill-Chounlamountry, Agnès; Capelle, Nathalie; Tessier, Catherine; Pradat-Diehl, Pascale

2013-01-01

To determine whether phonological multimodal therapy can improve naming and communication in a patient showing a lexical phonological naming disorder. This study employed oral and written learning tasks, using an error reduction procedure. A single-case design computer-assisted treatment was used with a 52 year-old woman with fluent aphasia consecutive to a cerebral infarction. The cognitive analysis of her word retrieval disorder exhibited a phonological encoding dysfunction. Thus, a phonological procedure was designed addressing the output phonological lexicon using computer analysis of spoken and written words. The effects were tested for trained words, generalization to untrained words, maintenance and specificity. Transfer of improvement to daily life was also assessed. After therapy, the verbal naming of both trained and untrained words was improved at p < 0.001. The improvement was still maintained after 3 months without therapy. This treatment was specific since the word dictation task did not change. Communication in daily life was improved at p < 0.05. This study of a patient with word retrieval disorder due to phonological encoding dysfunction demonstrated the effectiveness of a phonological and multimodal therapeutic treatment.

An Aristotelian view of therapists' practice in multifamily therapy for young adults with severe eating disorders.

PubMed

Brinchmann, Berit Støre; Moe, Cathrine; Valvik, Mildrid Elisabeth; Balmbra, Steven; Lyngmo, Siri; Skarbø, Tove

2017-01-01

Eating disorders are serious conditions which also impact the families of adult patients. There are few qualitative studies of multifamily therapy with adults with severe eating disorders and none concerning the practice of therapists in multifamily therapy. The aim of the study is to explore therapists' practice in multifamily therapy. Research design and participants: A grounded theory approach was chosen. Data were collected through participant observation in two multifamily therapy groups and qualitative interviews with the therapists in those groups. Ethical considerations: The study conforms to the principles outlined in the Declaration of Helsinki. All participants in the multifamily therapy groups received information about the research project and signed consent forms. The data are treated confidentially and anonymised. The core category was identified as 'having many strings to one's bow', consisting of three subcategories: 'planning and readjusting', 'developing as therapist and team' and 'regulating the temperature of the group'. This article discusses the empirical findings in the frame of Aristotelian virtue ethics.

Benefits of Student Engagement in Intervention Research.

PubMed

Schwartz, Jaclyn K; Smith, Roger O

2015-01-01

Accreditation standards require entry-level occupational therapy students to understand, critique, and design research. However, the extent to which students should be embedded in research projects is unclear. The purpose of this study was to understand the benefits of student immersion in research for student learning and research quality. Using a multiple case study design, the principal investigator trained six occupational therapy students to implement a manualized intervention with research participants. Learning quizzes, video analysis of research activities, a practical exam, student documentation, an exit interview, and an exit survey identified student learning and research outcomes. Students successfully implemented the study protocols with good reliability (intraclass correlation coefficient = .89) and fidelity (99%). Students also reported improvements in comfort with client interactions, confidence in practice skills, self-efficacy in research, and clinical reasoning. Student participation in hands-on research supports researchers in attaining their research goals and provides students with valuable learning experiences. Copyright © 2015 by the American Occupational Therapy Association, Inc.

Cognitive group therapy for depressive students: The case study

PubMed Central

Tiuraniemi, Juhani; Korhola, Jarno

2009-01-01

The aims of this study were to assess whether a course of cognitive group therapy could help depressed students and to assess whether assimilation analysis offers a useful way of analysing students' progress through therapy. “Johanna” was a patient in a group that was designed for depressive students who had difficulties with their studies. The assimilation of Johanna's problematic experience progressed as the meetings continued from level one (unpleasant thoughts) to level six (solving the problem). Johanna's problematic experience manifested itself as severe and excessive criticism towards herself and her study performance. As the group meetings progressed, Johanna found a new kind of tolerance that increased her determination and assertiveness regarding the studies. The dialogical structure of Johanna's problematic experience changed: she found hope and she was more assertive after the process. The results indicated that this kind of psycho-educational group therapy was an effective method for treating depression. The assimilation analysis offered a useful way of analysing the therapy process. PMID:20523883

Brief Report: Effects of Solution-Focused Brief Therapy Group-Work on Promoting Post-Traumatic Growth of Mothers Who Have a Child with ASD

ERIC Educational Resources Information Center

Zhang, Wei; Yan, Ting-ting; Du, Ya-song; Liu, Xiao-hong

2014-01-01

The study evaluated the impact of solution-focused brief therapy (SFBT) group-work on the post-traumatic growth (PTG) of mothers who have a child with ASD. A quasi-experimental design was used in which 43 mothers participated. 18 mothers in 2 SFBT groups (n = 9 in each group) received a 6-session SFBT group therapy while 25 mothers in a control…

Treatment of melasma with topical agents, peels and lasers: an evidence-based review.

PubMed

Rivas, Shelly; Pandya, Amit G

2013-10-01

Melasma is an acquired disorder of hyperpigmentation occurring on the face and predominantly affecting women of childbearing age. It is a chronic, often relapsing condition with a negative impact on quality of life. Current treatments for melasma are unsatisfactory. The aim of this article was to conduct an evidence-based review of interventions available for the treatment of melasma. A systematic literature search was performed using PubMed and the keywords 'melasma' or 'chloasma' in the title. The search was further refined by using a filter for 'controlled clinical trials' and 'randomized controlled trial'. The included studies were used to develop recommendations for treatment. The electronic search yielded a total of 80 citations. Forty studies were included in this review, which had a total of 2,912 participants. Three different therapeutic modalities were investigated-topical agents, chemical peels, and laser and light therapies. Topical depigmenting agents were found to be the most effective in treating moderate-to-severe melasma, with combination therapies, such as triple-combination therapy (hydroquinone, tretinoin, and fluocinolone acetonide), yielding the best results. Chemical peels as well as laser and light therapies were found to have moderate benefit but more studies are needed to determine their efficacy and long-term safety. Adverse events associated with treatment were mild and short-lasting and included skin irritation, dryness, burning, and erythema. The data could not be statistically pooled because of the heterogeneity of treatments and lack of consistency across study designs. Topical combination therapies were found to be more effective than monotherapy. Triple combination therapy was found to be the most effective, but approximately 40 % of patients develop erythema and peeling. Chemical peels and laser and light therapies produced mixed results, with increased risk of irritation and subsequent hyperpigmentation, particularly in darker-skinned individuals. Hence, current treatments available for melasma remain unsatisfactory. Many of the studies lacked long-term follow-up. Limitations of current literature include the heterogeneity of study designs, small sample sizes, and poor follow-up rates. Additional evidence for the effects and role of sunscreens is needed. Categorization or stratification of demographic data should also be included in future studies, such as age, melasma type, and duration of melasma prior to initiation of treatment. Patient's perception of improvement versus investigator's assessment of improvement should also be included in future studies and standardized methods of study design and assessment of outcomes are needed to form definitive conclusions on the efficacy of different treatment modalities.

Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD.

PubMed

Rutledge, Thomas; Nidich, Sanford; Schneider, Robert H; Mills, Paul J; Salerno, John; Heppner, Pia; Gomez, Mayra A; Gaylord-King, Carolyn; Rainforth, Maxwell

2014-09-01

Although meditation therapies such as the Transcendental Meditation (TM) technique are commonly used to assist with stress and stress-related diseases, there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness. This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder (PTSD) in a Veteran population. This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure (PE) - and an active control condition (health education [HE]) for PTSD. This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD, with testing conducted at 0 and 3 months for PTSD symptoms, depression, mood disturbance, quality of life, behavioral factors, and physiological/biochemical and gene expression mechanisms using validated measures. The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms, using the Clinician Administered PTSD Scale (CAPS). The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD. The projected results will help to establish the overall efficacy of TM for PTSD among Veterans, identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms, and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD. Published by Elsevier Inc.

Mental health consumer participation in education: a structured literature review.

PubMed

Arblaster, Karen; Mackenzie, Lynette; Willis, Karen

2015-10-01

Consumer participation in design, delivery and evaluation of occupational therapy educational programs is a recently introduced requirement for accreditation. It aligns with the principle of recovery, which underpins Australian mental health policy. Graduates' capabilities for recovery-oriented practice are thought to be enhanced through learning from consumers' lived experience. This structured literature review evaluates the current evidence for mental health consumer participation in health professional education to inform occupational therapy educators. Searches were completed in five online databases, one journal and published reading lists on the topic. Studies were included if they addressed mental health consumer participation in health professional education programs, were published in peer reviewed journals between 2000 and 2014 and were in English. Articles were critically reviewed, and analysed for key findings related to stages of the educational process and recovery-oriented practice capabilities. An emerging body of evidence for consumer participation in mental health education was identified. Studies are characterised by a lack of quality and a low to medium level of evidence. Findings relate to design, planning, delivery and evaluation of education as well as to most aspects of recovery-oriented practice. Emphases on exploratory research and proximal outcomes, and a reliance on published outcome measurement instruments designed for other purposes are key limitations in this body of evidence. This study identifies a weak evidence base for the requirement for consumer participation in occupational therapy programs, specifically related to mental health curricula. A research agenda is proposed in response. © 2015 Occupational Therapy Australia.

Reinventing clinical trials: a review of innovative biomarker trial designs in cancer therapies.

PubMed

Lin, Ja-An; He, Pei

2015-06-01

Recently, new clinical trial designs involving biomarkers have been studied and proposed in cancer clinical research, in the hope of incorporating the rapid growing basic research into clinical practices. Journal articles related to various biomarkers and their role in cancer clinical trial, articles and books about statistical issues in trial design, and regulatory website, documents, and guidance for submission of targeted cancer therapies. The drug development process involves four phases. The confirmatory Phase III is essential in regulatory approval of a special treatment. Regulatory agency has restrictions on confirmatory trials 'using adaptive designs'. No rule of thumb to pick the most appropriate design for biomarker-related trials. Statistical issues to solve in new designs. Regulatory acceptance of the 'newly proposed trial designs'. Biomarker-related trial designs that can resolve the statistical issues and satisfy the regulatory requirement. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Acupuncture Therapy for the Treatment of Myelosuppression after Chemotherapy: A Literature Review over the Past 10 Years.

PubMed

Fu, Hongwei; Chen, Bo; Hong, Shouhai; Guo, Yi

2015-06-01

The aim of this study is to review current studies on the effect of acupuncture therapy on bone marrow suppression after chemotherapy. The authors of the present paper have searched related literature over the past 10 years at home and abroad, analyzing the features and the effects of acupuncture therapy (including acupuncture, moxibustion, point injection, point application, etc.) for treating myelosuppression after tumor chemotherapy. We also discuss the year of publication, document type, acupuncture therapy, acupoint selection, and adverse effects with figures. We analyzed 159 articles related to acupuncture therapy from 2004 to 2013, and the analysis revealed that point injection was the most frequently used therapy for clinical applications, and that Zusanli (ST36) was the most frequently used acupoint. The results showed that some problems regarding the design method, acupoint selection, and acupuncture intervention measure existed in those research studies. We hope to provide readers with an overall and objective understanding of acupuncture and moxibustion therapy for treating myelosuppression after tumor chemotherapy. Copyright © 2015. Published by Elsevier B.V.

Eye Movement Desensitisation and Reprocessing Therapy for Posttraumatic Stress Disorder in a Child and an Adolescent with Mild to Borderline Intellectual Disability: A Multiple Baseline across Subjects Study

ERIC Educational Resources Information Center

Mevissen, Liesbeth; Didden, Robert; Korzilius, Hubert; de Jongh, Ad

2017-01-01

Background: This study explored the effectiveness of eye movement desensitisation and reprocessing (EMDR) therapy for post-traumatic stress disorder (PTSD) in persons with mild to borderline intellectual disability (MBID) using a multiple baseline across subjects design. Methods: One child and one adolescent with MBID, who met diagnostic criteria…

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

PubMed Central

2013-01-01

Background Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. Methods/design The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Discussion Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Trial registration Number Dutch Trial registration (Nederlands Trial Register): NTR3437 PMID:23855591

Onboard functional and molecular imaging: A design investigation for robotic multipinhole SPECT

PubMed Central

Bowsher, James; Yan, Susu; Roper, Justin; Giles, William; Yin, Fang-Fang

2014-01-01

Purpose: Onboard imaging—currently performed primarily by x-ray transmission modalities—is essential in modern radiation therapy. As radiation therapy moves toward personalized medicine, molecular imaging, which views individual gene expression, may also be important onboard. Nuclear medicine methods, such as single photon emission computed tomography (SPECT), are premier modalities for molecular imaging. The purpose of this study is to investigate a robotic multipinhole approach to onboard SPECT. Methods: Computer-aided design (CAD) studies were performed to assess the feasibility of maneuvering a robotic SPECT system about a patient in position for radiation therapy. In order to obtain fast, high-quality SPECT images, a 49-pinhole SPECT camera was designed which provides high sensitivity to photons emitted from an imaging region of interest. This multipinhole system was investigated by computer-simulation studies. Seventeen hot spots 10 and 7 mm in diameter were placed in the breast region of a supine female phantom. Hot spot activity concentration was six times that of background. For the 49-pinhole camera and a reference, more conventional, broad field-of-view (FOV) SPECT system, projection data were computer simulated for 4-min scans and SPECT images were reconstructed. Hot-spot localization was evaluated using a nonprewhitening forced-choice numerical observer. Results: The CAD simulation studies found that robots could maneuver SPECT cameras about patients in position for radiation therapy. In the imaging studies, most hot spots were apparent in the 49-pinhole images. Average localization errors for 10-mm- and 7-mm-diameter hot spots were 0.4 and 1.7 mm, respectively, for the 49-pinhole system, and 3.1 and 5.7 mm, respectively, for the reference broad-FOV system. Conclusions: A robot could maneuver a multipinhole SPECT system about a patient in position for radiation therapy. The system could provide onboard functional and molecular imaging with 4-min scan times. PMID:24387490

Onboard functional and molecular imaging: A design investigation for robotic multipinhole SPECT

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bowsher, James, E-mail: james.bowsher@duke.edu; Giles, William; Yin, Fang-Fang

2014-01-15

Purpose: Onboard imaging—currently performed primarily by x-ray transmission modalities—is essential in modern radiation therapy. As radiation therapy moves toward personalized medicine, molecular imaging, which views individual gene expression, may also be important onboard. Nuclear medicine methods, such as single photon emission computed tomography (SPECT), are premier modalities for molecular imaging. The purpose of this study is to investigate a robotic multipinhole approach to onboard SPECT. Methods: Computer-aided design (CAD) studies were performed to assess the feasibility of maneuvering a robotic SPECT system about a patient in position for radiation therapy. In order to obtain fast, high-quality SPECT images, a 49-pinholemore » SPECT camera was designed which provides high sensitivity to photons emitted from an imaging region of interest. This multipinhole system was investigated by computer-simulation studies. Seventeen hot spots 10 and 7 mm in diameter were placed in the breast region of a supine female phantom. Hot spot activity concentration was six times that of background. For the 49-pinhole camera and a reference, more conventional, broad field-of-view (FOV) SPECT system, projection data were computer simulated for 4-min scans and SPECT images were reconstructed. Hot-spot localization was evaluated using a nonprewhitening forced-choice numerical observer. Results: The CAD simulation studies found that robots could maneuver SPECT cameras about patients in position for radiation therapy. In the imaging studies, most hot spots were apparent in the 49-pinhole images. Average localization errors for 10-mm- and 7-mm-diameter hot spots were 0.4 and 1.7 mm, respectively, for the 49-pinhole system, and 3.1 and 5.7 mm, respectively, for the reference broad-FOV system. Conclusions: A robot could maneuver a multipinhole SPECT system about a patient in position for radiation therapy. The system could provide onboard functional and molecular imaging with 4-min scan times.« less

An updated review of the efficacy of cupping therapy.

PubMed

Cao, Huijuan; Li, Xun; Liu, Jianping

2012-01-01

Since 1950, traditional Chinese medicine (TCM) cupping therapy has been applied as a formal modality in hospitals throughout China and elsewhere in the world. Based on a previous systematic literature review of clinical studies on cupping therapy, this study presents a thorough review of randomized controlled trials (RCTs) to evaluate the therapeutic effect of cupping therapy. Six databases were searched for articles published through 2010. RCTs on cupping therapy for various diseases were included. Studies on cupping therapy combined with other TCM treatments versus non-TCM therapies were excluded. 135 RCTs published from 1992 through 2010 were identified. The studies were generally of low methodological quality. Diseases for which cupping therapy was commonly applied were herpes zoster, facial paralysis (Bell palsy), cough and dyspnea, acne, lumbar disc herniation, and cervical spondylosis. Wet cupping was used in most trials, followed by retained cupping, moving cupping, and flash cupping. Meta-analysis showed cupping therapy combined with other TCM treatments was significantly superior to other treatments alone in increasing the number of cured patients with herpes zoster, facial paralysis, acne, and cervical spondylosis. No serious adverse effects were reported in the trials. Numerous RCTs on cupping therapy have been conducted and published during the past decades. This review showed that cupping has potential effect in the treatment of herpes zoster and other specific conditions. However, further rigorously designed trials on its use for other conditions are warranted.

Importance of Virtual Reality to Virtual Reality Exposure Therapy, Study Design of a Randomized Trial.

PubMed

McLay, Robert N; Baird, Alicia; Murphy, Jennifer; Deal, William; Tran, Lily; Anson, Heather; Klam, Warren; Johnston, Scott

2015-01-01

Post Traumatic Stress Disorder (PTSD) can be a debilitating problem in service members who have served in Iraq or Afghanistan. Virtual Reality Exposure Therapy (VRET) is one of the few interventions demonstrated in randomized controlled trials to be effective for PTSD in this population. There are theoretical reasons to expect that Virtual Reality (VR) adds to the effectiveness of exposure therapy, but there is also added expense and difficulty in using VR. Described is a trial comparing outcomes from VRET and a control exposure therapy (CET) protocol in service members with PTSD.

Effects of music therapy on drug avoidance self-efficacy in patients on a detoxification unit: a three-group randomized effectiveness study.

PubMed

Silverman, Michael J

2014-01-01

Self-efficacy is a component of Bandura's social cognitive theory and can lead to abstinence and a reduction of relapse potential for people who have substance abuse disorders. To date, no music therapy researcher has utilized this theoretical model to address abstinence and reduce the likelihood of relapse in people who have addictions. The purpose of this study was to determine the effects of music therapy on drug avoidance self-efficacy in a randomized three-group wait-list control design with patients on a detoxification unit. Participants (N = 131) were cluster randomized to one of three single-session conditions: music therapy, verbal therapy, or wait-list control. Music therapy participants received a group lyric analysis intervention, verbal therapy participants received a group talk therapy session, and wait-list control participants eventually received a group recreational music therapy intervention. Although there was no significant between-group difference in drug avoidance self-efficacy, participants in the music therapy condition tended to have the highest mean drug avoidance self-efficacy scores. Posttest written comments supported the use of both music therapy and verbal therapy sessions. Two music therapy participants specifically noted that their initial skepticism had dissipated after receiving music therapy. Despite a lack of significant differences, the theoretical support of self-efficacy for substance abuse rehabilitation suggests that this may be an area of continued clinical focus and empirical investigation. Clinical anecdotes, limitations of the study, and suggestions for future research are provided.

The Effect of Music Therapy in Patients with Huntington's Disease: A Randomized Controlled Trial.

PubMed

van Bruggen-Rufi, Monique C H; Vink, Annemieke C; Wolterbeek, Ron; Achterberg, Wilco P; Roos, Raymund A C

2017-01-01

Music therapy may have beneficial effects on improving communication and expressive skills in patients with Huntington's disease (HD). Most studies are, however, small observational studies and methodologically limited. Therefore we conducted a multi-center randomized controlled trial. To determine the efficacy of music therapy in comparison with recreational therapy in improving quality of life of patients with advanced Huntington's disease by means of improving communication. Sixty-three HD-patients with a Total Functional Capacity (TFC) score of ≤7, admitted to four long-term care facilities in The Netherlands, were randomized to receive either group music therapy or group recreational therapy in 16 weekly sessions. They were assessed at baseline, after 8, 16 and 28 weeks using the Behaviour Observation Scale for Huntington (BOSH) and the Problem Behaviour Assessment-short version (PBA-s). A linear mixed model with repeated measures was used to compare the scores between the two groups. Group music therapy offered once weekly for 16 weeks to patients with Huntington's disease had no additional beneficial effect on communication or behavior compared to group recreational therapy. This was the first study to assess the effect of group music therapy on HD patients in the advanced stages of the disease. The beneficial effects of music therapy, recorded in many, mainly qualitative case reports and studies, could not be confirmed with the design (i.e. group therapy vs individual therapy) and outcome measures that have been used in the present study. A comprehensive process-evaluation alongside the present effect evaluation is therefore performed.

Interventions for Enhancing Adherence to Antiretroviral Therapy (ART): A Systematic Review of High Quality Studies

PubMed Central

Sivaramalingam, Bhairavi; Navarro, Tamara; Hobson, Nicholas; Keepanasseril, Arun; Wilczynski, Nancy J.; Haynes, R. Brian

2015-01-01

Abstract We sought to review the effectiveness of interventions designed to improve adherence to antiretroviral therapy (ART) from studies included in a recent Cochrane review that reported a clinical and an adherence outcome, with at least 80% follow-up for 6 months or more. Data were extracted independently and in duplicate, with an adjudicator for disagreements. Risk of bias was assessed using the Cochrane Risk of Bias tool. Of 182 relevant studies in the Cochrane review, 49 were related to ART. Statistical pooling was not warranted due to heterogeneity in interventions, participants, treatments, adherence measures and outcomes. Many studies had high risk of bias in elements of design and outcome ascertainment. Only 10 studies improved both adherence and clinical outcomes. These used the following interventions: adherence counselling (two studies); a once-daily regimen (compared to twice daily); text messaging; web-based cognitive behavioral intervention; face-to-face multi-session intensive behavioral interventions (two studies); contingency management; modified directly observed therapy; and nurse-delivered home visits combined with telephone calls. Patient-related adherence interventions were the most frequently tested. Uniform adherence measures and higher quality studies of younger populations are encouraged. PMID:25825938

Cost Sharing, Family Health Care Burden, and the Use of Specialty Drugs for Rheumatoid Arthritis

PubMed Central

Karaca-Mandic, Pinar; Joyce, Geoffrey F; Goldman, Dana P; Laouri, Marianne

2010-01-01

Objectives To examine the impact of benefit generosity and household health care financial burden on the demand for specialty drugs in the treatment of rheumatoid arthritis (RA). Data Sources/Study Setting Enrollment, claims, and benefit design information for 35 large private employers during 2000–2005. Study Design We estimated multivariate models of the effects of benefit generosity and household financial burden on initiation and continuation of biologic therapies. Data Extraction Methods We defined initiation of biologic therapy as first-time use of etanercept, adalimumab, or infliximab, and we constructed an index of plan generosity based on coverage of biologic therapies in each plan. We estimated the household's burden by summing up the annual out-of-pocket (OOP) expenses of other family members. Principal Findings Benefit generosity affected both the likelihood of initiating a biologic and continuing drug therapy, although the effects were stronger for initiation. Initiation of a biologic was lower in households where other family members incurred high OOP expenses. Conclusions The use of biologic therapy for RA is sensitive to benefit generosity and household financial burden. The increasing use of coinsurance rates for specialty drugs (as under Medicare Part D) raises concern about adverse health consequences. PMID:20831715

The top cited articles in occupational therapy: a citation analysis study.

PubMed

Nowrouzi-Kia, Behdin; Chidu, Carla; Carter, Lorraine; McDougall, Alicia; Casole, Jennifer

2018-01-01

The purpose of this study was to identify and review the most cited articles in the occupational therapy field. Using the multi-disciplinary Publish or Perish software to extract data, the top 50 lifetime and annual cited articles were examined. Studies were organized according to the following: year of publication, design, topic, number of authors, country of publication, and number of citations for each cohort. We found that randomized control trials were the dominant design type used in papers with the most lifetime (36.0%) and annual (26.0%) citations. Additionally, in both groups, the most frequently cited articles investigated predictors of functional outcome for patients. This comprehensive citation analysis will inform future research through its identification of major trends and well-established areas of study.

Influence of Music Therapy on Coping Skills and Anger Management in Forensic Psychiatric Patients: An Exploratory Study.

PubMed

Hakvoort, Laurien; Bogaerts, Stefan; Thaut, Michael H; Spreen, Marinus

2015-07-01

The effect of music therapy on anger management and coping skills is an innovative subject in the field of forensic psychiatry. This study explores the following research question: Can music therapy treatment contribute to positive changes in coping skills, anger management, and dysfunctional behavior of forensic psychiatric patients? To investigate this question, first a literature review is offered on music therapy and anger management in forensic psychiatry. Then, an explorative study is presented. In the study, a pre- and post-test design was used with a random assignment of patients to either treatment or control condition. Fourteen participants' complete datasets were collected. All participants received "treatment as usual." Nine of the participants received a standardized, music therapy anger management program; the five controls received, unplanned, an aggression management program. Results suggested that anger management skills improved for all participants. The improvement of positive coping skills and diminishing of avoidance as a coping skill were measured to show greater changes in music therapy participants. When controlling for the exact number of treatment hours, the outcomes suggested that music therapy might accelerate the process of behavioral changes. © The Author(s) 2013.

How do eHealth Programs for Adolescents With Depression Work? A Realist Review of Persuasive System Design Components in Internet-Based Psychological Therapies.

PubMed

Wozney, Lori; Huguet, Anna; Bennett, Kathryn; Radomski, Ashley D; Hartling, Lisa; Dyson, Michele; McGrath, Patrick J; Newton, Amanda S

2017-08-09

Major depressive disorders are common among adolescents and can impact all aspects of their daily life. Traditional therapies, cognitive behavioral therapy (CBT), and interpersonal psychotherapy (IPT) have been delivered face-to-face. However, Internet-based (online) delivery of these therapies is emerging as an option for adolescents. Internet-based CBT and IPT involve therapeutic content, interaction between the user and the system, and different technological features embedded into the online program (eg, multimedia). Studies of Internet-based CBT and IPT for adolescent depression differ on all three aspects, and variable, positive therapy effects have been reported. A better understanding of the treatment conditions that influence therapy outcomes is important to designing and evaluating these novel therapies. Our aim was to examine the technological and program delivery features of Internet-based CBT and IPT for adolescent depression and to document their potential relation to treatment outcomes and program use. We performed a realist synthesis. We started with an extensive search of published and gray literature. We included intervention studies that evaluated Internet-based CBT or IPT for adolescent depression. We included mixed-methods and qualitative studies, theoretical papers, and policy/implementation documents if they included a focus on how Internet-based psychological therapy is proposed to work for adolescents with depression/depressive symptoms. We used the Mixed-Methods Appraisal Tool to assess the methodological quality of studies. We used the Persuasive System Design (PSD) model as a framework for data extraction and analysis to examine how Internet-based CBT and IPT, as technology-based systems, influence the attitudes and behaviors of system users. PSD components described for the therapies were linked to reported outcomes using a cross-case comparison method and thematic synthesis. We identified 19 Internet-based CBT programs in 59 documents. Of those, 71% (42/59) were of moderate to high quality. The PSD features surface credibility (competent "look and feel"), dialogue support (online program + in-person support), liking and similarity (esthetics and content appeal to adolescent users), the reduction and tunneling of therapeutic content (reducing online content into simple tasks, guiding users), and use of self-monitoring were present in therapies that resulted in improved therapy engagement, satisfaction, and adherence, as well as symptom and functional impairments. When incorporated into Internet-based CBT for adolescent depression, PSD features may improve adolescent adherence, satisfaction, and depression-related outcomes. Testing of these features using hypothesis-driven dismantling approaches is recommended to advance our understanding of how these features contribute to therapy effectiveness. ©Lori Wozney, Anna Huguet, Kathryn Bennett, Ashley D Radomski, Lisa Hartling, Michele Dyson, Patrick J McGrath, Amanda S Newton. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 09.08.2017.

The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

2015-01-01

Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

"I Feel I Mean Something to Someone:" Solution-Focused Brief Therapy Support Groups for Bullied Schoolchildren

ERIC Educational Resources Information Center

Kvarme, Lisbeth Gravdal; Aabø, Liv Sandnes; Saeteren, Berit

2013-01-01

The aim of this study was to investigate how bullied schoolchildren experience solution-focused brief therapy support groups, and to examine how members of the support group experience their participation in the group. An explorative qualitative design, with individual and focus group interviews, was used. The sample consisted of 19…

Acceptance and Commitment Therapy for Self-Stigma around Sexual Orientation: A Multiple Baseline Evaluation

ERIC Educational Resources Information Center

Yadavaia, James E.; Hayes, Steven C.

2012-01-01

This study evaluated the effectiveness of 6 to 10 sessions of Acceptance and Commitment Therapy (ACT) for self-stigma around sexual orientation linked to same-sex attraction (what has generally been referred to as internalized homophobia; IH) in a concurrent multiple-baseline across-participants design. Three men and 2 women showed sizeable…

Acceptance and Commitment Therapy for Adults Who Stutter: Psychosocial Adjustment and Speech Fluency

ERIC Educational Resources Information Center

Beilby, Janet M.; Byrnes, Michelle L.; Yaruss, J. Scott

2012-01-01

The aim of the present study was to assess the effectiveness of an Acceptance and Commitment Therapy group intervention program for adults who stutter (N = 20). The program consisted of 2-h therapeutic sessions conducted weekly for eight consecutive weeks. It was an integrated program designed to improve: (a) psychosocial functioning, (b)…

A Cognitive Behavioral Therapy Model: Integrating Anxiety and Phobia Coping Strategies into Fundamentals of Public Speaking College Courses

ERIC Educational Resources Information Center

Oumano, Elena

2005-01-01

This study was designed to examine the effectiveness of the "Fear and Loathing of Speaking Out in Public" program. The program, a personal initiative, adapts primary features of the treatment offered by Cognitive Behavioral Therapy (CBT) for clients suffering from fears and phobias. CBT strategies include progressive desensitization, identifying…

Efficacy of Cognitive-Behavioral Therapy for Comorbid Panic Disorder with Agoraphobia and Generalized Anxiety Disorder

ERIC Educational Resources Information Center

Labrecque, Joane; Marchand, Andre; Dugas, Michel J.; Letarte, Andree

2007-01-01

The goal of this study was to evaluate the efficacy of cognitive-behavioral therapy for comorbid panic disorder with agoraphobia (PDA) and generalized anxiety disorder (GAD) by combining treatment strategies for both disorders. A single-case, multiple-baseline design across participants was used. Three participants with primary PDA and secondary…

Evaluation of Occupational Therapy Workshops to Prevent Work-Related Injuries or Illnesses among Vocational Students

ERIC Educational Resources Information Center

Lecours, Alexandra; Therriault, Pierre-Yves

2018-01-01

The few studies aiming to evaluate prevention interventions provided by occupational therapists in health at work were conducted in work settings. However, to intervene in primary prevention, developing occupational therapy interventions with students learning a trade is relevant. The objective is to evaluate workshops designed and set up by…

Sound Continuing Bonds with the Deceased: The Relevance of Music, Including Preloss Music Therapy, for Eight Bereaved Caregivers

ERIC Educational Resources Information Center

O'Callaghan, Clare C.; McDermott, Fiona; Hudson, Peter; Zalcberg, John R.

2013-01-01

This study examines music's relevance, including preloss music therapy, for 8 informal caregivers of people who died from cancer. The design was informed by constructivist grounded theory and included semistructured interviews. Bereaved caregivers were supported or occasionally challenged as their musical lives enabled a connection with the…

The Effect of Art Therapy with Clay on Hopelessness Levels Among Neurology Patients.

PubMed

Akhan, Latife Utas; Kurtuncu, Meltem; Celik, Sevim

This study was performed to determine the effect of art therapy with clay on hopelessness levels of patients under treatment in departments of neurology. The study was of one group, pre- and posttest design. This study was performed on patients who were hospitalized in the neurology departments of a university and a state hospital between February and May 2012 in Turkey. The sample for the study comprised 50 neurology patients with diagnoses of epilepsy (17 patients) and stroke (33 patients). The patients in the study were asked to create objects of clay of any shape they desired. Data for the research were collected with a sociodemographic data form and by using the Beck Hopelessness Scale (BHS). While BHS scores of neurology patients before clay therapy were found higher compared to the scores after therapy with clay, there was also a statistically significant difference. After clay therapy, BHS scores were lower in women, in married patients, in patients who suffered from a stroke, people who had chronic disease, people without psychological illness, and in the case of children. The study showed that clay therapy had an impact on the hopelessness levels of neurology patients. Art therapy with clay may be used for rehabilitation purposes in neurology patients, both in the hospital and at home after discharge.

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

PubMed Central

2014-01-01

Background 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. Methods 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. Results 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. Conclusion Demographic and clinical characteristics of the TOP MS sample at enrollment are consistent with other community-based MS samples, and the sample appears to be representative of DMT users in the US. TOP MS data can be used to explore the associations between disease-modifying therapy compliance and health outcomes. Trial registration ClinicalTrials.gov (NCT00819000) PMID:24624979

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

PubMed

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-based MS samples, and the sample appears to be representative of DMT users in the US. TOP MS data can be used to explore the associations between disease-modifying therapy compliance and health outcomes. ClinicalTrials.gov (NCT00819000).

[Dialectical Behavior Therapy (DBT)--developments and empirical evidence].

PubMed

Burmeister, Kerstin; Höschel, Klaus; von Auer, Anne Kristin; Reiske, Sophie; Schweiger, Ulrich; Sipos, Valerija; Philipsen, Alexandra; Priebe, Kathlen; Bohus, Martin

2014-07-01

Dialectical Behavior Therapy has been initially designed and evaluated as an outpatient-treatment program for chronic suicidal female patients. Within the last years, several adaptations of DBT for specific comorbidities, other settings or other disorders related to emotion dysregulation have been developed. This report reviews conceptual aspects and the scientific evidence of initially designed Dialectical Behavior Therapy and the adaptations. Systematic literature search and systematic review. Recently, two meta-analyses which are based on randomized controlled trials conclude robust and stabile effects of DBT Evidence from further RCTs and other studies show promise for the properties of many DBT adaptations. The current review of the literature suggests a good effectiveness of DBT, especially on complex disorders with deficits in the field of emotion regulation. © Georg Thieme Verlag KG Stuttgart · New York.

Aminoglycoside Therapy Manager: An Advanced Computer Program for Decision Support for Drug Dosing and Therapeutic Monitoring

PubMed Central

Lenert, Leslie; Lurie, Jon; Coleman, Robert; Klosterman, Heidrun; Blaschke, Terrence

1990-01-01

In this paper, we will describe an advanced drug dosing program, Aminoglycoside Therapy Manager that reasons using Bayesian pharmacokinetic modeling and symbolic modeling of patient status and drug response. Our design is similar to the design of the Digitalis Therapy Advisor program, but extends previous work by incorporating a Bayesian pharmacokinetic model, a “meta-level” analysis of drug concentrations to identify sampling errors and changes in pharmacokinetics, and including the results of the “meta-level” analysis in reasoning for dosing and therapeutic monitoring recommendations. The program is user friendly and runs on low cost general-purpose hardware. Validation studies show that the program is as accurate in predicting future drug concentrations as an expert using commercial Bayesian forecasting software.

Radiation shielding design of a new tomotherapy facility.

PubMed

Zacarias, Albert; Balog, John; Mills, Michael

2006-10-01

It is expected that intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT) will replace a large portion of radiation therapy treatments currently performed with conventional MLC-based 3D conformal techniques. IGRT may become the standard of treatment in the future for prostate and head and neck cancer. Many established facilities may convert existing vaults to perform this treatment method using new or upgraded equipment. In the future, more facilities undoubtedly will be considering de novo designs for their treatment vaults. A reevaluation of the design principles used in conventional vault design is of benefit to those considering this approach with a new tomotherapy facility. This is made more imperative as the design of the TomoTherapy system is unique in several aspects and does not fit well into the formalism of NCRP 49 for a conventional linear accelerator.

Using a digital game for training desirable behavior in cognitive-behavioral therapy of burnout syndrome: a controlled study.

PubMed

Zielhorst, Thomas; van den Brule, Daphne; Visch, Valentijn; Melles, Marijke; van Tienhoven, Sam; Sinkbaek, Helle; Schrieken, Bart; Tan, Eduard S-H; Lange, Alfred

2015-02-01

Burnout is a globally increasing illness, and as a result, many forms of burnout therapy have arisen. The use of digital games can be psychotherapeutically effective because they can transform exercises that are by themselves unattractive into intrinsically motivated action. This pilot study aims to test whether a specially designed game contributes to patients learning desired behavior and achieving other specific therapeutic goals in an online cognitive-behavioral therapy (CBT)-based burnout treatment context. In total, 101 participants took part in the experiment, under four conditions: (a) Game+Therapy, (b) Therapy Only, (c) Game Only, and (d) No Game+No Therapy. Pre- and postmeasures were taken online. Results showed that the two therapy conditions (Game+Therapy and Therapy Only) showed a greater decrease in complaints and disengagement, and a stronger increase in coping skills than the nontherapy conditions (Game Only and No Game+No Therapy). As expected, the Game+Therapy condition outperformed the Therapy Only condition on combined improvement measures of burnout symptoms. However, analyses of individual measures showed no effects. It can be cautiously concluded that the therapeutic digital game may be a useful tool when embedded in a therapeutic burnout treatment program and is probably more efficient than CBT, as it is used in current practice.

Genotoxicity of retroviral hematopoietic stem cell gene therapy

PubMed Central

Trobridge, Grant D

2012-01-01

Introduction Retroviral vectors have been developed for hematopoietic stem cell (HSC) gene therapy and have successfully cured X-linked severe combined immunodeficiency (SCID-X1), adenosine deaminase deficiency (ADA-SCID), adrenoleukodystrophy, and Wiskott-Aldrich syndrome. However, in HSC gene therapy clinical trials, genotoxicity mediated by integrated vector proviruses has led to clonal expansion, and in some cases frank leukemia. Numerous studies have been performed to understand the molecular basis of vector-mediated genotoxicity with the aim of developing safer vectors and safer gene therapy protocols. These genotoxicity studies are critical to advancing HSC gene therapy. Areas covered This review provides an introduction to the mechanisms of retroviral vector genotoxicity. It also covers advances over the last 20 years in designing safer gene therapy vectors, and in integration site analysis in clinical trials and large animal models. Mechanisms of retroviral-mediated genotoxicity, and the risk factors that contribute to clonal expansion and leukemia in HSC gene therapy are introduced. Expert opinion Continued research on virus–host interactions and next-generation vectors should further improve the safety of future HSC gene therapy vectors and protocols. PMID:21375467

Menopausal Symptom Relief and Side Effects Experienced by Women Using Bioidentical Hormone Replacement Therapy and Synthetic Conjugated Equine Estrogen and/or Progestin Hormone Replacement Therapy, Part 1.

PubMed

Deleruyelle, Laura J

2016-01-01

The use of compounded bioidentical hormone replacement therapy by menopausal women has become a popular alternative to traditional synthetic conjugated equine estrogen and progestin hormone replacement therapy due to safety concerns raised by recent studies. However, due to the lack of randomized, large-scale trials to evaluate the efficacy and side-effect profile of compounded bioidentical hormone replacement therapy many healthcare providers are reluctant to prescribe such therapy. The purpose of this study was to compare women's menopausal symptom relief and side effects experienced when using compounded bioidentical hormone replacement therapy and traditional hormone replacement therapy. A descriptive comparative design was used. Inferential and descriptive statistical procedures including a paired difference t -test, two-sample t -test, and f tests (percentage, mean, standard deviation, frequency) were run on the Statistical Package for the Social Sciences. The framework used to guide this study was Lenz and Pugh's Theory of Unpleasant Symptoms. Surveys were distributed once to a convenient sample of women aged 35 and older when they dropped off or picked up their prescriptions at a pharmacy. Of the 216 surveys distributed, 70 were returned from those women taking compounded bioidentical hormone replacement therapy and 53 from traditional hormone replacement therapy. The survey contained 15 questions pertaining to age, duration of hormone replacement therapy, type and formulation of hormone replacement therapy, reasons for initiating hormone replacement therapy, symptoms before and one month after hormone replacement therapy, and side effects related to hormone replacement therapy. The results of this study will be summarized in forthcoming articles in this series. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

TOOTH (The Open study Of dental pulp stem cell Therapy in Humans): Study protocol for evaluating safety and feasibility of autologous human adult dental pulp stem cell therapy in patients with chronic disability after stroke.

PubMed

Nagpal, Anjali; Kremer, Karlea L; Hamilton-Bruce, Monica A; Kaidonis, Xenia; Milton, Austin G; Levi, Christopher; Shi, Songtao; Carey, Leeanne; Hillier, Susan; Rose, Miranda; Zacest, Andrew; Takhar, Parabjit; Koblar, Simon A

2016-07-01

Stroke represents a significant global disease burden. As of 2015, there is no chemical or biological therapy proven to actively enhance neurological recovery during the chronic phase post-stroke. Globally, cell-based therapy in stroke is at the stage of clinical translation and may improve neurological function through various mechanisms such as neural replacement, neuroprotection, angiogenesis, immuno-modulation, and neuroplasticity. Preclinical evidence in a rodent model of middle cerebral artery ischemic stroke as reported in four independent studies indicates improvement in neurobehavioral function with adult human dental pulp stem cell therapy. Human adult dental pulp stem cells present an exciting potential therapeutic option for improving post-stroke disability. TOOTH (The Open study Of dental pulp stem cell Therapy in Humans) will investigate the use of autologous stem cell therapy for stroke survivors with chronic disability, with the following objectives: (a) determine the maximum tolerable dose of autologous dental pulp stem cell therapy; (b) define that dental pulp stem cell therapy at the maximum tolerable dose is safe and feasible in chronic stroke; and (c) estimate the parameters of efficacy required to design a future Phase 2/3 clinical trial. TOOTH is a Phase 1, open-label, single-blinded clinical trial with a pragmatic design that comprises three stages: Stage 1 will involve the selection of 27 participants with middle cerebral artery ischemic stroke and the commencement of autologous dental pulp stem cell isolation, growth, and testing in sequential cohorts (n = 3). Stage 2 will involve the transplantation of dental pulp stem cell in each cohort of participants with an ascending dose and subsequent observation for a 6-month period for any dental pulp stem cell-related adverse events. Stage 3 will investigate the neurosurgical intervention of the maximum tolerable dose of autologous dental pulp stem cell followed by 9 weeks of intensive task-specific rehabilitation. Advanced magnetic resonance and positron emission tomography neuro-imaging, and clinical assessment will be employed to probe any change afforded by stem cell therapy in combination with rehabilitation. Nine participants will step-wise progress in Stage 2 to a dose of up to 10 million dental pulp stem cell, employing a cumulative 3 + 3 statistical design with low starting stem cell dose and subsequent dose escalation, assuming that an acceptable probability of dose-limiting complications is between 1 in 6 (17%) and 1 in 3 (33%) of patients. In Stage 3, another 18 participants will receive an intracranial injection with the maximum tolerable dose of dental pulp stem cell. The primary outcomes to be measured are safety and feasibility of intracranial administration of autologous human adult DPSC in patients with chronic stroke and determination of the maximum tolerable dose in human subjects. Secondary outcomes include estimation of the measures of effectiveness required to design a future Phase 2/3 clinical trial. © 2016 World Stroke Organization.

Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia.

PubMed

Lee, Jeannette Y; Foster, Harris E; McVary, Kevin T; Meleth, Sreelatha; Stavris, Karen; Downey, Joe; Kusek, John W

2011-05-01

The timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy. CAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS. The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS. The target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms. Successful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated study population.

Manual Therapy With Cryotherapy Versus Manual Therapy With Kinesio Taping for Males With Lumbar Discopathy: A Pilot Randomized Trial.

PubMed

Lizis, Pawel; Kobza, Wojciech

2017-06-23

Context • Numerous modalities of therapeutic interventions exist for lumbar discopathy. Manual therapy is one option, although its effectiveness remains controversial. The addition of cryotherapy to manual therapy may enhance the health benefits in patients with lumbar discopathy.  Objective • The study intended to evaluate the efficacy of manual therapy combined with cryotherapy vs manual therapy combined with Kinesio taping for males with lumbar discopathy. Design • The research team designed a pilot randomized trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Setting • The study occurred in the Physiotherapy Outpatient Department of the Regional Hospital (Zywiec, Poland). Participants • The participants were 40 males with lumbar discopathy, aged 30-75 y, who were patients in the department at the hospital. Intervention • The participants were randomly assigned to an intervention group that received Kaltenborn-Evjenth orthopedic manual therapy (KEOMT) combined with cryotherapy, the KEOMT-C group (n = 20), or to a control group that received KEOMT combined with Kinesio taping, the KEOMT-K group (n = 20). The participants in both groups received 10 treatments, 2 per wk for 5 wk. Outcome Measures • The primary outcome was measured using a visual analog scale and the Laitinen scale pain ratings. The secondary outcome measured the quality of life using the short form-36 questionnaire. The participants completed the tests at baseline and postintervention. Results • After the treatments, the intervention group had significantly lower scores than the control group for pain as well as significantly higher scores for quality of life. Conclusions • Patients achieved better health benefits from manual therapy when it was combined with cryotherapy.

The Effects of Technological Advances on Outcomes for Elderly Persons with Exudative Age-Related Macular Degeneration

PubMed Central

Sloan, Frank A.; Hanrahan, Brian W.

2014-01-01

Importance Exudative age-related macular degeneration (AMD) is the major cause of blindness among U.S. elderly. Developing effective therapies for this disease has been difficult. Objective This study assessed the impacts of introducing new therapies for treating exudative AMD on vision of the affected population and other outcomes among newly diagnosed Medicare beneficiaries. Design The study used data from a 5% sample of Medicare claims and enrollment data with a combination of a regression continuity design and propensity score matching (PSM) to assess the impacts on introduction/receipt of new technologies on study outcomes during a two-year follow-up period. Setting The analysis was based on longitudinal data for the U.S., 1994–2011, for Medicare beneficiaries with fee-for-service coverage. Participants The sample was limited to beneficiaries aged 68+ newly diagnosed with exudative AMD as indicated by beneficiaries having no claims with this diagnosis in a three-year look-back period. Exposures The comparisons with vision outcomes were after versus before introduction of photodynamic therapy (PDT) and anti-VEGF therapy. The comparisons for depression and long-term care facility admission were between beneficiaries newly diagnosed with exudative AMD who received PDT or anti-VEGF therapy compared to beneficiaries with the diagnosis receiving no therapy for this disease. Main Outcome and Measure Onset of decrease in vision, vision loss or blindness, depression, and admission to long term care facilities. Results Introduction of anti-VEGF therapy reduced vision loss and onset of severe vision loss and blindness of beneficiaries newly diagnosed with exudative AMD by 43% [0.50 0.66] on average. Such beneficiaries who received anti-VEGF therapy and were not admitted to a long-term care facility during the look-back period were 19% less likely on average to be admitted to a long-term care facility during follow-up. Conclusions and Relevance This study demonstrates gains in population vision from the introduction of anti-VEGF therapy for patients with an exudative AMD diagnosis aged 68+ in community-based settings in the U.S. PMID:24458013

[Efficacy of antiretroviral therapy and influencing factors for people living with HIV/AIDS in designated hospitals in Harbin].

PubMed

Zhao, P Y; Yu, X; Yang, K; Feng, S Y; Wang, F X; Wang, B Y

2016-05-01

To understand the efficacy of antiretroviral therapy for people living with HIV/AIDS and influencing factors; and provide evidence to improve the treatment of HIV infection and AIDS for the better life of the patients. A cross sectional study was conducted in designated AIDS hospitals in Harbin. A questionnaire was used to collect the information of the patients receiving treatment in these hospitals. The statistical analysis was done with software SAS 9.2 and Excel 2010. Univariate analysis was performed with t test and multivariate analysis was performed with ordinal logistic regression model. Wilcoxon ranks sum test was conducted to compare the CD4(+) T lymphocyte counts. The number of the patients receiving antiretroviral therapy was in increase in recent years. The HIV infection route was mainly homosexual contact. The CD4(+)T lymphocyte count of the patients increased at different levels after ≥6 months treatment(P<0.01). Household income(P<0.05), adherence to treatment plan or not(P<0.05), social relationship(P< 0.05), concern of economic cost(P<0.01)medication compliance(P<0.01)and initial level of CD4(+) T lymphocyte(P<0.01)were the influencing factors for antiretroviral therapy efficacy. In designated hospitals in Harbin, the number of the patients receiving HIV antiretroviral therapy kept to increase and the efficacy of the treatment was obvious.

Motivational interviewing and cognitive behaviour therapy in the treatment of adolescent overweight and obesity: study design and methodology.

PubMed

Brennan, Leah; Walkley, Jeff; Fraser, Steve F; Greenway, Kate; Wilks, Ray

2008-05-01

Despite the high prevalence and negative physical and psychosocial consequences of overweight and obesity in adolescents, very little research has evaluated treatment in this population. Consequently, clinicians working with overweight and obese adolescents have little empirical research on which to base their practise. Cognitive behavioural therapy has demonstrated efficacy in promoting behaviour change in many treatment resistant disorders. Motivational interviewing has been used to increase motivation for change and improve treatment outcomes. In this paper we describe the rationale and design of a randomised controlled trial testing the efficacy of motivational interviewing and cognitive behaviour therapy in the treatment of overweight and obese adolescents. Participants took part in a motivational interview or a standard semi-structured assessment interview and were then randomly allocated to a cognitive behavioural intervention or a wait-list control condition. The cognitive behavioural intervention, the CHOOSE HEALTH Program, consisted of 13 individual treatment sessions (12 face-to-face, 1 phone call) followed by 9 maintenance sessions (7 phone calls, 2 face-to-face). Assessments were conducted prior to participation, after the treatment phase and after the maintenance phase of intervention. Improvement in body composition was the primary outcome; secondary outcomes included improved cardiovascular fitness, eating and physical activity habits, family and psychosocial functioning. Despite the demonstrated effectiveness of motivational interviewing and cognitive behavioural therapy in the long-term management of many treatment resistant disorders, these approaches have been under-utilised in adolescent overweight and obesity treatment. This study provides baseline data and a thorough review of the study design and treatment approach to allow for the assessment of the efficacy of motivational interviewing and cognitive behavioural therapy in the treatment of adolescent overweight and obesity. Data obtained in this study will also provide much needed information about the behavioural and psychosocial factors associated with adolescent overweight and obesity.

Genotype-guided tamoxifen therapy; time to pause for reflection?

PubMed Central

Lash, Timothy L.; Lien, Ernst A.; Sørensen, Henrik Toft; Hamilton-Dutoit, Stephen

2010-01-01

Tamoxifen remains a cornerstone of adjuvant therapy for early stage breast cancer patients with estrogen receptor-positive tumors. Accurate markers of tamoxifen resistance would allow prediction of tamoxifen response and personalization of combined therapies. Recently, it has been suggested that patients with inherited nonfunctional alleles of the cytochrome P450 CYP2D6 may be poor candidates for adjuvant tamoxifen therapy because women with these variant alleles have reduced concentrations of the tamoxifen metabolites that most strongly bind the estrogen receptor. In some studies, women with these alleles have a higher risk of recurrence than women with two functional alleles. However, dose-setting studies with clinical and biomarker outcomes, studies associating clinical outcomes with serum concentrations of tamoxifen and its metabolites, and a simple model of receptor binding, all suggest that tamoxifen and its metabolites should reach concentrations sufficient to achieve the therapeutic effect regardless of CYP2D6 inhibition. The ten epidemiology studies of the association between CYP2D6 genotype and breast cancer recurrence report widely heterogeneous results with relative risk estimates outside the range of reasonable bounds. None of the explanations proposed for the heterogeneity of results account adequately for the observed variability and no design feature sets apart any study or subset of studies as most likely to be accurate. The studies reporting a positive association may receive the most attention because they reported a result consistent with the profile of metabolite concentrations; not because they are more reliable by design. We argue that a recommendation for CYP2D6 genotyping of candidates for tamoxifen therapy, and its implicit conclusion regarding the association between genotype and recurrence risk, is premature. PMID:19647203

[Peloid therapy. An overview of the empirical status and evidence of mud therapy].

PubMed

Beer, A-M; Fetaj, S; Lange, U

2013-08-01

Numerous peloids for balneotherapy are currently available but in terms of effects and efficacy therapeutic peat has been studied best. Recent studies revealed that both thermal and physical effects of therapeutic peat are comparable and synergistic. The thermal effects of all types of peat used are approximately the same but chemical effects differ. These results have to been taken into account in future peloid analyses and indications and contraindications of mud therapy have to be reviewed in this respect. Some hypothetical aspects of these chemical effects have to be investigated in future clinical studies but clinical experience with mud therapy allows preliminary conclusions to be drawn. This statement is especially supported by recent molecular investigations. Knowledge about the chemical effects is also necessary for planning, defining and designing clinical studies and patients groups. Exemplarily, the therapeutic use of peat in rheumatic diseases and for fertility treatment will be demonstrated.

Evaluation of reach and grasp robot-assisted therapy suggests similar functional recovery patterns on proximal and distal arm segments in sub-acute hemiplegia.

PubMed

Loureiro, Rui C V; Harwin, William S; Lamperd, Robert; Collin, Christine

2014-05-01

This paper provides some additional evidence in support of the hypothesis that robot therapies are clinically beneficial in neurorehabilitation. Although only four subjects were included in the study, the design of the intervention and the measures were done so as to minimize bias. The results are presented as single case studies, and can only be interpreted as such due to the study size. The intensity of intervention was 16 h and the therapy philosophy (based on Carr and Shepherd) was that coordinated movements are preferable to joint based therapies, and that coordinating distal movements (in this case grasps) helps not only to recover function in these areas, but has greater value since the results are immediately transferable to daily skills such as reach and grasp movements.

Design control for clinical translation of 3D printed modular scaffolds.

PubMed

Hollister, Scott J; Flanagan, Colleen L; Zopf, David A; Morrison, Robert J; Nasser, Hassan; Patel, Janki J; Ebramzadeh, Edward; Sangiorgio, Sophia N; Wheeler, Matthew B; Green, Glenn E

2015-03-01

The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach founded on 3D printing for developing tissue engineering therapies and (2) illustrate the design control process for modular implementation of two scaffold based tissue engineering therapies: airway reconstruction and bone tissue engineering based spine fusion.

Design Control for Clinical Translation of 3D Printed Modular Scaffolds

PubMed Central

Hollister, Scott J.; Flanagan, Colleen L.; Zopf, David A.; Morrison, Robert J.; Nasser, Hassan; Patel, Janki J.; Ebramzadeh, Edward; Sangiorgio, Sophia N.; Wheeler, Matthew B.; Green, Glenn E.

2015-01-01

The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach founded on 3D printing for developing tissue engineering therapies and (2) illustrate the design control process for modular implementation of two scaffold based tissue engineering therapies: airway reconstruction and bone tissue engineering based spine fusion. PMID:25666115

'Dignity therapy', a promising intervention in palliative care: A comprehensive systematic literature review.

PubMed

Martínez, Marina; Arantzamendi, María; Belar, Alazne; Carrasco, José Miguel; Carvajal, Ana; Rullán, María; Centeno, Carlos

2017-06-01

Dignity therapy is psychotherapy to relieve psychological and existential distress in patients at the end of life. Little is known about its effect. To analyse the outcomes of dignity therapy in patients with advanced life-threatening diseases. Systematic review was conducted. Three authors extracted data of the articles and evaluated quality using Critical Appraisal Skills Programme. Data were synthesized, considering study objectives. PubMed, CINAHL, Cochrane Library and PsycINFO. The years searched were 2002 (year of dignity therapy development) to January 2016. 'Dignity therapy' was used as search term. Studies with patients with advanced life-threatening diseases were included. Of 121 studies, 28 were included. Quality of studies is high. Results were grouped into effectiveness, satisfaction, suitability and feasibility, and adaptability to different diseases and cultures. Two of five randomized control trials applied dignity therapy to patients with high levels of baseline psychological distress. One showed statistically significant decrease on patients' anxiety and depression scores over time. The other showed statistical decrease on anxiety scores pre-post dignity therapy, not on depression. Nonrandomized studies suggested statistically significant improvements in existential and psychosocial measurements. Patients, relatives and professionals perceived it improved end-of-life experience. Evidence suggests that dignity therapy is beneficial. One randomized controlled trial with patients with high levels of psychological distress shows DT efficacy in anxiety and depression scores. Other design studies report beneficial outcomes in terms of end-of-life experience. Further research should understand how dignity therapy functions to establish a means for measuring its impact and assessing whether high level of distress patients can benefit most from this therapy.

PACE team response shows a disregard for the principles of science.

PubMed

Edwards, Jonathan

2017-08-01

The PACE trial of cognitive behavioural therapy and graded exercise therapy for chronic fatigue syndrome/myalgic encephalomyelitis has raised serious questions about research methodology. An editorial article by Geraghty gives a fair account of the problems involved, if anything understating the case. The response by White et al. fails to address the key design flaw, of an unblinded study with subjective outcome measures, apparently demonstrating a lack of understanding of basic trial design requirements. The failure of the academic community to recognise the weakness of trials of this type suggests that a major overhaul of quality control is needed.

Multiple target drug cocktail design for attacking the core network markers of four cancers using ligand-based and structure-based virtual screening methods

PubMed Central

2015-01-01

Background Computer-aided drug design has a long history of being applied to discover new molecules to treat various cancers, but it has always been focused on single targets. The development of systems biology has let scientists reveal more hidden mechanisms of cancers, but attempts to apply systems biology to cancer therapies remain at preliminary stages. Our lab has successfully developed various systems biology models for several cancers. Based on these achievements, we present the first attempt to combine multiple-target therapy with systems biology. Methods In our previous study, we identified 28 significant proteins--i.e., common core network markers--of four types of cancers as house-keeping proteins of these cancers. In this study, we ranked these proteins by summing their carcinogenesis relevance values (CRVs) across the four cancers, and then performed docking and pharmacophore modeling to do virtual screening on the NCI database for anti-cancer drugs. We also performed pathway analysis on these proteins using Panther and MetaCore to reveal more mechanisms of these cancer house-keeping proteins. Results We designed several approaches to discover targets for multiple-target cocktail therapies. In the first one, we identified the top 20 drugs for each of the 28 cancer house-keeping proteins, and analyzed the docking pose to further understand the interaction mechanisms of these drugs. After screening for duplicates, we found that 13 of these drugs could target 11 proteins simultaneously. In the second approach, we chose the top 5 proteins with the highest summed CRVs and used them as the drug targets. We built a pharmacophore and applied it to do virtual screening against the Life-Chemical library for anti-cancer drugs. Based on these results, wet-lab bio-scientists could freely investigate combinations of these drugs for multiple-target therapy for cancers, in contrast to the traditional single target therapy. Conclusions Combination of systems biology with computer-aided drug design could help us develop novel drug cocktails with multiple targets. We believe this will enhance the efficiency of therapeutic practice and lead to new directions for cancer therapy. PMID:26680552

Building Capacity of Occupational Therapy Practitioners to Address the Mental Health Needs of Children and Youth: A Mixed-Methods Study of Knowledge Translation.

PubMed

Bazyk, Susan; Demirjian, Louise; LaGuardia, Teri; Thompson-Repas, Karen; Conway, Carol; Michaud, Paula

2015-01-01

We explored the meaning and outcomes of a 6-mo building capacity process designed to promote knowledge translation of a public health approach to mental health among pediatric occupational therapy practitioners participating in a Community of Practice. A one-group (N = 117) mixed-methods design using a pretest-posttest survey and qualitative analysis of written reflections was used to explore the meaning and outcomes of the building capacity process. Statistically significant improvements (p < .02) in pretest-posttest scores of knowledge, beliefs, and actions related to a public health approach to mental health were found. Qualitative findings suggest that participation resulted in a renewed commitment to addressing children's mental health. The building capacity process expanded practitioner knowledge, renewed energy, and promoted confidence, resulting in change leaders empowered to articulate, advocate for, and implement practice changes reflecting occupational therapy's role in addressing children's mental health. Copyright © 2015 by the American Occupational Therapy Association, Inc.

Impact of the ALMS and MAINTAIN trials on the management of lupus nephritis.

PubMed

Morris, Heather K; Canetta, Pietro A; Appel, Gerald B

2013-06-01

Current treatment of lupus nephritis consists of both induction and maintenance therapy, with the latter being designed to consolidate remissions and prevent relapses. Long-term maintenance treatment with intravenous cyclophosphamide was effective but associated with considerable toxicity. A small but well-designed controlled trial found that for post-induction maintenance therapy, both oral mycophenolate mofetil (MMF) and oral azathioprine were superior in efficacy and had reduced toxicity than a regimen of continued every third month intravenous cyclophosphamide. Although these oral agents were rapidly accepted and utilized as maintenance medications, their usage was based on scant evidence and there were no comparisons between the two. Recently, two relatively large, randomized, well-controlled, multicenter trials dealing with maintenance therapy for severe lupus nephritis have been completed. The Aspreva Lupus Management Study (ALMS) maintenance and MAINTAIN nephritis trials provide important information regarding the comparative efficacy and safety of MMF and azathioprine as maintenance therapies, as well as information on the effect of dosage and duration of treatment with these agents.

Design, development, and clinical validation of therapeutic toys for autistic children

PubMed Central

Tseng, Kevin C.; Tseng, Sung-Hui; Cheng, Hsin-Yi Kathy

2016-01-01

[Purpose] One of the characteristics of autistic children is social interaction difficulties. Although therapeutic toys can promote social interaction, however its related research remains insufficient. The aim of the present study was to build a set of cooperative play toys that are suitable for autistic children. [Subjects and Methods] This study used an innovative product design and development approach as the basis for the creation of cooperative play toys. [Results] The present study has successfully developed cooperative play toys. Compared to the traditional game therapy for autism, cooperative play toy therapy can significantly improve the interactions between autistic children and their peers. [Conclusion] The most critical design theme of cooperative play toys focuses on captivating the interest of autistic children. Based on the needs of the individual cases, the design of the therapeutic toy set was specifically tailored, i.e., by reinforcing the sound and light effects to improve the attractiveness of the toys. In the future, different play modes can be combined with this toy set to further enhance the degree of interaction of autistic children and improve their quality of life and social skills. PMID:27512246

Design, development, and clinical validation of therapeutic toys for autistic children.

PubMed

Tseng, Kevin C; Tseng, Sung-Hui; Cheng, Hsin-Yi Kathy

2016-07-01

[Purpose] One of the characteristics of autistic children is social interaction difficulties. Although therapeutic toys can promote social interaction, however its related research remains insufficient. The aim of the present study was to build a set of cooperative play toys that are suitable for autistic children. [Subjects and Methods] This study used an innovative product design and development approach as the basis for the creation of cooperative play toys. [Results] The present study has successfully developed cooperative play toys. Compared to the traditional game therapy for autism, cooperative play toy therapy can significantly improve the interactions between autistic children and their peers. [Conclusion] The most critical design theme of cooperative play toys focuses on captivating the interest of autistic children. Based on the needs of the individual cases, the design of the therapeutic toy set was specifically tailored, i.e., by reinforcing the sound and light effects to improve the attractiveness of the toys. In the future, different play modes can be combined with this toy set to further enhance the degree of interaction of autistic children and improve their quality of life and social skills.

Is hormonal therapy associated with better quality of life in transsexuals? A cross-sectional study.

PubMed

Gorin-Lazard, Audrey; Baumstarck, Karine; Boyer, Laurent; Maquigneau, Aurélie; Gebleux, Stéphanie; Penochet, Jean-Claude; Pringuey, Dominique; Albarel, Frédérique; Morange, Isabelle; Loundou, Anderson; Berbis, Julie; Auquier, Pascal; Lançon, Christophe; Bonierbale, Mireille

2012-02-01

Although the impact of sex reassignment surgery on the self-reported outcomes of transsexuals has been largely described, the data available regarding the impact of hormone therapy on the daily lives of these individuals are scarce. The objectives of this study were to assess the relationship between hormonal therapy and the self-reported quality of life (QoL) in transsexuals while taking into account the key confounding factors and to compare the QoL levels between transsexuals who have, vs. those who have not, undergone cross-sex hormone therapy as well as between transsexuals and the general population (French age- and sex-matched controls). This study incorporated a cross-sectional design that was conducted in three psychiatric departments of public university teaching hospitals in France. The inclusion criteria were as follows: 18 years or older, diagnosis of gender identity disorder (302.85) according to the Diagnostic and Statistical Manual, fourth edition text revision (DSM-IV TR), inclusion in a standardized sex reassignment procedure following the agreement of a multidisciplinary team, and pre-sex reassignment surgery. QoL was assessed using the Short Form 36 (SF-36). The mean age of the total sample was 34.7 years, and the sex ratio was 1:1. Forty-four (72.1%) of the participants received hormonal therapy. Hormonal therapy and depression were independent predictive factors of the SF-36 mental composite score. Hormonal therapy was significantly associated with a higher QoL, while depression was significantly associated with a lower QoL. Transsexuals' QoL, independently of hormonal status, did not differ from the French age- and sex-matched controls except for two subscales of the SF-36 questionnaire: role physical (lower scores in transsexuals) and general health (lower scores in controls). The present study suggests a positive effect of hormone therapy on transsexuals' QoL after accounting for confounding factors. These results will be useful for healthcare providers of transgender persons but should be confirmed with larger samples using a prospective study design. © 2011 International Society for Sexual Medicine.

Precision medicine for hepatocelluar carcinoma using molecular pattern diagnostics: results from a preclinical pilot study.

PubMed

Agarwal, Rahul; Cao, Yuan; Hoffmeier, Klaus; Krezdorn, Nicolas; Jost, Lukas; Meisel, Alejandro Rodriguez; Jüngling, Ruth; Dituri, Francesco; Mancarella, Serena; Rotter, Björn; Winter, Peter; Giannelli, Gianluigi

2017-06-08

The aim of this study was to design a road map for personalizing cancer therapy in hepatocellular carcinoma (HCC) by using molecular pattern diagnostics. As an exploratory study, we investigated molecular patterns of tissues of two tumors from individual HCC patients, which in previous experiments had shown contrasting reactions to the phase 2 transforming growth factor beta receptor 1 inhibitor galunisertib. Cancer-driving molecular patterns encompass - inter alias - altered transcription profiles and somatic mutations in coding regions differentiating tumors from their respective peritumoral tissues and from each other. Massive analysis of cDNA ends and all-exome sequencing demonstrate a highly divergent transcriptional and mutational landscape, respectively, for the two tumors, that offers potential explanations for the tumors contrasting responses to galunisertib. Molecular pattern diagnostics (MPDs) suggest alternative, individual-tumor-specific therapies, which in both cases deviate from the standard sorafenib treatment and from each other. Suggested personalized therapies use kinase inhibitors and immune-focused drugs as well as low-toxicity natural compounds identified using an advanced bioinformatics routine included in the MPD protocol. The MPD pipeline we describe here for the prediction of suitable drugs for treatment of two contrasting HCCs may serve as a blueprint for the design of therapies for various types of cancer.

Evaluation of the effectiveness of robotic gait training and gait-focused physical therapy programs for children and youth with cerebral palsy: a mixed methods RCT.

PubMed

Wiart, Lesley; Rosychuk, Rhonda J; Wright, F Virginia

2016-06-02

Robot assisted gait training (RAGT) is considered to be a promising approach for improving gait-related gross motor function of children and youth with cerebral palsy. However, RAGT has yet to be empirically demonstrated to be effective. This knowledge gap is particularly salient given the strong interest in this intensive therapy, the high cost of the technology, and the requirement for specialized rehabilitation centre resources. This is a research protocol describing a prospective, multi-centre, concurrent mixed methods study comprised of a randomized controlled trial (RCT) and an interpretive descriptive qualitative design. It is a mixed methods study designed to determine the relative effectiveness of three physical therapy treatment conditions (i.e., RAGT, a functional physical therapy program conducted over-ground (fPT), and RAGT + fPT) on gait related motor skills of ambulatory children with cerebral palsy. Children with cerebral palsy aged 5-18 years who are ambulatory (Gross Motor Function Classification System Levels II and III) will be randomly allocated to one of four treatment conditions: 1) RAGT, 2) fPT, 3) RAGT and fPT combined, or 4) a maintenance therapy only control group. The qualitative component will explicate child and parent experiences with the interventions, provide insight into the values that underlie their therapy goals, and assist with interpretation of the results of the RCT. n/a. NCT02391324 Registered March 12, 2015.

Unraveling the Mechanisms of Manual Therapy: Modeling an Approach.

PubMed

Bialosky, Joel E; Beneciuk, Jason M; Bishop, Mark D; Coronado, Rogelio A; Penza, Charles W; Simon, Corey B; George, Steven Z

2018-01-01

Synopsis Manual therapy interventions are popular among individual health care providers and their patients; however, systematic reviews do not strongly support their effectiveness. Small treatment effect sizes of manual therapy interventions may result from a "one-size-fits-all" approach to treatment. Mechanistic-based treatment approaches to manual therapy offer an intriguing alternative for identifying patients likely to respond to manual therapy. However, the current lack of knowledge of the mechanisms through which manual therapy interventions inhibit pain limits such an approach. The nature of manual therapy interventions further confounds such an approach, as the related mechanisms are likely a complex interaction of factors related to the patient, the provider, and the environment in which the intervention occurs. Therefore, a model to guide both study design and the interpretation of findings is necessary. We have previously proposed a model suggesting that the mechanical force from a manual therapy intervention results in systemic neurophysiological responses leading to pain inhibition. In this clinical commentary, we provide a narrative appraisal of the model and recommendations to advance the study of manual therapy mechanisms. J Orthop Sports Phys Ther 2018;48(1):8-18. doi:10.2519/jospt.2018.7476.

Current Status of Renal Denervation in Hypertension.

PubMed

Briasoulis, Alexander; Bakris, George L

2016-11-01

Over the past 7 years, prospective cohorts and small randomized controlled studies showed that renal denervation therapy (RDN) in patients with resistant hypertension is safe but associated with variable effects on BP which are not substantially better than medical therapy alone. The failure of the most rigorously designed randomized sham-control study, SYMPLICITY HTN-3, to meet the efficacy endpoints has raised several methodological concerns. However, recently reported studies and ongoing trials with improved procedural characteristics, identification of patients with true treatment-resistant hypertension on appropriate antihypertensive regimens further explore potential benefits of RDN. The scope of this review is to summarize evidence from currently completed studies on RDN and discuss future perspectives of RDN therapy in patients with resistant hypertension.

Does More Therapy in Skilled Nursing Facilities Lead to Better Outcomes in Patients With Hip Fracture?

PubMed Central

Trivedi, Amal N.; Grabowski, David C.; Mor, Vincent

2016-01-01

Background Skilled nursing facilities (SNFs) have increasingly been providing more therapy hours to beneficiaries of Medicare. It is not known whether these increases have improved patient outcomes. Objective The study objectives were: (1) to examine temporal trends in therapy hour volumes and (2) to evaluate whether more therapy hours are associated with improved patient outcomes. Design This was a retrospective cohort study. Methods Data sources included the Minimum Data Set, Medicare inpatient claims, and the Online Survey, Certification, and Reporting System. The study population consisted of 481,908 beneficiaries of Medicare fee-for-service who were admitted to 15,496 SNFs after hip fracture from 2000 to 2009. Linear regression models with facility and time fixed effects were used to estimate the association between the quantity of therapy provided in SNFs and the likelihood of discharge to home. Results The average number of therapy hours increased by 52% during the study period, with relatively little change in case mix at SNF admission. An additional hour of therapy per week was associated with a 3.1-percentage-point (95% confidence interval=3.0, 3.1) increase in the likelihood of discharge to home. The effect of additional therapy decreased as the Resource Utilization Group category increased, and additional therapy did not benefit patients in the highest Resource Utilization Group category. Limitations Minimum Data Set assessments did not cover details of therapeutic interventions throughout the entire SNF stay and captured only a 7-day retrospective period for measures of the quantity of therapy provided. Conclusions Increases in the quantity of therapy during the study period cannot be explained by changes in case mix at SNF admission. More therapy hours in SNFs appear to improve outcomes, except for patients with the greatest need. PMID:26586858

Rexin-G, a targeted genetic medicine for cancer.

PubMed

Gordon, Erlinda M; Hall, Frederick L

2010-05-01

Rexin-G, a tumor-targeted retrovector bearing a cytocidal cyclin G1 construct, is the first targeted gene therapy vector to gain fast track designation and orphan drug priorities for multiple cancer indications in the US. This review describes the major milestones in the clinical development of Rexin-G: from the molecular cloning and characterization of the human cyclin G1 proto-oncogene in 1994, to the design of the first knockout constructs and genetic engineering of the targeted delivery system from 1995 to 1997, through the initial proofs-of-concept, molecular pharmacology and toxicology studies of Rexin-G in preclinical cancer models from 1997 to 2001, to the pioneering clinical studies in humans from 2002 to 2004, which--together with the advancements in bioprocess development of high-potency clinical grade vectors circa 2005 - 2006--led to the accelerated approval of Rexin-G for all solid tumors by the Philippine FDA in 2007 and the rapid progression of clinical studies from 2007 to 2009 to the cusp of pivotal Phase III trials in the US. In recording the development of Rexin-G as a novel form of targeted biological therapy, this review also highlights important aspects of vector design engineering which served to overcome the physiological barriers to gene delivery as it addresses the key regulatory issues involved in the development of a targeted gene therapy product. Progressive clinical development of Rexin-G demonstrates the potential safety and efficacy of targeted genetic medicine, while validating the design engineering of the molecular biotechnology platform.

Occupational therapy students' perceptions of occupational therapy.

PubMed

Turpin, Merrill June; Rodger, Sylvia; Hall, Anna R

2012-10-01

An understanding of students' perceptions of occupational therapy on entry is required to recognise how professional socialisation occurs through curriculum. Findings pertain to a qualitative study investigating students' perceptions of occupational therapy upon entry to two occupational therapy programmes in Australia. Students commencing Bachelor of Occupational Therapy and Masters of Occupational Therapy Studies programmes participated in the study (n = 462). A purpose-designed questionnaire was distributed to students in the first lecture of each programme. Preliminary analysis comprised identification of keywords/phrases and coding categories were generated from patterns of keywords. Frequency counts and percentages of keywords/phrases within categories were completed. Students' responses were categorised as 'what' occupational therapists do; 'how' they do it; 'why' they do it; and 'who' they work with. In 'what' occupational therapists do students frequently described 'helping' people. Both undergraduate and graduate entry masters students used the term 'rehabilitation' to describe how occupational therapy is done, with graduate entry students occasionally responding with 'through occupation' and 'modifying the environment'. Students perceived the 'why' of occupational therapy as getting back to 'everyday activities', with some students emphasising returning to 'normal' activities or life. Regarding the 'who' category, students also thought occupational therapists worked with people with an 'injury' or 'disability'. Students entered their occupational therapy programmes with perceptions consistent with the general public's views of occupational therapy. However, graduate entry students exposed to a pre-reading package prior to entry had more advanced occupational therapy concepts than undergraduate students. © 2011 The Authors. Australian Occupational Therapy Journal © 2011 Occupational Therapy Australia.

The history of gold therapy for tuberculosis.

PubMed

Benedek, Thomas G

2004-01-01

This is a historical study of the popularization of a medical therapy contrary to pertinent experimental findings. Presumably this circumstance reflects the desperation about tuberculosis: highly prevalent, highly fatal, and lacking any etiologically directed therapy. Gold compounds were introduced, based initially on the reputation of Robert Koch, who had found gold cyanide effective against M. tuberculosis in cultures, but not in experimentally infected animals. Treatment of pulmonary tuberculosis with these compounds was popularized, particularly by Danish physicians, in the mid-1920s, despite consistently negative experimental results, based on Paul Ehrlich's theories of antimicrobial drug effects. Difficulties in the design of interpretable clinical studies were soon recognized but also generally ignored, thus permitting data to be interpreted as favorable to antituberculous gold therapy. Eventually toxicity was considered to outweigh the alleged therapeutic benefit of all gold compounds. This resulted in their discard shortly before the introduction of streptomycin therapy.

[Modern approaches to the use of neurotropic physical therapy in arterial hypertension].

PubMed

Orekhova, E M; Konchugova, T V; Kul'chitskaya, D B; Korchazhkina, N B; Egorova, L A; Chuich, N G

2016-01-01

The development and introduction into clinical practice of non-pharmacological methods for the prevention and treatment of arterial hypertension is a primary objective of modern physical therapy, especially as regards the neurotropic influences. This article was designed to report the results of the investigation into the hypotensive effect of transcerebral magnetic therapy obtained during the treatment of 60 patients presenting with arterial hypertension. The study included the comparative examination of two randomly formed groups containing 30 patients each. The patients of the main group received transcerebral magnetic therapy (to the frontal region) while those in the group of comparison were given magnetotherapy at the collar region. The study has demonstrated that transcerebral magnetic therapy given to the patients of the main group was a more efficient treatment than magnetotherapy at the collar region since it produced a more pronounced hypotensive effect irrespective of the initial hemodynamic type.

National Training Course. Emergency Medical Technician. Paramedic. Instructor's Lesson Plans. Module III. Shock and Fluid Therapy.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

This instructor's lesson plan guide on shock and fluid therapy is one of fifteen modules designed for use in the training of emergency medical technicians (paramedics). Six units of study are presented: (1) body fluids, electrolytes and their effect on the body, and the general principles of fluid and acid base balances; (2) characteristics of…

Effectiveness of Play Therapy on Problem Behaviors of Children with Intellectual Disabilities: A Single Subject Design

ERIC Educational Resources Information Center

Swan, Karrie L.

2011-01-01

A growing disparity between the mental health needs of children and their lack of treatment served as the basis of this study. To address this existent gap, I proposed that child-centered play therapy (CCPT), a holistic treatment that fosters children's emotional, developmental, and social growth would serve as a viable treatment. The purpose of…

A Comparison of Short- And Long-Term Family Therapy for Adolescent Anorexia Nervosa.

ERIC Educational Resources Information Center

Lock, James; Agras, W. Stewart; Bryson, Susan; Kraemer, Helena C.

2005-01-01

Objective: Research suggests that family treatment for adolescents with anorexia nervosa may be effective. This study was designed to determine the optimal length of such family therapy. Method: Eighty-six adolescents (12-18 years of age) diagnosed with anorexia nervosa were allocated at random to either a short-term (10 sessions over 6 months) or…

Resilient Therapy: Strategic Therapeutic Engagement with Children in Crisis

ERIC Educational Resources Information Center

Hart, Angie; Blincow, Derek

2008-01-01

This article offers an overview of Resilient Therapy (RT) and outlines a case study of how it can be used in practice. RT draws on the resilience research base, and has been designed to meet the needs of children in crisis by providing insights and analytical tools that help carers and practitioners build relationships of trust in the hardest of…

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

PubMed

Serabian, M A; Pilaro, A M

1999-01-01

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity). Guidances concerning the design of preclinical studies for such therapies are generally based on the clinical indication. Risk versus benefit decisions are made with an understanding of the nature of the patient population, the severity of disease, and the availability of alternative therapies. Key components of protocol design for preclinical studies addressing the risks of these agents include (a) a safe starting dose in humans, (b) identification of potential target organs, (c) identification of clinical parameters that should be monitored in humans, and (d) identification of at-risk populations. One of the distinct aspects of the safety evaluation of biotechnology-derived pharmaceuticals is the use of relevant and often nontraditional species and the use of animal models of disease in preclinical safety evaluation. Extensive contributions were made by the Center for Biologics Evaluation and Research to the ICH document on the safety of biotherapeutics, which is intended to provide worldwide guidance for a framework approach to the design and review of preclinical programs. Rational, scientifically sound study design and early identification of the potential safety concerns that may be anticipated in the clinical trial can result in preclinical data that facilitate use of these novel therapies for use in humans without duplication of effort or the unnecessary use of animals.

An Updated Review of the Efficacy of Cupping Therapy

PubMed Central

Cao, Huijuan; Li, Xun; Liu, Jianping

2012-01-01

Background Since 1950, traditional Chinese medicine (TCM) cupping therapy has been applied as a formal modality in hospitals throughout China and elsewhere in the world. Based on a previous systematic literature review of clinical studies on cupping therapy, this study presents a thorough review of randomized controlled trials (RCTs) to evaluate the therapeutic effect of cupping therapy. Method Six databases were searched for articles published through 2010. RCTs on cupping therapy for various diseases were included. Studies on cupping therapy combined with other TCM treatments versus non-TCM therapies were excluded. Results 135 RCTs published from 1992 through 2010 were identified. The studies were generally of low methodological quality. Diseases for which cupping therapy was commonly applied were herpes zoster, facial paralysis (Bell palsy), cough and dyspnea, acne, lumbar disc herniation, and cervical spondylosis. Wet cupping was used in most trials, followed by retained cupping, moving cupping, and flash cupping. Meta-analysis showed cupping therapy combined with other TCM treatments was significantly superior to other treatments alone in increasing the number of cured patients with herpes zoster, facial paralysis, acne, and cervical spondylosis. No serious adverse effects were reported in the trials. Conclusions Numerous RCTs on cupping therapy have been conducted and published during the past decades. This review showed that cupping has potential effect in the treatment of herpes zoster and other specific conditions. However, further rigorously designed trials on its use for other conditions are warranted. PMID:22389674

Music therapy in the treatment of multiple sclerosis: a comprehensive literature review.

PubMed

Ostermann, Thomas; Schmid, Wolfgang

2006-04-01

Coping with multiple sclerosis symptoms still remains a challenge for each patient suffering from this chronic inflammatory disease. Therefore, patients often turn to using complementary and alternative medicine (CAM). In this review, the authors aimed to investigate the current state of literature of music therapy in the treatment of multiple sclerosis (MS). Medline, PubMed, Embase, AMED, CAMbase and the Music Therapy World Journal Index were searched for the terms MS and 'music therapy'. In addition, an internet search using Google Scholar was performed. The authors found seven case-reports/series and seven studies on music therapy for MS-patients. Both the case reports and studies presented here are pioneer work. Most of the studies are naturally predominated by the use of qualitative and uncontrolled research designs. Nevertheless, the results of the studies as well as the case reports demonstrate patients' improvement in the domains of self-acceptance, anxiety and depression. The results of the studies as well as the case reports define a sufficient basis for further music therapeutical work as they show a variety of psychosocial and emotional benefits for MS patients.

Improvement in depression scores after 1 hour of light therapy treatment in patients with seasonal affective disorder.

PubMed

Reeves, Gloria M; Nijjar, Gagan Virk; Langenberg, Patricia; Johnson, Mary A; Khabazghazvini, Baharak; Sleemi, Aamar; Vaswani, Dipika; Lapidus, Manana; Manalai, Partam; Tariq, Muhammad; Acharya, Monika; Cabassa, Johanna; Snitker, Soren; Postolache, Teodor T

2012-01-01

The purpose of this study was to investigate possible rapid effects of light therapy on depressed mood in patients with seasonal affective disorder. Participants received 1 hour of bright light therapy and 1 hour of placebo dim red light in a randomized order crossover design. Depressed mood was measured at baseline and after each hour of light treatment using two self-report depression scales (Profile of Mood States-Depression-Dejection [POMS-D] subscale and the Beck Depression Inventory II [BDI-II]). When light effects were grouped for the two sessions, there was significantly greater reduction in self-report depression scores by -1.3 (p = 0.02) on the BDI-II and -1.2 (p = 0.02) on the POMS-D. A significant but modest improvement was detected after a single active light session. This is the first study, to our knowledge, to document an immediate improvement with light treatment using a placebo-controlled design with a clinical sample of depressed individuals.

Effect of Occupational Therapy-Led Playgroups in Early Intervention on Child Playfulness and Caregiver Responsiveness: A Repeated-Measures Design.

PubMed

Fabrizi, Sarah E; Ito, Max A; Winston, Kristin

2016-01-01

This study's objective was to investigate the effects of a community playgroup on the playfulness of children with special needs ages 15 mo to 3 yr and the responsiveness of their caregivers. Using a pretest-posttest, repeated-measures design, we evaluated 8 child-caregiver dyads participating in an 8-wk occupational therapist-led community playgroup recruited from a purposive sample enrolled in early intervention. Video recordings from four time points over 4 mo were used to determine playfulness (Test of Playfulness) of the child and the responsiveness of the caregiver. Blinded raters assessed playfulness and responsiveness outcomes. A repeated-measures analysis of variance demonstrated that participation in the playgroup significantly increased child playfulness (ηp² = .89, p < .01). Analysis did not detect a change in caregiver responsiveness. The results of this study have implications for the use of playgroups in comprehensive occupational therapy practice in early intervention. Copyright © 2016 by the American Occupational Therapy Association, Inc.

Nanotechnology-based drug delivery treatments and specific targeting therapy for age-related macular degeneration.

PubMed

Lin, Tai-Chi; Hung, Kuo-Hsuan; Peng, Chi-Hsien; Liu, Jorn-Hon; Woung, Lin-Chung; Tsai, Ching-Yao; Chen, Shih-Jen; Chen, Yan-Ting; Hsu, Chih-Chien

2015-11-01

Nanoparticles combined with cells, drugs, and specially designed genes provide improved therapeutic efficacy in studies and clinical setting, demonstrating a new era of treatment strategy, especially in retinal diseases. Nanotechnology-based drugs can provide an essential platform for sustaining, releasing and a specific targeting design to treat retinal diseases. Poly-lactic-co-glycolic acid is the most widely used biocompatible and biodegradable polymer approved by the Food and Drug Administration. Many studies have attempted to develop special devices for delivering small-molecule drugs, proteins, and other macromolecules consistently and slowly. In this article, we first review current progress in the treatment of age-related macular degeneration. Then, we discuss the function of vascular endothelial growth factor (VEGF) and the pharmacological effects of anti-VEGF-A antibodies and soluble or modified VEGF receptors. Lastly, we summarize the combination of antiangiogenic therapy and nanomedicines, and review current potential targeting therapy in age-related macular degeneration. Copyright © 2015. Published by Elsevier Taiwan.

Dietary Therapy in Patients With Inflammatory Arthritis.

PubMed

Mäkelä, Rauli; Mäkilä, Heli; Peltomaa, Ritva

2017-01-01

Context • The exact etiology of rheumatoid disease is currently unknown. Changes in the microbiota of the gastrointestinal (GI) tract, chronic bacterial infection of the upper urinary tract, increased permeability of the GI tract, and food sensitivities have been classified among the factors that may cause or aggravate the disease. Dietary deficiencies also may render patients more susceptible to inflammatory conditions and disorders of the immunological system. Objective • The study intended to determine the effects of a therapy consisting of dietary elimination, dietary supplements, and probiotics, collectively called DDP therapy, which is given either independently or in combination with conventional pharmacological agents. Design • The research team designed a retrospective survey, sending out a detailed questionnaire to determine the outcomes for patients who had received DDP therapy. Setting • The study took place at an antioxidant clinic in Helsinki, Finland. Participants • The participants were 104 patients with inflammatory arthritis who had undergone DDP therapy at the clinic. Intervention • The dietary elimination in DDP therapy included the omission of all animal milks, wheat, rye, barley, and oats, and the patients were asked to avoid added sugar and yeast. The dietary supplements included multivitamins with the main antioxidants, n-3-omega polyunsaturated fatty acids, and curcuminoids. The probiotic supplement most often used consisted of a mixture of 109 CFU/d of Bifidobacterium lactis and 109 CFU/d of Lactobacillus rhamnosus. Outcome Measures • The physician who had given the DDP therapy analyzed the patients' case histories to form his opinion on the efficacy of the therapy. In addition, a detailed questionnaire was sent to the 104 patients to obtain their evaluations of the outcomes for the DDP therapy. Results • Seventy-nine of the 104 patients (76%) returned their questionnaires. Of those respondents, 72 patients (91%) were taking conventional medication at baseline and 64 (81%) were using disease-modifying antirheumatic drugs. The average duration of their disease was 6.9 y. Seventy patients (88.6%) reported that they had benefited overall from the DDP therapy, expressed as a diminished need for conventional medications and/or an improvement in general health. Sixty-six of the patients (83.5%) reported a moderate or significant improvement in their joint symptoms. Reported adverse effects from DDP therapy were few and mild. Conclusions • This study demonstrates that patients with inflammatory arthritis perceive benefits from DDP therapy, and the risks appear to be low.

Edoxaban for the long-term treatment of venous thromboembolism: rationale and design of the Hokusai-venous thromboembolism study--methodological implications for clinical trials.

PubMed

Raskob, G; Büller, H; Prins, M; Segers, A; Shi, M; Schwocho, L; van Kranen, R; Mercuri, M

2013-07-01

New oral anticoagulants may simplify long-term therapy by eliminating the need for laboratory monitoring. Edoxaban is an oral, direct inhibitor of factor Xa that is given in a fixed dose once daily. The Hokusai-VTE study is a randomized, double-blind trial to evaluate whether initial low molecular weight heparin (LMWH) followed by edoxaban (60 mg once daily) is non-inferior to LMWH followed by warfarin (International Normalized Ratio of 2.0-3.0) for the prevention of recurrent thromboembolism in patients with acute symptomatic venous thromboembolism (VTE). The primary efficacy outcome is symptomatic recurrent VTE during the 12-month study period. The principal safety outcome is clinically relevant bleeding (major or non-major) occurring during or within 3 days of stopping study treatment. A clinical events committee adjudicates all suspected outcome events. A unique study design feature is the flexible treatment duration of between 3 and 12 months to simulate usual clinical practice, and enabled by: (i) double-blinding to minimize bias that could occur if knowledge of the patient's treatment influenced the duration of therapy; and (ii) follow-up for 12 months of all patients and inclusion in the primary efficacy analysis, regardless of the duration of therapy received. A second innovative design feature is the strategy for achieving an appropriate time in therapeutic range in the warfarin group, with central tracking for each participating center and feedback to the investigators. The standard methods combined with innovative design features should achieve study results that are both scientifically valid and relevant to clinical practice. © 2013 International Society on Thrombosis and Haemostasis.

Computer-Based Instruction in Dietetics Education.

ERIC Educational Resources Information Center

Schroeder, Lois; Kent, Phyllis

1982-01-01

Details the development and system design of a computer-based instruction (CBI) program designed to provide tutorial training in diet modification as part of renal therapy and provides the results of a study that compared the effectiveness of the CBI program with the traditional lecture/laboratory method. (EAO)

Outcomes of an acceptance and commitment therapy-based skills training group for students with high-functioning autism spectrum disorder: a quasi-experimental pilot study.

PubMed

Pahnke, Johan; Lundgren, Tobias; Hursti, Timo; Hirvikoski, Tatja

2014-11-01

Autism spectrum disorder is characterized by social impairments and behavioural inflexibility. In this pilot study, the feasibility and outcomes of a 6-week acceptance and commitment therapy-based skills training group were evaluated in a special school setting using a quasi-experimental design (acceptance and commitment therapy/school classes as usual). A total of 28 high-functioning students with autism spectrum disorder (aged 13-21 years) were assessed using self- and teacher-ratings at pre- and post-assessment and 2-month follow-up. All participants completed the skills training, and treatment satisfaction was high. Levels of stress, hyperactivity and emotional distress were reduced in the treatment group. The acceptance and commitment therapy group also reported increased prosocial behaviour. These changes were stable or further improved at the 2-month follow-up. Larger studies are needed to further evaluate the benefits of acceptance and commitment therapy for autism spectrum disorder. © The Author(s) 2013.

Femara® and the future: tailoring treatment and combination therapies with Femara

PubMed Central

Ma, Cynthia

2007-01-01

Long-term estrogen deprivation treatment for breast cancer can, in some patients, lead to the activation of alternate cellular pathways, resulting in the re-emergence of the disease. This is a distressing scenario for oncologists and patients, but recent intensive molecular and biochemical studies are beginning to unravel these pathways, revealing opportunities for new targeted treatments. Far from making present therapies redundant, these new discoveries open the door to novel combination therapies that promise to provide enhanced efficacy or overcome treatment resistance. Letrozole, one of the most potent aromatase inhibitors, is the ideal candidate for combination therapy; indeed, it is one of the most intensively studied aromatase inhibitors in the evolving combinatorial setting. Complementary to the use of combination therapy is the development of molecular tools to identify patients who will benefit the most from these new treatments. Microarray gene profiling studies, designed to detect letrozole-responsive targets, are currently under way to understand how the use of the drug can be tailored more efficiently to specific patient needs. PMID:17912640

Ethics and eplerenone.

PubMed

Gupta, Shruti; Fugh-Berman, Adriane J; Scialli, Anthony

2013-02-01

The use of a placebo arm in clinical trials is unethical if there is an active comparator that is acceptably safe and effective. We argue that reasonable evidence of effectiveness and safety of an inexpensive alternative to an expensive therapy is sufficient to require that the inexpensive therapy be included as a comparator when the expensive therapy is tested, and that use of an inactive placebo comparator only is not ethical. For example, studies of the expensive drug eplerenone for congestive heart failure have not included a spironolactone arm, although there is reasonable evidence that spironolactone would be safe and effective, and spironolactone is inexpensive. The requirement to study inexpensive therapies is based on avoidance of unnecessary cost in medical care as an example of non-maleficence. Several ethical actors in the design, conduct, and publication of clinical trials and their results bear responsibility for the appropriate conduct of clinical trials. That responsibility includes protecting study subjects from being asked to participate in clinical trials that serve primarily to promote the use of new and expensive therapies.

Bayesian Design of Superiority Clinical Trials for Recurrent Events Data with Applications to Bleeding and Transfusion Events in Myelodyplastic Syndrome

PubMed Central

Chen, Ming-Hui; Zeng, Donglin; Hu, Kuolung; Jia, Catherine

2014-01-01

Summary In many biomedical studies, patients may experience the same type of recurrent event repeatedly over time, such as bleeding, multiple infections and disease. In this article, we propose a Bayesian design to a pivotal clinical trial in which lower risk myelodysplastic syndromes (MDS) patients are treated with MDS disease modifying therapies. One of the key study objectives is to demonstrate the investigational product (treatment) effect on reduction of platelet transfusion and bleeding events while receiving MDS therapies. In this context, we propose a new Bayesian approach for the design of superiority clinical trials using recurrent events frailty regression models. Historical recurrent events data from an already completed phase 2 trial are incorporated into the Bayesian design via the partial borrowing power prior of Ibrahim et al. (2012, Biometrics 68, 578–586). An efficient Gibbs sampling algorithm, a predictive data generation algorithm, and a simulation-based algorithm are developed for sampling from the fitting posterior distribution, generating the predictive recurrent events data, and computing various design quantities such as the type I error rate and power, respectively. An extensive simulation study is conducted to compare the proposed method to the existing frequentist methods and to investigate various operating characteristics of the proposed design. PMID:25041037

Influence of study goals on study design and execution.

PubMed

Kirklin, J W; Blackstone, E H; Naftel, D C; Turner, M E

1997-12-01

From the viewpoint of a clinician who makes recommendations to patients about choosing from the multiple possible management schemes, quantitative information derived from statistical analyses of observational studies is useful. Although random assignment of therapy is optimal, appropriately performed studies in which therapy has been nonrandomly "assigned" are considered acceptable, albeit occasionally with limitations in inferences. The analyses are considered most useful when they generate multivariable equations suitable for predicting time-related outcomes in individual patients. Graphic presentations improve communication with patients and facilitate truly informed consent.

Alternative seating for young children with Autism Spectrum Disorder: effects on classroom behavior.

PubMed

Schilling, Denise Lynn; Schwartz, Ilene S

2004-08-01

A single subject, withdrawal design was used to investigate the effects of therapy balls as seating on engagement and in-seat behavior of young children with Autism Spectrum Disorder (ASD). In addition, social validity was assessed to evaluate teachers' opinions regarding the intervention. During baseline and withdrawal (A phases) participants used their typical classroom seating device (chair, bench or carpet square). During the intervention (B phases) participants sat on therapy balls. Results indicated substantial improvements in engagement and in-seat behavior when participants were seated on therapy balls. Social validity findings indicated that the teachers' preferred the therapy balls. This study suggests therapy balls as classroom seating may facilitate engagement and in-seat behavior and create opportunities to provide effective instruction.

Mistletoe in conventional oncological practice: exemplary cases.

PubMed

Legnani, Walter

2008-09-01

Mistletoe therapy, a cancer treatment suggested by Rudolf Steiner in 1920, is a typical and specific anthroposophic therapy, but could become more important today in the field of mainstream medicine. This article analyzes some of the most typical effects of mistletoe therapy based on the experience of more than 100 cases. A few patients were chosen who appear exemplary of the opportunities offered by mistletoe therapy. Their clinical history demonstrates an improvement in clinical condition and performance status, better quality of life, improved psychological status, reduction of infective events, better tolerance of concomitant chemoradiotherapy, and even a direct reduction of tumor size. The conclusion is that the patients may be indicative for future prospective clinical studies designed to confirm a real efficacy of mistletoe in cancer therapy.

Assessing women's sexuality after cancer therapy: checking assumptions with the focus group technique.

PubMed

Bruner, D W; Boyd, C P

1999-12-01

Cancer and cancer therapies impair sexual health in a multitude of ways. The promotion of sexual health is therefore vital for preserving quality of life and is an integral part of total or holistic cancer management. Nursing, to provide holistic care, requires research that is meaningful to patients as well as the profession to develop educational and interventional studies to promote sexual health and coping. To obtain meaningful research data instruments that are reliable, valid, and pertinent to patients' needs are required. Several sexual functioning instruments were reviewed for this study and found to be lacking in either a conceptual foundation or psychometric validation. Without a defined conceptual framework, authors of the instruments must have made certain assumptions regarding what women undergoing cancer therapy experience and what they perceive as important. To check these assumptions before assessing women's sexuality after cancer therapies in a larger study, a pilot study was designed to compare what women experience and perceive as important regarding their sexuality with what is assessed in several currently available research instruments, using the focus group technique. Based on the focus group findings, current sexual functioning questionnaires may be lacking in pertinent areas of concern for women treated for breast or gynecologic malignancies. Better conceptual foundations may help future questionnaire design. Self-regulation theory may provide an acceptable conceptual framework from which to develop a sexual functioning questionnaire.

Thinking About the Future Cognitive Remediation Therapy—What Works and Could We Do Better?

PubMed Central

Wykes, Til; Spaulding, Will D.

2011-01-01

This article reviews progress in the development of effective cognitive remediation therapy (CRT) and its translational process. There is now enough evidence that cognitive difficulties experienced by people with schizophrenia can change and that the agenda for the next generation of studies is to increase these effects systematically through cognitive remediation. We examine the necessary steps and challenges of moving CRT to treatment dissemination. Theories which have been designed to explain the effects of cognitive remediation, are important but we conclude that they are not essential for dissemination which could progress in an empirical fashion. One apparent barrier is that cognitive remediation therapies look different on the surface. However, they still tend to use many of the same training procedures. The only important marker for outcome identified in the current studies seems to be the training emphasis. Some therapies concentrate on massed practice of cognitive functions, whereas others also use direct training of strategies. These may produce differing effects as noted in the most recent meta-analyses. We recommend attention to several critical issues in the next generation of empirical studies. These include developing more complex models of the therapy effects that take into account participant characteristics, specific and broad cognitive outcomes, the study design, as well as the specific and nonspecific effects of treatment, which have rarely been investigated in this empirical programme. PMID:21860051

Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.

PubMed

Delaney, Anthony; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

2013-10-01

The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and prior to completion of the two related international studies. The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses. A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed. A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the study. This will minimise analytic bias and conforms to current best practice in conducting clinical trials. © 2013 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Treadmill training with partial body weight support and an electromechanical gait trainer for restoration of gait in subacute stroke patients: a randomized crossover study.

PubMed

Werner, C; Von Frankenberg, S; Treig, T; Konrad, M; Hesse, S

2002-12-01

The purpose of this study was to compare treadmill and electromechanical gait trainer therapy in subacute, nonambulatory stroke survivors. The gait trainer was designed to provide nonambulatory subjects the repetitive practice of a gait-like movement without overexerting therapists. This was a randomized, controlled study with a crossover design following an A-B-A versus a B-A-B pattern. A consisted of 2 weeks of gait trainer therapy, and B consisted of 2 weeks of treadmill therapy. Thirty nonambulatory hemiparetic patients, 4 to 12 weeks after stroke, were randomly assigned to 1 of the 2 groups receiving locomotor therapy every workday for 15 to 20 minutes for 6 weeks. Weekly gait ability (functional ambulation category [FAC]), gait velocity, and the required physical assistance during both kinds of locomotor therapy were the primary outcome measures, and other motor functions (Rivermead motor assessment score) and ankle spasticity (modified Ashworth score) were the secondary outcome measures. Follow-up occurred 6 months later. The groups did not differ at study onset with respect to the clinical characteristics and effector variables. During treatment, the FAC, gait velocity, and Rivermead scores improved in both groups, and ankle spasticity did not change. Median FAC level was 4 (3 to 4) in group A compared with 3 (2 to 3) in group B at the end of treatment (P=0.018), but the difference at 6-month follow up was not significant. The therapeutic effort was less on the gait trainer, with 1 instead of 2 therapists assisting the patient at study onset. All but seven patients preferred the gait trainer. The newly developed gait trainer was at least as effective as treadmill therapy with partial body weight support while requiring less input from the therapist. Further studies are warranted.

Myofascial treatment for patients with acetabular labral tears: a single-subject research design study.

PubMed

Cashman, Glenn E; Mortenson, W Ben; Gilbart, Michael K

2014-08-01

Single-subject research design using 4 consecutive patients. To assess whether treatment using soft tissue therapy (ART or Active Release Technique), stretching, and strengthening of the hip abductors, hip external rotators, and tensor fascia latae muscles reduces pain and improves self-reported hip function in patients with acetabular labral tears who also have posterolateral hip pain of suspected myofascial origin. Acetabular labral tears cause pain in some but not all patients. Pain commonly presents anteriorly but may also present posteriorly and laterally. The standard of care is arthroscopic repair, which helps many but not all patients. It is possible that these patients may present with extra-articular contributions to their pain, such as myofascial pain, making their clinical presentation more complex. No previous study has assessed soft tissue therapy as a treatment option for this subset of patients. This A-B-A design used repeated measures of the Hip Outcome Score and visual analog scale for pain. Four patients were treated for 6 to 8 weeks, using a combination of soft tissue therapy, stretching, and strengthening for the hip abductors, external rotators, and tensor fascia latae. Data were assessed visually, statistically, and by comparing mean differences before and after intervention. All 4 patients experienced both statistically significant and clinically meaningful improvement in posterolateral hip pain and hip-related function. Three patients also experienced reduction in anteromedial hip pain. Myofascial hip pain may contribute to hip-related symptoms and disability in patients with acetabular labral tears and posterolateral hip pain. These patients may benefit from soft tissue therapy combined with stretching and strengthening exercises targeting the hip abductors, tensor fascia latae, and hip external rotator muscles. Level of Evidence Therapy, level 4.

Design and Kinematic Evaluation of a Novel Joint-Specific Play Controller: Application for Wrist and Forearm Therapy

PubMed Central

Schwartz, Joel B.; Wilcox, Bethany; Costa, Laura; Kerman, Karen

2015-01-01

Background The wrist extensors and flexors are profoundly affected in most children with hemiparetic cerebral palsy (CP) and are the major target of physical therapists' and occupational therapists' efforts to restore useful hand functions. A limitation of any therapeutic or exercise program can be the level of the child's engagement or adherence. The proposed approach capitalizes on the primary learning avenue for children: toy play. Objective This study aimed to develop and evaluate the measurement accuracy of innovative, motion-specific play controllers that are engaging rehabilitative devices for enhancing therapy and promoting neural plasticity and functional recovery in children with CP. Design Design objectives of the play controller included a cost-effective, home-based supplement to physical therapy, the ability to calibrate the controller so that play can be accomplished with any active range of motion, and the capability of logging play activity and wrist motion over week-long periods. Methods Accuracy of the play controller in measuring wrist flexion-extension was evaluated in 6 children who were developing in a typical manner, using optical motion capture of the wrist and forearm as the gold standard. Results The error of the play controller was estimated at approximately 5 degrees in both maximum wrist flexion and extension. Limitations Measurements were taken during a laboratory session, with children without CP, and no toy or computer game was interfaced with the play controller. Therefore, the potential engagement of the proposed approach for therapy remains to be evaluated. Conclusions This study presented the concept, development, and wrist tracking accuracy of an inexpensive approach to extremity therapy that may have a health benefit for children with hemiparesis, and potentially for patients of any age with a wide range of extremity neuromotor impairments. PMID:25573759

Conceptual model and economic experiments to explain nonpersistence and enable mechanism designs fostering behavioral change.

PubMed

Djawadi, Behnud Mir; Fahr, René; Turk, Florian

2014-12-01

Medical nonpersistence is a worldwide problem of striking magnitude. Although many fields of studies including epidemiology, sociology, and psychology try to identify determinants for medical nonpersistence, comprehensive research to explain medical nonpersistence from an economics perspective is rather scarce. The aim of the study was to develop a conceptual framework that augments standard economic choice theory with psychological concepts of behavioral economics to understand how patients' preferences for discontinuing with therapy arise over the course of the medical treatment. The availability of such a framework allows the targeted design of mechanisms for intervention strategies. Our conceptual framework models the patient as an active economic agent who evaluates the benefits and costs for continuing with therapy. We argue that a combination of loss aversion and mental accounting operations explains why patients discontinue with therapy at a specific point in time. We designed a randomized laboratory economic experiment with a student subject pool to investigate the behavioral predictions. Subjects continue with therapy as long as experienced utility losses have to be compensated. As soon as previous losses are evened out, subjects perceive the marginal benefit of persistence lower than in the beginning of the treatment. Consequently, subjects start to discontinue with therapy. Our results highlight that concepts of behavioral economics capture the dynamic structure of medical nonpersistence better than does standard economic choice theory. We recommend that behavioral economics should be a mandatory part of the development of possible intervention strategies aimed at improving patients' compliance and persistence behavior. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

A mobile robot therapist for under-supervised training with robot/computer assisted motivating systems.

PubMed

Shakya, Yuniya; Johnson, Michelle J

2008-01-01

Robot assisted therapy is a new and promising area in stroke rehabilitation and has shown to be effective in reducing motor impairment, but is a costly solution for home rehabilitation. High medical costs could be reduced if we could improve rehabilitation exercise in unsupervised environments such as the home. Hence, there is an augmented need for a cost effective rehabilitation system that can be used outside the clinic. This paper presents the design concept for an autonomous robotic assistant that is low-cost and effective in engaging the users while assisting them with therapy in any under-supervised area. We investigated how the robot assistant can support TheraDrive, our low-cost therapy system. We present the design methods and a case study demonstrating the arm and video collection system.

Design of carbon therapy facility based on 10 years experience at HIMAC

NASA Astrophysics Data System (ADS)

Noda, K.; Furukawa, T.; Iwata, Y.; Kanai, T.; Kanazawa, M.; Kanematsu, N.; Kitagawa, A.; Komori, M.; Minohara, S.; Murakami, T.; Muramatsu, M.; Sato, S.; Sato, Y.; Shibuya, S.; Torikoshi, M.; Yamada, S.

2006-06-01

Since 1994, the clinical trial for cancer therapy with HIMAC has successfully progressed, and more than 2100 cancer patients have been treated with a carbon beam. Based on the development of the accelerator and irradiation technologies for 10 years, we have designed a new carbon-therapy facility for widespread use in Japan, and key technologies for the new facility have been developed. We describe the conceptual design of the new facility and the status of development for the key technologies.

Client Motivation for Therapy Scale: a measure of intrinsic motivation, extrinsic motivation, and amotivation for therapy.

PubMed

Pelletier, L G; Tuson, K M; Haddad, N K

1997-04-01

The purpose of this study was to examine the psychometric properties of a new measure of client motivation for therapy, the Client Motivation for Therapy Scale. This scale is designed to measure client's Intrinsic Motivation, four forms of regulation for Extrinsic Motivation (integrated, identified, introjected, and external regulation), and Amotivation for therapy. These subscales correspond to different forms of motivation identified by Deci and Ryan (1985) and fall along a self-determination continuum. An experimental version of the scale, along with related scales, was distributed to a total sample of 138 clients involved in therapy. The results supported the factor structure of the scale and revealed a satisfactory level of internal consistency. Correlations among the subscales revealed a simplex pattern that, in general, provides support for the self-determination continuum and the construct validity of the scale. Implications for research on client motivation for therapy are discussed.

How to Design and Equip a Mentalization-Based Play Therapy Room.

PubMed

Rüth, Ulrich; Holch, Astrid

2018-01-01

Designing and equipping a play therapy room as a differentiated tool in a psychodynamic approach to child psychotherapy is seldom discussed. This article sketches out the equipment and furnishing of a play therapy room to be used for mentalization-based psychodynamic psychotherapy and gives examples of the use of such a room in practice.

Treatment of obsessive morbid jealousy with cognitive analytic therapy: An adjudicated hermeneutic single-case efficacy design evaluation.

PubMed

Curling, Louise; Kellett, Stephen; Totterdell, Peter; Parry, Glenys; Hardy, Gillian; Berry, Katherine

2018-03-01

The evidence base for the treatment of morbid jealousy with integrative therapies is thin. This study explored the efficacy of cognitive analytic therapy (CAT). An adjudicated hermeneutic single-case efficacy design evaluated the cognitive analytic treatment of a patient meeting diagnostic criteria for obsessive morbid jealousy. A rich case record was developed using a matrix of nomothetic and ideographic quantitative and qualitative outcomes. This record was then debated by sceptic and affirmative research teams. Experienced psychotherapy researchers acted as judges, assessed the original case record, and heard the affirmative-versus-sceptic debate. Judges pronounced an opinion regarding the efficacy of the therapy. The efficacy of CAT was supported by all three judges. Each ruled that change had occurred due to the action of the therapy, beyond any level of reasonable doubt. This research demonstrates the potential usefulness of CAT in treating morbid jealousy and suggests that CAT is conceptually well suited. Suggestions for future clinical and research directions are provided. The relational approach of CAT makes it a suitable therapy for morbid jealousy. The narrative reformulation component of CAT appears to facilitate early change in chronic jealousy patterns. It is helpful for therapists during sessions to use CAT theory to diagrammatically spell out the patterns maintaining jealousy. © 2017 The British Psychological Society.

Menopausal Symptom Relief and Side Effects Experienced by Women Using Compounded Bioidentical Hormone Replacement Therapy and Synthetic Conjugated Equine Estrogen and/or Progestin Hormone Replacement Therapy, Part 2.

PubMed

Deleruyelle, Laura J

2016-01-01

The use of compounded bioidentical hormone replacement therapy by menopausal women has become a popular alternative to traditional synthetic conjugated equine estrogen and progestin hormone replacement therapy due to safety concerns raised by recent studies. However, due to the lack of randomized, large-scale trials to evaluate the efficacy and side-effect profile of compounded bioidentical hormone replacement therapy many healthcare providers are reluctant to prescribe such therapy. The purpose of this study was to compare women's menopausal symptom relief and side effects experienced when using compounded bioidentical hormone replacement therapy and traditional hormone replacement therapy. A descriptive comparative design was used. Inferential and descriptive statistical procedures including a paired difference t-test, two-sample t-test, and f-tests (percentage, mean, standard deviation, frequency) were run on the Statistical Package for the Social Sciences. The framework used to guide this study was Lenz and Pugh's Theory of Unpleasant Symptoms. Surveys were distributed once to a convenient sample of women aged 35 and older when they dropped off or picked up their prescriptions at a pharmacy. Of the 216 surveys distributed, 70 were returned from those women taking compounded bioidentical hormone replacement therapy and 53 from traditional hormone replacement therapy. The survey contained 15 questions pertaining to age, duration of hormone replacement therapy, type and formulation of hormone replacement therapy, reasons for initiating hormone replacement therapy, symptoms before and one month after hormone replacement therapy, and side effects related to hormone replacement therapy. Included in part 1 of this series of articles was the introduction to the study conducted and the results of the literature review that was conducted for the purpose of examining the current data related to the topic of hormone replacement therapy. Part 2 provides a brief discussion on the significance of this study to nursing and provides the methods used in this study. The results of this study will be summarized in forthcoming articles in this series. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Menopausal Symptom Relief and Side Effects Experienced by Women Using Compounded Bioidentical Hormone Replacement Therapy and Synthetic Conjugated Equine Estrogen and/or Progestin Hormone Replacement Therapy, Part 3.

PubMed

Deleruyelle, Laura J

2017-01-01

The use of compounded bioidentical hormone replacement therapy by menopausal women has become a popular alternative to traditional synthetic conjugated equine estrogen and progestin hormone replacement therapy due to safety concerns raised by recent studies. However, due to the lack of randomized, large-scale trials to evaluate the efficacy and side-effect profile of compounded bioidentical hormone replacement therapy many healthcare providers are reluctant to prescribe such therapy. The purpose of this study was to compare women's menopausal symptom relief and side effects experienced when using compounded bioidentical hormone replacement therapy and traditional hormone replacement therapy. A descriptive comparative design was used. Inferential and descriptive statistical procedures including a paired difference t-test, two-sample t-test, and f-tests (percentage, mean, standard deviation, frequency) were run on the Statistical Package for the Social Sciences. The framework used to guide this study was Lenz and Pugh's Theory of Unpleasant Symptoms. Surveys were distributed once to a convenient sample of women aged 35 and older when they dropped off or picked up their prescriptions at a pharmacy. Of the 216 surveys distributed, 70 were returned from those women taking compounded bioidentical hormone replacement therapy and 53 from traditional hormone replacement therapy. The survey contained 15 questions pertaining to age, duration of hormone replacement therapy, type and formulation of hormone replacement therapy, reasons for initiating hormone replacement therapy, symptoms before and one month after hormone replacement therapy, and side effects related to hormone replacement therapy. Included in part 1 of this series of articles was the introduction to the study conducted and the results of the literature review that was conducted for the purpose of examining the current data related to the topic of hormone replacement therapy. Part 2 provided a brief discussion on the significance of this study to nursing and provided the methods used in this study. The results and conclusion of this study are provided within this article. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Design and application of 3D-printed stepless beam modulators in proton therapy

NASA Astrophysics Data System (ADS)

Lindsay, C.; Kumlin, J.; Martinez, D. M.; Jirasek, A.; Hoehr, C.

2016-06-01

A new method for the design of stepless beam modulators for proton therapy is described and verified. Simulations of the classic designs are compared against the stepless method for various modulation widths which are clinically applicable in proton eye therapy. Three modulator wheels were printed using a Stratasys Objet30 3D printer. The resulting depth dose distributions showed improved uniformity over the classic stepped designs. Simulated results imply a possible improvement in distal penumbra width; however, more accurate measurements are needed to fully verify this effect. Lastly, simulations were done to model bio-equivalence to Co-60 cell kill. A wheel was successfully designed to flatten this metric.

Effect of neurofeedback and electromyographic-biofeedback therapy on improving hand function in stroke patients.

PubMed

Rayegani, S M; Raeissadat, S A; Sedighipour, L; Rezazadeh, I Mohammad; Bahrami, M H; Eliaspour, D; Khosrawi, S

2014-01-01

The aim of the present study was to evaluate the effect of applying electroencephalogram (EEG) biofeedback (neurobiofeedback) or electromyographic (EMG) biofeedback to conventional occupational therapy (OT) on improving hand function in stroke patients. This study was designed as a preliminary clinical trial. Thirty patients with stroke were entered the study. Hand function was evaluated by Jebsen Hand Function Test pre and post intervention. Patients were allocated to 3 intervention cohorts: (1) OT, (2) OT plus EMG-biofeedback therapy, and (3) OT plus neurofeedback therapy. All patients received 10 sessions of conventional OT. Patients in cohorts 2 and 3 also received EMG-biofeedback and neurofeedback therapy, respectively. EMG-biofeedback therapy was performed to strengthen the abductor pollicis brevis (APB) muscle. Neurofeedback training was aimed at enhancing sensorimotor rhythm after mental motor imagery. Hand function was improved significantly in the 3 groups. The spectral power density of the sensorimotor rhythm band in the neurofeedback group increased after mental motor imagery. Maximum and mean contraction values of electrical activities of the APB muscle during voluntary contraction increased significantly after EMG-biofeedback training. Patients in the neurofeedback and EMG-biofeedback groups showed hand improvement similar to conventional OT. Further studies are suggested to assign the best protocol for neurofeedback and EMG-biofeedback therapy.

Physical Therapy Interventions for Degenerative Lumbar Spinal Stenosis: A Systematic Review

PubMed Central

Macedo, Luciana Gazzi; Hum, Abraham; Kuleba, Laura; Mo, Joey; Truong, Linda; Yeung, Mankeen

2013-01-01

Background Physical therapy is commonly prescribed for patients with lumbar spinal stenosis (LSS); however, little is known about its effectiveness. Purpose The purpose of this study was to systematically review randomized controlled trials (RCTs), controlled trials, and cohort studies evaluating the effectiveness of physical therapy for LSS. Data Sources Studies were searched on electronic databases to January 2012. Study Selection Inclusion criteria were: clinical diagnosis of LSS with confirmatory imaging, evaluation of physical therapy treatment, presence of a comparison group, and outcomes of pain, disability, function, or quality of life. Data Extraction Outcomes were extracted and, when possible, pooled using RevMan 5, a freely available review program from the Cochrane Library. Data Synthesis Ten studies were included: 5 RCTs, 2 controlled trials, 2 mixed-design studies, and 1 longitudinal cohort study. Pooled effects of 2 studies revealed that the addition of a physical therapy modality to exercise had no statistically significant effect on outcome. Pooled effects results of RCTs evaluating surgery versus physical therapy demonstrated that surgery was better than physical therapy for pain and disability at long term (2 years) only. Other results suggested that exercise is significantly better than no exercise, that cycling and body-weight–supported treadmill walking have similar effects, and that corsets are better than no corsets. Limitations The limitations of this review include the low quality and small number of studies, as well as the heterogeneity in outcomes and treatments. Conclusions No conclusions could be drawn from the review regarding which physical therapy treatment is superior for LSS. There was low-quality evidence suggesting that modalities have no additional effect to exercise and that surgery leads to better long-term (2 years) outcomes for pain and disability, but not walking distance, than physical therapy in patients with LSS. PMID:23886845

Recent trends in the gene therapy of β-thalassemia

PubMed Central

Finotti, Alessia; Breda, Laura; Lederer, Carsten W; Bianchi, Nicoletta; Zuccato, Cristina; Kleanthous, Marina; Rivella, Stefano; Gambari, Roberto

2015-01-01

The β-thalassemias are a group of hereditary hematological diseases caused by over 300 mutations of the adult β-globin gene. Together with sickle cell anemia, thalassemia syndromes are among the most impactful diseases in developing countries, in which the lack of genetic counseling and prenatal diagnosis have contributed to the maintenance of a very high frequency of these genetic diseases in the population. Gene therapy for β-thalassemia has recently seen steadily accelerating progress and has reached a crossroads in its development. Presently, data from past and ongoing clinical trials guide the design of further clinical and preclinical studies based on gene augmentation, while fundamental insights into globin switching and new technology developments have inspired the investigation of novel gene-therapy approaches. Moreover, human erythropoietic stem cells from β-thalassemia patients have been the cellular targets of choice to date whereas future gene-therapy studies might increasingly draw on induced pluripotent stem cells. Herein, we summarize the most significant developments in β-thalassemia gene therapy over the last decade, with a strong emphasis on the most recent findings, for β-thalassemia model systems; for β-, γ-, and anti-sickling β-globin gene addition and combinatorial approaches including the latest results of clinical trials; and for novel approaches, such as transgene-mediated activation of γ-globin and genome editing using designer nucleases. PMID:25737641

Issues related to development of antiepileptogenic therapies.

PubMed

Pitkänen, Asla; Nehlig, Astrid; Brooks-Kayal, Amy R; Dudek, F Edward; Friedman, Daniel; Galanopoulou, Aristea S; Jensen, Frances E; Kaminski, Rafal M; Kapur, Jaideep; Klitgaard, Henrik; Löscher, Wolfgang; Mody, Istvan; Schmidt, Dieter

2013-08-01

Several preclinical proof-of-concept studies have provided evidence for positive treatment effects on epileptogenesis. However, none of these hypothetical treatments has advanced to the clinic. The experience in other fields of neurology such as stroke, Alzheimer's disease, or amyotrophic lateral sclerosis has indicated several problems in the design of preclinical studies, which likely contribute to failures in translating the positive preclinical data to the clinic. The Working Group on "Issues related to development of antiepileptogenic therapies" of the International League Against Epilepsy (ILAE) and the American Epilepsy Society (AES) has considered the possible problems that arise when moving from proof-of-concept antiepileptogenesis (AEG) studies to preclinical AEG trials, and eventually to clinical AEG trials. This article summarizes the discussions and provides recommendations on how to design a preclinical AEG monotherapy trial in adult animals. We specifically address study design, animal and model selection, number of studies needed, issues related to administration of the treatment, outcome measures, statistics, and reporting. In addition, we give recommendations for future actions to advance the preclinical AEG testing. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

Cost-Effectiveness of Earlier Initiation of Antiretroviral Therapy for Uninsured HIV-Infected Adults

PubMed Central

Schackman, Bruce R.; Goldie, Sue J.; Weinstein, Milton C.; Losina, Elena; Zhang, Hong; Freedberg, Kenneth A.

2001-01-01

Objectives. This study was designed to examine the societal cost-effectiveness and the impact on government payers of earlier initiation of antiretroviral therapy for uninsured HIV-infected adults. Methods. A state-transition simulation model of HIV disease was used. Data were derived from the Multicenter AIDS Cohort Study, published randomized trials, and medical care cost estimates for all government payers and for Massachusetts, New York, and Florida. Results. Quality-adjusted life expectancy increased from 7.64 years with therapy initiated at 200 CD4 cells/μL to 8.21 years with therapy initiated at 500 CD4 cells/μL. Initiating therapy at 500 CD4/μL was a more efficient use of resources than initiating therapy at 200 CD4/μL and had an incremental cost-effectiveness ratio of $17 300 per quality-adjusted life-year gained, compared with no therapy. Costs to state payers in the first 5 years ranged from $5500 to $24 900 because of differences among the states in the availability of federal funds for AIDS drug assistance programs. Conclusions. Antiretroviral therapy initiated at 500 CD4 cells/μL is cost-effective from a societal perspective compared with therapy initiated later. States should consider Medicaid waivers to expand access to early therapy. PMID:11527782

Endoscopic spray cryotherapy for esophageal cancer: safety and efficacy

PubMed Central

Greenwald, Bruce D.; Dumot, John A.; Abrams, Julian A.; Lightdale, Charles J.; David, Donald S.; Nishioka, Norman S.; Yachimski, Patrick; Johnston, Mark H.; Shaheen, Nicholas J.; Zfass, Alvin M.; Smith, Jenny O.; Gill, Kanwar Rupinder S.; Burdick, J. Steven; Mallat, Damien; Wolfsen, Herbert C.

2011-01-01

Background Few options exist for patients with localized esophageal cancer ineligible for conventional therapies. Endoscopic spray cryotherapy with low-pressure liquid nitrogen has demonstrated efficacy in this setting in early studies. Objective To assess the safety and efficacy of cryotherapy in esophageal carcinoma. Design Multicenter, retrospective cohort study. Setting Ten academic and community medical centers between 2006 and 2009. Patients Subjects with esophageal carcinoma in whom conventional therapy failed and those who refused or were ineligible for conventional therapy. Interventions Cryotherapy with follow-up biopsies. Treatment was complete when tumor eradication was confirmed by biopsy or when treatment was halted because of tumor progression, patient preference, or comorbid condition. Main Outcome Measurements Complete eradication of luminal cancer and adverse events. Results Seventy-nine subjects (median age 76 years, 81% male, 94% with adenocarcinoma) were treated. Tumor stage included T1-60, T2-16, and T3/4-3. Mean tumor length was 4.0 cm (range 1–15 cm). Previous treatment including endoscopic resection, photodynamic therapy, esophagectomy, chemotherapy, and radiation therapy failed in 53 subjects (67%). Forty-nine completed treatment. Complete response of intraluminal disease was seen in 31 of 49 subjects (61.2%), including 18 of 24 (75%) with mucosal cancer. Mean (standard deviation) length of follow-up after treatment was 10.6 (8.4) months overall and 11.5 (2.8) months for T1 disease. No serious adverse events were reported. Benign stricture developed in 10 (13%), with esophageal narrowing from previous endoscopic resection, radiotherapy, or photodynamic therapy noted in 9 of 10 subjects. Limitations Retrospective study design, short follow-up. Conclusions Spray cryotherapy is safe and well tolerated for esophageal cancer. Short-term results suggest that it is effective in those who could not receive conventional treatment, especially for those with mucosal cancer. PMID:20363410

Improved word comprehension in Global aphasia using a modified semantic feature analysis treatment.

PubMed

Munro, Philippa; Siyambalapitiya, Samantha

2017-01-01

Limited research has investigated treatment of single word comprehension in people with aphasia, despite numerous studies examining treatment of naming deficits. This study employed a single case experimental design to examine efficacy of a modified semantic feature analysis (SFA) therapy in improving word comprehension in an individual with Global aphasia, who presented with a semantically based comprehension impairment. Ten treatment sessions were conducted over a period of two weeks. Following therapy, the participant demonstrated improved comprehension of treatment items and generalisation to control items, measured by performance on a spoken word picture matching task. Improvements were also observed on other language assessments (e.g. subtests of WAB-R; PALPA subtest 47) and were largely maintained over a period of 12 weeks without further therapy. This study provides support for the efficacy of a modified SFA therapy in remediating single word comprehension in individuals with aphasia with a semantically based comprehension deficit.

Effects of virtual reality training with modified constraint-induced movement therapy on upper extremity function in acute stage stroke: a preliminary study.

PubMed

Ji, Eun-Kyu; Lee, Sang-Heon

2016-11-01

[Purpose] The purpose of this study was to investigate the effects of virtual reality training combined with modified constraint-induced movement therapy on upper extremity motor function recovery in acute stage stroke patients. [Subjects and Methods] Four acute stage stroke patients participated in the study. A multiple baseline single subject experimental design was utilized. Modified constraint-induced movement therapy was used according to the EXplaining PLastICITy after stroke protocol during baseline sessions. Virtual reality training with modified constraint-induced movement therapy was applied during treatment sessions. The Manual Function Test and the Box and Block Test were used to measure upper extremity function before every session. [Results] The subjects' upper extremity function improved during the intervention period. [Conclusion] Virtual reality training combined with modified constraint-induced movement is effective for upper extremity function recovery in acute stroke patients.

Learning style and teaching method preferences of Saudi students of physical therapy

PubMed Central

Al Maghraby, Mohamed A.; Alshami, Ali M.

2013-01-01

Context: To the researchers’ knowledge, there are no published studies that have investigated the learning styles and preferred teaching methods of physical therapy students in Saudi Arabia. Aim: The study was conducted to determine the learning styles and preferred teaching methods of Saudi physical therapy students. Settings and Design: A cross-sectional study design. Materials and Methods: Fifty-three Saudis studying physical therapy (21 males and 32 females) participated in the study. The principal researcher gave an introductory lecture to explain the different learning styles and common teaching methods. Upon completion of the lecture, questionnaires were distributed, and were collected on completion. Statistical Analysis Used: Percentages were calculated for the learning styles and teaching methods. Pearson’s correlations were performed to investigate the relationship between them. Results: More than 45 (85%) of the students rated hands-on training as the most preferred teaching method. Approximately 30 (57%) students rated the following teaching methods as the most preferred methods: “Advanced organizers,” “demonstrations,” and “multimedia activities.” Although 31 (59%) students rated the concrete-sequential learning style the most preferred, these students demonstrated mixed styles on the other style dimensions: Abstract-sequential, abstract-random, and concrete-random. Conclusions: The predominant concrete-sequential learning style is consistent with the most preferred teaching method (hands-on training). The high percentage of physical therapy students whose responses were indicative of mixed learning styles suggests that they can accommodate multiple teaching methods. It is recommended that educators consider the diverse learning styles of the students and utilize a variety of teaching methods in order to promote an optimal learning environment for the students. PMID:24672278

BODY-ORIENTED THERAPY IN RECOVERY FROM CHILD SEXUAL ABUSE: AN EFFICACY STUDY

PubMed Central

Price, Cynthia

2007-01-01

Context There has been little research on body therapy for women in sexual abuse recovery. This study examines body-oriented therapy—an approach focused on body awareness and involving the combination of bodywork and the emotional processing of psychotherapy. Objective To examine the efficacy and the perceived influence on abuse recovery of body-oriented therapy. Massage therapy served as a relative control condition to address the lack of touch-based comparisons in bodywork research. Design A 2-group, repeated measures design was employed, involving randomization to either body-oriented therapy or massage group, conducted in 8, hour-long sessions by 1 of 4 research clinicians. Statistical and qualitative analysis was employed to provide both empirical and experiential perspectives on the study process. Setting Participants were seen in treatment rooms of a university in the northwestern United States and in clinician’s private offices. Participants Twenty-four adult females in psychotherapy for child sexual abuse. Interventions Body-oriented therapy protocol was delivered in three stages, involving massage, body awareness exercises, and inner-body focusing process. Massage therapy protocol was stan- dardized. Both protocols were delivered over clothes. Main Outcome Measures The outcomes reflected 3 key con-structs—psychological well being, physical well-being, and body connection. Repeated measures included: Brief Symptom Inventory, Dissociative Experiences Scale, Crime-Related Post Traumatic Stress Disorder Scale, Medical Symptoms Checklist, Scale of Body Connection and Scale of Body Investment. Results were gathered at 6 time points: baseline, 2 times during intervention, post-intervention, and at 1 month and 3 months follow-up. To examine the experiential perspective of the study process, written questionnaires were administered before and after intervention and at 1 month and 3 months follow-up. Results Repeated measures analysis of variance (ANOVA) indicated significant improvement on all outcome measures for both intervention groups, providing support for the efficacy of body therapy in recovery from childhood sexual abuse. There were no statistically significant differences between groups; however, qualitative analysis of open-ended questions about participant intervention experience revealed that the groups differed on perceived experience of the intervention and its influence on therapeutic recovery. PMID:16189948

Effects of Live and Educational Music Therapy on Working Alliance and Trust With Patients on Detoxification Unit: A Four-Group Cluster-Randomized Trial.

PubMed

Silverman, Michael J

2016-11-09

Lyric analysis is a commonly utilized music therapy intervention for clients in substance abuse rehabilitation wherein participants interpret song lyrics related to their clinical objectives. For these patients, working alliance and trust in the therapist represent consequential factors that may influence outcomes. However, there is a lack of randomized controlled music therapy studies investigating working alliance and trust in the therapist within lyric analysis interventions for patients with addictions. The purpose of this study was to quantitatively differentiate live versus recorded and educational versus recreational music therapy interventions via measures of working alliance and trust with patients on a detoxification unit. Participants (N = 130) were cluster randomized in a single-session posttest-only design to one of four conditions: Live educational music therapy, recorded educational music therapy, education without music, or recreational music therapy. Dependent measures included working alliance and trust in the therapist. Educational music therapy interventions were scripted lyric analyses. There was no statistically significant between-group difference in any of the measures. Although not significant, a greater number of patients and research participants attended live educational music therapy sessions. Between-group descriptive data were consistently similar but attendance trends may have implications for engaging patients and billing. Implications for clinical practice, limitations of the study, and suggestions for future research are provided.

Mindfulness-based cognitive therapy for anxiety symptoms in older adults in residential care.

PubMed

Helmes, Edward; Ward, Bradley G

2017-03-01

Anxiety in older people is under-diagnosed and poorly treated despite significant impairments that arise from anxiety. Mindfulness-based cognitive therapy (MBCT) has been shown to be a promising treatment for anxiety. The aim of this study was to determine the effect of an MBCT program on anxiety symptoms in older people living in residential care. Fifty-two participants (34 females) were randomly allocated into therapy and control groups using a 2 × 3 mixed design. The average age of participants was 83 years. The group effect showed significant improvements on all measures at the end of the seven-week program in the therapy group, while the control group did not show significant changes. This study represents one of the first studies of the effectiveness of an MBCT program on anxiety symptoms for older people using a randomized controlled trial. The study has implications for future research that include the effectiveness of MBCT for the treatment of anxiety symptoms in older people, the utility of group therapy programs in residential care and the benefits of using specialized instruments for older populations.

Video games and rehabilitation: using design principles to enhance engagement in physical therapy.

PubMed

Lohse, Keith; Shirzad, Navid; Verster, Alida; Hodges, Nicola; Van der Loos, H F Machiel

2013-12-01

Patient nonadherence with therapy is a major barrier to rehabilitation. Recovery is often limited and requires prolonged, intensive rehabilitation that is time-consuming, expensive, and difficult. We review evidence for the potential use of video games in rehabilitation with respect to the behavioral, physiological, and motivational effects of gameplay. In this Special Interest article, we offer a method to evaluate effects of video game play on motor learning and their potential to increase patient engagement with therapy, particularly commercial games that can be interfaced with adapted control systems. We take the novel approach of integrating research across game design, motor learning, neurophysiology changes, and rehabilitation science to provide criteria by which therapists can assist patients in choosing games appropriate for rehabilitation. Research suggests that video games are beneficial for cognitive and motor skill learning in both rehabilitation science and experimental studies with healthy subjects. Physiological data suggest that gameplay can induce neuroplastic reorganization that leads to long-term retention and transfer of skill; however, more clinical research in this area is needed. There is interdisciplinary evidence suggesting that key factors in game design, including choice, reward, and goals, lead to increased motivation and engagement. We maintain that video game play could be an effective supplement to traditional therapy. Motion controllers can be used to practice rehabilitation-relevant movements, and well-designed game mechanics can augment patient engagement and motivation in rehabilitation. We recommend future research and development exploring rehabilitation-relevant motions to control games and increase time in therapy through gameplay.Video Abstract available (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A61) for more insights from the authors.

The use of control groups in music therapy research: a content analysis of articles in the Journal of Music Therapy.

PubMed

Jones, Jennifer D

2006-01-01

The use of a control group is fundamental to experimental research design, though the use with clinical populations must be carefully considered. The purpose of this research was to examine the use of control groups in research with clinical and nonclinical populations published in Journal of Musical Therapy from 1964 through 2004. Criteria for inclusion were music or music therapy as an independent variable applied to one or more groups and at least one control group that did not receive a music treatment. Control groups were qualified as alternative treatment, placebo, no contact, and treatment as usual. Of the 692 articles, 94 met these criteria, 62 clinical and 32 nonclinical, representing 13.5% of the publications. Results indicated that research with clinical populations involved a mean of 38.1 subjects typically divided into two groups, an experimental and a control group. The pretest-posttest design was the most common (55%) as was a treatment as usual control group (45%). These design methods maximized the impact of the experimental music treatment on outcome. Experimental music groups significantly improved over control groups in the vast majority of studies identified. Undoubtedly, the foundation for evidence-based clinical practice is firm.

Clinical trial registration in physical therapy journals: a cross-sectional study.

PubMed

Babu, Abraham Samuel; Veluswamy, Sundar Kumar; Rao, Pratiksha Tilak; Maiya, Arun G

2014-01-01

Clinical trial registration has become an important part of editorial policies of various biomedical journals, including a few physical therapy journals. However, the extent to which editorial boards enforce the need for trial registration varies across journals. The purpose of this study was to identify editorial policies and reporting of trial registration details in MEDLINE-indexed English-language physical therapy journals. This study was carried out using a cross-sectional design. Editorial policies on trial registration of MEDLINE-indexed member journals of the International Society of Physiotherapy Journal Editors (ISPJE) (Journal of Geriatric Physical Therapy, Journal of Hand Therapy, Journal of Neurologic Physical Therapy, Journal of Orthopaedic and Sports Physical Therapy, Journal of Physiotherapy [formerly Australian Journal of Physiotherapy], Journal of Science and Medicine in Sport, Manual Therapy, Physical Therapy, Physical Therapy in Sport, Physiotherapy, Physiotherapy Research International, Physiotherapy Theory and Practice, and Revista Brasileira de Fisioterapia) were reviewed in April 2013. Full texts of reports of clinical trials published in these journals between January 1, 2008, and December 31, 2012, were independently assessed for information on trial registration. Among the 13 journals, 8 recommended trial registration, and 6 emphasized prospective trial registration. As of April 2013, 4,618 articles were published between January 2008 and December 2012, of which 9% (417) were clinical trials and 29% (121/417) of these reported trial registration details. A positive trend in reporting of trial registration was observed from 2008 to 2012. The study was limited to MEDLINE-indexed ISPJE member journals. Editorial policies on trial registration of physical therapy journals and a rising trend toward reporting of trial registration details indicate a positive momentum toward trial registration. Physical therapy journal editors need to show greater commitment to prospective trial registration to make it a rule rather than an option.

Effectiveness of Problem-Solving Therapy for Older, Primary Care Patients with Depression: Results from the IMPACT Project

ERIC Educational Resources Information Center

Arean, Patricia; Hegel, Mark; Vannoy, Steven; Fan, Ming-Yu; Unuzter, Jurgen

2008-01-01

Purpose: We compared a primary-care-based psychotherapy, that is, problem-solving therapy for primary care (PST-PC), to community-based psychotherapy in treating late-life major depression and dysthymia. Design and Methods: The data here are from the IMPACT study, which compared collaborative care within a primary care clinic to care as usual in…

The Impact of School-Based Child Centered Play Therapy on Academic Achievement, Self-Concept, and Teacher-Child Relationship Stress

ERIC Educational Resources Information Center

Blanco, Pedro J.

2009-01-01

This study examined the effectiveness of child centered play therapy (CCPT) with academically at-risk 1st graders. In this quasi-experimental design, twenty-one 1st grade students were assigned to the experimental group and 20 students were assigned to the no treatment control group. The children in the experimental group received two 30 minute…

A Numerical Study on Microwave Coagulation Therapy

DTIC Science & Technology

2013-01-01

hepatocellular carcinoma (small size liver tumor). Through extensive numerical simulations, we reveal the mathematical relationships between some critical parameters in the therapy, including input power, frequency, temperature, and regions of impact. It is shown that these relationships can be approximated using simple polynomial functions. Compared to solutions of partial differential equations, these functions are significantly easier to compute and simpler to analyze for engineering design and clinical

Patients' Competence in and Performance of Cognitive Therapy Skills: Relation to the Reduction of Relapse Risk Following Treatment for Depression

ERIC Educational Resources Information Center

Strunk, Daniel R.; DeRubeis, Robert J.; Chiu, Angela W.; Alvarez, Jennifer

2007-01-01

Cognitive therapy (CT) for depression is designed to teach patients material that is believed to help prevent relapse following successful treatment. This study of 35 moderately to severely depressed patients who responded to CT provides the 1st evidence to suggest that both development and independent use of these competencies predict reduced…

A Pilot Randomized Clinical Trial of Intermittent Occlusion Therapy Liquid Crystal Glasses versus Traditional Patching for Treatment of Moderate Unilateral Amblyopia

PubMed Central

Wang, Jingyun; Neely, Daniel E.; Galli, Jay; Schliesser, Joshua; Graves, April; Damarjian, Tina G.; Kovarik, Jessica; Bowsher, James; Smith, Heather A.; Donaldson, Dana; Haider, Kathryn M.; Roberts, Gavin J.; Sprunger, Derek T.; Plager, David A.

2017-01-01

INTRODUCTION This pilot study was designed to compare the effectiveness of intermittent occlusion therapy (IO-Therapy) using liquid crystal glasses versus continuous occlusion therapy using traditional adhesive patches for treating amblyopia. DESIGN A randomized controlled trial. Children 3–8 years of age with previously untreated, moderate, unilateral amblyopia (visual acuity of 20/40 to 20/100 in the amblyopic eye) were enrolled. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn optimal refractive correction (if needed) for at least 12 weeks without improvement. Subjects were randomized into two treatment groups: a 4-hour IO-Therapy Group with liquid crystal glasses (Amblyz™), set at 30-second opaque/transparent intervals (occluded 50% of wear time) or a 2-hour continuous Patching Group (occluded 100% of wear time). For each patient, visual acuity was measured with the ATS-HOTV method before and after 12 weeks of treatment. RESULTS At the conclusion of the first 12 week-treatment interval, data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15±0.12 (95% CI=0.09 to 0.15) logMAR in the IO-Therapy Group (N=19) and 0.15±0.11 (95% CI=0.1 to 0.15) logMAR in the Patching Group (N=15). Improvements in both groups were significant. The difference between groups was not statistically significant (P=0.73). No adverse effects were reported. CONCLUSION In this pilot study, IO-Therapy with Amblyz liquid crystal glasses is not inferior to adhesive patching and is a promising alternative treatment for children 3–8 years of age with moderate amblyopia. A larger randomized clinical trial is needed to confirm results in future. PMID:27418249

Cost-Effectiveness of Competing Treatment Strategies for Clostridium difficile Infection: A Systematic Review.

PubMed

Le, Phuc; Nghiem, Van T; Mullen, Patricia Dolan; Deshpande, Abhishek

2018-04-01

BACKGROUND Clostridium difficile infection (CDI) presents a substantial economic burden and is associated with significant morbidity. While multiple treatment strategies have been evaluated, a cost-effective management strategy remains unclear. OBJECTIVE We conducted a systematic review to assess cost-effectiveness analyses of CDI treatment and to summarize key issues for clinicians and policy makers to consider. METHODS We searched PubMed and 5 other databases from inception to August 2016. These searches were not limited by study design or language of publication. Two reviewers independently screened the literature, abstracted data, and assessed methodological quality using the Drummond and Jefferson checklist. We extracted data on study characteristics, type of CDI, treatment characteristics, and model structure and inputs. RESULTS We included 14 studies, and 13 of these were from high-income countries. More than 90% of these studies were deemed moderate-to-high or high quality. Overall, 6 studies used a decision-tree model and 7 studies used a Markov model. Cost of therapy, time horizon, treatment cure rates, and recurrence rates were common influential factors in the study results. For initial CDI, fidaxomicin was a more cost-effective therapy than metronidazole or vancomycin in 2 of 3 studies. For severe initial CDI, 2 of 3 studies found fidaxomicin to be the most cost-effective therapy. For recurrent CDI, fidaxomicin was cost-effective in 3 of 5 studies, while fecal microbiota transplantation (FMT) by colonoscopy was consistently cost-effective in 4 of 4 studies. CONCLUSIONS The cost-effectiveness of fidaxomicin compared with other pharmacologic therapies was not definitive for either initial or recurrent CDI. Despite its high cost, FMT by colonoscopy may be a cost-effective therapy for recurrent CDI. A consensus on model design and assumptions are necessary for future comparison of CDI treatment. Infect Control Hosp Epidemiol 2018;39:412-424.

Inter-examiner classification reliability of Mechanical Diagnosis and Therapy for extremity problems - Systematic review.

PubMed

Takasaki, Hiroshi; Okuyama, Kousuke; Rosedale, Richard

2017-02-01

Mechanical Diagnosis and Therapy (MDT) is used in the treatment of extremity problems. Classifying clinical problems is one method of providing effective treatment to a target population. Classification reliability is a key factor to determine the precise clinical problem and to direct an appropriate intervention. To explore inter-examiner reliability of the MDT classification for extremity problems in three reliability designs: 1) vignette reliability using surveys with patient vignettes, 2) concurrent reliability, where multiple assessors decide a classification by observing someone's assessment, 3) successive reliability, where multiple assessors independently assess the same patient at different times. Systematic review with data synthesis in a quantitative format. Agreement of MDT subgroups was examined using the Kappa value, with the operational definition of acceptable reliability set at ≥ 0.6. The level of evidence was determined considering the methodological quality of the studies. Six studies were included and all studies met the criteria for high quality. Kappa values for the vignette reliability design (five studies) were ≥ 0.7. There was data from two cohorts in one study for the concurrent reliability design and the Kappa values ranged from 0.45 to 1.0. Kappa values for the successive reliability design (data from three cohorts in one study) were < 0.6. The current review found strong evidence of acceptable inter-examiner reliability of MDT classification for extremity problems in the vignette reliability design, limited evidence of acceptable reliability in the concurrent reliability design and unacceptable reliability in the successive reliability design. Copyright © 2017 Elsevier Ltd. All rights reserved.

Comparison of Pediatric Severe Sepsis Managed in U.S. and European ICUs

PubMed Central

Giuliano, John S.; Markovitz, Barry P.; Brierley, Joe; Levin, Richard; Williams, Gary; Lum, Lucy Chai See; Dorofaeff, Tavey; Cruces, Pablo; Bush, Jenny L.; Keele, Luke; Nadkarni, Vinay M.; Thomas, Neal J.; Fitzgerald, Julie C.; Weiss, Scott L.

2017-01-01

Objectives Pediatric severe sepsis remains a significant global health problem without new therapies despite many multicenter clinical trials. We compared children managed with severe sepsis in European and U.S. PICUs to identify geographic variation, which may improve the design of future international studies. Design We conducted a secondary analysis of the Sepsis PRevalence, OUtcomes, and Therapies study. Data about PICU characteristics, patient demographics, therapies, and outcomes were compared. Multivariable regression models were used to determine adjusted differences in morbidity and mortality. Setting European and U.S. PICUs. Patients Children with severe sepsis managed in European and U.S. PICUs enrolled in the Sepsis PRevalence, OUtcomes, and Therapies study. Interventions None. Measurements and Main Results European PICUs had fewer beds (median, 11 vs 24; p < 0.001). European patients were younger (median, 1 vs 6 yr; p < 0.001), had higher severity of illness (median Pediatric Index of Mortality −3, 5.0 vs 3.8; p = 0.02), and were more often admitted from the ward (37% vs 24%). Invasive mechanical ventilation, central venous access, and vasoactive infusions were used more frequently in European patients (85% vs 68%, p = 0.002; 91% vs 82%, p = 0.05; and 71% vs 50%; p < 0.001, respectively). Raw morbidity and mortality outcomes were worse for European compared with U.S. patients, but after adjusting for patient characteristics, there were no significant differences in mortality, multiple organ dysfunction, disability at discharge, length of stay, or ventilator/vasoactive-free days. Conclusions Children with severe sepsis admitted to European PICUs have higher severity of illness, are more likely to be admitted from hospital wards, and receive more intensive care therapies than in the United States. The lack of significant differences in morbidity and mortality after adjusting for patient characteristics suggests that the approach to care between regions, perhaps related to PICU bed availability, needs to be considered in the design of future international clinical trials in pediatric severe sepsis. PMID:27124566

Bayesian adaptive phase II screening design for combination trials.

PubMed

Cai, Chunyan; Yuan, Ying; Johnson, Valen E

2013-01-01

Trials of combination therapies for the treatment of cancer are playing an increasingly important role in the battle against this disease. To more efficiently handle the large number of combination therapies that must be tested, we propose a novel Bayesian phase II adaptive screening design to simultaneously select among possible treatment combinations involving multiple agents. Our design is based on formulating the selection procedure as a Bayesian hypothesis testing problem in which the superiority of each treatment combination is equated to a single hypothesis. During the trial conduct, we use the current values of the posterior probabilities of all hypotheses to adaptively allocate patients to treatment combinations. Simulation studies show that the proposed design substantially outperforms the conventional multiarm balanced factorial trial design. The proposed design yields a significantly higher probability for selecting the best treatment while allocating substantially more patients to efficacious treatments. The proposed design is most appropriate for the trials combining multiple agents and screening out the efficacious combination to be further investigated. The proposed Bayesian adaptive phase II screening design substantially outperformed the conventional complete factorial design. Our design allocates more patients to better treatments while providing higher power to identify the best treatment at the end of the trial.

Severe Postpartum Hemorrhage from Uterine Atony: A Multicentric Study

PubMed Central

Montufar-Rueda, Carlos; Rodriguez, Laritza; Jarquin, José Douglas; Barboza, Alejandra; Bustillo, Maura Carolina; Marin, Flor; Ortiz, Guillermo; Estrada, Francisco

2013-01-01

Objective. Postpartum hemorrhage (PPH) is an important cause of maternal mortality (MM) around the world. Seventy percent of the PPH corresponds to uterine atony. The objective of our study was to evaluate multicenter PPH cases during a 10-month period, and evaluate severe postpartum hemorrhage management. Study Design. The study population is a cohort of vaginal delivery and cesarean section patients with severe postpartum hemorrhage secondary to uterine atony. The study was designed as a descriptive, prospective, longitudinal, and multicenter study, during 10 months in 13 teaching hospitals. Results. Total live births during the study period were 124,019 with 218 patients (0.17%) with severe postpartum hemorrhage (SPHH). Total maternal deaths were 8, for mortality rate of 3.6% and a MM rate of 6.45/100,000 live births (LB). Maternal deaths were associated with inadequate transfusion therapy. Conclusions. In all patients with severe hemorrhage and subsequent hypovolemic shock, the most important therapy is intravascular volume resuscitation, to reduce the possibility of target organ damage and death. Similarly, the current proposals of transfusion therapy in severe or massive hemorrhage point to early transfusion of blood products and use of fresh frozen plasma, in addition to packed red blood cells, to prevent maternal deaths. PMID:24363935

Enhancing the development and approval of acute stroke therapies: Stroke Therapy Academic Industry roundtable.

PubMed

Fisher, Marc; Albers, Gregory W; Donnan, Geoffrey A; Furlan, Anthony J; Grotta, James C; Kidwell, Chelsea S; Sacco, Ralph L; Wechsler, Lawrence R

2005-08-01

Previous Stroke Therapy Academic Industry Roundtable (STAIR) meetings focused on preclinical evidence of drug efficacy and enhancing acute stroke trial design and performance. A fourth (STAIR-IV) was held to discuss relevant issues related to acute stroke drug development and regulatory approval. The STAIR-IV meeting had 3 main focus areas. The first topic was novel approaches to statistical design of acute stroke trials and appropriate outcome measures. The second focus was the need for better cooperation among participants in stroke therapy development that may be addressed through a national consortium of stroke trial centers in the United States and elsewhere. Lastly, regulatory issues related to the approval of novel mono and multiple acute stroke therapies were discussed. The development of additional acute stroke therapies represents a large unmet need with many remaining challenges and also opportunities to incorporate novel approaches to clinical trial design that will lead to regulatory approval. The STAIR-IV meeting explored new concepts of trial methodology and data analysis, initiatives for implementing a US clinical trialist consortium, and pertinent regulatory issues to expedite approval of novel therapies.

Testing the hypothesis of atherosclerotic plaque lipid depletion during lipid therapy by magnetic resonance imaging: study design of Carotid Plaque Composition Study.

PubMed

Zhao, Xue-Qiao; Phan, Binh An P; Chu, Baocheng; Bray, Frank; Moore, Andrew B; Polissar, Nayak L; Dodge, J Theodore; Lee, Colin D; Hatsukami, Thomas S; Yuan, Chun

2007-08-01

In vivo testing of the lipid depletion hypothesis in human beings during lipid-modifying therapy has not been possible until recent developments in magnetic resonance imaging (MRI). The Carotid Plaque Composition Study is a prospective, randomized study designed to test the lipid depletion hypothesis in vivo. One hundred twenty-three subjects with coronary artery disease (CAD) or carotid disease and with levels of apolipoprotein B > or = 120 mg/dL (low-density lipoprotein levels 100-190 mg/dL) were enrolled and randomized to (1) single therapy--atorvastatin alone, placebos for extended release (ER)-niacin and colesevelam; (2) double therapy--atorvastatin plus ER-niacin (2 g/d), and placebo for colesevelam; (3) triple therapy--atorvastatin, ER-niacin, plus colesevelam (3.8 g/d). All subjects will undergo MRI scans of bilateral carotid arteries at baseline and annually for 3 years for a total of 4 examinations while on active therapy. Among these 123 subjects with mean age of 55 years and mean body mass index of 30 kg/m2, 73% are male, 43% have a family history of premature cardiovascular disease, 37% have had a previous myocardial infarction, 80% have clinically established CAD, 52% are hypertensive, 12% have diabetes, 23% are current smokers, and 47% meet the criteria for metabolic syndrome. The baseline carotid disease is evaluated using a MRI-modified American Heart Association lesion type definition. Of the 123 enrolled subjects, 40% have type III lesions with small eccentric plaque, 52% have type IV to V lesions with a necrotic core, and only 4% have calcified plaque based on the most diseased carotid location. The Carotid Plaque Composition Study uses a state-of-the-art imaging technology and comprehensive lipid management to test the plaque lipid depletion hypothesis in CAD subjects.

Antithyroid drugs in Graves’ disease: Are we stretching it too far?

PubMed Central

Jayaraman, Muthukrishnan; Pawah, Anil Kumar; Narayanan, C. S.

2016-01-01

Introduction: Early and durable achievement of euthyroid or hypothyroid status with low likelihood of relapse is the key to effective treatment of Graves’ disease (GD). Although antithyroid drugs (ATDs) are commonly used first-line agents, likelihood of remission remains highest with radioactive iodine (RAI) therapy and surgery. Data regarding efficacy and economical superiority of RAI therapy over ATDs are lacking from India. This study was designed to study the response to long-term (>12 months) use of ATDs in GD with respect to attainment of remission and to compare the cost of treatment with ATDs versus RAI therapy beyond 12 months. Settings: The study was conducted in a tertiary care center. Study Design: This was a retrospective analysis. Materials and Methods: Patients of GD in our follow-up from February 2009 to March 2016 who had received ATDs for a duration exceeding 12 months were retrospectively analyzed. Patients who underwent radioablation after a period of at least 12 months on ATDs were analyzed and their status was recorded after a minimum of 6 months after radioablation. Patients who remained hyperthyroid beyond 12 months and received RAI therapy were further compared with those who continued on ATDs, for achievement of euthyroid or hypothyroid status. Cost analysis was done for follow-ups and treatment and compared. Statistical Analysis Used: All analyses were done using Fisher's exact test for categorical and descriptive statistics for numerical data. Results: Use of ATDs leading to euthyroid and hypothyroid status in GD patients was only significant beyond 24 years when compared to those at <12–18 months therapy (P = 0.0262 and P = 0.0217, respectively). The patients who ended up with hypothyroid status were significantly greater in RAI group compared to ATD group (P = 0.0003). Cost of therapy per patient beyond 12 months was lower in the RAI group compared to the ATD group (cost difference Rs. 5435.00). Conclusions: Within limitations, our study demonstrates that RAI is effective and economical option in GD. PMID:27730067

Therapies for bruxism: a systematic review and network meta-analysis (protocol).

PubMed

Mesko, Mauro Elias; Hutton, Brian; Skupien, Jovito Adiel; Sarkis-Onofre, Rafael; Moher, David; Pereira-Cenci, Tatiana

2017-01-13

Bruxism is a sleep disorder characterized by grinding and clenching of the teeth that may be related to irreversible tooth injuries. It is a prevalent condition occurring in up to 31% of adults. However, there is no definitive answer as to which of the many currently available treatments (including drug therapy, intramuscular injections, physiotherapy, biofeedback, kinesiotherapy, use of intraoral devices, or psychological therapy) is the best for the clinical management of the different manifestations of bruxism. The aim of this systematic review and network meta-analysis is to answer the following question: what is the best treatment for adult bruxists? Comprehensive searches of the Cochrane Library, MEDLINE (via PubMed), Scopus, and LILACS will be completed using the following keywords: bruxism and therapies and related entry terms. Studies will be included, according to the eligibility criteria (Controlled Clinical Trials and Randomized Clinical Trials, considering specific outcome measures for bruxism). The reference lists of included studies will be hand searched. Relevant data will be extracted from included studies using a specially designed data extraction sheet. Risk of bias of the included studies will be assessed, and the overall strength of the evidence will be summarized (i.e., GRADE). A random effects model will be used for all pairwise meta-analyses (with a 95% confidence interval). A Bayesian network meta-analysis will explore the relative benefits between the various treatments. The review will be reported using the Preferred Reporting Items for Systematic Reviews incorporating Network Meta-Analyses (PRISMA-NMA) statement. This systematic review aims at identifying and evaluating therapies to treat bruxism. This systematic review may lead to several recommendations, for both patients and researchers, as which is the best therapy for a specific patient case and how future studies need to be designed, considering what is available now and what is the reality of the patient. PROSPERO CRD42015023308.

Bioengineered Renal Cell Therapy Device for Clinical Translation

PubMed Central

Pino, Christopher J.; Westover, Angela J.; Buffington, Deborah A.; Humes, H. David

2016-01-01

The Bioartificial Renal Epithelial Cell System (BRECS), is a cell-based device to treat acute kidney injury through renal cell therapy from an extracorporeal circuit. To enable widespread implementation of cell therapy, the BRECS was designed to be cryopreserved as a complete device, cryostored, cryoshipped to an end-use site, thawed as a complete device, and employed in a therapeutic extracorporeal hemofiltration circuit. This strategy overcomes storage and distribution issues that have been previous barriers to cell therapy. Previous BRECS housings produced by Computer Numerical Control (CNC) machining, a slow process taking hours to produce one bioreactor, was also prohibitively expensive (>$600/CNC-BRECS); major obstacles to mass production. The goal of this study was to produce a BRECS to be mass produced by injection molding (IM-BRECS), decreasing cost (<$20/unit) and improving manufacturing speed (hundreds of units/hr), while maintaining the same cell therapy function as the previous CNC-BRECS, first evaluated through prototypes produced by stereolithography (SLA-BRECS). The finalized IM-BRECS design had a significantly lower fill volume (10 mL), mass (49 g) and footprint (8.5 cm×8.5 cm×1.5 cm), and was demonstrated to outperform the previous BRECS designs with respect to heat transfer, significantly improving control of cooling during cryopreservation and reducing thaw times during warming. During in vitro culture, IM-BRECS performed similarly to previous CNC-BRECS with respect to cell metabolic activity (lactate production, oxygen consumption and glutathione metabolism) and amount of cells supported. PMID:27922886

Dose-finding designs for trials of molecularly targeted agents and immunotherapies

PubMed Central

Chiuzan, Cody; Shtaynberger, Jonathan; Manji, Gulam A.; Duong, Jimmy K.; Schwartz, Gary K.; Ivanova, Anastasia; Lee, Shing M.

2017-01-01

Recently, there has been a surge of early phase trials of molecularly targeted agents (MTAs) and immunotherapies. These new therapies have different toxicity profiles compared to cytotoxic therapies. MTAs can benefit from new trial designs that allow inclusion of low-grade toxicities, late-onset toxicities, addition of an efficacy endpoint, and flexibility in the specification of a target toxicity probability. To study the degree of adoption of these methods, we conducted a Web of Science search of articles published between 2008 and 2014 that describe phase 1 oncology trials. Trials were categorized based on the dose-finding design used and the type of drug studied. Out of 1,712 dose-finding trials that met our criteria, 1,591 (92.9%) utilized a rule-based design, and 92 (5.4%; range 2.3% in 2009 to 9.7% in 2014) utilized a model-based or novel design. Over half of the trials tested an MTA or immunotherapy. Among the MTA and immunotherapy trials, 5.8% used model-based methods, compared to 3.9% and 8.3% of the chemotherapy or radiotherapy trials, respectively. While the percentage of trials using novel dose-finding designs has tripled since 2007, only 7.1% of trials use novel designs. PMID:28166468

The Use of Dialectical Behavior Therapy (DBT) in Music Therapy: A Sequential Explanatory Study.

PubMed

Chwalek, Carolyn M; McKinney, Cathy H

2015-01-01

There are published examples of how dialectical behavior therapy (DBT) and music therapy are effectively being used as separate therapies in the treatment of individuals with a variety of mental health disorders. However, research examining DBT-informed music therapy is limited. The purpose of this study was to determine whether music therapists working in mental health settings are implementing components of DBT in their work, and if so, how and why; and if not, why not and what is their level of interest in such work. We used a sequential explanatory mixed-methods research design implemented in two phases. Phase 1 was a quantitative survey of board-certified music therapists (n=260). Due to a low survey response rate (18%), and to enhance the validity of the findings, Phase 2, an embedded qualitative procedure in the form of interviews with clinicians experienced in the DBT approach, was added to the study. Both survey and interviews inquired about DBT training, use of DBT-informed music therapy, music therapy experiences used to address DBT skills, and experiences of implementing DBT-informed music therapy. Respondents indicating they implement DBT-informed music therapy (38.3%) are using components and adaptations of the standard DBT protocol. Advantages of implementing DBT-informed music therapy were identified, and more than half of the respondents who do not implement DBT in their music therapy practice also perceived this work as at least somewhat important. Disadvantages were also identified and support the need for further research. Components of DBT are used in music therapy and are valued, but there is a lack of empirical evidence to inform, refine, and guide practice. © the American Music Therapy Association 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A systematic review of randomized controlled trials using music therapy for children.

PubMed

Mrázová, Marcela; Celec, Peter

2010-10-01

Music therapy is a promising approach widening the potential applications of psychotherapy. Music influences both, psychologic and physiologic parameters, and children are especially responsive to this form of therapy. Many aspects of its action mechanisms remain to be elucidated, underscoring the need for evidence-based medicine (EBM) for clinical use of music therapy. This review seeks to highlight some of the issues of music therapy research and to initiate a discussion about the need for international multicenter cooperation to bring scientifically sound evidence of the benefits of music therapy in pediatric patients. Scientific bibliographic databases were searched for randomized controlled trials on use of music therapy for children. Identified articles were evaluated according to criteria for scientific quality. Twenty-eight studies were identified. Most of the trials were biased by the number of participants, and some trials showed the need to improve design of control groups. Indeed, the novelty of this area of study has produced a large number of different studies (with variability in diagnoses, interventions, control groups, duration, and/or outcome parameters), and there is a need for a more homogeneous and systematic approach. Available studies highlight the need to address reproducibility issues. This analysis identifies the need for a subsequent series of clinical studies on the efficacy of music in the pediatric population, with more focus on eligibility criteria with respect to EBM and reproducibility.

Effects of music therapy in the treatment of children with delayed speech development - results of a pilot study.

PubMed

Gross, Wibke; Linden, Ulrike; Ostermann, Thomas

2010-07-21

Language development is one of the most significant processes of early childhood development. Children with delayed speech development are more at risk of acquiring other cognitive, social-emotional, and school-related problems. Music therapy appears to facilitate speech development in children, even within a short period of time. The aim of this pilot study is to explore the effects of music therapy in children with delayed speech development. A total of 18 children aged 3.5 to 6 years with delayed speech development took part in this observational study in which music therapy and no treatment were compared to demonstrate effectiveness. Individual music therapy was provided on an outpatient basis. An ABAB reversal design with alternations between music therapy and no treatment with an interval of approximately eight weeks between the blocks was chosen. Before and after each study period, a speech development test, a non-verbal intelligence test for children, and music therapy assessment scales were used to evaluate the speech development of the children. Compared to the baseline, we found a positive development in the study group after receiving music therapy. Both phonological capacity and the children's understanding of speech increased under treatment, as well as their cognitive structures, action patterns, and level of intelligence. Throughout the study period, developmental age converged with their biological age. Ratings according to the Nordoff-Robbins scales showed clinically significant changes in the children, namely in the areas of client-therapist relationship and communication. This study suggests that music therapy may have a measurable effect on the speech development of children through the treatment's interactions with fundamental aspects of speech development, including the ability to form and maintain relationships and prosodic abilities. Thus, music therapy may provide a basic and supportive therapy for children with delayed speech development. Further studies should be conducted to investigate the mechanisms of these interactions in greater depth. The trial is registered in the German clinical trials register; Trial-No.: DRKS00000343.

Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial.

PubMed

Rohan, Kelly J; Evans, Maggie; Mahon, Jennifer N; Sitnikov, Lilya; Ho, Sheau-Yan; Nillni, Yael I; Postolache, Teodor T; Vacek, Pamela M

2013-03-21

Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. The central public health challenge in the management of SAD is prevention of winter depression recurrence. Light therapy (LT) is the established and best available acute SAD treatment. However, long-term compliance with daily LT from first symptom through spontaneous springtime remission every fall/winter season is poor. Time-limited alternative treatments with effects that endure beyond the cessation of acute treatment are needed to prevent the annual recurrence of SAD. This is an NIMH-funded R01-level randomized clinical trial to test the efficacy of a novel, SAD-tailored cognitive-behavioral group therapy (CBT) against LT in a head-to-head comparison on next winter outcomes. This project is designed to test for a clinically meaningful difference between CBT and LT on depression recurrence in the next winter (the primary outcome). This is a concurrent two-arm study that will randomize 160 currently symptomatic community adults with major depression, recurrent with seasonal pattern, to CBT or LT. After 6 weeks of treatment in the initial winter, participants are followed in the subsequent summer, the next winter, and two winters later. Key methodological issues surround timing study procedures for a predictably recurrent and time-limited disorder with a focus on long-term outcomes. The chosen design answers the primary question of whether prior exposure to CBT is associated with a substantially lower likelihood of depression recurrence the next winter than LT. This design does not test the relative contributions of the cognitive-behavioral treatment components vs. nonspecific factors to CBT's outcomes and is not adequately powered to test for differences or equivalence between cells at treatment endpoint. Alternative designs addressing these limitations would have required more patients, increased costs, and reduced power to detect a difference in the primary outcome. Clinicaltrials.gov identifier NCT01714050.

Bioengineering Strategies for Designing Targeted Cancer Therapies

PubMed Central

Wen, Xuejun

2014-01-01

The goals of bioengineering strategies for targeted cancer therapies are (1) to deliver a high dose of an anticancer drug directly to a cancer tumor, (2) to enhance drug uptake by malignant cells, and (3) to minimize drug uptake by nonmalignant cells. Effective cancer-targeting therapies will require both passive- and active targeting strategies and a thorough understanding of physiologic barriers to targeted drug delivery. Designing a targeted therapy includes the selection and optimization of a nanoparticle delivery vehicle for passive accumulation in tumors, a targeting moiety for active receptor-mediated uptake, and stimuli-responsive polymers for control of drug release. The future direction of cancer targeting is a combinatorial approach, in which targeting therapies are designed to use multiple targeting strategies. The combinatorial approach will enable combination therapy for delivery of multiple drugs and dual ligand targeting to improve targeting specificity. Targeted cancer treatments in development and the new combinatorial approaches show promise for improving targeted anticancer drug delivery and improving treatment outcomes. PMID:23768509

What is the role of combination drug therapy in the treatment of overactive bladder? ICI-RS 2014.

PubMed

Visco, Anthony G; Fraser, Matthew O; Newgreen, Donald; Oelke, Matthias; Cardozo, Linda

2016-02-01

The role of combination therapy using oral antimuscarinic medications for the treatment of overactive bladder was proposed at the 2014 International Consultation on Incontinence-Research Society in Bristol, UK to identify key factors to consider when making clinical decisions and to guide future research design. Combination therapy is justified if monotherapy is associated with suboptimal efficacy or bothersome side effects. Combination therapy has the potential to improve efficacy with fewer side effects than monotherapy. Two Phase 2 studies comparing combination therapy that included an antimuscarinic demonstrated improvement in mean voided volume, the primary outcome chosen, with some combinations showing improved micturition frequency and quality of life. The two studies found no evidence of an increased safety risk with combination therapy compared to monotherapy. Future studies should use clinically meaningful or patient reported outcomes such as incontinence episodes when comparing efficacy. If surrogate measures are used, a clear justification should be provided. Cost analyses should be planned for clinical research trials evaluating combination drug therapy. Combination therapy is reasonable when monotherapy has suboptimal efficacy or bothersome side effects. Future research studies evaluating combination therapy for urgency urinary incontinence should ideally(1) be performed as part of a randomized clinical trial,(2) evaluate non-responders to monotherapy,(3) evaluate combination therapy using medications with different mechanisms of action,(4) include clinically meaningful and patient reported outcomes when evaluating efficacy, and(5) include cost-effectiveness analyses to justify any increased cost by showing improvement in efficacy or reduction in side effects. © 2016 Wiley Periodicals, Inc.

The impact of group music therapy on depression and cognition in elderly persons with dementia: a randomized controlled study.

PubMed

Chu, Hsin; Yang, Chyn-Yng; Lin, Yu; Ou, Keng-Liang; Lee, Tso-Ying; O'Brien, Anthony Paul; Chou, Kuei-Ru

2014-04-01

The aims of this study were to determine the effectiveness of group music therapy for improving depression and delaying the deterioration of cognitive functions in elderly persons with dementia. The study had a prospective, parallel-group design with permuted-block randomization. Older persons with dementia (N = 104) were randomly assigned to the experimental or control group. The experimental group received 12 sessions of group music therapy (two 30-min sessions per week for 6 weeks), and the control group received usual care. Data were collected 4 times: (1) 1 week before the intervention, (2) the 6th session of the intervention, (3) the 12th session of the intervention, and (4) 1 month after the final session. Group music therapy reduced depression in persons with dementia. Improvements in depression occurred immediately after music therapy and were apparent throughout the course of therapy. The cortisol level did not significantly decrease after the group music therapy. Cognitive function significantly improved slightly at the 6th session, the 12th session, and 1 month after the sessions ended; in particular, short-term recall function improved. The group music therapy intervention had the greatest impact in subjects with mild and moderate dementia. The group music intervention is a noninvasive and inexpensive therapy that appeared to reduce elders' depression. It also delayed the deterioration of cognitive functions, particularly short-term recall function. Group music therapy may be an appropriate intervention among elderly persons with mild and moderate dementia.

Statistically designed nonionic surfactant vesicles for dermal delivery of itraconazole: characterization and in vivo evaluation using a standardized Tinea pedis infection model.

PubMed

Kumar, Neeraj; Goindi, Shishu

2014-09-10

The study aims to statistically develop a hydrogel of itraconazole loaded nonionic surfactant vesicles (NSVs) for circumventing the shortcomings and adverse effects of currently used therapies. Influential factors were screened using first-order Taguchi design, thereafter, optimization was performed via D-optimal design involving screened factors (surfactant type, content and molar ratio of cholesterol: surfactant). Response variables investigated were percent drug entrapment, vesicle size, drug skin retention and permeation in 6h. Suspensions of NSVs were gelled to improve topical applicability. Characterization of formulations was performed using vesicle shape, size, surface charge, texture analysis and rheology behavior. Ex vivo studies in rat skin depicted that optimized formulation augmented drug skin retention and permeation in 6h than conventional cream and oily solution of itraconazole. Standardized Tinea pedis model in Wistar rats exhibited in vivo antifungal efficacy of optimized formulation, observed in terms of physical manifestations, fungal-burden score and histopathological profiles. Also, a unique investigation involving studying local oxidative stress of infected paw skins as an indicator of fungal infection was performed. Rapid alleviation of infection in animals treated with optimized hydrogel was observed in comparison to commonly prescribed therapies. Therefore, the optimized NSVs may be a promising and efficient alternative to available antifungal therapies. Copyright © 2014 Elsevier B.V. All rights reserved.

Marginal Structural Models for Case-Cohort Study Designs to Estimate the Association of Antiretroviral Therapy Initiation With Incident AIDS or Death

PubMed Central

Cole, Stephen R.; Hudgens, Michael G.; Tien, Phyllis C.; Anastos, Kathryn; Kingsley, Lawrence; Chmiel, Joan S.; Jacobson, Lisa P.

2012-01-01

To estimate the association of antiretroviral therapy initiation with incident acquired immunodeficiency syndrome (AIDS) or death while accounting for time-varying confounding in a cost-efficient manner, the authors combined a case-cohort study design with inverse probability-weighted estimation of a marginal structural Cox proportional hazards model. A total of 950 adults who were positive for human immunodeficiency virus type 1 were followed in 2 US cohort studies between 1995 and 2007. In the full cohort, 211 AIDS cases or deaths occurred during 4,456 person-years. In an illustrative 20% random subcohort of 190 participants, 41 AIDS cases or deaths occurred during 861 person-years. Accounting for measured confounders and determinants of dropout by inverse probability weighting, the full cohort hazard ratio was 0.41 (95% confidence interval: 0.26, 0.65) and the case-cohort hazard ratio was 0.47 (95% confidence interval: 0.26, 0.83). Standard multivariable-adjusted hazard ratios were closer to the null, regardless of study design. The precision lost with the case-cohort design was modest given the cost savings. Results from Monte Carlo simulations demonstrated that the proposed approach yields approximately unbiased estimates of the hazard ratio with appropriate confidence interval coverage. Marginal structural model analysis of case-cohort study designs provides a cost-efficient design coupled with an accurate analytic method for research settings in which there is time-varying confounding. PMID:22302074

Wrist range of motion and motion frequency during toy and game play with a joint-specific controller specially designed to provide neuromuscular therapy: A proof of concept study in typically developing children.

PubMed

Crisco, Joseph J; Schwartz, Joel B; Wilcox, Bethany; Brideau, Holly; Basseches, Benjamin; Kerman, Karen

2015-08-20

Upper extremities affected by hemiplegic cerebral palsy (CP) and other neuromuscular disorders have been demonstrated to benefit from therapy, and the greater the duration of the therapy, the greater the benefit. A great motivator for participating in and extending the duration of therapy with children is play. Our focus is on active motion therapy of the wrist and forearm. In this study we examine the wrist motions associated with playing with two toys and three computer games controlled by a specially-designed play controller. Twenty children (ages 5-11) with no diagnosis of a muscular disorder were recruited. The play controller was fitted to the wrist and forearm of each child and used to measure and log wrist flexion and extension. Play activity and enjoyment were quantified by average wrist range of motion (ROM), motion frequency measures, and a discrete visual scale. We found significant differences in the average wrist ROM and motion frequency among the toys and games, yet there were no differences in the level of enjoyment across all toys and games, which was high. These findings indicate which toys and games may elicit the greater number of goal-directed movements, and lay the foundation for our long-term goal to develop and evaluate innovative motion-specific play controllers that are engaging rehabilitative devices for enhancing therapy and promoting neural plasticity and functional recovery in children with CP. Copyright © 2015 Elsevier Ltd. All rights reserved.

RESEARCH DESIGNS IN SPORTS PHYSICAL THERAPY

PubMed Central

2012-01-01

Research is designed to answer a question or to describe a phenomenon in a scientific process. Sports physical therapists must understand the different research methods, types, and designs in order to implement evidence‐based practice. The purpose of this article is to describe the most common research designs used in sports physical therapy research and practice. Both experimental and non‐experimental methods will be discussed. PMID:23091780

Attachment-Based Family Therapy: A Review of the Empirical Support.

PubMed

Diamond, Guy; Russon, Jody; Levy, Suzanne

2016-09-01

Attachment-based family therapy (ABFT) is an empirically supported treatment designed to capitalize on the innate, biological desire for meaningful and secure relationships. The therapy is grounded in attachment theory and provides an interpersonal, process-oriented, trauma-focused approach to treating adolescent depression, suicidality, and trauma. Although a process-oriented therapy, ABFT offers a clear structure and road map to help therapists quickly address attachment ruptures that lie at the core of family conflict. Several clinical trials and process studies have demonstrated empirical support for the model and its proposed mechanism of change. This article provides an overview of the clinical model and the existing empirical support for ABFT. © 2016 Family Process Institute.

Home-based music therapy--a systematic overview of settings and conditions for an innovative service in healthcare.

PubMed

Schmid, Wolfgang; Ostermann, Thomas

2010-10-14

Almost every Western healthcare system is changing to make their services more centered around out-patient care. In particular, long-term or geriatric patients who have been discharged from the hospital often require home-based care and therapy. Therefore, several programs have been developed to continue the therapeutic process and manage the special needs of patients after discharge from hospital. Music therapy has also moved into this field of healthcare service by providing home-based music therapy (HBMT) programs. This article reviews and summarizes the settings and conditions of HBMT for the first time. The following databases were used to find articles on home-based music therapy: AMED, CAIRSS, EMBASE, MEDLINE, PsychINFO, and PSYNDEX. The search terms were "home-based music therapy" and "mobile music therapy". Included articles were analyzed with respect to participants as well as conditions and settings of HBMT. Furthermore, the date of publication, main outcomes, and the design and quality of the studies were investigated. A total of 20 international publications, 11 clinical studies and nine reports from practice, mainly from the United States (n = 8), were finally included in the qualitative synthesis. Six studies had a randomized controlled design and included a total of 507 patients. The vast majority of clients of HBMT are elderly patients living at home and people who need hospice and palliative care. Although settings were heterogeneous, music listening programs played a predominant role with the aim to reduce symptoms like depression and pain, or to improve quality of life and the relationship between patients and caregivers as primary endpoints. We were able to show that HBMT is an innovative service for future healthcare delivery. It fits with the changing healthcare system and its conditions but also meets the therapeutic needs of the increasing number of elderly and severely impaired people. Apart from music therapists, patients and their families HBMT is also interesting as a blueprint for home based care for other groups of caregivers.

Does music therapy enhance behavioral and cognitive function in elderly dementia patients? A systematic review and meta-analysis.

PubMed

Zhang, Yingshi; Cai, Jiayi; An, Li; Hui, Fuhai; Ren, Tianshu; Ma, Hongda; Zhao, Qingchun

2017-05-01

Demographic aging is a worldwide phenomenon, cognitive and behavioral impairment is becoming global burden of nerve damage. However, the effect of pharmacological treatment is not satisfying. Therefore, we analyzed the efficacy of music therapy in elderly dementia patients, and if so, whether music therapy can be used as first-line non-pharmacological treatment. A comprehensive literature search was performed on PubMed, EMbase and the Cochrane Library from inception to September 2016. A total of 34 studies (42 analyses, 1757 subjects) were included; all of them had an acceptable quality based on the PEDro and CASP scale scores. Studies based on any type of dementia patient were combined and analyzed by subgroup. The standardized mean difference was -0.42 (-0.74 to -0.11) for disruptive behavior and 0.20 (-0.09 to 0.49) for cognitive function as primary outcomes in random effect models using controls as the comparator; the secondary outcomes were depressive score, anxiety and quality of life. No evidence of publication bias was found based on Begg's and Egger's test. The meta-analysis confirmed that the baseline differences between the two groups were balanced. Subgroup analyses showed that disease sub-type, intervention method, comparator, subject location, trial design, trial period and outcome measure instrument made little difference in outcomes. The meta-regression may have identified the causes of heterogeneity as the intervention method, comparator and trial design. Music therapy was effective when patients received interactive therapy with a compared group. There was positive evidence to support the use of music therapy to treat disruptive behavior and anxiety; there were positive trends supporting the use of music therapy for the treatment of cognitive function, depression and quality of life. This study is registered with PROSPERO, number CRD42016036153. Copyright © 2016 Elsevier B.V. All rights reserved.

Patent foramen ovale closure with GORE HELEX or CARDIOFORM Septal Occluder vs. antiplatelet therapy for reduction of recurrent stroke or new brain infarct in patients with prior cryptogenic stroke: Design of the randomized Gore REDUCE Clinical Study.

PubMed

Kasner, Scott E; Thomassen, Lars; Søndergaard, Lars; Rhodes, John F; Larsen, Coby C; Jacobson, Joth

2017-12-01

Rationale The utility of patent foramen ovale (PFO) closure for secondary prevention in patients with prior cryptogenic stroke is uncertain despite multiple randomized trials completed to date. Aims The Gore REDUCE Clinical Study (REDUCE) aims to establish superiority of patent foramen ovale closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients who have had a cryptogenic stroke. Methods and design This controlled, open-label trial randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus patent foramen ovale closure (with GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder) or antiplatelet therapy alone. Subjects will be prospectively followed for up to five years. Neuroimaging is required for all subjects at baseline and at two years or study exit. Study outcomes The two co-primary endpoints for the study are freedom from recurrent clinical ischemic stroke through at least 24 months post-randomization and incidence of new brain infarct (defined as clinical ischemic stroke or silent brain infarct) through 24 months. The primary analyses are an unadjusted log-rank test and a binomial test of subject-based proportions, respectively, both on the intent-to-treat population, with adjustment for testing multiplicity. Discussion The REDUCE trial aims to target a patient population with truly cryptogenic strokes. Medical therapy is limited to antiplatelet agents in both arms thereby reducing confounding. The trial should determine whether patent foramen ovale closure with the Gore septal occluders is safe and more effective than medical therapy alone for the prevention of recurrent clinical ischemic stroke or new silent brain infarct; the neuroimaging data will provide an opportunity to further support the proof of concept. The main results are anticipated in 2017. Registration Clinical trial registration-URL: http://clinicaltrials.gov/show/NCT00738894.

The mechanical design of a humanoid robot with flexible skin sensor for use in psychiatric therapy

NASA Astrophysics Data System (ADS)

Burns, Alec; Tadesse, Yonas

2014-03-01

In this paper, a humanoid robot is presented for ultimate use in the rehabilitation of children with mental disorders, such as autism. Creating affordable and efficient humanoids could assist the therapy in psychiatric disability by offering multimodal communication between the humanoid and humans. Yet, the humanoid development needs a seamless integration of artificial muscles, sensors, controllers and structures. We have designed a human-like robot that has 15 DOF, 580 mm tall and 925 mm arm span using a rapid prototyping system. The robot has a human-like appearance and movement. Flexible sensors around the arm and hands for safe human-robot interactions, and a two-wheel mobile platform for maneuverability are incorporated in the design. The robot has facial features for illustrating human-friendly behavior. The mechanical design of the robot and the characterization of the flexible sensors are presented. Comprehensive study on the upper body design, mobile base, actuators selection, electronics, and performance evaluation are included in this paper.

Recent developments in biofeedback for neuromotor rehabilitation

PubMed Central

Huang, He; Wolf, Steven L; He, Jiping

2006-01-01

The original use of biofeedback to train single muscle activity in static positions or movement unrelated to function did not correlate well to motor function improvements in patients with central nervous system injuries. The concept of task-oriented repetitive training suggests that biofeedback therapy should be delivered during functionally related dynamic movement to optimize motor function improvement. Current, advanced technologies facilitate the design of novel biofeedback systems that possess diverse parameters, advanced cue display, and sophisticated control systems for use in task-oriented biofeedback. In light of these advancements, this article: (1) reviews early biofeedback studies and their conclusions; (2) presents recent developments in biofeedback technologies and their applications to task-oriented biofeedback interventions; and (3) discusses considerations regarding the therapeutic system design and the clinical application of task-oriented biofeedback therapy. This review should provide a framework to further broaden the application of task-oriented biofeedback therapy in neuromotor rehabilitation. PMID:16790060

Carbon Beam Radio-Therapy and Research Activities at HIMAC

NASA Astrophysics Data System (ADS)

Kanazawa, Mitsutaka

2007-05-01

Radio-therapy with carbon ion beam has been carried out since 1994 at HIMAC (Heavy Ion Medical Accelerator in Chiba) in NIRS (National Institute of Radiological Sciences). Now, many types of tumors can be treated with carbon beam with excellent local controls of the tumors. Stimulated with good clinical results, requirement of the dedicated compact facility for carbon beam radio-therapy is increased. To realize this requirement, design study of the facility and the R&D's of the key components in this design are promoted by NIRS. According successful results of these activities, the dedicated compact facility will be realized in Gunma University. In this facility, the established irradiation method is expected to use, which is passive irradiation method with wobbler magnets and ridge filter. In this presentation, above R&D's will be presented together with clinical results and basic research activities at HIMAC.

International Educational Interactions and Students' Critical Consciousness: A Pilot Study.

PubMed

Aldrich, Rebecca M; Grajo, Lenin C

Online technologies facilitate connections between students around the world, but their impact on occupational science and occupational therapy students' critical consciousness about culture is underexplored. In this article we present research on five groups of occupational science and occupational therapy students across two cohorts at one Midwestern university. We used a pretest-posttest group design and the Multicultural Experiences Questionnaire to investigate the potential influence of students' exposure to international educational interactions on their multicultural experiences and desires. Of 157 students surveyed, those who experienced the greatest number of international educational interactions demonstrated statistically significant increases in their desire to become acquainted with other people of different backgrounds and to explore their own prejudices and biases. Given the transformative potential of international educational interactions, future research must assess the ways in which such interactions affect critical cultural consciousness apart from other educational content and design. Copyright © 2017 by the American Occupational Therapy Association, Inc.

Psychological intervention – a critical element of rehabilitation in chronic pulmonary diseases

PubMed Central

Popa-Velea, O; Purcarea, VL

2014-01-01

Abstract Chronic pulmonary diseases represent a segment of pathology with an increasing prevalence worldwide, this requiring joint efforts from specialists in this field to (a) identify those factors insufficiently explored so far, but critical for their evolution and (b) address them via new therapies. This study aims to explore the existing data regarding the psychological factors involved in the dynamics of chronic pulmonary diseases and the main possibilities of psychological intervention, as a distinct part of pulmonary rehabilitation (PR). 49 articles published on this topic in peer-reviewed journals between 1979 and 2010, indexed in PubMed, ProQuest and EBSCO databases, were examined for evidence. Among psychological factors considered important by study authors were the following: 1) the deficient instruction of the patient, 2) decreased treatment motivation, 3) a marginal social role, 4) a disadaptive cognitive style and 5) psychiatric comorbidity (especially anxiety and depression). Efficient interventions were, for physicians, 1) patient education and 2) designing a personalized self-management plan, and for the clinical psychologists, 1) cognitive-behavioral therapy, 2) biofeedback, 3) family therapy, 4) relaxation and 5) hypnosis. Despite the undeniable effect of these methods in selected cases, the high heterogeneity of designs and personal affiliations of researchers do not allow new generalizations about their efficacy or their routine implementation into PR. Further research including larger samples, more uniform designs, construction of consensual international standards regarding the objectives of PR, and assessments done by experts from multiple study domains could contribute to a better understanding of the role psychological interventions could play in PR. Abbreviations: COPD = chronic obstructive pulmonary disease; SES = socioeconomic status; PR = pulmonary rehabilitation; PEF = peak expiratory flow; CBT = cognitive-behavioral therapy; FEV1 = forced expiratory volume in one second PMID:25408739

Issues in the design of multisite clinical trials of psychotherapy: VA Cooperative Study No. 494 as an example.

PubMed

Schnurr, Paula P; Friedman, Matthew J; Engel, Charles C; Foa, Edna B; Shea, M Tracie; Resick, Patricia M; James, Kenneth E; Chow, Bruce K

2005-12-01

This article describes issues in the design of an ongoing multisite randomized clinical trial of psychotherapy for treating posttraumatic stress disorder (PTSD) in female veterans and active duty personnel. Research aimed at testing treatments for PTSD in women who have served in the military is especially important due to the high prevalence of PTSD in this population. VA Cooperative Study 494 was designed to enroll 384 participants across 12 sites. Participants are randomly assigned to receive 10 weekly sessions of individual psychotherapy: Prolonged Exposure, a specific cognitive-behavioral therapy protocol for PTSD, or present-centered therapy, a comparison treatment that addresses current interpersonal problems but avoids a trauma focus. PTSD is the primary outcome. Additional outcomes are comorbid problems such as depression and anxiety; psychosocial function and quality of life; physical health status; satisfaction with treatment; and service utilization. Follow-up assessments are conducted at the end of treatment and then 3 and 6 months after treatment. Both treatments are delivered according to a manual. Videotapes of therapy sessions are viewed by experts who provide feedback to therapists throughout the trial to ensure adherence to the treatment manual. Discussion includes issues encountered in multisite psychotherapy trials along with the rationale for our decisions about how we addressed these issues in CSP #494.

Preliminary results of a prototype C-shaped PET designed for an in-beam PET system

NASA Astrophysics Data System (ADS)

Kim, Hyun-Il; Chung, Yong Hyun; Lee, Kisung; Kim, Kyeong Min; Kim, Yongkwon; Joung, Jinhun

2016-06-01

Positron emission tomography (PET) can be utilized in particle beam therapy to verify the dose distribution of the target volume as well as the accuracy of the treatment. We present an in-beam PET scanner that can be integrated into a particle beam therapy system. The proposed PET scanner consisted of 14 detector modules arranged in a C-shape to avoid blockage of the particle beam line by the detector modules. Each detector module was composed of a 9×9 array of 4.0 mm×4.0 mm×20.0 mm LYSO crystals optically coupled to four 29-mm-diameter PMTs using the photomultiplier-quadrant-sharing (PQS) technique. In this study, a Geant4 Application for Tomographic Emission (GATE) simulation study was conducted to design a C-shaped PET scanner and then experimental evaluation of the proposed design was performed. The spatial resolution and sensitivity were measured according to NEMA NU2-2007 standards and were 6.1 mm and 5.61 cps/kBq, respectively, which is in good agreement with our simulation, with an error rate of 12.0%. Taken together, our results demonstrate the feasibility of the proposed C-shaped in-beam PET system, which we expect will be useful for measuring dose distribution in particle therapy.

Evaluation of the effect of Spiritual care on patients with generalized anxiety and depression: a randomized controlled study.

PubMed

Sankhe, A; Dalal, K; Save, D; Sarve, P

2017-12-01

The present study was conducted to assess the effect of spiritual care in patients with depression, anxiety or both in a randomized controlled design. The participants were randomized either to receive spiritual care or not and Hamilton anxiety rating scale-A (HAM-A), Hamilton depression rating scale-D (HAM-D), WHO-quality of life-Brief (WHOQOL-BREF) and Functional assessment of chronic illness therapy - Spiritual well-being (FACIT-Sp) were assessed before therapy and two follow-ups at 3 and 6 week. However, with regard to the spiritual care therapy group, statistically significant differences were observed in both HAM-A and HAM-D scales between the baseline and visit 2 (p < 0.001), thus significantly reducing symptoms of anxiety and depression, respectively. No statistically significant differences were observed for any of the scales during the follow-up periods for the control group of participants. When the scores were compared between the study groups, HAM-A, HAM-D and FACIT-Sp 12 scores were significantly lower in the interventional group as compared to the control group at both third and sixth weeks. This suggests a significant improvement in symptoms of anxiety and depression in the spiritual care therapy group than the control group; however, large randomized controlled trials with robust design are needed to confirm the same.

New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products.

PubMed

Nagai, Sumimasa; Ozawa, Keiya

2017-01-01

In Japan, the Pharmaceuticals and Medical Devices Law was passed in 2014. In this new law, regenerative medical products were defined, and a conditional and term-limited approval system only for regenerative medical products was instituted. Therefore, regenerative medical products can be approved based on phase I and/or II trials. Gene therapy and adoptive cellular therapy are categorized as regenerative medical products. This law is intended for registration trials for marketing authorization. The Act on the Safety of Regenerative Medicine was also implemented in 2014. This act is intended for clinical research and medical practice involving processed cells other than registration trials. Under this act, a review of plans on medical treatments or clinical studies by a certified committee and submission of the plans to the Ministry of Health, Labour and Welfare (MHLW) are mandatory. The MHLW instituted the SAKIGAKE (meaning a pioneer or forerunner in Japanese) designation system in 2015. This designation is similar to the breakthrough therapy designation in the US and PRIME in the EU. In addition, the MHLW started the "Project for Enhanced Practical Application of Innovative Drugs, Medical Devices and Regenerative Medical Products" to promote personnel exchange and cooperation in writing of guidelines on the evaluation of innovative medical products between the Pharmaceuticals and Medical Devices Agency and academia. Some new guidelines regarding gene and cellular therapy were published. In this review, we comprehensively described these complicated regulations and problems to be solved in order to facilitate global readers' understanding of Japanese regulatory frameworks. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The application of mixed methods designs to trauma research.

PubMed

Creswell, John W; Zhang, Wanqing

2009-12-01

Despite the use of quantitative and qualitative data in trauma research and therapy, mixed methods studies in this field have not been analyzed to help researchers designing investigations. This discussion begins by reviewing four core characteristics of mixed methods research in the social and human sciences. Combining these characteristics, the authors focus on four select mixed methods designs that are applicable in trauma research. These designs are defined and their essential elements noted. Applying these designs to trauma research, a search was conducted to locate mixed methods trauma studies. From this search, one sample study was selected, and its characteristics of mixed methods procedures noted. Finally, drawing on other mixed methods designs available, several follow-up mixed methods studies were described for this sample study, enabling trauma researchers to view design options for applying mixed methods research in trauma investigations.

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

PubMed

Krebs, Erin E; Jensen, Agnes C; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J; Kroenke, Kurt

2017-11-01

This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care. Published by Elsevier Inc.

Application of the Human Activity Assistive Technology model for occupational therapy research.

PubMed

Giesbrecht, Ed

2013-08-01

Theoretical models provide a framework for describing practice and integrating evidence into systematic research. There are few models that relate specifically to the provision of assistive technology in occupational therapy practice. The Human Activity Assistive Technology model is an enduring example that has continued to develop by integrating a social model of disability, concepts from occupational therapy theory and principles of assistive technology adoption and abandonment. This study first describes the core concepts of the Human Activity Assistive Technology model and reviews its development over three successive published versions. A review of the research literature reflects application of the model to clinical practice, study design, outcome measure selection and interpretation of results, particularly among occupational therapists. An evaluative framework is used to critique the adequacy of the Human Activity Assistive Technology model for practice and research, exploring attributes of clarity, simplicity, generality, accessibility and importance. Finally, recommendations are proposed for continued development of the model and research applications. Most of the existing research literature employs the Human Activity Assistive Technology model for background and study design; there is emerging evidence to support the core concepts as predictive factors. Although the concepts are generally simple, clear and applicable to occupational therapy practice and research, evolving terminology and outcomes become more complex with the conflation of integrated theories. The development of the Human Activity Assistive Technology model offers enhanced access and application for occupational therapists, but poses challenges to clarity among concepts. Suggestions are made for further development and applications of the model. © 2013 Occupational Therapy Australia.

Cell-Based Therapies for Joint Disease in Veterinary Medicine: What We Have Learned and What We Need to Know

PubMed Central

Bogers, Sophie Helen

2018-01-01

Biological cell-based therapies for the treatment of joint disease in veterinary patients include autologous-conditioned serum, platelet-rich plasma, and expanded or non-expanded mesenchymal stem cell products. This narrative review outlines the processing and known mechanism of action of these therapies and reviews current preclinical and clinical efficacy in joint disease in the context of the processing type and study design. The significance of variation for biological activity and consequently regulatory approval is also discussed. There is significant variation in study outcomes for canine and equine cell-based products derived from whole blood or stem cell sources such as adipose and bone marrow. Variation can be attributed to altering bio-composition due to factors including preparation technique and source. In addition, study design factors like selection of cases with early vs. late stage osteoarthritis (OA), or with intra-articular soft tissue injury, influence outcome variation. In this under-regulated field, variation raises concerns for product safety, consistency, and efficacy. Cell-based therapies used for OA meet the Food and Drug Administration’s (FDA’s) definition of a drug; however, researchers must consider their approach to veterinary cell-based research to meet future regulatory demands. This review explains the USA’s FDA guidelines as an example pathway for cell-based therapies to demonstrate safety, effectiveness, and manufacturing consistency. An understanding of the variation in production consistency, effectiveness, and regulatory concerns is essential for practitioners and researchers to determine what products are indicated for the treatment of joint disease and tactics to improve the quality of future research. PMID:29713634

Canted-Cosine-Theta Superconducting Accelerator Magnets for High Energy Physics and Ion Beam Cancer Therapy

NASA Astrophysics Data System (ADS)

Brouwer, Lucas Nathan

Advances in superconducting magnet technology have historically enabled the construction of new, higher energy hadron colliders. Looking forward to the needs of a potential future collider, a significant increase in magnet field and performance is required. Such a task requires an open mind to the investigation of new design concepts for high field magnets. Part I of this thesis will present an investigation of the Canted-Cosine-Theta (CCT) design for high field Nb3Sn magnets. New analytic and finite element methods for analysis of CCT magnets will be given, along with a discussion on optimization of the design for high field. The design, fabrication, and successful test of the 2.5 T NbTi dipole CCT1 will be presented as a proof-of-principle step towards a high field Nb3Sn magnet. Finally, the design and initial steps in the fabrication of the 16 T Nb3Sn dipole CCT2 will be described. Part II of this thesis will investigate the CCT concept extended to a curved magnet for use in an ion beam therapy gantry. The introduction of superconducting technology in this field shows promise to reduce the weight and cost of gantries, as well as open the door to new beam optics solutions with high energy acceptance. An analytic approach developed for modeling curved CCT magnets will be presented, followed by a design study of a superconducting magnet for a proton therapy gantry. Finally, a new magnet concept called the "Alternating Gradient CCT" (AG-CCT) will be introduced. This concept will be shown to be a practical magnet solution for achieving the alternating quadrupole fields desired for an achromatic gantry, allowing for the consideration of treatment with minimal field changes in the superconducting magnets. The primary motivation of this thesis is to share new developments for Canted-Cosine-Theta superconducting magnets, with the hope this design will improve technology for high energy physics and ion beam cancer therapy.

SYNCHROTRON RADIATION, FREE ELECTRON LASER, APPLICATION OF NUCLEAR TECHNOLOGY, ETC. Design of a multi-cusp ion source for proton therapy

NASA Astrophysics Data System (ADS)

Wu, Xiao-Bing; Huang, Tao; Ouyang, Hua-Fu; Zhang, Hua-Shun; Gong, Ke-Yun

2010-12-01

The permanent magnets of the discharge chamber in a multi-cusp proton source are studied and designed. The three electrode extraction system is adopted and simulated. A method to extract different amounts of current while keeping the beam emittance unchanged is proposed.

Rooftop hospital gardens for physical therapy: a post-occupancy evaluation.

PubMed

Davis, Brad E

2011-01-01

The goal of this study was to understand successes and weaknesses of a rooftop hospital garden used primarily for physical therapy. Literature on the healing benefits of nature and designed outdoor spaces in healthcare contexts continues to become more focused on specific patient populations. This study contributes to the knowledge of rooftop hospital gardens and gardens for physical rehabilitation. A post-occupancy evaluation was conducted using interviews with a lead therapist and landscape architect, behavior mapping, a staff survey, and a patient questionnaire. The designer and administrative staff perceived high accessibility while patients and staff reported low accessibility. Patients reported high satisfaction with the garden while staff reported little time for garden use. Poor maintenance decisions resulted in decreased functional and aesthetic value. Garden elements take on added layers of meaning and value to users seeking to escape the indoor environment, placing increased importance on evidence-based site design. Multiple perspectives must be considered in facility and garden master planning. Finally, designers and horticultural therapists must be retained in garden management to preserve and enhance garden functionality.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

PubMed Central

2009-01-01

Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. Conclusion The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. Trial registration ClinicalTrials.gov: NCT00964977 PMID:20028566

QSAR studies in the discovery of novel type-II diabetic therapies.

PubMed

Abuhammad, Areej; Taha, Mutasem O

2016-01-01

Type-II diabetes mellitus (T2DM) is a complex chronic disease that represents a major therapeutic challenge. Despite extensive efforts in T2DM drug development, therapies remain unsatisfactory. Currently, there are many novel and important antidiabetic drug targets under investigation by many research groups worldwide. One of the main challenges to develop effective orally active hypoglycemic agents is off-target effects. Computational tools have impacted drug discovery at many levels. One of the earliest methods is quantitative structure-activity relationship (QSAR) studies. QSAR strategies help medicinal chemists understand the relationship between hypoglycemic activity and molecular properties. Hence, QSAR may hold promise in guiding the synthesis of specifically designed novel ligands that demonstrate high potency and target selectivity. This review aims to provide an overview of the QSAR strategies used to model antidiabetic agents. In particular, this review focuses on drug targets that raised recent scientific interest and/or led to successful antidiabetic agents in the market. Special emphasis has been made on studies that led to the identification of novel antidiabetic scaffolds. Computer-aided molecular design and discovery techniques like QSAR have a great potential in designing leads against complex diseases such as T2DM. Combined with other in silico techniques, QSAR can provide more useful and rational insights to facilitate the discovery of novel compounds. However, since T2DM is a complex disease that includes several faulty biological targets, multi-target QSAR studies are recommended in the future to achieve efficient antidiabetic therapies.

Cost analysis of direct versus indirect and individual versus group modes of manual-based speech-and-language therapy for primary school-age children with primary language impairment.

PubMed

Dickson, Kirstin; Marshall, Marjorie; Boyle, James; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

The study is the first within trial cost analysis of direct versus indirect and individual versus group modes of speech-and-language therapy for children with primary language impairment. To compare the short-run resource consequences of the four interventions alongside the effects achieved measured by standardized scores on a test of expressive and receptive language. The study design was a cost analysis integrated within a randomized controlled trial using a 2x2 factorial design (direct/indirect versus individual/group therapy) together with a control group that received usual levels of community-based speech-and-language therapy. Research interventions were delivered in school settings in Scotland, UK. Children aged between 6 and 11 years, attending a mainstream school, with standard scores on the Clinical Evaluation of Language Fundamentals (CELF-III(UK)) of less than -1.25 standard deviation (SD) (receptive and/or expressive) and non-verbal IQ on the Wechsler Abbreviated Scale of Intelligence (WASI) above 75, and no reported hearing loss, no moderate/severe articulation/phonology/dysfluency problems or otherwise requiring individual work with a speech-and-language therapist. The intervention involved speech-and-language therapists and speech-and-language therapy assistants working with individual children or small groups of children. A therapy manual was constructed to assist the choice of procedures and activities for intervention. The cost analysis focused on the salary and travel costs associated with each mode of intervention. The cumulative distribution of total costs arising from the time of randomization to post-intervention assessment was estimated. Arithmetic mean costs were compared and reported with their 95% confidence intervals. The results of the intention-to-treat analysis revealed that there were no significant post-intervention differences between direct and indirect modes of therapy, or between individual and group modes on any of the primary language outcome measures. The cost analysis identified indirect therapy, particularly indirect group therapy, as the least costly of the intervention modes with direct individual therapy as the most costly option. The programme cost of providing therapy in practice over 30 weeks for children could represent between 30% and 75% of the total gross revenue spend in primary school per pupil, depending on the choice of assistant led group therapy or therapist-led individual therapy. This study suggests that speech-and-language therapy assistants can act as effective surrogates for speech-and-language therapists in delivering cost-effective services to children with primary language impairment. The resource gains from adopting a group-based approach may ensure that effective therapy is provided to more children in a more efficient way.

The effect of music therapy on mood states in neurological patients: a pilot study.

PubMed

Magee, Wendy L; Davidson, Jane W

2002-01-01

Music therapy as a clinical intervention has been demonstrated to improve mood states with a variety of populations, however, this has not yet been shown empirically with participants with neurological impairments. This report presents the results of a pilot study examining the effect of music therapy on moods states in patients with acquired and complex neuro-disabilities. Using a single subject design, pre and post session mood states were measured using the Profile of Mood States (Bipolar form). Analyses examined the main effects of pre/post measures as well as interactions between the specific musical therapeutic intervention, mood state, and diagnosis. Results showed that, in terms of composed-anxious, energetic-tired, and agreeable-hostile mood states, there was a significant difference between pre and post music therapy intervention in a positive direction. Although the study displayed that the benefits of music therapy in treating mood states in this patient group are limited, some of the results were affected by the difficulty of the POMS-BI questionnaire for the subject group. The results are discussed considering methodological improvements and arguing for the inclusion of music therapy as an effective intervention to address negative mood states in neuro-rehabilitation populations.

Effectiveness of cognitive behavioral therapy on health-related quality of life: An evaluation of therapies provided by trainee therapists.

PubMed

Henriksson, Sophie; Anclair, Malin; Hiltunen, Arto J

2016-06-01

The present study was carried out to examine the treatment effect of cognitive behavioral therapy provided by trainee therapists at a university clinic, focusing on health-related quality of life (HRQOL) optimism and symptoms. The study was conducted through a repeated measures design and included a treatment group (n = 21), which received cognitive behavioral therapy for an average of 10.7 therapy sessions and a control group (n = 14), that was put on a wait list for 8.6 weeks on average. After treatment, the treatment group improved significantly concerning general health (p = 0.028) and optimism (p = 0.027). In addition, clients improved in several areas within mental health and displayed some reduction in anxiety symptoms. Concurrently, the results also indicated some improvement within the control group, which may have been caused by the initial therapeutic contact, expectancy effects or spontaneous remission. The study concluded that cognitive behavioral therapy provided by trainee therapists may have a positive effect on areas within HRQOL and optimism. © 2016 Scandinavian Psychological Associations and John Wiley & Sons Ltd.

Pre-clinical Safety and Off-Target Studies to Support Translation of AAV-Mediated RNAi Therapy for FSHD.

PubMed

Wallace, Lindsay M; Saad, Nizar Y; Pyne, Nettie K; Fowler, Allison M; Eidahl, Jocelyn O; Domire, Jacqueline S; Griffin, Danielle A; Herman, Adam C; Sahenk, Zarife; Rodino-Klapac, Louise R; Harper, Scott Q

2018-03-16

RNAi emerged as a prospective molecular therapy nearly 15 years ago. Since then, two major RNAi platforms have been under development: oligonucleotides and gene therapy. Oligonucleotide-based approaches have seen more advancement, with some promising therapies that may soon reach market. In contrast, vector-based approaches for RNAi therapy have remained largely in the pre-clinical realm, with limited clinical safety and efficacy data to date. We are developing a gene therapy approach to treat the autosomal-dominant disorder facioscapulohumeral muscular dystrophy. Our strategy involves silencing the myotoxic gene DUX4 using adeno-associated viral vectors to deliver targeted microRNA expression cassettes (miDUX4s). We previously demonstrated proof of concept for this approach in mice, and we are now taking additional steps here to assess safety issues related to miDUX4 overexpression and sequence-specific off-target silencing. In this study, we describe improvements in vector design and expansion of our miDUX4 sequence repertoire and report differential toxicity elicited by two miDUX4 sequences, of which one was toxic and the other was not. This study provides important data to help advance our goal of translating RNAi gene therapy for facioscapulohumeral muscular dystrophy.

Precision Therapy for Lung Cancer: Tyrosine Kinase Inhibitors and Beyond.

PubMed

Rajan, Arun; Schrump, David S

2015-01-01

For patients with advanced cancers there has been a concerted effort to transition from a generic treatment paradigm to one based on tumor-specific biologic, and patient-specific clinical characteristics. This approach, known as precision therapy has been made possible owing to widespread availability and a reduction in the cost of cutting-edge technologies that are used to study the genomic, proteomic, and metabolic attributes of individual tumors. This review traces the evolution of precision therapy for lung cancer from the identification of molecular subsets of the disease to the development and approval of tyrosine kinase, as well as immune checkpoint inhibitors for lung cancer therapy. Challenges of the precision therapy era including the emergence of acquired resistance, identification of untargetable mutations, and the effect on clinical trial design are discussed. We conclude by highlighting newer applications for the concept of precision therapy. Published by Elsevier Inc.

Errors in fluid therapy in medical wards.

PubMed

Mousavi, Maryam; Khalili, Hossein; Dashti-Khavidaki, Simin

2012-04-01

Intravenous fluid therapy remains an essential part of patients' care during hospitalization. There are only few studies that focused on fluid therapy in the hospitalized patients, and there is not any consensus statement about fluid therapy in patients who are hospitalized in medical wards. The aim of the present study was to assess intravenous fluid therapy status and related errors in the patients during the course of hospitalization in the infectious diseases wards of a referral teaching hospital. This study was conducted in the infectious diseases wards of Imam Khomeini Complex Hospital, Tehran, Iran. During a retrospective study, data related to intravenous fluid therapy were collected by two clinical pharmacists of infectious diseases from 2008 to 2010. Intravenous fluid therapy information including indication, type, volume and rate of fluid administration was recorded for each patient. An internal protocol for intravenous fluid therapy was designed based on literature review and available recommendations. The data related to patients' fluid therapy were compared with this protocol. The fluid therapy was considered appropriate if it was compatible with the protocol regarding indication of intravenous fluid therapy, type, electrolyte content and rate of fluid administration. Any mistake in the selection of fluid type, content, volume and rate of administration was considered as intravenous fluid therapy errors. Five hundred and ninety-six of medication errors were detected during the study period in the patients. Overall rate of fluid therapy errors was 1.3 numbers per patient during hospitalization. Errors in the rate of fluid administration (29.8%), incorrect fluid volume calculation (26.5%) and incorrect type of fluid selection (24.6%) were the most common types of errors. The patients' male sex, old age, baseline renal diseases, diabetes co-morbidity, and hospitalization due to endocarditis, HIV infection and sepsis are predisposing factors for the occurrence of fluid therapy errors in the patients. Our result showed that intravenous fluid therapy errors occurred commonly in the hospitalized patients especially in the medical wards. Improvement in knowledge and attention of health-care workers about these errors are essential for preventing of medication errors in aspect of fluid therapy.

Changes in body composition after spasticity treatment with intrathecal baclofen.

PubMed

Skogberg, Olle; Samuelsson, Kersti; Ertzgaard, Per; Levi, Richard

2017-01-19

To assess changes in body composition, body weight and resting metabolic rate in patients who received intrathecal baclofen therapy for spasticity. Prospective, longitudinal, quasi-experimental, with a pre/post design. Twelve patients with spasticity, fulfilling study criteria, and due for pump implantation for intrathecal baclofen therapy, completed the study. Data were obtained before, 6 months and 12 months after commencement of intrathecal baclofen therapy as regards body composition (by skinfold calliper), body weight, and resting metabolic rate (by resting oxygen consumption). Spasticity was assessed according to the Modified Ashworth Scale (MAS) and Penn Spasm Frequency Scale (PSFS). A reduction in spasticity according to MAS occurred. Mean fat body mass increased and mean lean body mass decreased. Mean body weight showed a non-significant increase and resting metabolic rate a non-significant decrease. This explorative study indicates that unfavourable changes in body composition might occur after intrathecal baclofen therapy. Since obesity and increased fat body mass contribute to an increased cardiovascular risk, these findings may indicate a need for initiation of countermeasures, e.g. increased physical activity and/or dietary measures, in conjunction with intrathecal baclofen therapy. Further studies, including larger study samples and control groups, are needed to corroborate these findings.

A pilot validation of a modified Illness Perceptions Questionnaire designed to predict response to cognitive therapy for psychosis.

PubMed

Marcus, Elena; Garety, Philippa; Weinman, John; Emsley, Richard; Dunn, Graham; Bebbington, Paul; Freeman, Daniel; Kuipers, Elizabeth; Fowler, David; Hardy, Amy; Waller, Helen; Jolley, Suzanne

2014-12-01

Clinical responsiveness to cognitive behavioural therapy for psychosis (CBTp) varies. Recent research has demonstrated that illness perceptions predict active engagement in therapy, and, thereby, better outcomes. In this study, we aimed to investigate the psychometric properties of a modification of the Illness Perceptions Questionnaire (M-IPQ) designed to predict response following CBTp. Fifty-six participants with persistent, distressing delusions completed the M-IPQ; forty before a brief CBT intervention targeting persecutory ideation and sixteen before and after a control condition. Additional predictors of outcome (delusional conviction, symptom severity and belief inflexibility) were assessed at baseline. Outcomes were assessed at baseline and at follow-up four to eight weeks later. The M-IPQ comprised two factors measuring problem duration and therapy-specific perceptions of Cure/Control. Associated subscales, formed by summing the relevant items for each factor, were reliable in their structure. The Cure/Control subscale was also reliable over time; showed convergent validity with other predictors of outcome; predicted therapy outcomes; and differentially predicted treatment effects. We measured outcome without an associated measure of engagement, in a small sample. Findings are consistent with hypothesis and existing research, but require replication in a larger, purposively recruited sample. The Cure/Control subscale of the M-IPQ shows promise as a predictor of response to therapy. Specifically targeting these illness perceptions in the early stages of cognitive behavioural therapy may improve engagement and, consequently, outcomes. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Cyber Therapy II, Virtual Healing, Designing Reality

DTIC Science & Technology

2006-08-01

exposures. The initial, prototype model goal was to see if the subjects were able to use the addresses smallpox and uses chicken pox and system, and to...Barcelona, Spain training for schizophrenia as well as cognitive Autonomous University of State of Mexico therapy for autism. This study developed a system...Toluca, Mexico for measuring schizophrenia patients’ behavioral E-mail: claudia.liliana.hardy@estudiant.upc.edu characteristics in a Virtual

Modified Directly Observed Therapy to Facilitate Highly Active Antiretroviral Therapy Adherence in Beira, Mozambique

PubMed Central

Pearson, Cynthia R.; Micek, Mark; Simoni, Jane M.; Matediana, Eduardo; Martin, Diane P.; Gloyd, Stephen

2016-01-01

Summary As resource-limited countries expand access to highly active antiretroviral therapy (HAART) treatment, innovative programs are needed to support adherence in the context of significant health system barriers. Modified directly observed therapy (mDOT) is one such strategy, but little is known about the process of designing and implementing mDOT programs for HAART in resource-limited settings. In this descriptive study, we used a mixed-methods approach to describe the process of implementing mDOT for an ongoing randomized control trial (RCT) in Beira, Mozambique. Interviews with clinic staff, mDOT peers, and participants provided information on design elements, problems with implementation, satisfaction, and benefits. Acceptability and feasibility measures were obtained from the RCT. Most (81%, N = 350) eligible persons agreed to participate, and of those randomized to mDOT (n = 174), 95% reported that their time with peers was beneficial. On average, participants kept 93% of the 30 required daily mDOT visits. Key components of the intervention’s success included using peers who were well accepted by clinic staff, adequate training and retention of peers, adapting daily visit requirements to participants’ work schedules and physical conditions, and reimbursing costs of transportation. This study identified aspects of mDOT that are effective and can be adopted by other clinics treating HIV patients. PMID:17133197

Ensocopic-endoluminal therapies. A critical appraisal.

PubMed

Louis, Hubert; Devière, Jacques

2010-12-01

Due to its large prevalence, gastro-oesophageal reflux disease is an ideal target for companies developing medical devices designed to cure reflux. Indeed, because medications leave part of the patients unsatisfied, there is a potential place for alternative therapies, capable of restoring an efficacious anti-reflux barrier, but without the drawbacks of surgery. For more than a decade, several novel endoluminal therapies were developed, clinically evaluated, put on the market and, for many of them, withdrawn due to economic considerations, lack of efficacy or complications. These therapies were designed to act on the gastro-oesophageal junction and reinforce mechanically the anti-reflux barrier by three different ways: suturing, radiofrequency energy application, or implantation of foreign materials. Most of the published data come from open uncontrolled studies with short-term enthusiastic results. There are a few randomized control trials assessing the true efficacy of these modalities, showing often less impressive results than the open studies did, due to a high placebo effect in mild gastro-oesophageal reflux disease. Although endoscopic treatment of gastro-oesophageal disease is still an interesting topic of investigation, one can draw some lessons from the recent experiences and foresee which place these techniques could find in the management of patients suffering from reflux. Copyright © 2010 Elsevier Ltd. All rights reserved.

Efficacy of manual therapy in the treatment of tension-type headache. A systematic review from 2000-2013.

PubMed

Lozano López, C; Mesa Jiménez, J; de la Hoz Aizpurúa, J L; Pareja Grande, J; Fernández de Las Peñas, C

2016-01-01

To study the efficacy of manual therapy in the treatment of tension-type headache (TTH) by assessing the quality of randomized control trials (RCTs) published from the year 2000 to April 2013. A search was performed in the following databases: MEDLINE, EBSCO, CINAHL, SCOPUS, PEDRO and OVID. An analysis was made of RCT including patients with TTH receiving any manual therapy, and assessing outcome measures including the intensity, and frequency or duration of the headache. Two independent referees reviewed the methodological quality of RCTs using the Jadad scale. Data from the studies were extracted by two different reviewers. A total of fourteen RCTs were selected. Twelve studies showed acceptable quality (Jadad scale ≥3), and the remaining 2 had low quality (Jadad=2). The studies showed positive results, including reduction in headache intensity and/or frequency, reduction of medication consumption, and improvement in quality of life. The effectiveness of manual therapy for TTH cannot be completely assessed due to the heterogeneity in study design, outcome measures, and different treatments. Nevertheless, the results suggest patients with TTH receiving manual therapies showed better progress than those receiving conventional treatment or placebo. Further studies of high quality using manual therapy protocols, and also including standardized outcome measures, are now needed to clarify the efficacy of manual therapy in the management of TTH. Copyright © 2013 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

The Indigenous Red Ribbon Storytelling Study: What does it mean for Indigenous peoples living with HIV and a substance use disorder to access antiretroviral therapy in Saskatchewan?

PubMed Central

Nowgesic, Earl; Meili, Ryan; Stack, Sandra; Myers, Ted

2016-01-01

Indigenous peoples living with HIV are less likely than non-Indigenous peoples living with HIV to access antiretroviral therapy; however, there is not enough contextual information surrounding this issue. The Indigenous Red Ribbon Storytelling Study was conducted in part to examine how Indigenous peoples living with HIV construct and understand their experiences accessing antiretroviral therapy. Our study design was critical Indigenous qualitative research, using the Behavioral Model of Health Services Use and community-based participatory research approaches. The study was conducted in partnership with Indigenous and non-Indigenous organizations. Study participants were adults from two Canadian cities. The study methods included 20 individual and two Indigenous sharing circle interviews, six participant observation sessions, a short survey and thematic analysis. Accessing antiretroviral therapy within the context of living with a substance use disorder was an overarching theme. Indigenous peoples living with HIV felt they had to choose between living with their active substance use disorder and accessing antiretroviral therapy. They felt misunderstood as a person living with a substance use disorder and often felt coerced into using antiretroviral therapy. Despite these challenges, they persevered as Indigenous peoples living with HIV and a substance use disorder. Further research on antiretroviral therapy access among Indigenous peoples living with HIV and a substance use disorder, particularly from the perspective of health service providers, is needed. PMID:27867444

The Indigenous Red Ribbon Storytelling Study: What does it mean for Indigenous peoples living with HIV and a substance use disorder to access antiretroviral therapy in Saskatchewan?

PubMed

Nowgesic, Earl; Meili, Ryan; Stack, Sandra; Myers, Ted

2015-01-01

Indigenous peoples living with HIV are less likely than non-Indigenous peoples living with HIV to access antiretroviral therapy; however, there is not enough contextual information surrounding this issue. The Indigenous Red Ribbon Storytelling Study was conducted in part to examine how Indigenous peoples living with HIV construct and understand their experiences accessing antiretroviral therapy. Our study design was critical Indigenous qualitative research, using the Behavioral Model of Health Services Use and community-based participatory research approaches. The study was conducted in partnership with Indigenous and non-Indigenous organizations. Study participants were adults from two Canadian cities. The study methods included 20 individual and two Indigenous sharing circle interviews, six participant observation sessions, a short survey and thematic analysis. Accessing antiretroviral therapy within the context of living with a substance use disorder was an overarching theme. Indigenous peoples living with HIV felt they had to choose between living with their active substance use disorder and accessing antiretroviral therapy. They felt misunderstood as a person living with a substance use disorder and often felt coerced into using antiretroviral therapy. Despite these challenges, they persevered as Indigenous peoples living with HIV and a substance use disorder. Further research on antiretroviral therapy access among Indigenous peoples living with HIV and a substance use disorder, particularly from the perspective of health service providers, is needed.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design.

PubMed

Moergel, Maximilian; Jahn-Eimermacher, Antje; Krummenauer, Frank; Reichert, Torsten E; Wagner, Wilfried; Wendt, Thomas G; Werner, Jochen A; Al-Nawas, Bilal

2009-12-23

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. ClinicalTrials.gov: NCT00964977.

Designing a definitive trial for adjuvant targeted therapy in genotype defined lung cancer: the ALCHEMIST trials.

PubMed

Alden, Ryan S; Mandrekar, Sumithra J; Oxnard, Geoffrey R

2015-09-01

Genotype-directed targeted therapies have revolutionized the treatment of metastatic non-small cell lung cancer (NSCLC) but they have not yet been comprehensively studied in the adjuvant setting. Previous trials of adjuvant targeted therapy in unselected early stage NSCLC patients showed no benefit versus placebo, however retrospective data suggests improved disease free survival (DFS) with epidermal growth factor receptor (EGFR) inhibitors in patients with appropriate molecular alterations. A definitive prospective, randomized, placebo-controlled trial of targeted therapies for NSCLC is needed to determine the efficacy of targeted therapy following surgical resection and standard adjuvant therapy. The principal challenges facing such a trial are (I) identification of actionable alterations in early stage patients; and (II) realization of sufficient enrollment to power definitive analyses. The ALCHEMIST trial (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial) was designed to overcome these challenges. Using the national clinical trials network (NCTN) of the National Cancer Institute (NCI), several thousand patients with operable NSCLC will undergo tumor genotyping for EGFR mutations or rearrangement of anaplastic lymphoma kinase (ALK). Following resection and completion of standard adjuvant therapy, patients with EGFR-mutant NSCLC will be randomized to erlotinib versus placebo (1:1), those with ALK-rearranged NSCLC will be randomized to crizotinib versus placebo (1:1), while those not enrolled onto the adjuvant trials will continue to be followed on the screening trial. ALCHEMIST also provides for the collection of tissue at baseline and at recurrence (if available) to characterize mechanisms of recurrence and of resistance to targeted therapy. Thus, ALCHEMIST is a platform for validation of targeted therapy as part of curative care in NSCLC and creates an opportunity to advance our understanding of disease biology.

Clinical and cost-effectiveness of computerised cognitive behavioural therapy for depression in primary care: Design of a randomised trial

PubMed Central

de Graaf, L Esther; Gerhards, Sylvia AH; Evers, Silvia MAA; Arntz, Arnoud; Riper, Heleen; Severens, Johan L; Widdershoven, Guy; Metsemakers, Job FM; Huibers, Marcus JH

2008-01-01

Background Major depression is a common mental health problem in the general population, associated with a substantial impact on quality of life and societal costs. However, many depressed patients in primary care do not receive the care they need. Reason for this is that pharmacotherapy is only effective in severely depressed patients and psychological treatments in primary care are scarce and costly. A more feasible treatment in primary care might be computerised cognitive behavioural therapy. This can be a self-help computer program based on the principles of cognitive behavioural therapy. Although previous studies suggest that computerised cognitive behavioural therapy is effective, more research is necessary. Therefore, the objective of the current study is to evaluate the (cost-) effectiveness of online computerised cognitive behavioural therapy for depression in primary care. Methods/Design In a randomised trial we will compare (a) computerised cognitive behavioural therapy with (b) treatment as usual by a GP, and (c) computerised cognitive behavioural therapy in combination with usual GP care. Three hundred mild to moderately depressed patients (aged 18–65) will be recruited in the general population by means of a large-scale Internet-based screening (N = 200,000). Patients will be randomly allocated to one of the three treatment groups. Primary outcome measure of the clinical evaluation is the severity of depression. Other outcomes include psychological distress, social functioning, and dysfunctional beliefs. The economic evaluation will be performed from a societal perspective, in which all costs will be related to clinical effectiveness and health-related quality of life. All outcome assessments will take place on the Internet at baseline, two, three, six, nine, and twelve months. Costs are measured on a monthly basis. A time horizon of one year will be used without long-term extrapolation of either costs or quality of life. Discussion Although computerised cognitive behavioural therapy is a promising treatment for depression in primary care, more research is needed. The effectiveness of online computerised cognitive behavioural therapy without support remains to be evaluated as well as the effects of computerised cognitive behavioural therapy in combination with usual GP care. Economic evaluation is also needed. Methodological strengths and weaknesses are discussed. Trial registration The study has been registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (ISRCTN47481236). PMID:18590518

Mirror Therapy and Task-Oriented Training for People With a Paretic Upper Extremity.

PubMed

Bondoc, Salvador; Booth, Julie; Budde, Grace; Caruso, Katelyn; DeSousa, Michelle; Earl, Brittany; Hammerton, Kaitlynn; Humphreys, Jill

This study investigates the effect of mirror therapy and task-oriented training on the paretic upper extremity function and occupational performance of people with stroke. This study used a repeated-measures, case-series design in which 4 participants completed a 4-wk intervention consisting of mirror therapy and task-specific training. The intervention was conducted 2×/wk in the clinic and 4×/wk at home. All participants displayed clinically meaningful improvements in self-identified goals at the end of the intervention and at follow-up. Three participants showed clinically meaningful changes in motor function. Although only 1 participant improved in his reported amount of use, all participants showed clinically meaningful improvements in perceived movement quality at varying points of assessment. Mirror therapy, when used as priming for task-oriented training, can produce clinical improvements in upper extremity function and occupational performance in people with hemiparesis. Copyright © 2018 by the American Occupational Therapy Association, Inc.

Hormonal therapy is associated with better self-esteem, mood, and quality of life in transsexuals.

PubMed

Gorin-Lazard, Audrey; Baumstarck, Karine; Boyer, Laurent; Maquigneau, Aurélie; Penochet, Jean-Claude; Pringuey, Dominique; Albarel, Frédérique; Morange, Isabelle; Bonierbale, Mireille; Lançon, Christophe; Auquier, Pascal

2013-11-01

Few studies have assessed the role of cross-sex hormones on psychological outcomes during the period of hormonal therapy preceding sex reassignment surgery in transsexuals. The objective of this study was to assess the relationship between hormonal therapy, self-esteem, depression, quality of life (QoL), and global functioning. This study incorporated a cross-sectional design. The inclusion criteria were diagnosis of gender identity disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) and inclusion in a standardized sex reassignment procedure. The outcome measures were self-esteem (Social Self-Esteem Inventory), mood (Beck Depression Inventory), QoL (Subjective Quality of Life Analysis), and global functioning (Global Assessment of Functioning). Sixty-seven consecutive individuals agreed to participate. Seventy-three percent received hormonal therapy. Hormonal therapy was an independent factor in greater self-esteem, less severe depression symptoms, and greater "psychological-like" dimensions of QoL. These findings should provide pertinent information for health care providers who consider this period as a crucial part of the global sex reassignment procedure.

Bullying among radiation therapists: effects on job performance and work environment.

PubMed

Trad, Megan; Johnson, Jordan

2014-01-01

To identify the effects of workplace bullying in the radiation therapy department on job performance and explore the environment and morale of individuals who work with a bully. A quantitative research study was designed to assess the prevalence and effects of bullying in the radiation therapy workplace. A total of 308 radiation therapists participated in the study for a return rate of 46%. Of those, 194 indicated that workplace bullying was present either in their current workplace or in a previous radiation therapy environment and that it negatively affected job performance and satisfaction. Findings of this study indicate a need for evaluation of the radiation therapy workplace, education on how to identify and prevent bullying behavior, and better communication among members of the radiation therapy environment. Participants indicated that working in a hostile environment led to forgetfulness, ineffective communication, and perceived discrepancies in promotion and treatment by management. Any bullying behavior contributes to an overall toxic work environment, which is unhealthy and unsafe for patients and therapists. Those who manage therapists should promote a culture of safety and embrace their staff's independence.

Behavioural typologies of experienced benefit of psychomotor therapy in patients with chronic shoulder pain: A grounded theory approach.

PubMed

Stamp, Anne Schinkel; Pedersen, Lise Lang; Ingwersen, Kim Gordon; Sørensen, Dorthe

2018-05-01

In this study we aimed to develop a theoretical account of the experienced benefit of psychomotor therapy in addition to treatment as usual in patients with chronic shoulder pain. The qualitative study design was based on a grounded theory approach. Open-ended face-to-face interviews were conducted after treatment was completed. We generated data and performed analyses by constant comparative analysis and theoretical sampling that focused on the patients' behavioural characteristics related to the experienced benefit of psychomotor therapy. We conducted 12 interviews, eight of which were with men. "Regaining capability" emerged as representative of the pattern of behaviour. Through this pattern, the patients resolved concern about losing capability. Regaining capability involved three behavioural typologies: taking advice, minding the body, and encompassing life changes. The patients' behavioural typologies revealed different levels of life changes. Psychomotor therapy offered the patients in our study new and better ways of coping with their shoulder pain. Copyright © 2018 Department of Physio- and Occupational Therapy, Hospital Lillebaelt - Vejle Hospital. Published by Elsevier Ltd.. All rights reserved.

Implantable Cardioverter Defibrillator

MedlinePlus

... patients will benefit from an ICD. Improving ICD design. Although high-energy shocks are effective therapy for ... patients with many stressful decisions, and this study tests the effectiveness of educational videos and handouts to ...

Simulation in Occupational Therapy Curricula: A literature review.

PubMed

Bennett, Sally; Rodger, Sylvia; Fitzgerald, Cate; Gibson, Libby

2017-08-01

Simulated learning experiences are increasingly being used in health-care education to enhance student engagement and provide experiences that reflect clinical practice; however, simulation has not been widely investigated in occupational therapy curricula. The aim of this paper was to: (i) describe the existing research about the use and evaluation of simulation over the last three decades in occupational therapy curricula and (ii) consider how simulation has been used to develop competence in students. A literature review was undertaken with searches of MEDLINE, CINAHL and ERIC to locate articles that described or evaluated the use of simulation in occupational therapy curricula. Fifty-seven papers were identified. Occupational therapy educators have used the full scope of simulation modalities, including written case studies (22), standardised patients (13), video case studies (15), computer-based and virtual reality cases (7), role-play (8) and mannequins and part-task trainers (4). Ten studies used combinations of these modalities and two papers compared modalities. Most papers described the use of simulation for foundational courses, as for preparation for fieldwork, and to address competencies necessary for newly graduating therapists. The majority of studies were descriptive, used pre-post design, or were student's perceptions of the value of simulation. Simulation-based education has been used for a wide range of purposes in occupational therapy curricula and appears to be well received. Randomised controlled trials are needed to more accurately understand the effects of simulation not just for occupational therapy students but for longer term outcomes in clinical practice. © 2017 Occupational Therapy Australia.

The effectiveness of cognitive-behavioural play therapy on the symptoms of attention-deficit/hyperactivity disorder in children aged 7-9 years.

PubMed

Abdollahian, Ebrahim; Mokhber, Naghmeh; Balaghi, Atena; Moharrari, Fatemeh

2013-03-01

Attention-deficit/hyperactivity disorder (ADHD) is considered to be the most prevalent disorder of childhood and adolescence, and a variety of methods have been used in its diagnosis and treatment. This study was conducted to study the efficacy of play therapy on the symptoms of ADHD in children aged 7-9 years. Using a clinical trial design, we selected 30 study participants among individuals who had been referred to the Ebne-sina hospital, child and adolescent outpatient clinic, Mashhad, Iran, and who had been diagnosed with ADHD by psychiatrists. The 30 study participants were then divided into two groups, experimental and control, based on similar characteristics (Birth order, parents' educational level, parents' occupation and average of last year school marks). Pre-tests (the Rutter Parental Questionnaire and the Rutter Children Behaviour Questionnaire for teachers) were performed prior to play therapy, and all patients in both groups had been receiving medication. Following play therapy, post-tests were also conducted for both groups. Eight sessions of sham play therapy has been performed for case group. (Cognitive-behavioural play therapy has not been performed basically.) All results were evaluated using an independent t test and a comparative test. Play therapy appeared to significantly reduce the symptoms of ADHD. The significant differences found between the experimental and control groups indicate that play therapy could be used as an effective treatment method for children with ADHD.

The Design, Prototyping, and Formative Evaluation of an Assistive Robotic Table (ART) for Stroke Patients.

PubMed

Threatt, Anthony L; Merino, Jessica; Brooks, Johnell O; Healy, Stan; Truesdail, Constance; Manganelli, Joseph; Walker, Ian; Green, Keith Evan

2017-04-01

This article presents the results of an exploratory study in which 14 healthcare subject matter experts (H-SMEs) in addition to four research and design subject matter experts (RD-SMEs) at a regional rehabilitation hospital engaged in a series of complementary, participatory activities in order to design an assistive robotic table (ART). As designers, human factor experts, and healthcare professionals continue to work to integrate assistive human-robot technologies in healthcare, it is imperative to understand how the technology affects patient care from clinicians' perspectives. Fourteen clinical H-SMEs rated a subset of conceptual ART design ideas; participated in the iterative design process of ART; and evaluated a final cardboard prototype, the rehabilitation hospital's current over-the-bed table (OBT), an ART built with true materials, and two therapy surface prototypes. Four RD-SMEs conducted a heuristic evaluation on the ART built with true materials. Data were analyzed by frequency and content analysis. The results include a design and prototype for the next generation ART and a pneumatically controlled therapy surface, a broadened list of specifications for the future design and implementation of assistive robotic furniture, and final observations. When compared to the rehabilitation hospital's current OBT, the developed ART in this study was successful. Designing novel features is dependent upon ensuring patient safety. The inclusion of clinicians in the participatory iterative design and evaluation process and the use of personas provided a broadened list of specifications for the successful implementation of assistive robotic furniture.

Dry cupping for plantar fasciitis: a randomized controlled trial.

PubMed

Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

2017-05-01

[Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

Dry cupping for plantar fasciitis: a randomized controlled trial

PubMed Central

Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

2017-01-01

[Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested. PMID:28603360

Integrated motivational interviewing and cognitive-behavioural therapy for bipolar disorder with comorbid substance use.

PubMed

Jones, Steven H; Barrowclough, Christine; Allott, Rory; Day, Christine; Earnshaw, Paul; Wilson, Ian

2011-01-01

Although comorbid substance use is a common problem in bipolar disorder, there has been little research into options for psychological therapy. Studies to date have concentrated on purely cognitive-behavioural approaches, which are not equipped to deal with the ambivalence to change exhibited by many towards therapy designed to change substance use. This paper provides the first report of an integrated psychological treatment approach for bipolar disorder with comorbid substance use. The intervention reported combines motivational interviewing and cognitive-behavioural therapy to address ambivalence and equips individuals with strategies to address substance use. Across five individual case studies, preliminary evidence is reported to support the acceptability and the feasibility of this approach. Despite most participants not highlighting their substance use as a primary therapy target, all but one exhibited reduced use of drugs or alcohol at the end of therapy, sustained at 6 months' follow-up. There was some evidence for improvements in mood symptoms and impulsiveness, but this was less clear-cut. The impact of social and relationship issues on therapy process and outcome is discussed. The implications of the current findings for future intervention research in this area are considered. Copyright © 2011 John Wiley & Sons, Ltd.

Improving the design of maintenance studies for bipolar disorder.

PubMed

Gitlin, Michael J; Abulseoud, Osama; Frye, Mark A

2010-08-01

In contrast to the trial design of acute mania studies, there is no standard design for bipolar maintenance studies. Over the past 15 years, the design of monotherapy maintenance studies in bipolar disorder has evolved significantly, but recent study designs continue to differ in important ways. We reviewed the design of recent controlled bipolar maintenance studies, using PubMed, from August 2006 to August 2009, examining the strengths and weaknesses of different study design features. Design differences are sufficiently important that the disparate results across maintenance studies may reflect either true differences in medication efficacy or the effects of these design differences on outcome. Design elements such as recent episode polarity, stabilization criteria, using enriched versus nonenriched samples, length of stabilization before randomization, length of experimental phase, and recurrence outcome criteria are critical factors that differ widely across studies and likely play a role in study outcome. As consensus for trial designs for bipolar maintenance therapy is developed, it will be easier to develop algorithms for maintenance treatment based on results from studies as opposed to clinical opinions.

Using Virtual Reality and Videogames for Traumatic Brain Injury Rehabilitation: A Structured Literature Review.

PubMed

Pietrzak, Eva; Pullman, Stephen; McGuire, Annabel

2014-08-01

This article reviews the available literature about the use of novel methods of rehabilitation using virtual reality interventions for people living with posttraumatic brain injuries. The MEDLINE, EMBASE, SCOPUS, and Cochrane Library databases were searched using the terms "virtual reality" OR "video games" AND "traumatic brain injury." Included studies investigated therapeutic use of virtual reality in adults with a brain trauma resulting from acquired closed head injury, reported outcomes that included measures of motor or cognitive functionality, and were published in a peer-reviewed journal written in English. Eighteen articles fulfilled inclusion criteria. Eight were case studies, five studies had a quasi-experimental design with a pre-post comparison, and five were pilot randomized control trials or comparative studies. The virtual reality systems used were commercial or custom designed for the study and ranged from expensive, fully immersive systems to cheap online games or videogames. In before-after comparisons, improvements in balance were seen in four case studies and two small randomized control trials. Between-group comparisons in these randomized control trials showed no difference between virtual reality and traditional therapy. Post-training improvements were also seen for upper extremity functions (five small studies) and for various cognitive function measures (four case studies and one pilot randomized control trial). Attitudes of participants toward virtual reality interventions was more positive than for traditional therapy (three studies). The evidence that the use of virtual reality in rehabilitation of traumatic brain injury improves motor and cognitive functionality is currently very limited. However, this approach has the potential to provide alternative, possibly more affordable and available rehabilitation therapy for traumatic brain injury in settings where access to therapy is limited by geographical or financial constraints.

Cationic nanoemulsions as nucleic acids delivery systems.

PubMed

Teixeira, Helder Ferreira; Bruxel, Fernanda; Fraga, Michelle; Schuh, Roselena Silvestri; Zorzi, Giovanni Konat; Matte, Ursula; Fattal, Elias

2017-12-20

Since the first clinical studies, knowledge in the field of gene therapy has advanced significantly, and these advances led to the development and subsequent approval of the first gene medicines. Although viral vectors-based products offer efficient gene expression, problems related to their safety and immune response have limited their clinical use. Thus, design and optimization of nonviral vectors is presented as a promising strategy in this scenario. Nonviral systems are nanotechnology-based products composed of polymers or lipids, which are usually biodegradable and biocompatible. Cationic liposomes are the most studied nonviral carriers and knowledge about these systems has greatly evolved, especially in understanding the role of phospholipids and cationic lipids. However, the search for efficient delivery systems aiming at gene therapy remains a challenge. In this context, cationic nanoemulsions have proved to be an interesting approach, as their ability to protect and efficiently deliver nucleic acids for diverse therapeutic applications has been demonstrated. This review focused on cationic nanoemulsions designed for gene therapy, providing an overview on their composition, physicochemical properties, and their efficacy on biological response in vitro and in vivo. Copyright © 2017 Elsevier B.V. All rights reserved.

Systematic review of studies on measurement properties of instruments for adults published in the American Journal of Occupational Therapy, 2009-2013.

PubMed

Yuen, Hon K; Austin, Sarah L

2014-01-01

We describe the methodological quality of recent studies on instrument development and testing published in the American Journal of Occupational Therapy (AJOT). We conducted a systematic review using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist to appraise 48 articles on measurement properties of assessments for adults published in AJOT between 2009 and 2013. Most studies had adequate methodological quality in design and statistical analysis. Common methodological limitations included that methods used to examine internal consistency were not consistently linked to the theoretical constructs underpinning assessments; participants in some test-retest reliability studies were not stable during the interim period; and in several studies of reliability and convergent validity, sample sizes were inadequate. AJOT's dissemination of psychometric research evidence has made important contributions to moving the profession toward the American Occupational Therapy Association's Centennial Vision. This study's results provide a benchmark by which to evaluate future accomplishments. Copyright © 2014 by the American Occupational Therapy Association, Inc.

The Design of Clinical Trials in Portal Hypertension.

PubMed

Abraldes, Juan G; Garcia-Tsao, Guadalupe

2017-02-01

Portal hypertension (PH) is the main consequence of cirrhosis and is responsible for the majority of its complications. Gastroesophageal varices and variceal hemorrhage are direct consequences of PH; therefore, most clinical trials in PH have been directed toward treating or preventing variceal hemorrhage. However, varices and variceal hemorrhage are not isolated events; they must be considered in the context of the presence (or absence) of other complications of cirrhosis/PH. Cirrhosis progresses across different stages, each with a different prognosis and pathophysiology and hence different therapeutic targets. In this review, the authors discuss the design of proof-of-concept studies for the assessment of new drugs for the treatment of PH, that are mainly based on the drug's ability to reduce the hepatic venous pressure gradient. They further discuss the design of studies with clinical endpoints in the context of each stage of cirrhosis, specifically targets of therapy, optimal therapies in the control arm, risk stratification, and primary outcome. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Patients suffering from rheumatic disease describing own experiences from participating in Basic Body Awareness Group Therapy: A qualitative pilot study.

PubMed

Olsen, Aarid Liland; Skjaerven, Liv Helvik

2016-01-01

Rheumatic diseases have physical and psychological impact on patients' movement and function. Basic Body Awareness Therapy focuses on promoting more functional movement quality in daily life. The purpose of this study was to describe patient experiences from participating in Basic Body Awareness Group Therapy for inpatients with rheumatic disease. A phenomenological design included data collection in two focus group interviews with seven patients. Giorgi's four-step phenomenological method was used for data analysis. Four main themes emerged: (1) "Movement exploration-being guided in movement" described informants' exploration of bodily signals and movement habits; (2) "Movement awareness training in a relational perspective" informants described experiences from being in a group setting; (3) "Movement awareness-integration and insight" described informants' reflections on movement experiences; and (4) "Integrating and practicing new movement habits" informants described how they used their movement experiences in daily life. The study described perspectives in movement learning experienced by patients. The results support the view that contact with the body can help patients exploring and cultivating their own resources for a more functional movement quality. Descriptions of relational movement learning aspects can contribute to our understanding of physiotherapy group design.

Antibiotic treatment for Helicobacter pylori: Is the end coming?

PubMed Central

Kim, Su Young; Choi, Duck Joo; Chung, Jun-Won

2015-01-01

Infection with the Gram-negative pathogen Helicobacter pylori (H. pylori) has been associated with gastro-duodenal disease and the importance of H. pylori eradication is underscored by its designation as a group I carcinogen. The standard triple therapy consists of a proton pump inhibitor, amoxicillin and clarithromycin, although many other regimens are used, including quadruple, sequential and concomitant therapy regimens supplemented with metronidazole, clarithromycin and levofloxacin. Despite these efforts, current therapeutic regimens lack efficacy in eradication due to antibiotic resistance, drug compliance and antibiotic degradation by the acidic stomach environment. Antibiotic resistance to clarithromycin and metronidazole is particularly problematic and several approaches have been proposed to overcome this issue, such as complementary probiotic therapy with Lactobacillus. Other studies have identified novel molecules with an anti-H. pylori effect, as well as tailored therapy and nanotechnology as viable alternative eradication strategies. This review discusses current antibiotic therapy for H. pylori infections, limitations of this type of therapy and predicts the availability of newly developed therapies for H. pylori eradication. PMID:26558152

Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series

PubMed Central

Rimland, Joseph M; Trotta, Fabiana Mirella; Dell'Aquila, Giuseppina; Cruz-Jentoft, Alfonso; Petrovic, Mirko; Gudmundsson, Adalsteinn; Soiza, Roy; O'Mahony, Denis; Guaita, Antonio; Cherubini, Antonio

2017-01-01

Objective To provide an overview of non-pharmacological interventions for behavioural and psychological symptoms in dementia (BPSD). Design Systematic overview of reviews. Data sources PubMed, EMBASE, Cochrane Database of Systematic Reviews, CINAHL and PsycINFO (2009–March 2015). Eligibility criteria Systematic reviews (SRs) that included at least one comparative study evaluating any non-pharmacological intervention, to treat BPSD. Data extraction Eligible studies were selected and data extracted independently by 2 reviewers. The AMSTAR checklist was used to assess the quality of the SRs. Data analysis Extracted data were synthesised using a narrative approach. Results 38 SRs and 142 primary studies were identified, comprising the following categories of non-pharmacological interventions: (1) sensory stimulation interventions (12 SRs, 27 primary studies) that encompassed: acupressure, aromatherapy, massage/touch therapy, light therapy and sensory garden; (2) cognitive/emotion-oriented interventions (33 SRs; 70 primary studies) that included cognitive stimulation, music/dance therapy, dance therapy, snoezelen, transcutaneous electrical nerve stimulation, reminiscence therapy, validation therapy, simulated presence therapy; (3) behaviour management techniques (6 SRs; 32 primary studies) and (4) other therapies (5 SRs, 12 primary studies) comprising exercise therapy, animal-assisted therapy, special care unit and dining room environment-based interventions. Music therapy was effective in reducing agitation (SMD, −0.49; 95% CI −0.82 to −0.17; p=0.003), and anxiety (SMD, −0.64; 95% CI −1.05 to −0.24; p=0.002). Home-based behavioural management techniques, caregiver-based interventions or staff training in communication skills, person-centred care or dementia care mapping with supervision during implementation were found to be effective for symptomatic and severe agitation. Conclusions A large number of non-pharmacological interventions for BPSD were identified. The majority of the studies had great variation in how the same type of intervention was defined and applied, the follow-up duration, the type of outcome measured, usually with modest sample size. Overall, music therapy and behavioural management techniques were effective for reducing BPSD. PMID:28302633

Exploring the Interplay between Rescue Drugs, Data Imputation, and Study Outcomes: Conceptual Review and Qualitative Analysis of an Acute Pain Data Set.

PubMed

Singla, Neil K; Meske, Diana S; Desjardins, Paul J

2017-12-01

In placebo-controlled acute surgical pain studies, provisions must be made for study subjects to receive adequate analgesic therapy. As such, most protocols allow study subjects to receive a pre-specified regimen of open-label analgesic drugs (rescue drugs) as needed. The selection of an appropriate rescue regimen is a critical experimental design choice. We hypothesized that a rescue regimen that is too liberal could lead to all study arms receiving similar levels of pain relief (thereby confounding experimental results), while a regimen that is too stringent could lead to a high subject dropout rate (giving rise to a preponderance of missing data). Despite the importance of rescue regimen as a study design feature, there exist no published review articles or meta-analysis focusing on the impact of rescue therapy on experimental outcomes. Therefore, when selecting a rescue regimen, researchers must rely on clinical factors (what analgesics do patients usually receive in similar surgical scenarios) and/or anecdotal evidence. In the following article, we attempt to bridge this gap by reviewing and discussing the experimental impacts of rescue therapy on a common acute surgical pain population: first metatarsal bunionectomy. The function of this analysis is to (1) create a framework for discussion and future exploration of rescue as a methodological study design feature, (2) discuss the interplay between data imputation techniques and rescue drugs, and (3) inform the readership regarding the impact of data imputation techniques on the validity of study conclusions. Our findings indicate that liberal rescue may degrade assay sensitivity, while stringent rescue may lead to unacceptably high dropout rates.

Newcastle Disease Virus (PDQ®)—Health Professional Version

Cancer.gov

Newcastle disease virus (NDV)- based therapy has been reported to be of benefit in clinical studies, but results are considered inconclusive. Study designs were weak and the study reports were generally incomplete. Get detailed information about NDV use in cancer in this summary for clinicians.

A New Era for Cancer Target Therapies: Applying Systems Biology and Computer-Aided Drug Design to Cancer Therapies.

PubMed

Wong, Yung-Hao; Chiu, Chia-Chiun; Lin, Chih-Lung; Chen, Ting-Shou; Jheng, Bo-Ren; Lee, Yu-Ching; Chen, Jeremy; Chen, Bor-Sen

In recent years, many systems biology approaches have been used with various cancers. The materials described here can be used to build bases to discover novel cancer therapy targets in connection with computer-aided drug design (CADD). A deeper understanding of the mechanisms of cancer will provide more choices and correct strategies in the development of multiple target drug therapies, which is quite different from the traditional cancer single target therapy. Targeted therapy is one of the most powerful strategies against cancer and can also be applied to other diseases. Due to the large amount of progress in computer hardware and the theories of computational chemistry and physics, CADD has been the main strategy for developing novel drugs for cancer therapy. In contrast to traditional single target therapies, in this review we will emphasize the future direction of the field, i.e., multiple target therapies. Structure-based and ligand-based drug designs are the two main topics of CADD. The former needs both 3D protein structures and ligand structures, while the latter only needs ligand structures. Ordinarily it is estimated to take more than 14 years and 800 million dollars to develop a new drug. Many new CADD software programs and techniques have been developed in recent decades. We conclude with an example where we combined and applied systems biology and CADD to the core networks of four cancers and successfully developed a novel cocktail for drug therapy that treats multiple targets.

An Evaluation of the Design and Usability of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients with Stroke.

PubMed

Pei, Yu-Cheng; Chen, Jean-Lon; Wong, Alice M K; Tseng, Kevin C

2017-01-01

Case series. IV (case series). Robot-assisted therapy for upper limb rehabilitation is an emerging research topic and its design process must integrate engineering, neurological pathophysiology, and clinical needs. This study developed/evaluated the usefulness of a novel rehabilitation device, the MirrorPath , designed for the upper limb rehabilitation of patients with hemiplegic stroke. The process follows Tseng's methodology for innovative product design and development, namely two stages, device development and usability assessment. During the development process, the design was guided by patients' rehabilitation needs as defined by patients and their therapists. The design applied synchronic movement of the bilateral upper limbs, an approach that is compatible with the bilateral movement therapy and proprioceptive neuromuscular facilitation theories. MirrorPath consists of a robotic device that guides upper limb movement linked to a control module containing software controlling the robotic movement. Five healthy subjects were recruited in the pretest, and 4 patients, 4 caregivers, and 4 therapists were recruited in the formal test for usability. All recruited subjects were allocated to the test group, completed the evaluation, and their data were all analyzed. The total system usability scale score obtained from the patients, caregivers, and therapists was 71.8 ± 11.9, indicating a high level of usability and product acceptance. Following a standard development process, we could yield a design that meets clinical needs. This low-cost device provides a feasible platform for carrying out robot-assisted bilateral movement therapy of patients with hemiplegic stroke. identifier NCT02698605.

Where We Have Been and Where We Are Going: A Content Analysis of Articles Published in the Journal of Women's Health Physical Therapy From 2005 to 2015

PubMed Central

Coronado, Rogelio A.; Hill, Alexandra D.; Alappattu, Meryl J.

2018-01-01

Objective The objective of this study was to examine the type and content of Journal of Women’s Health Physical Therapy (JWHPT) publications over the last decade. Study Design Content and bibliometric analysis of published literature Background Component sections, such as the Section on Women’s Health (SoWH) of the American Physical Therapy Association provide content expertise to areas of specialty physical therapist practice, thereby supporting the dissemination of evidence for physical therapists to use. Closely aligned with the mission of the SoWH, JWHPT provides evidence reflecting this practice area. The purpose of our analysis was to examine publications within JWHPT to determine how closely JWHPT is meeting the mission and focus of section members. Methods and Measures We used established bibliographic methodology to code and review manuscripts published online between 2005 and 2015 in JWHPT using established domains (article type, participant type, research design, study purpose, and area of focus). Total publications and proportion of publications based on domain were described. Impact by citation and author was examined using bibliometric software. Results Eighteen percent of the items published in JWHPT were original research papers submitted for the first time. Of those papers, the primary study design was cross-sectional experimental research, most commonly studying interventions. The primary practice area reported was management of incontinence. Conclusions We suggest that a continued need to increase efforts for the submission and publication of a greater proportion of randomized controlled trials and metric articles. PMID:29375281

A design study of the energy selection system for carbon-ion therapy

NASA Astrophysics Data System (ADS)

Hahn, Garam; An, Dong Hyun; Hong, Bong Hwan; Kim, Geun Beom; Yim, Heejoong; Chang, Hong Seok; Jung, In Su; Kang, Kun Uk; Nam, Sang Hoon; Park, Inkyu

2015-02-01

KHIMA, a research project to construct a carbon radio-therapy facility in Korea, has been developing a superconducting cyclotron named KIRAMS-430 as a carbon(12 C 6+) particle accelerator. Due to the fixed beam energy of the cyclotron, an energy selection system (ESS) is required for treatment of tumors located at various depths in the human body. In the present paper, two design stages of the ESS are discussed. First, the beam tracks behind the degrader block and the statistical twiss parameters for the entire energy range were calculated by using the GEANT4 simulation toolkit. Analysis of the beam transmission and the contamination ratios were performed. In the second stage, the beam optics was designed to support the same phase profile at the end regardless of the variations in all of input twiss parameters and the emittance.

A critical methodological review of discourse and conversation analysis studies of family therapy.

PubMed

Tseliou, Eleftheria

2013-12-01

Discourse (DA) and conversation (CA) analysis, two qualitative research methods, have been recently suggested as potentially promising for the study of family therapy due to common epistemological adherences and their potential for an in situ study of therapeutic dialog. However, to date, there is no systematic methodological review of the few existing DA and CA studies of family therapy. This study aims at addressing this lack by critically reviewing published DA and CA studies of family therapy on methodological grounds. Twenty-eight articles in total are reviewed in relation to certain methodological axes identified in the relevant literature. These include choice of method, framing of research question(s), data/sampling, type of analysis, epistemological perspective, content/type of knowledge claims, and attendance to criteria for good quality practice. It is argued that the reviewed studies show "glimpses" of the methods' potential for family therapy research despite the identification of certain "shortcomings" regarding their methodological rigor. These include unclearly framed research questions and the predominance of case study designs. They also include inconsistencies between choice of method, stated or unstated epistemological orientations and knowledge claims, and limited attendance to criteria for good quality practice. In conclusion, it is argued that DA and CA can add to the existing quantitative and qualitative methods for family therapy research. They can both offer unique ways for a detailed study of the actual therapeutic dialog, provided that future attempts strive for a methodologically rigorous practice and against their uncritical deployment. © FPI, Inc.

Combination cell therapy with mesenchymal stem cells and neural stem cells for brain stroke in rats.

PubMed

Hosseini, Seyed Mojtaba; Farahmandnia, Mohammad; Razi, Zahra; Delavari, Somayeh; Shakibajahromi, Benafsheh; Sarvestani, Fatemeh Sabet; Kazemi, Sepehr; Semsar, Maryam

2015-05-01

Brain stroke is the second most important events that lead to disability and morbidity these days. Although, stroke is important, there is no treatment for curing this problem. Nowadays, cell therapy has opened a new window for treating central nervous system disease. In some previous studies the Mesenchymal stem cells and neural stem cells. In this study, we have designed an experiment to assess the combination cell therapy (Mesenchymal and Neural stem cells) effects on brain stroke. The Mesenchymal stem cells were isolated from adult rat bone marrow and the neural stem cells were isolated from ganglion eminence of rat embryo 14 days. The Mesenchymal stem cells were injected 1 day after middle cerebral artery occlusion (MCAO) and the neural stem cells transplanted 7 day after MCAO. After 28 days, the neurological outcomes and brain lesion volumes were evaluated. Also, the activity of Caspase 3 was assessed in different groups. The group which received combination cell therapy had better neurological examination and less brain lesion. Also the combination cell therapy group had the least Caspase 3 activity among the groups. The combination cell therapy is more effective than Mesenchymal stem cell therapy and neural stem cell therapy separately in treating the brain stroke in rats.

Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

PubMed

Silverman, Michael J

2013-10-01

Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. © 2013.

Traditional manual acupuncture combined with rehabilitation therapy for shoulder hand syndrome after stroke within the Chinese healthcare system: a systematic review and meta-analysis.

PubMed

Peng, Le; Zhang, Chao; Zhou, Lan; Zuo, Hong-Xia; He, Xiao-Kuo; Niu, Yu-Ming

2018-04-01

To investigate the effectiveness of traditional manual acupuncture combined with rehabilitation therapy versus rehabilitation therapy alone for shoulder hand syndrome after stroke. PubMed, EMBASE, the Cochrane Library, Chinese Biomedicine Database, China National Knowledge Infrastructure, VIP Information Database, Wan Fang Database and reference lists of the eligible studies were searched up to July 2017 for relevant studies. Randomized controlled trials that compared the combined effects of traditional manual acupuncture and rehabilitation therapy to rehabilitation therapy alone for shoulder hand syndrome after stroke were included. Two reviewers independently screened the searched records, extracted the data and assessed risk of bias of the included studies. The treatment effect sizes were pooled in a meta-analysis using RevMan 5.3 software. A total of 20 studies involving 1918 participants were included in this study. Compared to rehabilitation therapy alone, the combined therapy significantly reduced pain on the visual analogue scale and improved limb movement on the Fugl-Meyer Assessment scale and the performance of activities of daily living (ADL) on the Barthel Index scale or Modified Barthel Index scale. Of these, the visual analogue scale score changes were significantly higher (mean difference = 1.49, 95% confidence interval = 1.15-1.82, P < 0.00001) favoring the combined therapy after treatment, with severe heterogeneity ( I 2  = 71%, P = 0.0005). Current evidence suggests that traditional manual acupuncture integrated with rehabilitation therapy is more effective in alleviating pain, improving limb movement and ADL. However, considering the relatively low quality of available evidence, further rigorously designed and large-scale randomized controlled trials are needed to confirm the results.

Nanotechnology meets 3D in vitro models: tissue engineered tumors and cancer therapies.

PubMed

da Rocha, E L; Porto, L M; Rambo, C R

2014-01-01

Advances in nanotechnology are providing to medicine a new dimension. Multifunctional nanomaterials with diagnostics and treatment modalities integrated in one nanoparticle or in cooperative nanosystems are promoting new insights to cancer treatment and diagnosis. The recent convergence between tissue engineering and cancer is gradually moving towards the development of 3D disease models that more closely resemble in vivo characteristics of tumors. However, the current nanomaterials based therapies are accomplished mainly in 2D cell cultures or in complex in vivo models. The development of new platforms to evaluate nano-based therapies in parallel with possible toxic effects will allow the design of nanomaterials for biomedical applications prior to in vivo studies. Therefore, this review focuses on how 3D in vitro models can be applied to study tumor biology, nanotoxicology and to evaluate nanomaterial based therapies. © 2013.

Effectiveness of massage therapy for shoulder pain: a systematic review and meta-analysis.

PubMed

Yeun, Young-Ran

2017-05-01

[Purpose] This study performed an effect-size analysis of massage therapy for shoulder pain. [Subjects and Methods] The database search was conducted using PubMed, CINAHL, Embase, PsycINFO, RISS, NDSL, NANET, DBpia, and KoreaMed. The meta-analysis was based on 15 studies, covering a total of 635 participants, and used a random effects model. [Results] The effect size estimate showed that massage therapy had a significant effect on reducing shoulder pain for short-term efficacy (SMD: -1.08, 95% CI: -1.51 to -0.65) and for long-term efficacy (SMD: -0.47, 95% CI: -0.71 to -0.23). [Conclusion] The findings from this review suggest that massage therapy is effective at improving shoulder pain. However, further research is needed, especially a randomized controlled trial design or a large sample size, to provide evidence-based recommendations.

Chimeric Antigen Receptor T Cell Therapy in Hematology.

PubMed

Ataca, Pınar; Arslan, Önder

2015-12-01

It is well demonstrated that the immune system can control and eliminate cancer cells. Immune-mediated elimination of tumor cells has been discovered and is the basis of both cancer vaccines and cellular therapies including hematopoietic stem cell transplantation. Adoptive T cell transfer has been improved to be more specific and potent and to cause less off-target toxicity. Currently, there are two forms of engineered T cells being tested in clinical trials: T cell receptor (TCR) and chimeric antigen receptor (CAR) modified T cells. On 1 July 2014, the United States Food and Drug Administration granted 'breakthrough therapy' designation to anti-CD19 CAR T cell therapy. Many studies were conducted to evaluate the benefits of this exciting and potent new treatment modality. This review summarizes the history of adoptive immunotherapy, adoptive immunotherapy using CARs, the CAR manufacturing process, preclinical and clinical studies, and the effectiveness and drawbacks of this strategy.

Pulmonary surfactant for neonatal respiratory disorders.

PubMed

Merrill, Jeffrey D; Ballard, Roberta A

2003-04-01

Surfactant therapy has revolutionized neonatal care and is used routinely for preterm infants with respiratory distress syndrome. Recent investigation has further elucidated the function of surfactant-associated proteins and their contribution toward surfactant and lung immune defense functions. As the field of neonatology moves away from intubation and mechanical ventilation of preterm infants at birth toward more aggressive use of nasal continuous positive airway pressure, the optimal timing of exogenous surfactant therapy remains unclear. Evidence suggests that preterm neonates with bronchopulmonary dysplasia and prolonged mechanical ventilation also experience surfactant dysfunction; however, exogenous surfactant therapy beyond the first week of life has not been well studied. Surfactant replacement therapy has been studied for use in other respiratory disorders, including meconium aspiration syndrome and pneumonia. Commercial surfactant preparations currently available are not optimal, given the variability of surfactant protein content and their susceptibility to inhibition. Further progress in the treatment of neonatal respiratory disorders may include the development of "designer" surfactant preparations.

Mechanisms of Undersensing by a Noise Detection Algorithm That Utilizes Far-Field Electrograms With Near-Field Bandpass Filtering.

PubMed

Koneru, Jayanthi N; Swerdlow, Charles D; Ploux, Sylvain; Sharma, Parikshit S; Kaszala, Karoly; Tan, Alex Y; Huizar, Jose F; Vijayaraman, Pugazhendi; Kenigsberg, David; Ellenbogen, Kenneth A

2017-02-01

Implantable cardioverter defibrillators (ICDs) must establish a balance between delivering appropriate shocks for ventricular tachyarrhythmias and withholding inappropriate shocks for lead-related oversensing ("noise"). To improve the specificity of ICD therapy, manufacturers have developed proprietary algorithms that detect lead noise. The SecureSense TM RV Lead Noise discrimination (St. Jude Medical, St. Paul, MN, USA) algorithm is designed to differentiate oversensing due to lead failure from ventricular tachyarrhythmias and withhold therapies in the presence of sustained lead-related oversensing. We report 5 patients in whom appropriate ICD therapy was withheld due to the operation of the SecureSense algorithm and explain the mechanism for inhibition of therapy in each case. Limitations of algorithms designed to increase ICD therapy specificity, especially for the SecureSense algorithm, are analyzed. The SecureSense algorithm can withhold appropriate therapies for ventricular arrhythmias due to design and programming limitations. Electrophysiologists should have a thorough understanding of the SecureSense algorithm before routinely programming it and understand the implications for ventricular arrhythmia misclassification. © 2016 Wiley Periodicals, Inc.

High gradient linac for proton therapy

NASA Astrophysics Data System (ADS)

Benedetti, S.; Grudiev, A.; Latina, A.

2017-04-01

Proposed for the first time almost 30 years ago, the research on radio frequency linacs for hadron therapy experienced a sparkling interest in the past decade. The different projects found a common ground on a relatively high rf operating frequency of 3 GHz, taking advantage of the availability of affordable and reliable commercial klystrons at this frequency. This article presents for the first time the design of a proton therapy linac, called TULIP all-linac, from the source up to 230 MeV. In the first part, we will review the rationale of linacs for hadron therapy. We then divided this paper in two main sections: first, we will discuss the rf design of the different accelerating structures that compose TULIP; second, we will present the beam dynamics design of the different linac sections.

[Clinical and health economic challenges of personalized medicine].

PubMed

Brüggenjürgen, B; Kornbluth, L; Ferrara, J V; Willich, S N

2012-05-01

Healthcare systems across the globe are currently challenged by aging populations, increases in chronic diseases and the difficult task of managing a healthcare budget. In this health economic climate, personalized medicine promises not only an improvement in healthcare delivery but also the possibility of more cost-effective therapies. It is important to remember, however, that personalized medicine has the potential to both increase and decrease costs. Each targeted therapy must be evaluated individually. However, standard clinical trial design is not suitable for personalized therapies. Therefore, both scientists and regulatory authorities will need to accept innovative study designs in order to validate personalized therapies. Hence correct economic evaluations are difficult to carry out due to lack of clear clinical evidence, longitudinal accounting and experience with patient/clinician behavior in the context of personalized medicine. In terms of reimbursement, payers, pharmaceutical companies and companion diagnostic manufacturers will also need to explore creative risk-sharing concepts. Germany is no exception to the challenges that face personalized medicine and for personalized medicine to really become the future of medicine many health economic challenges first need to be overcome. The health economic implications of personalized medicine remain unclear but it is certain that the expansion of targeted therapies in current healthcare systems will create a host of challenges.

A pilot study of factors associated with glycaemic control in adults with Type 1 diabetes mellitus on insulin pump therapy.

PubMed

Wen, W; Frampton, R; Wright, K; Fattore, S; Shadbolt, B; Perampalam, S

2016-02-01

To identify the knowledge and management factors associated with glycaemic control among adults with Type 1 diabetes mellitus treated with insulin pump therapy. A cross-sectional study of adults with Type 1 diabetes mellitus on insulin pump therapy for at least 12 months (n = 50, 18-70 years old) was undertaken between December 2013 and May 2014. A new questionnaire was developed to evaluate participants' knowledge and management related to insulin pump therapy, and were correlated with insulin pump data, HbA1c and frequency of hypoglycaemia. Participants who changed their insulin pump settings when indicated had significantly better glycaemic control than those who did not (P = 0.04). Multivariate logistic regression analysis found that better overall insulin pump therapy management was a significant predictor of better glycaemic control (odds ratio 4.45, 95% confidence interval 1.61-12.3; P = 0.004) after adjusting for potential confounders including age, gender, duration of diabetes and insulin pump therapy. However, overall insulin pump therapy knowledge was not a significant predictor of glycaemic control (P = 0.058). There was no significant association between frequency of hypoglycaemia and insulin pump therapy knowledge or management. We identified some key knowledge and management factors associated with glycaemic control in adults with Type 1 diabetes mellitus on insulin pump therapy using a newly designed questionnaire. The pilot study assessed the clinical utility of this evaluation tool, which may facilitate provision of targeted education to insulin pump therapy users to achieve optimal glycaemic control. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

Theory and Practice of Positive Feminist Therapy: A Culturally Responsive Approach to Divorce Therapy with Chinese Women

ERIC Educational Resources Information Center

Tzou, Jean Yuh-Jin; Kim, Eunha; Waldheim, Kim

2012-01-01

Positive Feminist Therapy (PFT) is a strength-based culturally responsive therapy model specifically designed for helping Chinese women facing marital conflicts and divorce, integrating Empowerment Feminist Therapy, systems theory, and positive psychology. To help clients become change agents, PFT uses clients' existing strengths to develop…

Anatomical information in radiation treatment planning.

PubMed

Kalet, I J; Wu, J; Lease, M; Austin-Seymour, M M; Brinkley, J F; Rosse, C

1999-01-01

We report on experience and insights gained from prototyping, for clinical radiation oncologists, a new access tool for the University of Washington Digital Anatomist information resources. This access tool is designed to integrate with a radiation therapy planning (RTP) system in use in a clinical setting. We hypothesize that the needs of practitioners in a clinical setting are different from the needs of students, the original targeted users of the Digital Anatomist system, but that a common knowledge resource can serve both. Our prototype was designed to help define those differences and study the feasibility of a full anatomic reference system that will support both clinical radiation therapy and all the existing educational applications.

A Dual-Beam Irradiation Facility for a Novel Hybrid Cancer Therapy

NASA Astrophysics Data System (ADS)

Sabchevski, Svilen Petrov; Idehara, Toshitaka; Ishiyama, Shintaro; Miyoshi, Norio; Tatsukawa, Toshiaki

2013-01-01

In this paper we present the main ideas and discuss both the feasibility and the conceptual design of a novel hybrid technique and equipment for an experimental cancer therapy based on the simultaneous and/or sequential application of two beams, namely a beam of neutrons and a CW (continuous wave) or intermittent sub-terahertz wave beam produced by a gyrotron for treatment of cancerous tumors. The main simulation tools for the development of the computer aided design (CAD) of the prospective experimental facility for clinical trials and study of such new medical technology are briefly reviewed. Some tasks for a further continuation of this feasibility analysis are formulated as well.

Accessible virtual reality therapy using portable media devices.

PubMed

Bruck, Susan; Watters, Paul A

2010-01-01

Simulated immersive environments displayed on large screens are a valuable therapeutic asset in the treatment of a range of psychological disorders. Permanent environments are expensive to build and maintain, require specialized clinician training and technical support and often have limited accessibility for clients. Ideally, virtual reality exposure therapy (VRET) could be accessible to the broader community if we could use inexpensive hardware with specifically designed software. This study tested whether watching a handheld non-immersive media device causes nausea and other cybersickness responses. Using a repeated measure design we found that nausea, general discomfort, eyestrain, blurred vision and an increase in salivation significantly increased in response to handheld non-immersive media device exposure.

A new non-pharmacological vacuum therapy for female sexual dysfunction.

PubMed

Billups, K L; Berman, L; Berman, J; Metz, M E; Glennon, M E; Goldstein, I

2001-01-01

Although Female Sexual Dysfunction (FSD) affects 40% of American women, there is no FDA-approved pharmaceutical therapy. The EROS-CTD (Clitoral Therapy Device, UroMetrics, Inc., St. Paul, MN) treatment is the first FDA cleared-to-market therapy for FSD. Clitoral engorgement is believed to play an important role in female sexual arousal and overall sexual satisfaction. The EROS-CTD is a small, battery-powered device designed to enhance clitoral engorgement, increase blood flow to the clitoris, and ultimately improve arousal in women with FSD. The objective of this study was to assess the effectiveness of the EROS-CTD on sexual arousal (genital sensation, vaginal lubrication, ability to reach orgasm, and sexual satisfaction) in normal volunteers and women with FSD.

Schema therapy for personality disorders in older adults: a multiple-baseline study.

PubMed

Videler, Arjan C; van Alphen, Sebastiaan P J; van Royen, Rita J J; van der Feltz-Cornelis, Christina M; Rossi, Gina; Arntz, Arnoud

2018-06-01

No studies have been conducted yet into the effectiveness of treatment of personality disorders in later life. This study is a first test of the effectiveness of schema therapy for personality disorders in older adults. Multiple-baseline design with eight cluster C personality disorder patients, with a mean age of   69. After a baseline phase with random length, schema therapy was given during the first year, followed by follow-up sessions during six months. Participants weekly rated the credibility of dysfunctional core beliefs. Symptomatic distress, early maladaptive schemas, quality of life and target complaints were assessed every six months and personality disorder diagnosis was assessed before baseline and after follow-up. Data were analyzed with mixed regression analyses. Results revealed significant linear trends during treatment phases, but not during baseline and follow-up. The scores during follow-up remained stable and were significantly lower compared to baseline, with high effect sizes. Seven participants remitted from their personality disorder diagnosis. Schema therapy appears an effective treatment for cluster C personality disorders in older adults. This finding is highly innovative as this is the first study exploring the effectiveness of psychotherapy, in this case schema therapy, for personality disorders in older adults.

Bayesian adaptive phase II screening design for combination trials

PubMed Central

Cai, Chunyan; Yuan, Ying; Johnson, Valen E

2013-01-01

Background Trials of combination therapies for the treatment of cancer are playing an increasingly important role in the battle against this disease. To more efficiently handle the large number of combination therapies that must be tested, we propose a novel Bayesian phase II adaptive screening design to simultaneously select among possible treatment combinations involving multiple agents. Methods Our design is based on formulating the selection procedure as a Bayesian hypothesis testing problem in which the superiority of each treatment combination is equated to a single hypothesis. During the trial conduct, we use the current values of the posterior probabilities of all hypotheses to adaptively allocate patients to treatment combinations. Results Simulation studies show that the proposed design substantially outperforms the conventional multiarm balanced factorial trial design. The proposed design yields a significantly higher probability for selecting the best treatment while allocating substantially more patients to efficacious treatments. Limitations The proposed design is most appropriate for the trials combining multiple agents and screening out the efficacious combination to be further investigated. Conclusions The proposed Bayesian adaptive phase II screening design substantially outperformed the conventional complete factorial design. Our design allocates more patients to better treatments while providing higher power to identify the best treatment at the end of the trial. PMID:23359875

Therapeutically induced changes in couple identity: the role of we-ness and interpersonal processing in relationship satisfaction.

PubMed

Reid, David W; Dalton, E Jane; Laderoute, Kristine; Doell, Faye K; Nguyen, Thao

2006-08-01

Changes in partners' sense of self-in-relationship, which a systemic-constructivist couple therapy (SCCT) induced, led to robust improvement in satisfaction in 2 studies and a follow-up study. In each study, 13 referred couples completed measures of satisfaction, mutuality, similarities, and other-in-self construal pre-post 12 hours of SCCT. The authors reliably coded transcripts of 1st and final sessions for each partner's we-ness, the identity that each partner establishes in relationship to the other. Having met the criteria for the rigorous study of change in single group process-outcome design, changes in we-ness accompanied large posttherapy dyadic increments on all variables in each study. Therapeutic gains appeared at follow-up and correlated with increased we-ness obtained at end of therapy 2 years earlier. The authors raise theoretical implications for all types of couple therapies and explain clinical techniques.

A systematic review of clinical studies of electrical stimulation for treatment of lower urinary tract dysfunction.

PubMed

Monga, Ash K; Tracey, Michael R; Subbaroyan, Jeyakumar

2012-08-01

The aim of this manuscript was to provide a systematic literature review of clinical trial evidence for a range of electrical stimulation therapies in the treatment of lower urinary tract symptoms (LUTS). The databases MEDLINE, BIOSIS Previews, Inside Conferences, and EMBASE were searched. Original clinical studies with greater than 15 subjects were included. Seventy-three studies were included, representing implanted sacral nerve stimulation (SNS), percutaneous posterior tibial nerve stimulation (PTNS), and transcutaneous electrical stimulation (TENS) therapy modalities. Median mean reductions in incontinence episodes and voiding frequency were similar for implanted SNS and PTNS. However, long-term follow-up data to validate the sustained benefit of PTNS are lacking. Despite a substantial body of research devoted to SNS validation, it is not possible to definitively define the appropriate role of this therapy owing largely to study design flaws that inhibited rigorous intention to treat analyses for the majority of these studies.

The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients.

PubMed

Ederer, F; Gaasterland, D E; Sullivan, E K

1994-08-01

Medical therapy has been the standard initial treatment for open-angle glaucoma. When some visual field has been lost and maximum tolerated and effective medical therapy does not succeed in controlling the disease, the patient is considered to have advanced glaucoma, and the first of a potential sequence of surgical treatments is usually indicated. Little is known about the long-term course and prognosis of advanced glaucoma or about the long-term effectiveness of sequential surgical treatments in controlling the disease and preventing vision loss and blindness. The Advanced Glaucoma Intervention Study was designed to study, in advanced glaucoma, the long-term clinical course and prognosis, and, in a randomized trial, the comparative outcomes of two sequences of surgical treatments. Toward these goals, 789 eyes in 591 patients were enrolled at 11 clinical centers between 1988 and 1992. Follow-up will continue until 1996. Eyes were randomly assigned to one of two sequences of surgical treatments. One sequence begins with argon laser trabeculoplasty (ALT), is followed by trabeculectomy, an incisional surgical filtering procedure, should ALT fail to control the disease, and by a second trabeculectomy should the first trabeculectomy fail. The other sequence begins with trabeculectomy, is followed by ALT should the trabeculectomy fail, and by a second trabeculectomy should ALT fail. The main outcome of interest is visual function (visual field and visual acuity). Other important outcomes are intraocular pressure, complications of surgery, time to treatment failure, and extent of need for additional medical therapy. We present in this paper the rationale, objectives, design and methods of the study, and the baseline characteristics of study patients and eyes.

Using a mixed methods research design to investigate complementary alternative medicine (CAM) use among women with breast cancer in Ireland.

PubMed

Fox, Patricia; Butler, Michelle; Coughlan, Barbara; Murray, Mary; Boland, Noreen; Hanan, Terry; Murphy, Hilary; Forrester, Pauline; O' Brien, Marie; O' Sullivan, Nollaig

2013-08-01

To investigate complementary and alternative medicine (CAM) use among women with breast cancer in Ireland using a mixed methods modified sequential explanatory design. Semi-structured interviews were conducted with oncology professionals (n = 20) and CAM practitioners (n = 20) and this was followed by a survey of 406 women with breast cancer using the 'Use of Complementary and Alternative Therapies Survey' questionnaire (UCATS) (Lengacher et al., 2003). Follow up interviews were subsequently undertaken with a subset of this survey sample (n = 31). Over half of those surveyed (55.7%, n = 226) used some form of CAM since diagnosis. The most frequently used therapies were massage, herbal supplements (including herbs with oestrogenic properties), antioxidants, relaxation, counselling, health supplements, reflexology, reiki and support groups. Dietary interventions were used primarily to reduce symptoms and/or side effects while reduction of psychological stress was the primary reason for use of stress-reducing therapies. Most respondents reported that the CAM therapies they had used were helpful. The qualitative data elaborated on and provided clarification of the survey results. Similar to international studies, CAM is popular among women with breast cancer in Ireland. As such, the challenge for Irish oncology professionals is to identify low risk CAM therapies that are likely to benefit patients while educating patients and themselves on therapies which may be of concern. This study clearly illustrates the benefits of using a mixed methods approach to enhance our understanding of a complex clinical issue and thus we recommend that this method should be the method of choice when planning health services research. Copyright © 2012 Elsevier Ltd. All rights reserved.

Canine-assisted therapy for children with ADHD: preliminary findings from the positive assertive cooperative kids study.

PubMed

Schuck, Sabrina E B; Emmerson, Natasha A; Fine, Aubrey H; Lakes, Kimberley D

2015-02-01

The objective of this study was to provide preliminary findings from an ongoing randomized clinical trial using a canine-assisted intervention (CAI) for 24 children with ADHD. Project Positive Assertive Cooperative Kids (P.A.C.K.) was designed to study a 12-week cognitive-behavioral intervention delivered with or without CAI. Children were randomly assigned to group therapy with or without CAI. Parents of children in both groups simultaneously participated in weekly parent group therapy sessions. Across both treatment groups, parents reported improvements in children's social skills, prosocial behaviors, and problematic behaviors. In both groups, the severity of ADHD symptoms declined during the course of treatment; however, children who received the CAI model exhibited greater reductions in the severity of ADHD symptoms than did children who received cognitive-behavioral therapy without CAI. Results suggest that CAI offers a novel therapeutic strategy that may enhance cognitive-behavioral interventions for children with ADHD. © 2013 SAGE Publications.

Effectiveness of Adherence Therapy for People With Schizophrenia in Turkey: A Controlled Study.

PubMed

Dikec, Gul; Kutlu, Yasemin

2016-04-01

This study used a quasi-experimental design with a pretest-posttest control group and follow-up to determine the efficacy of adherence therapy in patients with schizophrenia in Turkey. The sample of this study consisted of patients with schizophrenia (n=30). The Questionnaire Form, Medication Adherence Rating Scale, Internalized Stigma of Mental Illness Scale, and Beck Cognitive Insight Scale were used. The patients were assigned to experimental (n=15) and control (n=15) groups using the randomization method. The experimental group received adherence therapy in eight sessions. When the scores of the patients in the experimental and control groups were compared at the pretest, posttest, and 3- and 6-months follow ups, a significant difference was only found in the Medication Adherence Rating Scale posttest scores. Adherence therapy is effective in improving adherence to treatment but is not effective with regard to insight and internalized stigma in patients with schizophrenia. Copyright © 2015 Elsevier Inc. All rights reserved.

The Effectiveness and Safety of Manual Therapy on Pain and Disability in Older Persons With Chronic Low Back Pain: A Systematic Review.

PubMed

de Luca, Katie E; Fang, Sheng Hung; Ong, Justin; Shin, Ki-Soo; Woods, Samuel; Tuchin, Peter J

2017-09-01

The aim of this study was to perform a systematic review of the literature of the effectiveness and safety of manual therapy interventions on pain and disability in older persons with chronic low back pain (LBP). A literature search of 4 electronic databases was performed (PubMed, EMBASE, OVID, and CINAHL). Inclusion criteria included randomized controlled trials of manual therapy interventions on older persons who had chronic LBP. Effectiveness was determined by extracting and examining outcomes for pain and disability, with safety determined by the report of adverse events. The PEDro scale was used for quality assessment of eligible studies. The search identified 405 articles, and 38 full-text articles were assessed. Four studies met the inclusion criteria. All trials were of good methodologic quality and had a low risk of bias. The included studies provided moderate evidence supporting the use of manual therapy to reduce pain levels and alleviate disability. A limited number of studies have investigated the effectiveness and safety of manual therapy in the management of older people with chronic LBP. The current evidence to make firm clinical recommendations is limited. Research with appropriately designed trials to investigate the effectiveness and safety of manual therapy interventions in older persons with chronic LBP is required. Copyright © 2017. Published by Elsevier Inc.

Sex Differences in Stroke Therapies

PubMed Central

Sohrabji, Farida; Park, Min Jung; Mahnke, Amanda H

2016-01-01

Stroke is the 5th leading cause of death and acquired disability in aged populations. Women are disproportionally affected by stroke, having a higher incidence and worse outcomes than men. Numerous preclinical studies have discovered novel therapies for the treatment of stroke, but almost all of these were found to be unsuccessful in clinical trials. Despite known sex differences in occurrence and severity of stroke, few therapeutics, both preclinically and clinically, take into account possible sex differences in treatment. Reanalysis of data from the only currently FDA-approved stroke therapy, tPA, has shown to not only improve stroke outcomes for both sexes, but to also show sexual dimorphism by more robust improvement in stroke outcome in females. Experimental evidence supports the inclusion of sex as a variable in the study of a number of novel stroke drugs and therapies, including preclinical studies of anti-inflammatory drugs (minocycline), stimulators of cell survival (IGF-1), and inhibitors of cell death pathways (pharmacological inhibition of PARP-1, NO production, and caspase activation), as well as in current clinical trials of stem cell therapy and cortical stimulation. Overall, study design and analyses in clinical trials, as well as in preclinical studies, must include both sexes equally, consider possible sex differences in the analyses, and report the differences/similarities in more systemized/structured way to translate promising therapies to both sexes and increase stroke recovery. PMID:27870437

Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality.

PubMed

McCann, Russell A; Armstrong, Christina M; Skopp, Nancy A; Edwards-Stewart, Amanda; Smolenski, Derek J; June, Jennifer D; Metzger-Abamukong, Melinda; Reger, Greg M

2014-08-01

Randomized controlled trials (RCTs) support the effectiveness of virtual reality exposure therapy (VRET) for anxiety disorders; however, the overall quality of the VRET RCT literature base has yet to be evaluated. This study reviewed 27 VRET RCTs and the degree of adherence to 8 RCT research design criteria derived from existing standards. Adherence to the study quality criteria was generally low as the articles met an average 2.85 criteria (SD=1.56). None of the studies met more than six quality criteria. Study quality did not predict effect size; however, a reduction in effect size magnitude was observed for studies with larger sample sizes when comparing VRET to non-active control groups. VRET may be an effective method of treatment but caution should be exercised in interpreting the existing body of literature supporting VRET relative to existing standards of care. The need for well-designed VRET research is discussed. Copyright © 2014. Published by Elsevier Ltd.

Pilot study: incorporation of pharmacogenetic testing in medication therapy management services.

PubMed

Haga, Susanne B; Allen LaPointe, Nancy M; Moaddeb, Jivan; Mills, Rachel; Patel, Mahesh; Kraus, William E

2014-11-01

Aim: To describe the rationale and design of a pilot study evaluating the integration of pharmacogenetic (PGx) testing into pharmacist-delivered medication therapy management (MTM). Study rationale: Clinical delivery approaches of PGx testing involving pharmacists may overcome barriers of limited physician knowledge about and experience with testing. Study design: We will assess the addition of PGx testing to MTM services for cardiology patients taking three or more medications including simvastatin or clopidogrel. We will measure the impact of MTM plus PGx testing on drug/dose adjustment and clinical outcomes. Factors associated with delivery, such as time to prepare and conduct MTM and consult with physicians will be recorded. Additionally, patient interest and satisfaction will be measured. Anticipated results: We anticipate that PGx testing can be practically integrated into standard a MTM service, providing a viable delivery model for testing. Conclusion: Given the lack of evidence of an effective PGx delivery models, this study will provide preliminary evidence regarding a pharmacist-delivered approach.

Energy expenditure in growing preterm infants receiving massage therapy.

PubMed

Lahat, Sharon; Mimouni, Francis B; Ashbel, Gina; Dollberg, Shaul

2007-08-01

Massage therapy has been consistently shown to increase weight gain in preterm infants. The mechanism of this presumed improved metabolic efficiency is unknown. We conducted the following trial to test the hypothesis that massage therapy reduces energy expenditure in growing healthy preterm infants. A prospective, randomized, cross-over design study was conducted in 10 healthy, appropriate weights for gestational age, gavage fed preterm infants. Each infant was studied twice: after a period of either 5 days of massage therapy, or after a period of 5 days without massage therapy. Infants were randomized to 5 days of massage followed by 5 days of no massage (n = 5) or the opposite sequence (n = 5). During the massage therapy period, massage was provided daily for three 15 minute periods at the beginning of each 3 hour period every morning. Metabolic measurements were performed by indirect calorimetry, using the Deltatrac II Metabolic cart. Energy expenditure was significantly lower in infants after the 5 day massage therapy period (59.6 +/- 3.6 Kcal/Kg/ 24 hours) than after the period without (63.1 +/- 5.4 Kcal/Kg/ 24 hours) (p = 0.05). Energy expenditure is significantly lowered by 5 days of massage therapy in metabolically and thermally stable preterm infants. This decrease in energy expenditure may be in part responsible for the enhanced growth caused by massage therapy.

Glucocorticoids enhance in vivo exposure-based therapy of spider phobia.

PubMed

Soravia, Leila M; Heinrichs, Markus; Winzeler, Livia; Fisler, Melanie; Schmitt, Wolfgang; Horn, Helge; Dierks, Thomas; Strik, Werner; Hofmann, Stefan G; de Quervain, Dominique J-F

2014-05-01

Preclinical and clinical studies indicate that the administration of glucocorticoids may promote fear extinction processes. In particular, it has been shown that glucocorticoids enhance virtual reality based exposure therapy of fear of heights. Here, we investigate whether glucocorticoids enhance the outcome of in vivo exposure-based group therapy of spider phobia. In a double blind, block-randomized, placebo-controlled, between-subject study design, 22 patients with specific phobia of spiders were treated with two sessions of in vivo exposure-based group therapy. Cortisol (20 mg) or placebo was orally administered 1 hr before each therapy session. Patients returned for a follow-up assessment one month after therapy. Exposure-based group therapy led to a significant decrease in phobic symptoms as assessed with the Fear of Spiders Questionnaire (FSQ) from pretreatment to immediate posttreatment and to follow-up. The administration of cortisol to exposure therapy resulted in increased salivary cortisol concentrations and a significantly greater reduction in fear of spiders (FSQ) as compared to placebo at follow-up, but not immediately posttreatment. Furthermore, cortisol-treated patients reported significantly less anxiety during standardized exposure to living spiders at follow-up than placebo-treated subjects. Notably, groups did not differ in phobia-unrelated state-anxiety before and after the exposure sessions and at follow-up. These findings indicate that adding cortisol to in vivo exposure-based group therapy of spider phobia enhances treatment outcome. © 2013 Wiley Periodicals, Inc.

[Dance/movement therapy in oncological rehabilitation].

PubMed

Mannheim, Elana G; Helmes, Almut; Weis, Joachim

2013-01-01

Dance/movement therapy may be defined as a psychosocial and body-oriented art therapy, which uses dance for the expression of emotional and cognitive issues. Dance/movement therapy is an important intervention for cancer patients to enhance coping strategies. There are only few studies investigating dance therapy with cancer patients. The present study investigates effects of dance/movement therapy (n = 115) in the setting of inpatient rehabilitation based on a pre-post design with a control group as well as a follow-up 3 months later. Standardized questionnaires measuring quality of life, anxiety and depression, and self-concept (EORTC QLQ-C30, HADS, FSKN) were used. In addition, at the end of the inpatient rehabilitation program subjective expectations of the dance/movement therapy and the patients' subjective evaluation of the benefits of the intervention were measured by a new developed questionnaire. As process factors of dance/movement therapy, expression of emotions, enhancement of self-esteem, development of the personality, vitality, getting inner balance, and getting in touch with the body have been identified. In terms of quality of life and psychological well-being, the results showed significant improvements with medium to large effect sizes. Even though those effects may not be attributed to the intervention alone, the analysis of the data and the patients' subjective statements help to reveal therapeutic factors and process characteristics of dance/movement therapy within inpatient rehabilitation. Copyright © 2013 S. Karger AG, Basel.

Evaluation of synergistic effects of resynchronization therapy and a β-blocker up-titration strategy based on a predefined patient-management program: the RESTORE study.

PubMed

Palmisano, Pietro; Ammendola, Ernesto; D'Onofrio, Antonio; Accogli, Michele; Calò, Leonardo; Ruocco, Antonio; Rapacciuolo, Antonio; Del Giorno, Giuseppe; Bianchi, Valter; Malacrida, Maurizio; Valsecchi, Sergio; Gronda, Edoardo

2015-01-01

Prior studies have suggested that a substantial number of eligible heart failure (HF) patients fail to receive β-blocker therapy, or receive it at a suboptimal dose. The aim of this study is to assess the benefit of a predefined management program designed for β-blocker up-titration, evaluating the synergistic effect of cardiac resynchronization therapy (CRT) and β-blockers in a HF population. The Resynchronization Therapy and β-Blocker Titration (RESTORE) study is a prospective, case-control, multicenter cohort study designed to test the hypothesis that a β-blocker up-titration strategy based on a predefined management program maximizes the beneficial effect of CRT, increasing the number of patients reaching the target dose of β-blockers and improving their clinical outcome. All study patients receive an implantable defibrillator for CRT delivery in accordance with current guidelines. Enrollments started in December 2011 and are scheduled to end in December 2014. Approximately 250 consecutive patients will be prospectively enrolled in 6 Italian centers and followed up for 24 months after implantation. The primary endpoint is to demonstrate that CRT may allow titration of β-blockers until the optimal dose, or at least to the effective dose, in patients with HF. This study might provide important information about the benefit of a predefined management program for β-blocker up-titration in patients receiving CRT. Moreover, assessment of health-care utilization and the consumption of resources will allow estimating the potential utility of remote monitoring by means of an automated telemedicine system in facilitating the titration of β-blockers in comparison with a standard in-hospital approach. © 2015 Wiley Periodicals, Inc.

The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?*.

PubMed

Opal, Steven M; Dellinger, R Phillip; Vincent, Jean-Louis; Masur, Henry; Angus, Derek C

2014-07-01

The developmental pipeline for novel therapeutics to treat sepsis has diminished to a trickle compared to previous years of sepsis research. While enormous strides have been made in understanding the basic molecular mechanisms that underlie the pathophysiology of sepsis, a long list of novel agents have now been tested in clinical trials without a single immunomodulating therapy showing consistent benefit. The only antisepsis agent to successfully complete a phase III clinical trial was human recumbent activated protein C. This drug was taken off the market after a follow-up placebo-controlled trial (human recombinant activated Protein C Worldwide Evaluation of Severe Sepsis and septic Shock [PROWESS SHOCK]) failed to replicate the favorable results of the initial registration trial performed ten years earlier. We must critically reevaluate our basic approach to the preclinical and clinical evaluation of new sepsis therapies. We selected the major clinical studies that investigated interventional trials with novel therapies to treat sepsis over the last 30 years. Phase II and phase III trials investigating new treatments for sepsis and editorials and critiques of these studies. Selected manuscripts and clinical study reports were analyzed from sepsis trials. Specific shortcomings and potential pit falls in preclinical evaluation and clinical study design and analysis were reviewed and synthesized. After review and discussion, a series of 12 recommendations were generated with suggestions to guide future studies with new treatments for sepsis. We need to improve our ability to define appropriate molecular targets for preclinical development and develop better methods to determine the clinical value of novel sepsis agents. Clinical trials must have realistic sample sizes and meaningful endpoints. Biomarker-driven studies should be considered to categorize specific "at risk" populations most likely to benefit from a new treatment. Innovations in clinical trial design such as parallel crossover design, alternative endpoints, or adaptive trials should be pursued to improve the outlook for future interventional trials in sepsis.

Effects of Horticultural Therapy on Psychosocial Health in Older Nursing Home Residents: A Preliminary Study.

PubMed

Chen, Yuh-Min; Ji, Jeng-Yi

2015-09-01

This preliminary study examined the effect of horticultural therapy on psychosocial health in older nursing home residents. A combined quantitative and qualitative design was adopted. Convenience sampling was used to recruit 10 older residents from a nursing home in Taichung, Taiwan. Participants joined a 10-week indoor horticultural program once a week, with each session lasting for about 1.5 hours. A single-group design with multiple measurements was adopted for the quantitative component of this study. Interviews held 1-2 days before the intervention (T0) were used to collect baseline data. The two outcome variables of this study, depression and loneliness, were reassessed during the 5th (T1) and 10th (T2) weeks of the intervention. Generalized estimating equations were used to test the mean differences among T0, T1, and T2 measures. After the 10-week program, qualitative data were collected by asking participants to share their program participation experiences. The results of generalized estimating equation showed significant improvements in depression and loneliness. Four categories emerged from the qualitative data content analysis: social connection, anticipation and hope, sense of achievement, and companionship. Given the beneficial effects of the horticulture therapy, the inclusion of horticultural activities in nursing home activity programs is recommended.

Attitudes and Preferences on the Use of Mobile Health Technology and Health Games for Self-Management: Interviews With Older Adults on Anticoagulation Therapy

PubMed Central

Nguyen, Annie Lu; Berg, Jill; Amin, Alpesh; Bachman, Mark; Guo, Yuqing; Evangelista, Lorraine

2014-01-01

Background Older adults are at substantial risk for cardiovascular disorders that may require anticoagulation therapy. Those on warfarin therapy report dissatisfaction and reduced quality of life (QOL) resulting from the treatment. Advances in the area of mobile health (mHealth) technology have resulted in the design and development of new patient-centric models for the provision of personalized health care services to improve care delivery. However, there is a paucity of research examining the effectiveness of mHealth tools on knowledge, attitudes, and patient satisfaction with treatment, as well as self-management, adherence to therapy, and QOL in older adults with chronic illness conditions requiring long-term warfarin therapy. Objective The objective of the study was to explore the attitudes and preferences of older adults on warfarin therapy regarding the use of mHealth technology and health games to gain skills for self-management. Methods We conducted group and individual interviews with patients (60 years or older) on warfarin therapy at two anticoagulation clinics affiliated with an academic medical center. We held 4 group and 2 individual interviews, resulting in 11 patient participants and 2 family caregiver participants. We used structured questions on three topic areas including medication self-management strategies, mHealth technology use, and health games for exercise. We demonstrated some commercial health apps related to medication management, vitamin K content of food, and a videogame for balance exercise. Discussions were audiotaped and transcribed verbatim. Common themes were drawn using content analysis. Results The participants reported awareness of the importance of staying on schedule with warfarin therapy. They also acknowledged that negative experiences of friends or family members who were taking warfarin influenced their desire to keep on schedule with warfarin therapy. In addition, the participants expressed that the use of mHealth technology may be helpful for medication management. They also expressed the need for family support in the use of health technology devices. Moreover, the participants discussed concerns and challenges to use health technology and health games, and provided suggestions on ways to make mHealth technology and health games elder-friendly. Conclusions These findings indicate that our older adults on warfarin therapy are interested in mHealth technology specific to warfarin medication management and health games. Further research needs to be done to validate these findings. Elder-friendly designs, technology support, and physical safety using mHealth technology may be useful in this population. These findings can be used to inform a larger study to design and test an elder-centered mHealth technology in this target population. PMID:25098413

Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

PubMed Central

Siriwardena, A Niroshan; Apekey, Tanefa; Tilling, Michelle; Harrison, Andrew; Dyas, Jane V; Middleton, Hugh C; Ørner, Roderick; Sach, Tracey; Dewey, Michael; Qureshi, Zubair M

2009-01-01

Background Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi) have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. Methods and design This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity) and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs). Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours) to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. Discussion Previous studies in adults have shown that psychological treatments for insomnia administered by specialist nurses to groups of patients can be effective within a primary care setting. This will be a pilot study to determine whether an educational intervention aimed at primary care teams to deliver problem focused therapy for insomnia can improve sleep management and outcomes for individual adult patients presenting to general practice. The study will also test procedures and collect information in preparation for a larger definitive cluster-randomised trial. The study is funded by The Health Foundation. Trial Registration ClinicalTrials.gov ID ISRCTN55001433 – PMID:19171070

Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia.

PubMed

Morin, Mélanie; Carroll, Marie-Soleil; Bergeron, Sophie

2017-07-01

Pelvic floor muscle physical therapy is recommended in clinical guidelines for women with provoked vestibulodynia (PVD). Including isolated or combined treatment modalities, physical therapy is viewed as an effective first-line intervention, yet no systematic review concerning the effectiveness of physical therapy has been conducted. To systematically appraise the current literature on the effectiveness of physical therapy modalities for decreasing pain during intercourse and improving sexual function in women with PVD. A systematic literature search using PubMed, Scopus, CINHAL, and PEDro was conducted until October 2016. Moreover, a manual search from reference lists of included articles was performed. Ongoing trials also were reviewed using clinicaltrial.gov and ISRCTNregistry. Randomized controlled trials, prospective and retrospective cohorts, and case reports evaluating the effect of isolated or combined physical therapy modalities in women with PVD were included in the review. Main outcome measures were pain during intercourse, sexual function, and patient's perceived improvement. The literature search resulted in 43 eligible studies including 7 randomized controlled trials, 20 prospective studies, 5 retrospective studies, 6 case reports, and 6 study protocols. Most studies had a high risk of bias mainly associated with the lack of a comparison group. Another common bias was related to insufficient sample size, non-validated outcomes, non-standardized intervention, and use of other ongoing treatment. The vast majority of studies showed that physical therapy modalities such as biofeedback, dilators, electrical stimulation, education, multimodal physical therapy, and multidisciplinary approaches were effective for decreasing pain during intercourse and improving sexual function. The positive findings for the effectiveness of physical therapy modalities in women with PVD should be investigated further in robust and well-designed randomized controlled trials. Morin M, Carroll M-S, Bergeron S. Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia. Sex Med Rev 2017;5:295-322. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Patient-Reported Outcomes Associated With Use of Physical Therapist Services by Older Adults With a New Visit for Back Pain

PubMed Central

Sherman, Karen J.; Heagerty, Patrick J.; Mock, Charles; Jarvik, Jeffrey G.

2015-01-01

Background Among older adults, it is not clear how different types or amounts of physical therapy may be associated with improvements in back pain and function. Objective The study objective was to investigate the association between types or amounts of physical therapist services and 1-year outcomes among older adults with back pain. Design This was a prospective cohort study. Methods A total of 3,771 older adults who were enrolled in a cohort study and who had a new primary care visit for back pain participated. Physical therapy use was ascertained from electronic health records. The following patient-reported outcomes were collected over 12 months: back-related disability (Roland-Morris Disability Questionnaire) and back and leg pain intensity (11-point numerical rating scale). Marginal structural models were used to estimate average effects of different amounts of physical therapy use on disability and pain for all types of physical therapy and for active, passive, and manual physical therapy. Results A total of 1,285 participants (34.1%) received some physical therapy. There was no statistically significant gradient in relationships between physical therapy use and back-related disability score. The use of passive or manual therapy was not consistently associated with pain outcomes. Higher amounts of active physical therapy were associated with decreased back and leg pain and increased odds of clinically meaningful improvements in back and leg pain relative to results obtained with no active physical therapy. Limitations The fact that few participants had high amounts of physical therapy use limited precision and the ability to test for nonlinear relationships for the amount of use. Conclusions Higher amounts of active physical therapy were most consistently related to the greatest improvements in pain intensity; however, as with all observational studies, the results must be interpreted with caution. PMID:25278334

Recent insights in nanotechnology-based drugs and formulations designed for effective anti-cancer therapy.

PubMed

Piktel, Ewelina; Niemirowicz, Katarzyna; Wątek, Marzena; Wollny, Tomasz; Deptuła, Piotr; Bucki, Robert

2016-05-26

The rapid development of nanotechnology provides alternative approaches to overcome several limitations of conventional anti-cancer therapy. Drug targeting using functionalized nanoparticles to advance their transport to the dedicated site, became a new standard in novel anti-cancer methods. In effect, the employment of nanoparticles during design of antineoplastic drugs helps to improve pharmacokinetic properties, with subsequent development of high specific, non-toxic and biocompatible anti-cancer agents. However, the physicochemical and biological diversity of nanomaterials and a broad spectrum of unique features influencing their biological action requires continuous research to assess their activity. Among numerous nanosystems designed to eradicate cancer cells, only a limited number of them entered the clinical trials. It is anticipated that progress in development of nanotechnology-based anti-cancer materials will provide modern, individualized anti-cancer therapies assuring decrease in morbidity and mortality from cancer diseases. In this review we discussed the implication of nanomaterials in design of new drugs for effective antineoplastic therapy and describe a variety of mechanisms and challenges for selective tumor targeting. We emphasized the recent advantages in the field of nanotechnology-based strategies to fight cancer and discussed their part in effective anti-cancer therapy and successful drug delivery.

Study design of the CLOSURE I Trial: a prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale.

PubMed

Furlan, Anthony J; Reisman, Mark; Massaro, Joseph; Mauri, Laura; Adams, Harold; Albers, Gregory W; Felberg, Robert; Herrmann, Howard; Kar, Saibal; Landzberg, Michael; Raizner, Albert; Wechsler, Lawrence

2010-12-01

Some strokes of unknown etiology may be the result of a paradoxical embolism traversing through a nonfused foramen ovale (patent foramen ovale [PFO]). The utility of percutaneously placed devices for treatment of patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO is unknown. In addition, there are no clear data about the utility of medical interventions or other surgical procedures in this situation. Despite limited data, many patients are being treated with PFO closure devices. Thus, there is a strong need for clinical trials that test the potential efficacy of PFO occlusive devices in this situation. To address this gap in medical knowledge, we designed the CLOSURE I trial, a randomized, clinical trial comparing the use of a percutaneously placed PFO occlusive device and best medical therapy versus best medical therapy alone for prevention of recurrent ischemic neurologic symptoms among persons with TIA or ischemic stroke. This prospective, multicenter, randomized, controlled trial has finished enrollment. Two-year follow-up for all 910 patients is required. The primary end point is the 2-year incidence of stroke or TIA, all-cause mortality for the first 30 days, and neurologic mortality from ≥ 31 days of follow-up, as adjudicated by a panel of physicians who are unaware of treatment allocation. This article describes the rationale and study design of CLOSURE I. This trial should provide information as to whether the STARFlex septal closure system is safe and more effective than best medical therapy alone in preventing recurrent stroke/TIA and mortality in patients with PFO and whether the STARFlex septal closure device can demonstrate superiority compared with best medical therapy alone. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00201461.

Effects of music therapy in the treatment of children with delayed speech development - results of a pilot study

PubMed Central

2010-01-01

Background Language development is one of the most significant processes of early childhood development. Children with delayed speech development are more at risk of acquiring other cognitive, social-emotional, and school-related problems. Music therapy appears to facilitate speech development in children, even within a short period of time. The aim of this pilot study is to explore the effects of music therapy in children with delayed speech development. Methods A total of 18 children aged 3.5 to 6 years with delayed speech development took part in this observational study in which music therapy and no treatment were compared to demonstrate effectiveness. Individual music therapy was provided on an outpatient basis. An ABAB reversal design with alternations between music therapy and no treatment with an interval of approximately eight weeks between the blocks was chosen. Before and after each study period, a speech development test, a non-verbal intelligence test for children, and music therapy assessment scales were used to evaluate the speech development of the children. Results Compared to the baseline, we found a positive development in the study group after receiving music therapy. Both phonological capacity and the children's understanding of speech increased under treatment, as well as their cognitive structures, action patterns, and level of intelligence. Throughout the study period, developmental age converged with their biological age. Ratings according to the Nordoff-Robbins scales showed clinically significant changes in the children, namely in the areas of client-therapist relationship and communication. Conclusions This study suggests that music therapy may have a measurable effect on the speech development of children through the treatment's interactions with fundamental aspects of speech development, including the ability to form and maintain relationships and prosodic abilities. Thus, music therapy may provide a basic and supportive therapy for children with delayed speech development. Further studies should be conducted to investigate the mechanisms of these interactions in greater depth. Trial registration The trial is registered in the German clinical trials register; Trial-No.: DRKS00000343 PMID:20663139

In vivo validation of the adequacy calculator for continuous renal replacement therapies

PubMed Central

Ricci, Zaccaria; Salvatori, Gabriella; Bonello, Monica; Pisitkun, Tirak; Bolgan, Irene; D'Amico, Giuseppe; Dan, Maurizio; Piccinni, Pasquale; Ronco, Claudio

2005-01-01

Introduction The study was conducted to validate in vivo the Adequacy Calculator, a Microsoft Excel-based program, designed to assess the prescription and delivery of renal replacement therapy in the critical care setting. Methods The design was a prospective cohort study, set in two intensive care units of teaching hospitals. The participants were 30 consecutive critically ill patients with acute renal failure treated with 106 continuous renal replacement therapies (CRRT). Urea clearance computation was performed with the Adequacy Calculator (KCALC). Simultaneous blood and effluent urea samples were collected to measure the effectively delivered urea clearance (KDEL) at the beginning of each treatment and, during 73 treatments, between the 18th and 24th treatment hour. The correlation between 179 computed and 179 measured clearances was assessed. Fractional clearances for urea were calculated as spKt/V (where sp represents single pool, K is clearance, t is time, and V is urea volume of distribution) obtained from software prescription and compared with the delivered spKt/V obtained from empirical data. Results We found that the value of clearance predicted by the calculator was strongly correlated with the value obtained from computation on blood and dialysate determination (r = 0.97) during the first 24 treatment hours, regardless of the renal replacement modality used. The delivered spKt/V (1.25) was less than prescribed (1.4) from the Adequacy Calculator by 10.7%, owing to therapy downtime. Conclusion The Adequacy Calculator is a simple tool for prescribing CRRT and for predicting the delivered dose. The calculator might be a helpful tool for standardizing therapy and for comparing disparate treatments, making it possible to perform large multi-centre studies on CRRT. PMID:15987400

Rationale and study design of a trial of mindfulness-based cognitive therapy for preventing suicidal behavior (MBCT-S) in military veterans.

PubMed

Kline, Anna; Chesin, Megan; Latorre, Miriam; Miller, Rachael; St Hill, Lauren; Shcherbakov, Anton; King, Arlene; Stanley, Barbara; Weiner, Marc D; Interian, Alejandro

2016-09-01

Although suicide ranks 10th as a cause of death in the United States, and 1st among active military personnel, there are surprisingly few evidence-based therapies addressing suicidality, and development of new treatments is limited. This paper describes a clinical trial testing a novel therapy for reducing suicide risk in military veterans. The intervention, Mindfulness-Based Cognitive Therapy for Preventing Suicide Behavior (MBCT-S), is a 10-week group intervention adapted from an existing treatment for depression (Mindfulness-Based Cognitive Therapy - MBCT). MBCT-S incorporates the Safety Planning Intervention, which is currently implemented throughout the Veterans Health Administration (VHA) for veterans at high suicide risk. MBCT-S is being tested in a VHA setting using an intention-to-treat, two-group randomized trial design in which 164 high suicide risk veterans are randomized to either VHA Treatment As Usual (TAU; n=82) or TAU+MBCT-S (n=82). Our primary outcome measure, suicide-related event, defined to include suicide preparatory behaviors, self-harm behavior with suicidal or indeterminate intent, suicide-related hospitalizations and Emergency Department (ED) visits, will be measured through five assessments administered by blinded assessors between baseline and 12months post-baseline. We will measure suicide attempts and suicide deaths as a secondary outcome, because of their anticipated low incidence during the study period. Secondary outcomes also include severity of suicidal ideation, hopelessness and depression. This study has the potential to significantly enhance the quality and efficiency of VHA care for veterans at suicide risk and to substantially improve the quality of life for veterans and their families. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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.

Designing and implementing a physiology course for a new doctoral occupational therapy program with student feedback.

PubMed

Goodman, Barbara E; Ikiugu, Moses N

2017-09-01

Recently, the Occupational Therapy Department requested a custom-designed medical physiology course for the students in the new occupational therapy doctoral program. The first author, a physiologist with extensive experience in teaching both undergraduate preprofessional and medical students in human physiology, was recruited to design and implement the course. The course was designed to be consistent with the constructivist philosophy that guides the occupational therapy curriculum. The course was offered for the first time during fall/spring 2015/2016 and included both first- and second-year occupational therapy doctoral students. A number of anonymous assessment tools were used to evaluate students' perceptions regarding the effectiveness of various pedagogies used in the course in enhancing their learning. A summative course assessment survey with comments was used at the end of the course. This paper describes the model of course design and the student feedback, which generated some suggestions for improvement of the course. This approach in designing a new course for a new disciplinary group of students should be helpful to other faculty involved in developing courses for health career programs populated by students with variable physiology backgrounds and different educational needs. The final relevant feedback from the course would be to have the students evaluate the usefulness of the course to their future careers immediately following their certification examinations in a year or two and during their subsequent clinical experiences; however, that information will likely be more difficult to obtain. Copyright © 2017 the American Physiological Society.

Enhancing legacy in palliative care: study protocol for a randomized controlled trial of Dignity Therapy focused on positive outcomes.

PubMed

Montross-Thomas, Lori P; Irwin, Scott A; Meier, Emily A; Gallegos, Jarred V; Golshan, Shahrokh; Roeland, Eric; McNeal, Helen; Munson, Diane; Rodseth, Laura

2015-09-21

Dignity Therapy is a brief psychotherapy that can enhance a sense of legacy while addressing the emotional and existential needs of patients receiving hospice or palliative care. In Dignity Therapy, patients create a formalized "legacy" document that records their most cherished memories, their lessons learned in life, as well as their hopes and dreams for loved ones in the future. To date, this treatment has been studied for its impact on mitigating distress within hospice and palliative care populations and has provided mixed results. This study will instead focus on whether Dignity Therapy enhances positive outcomes in this population. In this study, 90 patients with cancer receiving hospice or palliative care will complete a mixed-methods randomized controlled trial of Dignity Therapy (n = 45) versus Supportive Attention (n = 45). The patients will be enrolled in the study for 3 weeks, receiving a total of six study visits. The primary outcomes examine whether the treatment will quantitatively increase levels of positive affect and a sense of life closure. Secondary outcomes focus on gratitude, hope, life satisfaction, meaning in life, resilience, and self-efficacy. Using a fixed, embedded dataset design, this study will additionally use qualitative interviews to explore patients' perceptions regarding the use of positive outcome measures and whether these outcomes are appropriately matched to their experiences in therapy. Dignity Therapy has shown mixed results when evaluating its impact on distress, although no other study to date has solely focused on the potential positive aspects of this treatment. This study is novel in its use of mixed methods assessments to focus on positive outcomes, and will provide valuable information about patients' direct experiences in this area. ISRCTN91389194.

21st Century Cognitive Behavioural Therapy for Anger: A Systematic Review of Research Design, Methodology and Outcome.

PubMed

Fernandez, Ephrem; Malvaso, Catia; Day, Andrew; Guharajan, Deepan

2018-07-01

Past reviews of cognitive behavioural therapy (CBT) for anger have focused on outcome in specific subpopulations, with few questions posed about research design and methodology. Since the turn of the century, there has been a surge of methodologically varied studies awaiting systematic review. The basic aim was to review this recent literature in terms of trends and patterns in research design, operationalization of anger, and covariates such as social desirability bias (SDB). Also of interest was clinical outcome. After successive culling, 42 relevant studies were retained. These were subjected to a rapid evidence assessment (REA) with special attention to design (ranked on the Scientific Methods Scale) measurement methodology (self-monitored behaviour, anger questionnaires, and others' ratings), SDB assessment, and statistical versus clinical significance. The randomized controlled trial characterized 60% of the studies, and the State Trait Anger Expression Inventory was the dominant measure of anger. All but one of the studies reported statistically significant outcome, and all but one of the 21 studies evaluating clinical significance laid claim to it. The one study with neither statistical nor clinical significance was the only one that had assessed and corrected for SDB. Measures remain relatively narrow in scope, but study designs have improved, and the outcomes suggest efficacy and clinical effectiveness. In conjunction with previous findings of an inverse relationship between anger and SDB, the results raise the possibility that the favourable picture of CBT for anger may need closer scrutiny with SDB and other methodological details in mind.

Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

PubMed

Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

2016-04-01

The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662 patients will be enrolled to reach a total of 1,028 patients for evaluation of the secondary end-point of pump replacement at 2 years. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

The contribution of conceptual frameworks to knowledge translation interventions in physical therapy.

PubMed

Hudon, Anne; Gervais, Mathieu-Joël; Hunt, Matthew

2015-04-01

There is growing recognition of the importance of knowledge translation activities in physical therapy to ensure that research findings are integrated into clinical practice, and increasing numbers of knowledge translation interventions are being conducted. Although various frameworks have been developed to guide and facilitate the process of translating knowledge into practice, these tools have been infrequently used in physical therapy knowledge translation studies to date. Knowledge translation in physical therapy implicates multiple stakeholders and environments and involves numerous steps. In light of this complexity, the use of explicit conceptual frameworks by clinicians and researchers conducting knowledge translation interventions is associated with a range of potential benefits. This perspective article argues that such frameworks are important resources to promote the uptake of new evidence in physical therapist practice settings. Four key benefits associated with the use of conceptual frameworks in designing and implementing knowledge translation interventions are identified, and limits related to their use are considered. A sample of 5 conceptual frameworks is evaluated, and how they address common barriers to knowledge translation in physical therapy is assessed. The goal of this analysis is to provide guidance to physical therapists seeking to identify a framework to support the design and implementation of a knowledge translation intervention. Finally, the use of a conceptual framework is illustrated through a case example. Increased use of conceptual frameworks can have a positive impact on the field of knowledge translation in physical therapy and support the development and implementation of robust and effective knowledge translation interventions that help span the research-practice gap. © 2015 American Physical Therapy Association.

Mapping the scope of occupational therapy practice in palliative care: A European Association for Palliative Care cross-sectional survey

PubMed Central

Eva, Gail; Morgan, Deidre

2018-01-01

Background: Occupational therapists play an integral role in the care of people with life-limiting illnesses. However, little is known about the scope of occupational therapy service provision in palliative care across Europe and factors influencing service delivery. Aim: This study aimed to map the scope of occupational therapy palliative care interventions across Europe and to explore occupational therapists’ perceptions of opportunities and challenges when delivering and developing palliative care services. Design: A 49-item online cross-sectional survey comprised of fixed and free text responses was securely hosted via the European Association for Palliative Care website. Survey design, content and recruitment processes were reviewed and formally approved by the European Association for Palliative Care Board of Directors. Descriptive statistics and thematic analysis were used to analyse data. Setting/respondents: Respondents were European occupational therapists whose caseload included palliative care recipients (full-time or part-time). Results: In total, 237 valid responses were analysed. Findings demonstrated a consistency in occupational therapy practice in palliative care between European countries. Clinician time was prioritised towards indirect patient care, with limited involvement in service development, leadership and research. A need for undergraduate and postgraduate education was identified. Organisational expectations and understanding of the scope of the occupational therapy role constrain the delivery of services to support patients and carers. Conclusion: Further development of occupational therapy in palliative care, particularly capacity building in leadership and research activities, is warranted. There is a need for continuing education and awareness raising of the role of occupational therapy in palliative care. PMID:29756556

Effects of Localized Cold Therapy on Pain in Postoperative Spinal Fusion Patients: A Randomized Control Trial.

PubMed

Quinlan, Patricia; Davis, Jack; Fields, Kara; Madamba, Pia; Colman, Lisa; Tinca, Daniela; Cannon Drake, Regina

Cold therapy used in the sports medicine settings has been found to be effective in reducing postoperative pain; however, there are limited studies that examine the effect of cold therapy on postoperative pain in patients with posterior lumbar spinal fusion. The purpose of this study was to determine the effects of cold on postoperative spine pain and add to the body of knowledge specific to practical application of cold therapy in the spine surgery setting. Researchers used a two-group randomized control design to evaluate the effects of local cold therapy on postoperative pain and analgesia use after lumbar spinal fusion surgery. The primary outcome was postoperative pain. Secondary outcomes included analgesia use and perceived benefit of cold therapy. The intervention (cold) group had a marginally greater reduction in mean Numerical Rating Scale score across all 12 pain checks (M ± SD = -1.1 ± 0.8 points reduction vs. -1.0 ± 0.8 points reduction, p = .589). On average, the intervention group used less morphine equivalents (M ± SD = 12.6 ± 31.5 vs. 23.7 ± 40.0) than the control group across pain checks seven to 12 (p = .042). This study provides additional evidence to support the use of cold therapy as an adjuvant pain management strategy to optimize pain control and reduce opioid consumption following spine fusion surgical procedures.

Assessment of Quality of Life in a Cohort of Newly Diagnosed Patients on HAART Regimen, in Resource Restricted Tribal Region of Chhattisgarh, India: A Prospective Study

PubMed Central

Singh, Harminder; Kaur, Kamalpreet; Dulhani, Navin; Bansal, Akash; Kumar, Bithika N.; Chouhan, Vinod Kumar Singh

2013-01-01

Background: Highly active antiretroviral therapy regimens have resulted in the systemic/clinical healing for human immune deficiency virus-infected patients but the consequence of antiretroviral therapy on the whole quality of life has become a major concern. The current study correlates the relationship of quality of life with successful highly active antiretroviral therapy. Aim: To determine the health-related quality of life in human immune deficiency virus-infected patients on highly active anti-retroviral therapy regimen in tribal region of Chhattisgarh. Design: An open label prospective study. Materials and Methods: Health-related quality of life was assessed using a standardized questionnaire, the Medical Outcomes Survey Short Form 36. Physical health summary scores and mental health summary scores were compared of pre-Highly Active Anti-Retroviral Therapy (at baseline) and post 12 months of therapy. Results: The increase in CD4 cell counts was extremely significant (P < 0.0001). The Physical Composite Summary (P value = 0.0003) improved significantly, whereas the Mental Composite Summary (with a baseline value of 40.7), post 12 months, was calculated as 42.8 (P value = 0.2371) and was statistically not significant. Conclusion: Efficacy measurement is the key ingredient of highly active anti-retroviral therapy, which must also include assessment of health-related quality of life to maximize the holistic approach towards disease. PMID:24049364

The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT)

PubMed Central

2010-01-01

Background Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU) has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. Methods/Design This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum) till one year (maximum) will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands. The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy), also for a period of six weeks. Primary outcomes are Global Perceived Effect (GPE) and functional status (Neck Disability Index (NDI-DV)). Secondary outcomes are neck pain (Numeric Rating Scale (NRS)), Eurocol, costs and quality of life (SF36). Discussion This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. Trial registration ClinicalTrials.gov Identifier: NCT00713843 PMID:20096136

Implementing multifactorial psychotherapy research in online virtual environments (IMPROVE-2): study protocol for a phase III trial of the MOST randomized component selection method for internet cognitive-behavioural therapy for depression.

PubMed

Watkins, Edward; Newbold, Alexandra; Tester-Jones, Michelle; Javaid, Mahmood; Cadman, Jennifer; Collins, Linda M; Graham, John; Mostazir, Mohammod

2016-10-06

Depression is a global health challenge. Although there are effective psychological and pharmaceutical interventions, our best treatments achieve remission rates less than 1/3 and limited sustained recovery. Underpinning this efficacy gap is limited understanding of how complex psychological interventions for depression work. Recent reviews have argued that the active ingredients of therapy need to be identified so that therapy can be made briefer, more potent, and to improve scalability. This in turn requires the use of rigorous study designs that test the presence or absence of individual therapeutic elements, rather than standard comparative randomised controlled trials. One such approach is the Multiphase Optimization Strategy, which uses efficient experimentation such as factorial designs to identify active factors in complex interventions. This approach has been successfully applied to behavioural health but not yet to mental health interventions. A Phase III randomised, single-blind balanced fractional factorial trial, based in England and conducted on the internet, randomized at the level of the patient, will investigate the active ingredients of internet cognitive-behavioural therapy (CBT) for depression. Adults with depression (operationalized as PHQ-9 score ≥ 10), recruited directly from the internet and from an UK National Health Service Improving Access to Psychological Therapies service, will be randomized across seven experimental factors, each reflecting the presence versus absence of specific treatment components (activity scheduling, functional analysis, thought challenging, relaxation, concreteness training, absorption, self-compassion training) using a 32-condition balanced fractional factorial design (2 IV 7-2 ). The primary outcome is symptoms of depression (PHQ-9) at 12 weeks. Secondary outcomes include symptoms of anxiety and process measures related to hypothesized mechanisms. Better understanding of the active ingredients of efficacious therapies, such as CBT, is necessary in order to improve and further disseminate these interventions. This study is the first application of a component selection experiment to psychological interventions in depression and will enable us to determine the main effect of each treatment component and its relative efficacy, and cast light on underlying mechanisms, so that we can systematically enhance internet CBT. Current Controlled Trials ISRCTN24117387 . Registered 26 August 2014.

Impact of Combined Estradiol and Norethindrone Therapy on Visuospatial Working Memory Assessed by Functional Magnetic Resonance Imaging**

PubMed Central

Smith, Yolanda R.; Love, Tiffany; Persad, Carol C.; Tkaczyk, Anne; Nichols, Thomas E.; Zubieta, Jon-Kar

2007-01-01

Context Hormones regulate neuronal function in brain regions critical to cognition; however the cognitive effects of postmenopausal hormone therapy are controversial. Objective The goal was to evaluate the effect of postmenopausal hormone therapy on neural circuitry involved in spatial working memory. Design A randomized, double-blind placebo-controlled cross-over study was performed. Setting The study was performed in a tertiary care university medical center. Participants Ten healthy postmenopausal women of average age 56.9 years were recruited. Interventions Volunteers were randomized to the order they received hormone therapy, 5 ug ethinyl estradiol and 1 mg norethindrone acetate. Subjects received hormone therapy or placebo for 4 weeks, followed by a one month washout period with no medications, and then received the other treatment for 4 weeks. At the end of each 4 week treatment period a functional magnetic resonance imaging (fMRI) study was performed utilizing a nonverbal (spatial) working memory task, the Visual Delayed Matching to Sample task. Main Outcome Measure The effects of hormone therapy on brain activation patterns were compared to placebo. Results Compared to the placebo condition, hormone therapy was associated with a more pronounced activation in the prefrontal cortex (BA 44 and 45), bilaterally (p<0.001). Conclusions Hormone therapy was associated with more effective activation of a brain region critical in primary visual working memory tasks. The data suggest a functional plasticity of memory systems in older women that can be altered by hormones. PMID:16912129

Yoga therapy for promoting emotional sensitivity in University students.

PubMed

Ganpat, Tikhe Sham; Dash, Sasmita; Ramarao, Nagendra Hongasandra

2014-01-01

Students need emotional intelligence (EI) for their better academic excellence. There are three important psychological dimensions of EI: Emotional sensitivity (ES), emotional maturity (EM) and emotional competency (EC), which motivate students to recognize truthfully, interpret honestly and handle tactfully the dynamics of their behavioral pattern. The study was designed to assess ES in the students undergoing yoga therapy program in the form of yoga instructor's course (YIC) module. One hundred and eighty four YIC students with 25.77 ± 4.85 years of mean age participated in this study of 21 days duration (a single group pre-post design). The ES data was collected before (pre) and after (post) YIC module using Emotional Quotient test developed by Dr Dalip Singh and Dr N K Chadha. Means, standard deviations, Kolmogorov-Smirnov test, and Wilcoxon signed rank test were used for analyzing the data with the help of SPSS 16. The data analysis showed 3.63% significant increase (P < 0.01) in ES. The present study suggests that YIC module can result in improvement of ES among university students, thus paving the way for their academic success. Additional well-designed studies are needed before a strong recommendation can be made.

Barrier-free design: a review and critique of the occupational therapy perspective.

PubMed

Cooper, B A; Cohen, U; Hasselkus, B R

1991-04-01

This review of the occupational therapy literature on barrier-free design identifies both a paucity of related occupational therapy research on the topic and a lack of a common conceptual base with which to guide the development and use of environmental assessments. Nonetheless, two fledgling themes can be extrapolated: the consistent reference to the concepts of accessibility, mobility, function, and safety and an increased awareness among occupational therapists regarding the accessibility standards developed by the American National Standards Institute (ANSI) (ANSI, 1971, 1980). A problem-solving model suggested by designers for the 1979 revision of ANSI standards that incorporates these conceptual themes is described and discussed.

Investigating the Effects of Robot-Assisted Therapy among Children with Autism Spectrum Disorder using Bio-markers

NASA Astrophysics Data System (ADS)

Bharatharaj, Jaishankar; Huang, Loulin; Al-Jumaily, Ahmed; Elara, Mohan Rajesh; Krägeloh, Chris

2017-09-01

Therapeutic pet robots designed to help humans with various medical conditions could play a vital role in physiological, psychological and social-interaction interventions for children with autism spectrum disorder (ASD). In this paper, we report our findings from a robot-assisted therapeutic study conducted over seven weeks to investigate the changes in stress levels of children with ASD. For this study, we used the parrot-inspired therapeutic robot, KiliRo, we developed and investigated urinary and salivary samples of participating children to report changes in stress levels before and after interacting with the robot. This is a pioneering human-robot interaction study to investigate the effects of robot-assisted therapy using salivary samples. The results show that the bio-inspired robot-assisted therapy can significantly help reduce the stress levels of children with ASD.

Quality cell therapy manufacturing by design.

PubMed

Lipsitz, Yonatan Y; Timmins, Nicholas E; Zandstra, Peter W

2016-04-01

Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.

What is the role of neoadjuvant chemotherapy, radiation, and adjuvant treatment in resectable esophageal cancer?

PubMed

Altorki, Nasser; Harrison, Sebron

2017-03-01

The majority of patients with operable esophageal cancers present with locally advanced disease, for which surgical resection as a sole treatment modality has been historically associated with poor survival. Even following radical resection, most of these patients will eventually succumb to their disease due to distant metastasis. For this reason, there has been intense interest in the role of neoadjuvant therapy. Neoadjuvant therapy primarily consists of either chemotherapy, radiation therapy, or a combination of the two. Multiple studies of variable scope, design, and patient characteristics have been conducted to determine whether neoadjuvant therapy is warranted, and-if so-what is the best modality of treatment. Despite nearly three decades of study, decisions regarding neoadjuvant therapy for esophageal cancer remain controversial. Regardless, the available evidence provided by large, prospective studies supports preoperative chemotherapy as opposed to surgery alone. Therefore, in our opinion, there is no longer any question as to whether induction therapy is appropriate for locally advanced esophageal cancer. Less clear, however, is the evidence that the addition of radiation to chemotherapy in the preoperative setting is superior to neoadjuvant chemotherapy alone. Our group generally advocates for neoadjuvant chemotherapy alone followed by radical esophageal resection. The data for adjuvant therapy are soft, and particularly troubling is the high rate of treatment drop out in trials studying adjuvant therapy. Therefore, we strongly prefer neoadjuvant chemotherapy and reserve adjuvant chemotherapy for those rare, highly selected patients-patients with T1 tumors, for example-who do not receive neoadjuvant treatment and are found to have occult nodal disease at the time of surgery.

Key constructs in "classical" and "new wave" cognitive behavioral psychotherapies: relationships among each other and with emotional distress.

PubMed

Cristea, Ioana A; Montgomery, Guy H; Szamoskozi, Stefan; David, Daniel

2013-06-01

We aimed to relate key constructs from three forms of cognitive behavioral therapy that are often placed in competition: rational emotive behavior therapy, cognitive therapy, and acceptance and commitment therapy. The key constructs of the underlying theories (i.e., irrational beliefs/unconditional self-acceptance, dysfunctional cognitions, experiential avoidance/psychological inflexibility) of these therapies have not been explicitly studied in their relationships to each other and with emotional distress. We used a cross-sectional design. The variables were selected to indicate key constructs of the three major forms of therapy considered. Study 1 used a sample of 152 students, who were assessed during a stressful period of their semester (mean age = 21.71; 118 females), while Study 2 used a clinical sample of 28 patients with generalized anxiety disorder (mean age = 26.67; 26 females). Results showed that these constructs, central in the therapies considered, had medium to high associations to each other and to distress. Experiential avoidance was found to mediate the relationship between the other, schema-type cognitive constructs and emotional distress. Moreover, multiple mediation analysis in Study 2 seemed to indicate that the influence of the more general constructs on distress was mediated by experiential avoidance, whose effect seemed to be carried on further by automatic thoughts that were the most proximal to distress. Although each of the cognitive constructs considered comes with its underlying theory, the relationships between them can no longer be ignored and cognitive behavioral therapy theoretical models reliably accounting for these relationships should be proposed and tested. © 2013 Wiley Periodicals, Inc.

Dependence and addiction during chronic opioid therapy.

PubMed

Juurlink, David N; Dhalla, Irfan A

2012-12-01

The use of opioids for chronic noncancer pain has increased dramatically over the past 25 years in North America and has been accompanied by a major increase in opioid addiction and overdose deaths. The increase in opioid prescribing is multifactorial and partly reflects concerns about the effectiveness and safety of alternative medications, particularly the nonsteroidal anti-inflammatory drugs. However, much of the rise in opioid prescribing reflects the assertion, widely communicated to physicians in the 1990s, that the risks of dependence and addiction during chronic opioid therapy were low, predictable, and could be minimized by the use of controlled-release opioid formulations. In this narrative review, we offer a critical appraisal of the publications most frequently cited as evidence that the risk of addiction during chronic opioid therapy is low. We conclude that very few well-designed studies support the notion that opioid addiction is rare during chronic opioid therapy and that none can be readily generalized to present-day practice. Despite serious methodological limitations, these studies have been repeatedly mischaracterized as showing that the risk of addiction during chronic opioid therapy is rare. These studies are countered by a larger, more rigorous and contemporary body of evidence demonstrating that dependence and addiction are relatively common consequences of chronic opioid therapy, occurring in up to one-third of patients in some series.

Antithrombotic therapy in peripheral artery disease: A review of the EUCLID trial results and current ongoing trials.

PubMed

Ward, Rachael; Long, Chandler; Patel, Manesh R; Jones, William S

2018-01-01

In addition to risk-factor modification, antithrombotic therapy is the hallmark of management to reduce cardiovascular ischemic events in patients with peripheral artery disease (PAD). Currently, the guidelines recommend long-term antiplatelet therapy with aspirin or clopidogrel in this patient population to reduce myocardial infarction, stroke, and vascular death. Past outcomes studies have shown some benefit of ticagrelor, another antiplatelet agent, as compared with clopidogrel in patients with coronary disease and concomitant PAD. However, most recently, the Examining Use of Ticagrelor in Peripheral Artery Disease (EUCLID) trial has shown no additional benefit of ticagrelor over clopidogrel. In this trial, a minority of patients had concomitant coronary artery disease, making it unique to previous studies. The EUCLID trial's evidence of neutrality between clopidogrel and ticagrelor sheds light into the complexity of studying the PAD population and the continued need to meticulously design trials to investigate the optimal therapies. The topics that will be discussed in this review include the role of antiplatelet therapy in the management of patients with PAD, a review of the EUCLID trial results and the important factors to be considered in interpreting the surprising results, and promising recent ongoing clinical trials assessing therapies in the treatment of patients with PAD. © 2018 Wiley Periodicals, Inc.

Group treatment for depression in mothers of young children compared to standard individual therapy.

PubMed

Frisch, Ulrike; Hofecker-Fallahpour, Maria; Stieglitz, Rolf-Dieter; Riecher-Rössler, Anita

2013-01-01

Studies on specific psychotherapy for depressed mothers of small children are rare. The aim of the present study was to investigate the effectiveness of a newly developed cognitive-behavioral group intervention for depressed mothers compared to standard individual therapy. In a naturalistic design, 31 mothers suffering from depressive disorders with children aged ≤4 years who had consecutively been admitted to our specialized clinic for mentally ill mothers were assigned to the group treatment, and the following 21 were admitted to the control group receiving standard individual therapy. The group treatment consisted of 12 group sessions and 1 couple session and was administered to five consecutive groups. Participants completed interviews and questionnaires - the Beck Depression Inventory and the Symptom Checklist- 90-R - before and 3 months after therapy. The treatment group and the control group showed a significant improvement in their depression, with no significant differences between the two treatment strategies. The women in group therapy, however, required fewer antidepressants, and group treatment was observed to be more effective in reducing anger and hostility. This form of group treatment for depressed women in early motherhood may have some important advantages over individual therapy; effects were small, however, and should be replicated in a further study. Copyright © 2012 S. Karger AG, Basel.

Music therapy in pediatric palliative care: family-centered care to enhance quality of life.

PubMed

Lindenfelser, Kathryn J; Hense, Cherry; McFerran, Katrina

2012-05-01

Research into the value of music therapy in pediatric palliative care (PPC) has identified quality of life as one area of improvement for families caring for a child in the terminal stages of a life-threatening illness. This small-scale investigation collected data in a multisite, international study including Minnesota, USA, and Melbourne, Australia. An exploratory mixed method design used the qualitative data collected through interviews with parents to interpret results from the PedsQL Family Impact Module of overall parental quality of life. Parents described music therapy as resulting in physical improvements of their child by providing comfort and stimulation. They also valued the positive experiences shared by the family in music therapy sessions that were strength oriented and family centered. This highlighted the physical and communication scales within the PedsQL Family Impact Module, where minimal improvements were achieved in contrast to some strong results suggesting diminished quality of life in cognitive and daily activity domains. Despite the significant challenges faced by parents during this difficult time, parents described many positive experiences in music therapy, and the overall score for half of the parents in the study did not diminish. The value of music therapy as a service that addresses the family-centered agenda of PPC is endorsed by this study.

Open ear hearing aids in tinnitus therapy: An efficacy comparison with sound generators.

PubMed

Parazzini, Marta; Del Bo, Luca; Jastreboff, Margaret; Tognola, Gabriella; Ravazzani, Paolo

2011-08-01

This study aimed to compare the effectiveness of tinnitus retraining therapy (TRT) with sound generators or with open ear hearing aids in the rehabilitation of tinnitus for a group of subjects who, according to Jastreboff categories, can be treated with both approaches to sound therapy (borderline of Category 1 and 2). This study was a prospective data collection with a parallel-group design which entailed that each subject was randomly assigned to one of the two treatments group: half of the subjects were fitted binaurally with sound generators, and the other half with open ear hearing aids. Both groups received the same educational counselling sessions. Ninety-one subjects passed the screening criteria and were enrolled into the study. Structured interviews, with a variety of measures evaluated through the use of visual-analog scales and the tinnitus handicap inventory self-administered questionnaire, were performed before the therapy and at 3, 6, and 12 months during the therapy. Data showed a highly significant improvement in both tinnitus treatments starting from the first three months and up to one year of therapy, with a progressive and statistically significant decrease in the disability every three months. TRT was equally effective with sound generator or open ear hearing aids: they gave basically identical, statistically indistinguishable results.

Stem cells in animal asthma models: a systematic review.

PubMed

Srour, Nadim; Thébaud, Bernard

2014-12-01

Asthma control frequently falls short of the goals set in international guidelines. Treatment options for patients with poorly controlled asthma despite inhaled corticosteroids and long-acting β-agonists are limited, and new therapeutic options are needed. Stem cell therapy is promising for a variety of disorders but there has been no human clinical trial of stem cell therapy for asthma. We aimed to systematically review the literature regarding the potential benefits of stem cell therapy in animal models of asthma to determine whether a human trial is warranted. The MEDLINE and Embase databases were searched for original studies of stem cell therapy in animal asthma models. Nineteen studies were selected. They were found to be heterogeneous in their design. Mesenchymal stromal cells were used before sensitization with an allergen, before challenge with the allergen and after challenge, most frequently with ovalbumin, and mainly in BALB/c mice. Stem cell therapy resulted in a reduction of bronchoalveolar lavage fluid inflammation and eosinophilia as well as Th2 cytokines such as interleukin-4 and interleukin-5. Improvement in histopathology such as peribronchial and perivascular inflammation, epithelial thickness, goblet cell hyperplasia and smooth muscle layer thickening was universal. Several studies showed a reduction in airway hyper-responsiveness. Stem cell therapy decreases eosinophilic and Th2 inflammation and is effective in several phases of the allergic response in animal asthma models. Further study is warranted, up to human clinical trials. Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Tissue-mimicking gel phantoms for thermal therapy studies.

PubMed

Dabbagh, Ali; Abdullah, Basri Johan Jeet; Ramasindarum, Chanthiriga; Abu Kasim, Noor Hayaty

2014-10-01

Tissue-mimicking phantoms that are currently available for routine biomedical applications may not be suitable for high-temperature experiments or calibration of thermal modalities. Therefore, design and fabrication of customized thermal phantoms with tailored properties are necessary for thermal therapy studies. A multitude of thermal phantoms have been developed in liquid, solid, and gel forms to simulate biological tissues in thermal therapy experiments. This article is an attempt to outline the various materials and techniques used to prepare thermal phantoms in the gel state. The relevant thermal, electrical, acoustic, and optical properties of these phantoms are presented in detail and the benefits and shortcomings of each type are discussed. This review could assist the researchers in the selection of appropriate phantom recipes for their in vitro study of thermal modalities and highlight the limitations of current phantom recipes that remain to be addressed in further studies. © The Author(s) 2014.

An individually tailored behavioral medicine treatment in physical therapy for tension-type headache - two experimental case studies.

PubMed

Söderlund, Anne; Lagerlöf, Helena

2016-01-01

The aim of this study was to describe and evaluate the effect of an individually tailored behavioral medicine treatment in physical therapy, based on a functional behavioral analysis (FBA), for tension-type headache (TTH). Two case studies with A1-A2-B-A3 design of two patients with TTH was conducted. Outcome variables were headache frequency, headache index (mean intensity), consumption of analgesics, self-efficacy in headache management (Headache Management Self-efficacy Scale [HMSE]), disability, and perceived loss of happiness for activities with family and friends. The results showed that headache frequency and headache index decreased for one of the patients. Self-efficacy in headache management increased markedly for both patients. A behavioral medicine treatment in physical therapy based on an FBA can be a way for physical therapists to handle patients with TTH. Future investigations should focus on large group studies with longer observation periods.

Tutorial for writing systematic reviews for the Brazilian Journal of Physical Therapy (BJPT)

PubMed Central

Mancini, Marisa C.; Cardoso, Jefferson R.; Sampaio, Rosana F.; Costa, Lucíola C. M.; Cabral, Cristina M. N.; Costa, Leonardo O. P.

2014-01-01

Systematic reviews aim to summarize all evidence using very rigorous methods in order to address a specific research question with less bias as possible. Systematic reviews are widely used in the field of physical therapy, however not all reviews have good quality. This tutorial aims to guide authors of the Brazilian Journal of Physical Therapy on how systematic reviews should be conducted and reported in order to be accepted for publication. It is expected that this tutorial will help authors of systematic reviews as well as journal editors and reviewers on how to conduct, report, critically appraise and interpret this type of study design. PMID:25590440

Tutorial for writing systematic reviews for the Brazilian Journal of Physical Therapy (BJPT).

PubMed

Mancini, Marisa C; Cardoso, Jefferson R; Sampaio, Rosana F; Costa, Lucíola C M; Cabral, Cristina M N; Costa, Leonardo O P

2014-01-01

Systematic reviews aim to summarize all evidence using very rigorous methods in order to address a specific research question with less bias as possible. Systematic reviews are widely used in the field of physical therapy, however not all reviews have good quality. This tutorial aims to guide authors of the Brazilian Journal of Physical Therapy on how systematic reviews should be conducted and reported in order to be accepted for publication. It is expected that this tutorial will help authors of systematic reviews as well as journal editors and reviewers on how to conduct, report, critically appraise and interpret this type of study design.

Accurate Monte Carlo simulations for nozzle design, commissioning and quality assurance for a proton radiation therapy facility.

PubMed

Paganetti, H; Jiang, H; Lee, S Y; Kooy, H M

2004-07-01

Monte Carlo dosimetry calculations are essential methods in radiation therapy. To take full advantage of this tool, the beam delivery system has to be simulated in detail and the initial beam parameters have to be known accurately. The modeling of the beam delivery system itself opens various areas where Monte Carlo calculations prove extremely helpful, such as for design and commissioning of a therapy facility as well as for quality assurance verification. The gantry treatment nozzles at the Northeast Proton Therapy Center (NPTC) at Massachusetts General Hospital (MGH) were modeled in detail using the GEANT4.5.2 Monte Carlo code. For this purpose, various novel solutions for simulating irregular shaped objects in the beam path, like contoured scatterers, patient apertures or patient compensators, were found. The four-dimensional, in time and space, simulation of moving parts, such as the modulator wheel, was implemented. Further, the appropriate physics models and cross sections for proton therapy applications were defined. We present comparisons between measured data and simulations. These show that by modeling the treatment nozzle with millimeter accuracy, it is possible to reproduce measured dose distributions with an accuracy in range and modulation width, in the case of a spread-out Bragg peak (SOBP), of better than 1 mm. The excellent agreement demonstrates that the simulations can even be used to generate beam data for commissioning treatment planning systems. The Monte Carlo nozzle model was used to study mechanical optimization in terms of scattered radiation and secondary radiation in the design of the nozzles. We present simulations on the neutron background. Further, the Monte Carlo calculations supported commissioning efforts in understanding the sensitivity of beam characteristics and how these influence the dose delivered. We present the sensitivity of dose distributions in water with respect to various beam parameters and geometrical misalignments. This allows the definition of tolerances for quality assurance and the design of quality assurance procedures.

Pilot study: whole body manual subcutaneous adipose tissue (SAT) therapy improved pain and SAT structure in women with lipedema.

PubMed

Herbst, Karen L; Ussery, Christopher; Eekema, Alyna

2017-09-20

Background Lipedema is a common painful subcutaneous adipose tissue (SAT) disorder in women affecting the limbs. SAT therapy is a manual therapy to improve soft tissue quality. Objective Determine if SAT therapy improves pain and structure of lipedema SAT. Design Single arm prospective pilot study. Setting Academic medical center. Patients Seven women, 46 ± 5 years, weight 90 ± 19 kg, with lipedema. Intervention Twelve 90-min SAT therapy sessions over 4 weeks. Outcomes Dual X-ray absorptiometry (DXA) scans, SAT ultrasound (Vevo 2100), leg volumetrics, skin caliper assessment, tissue exam, weight, resting metabolic rate, pain assessment, lower extremity functional scale (LEFS) and body shape questionnaire (BSQ) at baseline and end of study. Results Weight, resting metabolic rate and BSQ did not change significantly. Limb fat over total body fat mass (p = 0.08) and trunk fat over total body mass trended down from baseline (p = 0.08) by DXA. Leg volume and caliper assessments in eight of nine areas (p < 0.007), LEFS (p = 0.002) and average pain (p = 0.007) significantly decreased from baseline. Fibrosis significantly decreased in the nodules, hips and groin. Ultrasound showed improved SAT structure in some subjects. Side effects included pain, bruising, itching, swelling and gastroesophageal reflux disease. All women said they would recommend SAT therapy to other women with lipedema. Limitations Small number of subjects. Conclusion SAT therapy in 4 weeks improved tissue structure, perceived leg function, and volume although shape was not affected. While side effects of SAT therapy were common, all women felt the therapy was beneficial.

Hepatic Enzyme Alterations in HIV Patients on Antiretroviral Therapy: A Case-Control Study in a Hospital Setting in Ghana.

PubMed

Osakunor, Derick Nii Mensah; Obirikorang, Christian; Fianu, Vincent; Asare, Isaac; Dakorah, Mavis

2015-01-01

Diagnosing hepatic injury in HIV infection can be a herculean task for clinicians as several factors may be involved. In this study, we sought to determine the effects of antiretroviral therapy (ART) and disease progression on hepatic enzymes in HIV patients. A case-control study conducted from January to May 2014 at the Akwatia Government Hospital, Eastern region, Ghana, The study included 209 HIV patients on ART (designated HIV-ART) and 132 ART-naive HIV patients (designated HIV-Controls). Data gathered included demography, clinical history and results of blood tests for hepatic enzymes. We employed the Fisher's, Chi-square, unpaired t-test and Pearson's correlation in analysis, using GraphPad Prism and SPSS. A P value < 0.05 was considered significant. Median CD4 lymphocyte count of HIV-ART participants (604.00 cells/mm3) was higher than that of HIV-Controls (491.50 cells/mm3; P = 0.0005). Mean values of ALP, ALT, AST and GGT did not differ between the two groups compared (P > 0.05). There was a significant positive correlation between hepatic enzymes (ALP, ALT, AST and GGT) for both groups (p < 0.01 each). Duration of ART correlated positively with ALT (p < 0.05). The effect size of disease progression on hepatic enzymes for both groups was small. Antiretroviral therapy amongst this population has minimal effects on hepatic enzymes and does not suggest modifications in therapy. Hepatic injury may occur in HIV, even in the absence of ART and other traditional factors. Monitoring of hepatic enzymes is still important in HIV patients.

Effects of Bobath-based therapy on depression, shoulder pain and health-related quality of life in patients after stroke.

PubMed

Hafsteinsdóttir, Thóra B; Kappelle, Jaap; Grypdonck, Maria H F; Algra, Ale

2007-10-01

To measure the effects of Bobath-based (BB) therapy on depression, shoulder pain and health-related quality of life (HRQoL) of patients during one year after stroke. In a prospective, non-randomized design, the use of BB therapy was compared with a more task-oriented therapy and no BB therapy. A total of 324 patients in 12 hospitals. Patients in the intervention group received BB therapy, whereas patients in the control group received no BB therapy and a more task-oriented therapy. HRQoL was measured using the SF-36; depression was measured with the Center of Epidemiological Studies Depression Scale and shoulder pain was measured with the Visual Analogue Scale at discharge, 6 and 12 months. Linear and logistic regression analyses were performed. No effects of BB therapy on HRQoL or shoulder pain were found. After one year fewer patients were depressed in the BB group (30%) than in the non-BB group (43%); the adjusted odds ratio was 0.6 (95% confidence interval 0.3-1.0). BB therapy did not have any effect on HRQoL or shoulder pain in stroke patients. Healthcare professionals should reconsider the use of BB therapy in the care of stroke patients.

Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial.

PubMed

Lazarov, Amit; Pine, Daniel S; Bar-Haim, Yair

2017-07-01

Patients with social anxiety disorder exhibit increased attentional dwelling on social threats, providing a viable target for therapeutics. This randomized controlled trial examined the efficacy of a novel gaze-contingent music reward therapy for social anxiety disorder designed to reduce attention dwelling on threats. Forty patients with social anxiety disorder were randomly assigned to eight sessions of either gaze-contingent music reward therapy, designed to divert patients' gaze toward neutral stimuli rather than threat stimuli, or to a control condition. Clinician and self-report measures of social anxiety were acquired pretreatment, posttreatment, and at 3-month follow-up. Dwell time on socially threatening faces was assessed during the training sessions and at pre- and posttreatment. Gaze-contingent music reward therapy yielded greater reductions of symptoms of social anxiety disorder than the control condition on both clinician-rated and self-reported measures. Therapeutic effects were maintained at follow-up. Gaze-contingent music reward therapy, but not the control condition, also reduced dwell time on threat, which partially mediated clinical effects. Finally, gaze-contingent music reward therapy, but not the control condition, also altered dwell time on socially threatening faces not used in training, reflecting near-transfer training generalization. This is the first randomized controlled trial to examine a gaze-contingent intervention in social anxiety disorder. The results demonstrate target engagement and clinical effects. This study sets the stage for larger randomized controlled trials and testing in other emotional disorders.

Manualized therapy for PTSD: flexing the structure of cognitive processing therapy.

PubMed

Galovski, Tara E; Blain, Leah M; Mott, Juliette M; Elwood, Lisa; Houle, Timothy

2012-12-01

This study tested a modified cognitive processing therapy (MCPT) intervention designed as a more flexible administration of the protocol. Number of sessions was determined by client progress toward a priori defined end-state criteria, "stressor sessions" were inserted when necessary, and therapy was conducted by novice CPT clinicians. A randomized, controlled, repeated measures, semicrossover design was utilized (a) to test the relative efficacy of the MCPT intervention compared with a symptom-monitoring delayed treatment (SMDT) condition and (b) to assess within-group variation in change with a sample of 100 male and female interpersonal trauma survivors with posttraumatic stress disorder (PTSD). Hierarchical linear modeling analyses revealed that MCPT evidenced greater improvement on all primary (PTSD and depression) and secondary (guilt, quality of life, general mental health, social functioning, and health perceptions) outcomes compared with SMDT. After the conclusion of SMDT, participants crossed over to MCPT, resulting in a combined MCPT sample (n = 69). Of the 50 participants who completed MCPT, 58% reached end-state criteria prior to the 12th session, 8% at Session 12, and 34% between Sessions 12 and 18. Maintenance of treatment gains was found at the 3-month follow-up, with only 2 of the treated sample meeting criteria for PTSD. Use of stressor sessions did not result in poorer treatment outcomes. Findings suggest that individuals respond at a variable rate to CPT, with significant benefit from additional therapy when indicated and excellent maintenance of gains. Insertion of stressor sessions did not alter the efficacy of the therapy.

The Technologist Function in Fields Related to Radiology: Tasks in Radiation Therapy and Diagnostic Ultrasound. Research Report No. 9; Relating Technologist Tasks in Diagnostic Radiology, Ultrasound and Radiation Therapy. Research Report No. 10.

ERIC Educational Resources Information Center

Gilpatrick, Eleanor

The two research reports included in this document describe the application of the Health Services Mobility Study (HSMS) task analysis method to two technologist functions and examine the interrelationships of these tasks with those in diagnostic radiology. (The HSMS method includes processes for using the data for designing job ladders, for…

[Cost-effectiveness analysis of renal replacement therapies: how should we design research on these interventions in Brazil?].

PubMed

Sancho, Leyla Gomes; Dain, Sulamis

2008-06-01

This study aims to contribute to the discussion on the possibility of applying health economics assessment, specifically the cost-effectiveness technique, to renal replacement therapies for end-stage renal failure. A review was conducted on the interventions and their alternative courses from the perspective of the various methodological proposals in the literature, considering the availability of data and information in Brazil to back this type of research.

CD28z CARs and Armored CARs

PubMed Central

Pegram, Hollie J.; Park, Jae H.; Brentjens, Renier J.

2015-01-01

CD19-targeted chimeric antigen receptor (CAR) T cells are currently being tested in the clinic with very promising outcomes. However, limitations to CAR T cell therapy exist. These include lack of efficacy against some tumors, specific targeting of tumor cells without affecting normal tissue and retaining activity within the suppressive tumor microenvironment. Whilst promising clinical trials are in progress, preclinical development is focused on optimizing CAR design, to generate “armored CAR T cells” which are protected from the inhibitory tumor microenvironment. Studies investigating the expression of cytokine transgenes, combination therapy with small molecule inhibitors or monoclonal antibodies are aimed at improving the anti-tumor efficacy of CAR T cell therapy. Other strategies aimed at improving CAR T cell therapy include utilizing dual CARs and chemokine receptors to more specifically target tumor cells. This review will describe the current clinical data and some novel “armored CAR T cell” approaches for improving anti-tumor efficacy therapy. PMID:24667958

CD28z CARs and armored CARs.

PubMed

Pegram, Hollie J; Park, Jae H; Brentjens, Renier J

2014-01-01

CD19-targeted chimeric antigen receptor (CAR) T cells are currently being tested in the clinic with very promising outcomes. However, limitations to CAR T cell therapy exist. These include lack of efficacy against some tumors, specific targeting of tumor cells without affecting normal tissue and retaining activity within the suppressive tumor microenvironment. Whereas promising clinical trials are in progress, preclinical development is focused on optimizing CAR design, to generate "armored CAR T cells," which are protected from the inhibitory tumor microenvironment. Studies investigating the expression of cytokine transgenes, combination therapy with small molecule inhibitors, or monoclonal antibodies, are aimed at improving the antitumor efficacy of CAR T cell therapy. Other strategies aimed at improving CAR T cell therapy include using dual CARs and chemokine receptors to more specifically target tumor cells. This review will describe the current clinical data and some novel armored CAR T cell approaches for improving antitumor efficacy therapy.

Stimuli-Responsive NO Release for On-Demand Gas-Sensitized Synergistic Cancer Therapy.

PubMed

Fan, Wenpei; Yung, Bryant C; Chen, Xiaoyuan

2018-03-08

Featuring high biocompatibility, the emerging field of gas therapy has attracted extensive attention in the medical and scientific communities. Currently, considerable research has focused on the gasotransmitter nitric oxide (NO) owing to its unparalleled dual roles in directly killing cancer cells at high concentrations and cooperatively sensitizing cancer cells to other treatments for synergistic therapy. Of particular note, recent state-of-the-art studies have turned our attention to the chemical design of various endogenous/exogenous stimuli-responsive NO-releasing nanomedicines and their biomedical applications for on-demand NO-sensitized synergistic cancer therapy, which are discussed in this Minireview. Moreover, the potential challenges regarding NO gas therapy are also described, aiming to advance the development of NO nanomedicines as well as usher in new frontiers in this fertile research area. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

A systematic review of the evidence regarding cognitive therapy skills that assist cognitive behavioural therapy in adults who have an intellectual disability.

PubMed

Cooney, Patricia; Tunney, Conall; O'Reilly, Gary

2018-01-01

Cognitive behavioural therapy (CBT) is being increasingly adapted for use with people who have an intellectual disability. However, it remains unclear whether inherent cognitive deficits that are present in adults who have an intellectual disability preclude the use of cognitive-based therapies. This review aims to systematically examine "cognitive therapy skills" in adults who have an intellectual disability that assist engagement in CBT. Two authors independently reviewed titles and abstracts of articles located through electronic database searching. Outcomes of the 18 studies selected for full-text review are mixed and limited by a moderately high risk of bias. The authors suggest eleven findings from research areas of emotion recognition, cognitive mediation, discriminating between thoughts, feelings and behaviours, linking events and emotions that have implications for the design of CBT programmes and future research for this population. © 2017 John Wiley & Sons Ltd.

[Physiotherapy for juvenile idiopathic arthritis].

PubMed

Spamer, M; Georgi, M; Häfner, R; Händel, H; König, M; Haas, J-P

2012-07-01

Control of disease activity and recovery of function are major issues in the treatment of children and adolescents suffering from juvenile idiopathic arthritis (JIA). Functional therapies including physiotherapy are important components in the multidisciplinary teamwork and each phase of the disease requires different strategies. While in the active phase of the disease pain alleviation is the main focus, the inactive phase requires strategies for improving motility and function. During remission the aim is to regain general fitness by sports activities. These phase adapted strategies must be individually designed and usually require a combination of different measures including physiotherapy, occupational therapy, massage as well as other physical procedures and sport therapy. There are only few controlled studies investigating the effectiveness of physical therapies in JIA and many strategies are derived from long-standing experience. New results from physiology and sport sciences have contributed to the development in recent years. This report summarizes the basics and main strategies of physical therapy in JIA.

Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial.

PubMed

Wang, Chenchen; Iversen, Maura D; McAlindon, Timothy; Harvey, William F; Wong, John B; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Rones, Ramel; Gamache, Tressa; Schmid, Christopher H

2014-09-08

Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs. Results of this study are expected to have important public health implications for the large and growing population with knee OA. ClinicalTrials.gov identifier: NCT01258985.

Physiological and neurophysiological determinants of postcancer fatigue: design of a randomized controlled trial

PubMed Central

2012-01-01

Background Postcancer fatigue is a frequently occurring, severe, and invalidating problem, impairing quality of life. Although it is possible to effectively treat postcancer fatigue with cognitive behaviour therapy, the nature of the underlying (neuro)physiology of postcancer fatigue remains unclear. Physiological aspects of fatigue include peripheral fatigue, originating in muscle or the neuromuscular junction; central fatigue, originating in nerves, spinal cord, and brain; and physical deconditioning, resulting from a decreased cardiopulmonary function. Studies on physiological aspects of postcancer fatigue mainly concentrate on deconditioning. Peripheral and central fatigue and brain morphology and function have been studied for patients with fatigue in the context of chronic fatigue syndrome and neuromuscular diseases and show several characteristic differences with healthy controls. Methods/design Fifty seven severely fatigued and 21 non-fatigued cancer survivors will be recruited from the Radboud University Nijmegen Medical Centre. Participants should have completed treatment of a malignant, solid tumour minimal one year earlier and should have no evidence of disease recurrence. Severely fatigued patients are randomly assigned to either the intervention condition (cognitive behaviour therapy) or the waiting list condition (start cognitive behaviour therapy after 6 months). All participants are assessed at baseline and the severely fatigued patients also after 6 months follow-up (at the end of cognitive behaviour therapy or waiting list). Primary outcome measures are fatigue severity, central and peripheral fatigue, brain morphology and function, and physical condition and activity. Discussion This study will be the first randomized controlled trial that characterizes (neuro)physiological factors of fatigue in disease-free cancer survivors and evaluates to which extent these factors can be influenced by cognitive behaviour therapy. The results of this study are not only essential for a theoretical understanding of this invalidating condition, but also for providing an objective biological marker for fatigue that could support the diagnosis and follow-up of treatment. Trial registration The study is registered at http://ClinicalTrials.gov (NCT01096641). PMID:22708881

Tolvaptan in Patients Hospitalized With Acute Heart Failure: Rationale and Design of the TACTICS and the SECRET of CHF Trials.

PubMed

Felker, G Michael; Mentz, Robert J; Adams, Kirkwood F; Cole, Robert T; Egnaczyk, Gregory F; Patel, Chetan B; Fiuzat, Mona; Gregory, Douglas; Wedge, Patricia; O'Connor, Christopher M; Udelson, James E; Konstam, Marvin A

2015-09-01

Congestion is a primary reason for hospitalization in patients with acute heart failure (AHF). Despite inpatient diuretics and vasodilators targeting decongestion, persistent congestion is present in many AHF patients at discharge and more severe congestion is associated with increased morbidity and mortality. Moreover, hospitalized AHF patients may have renal insufficiency, hyponatremia, or an inadequate response to traditional diuretic therapy despite dose escalation. Current alternative treatment strategies to relieve congestion, such as ultrafiltration, may also result in renal dysfunction to a greater extent than medical therapy in certain AHF populations. Truly novel approaches to volume management would be advantageous to improve dyspnea and clinical outcomes while minimizing the risks of worsening renal function and electrolyte abnormalities. One effective new strategy may be utilization of aquaretic vasopressin antagonists. A member of this class, the oral vasopressin-2 receptor antagonist tolvaptan, provides benefits related to decongestion and symptom relief in AHF patients. Tolvaptan may allow for less intensification of loop diuretic therapy and a lower incidence of worsening renal function during decongestion. In this article, we summarize evidence for decongestion benefits with tolvaptan in AHF and describe the design of the Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure Study (TACTICS) and Study to Evaluate Challenging Responses to Therapy in Congestive Heart Failure (SECRET of CHF) trials. © 2015 American Heart Association, Inc.

New single-layer compression bandage system for chronic venous leg ulcers.

PubMed

Lee, Gillian; Rajendran, Subbiyan; Anand, Subhash

A new single-layer bandage system for the treatment of venous leg ulcers has been designed and developed at the University of Bolton. This three-dimensional (3D) knitted spacer fabric structure has been designed by making use of mathematical modelling and Laplace's law. The sustained graduated compression of the developed 3D knitted spacer bandages were tested and characterized, and compared with that of commercially available compression bandages. It was observed that the developed 3D single-layer bandage meets the ideal criteria stipulated for compression therapy. The laboratory results were verified by carrying out a pilot user study incorporating volunteers from different age groups. This article examines the insight into the design and development of the new 3D knitted spacer bandage, along with briefly discussing the issues of compression therapy systems intended for the treatment of venous leg ulcers.

Sex differences in stroke therapies.

PubMed

Sohrabji, Farida; Park, Min Jung; Mahnke, Amanda H

2017-01-02

Stroke is the fifth leading cause of death and acquired disability in aged populations. Women are disproportionally affected by stroke, having a higher incidence and worse outcomes than men. Numerous preclinical studies have discovered novel therapies for the treatment of stroke, but almost all of these have been shown to be unsuccessful in clinical trials. Despite known sex differences in occurrence and severity of stroke, few preclinical or clinical therapeutics take into account possible sex differences in treatment. Reanalysis of data from studies of tissue plasminogen activator (tPA), the only currently FDA-approved stroke therapy, has shown that tPA improves stroke outcomes for both sexes and also shows sexual dimorphism by more robust improvement in stroke outcome in females. Experimental evidence supports the inclusion of sex as a variable in the study of a number of novel stroke drugs and therapies, including preclinical studies of anti-inflammatory drugs (minocycline), stimulators of cell survival (insulin-like growth factor-1), and inhibitors of cell death pathways (pharmacological inhibition of poly[ADP-ribose] polymerase-1, nitric oxide production, and caspase activation) as well as in current clinical trials of stem cell therapy and cortical stimulation. Overall, study design and analysis in clinical trials as well as in preclinical studies must include both sexes equally, consider possible sex differences in the analyses, and report the differences/similarities in more systematic/structured ways to allow promising therapies for both sexes and increase stroke recovery. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Effect of Group Sandtray Therapy with Preadolescents

ERIC Educational Resources Information Center

Flahive, Mon-hsin Wang; Ray, Dee

2007-01-01

The effectiveness of group sandtray therapy, a model of play therapy, was evaluated using a pretest-posttest control group design with 56 preadolescents exhibiting behavioral difficulties. The experimental group (n = 28) received sandtray therapy in small groups for 10 weeks while the wait-list control group (n = 28) received no treatment. Results…

Identification of potential neuromotor mechanisms of manual therapy in patients with musculoskeletal disablement: rationale and description of a clinical trial.

PubMed

Fisher, Beth E; Davenport, Todd E; Kulig, Kornelia; Wu, Allan D

2009-05-21

Many health care practitioners use a variety of hands-on treatments to improve symptoms and disablement in patients with musculoskeletal pathology.Research to date indirectly suggests a potentially broad effect of manual therapy on the neuromotor processing of functional behavior within the supraspinal central nervous system (CNS) in a manner that may be independent of modification at the level of local spinal circuits. However, the effect of treatment speed, as well as the specific mechanism and locus of CNS changes, remain unclear. We developed a placebo-controlled, randomized study to test the hypothesis that manual therapy procedures directed to the talocrural joint in individuals with post-acute ankle sprain induce a change in corticospinal excitability that is relevant to improve the performance of lower extremity functional behavior. This study is designed to identify potential neuromotor changes associated with manual therapy procedures directed to the appendicular skeleton, compare the relative effect of treatment speed on potential neuromotor effects of manual therapy procedures, and determine the behavioral relevance of potential neuromotor effects of manual therapy procedures. http://www.clinicaltrials.gov identifier NCT00847769.

Optimal medical treatment versus carotid endarterectomy: the rationale and design of the Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC) study.

PubMed

Kolos, Igor; Loukianov, Mikhail; Dupik, Nikolay; Boytsov, Sergey; Deev, Alexandr

2015-02-01

Carotid endarterectomy and medical therapy (aspirin) were shown superior to medical therapy alone for asymptomatic (≥ 60%) carotid stenosis. The role of modern medical therapy (statins, antihypertensive treatment, and aspirin) in the treatment of such patients is undefined. Establishing the safety, efficacy, and durability of optimal medical therapy and lifestyle modification requires rigorous comparison with carotid endarterectomy in asymptomatic patients. The objective is to compare the efficacy of carotid endarterectomy + optimal medical therapy versus optimal medical therapy alone in patients with asymptomatic (70-79%) extracranial carotid stenosis. The Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis study is a prospective, randomized, parallel, two-arm, multicenter trial. Primary end-points will be analyzed using standard time-to-event statistical modeling with adjustment for major baseline covariates. The primary analysis is on an intent-to-treat basis. The primary outcome is nonfatal stroke, nonfatal myocardial infarction, and death during follow-up of up to five-years, and the secondary outcome includes death from any cause and stroke. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

Case Series of an Intraoral Balancing Appliance Therapy on Subjective Symptom Severity and Cervical Spine Alignment

PubMed Central

Lee, Young Jun; Lee, Joo Kang; Jung, Soo Chang; Lee, Hwang-woo; Yin, Chang Shik; Lee, Young Jin

2013-01-01

Objective. The objective of this study was to investigate the effect of a holistic intraoral appliance (OA) on cervical spine alignment and subjective symptom severity. Design. An observational study on case series with holistic OA therapy. Setting. An outpatient clinic for holistic temporomandibular joint (TMJ) therapy under the supervision of the Pain Center, CHA Biomedical center, CHA University. Subjects. Ambulatory patients presenting with diverse chief complaints in the holistic TMJ clinic. Main Measures. Any immediate change in the curvature of cervical spine and the degree of atlantoaxial rotation was investigated in the images of simple X-ray and computed tomography of cervical spine with or without OA. Changes of subjective symptom severity were also analyzed for the holistic OA therapy cases. Results. A total of 59 cases were reviewed. Alignment of upper cervical spine rotation showed an immediate improvement (P < 0.001). Changes of subjective symptom severity also showed significant improvement (P < 0.05). Conclusion. These cases revealed rudimentary clinical evidence that holistic OA therapy may be related to an alleviated symptom severity and an improved cervical spinal alignment. These results show that further researches may warrant for the holistic TMJ therapy. PMID:23935655

A scoping review of the role of LEGO® therapy for improving inclusion and social skills among children and youth with autism.

PubMed

Lindsay, Sally; Hounsell, Kara Grace; Cassiani, Celia

2017-04-01

LEGO ® therapy uses children's natural interest in play to help motivate behavioural change and may be an effective teaching tool to increase social competency and communication skills. Although the literature is growing it has not been synthesized. To review the literature on the role of LEGO ® therapy on social skills and inclusion among children and youth with Autism Spectrum Disorder (ASD). A scoping review was conducted, involving comprehensive searches of international databases. Eligible articles included: (a) youth aged 19 or younger, with ASD; (b) empirical research on LEGO ® therapy interventions; (c) published from 1996 to 2016 in a peer-reviewed journal, conference proceedings, or dissertation. Of the 6964 studies identified, 15 articles-involving 293 participants, aged 5-16 (mean age 8.7 years), across five countries-met the inclusion criteria. Although the outcomes of the LEGO ® therapy varied across the studies, 14 studies reported at least one improvement in social and communication skills (e.g., building friendships, improved social interactions and social competence), ASD-specific behaviors, belonging, family relationships, coping, and reductions in playing alone. Although LEGO ® therapy shows promise as an intervention for children and youth with ASD, more rigorously designed studies are needed to fully understand its impact. Copyright © 2016 Elsevier Inc. All rights reserved.

Review of the novelties presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) (III).

PubMed

Fernández, Óscar; Arnal-García, Carmen; Arroyo-González, Rafael; Brieva, Lluís; Calles-Hernández, M Carmen; Casanova-Estruch, Bonaventura; Comabella, Manuel; de las Heras, Virginia; García-Merino, Juan A; Hernández-Pérez, Miguel A; Izquierdo, Guillermo; Matas, Elisabet; Meca-Lallana, José E; Mendibe-Bilbao, María del Mar; Muñoz-García, Delicias; Olascoaga, Javier; Oreja-Guevara, Celia; Prieto, José M; Ramió-Torrentà, Lluís; Rodríguez-Antigüedad, Alfredo; Saiz, Albert; Téllez, Nieves; Villar, Luisa M; Tintoré, Mar

2013-10-01

The most significant data presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held in France in October 2012, have been summarised in the fifth edition of the Post-ECTRIMS Experts Meeting, held in Madrid in October 2012. This led to the drafting of this review, which has been published in three parts. This third part of the Post-ECTRIMS review presents the findings from the latest studies conducted with disease-modifying treatments, more specifically with glatiramer acetate, laquinimod, ponesimod, BG-12, teriflunomide, daclizumab, natalizumab and secukinumab (AIN457). Likewise, we also address the reasons that justify the search for innovative treatments for multiple sclerosis, with antigen-specific therapy, cell therapy and therapy aimed at promoting remyelination being highlighted among other future therapeutic strategies. Access to new pharmacological agents and the complexity of the therapy of multiple sclerosis in the future will require new design strategies and directions in clinical trials, including the use of surrogate markers, new statistical applications, superiority, inferiority or equivalence clinical trials and adaptable designs.

"I look at my own forest and fields in a different way": the lived experience of nature-based therapy in a therapy garden when suffering from stress-related illness.

PubMed

Sidenius, Ulrik; Stigsdotter, Ulrika K; Varning Poulsen, Dorthe; Bondas, Terese

2017-12-01

Evidence confirms that nature-based therapy (NBT) has a positive effect on people with mental illnesses. However, there is a lack of evidence on the meaning of NBT for specific patient groups. The Nacadia® Therapy Garden was designed according to an evidence-based design process, and an NBT programme was developed. The aim of the study was to illuminate the phenomenon of participants' lived experience of the NBT in Nacadia. Fourteen participants took part in semi-structured interviews (SSIs), and by way of reflective lifeworld research, the SSIs were analysed to identify and describe the meanings of the phenomenon. The essence of the phenomenon was found to be a process of adopting a searching approach to NBT and Nacadia to become familiar with the conditions. This familiarity stimulated the development of confidentiality and attachment to Nacadia. Feeling protected, safe, cared for, and not exposed was important, and motivated feelings of freedom, reduced demands, and increased the ability to access and try a spectrum of NBT activities. It encouraged participants to develop personal approaches and coping strategies to implement in their everyday lives for moving on.

Smart Radiation Therapy Biomaterials.

PubMed

Ngwa, Wilfred; Boateng, Francis; Kumar, Rajiv; Irvine, Darrell J; Formenti, Silvia; Ngoma, Twalib; Herskind, Carsten; Veldwijk, Marlon R; Hildenbrand, Georg Lars; Hausmann, Michael; Wenz, Frederik; Hesser, Juergen

2017-03-01

Radiation therapy (RT) is a crucial component of cancer care, used in the treatment of over 50% of cancer patients. Patients undergoing image guided RT or brachytherapy routinely have inert RT biomaterials implanted into their tumors. The single function of these RT biomaterials is to ensure geometric accuracy during treatment. Recent studies have proposed that the inert biomaterials could be upgraded to "smart" RT biomaterials, designed to do more than 1 function. Such smart biomaterials include next-generation fiducial markers, brachytherapy spacers, and balloon applicators, designed to respond to stimuli and perform additional desirable functions like controlled delivery of therapy-enhancing payloads directly into the tumor subvolume while minimizing normal tissue toxicities. More broadly, smart RT biomaterials may include functionalized nanoparticles that can be activated to boost RT efficacy. This work reviews the rationale for smart RT biomaterials, the state of the art in this emerging cross-disciplinary research area, challenges and opportunities for further research and development, and a purview of potential clinical applications. Applications covered include using smart RT biomaterials for boosting cancer therapy with minimal side effects, combining RT with immunotherapy or chemotherapy, reducing treatment time or health care costs, and other incipient applications. Copyright © 2016 Elsevier Inc. All rights reserved.

The effect of stimulation therapy and donepezil on cognitive function in Alzheimer's disease. A community based RCT with a two-by-two factorial design.

PubMed

Andersen, Fred; Viitanen, Matti; Halvorsen, Dag S; Straume, Bjørn; Wilsgaard, Tom; Engstad, Torgeir A

2012-07-19

Progressive neurodegeneration in Alzheimer's disease (AD) induces cognitive deterioration, and there is controversy regarding the optimal treatment strategy in early AD. Stimulation therapy, including physical exercise and cholinesterase inhibitors are both reported to postpone cognitive deterioration in separate studies. We aimed to study the effect of stimulation therapy and the additional effect of donepezil on cognitive function in early AD. A two-by-two factorial trial comprising stimulation therapy for one year compared to standard care to which a randomized double-blinded placebo controlled trial with donepezil was added. Nine rural municipalities in Northern Norway. 187 participants 65 years and older with a recent diagnosis of mild or moderate AD were included in the study of which 146 completed a one-year follow-up. In five municipalities the participants received stimulation therapy whereas participants in four received standard care. All participants were randomised double-blindly to donepezil or placebo and tested with three different cognitive tests four times during the one-year study period. Changes in MMSE sum score.Secondary outcome: Changes in ADAS-Cog and Clock Drawing Test. MMSE scores remained unchanged amongst AD participants receiving stimulation therapy and those receiving standard care. The results were consistent for ADAS-Cog and Clock Drawing Test. No time trend differences were found during one-year follow-up between groups receiving stimulation therapy versus standard care or between donepezil versus placebo. In rural AD patients non-pharmacological and pharmacological therapy did not improve outcome compared with standard care but all groups retained cognitive function during one year follow-up. Other studies are needed to confirm these results. ClinicalTrials.gov (Identifier: NCT00443014). EudraCT database (no 2004-002613-37).

[Continuous insulin therapy versus multiple insulin injections in the management of type 1 diabetes: a longitutinal study].

PubMed

Ribeiro, Maria Estela Bellini; Del Roio Liberatore Junior, Raphael; Custodio, Rodrigo; Martinelli Junior, Carlos Eduardo

2016-01-01

To compare multiple doses of insulin and continuous insulin infusion therapy as treatment for type 1 diabetes melito. 40 patients with type 1 diabetes melito (21 female) with ages between 10 and 20 years (mean=14.2) and mean duration of diabetes of 7 years used multiple doses of insulin for at least 6 months and after that, continuous insulin infusion therapy for at least 6 months. Each one of the patients has used multiple doses of insulin and continuous insulin infusion therapy. For analysis of HbA1c, mean glycated hemoglobin levels (mHbA1c) were obtained during each treatment period (multiple doses of insulin and continuous insulin infusion therapy period). Although mHbA1c levels were lower during continuous insulin infusion therapy the difference was not statistically significant. During multiple doses of insulin, 14.2% had mHbA1c values below 7.5% vs. 35.71% while on continuous insulin infusion therapy; demonstrating better glycemic control with the use of continuous insulin infusion therapy. During multiple doses of insulin, 15-40 patients have severe hypoglycemic events versus 5-40 continuous insulin infusion therapy. No episodes of ketoacidosis events were recorded. This is the first study with this design comparing multiple doses of insulin and continuous insulin infusion therapy in Brazil showing no significant difference in HbA1c; hypoglycemic events were less frequent during continuous insulin infusion therapy than during multiple doses of insulin and the percentage of patients who achieved a HbA1c less than 7.5% was greater during continuous insulin infusion therapy than multiple doses of insulin therapy. Copyright © 2015 Sociedade de Pediatria de São Paulo. Publicado por Elsevier Editora Ltda. All rights reserved.

Quality of Life in Patients with Noninfectious Uveitis Treated with or without Systemic Anti-inflammatory Therapy.

PubMed

Gui, Wei; Dombrow, Matthew; Marcus, Inna; Stowe, Meredith H; Tessier-Sherman, Baylah; Yang, Elizabeth; Huang, John J

2015-04-01

To compare vision-related (VR-QOL) and health-related quality of life (HR-QOL) in patients with noninfectious uveitis treated with systemic anti-inflammatory therapy versus nonsystemic therapy. A prospective, cross-sectional study design was employed. VR-QOL and HR-QOL were assessed by the 25-Item Visual Function Questionnaire (VFQ-25) and the Short Form 12-Item Health Survey (SF-12), respectively. Multivariate regression analysis was performed to assess the VR-QOL and HR-QOL based on treatment. Among the 80 patients, the median age was 51 years with 28 males (35%). The adjusted effect of treatment modality on VR-QOL or HR-QOL showed no statistically significant difference in all subscores of VFQ-25 or physical component score (PCS) and mental component score (MCS) of SF-12. Systemic therapy did not compromise VR-QOL or HR-QOL compared to nonsystemic therapy. Systemic therapy can be effectively used to control serious cases of noninfectious uveitis without significant relative adverse impact on quality of life.

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

PubMed

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.

Developing Occupation-Based Preventive Programs for Late-Middle-Aged Latino Patients in Safety-Net Health Systems.

PubMed

Schepens Niemiec, Stacey L; Carlson, Mike; Martínez, Jenny; Guzmán, Laura; Mahajan, Anish; Clark, Florence

2015-01-01

Latino adults between ages 50 and 60 yr are at high risk for developing chronic conditions that can lead to early disability. We conducted a qualitative pilot study with 11 Latinos in this demographic group to develop a foundational schema for the design of health promotion programs that could be implemented by occupational therapy practitioners in primary care settings for this population. One-on-one interviews addressing routines and activities, health management, and health care utilization were conducted, audiotaped, and transcribed. Results of a content analysis of the qualitative data revealed the following six domains of most concern: Weight Management; Disease Management; Mental Health and Well-Being; Personal Finances; Family, Friends, and Community; and Stress Management. A typology of perceived health-actualizing strategies was derived for each domain. This schema can be used by occupational therapy practitioners to inform the development of health-promotion lifestyle interventions designed specifically for late-middle-aged Latinos. Copyright © 2015 by the American Occupational Therapy Association, Inc.