Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M
Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.
Lebwohl, Mark G; Papp, Kim A; Marangell, Lauren B; Koo, John; Blauvelt, Andrew; Gooderham, Melinda; Wu, Jashin J; Rastogi, Shipra; Harris, Susan; Pillai, Radhakrishnan; Israel, Robert J
Individuals with psoriasis are at increased risk for psychiatric comorbidities, including suicidal ideation and behavior (SIB). To distinguish between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis being treated with brodalumab, a fully human anti-interleukin 17 receptor A monoclonal antibody. Data were evaluated from a placebo-controlled, phase 2 clinical trial; the open-label, long-term extension of the phase 2 clinical trial; and three phase 3, randomized, double-blind, controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3) and their open-label, long-term extensions of patients with moderate-to-severe psoriasis. The analysis included 4464 patients with 9161.8 patient-years of brodalumab exposure. The follow-up time-adjusted incidence rates of SIB events were comparable between the brodalumab and ustekinumab groups throughout the 52-week controlled phases (0.20 vs 0.60 per 100 patient-years). In the brodalumab group, 4 completed suicides were reported, 1 of which was later adjudicated as indeterminate; all patients had underlying psychiatric disorders or stressors. There was no comparator arm past week 52. Controlled study periods were not powered to detect differences in rare events such as suicide. Comparison with controls and the timing of events do not indicate a causal relationship between SIB and brodalumab treatment. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Jensen, P.S.; Buitelaar, J.K.; Pandina, G.J.; Binder, C.; Haas, M. de
We aimed to provide a descriptive review of treatment studies of atypical antipsychotics in paediatric psychiatric disorders. A systematic review of the literature used Medline and EMBASE databases to identify clinical trials of atypical antipsychotics in children and adolescents between 1994 and
Biegel, Gina M.; Brown, Kirk Warren; Shapiro, Shauna L.; Schubert, Christine M.
Research has shown that mindfulness-based treatment interventions may be effective for a range of mental and physical health disorders in adult populations, but little is known about the effectiveness of such interventions for treating adolescent conditions. The present randomized clinical trial was designed to assess the effect of the…
Chien, Wai-Tong; Bressington, Daniel
This study aimed to test the effectiveness of a nurse-led structured psychosocial intervention program in Chinese patients with first-onset mental illness. A single-blind, parallel group, randomized controlled trial design was used. The study involved 180 participants with mild to moderate-severe symptoms of psychotic or mood disorders who were newly referred to two psychiatric outpatient clinics in Hong Kong. Patients were randomly assigned to either an eight-session nurse-led psychosocial intervention program (plus usual care) or usual psychiatric outpatient care (both n=90). The primary outcome was psychiatric symptoms. Outcomes were measured at recruitment, one week and 12 months post-intervention. Patients in the psychosocial intervention group reported statistically significant improvements in symptoms compared to treatment as usual. There were also significant improvements in illness insight and perceived quality of life and reduction in length of re-hospitalizations over the 12-month follow-up. The findings provide evidence that the nurse-led psychosocial intervention program resulted in improved health outcomes in Chinese patients with first-onset mental illness. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Edinger, Jack D; Olsen, Maren K; Stechuchak, Karen M; Means, Melanie K; Lineberger, Margaret D; Kirby, Angela; Carney, Colleen E
This study was conducted to evaluate the efficacy of cognitive behavioral therapy (CBT) against a sleep hygiene education control therapy in patients with primary or comorbid insomnia. Randomized, parallel-group, clinical trial conducted at a single Veterans Affairs medical center, with recruitment from March 2001 to June 2005. Eighty-one adults (n = 11 women; mean age, 54.2 years) with chronic primary (n = 40) or comorbid insomnia associated predominantly with mixed psychiatric disorders (n = 41). Patients, screened via structured interviews and diagnostic polysomnography, were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions; 20 patients with primary and 21 with comorbid insomnia), or sleep hygiene (SH: education about aspects of lifestyle and the bedroom environment that affect sleep; 20 patients with primary and 20 with comorbid insomnia). Outpatient treatment included 4 biweekly sessions with a posttreatment assessment and a follow-up conducted at 6 months. Participants completed actigraphy and sleep diaries for 2 weeks prior to therapy, during a 2-week posttreatment assessment, and during 2 weeks at follow-up. They also completed questionnaires measuring global insomnia symptoms, general sleep quality, and sleep-disruptive beliefs before treatment, immediately following treatment, and at the follow-up time point. Consistent with previous studies, CBT outperformed sleep hygiene across several study outcome measures for the sample as a whole. Statistical analyses showed no significant 3-way interaction of treatment group, time, and insomnia type for any of the sleep or questionnaire measures, suggesting the benefits of CBT over sleep hygiene were comparable for patients with primary insomnia and comorbid insomnia. Moreover, only 1 of several indexes of clinically notable improvement suggested a significantly better response to CBT by patients with primary insomnia, as compared with those with comorbid insomnia. A
Christina M van der Feltz-Cornelis
Full Text Available Christina M van der Feltz-Cornelis1, Rob Hoedeman2, Fransina J de Jong3, Jolanda AC Meeuwissen3, Hanneke W Drewes3, Niels C van der Laan4, Herman J Adèr51Department of Developmental, Clinical and Crosscultural Psychology, Tilburg University, Tilburg, The Netherlands; 2Department of Health Sciences, University Medical Center Groningen, The Netherlands; 3Trimbos instituut, NIMHA, Utrecht, The Netherlands; 4Psychiatric Consultation Practice, The Netherlands; 5Retired from Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The NetherlandsIntroduction: Return to work (RTW of employees on sick leave for common mental disorders may require a multidisciplinary approach. This article aims to assess time to RTW after a psychiatric consultation providing treatment advice to the occupational physician (OP for employees on sick leave for common mental disorders in the occupational health (OH setting, compared to care as usual (CAU. Methods: Cluster randomized clinical trial evaluating patients of 12 OPs receiving consultation by a psychiatrist, compared to CAU delivered by 12 OPs in the control group. 60 patients suffering from common mental disorders and ≥ six weeks sicklisted were included. Follow up three and six months after inclusion. Primary outcome measure was time to RTW. Intention-to-treat multilevel analysis and a survival analysis were performed to evaluate time to RTW in both groups. Results: In CAU, referral was the main intervention. Both groups improved in terms of symptom severity and quality of life, but time to RTW was significantly shorter in the psychiatric consultation group. At three months follow up, 58% of the psychiatric consultation group had full RTW versus 44% of the control group, a significant finding (P = 0.0093. Survival analysis showed 68 days earlier RTW after intervention in the psychiatric consultation group (P = 0.078 compared to CAU. Conclusion: Psychiatric
van der Feltz-Cornelis, Christina M; Hoedeman, Rob; de Jong, Fransina J; Meeuwissen, Jolanda AC; Drewes, Hanneke W; van der Laan, Niels C; Adèr, Herman J
Introduction Return to work (RTW) of employees on sick leave for common mental disorders may require a multidisciplinary approach. This article aims to assess time to RTW after a psychiatric consultation providing treatment advice to the occupational physician (OP) for employees on sick leave for common mental disorders in the occupational health (OH) setting, compared to care as usual (CAU). Methods Cluster randomized clinical trial evaluating patients of 12 OPs receiving consultation by a psychiatrist, compared to CAU delivered by 12 OPs in the control group. 60 patients suffering from common mental disorders and ≥ six weeks sicklisted were included. Follow up three and six months after inclusion. Primary outcome measure was time to RTW. Intention- to-treat multilevel analysis and a survival analysis were performed to evaluate time to RTW in both groups. Results In CAU, referral was the main intervention. Both groups improved in terms of symptom severity and quality of life, but time to RTW was significantly shorter in the psychiatric consultation group. At three months follow up, 58% of the psychiatric consultation group had full RTW versus 44% of the control group, a significant finding (P = 0.0093). Survival analysis showed 68 days earlier RTW after intervention in the psychiatric consultation group (P = 0.078) compared to CAU. Conclusion Psychiatric consultation for employees on sick leave in the OH setting improves time to RTW in patients with common mental disorders as compared to CAU. In further research, focus should be on early intervention in patients with common mental disorders on short sick leave duration. Psychiatric consultation might be particularly promising for improvement of RTW in those patients. Trial registration number ISRCTN: 86722376 PMID:20856601
Full Text Available ... they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner ... the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing ...
Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...
Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...
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Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...
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Ekeblad, Annika; Falkenström, Fredrik; Andersson, Gerhard; Vestberg, Robert; Holmqvist, Rolf
Interpersonal psychotherapy (IPT) and cognitive behavioral therapy (CBT) are both evidence-based treatments for major depressive disorder (MDD). Several head-to-head comparisons have been made, mostly in the United States. In this trial, we compared the two treatments in a small-town outpatient psychiatric clinic in Sweden. The patients had failed previous primary care treatment and had extensive Axis-II comorbidity. Outcome measures were reduction of depressive symptoms and attrition rate. Ninety-six psychiatric patients with MDD (DSM-IV) were randomized to 14 sessions of CBT (n = 48) or IPT (n = 48). A noninferiority design was used with the hypothesis that IPT would be noninferior to CBT. A three-point difference on the Beck Depression Inventory-II (BDI-II) was used as noninferiority margin. IPT passed the noninferiority test. In the ITT group, 53.5% (23/43) of the IPT patients and 51.0% (24/47) of the CBT patients were reliably improved, and 20.9% (9/43) and 19.1% (9/47), respectively, were recovered (last BDI score depressed psychiatric patients in a community-based outpatient clinic. CBT had significantly more dropouts than IPT, indicating that CBT may be experienced as too demanding. Since about half the patients did not recover, there is a need for further treatment development for these patients. The study should be considered an effectiveness trial, with strong external validity but some limitations in internal validity. © 2016 Wiley Periodicals, Inc.
Bürge, Elisabeth; Berchtold, André; Maupetit, Christine; Bourquin, Nathalie M-P; von Gunten, Armin; Ducraux, Daniel; Zumbach, Serge; Peeters, Anne; Kuhne, Nicolas
Several studies on the effect of physical exercise on activities of daily living (ADL) for people with dementia exist; yet, data concerning the specific context of acute psychiatric hospitals remain scant. This study measured the effect of a physical exercise program on ADL scores in patients with moderate to severe dementia hospitalized in an acute psychiatric ward. A multicenter clinical trial was conducted in five Swiss and Belgian psychiatric hospitals. Participants were randomly allocated to either an experimental group (EG) or a control group (CG). Members of the EG received 20 physical exercise sessions (strengthening, balance, and walking) over a four-week period while members of the CG participated in social interaction sessions of equivalent duration and frequency, but without physical exercise. The effect of exercise on ADL was measured by comparing scores of the Barthel Index and the Functional Independence Measure in the EG and CG before and after the intervention, and two weeks later. Hundred and sixty patients completed the program. Characteristics of participants of both groups were similar at the inception of the study. The mean ADL score of EG decreased slightly over time, whereas that of the CG significantly decreased compared to initial scores. Overall differences between groups were not significant; however, significant differences were found for mobility-related items. ADL scores in elderly with moderate to severe dementia deteriorate during acute psychiatric hospitalization. An exercise program delays the loss of mobility but does not have a significant impact on overall ADL scores.
Full Text Available ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...
Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...
Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at firstname.lastname@example.org or call ...
Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...
Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...
Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...
Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...
Full Text Available ... The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common ...
Full Text Available ... review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results from other relevant studies. These results may ...
Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...
Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...
Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...
Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...
Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...
Full Text Available ... States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines ...
Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...
Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...
Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...
Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...
Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...
Full Text Available Daniel J Pilowsky1, Li-Tzy Wu2, Bruce Burchett2, Dan G Blazer2, George E Woody3, Walter Ling41Departments of Epidemiology and Psychiatry, Columbia University, and the New York State Psychiatric Institute, New York City, NY; 2Department of Psychiatry and Behavioral Sciences, School of Medicine, Duke University Medical Center, Durham, NC; 3Department of Psychiatry, School of Medicine, University of Pennsylvania and Treatment Research Institute, Philadelphia, PA; 4David Geffen School of Medicine, NPI/Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USABackground: In response to the rising rate of treatment admissions related to illicit use of amphetamines (eg, methamphetamine, we examined the prevalence of amphetamine use among treatment-seeking, opioid-dependent adults, explored whether amphetamine users were as likely as nonamphetamine users to enroll in opioid-dependence treatment trials, and determined whether amphetamine users manifested greater levels of medical and psychiatric comorbidity than nonusers.Methods: The sample included 1257 opioid-dependent adults screened for participation in threemultisite studies of the National Drug Abuse Treatment Clinical Trials Network (CTN001-003, which studied the effectiveness of buprenorphine for opioid detoxification under varying treatment conditions. Patients were recruited from 23 addiction treatment programs across the US. Medical and psychiatric comorbidity were examined by past-month amphetamine use (current vs former and route of administration. Five mutually exclusive groups were examined, ie, nonusers, current amphetamine injectors, current amphetamine noninjectors, former amphetamine injectors, and former amphetamine noninjectors.Results: Of the sample (n = 1257, 22.3% had a history of regular amphetamine use. Of the 280 amphetamine users, 30.3% reported injection as their primary route. Amphetamine users were more likely than nonusers to be white and use more
Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...
Full Text Available ... educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board ... of a group of research and study topic experts. The NIH also requires ...
Full Text Available ... examples of clinical trials that test principles or strategies include studies that explore whether surgery or other medical treatments ... board consists of a group of research and study topic experts. The NIH also ... alternative strategies for diagnosis or treatment. In addition, the NIH ...
SOARES CLÁUDIO DE NOVAES
Full Text Available BACKGROUND: Untreated GH-deficient adults have a diversity of dysfunctions (e.g. reduced muscle strength, emotional instability during stress, depressive symptoms that may cause deleterious effects on quality of life, and may be positively influenced by recombinant human growth hormone (rh-GH therapy. AIM: To evaluate the impact of a clinical intervention with rh-GH therapy on GH - deficient adults. METHOD: The physical, psychiatric and neuropsychological status of 9 GH-deficient adults was determined before and after the administration of rh-GH (0.250 IU/Kg/week in a double blind placebo-controlled trial for six months. Patients then received rh-GH for a further period of 6 months and their status was re-evaluated. RESULTS: Rh-GH was significant better than placebo at 6th month (p<0.05, producing increased serum Insulin like growth factor-I (IGF-1 levels, reduced body mass index (BMI and body fat, increased lean body mass and water, reduced waist/hip ratio and increased energy expenditure. The rh-GH therapy was also significantly better than placebo on depressive features as measured by the Hamilton Depression Scale (17-items (p= 0.0431 and the Beck Depression Inventory (p= 0.0431. Neuropsychological evaluations showed significant improvements in measures of Attention: Digit Backward (p= 0.035,Verbal Fluency (FAS (p= 0.02 and Cognitive Efficiency (WAIS-R tests: Vocabulary (p= 0.027 , Picture Arrangements (p= 0.017, and Comprehension (p= 0.01 following rh-GH therapy. CONCLUSION: The clinical, psychiatric, and neuropsychological impairments of untreated GH-deficient adults can be decreased by rh-GH therapy.
... Contracts section of the NIH website. Find NICHD Clinical Trials NIH maintains the ClinicalTrials.gov website as the main database of publicly and privately funded clinical trials. Each trial has its own pre-defined research ...
Gonge, Henrik; Buus, Niels
AIM: To test the effects of a meta-supervision intervention in terms of participation, effectiveness and benefits of clinical supervision of psychiatric nursing staff. BACKGROUND: Clinical supervision is regarded as a central component in developing mental health nursing practices, but the evidence...... supporting positive outcomes of clinical supervision in psychiatric nursing is not convincing. DESIGN: The study was designed as a randomized controlled trial. All permanently employed nursing staff members at three general psychiatric wards at a Danish university hospital (n = 83) were allocated to either...... on individuals or wards already actively engaged in clinical supervision, which suggested that individuals and wards without well-established supervision practices may require more comprehensive interventions targeting individual and organizational barriers to clinical supervision....
Day, Simon; Machin, David; Green, Sylvan B
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...
Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...
Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...
Full Text Available ... research—that is, who is eligible. Each trial must include only people who fit the patient traits ... to take part in the study. Each trial must include only people who fit the patient traits ...
Full Text Available ... also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or ...
Parellada, Mara; Moreno, Carmen; Moreno, Miguel; Espliego, Ana; de Portugal, Enrique; Arango, Celso
Much literature has been written in the field of child psychiatry regarding the placebo as a tool to test drug efficacy in clinical trials, but quite little regarding the placebo effect itself or its clinical use in child psychiatry. In this article, we aim to critically review the literature regarding the placebo effect in children and adolescents with mental disorders, focusing especially on factors influencing the placebo effect and how they may influence the interpretation of clinical trials. The placebo effect seems to be more marked in children than adults, and particularly in children and adolescents with depression, although it is pervasive across ages and is present in non-psychiatric conditions as well. The use of a placebo in clinical trials as a comparator with drugs that have moderate efficacy at most makes it difficult to obtain positive results, and much effort is needed to design very high quality clinical trials that may overcome the limitations of using a placebo. In addition, the placebo effect across ages and clinical conditions must be tested directly (compared with no treatment whenever possible), in order to characterise which placebos work for what and to determine their use in clinical settings. Copyright © 2011 Elsevier B.V. and ECNP. All rights reserved.
Full Text Available ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...
Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...
May 28, 2013 ... East African Medical Journal Vol. 89 No. 2 February 2012. PSYCHIATRIC MORBIDITY IN A NIGERIAN NEUROLOGY CLINIC. P. O. Ajiboye, FWACP, Senior Lecturer/ Consultant Psychiatrist, Department of Behavioural Sciences, University of Ilorin/. University of Ilorin Teaching Hospital, Ilorin, Kwara State, ...
Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the ... Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study ...
Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...
Full Text Available ... scale phase III trials begin, the FDA provides input on how these studies should be done. Patient ... of stakeholders and advisory groups, NHLBI has received input and has established a multi-pronged approach to ...
Full Text Available ... long and careful research process. The process often begins in a laboratory (lab), where scientists first develop ... IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals ...
Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...
Nancy P. Hanrahan
Full Text Available Individuals with serious mental illness have greater risk for contracting HIV, multiple morbidities, and die 25 years younger than the general population. This high need and high cost subgroup face unique barriers to accessing required health care in the current health care system. The effectiveness of an advanced practice nurse model of care management was assessed in a four-year random controlled trial. Results are reported in this paper. In a four-year random controlled trial, a total of 238 community-dwelling individuals with HIV and serious mental illness (SMI were randomly assigned to an intervention group (n=128 or to a control group (n=110. Over 12 months, the intervention group received care management from advanced practice psychiatric nurse, and the control group received usual care. The intervention group showed significant improvement in depression (P=.012 and the physical component of health-related quality of life (P=.03 from baseline to 12 months. The advanced practice psychiatric nurse intervention is a model of care that holds promise for a higher quality of care and outcomes for this vulnerable population.
Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and ...
Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...
Full Text Available ... preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term "masking" ... Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill ...
Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical ...
Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... have not only shaped medical practice around the world, but have improved the health of millions of ...
Full Text Available ... works well in the lab or animals doesn't always work well in people. Thus, research in ... Clinical research is done only if doctors don't know whether a new approach works well in ...
... and her initial results. Nueva Esperanza Para Las Enfermedades Del Corazón 09/23/2014 Milena tuvo un ... Story 09/23/2014 Nueva Esperanza Para Las Enfermedades Del Corazón 09/23/2014 Children and Clinical ...
de Knegt, R. J.; Bezemer, G.; van Gool, A. R.; Drenth, J. P. H.; Hansen, B. E.; Droogleever Fortuyn, H. A.; Weegink, C. J.; Hengeveld, M. W.; Janssen, H. L. A.
Background Treatment of hepatitis C with peginterferon and ribavirin is associated with psychiatric side-effects, frequently necessitating dose reduction or therapy cessation. Aim To assess the efficacy of prophylactic escitalopram to prevent psychiatric side-effects during peginterferon and
... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...
Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden
Peace, Karl E; Chen, Ding-Geng
"Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...
... Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...
Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.
Background to the study: Medical student's attitude towards people with mental illness (PWMI) is very important for the future care of psychiatric patients. It has been postulated that psychiatric education could lead to a reduction in negative attitude towards PWMI. Objective: To assess the effect of clinical psychiatric training ...
... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...
Müller, Wolf; Haffelder, Günter; Schlotmann, Angelika; Schaefers, Andrea T U; Teuchert-Noodt, Gertraud
This pilot study examined, whether long-term exposure of psychiatric patients to music that was individually adapted to brain rhythm disorders associated with psychoticism could act to ameliorate psychiatric symptoms. A total of 50 patients with various psychiatric diagnoses were randomised in a 1:1 ratio to listen to CDs containing either music adapted to brain rhythm anomalies associated with psychoticism - measured via a specific spectral analysis - or standard classical music. Participants were instructed to listen to the CDs over the next 18 months. Psychiatric symptoms in both groups were assessed at baseline and at 4, 8 and 18 months, using the Brief Symptom Inventory (BSI). At 18 months, patients in the experimental group showed significantly decreased BSI scores compared to control patients. Intriguingly, this effect was not only seen for symptoms of psychoticism and paranoia but also for anxiety, phobic anxiety and somatisation. Exposure to the adapted music was effective in ameliorating psychotic, anxiety and phobic anxiety symptoms. Based on the theories of neuroplasticity and brain rhythms, it can be hypothesised that this intervention may be enhancing brain-rhythm synchronisation and plasticity in prefrontal-hippocampal circuits that are implicated in both psychosis/paranoia and anxiety/phobic anxiety.
van der Feltz-Cornelis, Christina M.; Hoedeman, Rob; de Jong, Fransina J.; Meeuwissen, Jolanda A. C.; Drewes, Hanneke W.; van der Laan, Niels C.; Ader, Herman J.
Introduction: Return to work (RTW) of employees on sick leave for common mental disorders may require a multidisciplinary approach. This article aims to assess time to RTW after a psychiatric consultation providing treatment advice to the occupational physician (OP) for employees on sick leave for
Knegt, R.J. de; Bezemer, G.; Gool, A.R. van; Drenth, J.P.H.; Hansen, B.E.; Droogleever Fortuyn, H.A.; Weegink, C.J.; Hengeveld, M.W.; Janssen, H.L.
Aliment Pharmacol Ther 2011; 34: 1306-1317 SUMMARY: Background Treatment of hepatitis C with peginterferon and ribavirin is associated with psychiatric side-effects, frequently necessitating dose reduction or therapy cessation. Aim To assess the efficacy of prophylactic escitalopram to prevent
Emons, Barbara; Haussleiter, Ida Sybille; Kalthoff, Jörg; Schramm, Anja; Hoffmann, Knut; Jendreyschak, Jasmin; Schaub, Markus; Armgart, Carina; Juckel, Georg; Illes, Franciska
Germany provides a wide range of highly developed mental health care to its citizens. The aim of this study was to identify factors influencing the voluntariness of admissions to psychiatric hospitals. Especially the impact of demographic factors of the region, characteristics of the psychiatric hospitals and characteristics of the psychosocial services was analyzed. A retrospective analysis of hospital admission registers from 13 German adult psychiatric hospitals in 2009 was conducted. Public data on the regional psychiatric accommodation and demographic situation were added. Hospitals were dichotomously divided according to their index of involuntary admissions. Group comparisons were performed between the clinics with low and high involuntary admission indices. Analysis was conducted with clinical, psychiatric provision and demographic data related to inpatients in the Landschaftsverbands Westfalen-Lippe (LWL)-PsychiatryNetwork. Especially the range of services provided by the social-psychiatric services in the region such as number of supervised patients and home visits had an influence on the proportion of involuntary admissions to a psychiatric hospital. Some demographic characteristics of the region such as discretionary income showed further influence. Contrary to our expectations, the characteristics of the individual hospital seem to have no influence on the admission rate. Social-psychiatric services show a preventive impact on involuntary acute psychiatry interventions. Sociodemographic factors and patient variables play a role with regard to the number of involuntary hospitalizations, whereas characteristics of hospitals seemed to play no role. © The Author(s) 2013.
Daradkeh, T K
This is a retrospective study that aimed at studying the diagnostic stability of psychiatric diagnoses over a 4-year period. Three-hundred and twelve patients (n = 312) admitted more than once to Al Ain in-patient unit from January 1, 1990 to December 31, 1993, were the subjects for this study. The sample included patients with the following index diagnoses: acute psychoses (n = 37), alcohol abuse (n = 15), bipolar disorder (n = 27), depressive disorders (n = 63), drug abuse (n = 21), hysteria (n = 23), neurotic disorders (n = 50) and schizophrenia (n = 76). Diagnoses on discharge for first admissions were considered the index diagnoses. The shift from index diagnoses to subsequent diagnoses was counted. Diagnostic stability was calculated as the percentages of index diagnoses that did not change over time. In nearly half of the patients the index diagnoses changed over the 4-year period. Highest diagnostic stability was found in patients with index diagnoses of alcohol abuse, schizophrenia and drug abuse (92%, 74% and 71% respectively), while the lowest stability was found in patients with neurotic, hysterical, depressive disorders, acute psychoses and bipolar disorders (38%, 48% and 45%, 42%, 52% respectively). Two distinct patterns of shifts were noted. First shift occurred between functional psychoses and second shift between depressive and neurotic disorders. This study provides further support to the notion that diagnostic stability in clinical practice is still far from being satisfactory.
Evans, Scott R.
Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. The selection of a clinical trial design structure requires logic and creativity. Common structural designs are discussed.
Kraus, V B; Blanco, F J; Englund, M
The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...... and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety...
Shacham, Enbal; Önen, Nur F; Donovan, Michael F; Rosenburg, Neal; Overton, E Turner
As individuals with HIV infection are living longer, the management of psychiatric disorders has increasingly been incorporated into comprehensive care. Individuals were recruited from an outpatient HIV clinic to assess the prevalence and related associations of current psychiatric disorders and biomarkers. Of the 201 participants who completed the interviews, the median age was 43.5 years, and the majority was male and African American. Most were receiving HIV therapy and 78% of those had achieved virologic suppression. Prevalent psychiatric diagnoses included major depressive disorder, generalized anxiety, and agoraphobia. Alcohol and cocaine/crack abuse and dependence were common substance use disorders. Current receipt of HIV therapy was less common among those diagnosed with generalized anxiety disorder. Agoraphobia was the only disorder associated with unsuppressed viral load. Psychiatric and substance use disorders are highly prevalent among an urban HIV clinic population, although we identified few associations between psychiatric diagnoses and HIV diseases status. © The Author(s) 2014.
Aagaard, Jørgen; Buus, Niels; Wernlund, Andreas Glahn
OBJECTIVE: The aim of this study was to examine changes in the distribution of causes of death and mortality rates among psychiatric patients visiting a psychiatric emergency room (PER), to determine clinically useful predictors for avoiding premature mortality among these patients and to discuss...... by substance use disorder is preventable, and PERs are ideal points of early intervention. Systematic screening for substance use disorder at the PER and/or crisis intervention teams may be effective intervention strategies....
Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...
The Effect of Clinical Psychiatric Training on Medical Students'. Belief and .... ill lead to strained social interaction, low self-esteem, ...... psychiatry and mental illness in a Malaysian medical school. ... english/media/vol_3.pdf (accessed. January ...
May 28, 2013 ... medication effects and psychological reactions to the illness. Parkinson's disease (PD) is a good example of a disabling neurological disorder and it is now apparent that the underlying neurodegenerative disorder is a major cause of psychiatric disturbances even though the psychological reactions to the ...
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U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...
Crider, Mark C; McNiesh, Susan G
In this article, we present a theory-based application of clinical simulation in psychiatric-mental health nursing education. As described by Benner, Sutphen, Leonard, and Day, a three-pronged apprenticeship that integrates intellectual, practical, and ethical aspects of the professional role is critical in the development of practical reasoning in nursing education and training. Clinical encounters are often fraught with ambiguity and uncertainty. Therefore, educating for a practice discipline requires experiential and situated learning. Using the three-pronged experiential model in simulated psychiatric-mental health nursing practice supports the development of critical nursing skills, ethics, and theoretical concepts. A clinical scenario is presented that demonstrates the application of this model of professional apprenticeship in psychiatric-mental health education. Applications of the concept presented may be used in training nurses new to the practice of psychiatric-mental health nursing. Copyright 2011, SLACK Incorporated.
Vinkers, David J; de Beurs, Edwin; Barendregt, Marko; Rinne, Thomas; Hoek, H Wijbrand
Black and ethnic minorities (BME) are disproportionally represented in western prisons and forensic psychiatric facilities. The authors wished to determine whether patient-related or services-related factors account for this overrepresentation. This study examined the relationship among the assessments of psychological accountability for a crime, treatment recommendations, and ethnicity among persons accused of a crime and suspected of having a mental disorder. We examined all 21,857 pre-trial psychiatric reports requested by Dutch courts between 2000 and 2006. Ethnicity was classified as Dutch native (n=15,004), Black and minority ethnic (BME) groups (n=6202), and Whites from other western countries (n=638). Accountability assessments and treatment recommendations were compared using chi-square tests and logistic regression models, adjusted for demographic, psychiatric, and judiciary characteristics. Among BME and Whites from other western countries, accountability for the crimes committed was more often judged to be at the extreme ends of the spectrum, that is, "fully responsible" or "not responsible." Compulsory admission to a psychiatric hospital was more frequently recommended for BME persons (OR: 1.38, 95% CI: 1.16-1.64) and Whites from other western countries (OR: 1.54, 95% CI: 1.05-2.27), but not admission to a penitentiary hospital or use of medication. The compulsory admission findings are largely explained by a higher prevalence of psychotic disorders in BME persons (19.8%) and Whites from other western countries (19.3%) as compared to Dutch natives (9.2%). Outpatient treatment was less often recommended for BME persons (OR: 0.81, 95% CI: 0.76-0.87) and Whites from other western countries (OR: 0.83, 95% CI: 0.70-0.99) than for Dutch natives. Both patient-related and services-related factors play a role in the increased admission of BME groups and Whites from other western countries to psychiatric hospitals.
Good, B J; Herrera, H; Good, M J; Cooper, J
A Mexican-American woman who complained of persistent head pain and a bothersome "voice" was seen by a team consisting of a psychiatrist, social scientists, and spiritualist healers in a Cultural Consultation Clinic of a Psychiatric Consultation Liaison Service. This single case is analyzed to provide an understanding of the interpretive dimensions of psychiatric practice. It is argued that a hermeneutic analysis of clinical phenomena focuses attention on three distinct aspects of interpretation: on the interpretation by clinicians and clients of the discourse of the other in terms of their own clinical models; on the influence of deeply embedded personal meanings on this interpretive process; and on the role of the observer in clinical ethnography. It is argued that to sustain a hermeneutic analysis of psychiatric practice, an account of transference and countertransference in terms of interpretation theory will have to be developed.
Mullen, Antony; Drinkwater, Vincent; Lewin, Terry J
To implement and evaluate the care zoning model in an eight-bed psychiatric intensive care unit and, specifically, to examine the model's ability to improve the documentation and communication of clinical risk assessment and management. Care zoning guides nurses in assessing clinical risk and planning care within a mental health context. Concerns about the varying quality of clinical risk assessment prompted a trial of the care zoning model in a psychiatric intensive care unit within a regional mental health facility. The care zoning model assigns patients to one of 3 'zones' according to their clinical risk, encouraging nurses to document and implement targeted interventions required to manage those risks. An implementation trial framework was used for this research to refine, implement and evaluate the impact of the model on nurses' clinical practice within the psychiatric intensive care unit, predominantly as a quality improvement initiative. The model was trialled for three months using a pre- and postimplementation staff survey, a pretrial file audit and a weekly file audit. Informal staff feedback was also sought via surveys and regular staff meetings. This trial demonstrated improvement in the quality of mental state documentation, and clinical risk information was identified more accurately. There was limited improvement in the quality of care planning and the documentation of clinical interventions. Nurses' initial concerns over the introduction of the model shifted into overall acceptance and recognition of the benefits. The results of this trial demonstrate that the care zoning model was able to improve the consistency and quality of risk assessment information documented. Care planning and evaluation of associated outcomes showed less improvement. Care zoning remains a highly applicable model for the psychiatric intensive care unit environment and is a useful tool in guiding nurses to carry out routine patient risk assessments. © 2013 John Wiley & Sons
It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the
Naccarelli, G V; Wolbrette, D L; Patel, H M; Luck, J C
Amiodarone is an antiarrhythmic agent commonly used in the treatment of supraventricular and ventricular tachyarrhythmias. This article reviews the results and clinical implications of primary and secondary prevention trials in which amiodarone was used in one of the treatment arms. Key post-myocardial infarction primary prevention trials include the European Myocardial Infarct Amiodarone Trial (EMIAT) and the Canadian Amiodarone Myocardial Infarction Trial (CAMIAT), both of which demonstrated that amiodarone reduced arrhythmic but not overall mortality. In congestive heart failure patients, amiodarone was studied as a primary prevention strategy in two pivotal trials: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiac en Argentina (GESICA) and Amiodarone in Patients With Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia (CHF-STAT). Amiodarone was associated with a neutral overall survival and a trend toward improved survival in nonischemic cardiomyopathy patients in CHF/STAT and improved survival in GESICA. In post-myocardial infarction patients with nonsustained ventricular tachycardia and a depressed ejection fraction, the Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated that implantable cardioverter-defibrillators (ICD) statistically improved survival compared to the antiarrhythmic drug arm, most of whose patients were taking amiodarone. In patients with histories of sustained ventricular tachycardia or ventricular fibrillation, the Cardiac Arrest Study in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) trial demonstrated that empiric amiodarone lowered arrhythmic recurrence rates compared to other drugs guided by serial Holter or electrophysiologic studies. However, arrhythmic death rates were high in both treatment arms of the study. Several secondary prevention trials, including the Antiarrhythmics Versus Implantable Defibrillators Study (AVID), the Canadian Implantable Defibrillator Study
Specific diagnoses recorded were depression (19.2%), generalised anxiety disorder (9.6%), harmful alcohol use (2.4%); dementia, somatoform disorder, phobia and delusional disorder each had a prevalence of 1.2%. Clinical and sociodemographic variables were not significantly associated with psychiatric morbidity.
Evans, Scott R.
Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. Issues in trial conduct and analyses should be anticipated during trial design and thoughtfully addressed. Fundamental clinical trial design issues are discussed.
McMain, Shelley F; Links, Paul S; Gnam, William H; Guimond, Tim; Cardish, Robert J; Korman, Lorne; Streiner, David L
The authors sought to evaluate the clinical efficacy of dialectical behavior therapy compared with general psychiatric management, including a combination of psychodynamically informed therapy and symptom-targeted medication management derived from specific recommendations in APA guidelines for borderline personality disorder. This was a single-blind trial in which 180 patients diagnosed with borderline personality disorder who had at least two suicidal or nonsuicidal self-injurious episodes in the past 5 years were randomly assigned to receive 1 year of dialectical behavior therapy or general psychiatric management. The primary outcome measures, assessed at baseline and every 4 months over the treatment period, were frequency and severity of suicidal and nonsuicidal self-harm episodes. Both groups showed improvement on the majority of clinical outcome measures after 1 year of treatment, including significant reductions in the frequency and severity of suicidal and nonsuicidal self-injurious episodes and significant improvements in most secondary clinical outcomes. Both groups had a reduction in general health care utilization, including emergency visits and psychiatric hospital days, as well as significant improvements in borderline personality disorder symptoms, symptom distress, depression, anger, and interpersonal functioning. No significant differences across any outcomes were found between groups. These results suggest that individuals with borderline personality disorder benefited equally from dialectical behavior therapy and a well-specified treatment delivered by psychiatrists with expertise in the treatment of borderline personality disorder.
Amore, Mario; Menchetti, Marco; Tonti, Cristina; Scarlatti, Fabiano; Lundgren, Eva; Esposito, William; Berardi, Domenico
Violence risk prediction is a priority issue for clinicians working with mentally disordered offenders. The aim of the present study was to determine violence risk factors in acute psychiatric inpatients. The study was conducted in a locked, short-term psychiatric inpatient unit and involved 374 patients consecutively admitted in a 1-year period. Sociodemographic and clinical data were obtained through a review of the medical records and patient interviews. Psychiatric symptoms at admission were assessed using the Brief Psychiatric Rating Scale (BPRS). Psychiatric diagnosis was formulated using the Structured Clinical Interview for DSM-IV. Past aggressive behavior was evaluated by interviewing patients, caregivers or other collateral informants. Aggressive behaviors in the ward were assessed using the Overt Aggression Scale. Patients who perpetrated verbal and against-object aggression or physical aggression in the month before admission were compared to non-aggressive patients, moreover, aggressive behavior during hospitalization and persistence of physical violence after admission were evaluated. Violent behavior in the month before admission was associated with male sex, substance abuse and positive symptoms. The most significant risk factor for physical violence was a past history of physically aggressive behavior. The persistent physical assaultiveness before and during hospitalization was related to higher BPRS total scores and to more severe thought disturbances. Higher levels of hostility-suspiciousness BPRS scores predicted a change for the worse in violent behavior, from verbal to physical. A comprehensive evaluation of the history of past aggressive behavior and psychopathological variables has important implications for the prediction of violence in psychiatric settings.
Full Text Available Abstract Background Patients admitted to a psychiatric hospital with suicidal behavior (SB are considered to be especially at high risk of suicide. However, the number of studies that have addressed this patient population remains insufficient compared to that of studies on suicidal patients in emergency or medical settings. The purpose of this study is to seek features of a sample of newly admitted suicidal psychiatric patients in a metropolitan area of Japan. Method 155 suicidal patients consecutively admitted to a large psychiatric center during a 20-month period, admission styles of whom were mostly involuntary, were assessed using Structured Clinical Interviews for DSM-IV Axis I and II Disorders (SCID-I CV and SCID-II and SB-related psychiatric measures. Associations of the psychiatric diagnoses and SB-related characteristics with gender and age were examined. Results The common DSM-IV axis I diagnoses were affective disorders 62%, anxiety disorders 56% and substance-related disorders 38%. 56% of the subjects were diagnosed as having borderline PD, and 87% of them, at least one type of personality disorder (PD. SB methods used prior to admission were self-cutting 41%, overdosing 32%, self-strangulation 15%, jumping from a height 12% and attempting traffic death 10%, the first two of which were frequent among young females. The median (range of the total number of SBs in the lifetime history was 7 (1-141. Severity of depressive symptomatology, suicidal intent and other symptoms, proportions of the subjects who reported SB-preceding life events and life problems, and childhood and adolescent abuse were comparable to those of the previous studies conducted in medical or emergency service settings. Gender and age-relevant life-problems and life events were identified. Conclusions Features of the studied sample were the high prevalence of affective disorders, anxiety disorders and borderline PD, a variety of SB methods used prior to admission
McAlindon, T. E.; Driban, J. B.; Henrotin, Y.
the members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population......The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...
Franza, Francesco; Del Buono, Gianfranco; Pellegrino, Ferdinando
The capacity to work productively is a key component of health and emotional well-being. People who work in health care can be exposed to the fatigue of care. Compassion fatigue has been described as an occupational hazard specific to clinical work related severe emotional distress. In our study, we have evaluated compassion fatigue in a mental health group (47 psychiatric staff) and its relationship with inpatients (237 inpatients) affected by some psychiatric disorders. At baseline, the more significant data indicate a high percentage of Job Burnout and Compassion Fatigue in psychiatric nurses (respectively, 39.28%, 28.57%). Significant Compassion Fatigue percentage is present also in psychologist group (36.36%). Finally, in psychiatrists, the exposure to patients increased vicarious trauma (28.57%), but not job burnout. After a year of participation in Balint Groups, the psychiatric staff presented an overall reduction in total mean score in any administered scale (CBI: pBurnout: pfatigue causes concern among mental health professionals, and Balint Groups may represent a therapeutic strategy to help health professionals to face difficulties in challenging work environments.
Kittelsen, Sverre A.C.; Magnussen, Jon
While measures of output in mental health care are even harder to find than in other health care activities, some indicators are available. In modelling productive efficiency the problem is to select the output variables that best reflect the use of resources, in the sense that these variables have a significant impact on measures of efficiency. The paper analyses cross-sectional data on the psychiatric outpatient clinics of Norway using the Data Envelopment Analysis (DEA) non-parametric effi...
Avny, Ohad; Teitelbaum, Tatiana; Simon, Moshe; Michnick, Tatiana; Siman-Tov, Maya
A consultation model between primary care physicians and psychiatrists that has been in operation for 12 years in the Jerusalem district of the Clalit Health Services in Israel is evaluated. In this model psychiatrists provide consultations twice a month at the primary care clinic. All patients are referred by their family physicians. Communication between the psychiatric consultant and the referring physician is carried out by telephone, correspondence and staff meetings. Evaluation of the psychiatric care consultation model in which a psychiatrist consults at the primary care clinic. A questionnaire-based survey distributed to 17 primary care physicians in primary care clinics in Jerusalem in which a psychiatric consultant is present. Almost all of the doctors (93%) responded that the consultation model was superior to the existing model of referral to a secondary psychiatric clinic alone and reduced the workload in caring for the referred patients. The quality of psychiatric care was correlated with the depression prevalence among patients referred for consultation at their clinic (r=0.530, p=0.035). In addition, correlation was demonstrated between primary care physicians impression of alleviation of care of patients and their impression of extent of the patients' cooperation with the consulting psychiatrist (r=0.679, p = 0.015) Conclusions: Very limited conclusions may be drawn from this questionnaire distributed to primary care physicians who were asked to assess psychiatric consultation in their clinic. Our conclusion could be influenced by the design and the actual distribution of the questionnaires by the consulting psychiatrist. Nevertheless answers to the questionnaire might imply that the consultation model of care between a psychiatric consultant and the primary care physician, where the patient's primary care physician takes a leading role in his psychiatric care, is perceived by family physicians as a good alternative to referral to a psychiatric
Full Text Available Abstract Background Few data are available on subjects presenting to acute wards for the first time with psychotic symptoms. The aims of this paper are (i to describe the epidemiological and clinical characteristics of patients at their first psychiatric admission (FPA, including socio-demographic features, risk factors, life habits, modalities of onset, psychiatric diagnoses and treatments before admission; (ii to assess the aggressive behavior and the clinical management of FPA patients in Italian acute hospital psychiatric wards, called SPDCs (Servizio Psichiatrico Diagnosi e Cura = psychiatric service for diagnosis and management. Method Cross-sectional observational multi-center study involving 62 Italian SPDCs (PERSEO – Psychiatric EmeRgency Study and EpidemiOlogy. Results 253 FPA aged Conclusion Subjects presenting at their first psychiatric ward admission have often not undergone previous adequate psychiatric assessment and diagnostic procedures. The first hospital admission allows diagnosis and psychopharmacological treatment to be established. In our population, aggressive behaviors were rather frequent, although most commonly verbal. Psychiatric symptoms, as evaluated by psychiatrists and patients, improved significantly from admission to discharge both for FPA and non-FPA patients.
Choi, Heeseung; Hwang, Boyoung; Kim, Sungjae; Ko, Heesung; Kim, Sumi; Kim, Chanhee
In response to current challenges in psychiatric mental health nursing education, nursing schools have implemented new strategies in teaching undergraduate nursing students. The objectives of the study were to evaluate learning outcomes of a mental health nursing clinical practicum and to explore students' perceptions of the clinical practicum. This was a mixed-method study. Sixty-three undergraduate nursing students, who were undertaking their first mental health clinical practicum, completed a set of structured questionnaires and answered open-ended questions about the clinical practicum. Answers to open-ended questions were analyzed qualitatively, and learning outcomes (i.e., empathy, mental illness prejudice, simulation-related efficacy, and satisfaction) were measured at three time points: pre-clinical, post-simulation, and post-clinical. Students reported improvement in empathy and simulation-related self-efficacy after the clinical practicum, but no change was found in mental illness prejudice. Students' expectations for and evaluation of the clinical practicum are summarized. The observed improvement in learning outcomes of the clinical practicum may be attributed to the unique contribution of each component of the clinical practicum and the synergic effect of these diverse components. To manage emerging challenges in clinical settings and nursing education, it is critical to develop systematic and comprehensive mental health nursing clinical practicums for undergraduate nursing students. Copyright © 2016 Elsevier Ltd. All rights reserved.
Hylwa, Sara A; Foster, Ashley A; Bury, Jessica E; Davis, Mark D P; Pittelkow, Mark R; Bostwick, J Michael
Delusional infestation, which encompasses both delusions of parasitosis and delusions of infestation with inanimate objects (sometimes called Morgellons disease), has been said to represent a distinct and encapsulated delusion, that is, a stand-alone diagnosis. Anecdotally, we have observed that patients with delusional infestation often have one or more psychiatric comorbid conditions and that delusional infestation should not be regarded as a stand-alone diagnosis. The purpose of this study was to identify whether patients with delusional infestation have psychiatric comorbid conditions. We therefore identified patients who had been formally evaluated in the Department of Psychiatry during their visit to Mayo Clinic. We retrospectively searched for and reviewed the cases of all patients with delusional infestation seen from 2001 through 2007 at Mayo Clinic, Rochester, Minnesota, and who underwent psychiatric evaluation. The diagnoses resulting from psychiatric evaluation were analyzed. During the 7-year study period, 109 patients seen for delusional infestation at Mayo Clinic were referred to the Department of Psychiatry, 54 (50%) of whom actually followed through with psychiatric consultation. Of these 54 patients, 40 (74%) received additional active psychiatric diagnoses; 14 patients (26%) had delusional infestation alone. Abnormal personality traits were rarely documented. Most patients with delusional infestation have multiple coexisting or underlying psychiatric disorders. Therefore, evaluation by a psychiatrist, when possible, is advised for all patients with delusional infestation. Copyright © 2012 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.
Kleijnen, J.; Knipschild, P.; ter Riet, G.
OBJECTIVE: To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN: Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using
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Full Text Available Background: Epicrania fugax (EF is a rare newly described primary headache characterized by paroxysms of unilateral pain radiating across one hemicranium. Aim: We aimed to describe 10 new cases of EF and assess the psychiatric comorbidity. Materials and Methods: Cases of EF were identified from patients attending the neurology outpatient department of a tertiary level referral and teaching hospital by the first author during a period extending from January 1, 2015 to April 31, 2017. Case ascertainment was done as per ICHD 3 beta criteria from among patients presenting with complaints of headache after detailed history and clinical examination. Clinical and demographic features were noted and patients were subjected to Mini Neuropsychiatric Interview to screen for psychiatric comorbidity followed by Becks Anxiety/Depression Inventory. Results: A total of 10 subjects were obtained during the study period, 4 males, and 6 females. Mean age of subjects was 45.3 years (standard deviation-10. Seventy percent had anteroposterior, and 30% had posteroanterior radiation of pain. The most common character of pain was stabbing (50% followed by electrical (40% and pressing (10%. None of the subjects had autonomic symptoms or focal symptoms in the scalp while 30% subjects had hyperesthesia in the affected area of the scalp.Six subjects (60% patients had episodic course while 40% had chronic course. Sixty percent had comorbid anxiety while one (10% had comorbid depression. A significant relation was obtained between duration of disease and occurrence of anxiety as well as Becks Anxiety Inventory scores while there was no correlation with attack duration. There was also a nonsignificant correlation between visual analog score and occurrence of anxiety symptoms. Conclusions: Our study conclusively proves the existence of EF as a rare, distinct primary headache syndrome in our study population. It has a significant psychiatric comorbidity consisting of 60% of
Østervig, R M; Sonne, A; Rasmussen, L S
starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...... the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...
Holmes, Jonathan M
Randomized clinical trial (RCT) study design leads to one of the highest levels of evidence, and is a preferred study design over cohort studies, because randomization reduces bias and maximizes the chance that even unknown confounding factors will be balanced between treatment groups. Recent randomized clinical trials and observational studies in amblyopia can be taken together to formulate an evidence-based approach to amblyopia treatment, which is presented in this review. When designing future clinical studies of amblyopia treatment, issues such as regression to the mean, sample size and trial duration must be considered, since each may impact study results and conclusions. Copyright © 2015 Elsevier Ltd. All rights reserved.
Katz, J N; Losina, E; Lohmander, L S
To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each...... relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies...
B.A. Kirwan (Bridget Anne)
textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients
Zander, Eduard; Wyder, Lea; Holtforth, Martin Grosse; Schnyder, Ulrich; Hepp, Urs; Stulz, Niklaus
To examine the validity of diagnoses obtained by clinicians during routine clinical examination on acute psychiatric inpatient wards. N=100 inpatients with a broad spectrum of major mental disorders were randomly selected in a mental hospital's department of general psychiatry. Patients were diagnosed by independent assessors within Md = 5 (Range: 1-18) days of admission using the SCID I in order to examine the validity of the diagnoses given by the clinical staff based on routine assessments. The commonly used clinical examination technique had good overall agreement with the SCID I assessments regarding primary diagnoses at the level of ICD-10 main categories (F2, F30-31, F32-F33, F4; κ = 0.65). However, agreement between routine clinical diagnoses and the SCID I diagnoses tended to be low for some specific mental disorders (e.g., depressive disorders) and for secondary diagnoses. The validity of routine clinical diagnoses established in acute inpatient settings is limited and should be improved. Copyright © 2017 Elsevier B.V. All rights reserved.
Emery, C. A.; Roos, Ewa M.; Verhagen, E.
The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...
Kjaergard, L L; Nikolova, D; Gluud, C
Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998......-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate......, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers...
Champion, Kim M; Jones, Gemma R
Clinical trials are performed to discover or verify the efficacy and safety of one or more investigational medicinal product (IMP). Biological medicinal products, including gene therapies, offer groundbreaking new opportunities for the treatment of disease and injury, but they are also highly regulated and trials with these products can be logistically challenging to set up and execute. To ensure a compliant and successful trial, it is important to know and understand the regulatory framework, and to be aware of available guidance documents published to advise the different stakeholders on how to develop, manufacture, handle, administer, or destroy these products safely and legally. This chapter summarizes the standard requirements and considerations applicable for clinical trials with IMPs and also describes additional requirements for trials with gene therapies or genetically modified microorganisms (GMM).This chapter has been written from the perspective of a UK noncommercial (academic) sponsor. As such, the discussion and guidance has its basis in gene therapy research as governed by UK law. Nevertheless, European legislation and guidance documents are also referenced; most of the following recommendations will be applicable to clinical trials with a gene therapy medicinal product in any European Member State, and the overriding principles would be applicable to any trial.
... Who will be in charge of my care? Personal issues How could being in this study affect ... iStock Only through clinical research can we gain insights and answers about the safety and effectiveness of ...
Jan 30, 2006 ... surrounding primary care clinics or hospitals and from ambulatory community psychiatric clinics. After screening and initial treatment, service users were referred to other specialized units such as the forensic, adolescent, psychotherapy and eating disorder units of the two psychiatric hospitals on the circuit.
Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D
Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.
Kiszka-Kanowitz, Marianne; Theede, Klaus; Mertz-Nielsen, Anette
remission rates and lower incidence of adverse events. AIM: To compare the rates of clinical remission and the rates of adverse events in IBD patients treated with either standard treatment with azathioprine or low-dose azathioprine in combination with allopurinol. METHODS: A prospective, open-label study...... to treat analysis and found a significant (69.6%) proportion of the patients treated with low-dose azathioprine in combination with allopurinol was in clinical remission without the need for steroid or biologic treatment at week 24 compared to 34.7% of the patients treated with azathioprine monotherapy (RR...
Kamphuis, Jeanine; Karsten, Julie; de Weerd, Al; Lancel, Marike
Objective: Poor sleep is known to cause detrimental effects on the course of diverse psychiatric disorders and is a putative risk factor for hostility and aggression. Thus, sleep may be crucial in forensic psychiatric practice. However, little is known about the prevalence of sleep disturbances in
The procurement, transport, storage, manufacturing or compounding, the application, disposal, documentation, and the quality assurance of investigational medicinal products (IMPs) have to be done according to the pharmaceutical sciences. Medicines related to clinical trials in the European Union are regulated in volume 10 of the EudraLex. The rules for commercially manufactured medicines for human use are not valid for medicines which are individually compounded for a certain patient in the pharmacy. They are also not valid for medicines dedicated for experiments in research and development. The present article describes standards concerning the participation of the pharmacy in clinical trials, the pathway of the drug including the role of the study personnel, and its qualification and training. The issue of stability and compatibility of IMPs is an important topic which may influence the outcome of clinical trials. To avoid quality shifts Standard Operating Procedures (SOPs) have to be established. Copyright 2008 S. Karger AG, Basel.
Žagar Zlatko A.
Full Text Available Prior the commencement of the clinical trial in Serbia the Sponsor is obliged to provide the insurance policy covering the patient's bodily injury and damaged health caused by the clinical trial. According to provisions of Serbian Insurance law insurance polices have to be issued by the insurance companies established in Serbia. Every insurance policy not issued by the insurance company established in Serbia shall be deemed as null and void. The only expectance, is when the foreign clinical trial liability policy is stipulated that the insurance contract acknowledges the jurisdiction of Serbian domestic courts and other Serbian authorities to decide on damage claims (that never happened in Serbian practice. The Sponsor will fulfill this obligation stipulated in Serbian law when provides the Clinical Trial Liability policy issued by the Serbian insurance company. Nowadays, few of Serbian insurance companies are issuing such polices. Under the clinical trial liability insurance cover the insured's are: Sponsor, Medical Centers in Serbia performing or controlling the clinical trial, Principal Investigators and their assistant staff performing or controlling the clinical trial. The beneficiaries of the insurance cover are patients and/or members of their families - inheritresses. The insurance company will indemnify the beneficiary mentioned in the policy when the insured event occurred i.e. when occurred bodily injury, psychic disease and alienation, psychic damages, illnesses and deaths caused by the clinical trial. The amount of indemnity by the insurance company to the beneficiaries is limited by the amount of sum insured per occurrence and/or by the total amount of the sum insured for the total period of the insurance cover. According to case-law in Serbia the total sum insured between EUR 500.000 and EUR 1.000.000 is considered as sufficient so far to indemnify the patients in case of the insured event. If an insurance event occurs the
Summers, Ron; Vyas, Hiten; Dudhal, Nilesh; Doherty, Neil F; Coombs, Crispin R; Hepworth, Mark
This paper will investigate innovations in information management for use in clinical trials. The application typifies a complex, adaptive, distributed and information-rich environment for which continuous innovation is necessary. Organisational innovation is highlighted as well as the technical innovations in workflow processes and their representation as an integrated set of web services. Benefits realization uncovers further innovations in the business strand of the work undertaken. Following the description of the development of this information management system, the semantic web is postulated as a possible solution to tame the complexity related to information management issues found within clinical trials support systems.
Maha S. Younis
Full Text Available Objective: Few studies have examined clinical and demographic profile of attendees of a walk-in psychiatric clinic in countries ravaged by wars. The aim of this study is to quantify the characteristics of attendees of an open walk-in psychiatric clinic in a general hospital in Baghdad and the suburb towns of Iraq in the year 2010.Methods: As part of a retrospective survey, information on specific variables (socio-demographic background, clinical characteristics and attendance rate were sought from medical records in the year 2010 (January to December.Results: Despite the shortcomings expected from a country coming out of the ravage of war, the survey included 2,979 attendees (1,864 [63%] males and 1,115 [37%] females of a walk-in psychiatric clinic who fulfilled the inclusion criteria. The profile of attendees indicated that a majority of the cohort was self-referred with a predominance of employed males, aged 19 to 49 years, residing in Baghdad City. Depression and psychosis were the most common diagnosis given.Conclusion: The observed patterns are discussed within the available literature relevant to consultation liaison psychiatry, and specific to situations in Iraq and Arab/Islamic cultural patterning.
W.J.C. Van Rhyn; M.R. Gontsana
An exploratory study was conducted with the aim of discovering and describing experiences of psychiatric nursing students during clinical placement in a psychiatric unit. For the purpose of the study an unstructured interview was conducted with each participant during their first placement in a psychiatric unit to identify the factors experienced as stressful. The results indicated that all eight participants experienced average to high stress. Sources of stress identified included, among oth...
Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.
In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.
Buus, Niels; Angel, Sanne; Traynor, Michael
This paper is a report of an interview study exploring psychiatric hospital nursing staff members' reflections on participating in supervision. Clinical supervision is a pedagogical process designed to direct, develop, and support clinical nurses. Participation rates in clinical supervision...... they influence participation rates. Twenty-two psychiatric hospital nursing staff members were interviewed with a semistructured interview guide. Interview transcripts were interpreted by means of Ricoeur's hermeneutic method. The respondents understood clinical supervision to be beneficial, but with very...
Aug 27, 2009 ... ondersteuning ontvang en dat daar beter oor hulle toesig gehou word. INFORMED CONSENT IN CLINICAL TRIALS: PERCEPTIONS AND. EXPERIENCES OF A SAMPLE OF SOUTH AFRICAN RESEARCHERS. INTRODUCTION. First articulated in the Nuremberg Code in 1947, informed consent (IC) has ...
The NCI Community Oncology Research Program (NCORP) is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico.
... Clinical Trials: Information and Options for People with Mood Disorders What are clinical trials? Clinical trials are research ... during a clinical trial? Clinical trials that test mood disorder treatments are usually conducted on an outpatient basis, ...
Background to the study: Medical student's attitude towards people with mental illness (PWMI) is very important for the future care of psychiatric patients. .... Nigeria. The College provides training for medical and dental ..... friendship with. PWMI.
Tudor, Megan E.; DeVincent, Carla J.; Gadow, Kenneth D.
The current study examined the association between prenatal pregnancy complications (PPC) and childhood psychiatric symptoms in children with an autism spectrum disorder (ASD) and non-ASD children who were referred to a psychiatric clinic (Controls). Parents completed a "DSM-IV"-referenced rating scale and developmental history questionnaire.…
Forsner, Tord; Wistedt, Anna Åberg; Brommels, Mats; Forsell, Yvonne
Abstract Background The aim of this study was to measure six months compliance to Swedish clinical guidelines in psychiatric care after an active supported implementation process, using structured measures derived from the guidelines. Methods In this observational study four psychiatric clinics each participated in active implementation of the clinical guidelines for the assessment and treatment of depression and guidelines for assessment and treatment of patients with suicidal behaviours dev...
Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida
The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763
Ladois-Do Pilar Rei, A; Chraïbi, S
The psychiatric ward is a place where all forms of violence are treated. Occasionally, this violence involves acts of aggression between patients in emergency psychiatric units or hospital wards. Such events can lead to the development or worsening of posttraumatic stress disorder. To establish the context, we first examined the epidemiology data concerning posttraumatic stress disorder in psychiatric patients who were frequently exposed to assaults. Secondly, we examined the issue of sexual and physical assaults between patients receiving treatment in a psychiatric ward. In this context, we studied possible occurrence of posttraumatic stress disorder associated with exposure to assaults of this kind. In certain cases, potentially traumatic exposure to violence was unknown to the medical staff or not taken into consideration. This would induce a risk of later development of posttraumatic stress disorder that would not be treated during the stay in psychiatry. To date, few scientific studies have focused on the proportion of patients assaulted by other patients during treatment in a psychiatric ward and the subsequent development of peritraumatic reactions and/or posttraumatic stress disorder associated with these assaults. We know that an insufficient number of public and private health institutions report the existence of such facts to the competent authorities. Also, a minority of clinicians and caregivers are trained in screening and management of trauma victims. Yet, these issues are particularly relevant in the scope of public health and health promotion. Copyright © 2017 Elsevier Masson SAS. All rights reserved.
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Pihlstrom, B L; Barnett, M L
Randomized controlled clinical trials offer the best evidence for changing clinical practice and informing public health policy. Using examples from the literature, this paper reviews clinical trials for those who may be unfamiliar with their design, operation, and interpretation. In the design of a clinical trial, the question to be answered and a clinically meaningful outcome must be clearly defined. Ethics must be considered, sample size carefully estimated, and use of biomarkers and surrogate outcomes understood. Prominent issues in trial implementation include developing a manual of operations, trial registration, subject recruitment and retention, use of a data coordinating center, and data and safety monitoring. Interpretation of clinical trials requires understanding differences between efficacy and effectiveness; superiority, equivalence, and non-inferiority; intent-to-treat; primary and secondary analyses; and limitations of unregistered small clinical trials compared with large multi-center Phase III trials that are more likely to be representative of a population and change clinical practice or public health policy.
.... Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases...
Kobes, M.H.B.M.; Nijman, H.L.I.; Bulten, B.H.
Objectives Accurate observation of aggressive behavior among forensic psychiatric patients requires valid instruments. This study examines the validity and clinical utility of combining the social dysfunction and aggression scale (SDAS) and staff observation aggression scale revised
Gonge, Henrik; Buus, Niels
This article reports findings from a longitudinal controlled intervention study of 115 psychiatric nursing staff. The twofold objective of the study was: (a) To test whether the intervention could increase clinical supervision participation and effectiveness of existing supervision practices...
McDonald, S W; Thom, A; Thom, A
In 1697, seven people were condemned at Paisley for using witchcraft to torment Christian Shaw, daughter of the laird of Bargarran. For seven months, Christian had bizarre seizures during which she claimed to see the Devil and her tormentors assaulting her. She also exhibited pica and said that the foreign material had been forced into her mouth by her invisible assailants. The notable Glasgow physician, Matthew Brisbane, was consulted and gave evidence at the trial; he could find no natural explanation for the pica. It is likely that Christian had a dissociative (conversion) disorder after being cursed by a servant. Christian recovered and later married the minister of Kilmaurs. After his untimely death, she established a highly successful spinning business which lead to the Paisley cotton industry.
Buus, Niels; Angel, Sanne; Traynor, Michael
Group-based clinical supervision is commonly offered as a stress-reducing intervention in psychiatric settings, but nurses often feel ambivalent about participating. This study aimed at exploring psychiatric nurses' experiences of participating in groupbased supervision and identifying psychosocial...... reasons for their ambivalence. Semi-structured interviews were conducted with 22 psychiatric nurses at a Danish university hospital. The results indicated that participation in clinical supervision was difficult for the nurses because of an uncomfortable exposure to the professional community. The sense...... of exposure was caused by the particular interactional organisation during the sessions, which brought to light pre-existing but covert conflicts among the nurses....
Refolo, P; Sacchini, D; Minacori, R; Spagnolo, A G
Recruiting patients is a critical point of today's clinical research and, along the years, several solutions have been proposed, even if their efficacy seems to be doubtful. On the other hand, nowadays, Internet represents a great opportunity for improving clinical trial recruitments. Nevertheless, on-line recruitment services (e-recruitment) could ensure some advantages (such as facilitating interaction between supply and demand of clinical research, time and money savings/optimizations, data entry errors reduction), but also raise some issues (such as those related to sampling, information, consent, real identity of participants and risks for data breaches). The article debates on the difficulties to recruit patients for clinical research, in general, and e-recruitment particularly, discussing some ethical issues raised by internet enrolment.
D.Cur. The purpose of this research study was to describe a model to facilitate collaboration between the institutions of higher education and psychiatric health care services in order to promote psychiatric clinical nursing education, with guidelines to operationalise the model. In spite of the calls by statutory bodies and contemporary legislation for collaboration between institutions of higher education and psychiatric health care services, there are few instances where formalised coll...
implication for the future care of psychiatric patients. No doubt, medical students' attitudes are key factors in determining their willingness to deal with mentally ill patients, even in general practice. Stigma and negative attitudes towards the mentally ill lead to strained social interaction, low self-esteem, loss of employment and ...
Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.
Cosín Aguilar, J; Hernándiz Martínez, A
n 1987 the results of the Consensus study were published, and showed that enalapril, an angiotensin convertor enzyme inhibitor (ACEI), was able to modify the clinical course of the heart failure syndrome thereby reducing mortality. Other ACEI later demonstrated the same effect on the different degrees of symptomatic heart failure, left ventricular dysfunction, myocardial infarction and more recently in diabetic patients. In 1996 studies on the betablockers carvedilol, bisoprolol and metoprolol showed their efficacy in reducing deaths due to progressive heart impairment and sudden death in chronic heart failure. The RALES study showed that small doses of spironolactone also improved the prognosis on this disease. Digital improves the quality of life but not the survival rate. Only amiodarone (among the antiarrhythmics) reduces sudden death. Other drugs and groups of drugs can not be considered for chronic outpatient treatment of heart failure. Multicenter trials make it possible to obtain scientific evidence for establishing rational treatments. Many groups of patients such as women, elderly people and the more severe cases of the disease are often not included in these trials. Occasionally, multicenter trials are badly designed (CIBIS and MCD), which in the case of betablockers, led to a substantial delay in their administration. Other times, as in the ELITE study, the results were badly interpreted. The knowledge obtained from these studies is slow in reaching patients, with few patients taking betablockers. It is known that most patients do not take the doses found to be effective in multicenter trials.
Califf, R.M.; Zarin, D.A.; Kramer, J.M.; Sherman, R.E.; Aberle, L.H.; Tasneem, A.
CONTEXT: Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials
Cihoric, Nikola; Tsikkinis, Alexandros; van Rhoon, Gerard; Crezee, Hans; Aebersold, Daniel M.; Bodis, Stephan; Beck, Marcus; Nadobny, Jacek; Budach, Volker; Wust, Peter; Ghadjar, Pirus
Hyperthermia has been shown to improve the effectiveness of chemotherapy and radiotherapy in the treatment of cancer. This paper summarises all recent clinical trials registered in the ClinicalTrials.gov registry. The records of 175,538 clinical trials registered at ClinicalTrials.gov were
Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.
Zarea, Kourosh; Nikbakht-Nasrabadi, Alireza; Abbaszadeh, Abbas; Mohammadpour, Ali
Psychiatric nurses play an important role in the process of caring for mentally ill patients and are continually faced with the numerous challenges and complex issues related to this field. This study aimed to understand the perspectives of psychiatric nurses regarding the issues they face while providing care and examine the possible solutions for improvement of inpatient care in clinical settings. The study adopted a qualitative approach that utilized a content analysis of audio taped, semi-structured interviews that had been conducted with 24 nurses. Two main themes emerged from the data. The first, Challenges in Providing Care within Psychiatric Wards, had the following subthemes: Politics and Rules of Organization, Safety and Security Issues, Uncertainty about the Role, Lack of Trained Staff, and Sociocultural Issues. The second theme, Solutions for Improving Psychiatric Care, had the subthemes of Empowerment across four domains: Psychiatric Nurses, Mentally Ill Patients and their Families, The Psychiatric Mental Health System, and the Cultural Context. The results indicated that if nurses are expected to provide optimal nursing care within a psychiatric ward, then there is a need for a stable and responsible organizational structure, skilled psychiatric nurses, and community-based care along with an anti-stigma program.
Raptis, Dimitri Aristotle; Mettler, Tobias; Fischer, Michael Alexander; Patak, Michael; Lesurtel, Mickael; Eshmuminov, Dilmurodjon; de Rougemont, Olivier; Graf, Rolf; Clavien, Pierre-Alain; Breitenstein, Stefan
Multicentre clinical trials are challenged by high administrative burden, data management pitfalls and costs. This leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reluctance in conducting multicentre clinical trials. The purpose of this study was to develop a web-based open source platform to support a multi-centre clinical trial. We developed on Drupal, an open source software distributed under the terms of the General Public License, a web-based, multi-centre clinical trial management system with the design science research approach. This system was evaluated by user-testing and well supported several completed and on-going clinical trials and is available for free download. Open source clinical trial management systems are capable in supporting multi-centre clinical trials by enhancing efficiency, quality of data management and collaboration.
Gelfand, Yaroslav; Kaplitt, Michael G
Gene therapy has become of increasing interest in clinical neurosurgery with the completion of numerous clinical trials for Parkinson disease, Alzheimer disease, and pediatric genetic disorders. With improved understanding of the dysfunctional circuitry mediating various psychiatric disorders, deep brain stimulation for refractory psychiatric diseases is being increasingly explored in human patients. These factors are likely to facilitate development of gene therapy for psychiatric diseases. Because delivery of gene therapy agents would require the same surgical techniques currently being employed for deep brain stimulation, neurosurgeons are likely to lead the development of this field, as has occurred in other areas of clinical gene therapy for neurologic disorders. We review the current state of gene therapy for psychiatric disorders and focus specifically on particular areas of promising research that may translate into human trials for depression, drug addiction, obsessive-compulsive disorder, and schizophrenia. Issues that are relatively unique to psychiatric gene therapy are also discussed. Copyright © 2013. Published by Elsevier Inc.
Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.
Gustafsson, Finn; Atar, Dan; Pitt, Bertram
Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...
Berry, Scott M; Muller, Peter
Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISP...
Ahn, Chul; Ahn, Daniel
A randomized clinical trial (RCT) is widely regarded as the most rigorous study design to determine the efficacy of intervention since spurious causality and bias associated with other experimental designs can be avoided. The purpose of this article is to provide clinicians and clinical researchers with the types of randomized clinical trials used in stroke studies and to discuss the advantages and limitations in each type of randomized stroke clinical trials.
Watters, Julie T; Pitzen, Jason H; Sanders, Linda J; Bruce, Virginia Nickie M; Cornell, Alissa R; Cseko, Gary C; Grace, Janice S; Kwon, Pamela S; Kukla, Andrea K; Lee, Michael S; Monosmith, Michelle D; Myren, John D; Kottschade, Rebecca S; Shaft, Marc N; Weis, Jennifer Jenny A; Welter, Jane C; Bharucha, Adil E
The Institute of Medicine and US Food and Drug Administration (FDA) recognize that activating clinical trials in the United States is lengthy and inefficient. Downstream consequences include increased expense, suboptimal accrual, move of clinical trials overseas, and delayed availability of treatments for patients. An in-tandem processing initiative is here highlighted that transformed the activation of clinical trials (TACT), reduced the activation time by 70%, and offers a paradigm for enhanced translational readiness. © 2017 American Society for Clinical Pharmacology and Therapeutics.
Valdes-Stauber, Juan; Kilian, Reinhold
This study examines whether psychiatric outpatient clinics fulfill their statutory role of providing psychiatric services for patients with severe mental disorders. A retrospective cross-sectional study on 1,672 patients of a psychiatric outpatient clinic for the year 2010, based on 30 variables. Associations between variables were explored by means of robust multivariate regression models and polynomial regression plots. The patients' average CGI value was found to be 5.98, the mean GAF-score 47.3, and the mean duration of illness 13.8 years. A third of the sample attempted suicide in the past. Metabolic comorbidity was found in 23.1 % of the sample. Results of regression analyses reveal positive effects of the disease severity and functional impairment on the use of psychiatric care. Patients with affective and schizophrenic disorders received more units of care and caused more costs. Patients living in nursing homes received less in- and outpatient care but caused more medication costs. Study results support the assumption that German psychiatric outpatient clinics fulfill their statutory duties by treating severely chronically mentally ill patients. The patients' use of care is positively related to the disease severity and their functional impairment. However, results of the regression analyses suggest that patients living in nursing homes received less psychiatric care than patients who live more independently. © Georg Thieme Verlag KG Stuttgart · New York.
Orui, Masatsugu; Hirokawa, Seiko; Akazawa, Masato; Tachimori, Hisateru; Kawano, Kenji; Mori, Takao; Akita, Hiroya; Takeshima, Tadashi
Although factors related to suicide are complicated, mental health disorders are an important risk factor. It is anticipated that suicide prevention measures will be implemented from the perspective of improved psychiatric medicine. No national-scale study has been carried out in Japan on the state of psychiatric medicine and its influence on suicide since 2000. Moreover, many efforts not intended for suicide prevention have been shown to be effective for this purpose. Here, we conducted surveys to obtain basic data on suicide prevention and improvements in mental health care among 1,728 psychiatric hospitals and clinics in Japan in 2010. The incidence of suicide in psychiatric hospitals and clinics from January to December 2009 was estimated to be 100.5 for outpatients and 154.5 for inpatients per 100,000 patients. Regarding the duration from consultation to suicide, 87% of outpatients committed suicide less than one month following their last consultation. Moreover, approximately two-thirds of patients had undergone consultations for more than one year. A number of suicides in psychiatric hospitals and clinics occurred while patients were continuously undergoing treatment. Efforts shown to be effective in suicide prevention included risk assessment with multiple medical staff (i.e., doctors and nurses), a 24-hour crisis line, and a follow-up system for discontinued outpatients. We expect that the results of this survey will aid in the implementation of effective suicide prevention in psychiatric medicine.
Full Text Available Background: Stigma or negative discriminatory attitudes towards psychiatric patients are common in the general public. These attitudes are also demonstrated by medical practitioners and by medical students, which can lead to medical harm to psychiatric patients. This study aimed to improve attitudes of medical students towards psychiatric patients before their clinical rotations. Methods: Second year preclinical medical students participated in a brief structured early clinical experience which involved introduction to a psychiatric patient in a hospital/clinic setting or in a community vocational setting. Students were randomized to either setting. Data were collected one week before, one week after, and 3 months after the early clinical experience by administering the Medical Condition Regard Scale. Results: The students’ attitudes towards psychiatric patients improved, particularly at follow up. Only male student attitudes improved significantly. Conclusion: Further study is required to understand and improve medical students’ attitudes towards psychiatric patients, perhaps particularly in relation to female students’ attitudes.
Baradell, J G
Survey research was conducted to examine clinical outcomes and satisfaction of patients of psychiatric mental health clinical nurse specialists (CNSs). Patients who had terminated from outpatient psychotherapy with 6 CNSs in 1993 were mailed a questionnaire (N = 223). Follow-ups by mail yielded a response rate of 45% (n = 100). The questionnaires included the Profile of Mood States-Short Form ([POMS-SF]; McNair, Lorr, & Droppleman, 1992). Quality of Life Function ([QOL]; Lehman, 1991), and Patient Satisfaction Scale (Baradell, 1994). Paired difference t-tests were used to evaluate clinical outcomes. Percentages were used to report satisfaction, and Pearson correlations were used to examine the relationship between clinical outcomes and patient satisfaction. The mean age for respondents was 37 years; 82% were female. Diagnoses included depression (46%), adjustment disorders (34%), anxiety (10%), and other (10%). Patients reported significant improvement in all clinical symptoms: anxiety, depression, anger, confusion, fatigue and vigor. Patients reported significant improvement in all domains of QOL: family, social, and job. Patients reported a very high level of satisfaction with the care provided. The more clinical improvement the patients reported, the more satisfied they were with the care provided. If nurses are to be included in a reformed health care delivery system in the future, additional research is essential.
Balevic, Stephen J; Becker, Mara L; Cohen-Wolkowiez, Michael; Schanberg, Laura E
Randomized clinical trials provide the gold standard evidence base to guide clinical practice. Despite major advances in trial design, pediatric clinical trials are still difficult to perform and pose unique challenges, including the need to consider the impact of developmental changes in trial design. Advances within pediatric rheumatology combined with the need to comply with legislative requirements have driven new approaches to performing pediatric clinical trials such as utilization of large research networks, incorporation of patient and family stakeholders in the planning and implementation of clinical trials, and the development of novel trial designs. The expansion of available biological therapeutics that now includes biosimilar drugs highlights the important and difficult balance of providing new and cost-effective drugs to children while ensuring safety in a vulnerable population. Future advances in juvenile idiopathic arthritis (JIA) clinical trials will likely be the application of precision medicine based on biologic, rather than phenotypic, classification of JIA, with improved understanding of pediatric clinical pharmacology. Clinical trial simulations and comparative effectiveness studies are important supplements to traditional clinical trials, permitting efficient studies and results that are more generalizable.
W.J.C. Van Rhyn
Full Text Available An exploratory study was conducted with the aim of discovering and describing experiences of psychiatric nursing students during clinical placement in a psychiatric unit. For the purpose of the study an unstructured interview was conducted with each participant during their first placement in a psychiatric unit to identify the factors experienced as stressful. The results indicated that all eight participants experienced average to high stress. Sources of stress identified included, among others, ineffective teaching and learning programmes, poor managerial governance of the service, detachment of professional nurses from their teaching role, poor relationships among staff, overreliance on the medical model of care and patient neglect. Psychiatric nursing students sampled indicated universal support for in-service education and training for professional nurses, attitude change of professional nurses towards students, support for student initiatives, student involvement in patient care and adequate allocation of resources for patient care and nurse training. The exploration and description of experiences of the psychiatric nursing students will help nurse educators plan clinical learning opportunities in such a way that they are less stressful, thus ensuring that psychiatric nursing students are equipped to utilise themselves as therapeutic instruments.
W Adams, Zachary; McClure, Erin A; Gray, Kevin M; Danielson, Carla Kmett; Treiber, Frank A; Ruggiero, Kenneth J
Psychiatric disorders are linked to a variety of biological, psychological, and contextual causes and consequences. Laboratory studies have elucidated the importance of several key physiological and behavioral biomarkers in the study of psychiatric disorders, but much less is known about the role of these biomarkers in naturalistic settings. These gaps are largely driven by methodological barriers to assessing biomarker data rapidly, reliably, and frequently outside the clinic or laboratory. Mobile health (mHealth) tools offer new opportunities to study relevant biomarkers in concert with other types of data (e.g., self-reports, global positioning system data). This review provides an overview on the state of this emerging field and describes examples from the literature where mHealth tools have been used to measure a wide array of biomarkers in the context of psychiatric functioning (e.g., psychological stress, anxiety, autism, substance use). We also outline advantages and special considerations for incorporating mHealth tools for remote biomarker measurement into studies of psychiatric illness and treatment and identify several specific opportunities for expanding this promising methodology. Integrating mHealth tools into this area may dramatically improve psychiatric science and facilitate highly personalized clinical care of psychiatric disorders. Copyright © 2016 Elsevier Ltd. All rights reserved.
Krooks, J A; Weatherall, A G; Holland, P J
Approximately half of all patients presenting to dermatologists exhibit signs and symptoms of psychiatric conditions that are either primary or secondary to cutaneous disease. Because patients typically resist psychiatric consult, dermatologists often are on the front line in evaluating and treating these patients. Accordingly, distinguishing the specific underlying or resulting psychiatric condition is essential for effective treatment. The etiology, epidemiology, clinical presentation, diagnosis, and first-line treatment of specific primary psychiatric causes of dermatologic conditions, including delusional infestation, Morgellons syndrome, olfactory reference syndrome, body dysmorphic disorder, excoriation disorder, trichotillomania, and dermatitis artefacta are discussed here, followed by a discussion of the recommended treatment approach with an overview of the different first-line therapies discussed in this review, specifically cognitive behavioral therapy, atypical antipsychotics, selective serotonin reuptake inhibitors, and tricyclic antidepressants. Included is a guide for dermatologists to use while prescribing these medications.
Podsevatkin, V G; Blinov, D S; Podsevatkin, D V; Podsevatkina, S V; Smirnova, O A
The new technology of hospital psychiatric care, developed and implemented in the Mordovia republican clinical hospital, permits resolving problems of hospitalism, lethality, pharmaceutical resistance and others. The essence of this technology is in staging of hospital care under condition of intensification and standardization of curative diagnostic process, implementation of complex approach to treatment of psychiatric disorders. The patient sequentially passes through three stages: intensive diagnostics and intensive treatment (intensive care department, intensive therapy department), supportive therapy (general psychiatric department); rehabilitation measures (curative rehabilitative department). The concentration of resources at the first stage, application of intensive therapy techniques permit in the shortest period to arrest acute psychotic symptomatic. The described new technology of hospital psychiatric care permits enhancing effectiveness of treatment, significantly shorten period of hospitalization (37.5 days), to obtain lasting and qualitative remission, to rehabilitate most fully social working status of patient and to significantly decrease lethality.
Schweitzer, Pernilla J.; Rice, Timothy R.
Objective: Student-run clinics are increasingly common in medical schools across the United States and may provide new opportunities for psychiatric education. This study investigates the educational impact of a novel behavioral health program focused on depressive disorders at a student-run clinic. Method: The program was assessed through chart…
Conclusion: The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.
Full Text Available Abstract Background Internet administered cognitive behaviour therapy (CBT is a promising new way to deliver psychological treatment, but its effectiveness in regular care settings and in relation to more traditional CBT group treatment has not yet been determined. The primary aim of this study was to compare the effectiveness of Internet-and group administered CBT for panic disorder (with or without agoraphobia in a randomised trial within a regular psychiatric care setting. The second aim of the study was to establish the cost-effectiveness of these interventions. Methods Patients referred for treatment by their physician, or self-referred, were telephone-screened by a psychiatric nurse. Patients fulfilling screening criteria underwent an in-person structured clinical interview carried out by a psychiatrist. A total of 113 consecutive patients were then randomly assigned to 10 weeks of either guided Internet delivered CBT (n = 53 or group CBT (n = 60. After treatment, and at a 6-month follow-up, patients were again assessed by the psychiatrist, blind to treatment condition. Results Immediately after randomization 9 patients dropped out, leaving 104 patients who started treatment. Patients in both treatment conditions showed significant improvement on the main outcome measure, the Panic Disorder Severity Scale (PDSS after treatment. For the Internet treatment the within-group effect size (pre-post on the PDSS was Cohen's d = 1.73, and for the group treatment it was d = 1.63. Between group effect sizes were low and treatment effects were maintained at 6-months follow-up. We found no statistically significant differences between the two treatment conditions using a mixed models approach to account for missing data. Group CBT utilised considerably more therapist time than did Internet CBT. Defining effect as proportion of PDSS responders, the cost-effectiveness analysis concerning therapist time showed that Internet treatment had superior cost
Vieira, Jean Mendes de Lucena; Lima, Elisangela da Costa; Land, Marcelo Gerardin Poirot; Ventura, Miriam; Coelho, Helena Lutescia Luna
This study aimed to characterize the clinical trials with medicines enrolling Brazilian children and adolescents, registered in the databases of Clinical Trials and the Brazilian Clinical Trials Network (ReBEC) from 1994 to 2014. Only 462 clinical trials enrolled Brazilian children and adolescents. There was an increase in registrations beginning in 2003, with an important drop in 2011. Among these trials, 35.5% were hosted in Brazil. The international clinical trials were mostly conducted by North American companies. In both cases, multinational industry was the principal source of funding. The clinical trials were predominantly phase III with injectable and solid oral pharmaceutical forms of antiviral drugs. Domestic clinical trials showed wider variation in the pharmaceutical forms and higher percentage of liquid formulations, when compared to the international trials. In addition to heavy external dependence for conducting clinical trials, the study emphasized the challenge for pediatric care in Brazil, which presents epidemiological peculiarities in an environment prone to the use of unlicensed medicines for children.
Full Text Available Background: Autism Spectrum Disorder (ASD is an early neurodevelopmental disorder that accompanies the individual throughout life. There is a significant clinical overlap of ASD with other psychiatric disorders including personality disorders, psychotic disorders, obsessive-compulsive disorder and depression. Additionally, the presence of high rates of psychiatric comorbidity, often with atypical presentations, delays the ASD diagnosis and makes it more difficult to manage. Aims: To illustrate the complexity of ASD diagnosis and approach in adults. Methods: Report of a clinical case and review of the literature. Results and Conclusion: This paper presents the case of a 46-year-old patient, with ASD, with a long history of interpersonal difficulties and psychiatric symptomatology. Over the years, different diagnoses have been made, particularly schizoid and schizotypal personality disorders, psychosis not otherwise specified and paranoid schizophrenia, which led to poor adherence to treatment, and prevented a full understanding of the patient’s clinical presentation and lifelong struggles.
Gowri, S; Kannan, Sridharan
Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy
Swartz, Holly A; Zuckoff, Allan; Frank, Ellen; Spielvogle, Heather N; Shear, M Katherine; Fleming, M A Dana; Scott, John
Major depression affects one out of five women during her lifetime. Depressed mothers with psychiatrically ill children represent an especially vulnerable population. Challenged by the demands of caring for ill children, these mothers often put their own needs last; consequently, their depressions remain untreated. This population is especially difficult to engage in treatment. We have developed a nine-session intervention, an engagement session followed by eight sessions of brief interpersonal psychotherapy designed to increase maternal participation in their own psychotherapy, resolve symptoms of maternal depression, and enhance relationships (IPT-MOMS). This open-label trial assesses the feasibility and acceptability of providing this treatment to depressed mothers. Thirteen mothers meeting DSM-IV criteria for major depression were recruited from a pediatric mental health clinic where their school-age children were receiving psychiatric treatment. Subjects (mothers) were treated openly with IPT-MOMS. Eighty-five percent (11/13) completed the study. Subjects were evaluated with the Hamilton Rating Scale for Depression, and completed self-report measures of quality of life and functioning at three time points: baseline, after treatment completion, and 6-months posttreatment. A signed rank test was used to compare measurement changes between assessment time points. Subjects showed significant improvement from baseline to posttreatment on measures of maternal symptoms and functioning. These gains were maintained at 6-month follow-up. Therapy was well tolerated and accepted by depressed mothers, who are typically difficult to engage in treatment. A high proportion of subjects completed treatment and experienced improvements in functioning. Future randomized clinical trials are needed to establish the efficacy of this approach.
Dijkstra, B.A.; Jong, C.A.J. de; Wensing, M.J.P.; Krabbe, P.F.M.; Staak, C.P. van der
Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results
Dijkstra, B.A.G.; Jong, C.A.J. de; Wensing, M.J.P.; Krabbe, P.F.M.; Staak, C.P.F. van der
Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results
Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F
Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results
Fekadu, Abebaw; Teferra, Solomon; Hailu, Asrat; Gebre-Mariam, Tsige; Addissie, Adamu; Deressa, Wakgari; Yimer, Getnet; Reja, Ahmed
Low income countries like Ethiopia are underrepresented in clinical research. As a major public commitment to clinical research, Ethiopia celebrated the International Clinical Trial Day (ICTD) for the first time on 20 May 2014 under the auspices of Addis Ababa University. The motto for the day was 'Clinical Trials for Excellence in Patient Care'. The celebration offered an opportunity to inform academic staff, researchers, students and the leadership about clinical trials being conducted and to discuss the future of clinical trials in the country. Although clear challenges to the conduct of trials abound, clinical trials registered from Ethiopia in trial registration databases is increasing. Cross-country collaborations, international funding support, motivation of academic staff to conduct clinical trials and the commitment and engagement of the leadership in research are all improving. The overall impact of clinical trials is also encouraging. For example, some of the trials conducted in Ethiopia have informed treatment guidelines. However, administrative capacity, research infrastructure as well as financial support remain weak. There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence. Ethiopia, as well as the whole of Africa, has an unparalleled opportunity to lead the way in clinical trials, given its prospect of development and the need to have locally relevant evidence for its growing population. In this commentary we reflect on the celebration of ICTD, the status and opportunities for conducting clinical trials and the way forward for facilitating clinical trials in Ethiopia and Africa.
Wong, Wing S; Chen, Phoon P; Yap, Jackequaline; Mak, Kan Hing; Tam, Barry Ka H; Fielding, Richard
The objective of this study was to examine the associations between chronic pain and psychiatric morbidity using interview-based assessments of psychiatric symptomatology. We compared the prevalence of common mental disorder (CMD; consistent with neurotic and somatic symptoms, fatigue, and negative affect), depression, and anxiety disorder(s), and associated factors with these psychiatric illnesses among Chinese patients with chronic pain attending specialist orthopedics clinic and multidisciplinary pain clinic. A total of 370 patients with chronic pain were recruited from an Orthopedics Clinic (N=185) and a Pain Clinic (N=185) in Hong Kong. Psychiatric morbidity was assessed using the Revised Clinical Interview Schedule. Individual scores for neurotic symptoms and neurotic disorders (including depression and four types of anxiety disorders) were also calculated. The reported lifetime prevalence rates of CMD were 35.3% and 75.3% for the Orthopedics and Pain Clinic samples, respectively. Rates of depression and anxiety disorders in the Pain Clinic (57.1% and 23.2%, respectively) were significantly higher than those in the Orthopedics sample (20.2% and 5.9%, respectively) (all P<0.001). Pain characteristics including number of pain sites, pain duration, pain intensity, and pain interference were all significantly associated with psychiatric morbidity after controlling for sociodemographic factors. Pain duration and litigation/compensation status consistently predicted concurrent pain intensity and disability. Chronic pain is associated with psychiatric morbidity. The higher rate of depression than anxiety disorder(s) among patients with chronic pain is consistent with previous studies that have found depression to be highly prevalent in chronic pain. Wiley Periodicals, Inc.
Alosaimi, Fahad Dakheel; Altuwirqi, Maram Hani; Bukhari, Mujahid; Abotalib, Zeinab; BinSaleh, Saleh
No study has assessed psychiatric disorders among infertile men and women seeking fertility treatment in Saudi Arabia. Therefore, we sought to measure the rate of psychiatric disorders in this population. This was a cross-sectional observational study among patients attending infertility clinics at three referral hospitals in Riyadh, Saudi Arabia, between January 2013 and September 2014. 406 patients (206 women and 200 men) participated in the study. The approved Arabic version of the MINI tool was used to assess 18 common psychiatric illnesses. The response rate was 81%. Of the men surveyed, only 4.5% self-reported having a psychiatric disorder. Of the women surveyed, only 10.2% reported having a psychiatric disorder. However, using the MINI scale, psychiatric illness was documented in 30% of males and 36.9% of females. The most common diagnoses for both genders were depression (21.7%) and anxiety (21.2%). Significantly more females than males exhibited suicidality and depression. In contrast, significantly more males than females had bipolar disorders and substance-related disorders. A low monthly income among male and female participants and polygamy among female participants were significantly associated with psychiatric disorders. This study shows that a higher prevalence of psychiatric disorders, particularly depression and anxiety, among infertile men and women in Saudi Arabia is associated with lower income and polygamy. This study highlights the importance of integrated care for alleviating the psychological burden of this unfortunate population and improving outcomes and quality of life. This study also encourages follow-up studies that aim to further understand the complex relationship between fertility and psychological well-being.
Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan
In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical
Full Text Available Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP. This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field.
Okonta, Patrick I
The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.
C. A. Caramori
Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.
Buhmann, Cæcilie; Lykke Mortensen, Erik; Nordentoft, Merete
PURPOSE: To describe change in mental health after treatment with antidepressants and trauma-focused cognitive behavioral therapy. METHODS: Patients receiving treatment at the Psychiatric Trauma Clinic for Refugees in Copenhagen completed self-ratings of level of functioning, quality of life...
Haubold, Alexander; Peterson, Bradley S.; Bansal, Ravi
Brain morphometry in recent decades has increased our understanding of the neural bases of psychiatric disorders by localizing anatomical disturbances to specific nuclei and subnuclei of the brain. At least some of these disturbances precede the overt expression of clinical symptoms and possibly are endophenotypes that could be used to diagnose an…
Background: Co-morbid psychiatric disorders may mask or be masked by Attention-deficit hyperactivity disorder (ADHD), thereby confounding the clinical assessment ... awareness of these co-morbid disorders, which could become targets for interventions that may reduce the overall morbidity profile of children with ADHD.
Baer, Susan; Saran, Kelly; Green, David A; Hong, Irene
Electronic media use is highly prevalent among today's youth, and its overuse in the general population has been consistently associated with the presence of psychiatric symptoms. In contrast, little information exists about electronic media use among youth with psychiatric disorders. Our study aims to compare patterns of television and computer and gaming station use among youth in psychiatric clinic and community-based school populations. Surveys were completed by 210 youth and parents, from school (n = 110) and psychiatric clinic (n = 100) populations. Duration and frequency of television, video gaming, and nongaming computer activities were ascertained, along with addictive features of use. Descriptive and comparative analyses were conducted, with a statistical threshold of P addictive patterns related to computer and gaming station use were similar between the 2 populations. However, the clinically based sample favoured more violent games, with 29% reporting playing mature-rated games, compared with 13% reported by the school-based sample (P = 0.02). Youth with externalizing disorders expended greater time video gaming, compared with youth with internalizing disorders (P = 0.01). Clinically based samples of youth with mental illnesses spend more time engaged in electronic media activities and are more likely to play violent video games, compared with youth in the general population. Further research is needed to determine the long-term implications of these differences.
Vanessa de Albuquerque Citero
Full Text Available ABSTRACT CONTEXT: An almost 50% prevalence of psychiatric disorders among cancer patients has prompted a series of studies on consultation-liaison psychiatry. Nonetheless, there are few reports on the epidemiological factors involving comorbidity between cancer and psychiatric disorders. OBJECTIVE: To evaluate the epidemiological profile of cancer inpatients referred to the consultation-liaison psychiatric service in an oncology hospital during its first year of activity. TYPE OF STUDY: Descriptive study. SETTING: Tertiary-care teaching hospital. PARTICIPANTS: 319 patients referred 412 times to the consultation-liaison psychiatry service. PROCEDURES: From August 97 to July 98, an appraisal was made of data on all admissions registered at the Hospital do Câncer, and also all referrals registered at the consultation-liaison psychiatry service. MAIN MEASUREMENTS: The demographics and patients' clinical data, the type and flow of the request, and the evaluation conducted by the service were analyzed and comparisons with the hospital data were made. The distribution of the number of referrals was used to construct a profile of patients who had repeatedly used the service. RESULTS: Psychiatric diagnoses were found in 59% of the cases. Forty-three percent of these required medication, 18.3% needed psychotherapy, 22.1% family intervention and 20.5% guidance from the staff. Over 22.8% of the consultations were reevaluations, mainly involving younger male patients with worst prognoses. These patients required lengthier and more elaborate intervention, and had higher prevalence of depressive and behavioral disorders. CONCLUSION: A younger and mainly male population of non-surgical oncological cases was referred to the consultation-liaison psychiatric service during its first year of activity. The psychiatric disorder prevalence was higher than expected, and consisted predominantly of mood disorders. We detected a priority group, namely the reevaluated
Klimt, C R
The subject of varied acceptance of clinical trial results is discussed in the context of review of trials with which I have been involved and my subjective evaluation of their impact on the practice of clinical medicine. My experience goes back to 1949 and a World Health Organization trial of hyperimmune gamma globulin against rabies. This was followed by a large trial of secondary prevention of poliomyelitis. I participated in the planning and initiation of the first chronic disease trial, the University Group Diabetes Program (UGDP). The latter lasted for 15 years and its ramifications continue to this day. My next trial was the Coronary Drug Project (CDP), a complex trial with more than 8,000 patients. The trials of aspirin and aspirin combined with persantine (the CDPA, AMIS, PARIS I, and PARIS II) followed. My last three trials were a trial of photocoagulation in diabetic retinopathy (DRS), a six-country trial of the antiarrhythmic drug mexiletine (IMPACT), and a study involving two diagnostic procedures for pulmonary embolism (PIOPED). When one considers, in retrospect, the plethora of trials one is struck by the uniform absence of a priori considerations of the impact on medical practice, or likely lack thereof, of possible outcomes.
de Jong Fransina J
Full Text Available Abstract Background Common mental disorders are the most prevalent of all mental disorders, with the highest burden in terms of work absenteeism and utilization of health care services. Evidence-based treatments are available, but recognition and treatment could be improved, especially in the occupational health setting. The situation in this setting has recently changed in the Netherlands because of new legislation, which has resulted in reduced sickness absence. Severe mental disorder has now become one of the main causes of work absenteeism. Occupational physicians (OPs are expected to take an active role in diagnosis and treatment, and seem to be in need of support for a new approach to handle cases of more complex mental disorders. Psychiatric consultation can be a collaborative care model to achieve this. Methods/design This is a two-armed cluster-randomized clinical trial, with randomization among OPs. Forty OPs in two big companies providing medical care for multiple companies will be randomized to either the intervention group, i.e. psychiatric consultation embedded in a training programme, or the control group, i.e. only training aimed at recognition and providing Care As Usual. 60 patients will be included who have been absent from work for 6–52 weeks and who, after screening and a MINI interview, are diagnosed with depressive disorder, anxiety disorder or somatoform disorder based on DSM-IV criteria. Baseline measurements and follow up measurements (at 3 months and 6 months will be assessed with questionnaires and an interview. The primary outcome measure is level of general functioning according to the SF-20. Secondary measures are severity of the mental disorder according to the PHQ and the SCL-90, quality of life (EQ-D5, measures of Return To Work and cost-effectiveness of the treatment assessed with the TiC-P. Process measures will be adherence to the treatment plan and assessment of the treatment provided by the Psychiatric
The making of decisions pertaining to health and personal issues is dependent on the ability of the patient to function in various areas. The concept of competence is viewed differently from the clinical as opposed to the legal viewpoint. Some jurisdictions have introduced into legislation more specific legal guidelines for ...
Dalai, Venkata V; Khalid, Sana; Gottipati, Dinesh; Kannampallil, Thomas; John, Vineeth; Blatter, Brett; Patel, Vimla L; Cohen, Trevor
Clinicians' attention is a precious resource, which in the current healthcare practice is consumed by the cognitive demands arising from complex patient conditions, information overload, time pressure, and the need to aggregate and synthesize information from disparate sources. The ability to organize information in ways that facilitate the generation of effective diagnostic solutions is a distinguishing characteristic of expert physicians, suggesting that automated systems that organize clinical information in a similar manner may augment physicians' decision-making capabilities. In this paper, we describe the design and evaluation of a theoretically driven cognitive support system (CSS) that assists psychiatrists in their interpretation of clinical cases. The system highlights, and provides the means to navigate to, text that is organized in accordance with a set of diagnostically and therapeutically meaningful higher-level concepts. To evaluate the interface, 16 psychiatry residents interpreted two clinical case scenarios, with and without the CSS. Think-aloud protocols captured during their interpretation of the cases were transcribed and analyzed qualitatively. In addition, the frequency and relative position of content related to key higher-level concepts in a verbal summary of the case were evaluated. In addition the transcripts from both groups were compared to an expert derived reference standard using latent semantic analysis (LSA). Qualitative analysis showed that users of the system better attended to specific clinically important aspects of both cases when these were highlighted by the system, and revealed ways in which the system mediates hypotheses generation and evaluation. Analysis of the summary data showed differences in emphasis with and without the system. The LSA analysis suggested users of the system were more "expert-like" in their emphasis, and that cognitive support was more effective in the more complex case. Cognitive support impacts
Klimt, C R
Long-term clinical trials often include more than one active treatment group. These may be discontinued independently if found to be ineffective or possibly harmful. Certain subgroups of patients may be discovered, in the course of a clinical trial, who do not respond satisfactorily and are, therefore, excluded during the course of a trial. Yet another kind of termination comes when we have a therapeutic breakthrough or when hope has to be abandoned for demonstrating beneficial effects for one, several, or all treatments included in a trial. Examples from the authors' experience are presented, as are successful and unsuccessful techniques in managing terminations of various types.
Rejón Altable, Carlos
The logical nature of clinical judgment has been conceptualized in different ways, but a clear connection between the features of clinical judgment and those of semiology is still lacking. The characteristics of clinical judgment, medical semiology, and psychiatric semiology are described. Connections between them are drawn. Clinical judgment is described as an abductive inference. Abductive inferences are especially useful to balance universal and singular information. In psychiatric semiology, due to some specific features, a careful balance between the information present in descriptive definitions and the information absent from the definition but present in singular symptoms is needed. The main types of out-of-definition information are reviewed. The implications of the results for diagnosis and research are drawn. Copyright © 2012 S. Karger AG, Basel.
Woodruff, P W; Higgins, E M; du Vivier, A W; Wessely, S
There is a recognized psychiatric morbidity among those who attend dermatology clinics. We aimed to determine the pattern of psychological and social problems among patients referred to a liaison psychiatrist within a dermatology clinic. Notes from 149 patients were reviewed and more detailed assessments performed in a subgroup of 32 consecutive referrals. All but 5% merited a psychiatric diagnosis. Of these, depressive illness accounted for 44% and anxiety disorders, 35%. Less common general psychiatric disorders included social phobia, somatization disorder, alcohol dependence syndrome, obsessive-convulsive disorder, posttraumatic stress disorder, anorexia nervosa, and schizophrenia. Classical disorders such as dermatitis artefacta and delusional hypochondriasis were uncommon. Commonly, patients presented with longstanding psychological problems in the context of ongoing social difficulties rather than following discrete precipitants. Psychiatric intervention resulted in clinical improvement in most of those followed up. Of the dermatological categories 1) exacerbation of preexisting chronic skin disease; 2) symptoms out of proportion to the skin lesion; 3) dermatological nondisease; 4) scratching without physical signs, the commonest were dermatological nondisease and exacerbation of chronic skin disease. Anxiety was common in those from all dermatological categories. Patients with dermatological nondisease had the highest prevalence of depression. Skin patients with significant psychopathology may go untreated unless referred to a psychiatrist. The presence of dermatological nondisease or symptoms out of proportion to the skin disease should particularly alert the physician to the possibility of underlying psychological problems.
Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena
After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.
Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.
Seow, Hsien-Yeang; Whelan, Patrick; Levine, Mark N; Cowan, Kathryn; Lysakowski, Barbara; Kowaleski, Brenda; Snider, Anne; Xu, Rebecca Y; Arnold, Andrew
Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an "l" shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.
Ness, Elizabeth A; Royce, Cheryl
Clinical trials are paramount to improving human health. New trial designs and informed consent issues are emerging as a result of genomic profiling and the development of molecularly targeted agents. Many groups and individuals are responsible for ensuring the protection of research participants and the quality of the data produced. The specialty role of the clinical trials nurse (CTN) is critical to clinical trials. Oncology CTNs have competencies that can help guide their practice; however, not all oncology clinical trials are supervised by a nurse. Using the process of engagement, one organization has restructured oncology CTNs under a nurse-supervised model. Published by Elsevier Inc.
Aggarwal, Neil Krishan
This paper considers revisions to the DSM-IV Outline for Cultural Formulation from the perspective of clinical practice. First, the paper explores the theoretical development of the Cultural Formulation. Next, a case presentation demonstrates challenges in its actual implementation. Finally, the paper recommends a set of questions for the clinician on barriers to care and countertransference. The development of a standardized, user-friendly format can increase the Cultural Formulation’s utilization among all psychiatrists beyond those specializing in cultural psychiatry. PMID:22418398
Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K
Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.
Gloria Maria de Almeida Souza Tedrus
Full Text Available Objective To study socio-demographic and clinical aspects, as well as psychiatric co-morbidity that influence the quality of life of adult epileptic patients. Methods One hundred and thirty-two individuals diagnosed with epilepsy were evaluated from neurological/clinical and psychiatric points of view and by the Quality of Life in Epilepsy Inventory (QOLIE-31. Predictive factors for the QOLIE-31 scores were studied. Results The regression analyses indicated the existence of psychiatric co-morbidity (total score, seizure worry, emotional well-being, energy/fatigue, social function and cognitive function and a greater seizure frequency (total score, cognitive function and energy/fatigue as predictive factors for lower scores in the total QOLIE-31 score and in various dimensions. Abnormalities in the neurological exam and poly-therapy with anti-epileptic drugs were negative factors limited to one of the dimensions cognitive function and social function, respectively. Conclusion The presence of psychiatric co-morbidity and a greater seizure frequency were the main factors influencing the quality of life in epileptic patients as evaluated by QOLIE-31.
Lidiane S. Campos
Full Text Available Objective To estimate the clinical and demographics aspects that may contribute to cognitive impairment and psychiatric symptoms in Parkinson’s disease (PD. Method All patients answered a structured standardized clinical questionnaire. Two movement disorders specialists performed the following scale: Unified Parkinson’s disease rating score (UPDRS, the modified Hoehn and Yahr staging, Schwab and England Scale, SCOPA cognition (SCOPA-COG, SCOPA-Psychiatric complications (SCOPA-PC and Non-Motor Symptoms Scale (NMSS. We built a generalized linear model to assess predictors for the SCOPA-COG and SCOPA-PC scores. Results Almost 37% of our patients were demented as per SCOPA-COG scores. Level of education and the UPDRS-Subscale III were predictors of cognitive impairment. Higher scores in domain 3 of NMSS and male gender were associated with psychiatric complications as assessed per the SCOPA-PC. Conclusion Level of education and disease severity are predictors of dementia in PD. Psychiatric complications are more commonly observed in men.
Hansen, Hanne Hoff; Hasselgård, Cecilie Edh; Undheim, Anne Mari; Indredavik, Marit Sæbø
Few studies have focused the association between bullying and psychiatric disorders in clinical samples. The aim of this study was to examine if bullying behaviour was associated with psychiatric disorders and school well-being. The cross-sectional study was part of a health survey at St. Olav's University Hospital. The sample consisted of 685 adolescent patients aged 13-18 years who completed an electronic questionnaire. Clinical diagnoses were collected from clinical records. In this clinical psychiatric sample, 19% reported being bullied often or very often, and 51% reported being bullied from time to time. Logistic regression analyses showed associations between being a victim and having a mood disorder, and between being involved in bullying behaviour and reporting lower scores on school well-being. No difference was found in bullying behaviour on gender, age and SES. The risk of being a victim was high among adolescents in this clinical sample, especially among patients with mood disorders. Any involvement in bullying behaviour was associated with reduced school well-being.
Ketola, J; Stein, J V
Psychiatric nursing teaches students how to engage and communicate with patients who have severe emotional distress. Nurses need this knowledge as the majority of patients encountered in hospitals are distressed. This study explores the impact of a psychiatric clinical course in helping students learn to relate to distressed patients. The study used a mixed research methodology to survey 67 baccalaureate students about their experiences in the placement portion of the psychiatric nursing course. The pre-clinical questions focused on students' anticipation regarding individuals with mental illness and how the clinical experience would affect them as nurses and as individuals. The post-clinical questions asked how the clinical experience affected them. The students stated that their time with patients had changed them. Ninety-nine per cent were no longer frightened of the patients. Students realized the patients were distressed and were glad to help them. This work sensitized them to the individual rather than the generic patient. It initiated a process in self-awareness, in sensitivity to the feelings of another person and in communication skills. These are steps in the development of an empathetic presence. The students recognized the need for these skills in all nursing. The authors recommend strategies to assist students in developing an empathetic presence. © 2012 Blackwell Publishing.
H.M. James Hung
Full Text Available The concept of adaptation of trial design during the course of a clinical trial has recently drawn much interest from the pharmaceutical industry. The interest arises partly because statistical decision trees employed to address multiple complex clinical hypotheses within a clinical trial are increasingly complex, and the statistical information generated from learning data prior to designing the trial is often insufficient to provide informative guidance for planning a pivotal trial. While the conventional fixed designs, which usually permit no modification influenced by the internal trial data of key design specifications, often cannot cover the range of complex statistical decision trees that must be prespecified in the study protocol, it seems natural to consider modifications of trial design at some point in the trial. In regulatory practice, some adjustments to study protocols are mostly made known to regulatory agencies in the form of so-called protocol amendments. However, such design modifications may demand careful consideration in dealing with any biases that may be caused by the adaptation, and may impede the interpretability of trial results.
Gustafsson, Finn; Atar, Dan; Pitt, Bertram
, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...
Hróbjartsson, A; Boutron, I
Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...
Scientific review ensures that studies are based on sound science, which contributes to the safety of clinical trial participants. Learn about the role of Institutional Review Boards (IRBs), Data and Safety Monitoring Boards (DSMBs), and government agenci
Nanoformulations and Clinical Trial Candidates as Probably Effective and Safe Therapy for Tuberculosis. Madeeha Laghari, Yusrida Darwis, Abdul Hakeem Memon, Arshad Ali Khan, Ibrahim Mohammed Tayeb Abdulbaqi, Reem Abou Assi ...
Molloy, Síle F; Henley, Patricia
This article describes the processes and procedures involved in planning, conducting and reporting monitoring activities for large Clinical Trials of Investigational Medicinal Products (CTIMPs), focusing on those conducted in resource-limited settings. © 2016 John Wiley & Sons Ltd.
Chen, Ding-Geng; Peace, Karl E
.... Case studies demonstrate how to select the appropriate clinical trial data. The authors introduce the corresponding biostatistical analysis methods, followed by the step-by-step data analysis using R...
Riley, Isaretta L; Boulware, L Ebony; Sun, Jie-Lena; Chiswell, Karen; Que, Loretta G; Kraft, Monica; Todd, Jamie L; Palmer, Scott M; Anderson, Monique L
Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0
Perlis, Roy H; Perlis, Clifford S; Wu, Yelena; Hwang, Cindy; Joseph, Megan; Nierenberg, Andrew A
Financial conflict of interest has been reported to be prevalent in clinical trials in general medicine and associated with a greater likelihood of reporting results favorable to the intervention being studied. The extent and implications of industry sponsorship and financial conflict of interest in psychiatric clinical trials have not been investigated, to the authors' knowledge. The authors examined funding source and author financial conflict of interest in all clinical trials published in the American Journal of Psychiatry, the Archives of General Psychiatry, the Journal of Clinical Psychopharmacology, and the Journal of Clinical Psychiatry between 2001 and 2003. Among 397 clinical trials identified, 239 (60%) reported receiving funding from a pharmaceutical company or other interested party, and 187 studies (47%) included at least one author with a reported financial conflict of interest. Among the 162 randomized, double-blind, placebo-controlled studies examined, those that reported conflict of interest were 4.9 times more likely to report positive results; this association was significant only among the subset of pharmaceutical industry-funded studies. Author conflict of interest appears to be prevalent among psychiatric clinical trials and to be associated with a greater likelihood of reporting a drug to be superior to placebo.
Reekie, J; Mocroft, A; J, Neaton
and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates......Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...
Reekie, J; Mocroft, A; J, Neaton
Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...
Lambers Heerspink, Hiddo J.; Dobre, Daniela; Hillege, Hans L.; Grobbee, Diederick E.; de Zeeuw, Dick
AIMS To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries
Aug 27, 2009 ... recommended that more recognition be given to the important role of trial ... Founded upon the principle of respect for the autonomy of persons, IC seeks to protect the individual's .... section of the population and the multicultural population all ... perceived difficulties, challenges and solutions, regarding the.
Oud, Johan; Ghidey, Wendimagegn
This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.
Kaplan, Celia P
.... While inroads to increasing minority inclusion in breast cancer clinical trials have been made, recent reports continue to demonstrate lower enrollment among African Americans, Asian Americans...
Full Text Available Abstract Background The PERSEO study (psychiatric emergency study and epidemiology is a naturalistic, observational clinical survey in Italian acute hospital psychiatric units, called SPDCs (Servizio Psichiatrico Diagnosi e Cura; in English, the psychiatric service for diagnosis and management. The aims of this paper are: (i to describe the epidemiological and clinical characteristics of patients, including sociodemographic features, risk factors, life habits and psychiatric diagnoses; and (ii to assess the clinical management, subjective wellbeing and attitudes toward medications. Methods A total of 62 SPDCs distributed throughout Italy participated in the study and 2521 patients were enrolled over the 5-month study period. Results Almost half of patients (46% showed an aggressive behaviour at admission to ward, but they engaged more commonly in verbal aggression (38%, than in aggression toward other people (20%. A total of 78% of patients had a psychiatric diagnosis at admission, most frequently schizophrenia (36%, followed by depression (16% and personality disorders (14%, and no relevant changes in the diagnoses pattern were observed during hospital stay. Benzodiazepines were the most commonly prescribed drugs, regardless of diagnosis, at all time points. Overall, up to 83% of patients were treated with neuroleptic drugs and up to 27% received more than one neuroleptic either during hospital stay or at discharge. Atypical and conventional antipsychotics were equally prescribed for schizophrenia (59 vs 65% during stay and 59 vs 60% at discharge, while atypical drugs were preferred in schizoaffective psychoses (72 vs 49% during stay and 70 vs 46% at discharge and depression (41 vs 32% during stay and 44 vs 25% at discharge. Atypical neuroleptics were slightly preferred to conventional ones at hospital discharge (52 vs 44%. Polypharmacy was in general widely used. Patient attitudes toward medications were on average positive and self
Full Text Available Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety.
Lugnegård, Tove; Hallerbäck, Maria Unenge; Gillberg, Christopher
In children with autism spectrum disorders, previous studies have shown high rates of psychiatric comorbidity. To date, studies on adults have been scarce. The aim of the present study was to investigate psychiatric comorbidity in young adults with Asperger syndrome. Participants were 26 men and 28 women (mean age 27 years) with a clinical diagnosis of Asperger syndrome. Psychiatric comorbidity was assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders. IQ was measured using the Wechsler Adult Intelligence Scale, Third Edition. Autism spectrum diagnoses were confirmed using the DIagnostic Interview for Social and Communication Disorders. In our study group, 70% had experienced at least one episode of major depression, and 50% had suffered from recurrent depressive episodes. Anxiety disorders were seen in about 50%. Psychotic disorders and substance-induced disorders were uncommon. In conclusion, young adults with autism spectrum disorders are at high risk for mood and anxiety disorders. To identify these conditions and offer treatment, elevated vigilance is needed in clinical practice. Copyright © 2011 Elsevier Ltd. All rights reserved.
Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen
To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.
Kidson, M A; Douglas, J C; Holwill, B J
To ascertain the frequency of post-traumatic stress disorder (PTSD) in World War II veterans attending a psychiatric outpatient clinic in an Australian veterans' hospital and to compare veterans with and without PTSD according to certain psychological variables. Over a three-month period veterans were assessed at their next appointment by their treating doctors (psychiatrists or psychiatric registrars) for PTSD according to the criteria of the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-III-R). At the same time they completed two questionnaires and provided information about their war experiences. The psychiatric outpatient department at Heidelberg Repatriation Hospital, Melbourne. One hundred and twenty World War II veterans attended during the three-month period and 108 (90%) agreed to participate and are included in this study. The treating doctors recorded the presence or absence and severity of veterans' symptoms of PTSD. The General Health Questionnaire (GHQ-60) and the Impact of Events Scale (IES) were then completed by participants under supervision. Forty-nine veterans (45%) were found to have active PTSD 45 years after the war. The presence of PTSD was significantly associated with the taking of casualties (an indicator of severity of war stress as reported by the veterans themselves) and with combat stress as rated by their treating doctors. The veterans with PTSD obtained significantly higher scores on both the GHQ-60 and the IES, and reported no significant reduction in symptoms of PTSD over the preceding 10 years. The presence of both an anxiety and a depressive disorder was substantially and significantly more common in the veterans who had PTSD. Overall, the study revealed a high frequency of PTSD and a strong persistence of this condition in psychiatric outpatients who were veterans of World War II.
Sheftell, Fred D; Atlas, Susan J
To review psychiatric issues that accompany migraine and means of addressing these issues. Psychiatric factors and migraine may interact in three general ways, etiologically, psychophysiologically or biobehaviorally, and comorbidly (the two disorders coexist), which is the present focus. There are several possible mechanisms of comorbidity. The relation between two disorders may be a result of chance. One disorder can cause another disorder: Diabetes can cause diabetic neuropathy. There might be shared environmental risks: Head trauma can cause both posttraumatic epilepsy and posttraumatic headache. And there may be environmental or genetic risk factors that produce a brain state giving rise to both conditions, that is, there may be some common biology underlying both conditions. This last mechanism seems to be the most likely one underlying comorbidity of migraine and psychiatric disorders. We introduce a possible role for classical paradigms of learned helplessness in regard to psychiatric comorbid depressive and anxiety disorders and migraine. There appears to be an association between migraine and affective disorders, particularly depression and anxiety. There are a number of formal tools for recognizing depression, but clinical evaluation should not be overlooked. Once diagnosed, depression and anxiety should be treated, both to improve the success of migraine treatment and to improve the patient's quality of life. Patients with recurring headaches are much more likely to overuse and misuse, rather than abuse, pain medications. It is important to be alert for signs that the patient may be misusing medication. Behavioral approaches can surround and support pharmacological therapy. Migraine is often comorbid with psychiatric disorders, particularly depression and anxiety. The relationship is likely based on shared mechanisms and successful treatment is possible.
Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.
Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P
To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population
Schott, Anne F.; Welch, John J.; Verschraegen, Claire F.; Kurzrock, Razelle
Rare cancers account for 27% of neoplasms diagnosed each year, and 25% of cancer-related deaths in the United States. However, rare cancers show some of the highest response rates to targeted therapies, probably due to identification of oncogenic drivers with little inter-patient variability. Although the low incidence of rare cancers make large scale randomized trials involving single histologies difficult to perform, drugs have been successfully developed in rare cancers utilizing clinical trial designs that combine microscopic anatomies. Such trials are being pursued within the National Clinical Trials Network (NCTN), which possesses unique qualifications to perform widespread molecular screening of tumors for patient enrollment onto therapeutic clinical trials. When larger clinical trials are needed to determine optimum treatment strategies in rare cancers, the NCTN's broad reach in North America and internationally, and ability to partner with both US-based and international research organizations, can make these challenging studies feasible. PMID:26433554
Lee, Haoyu; Iglewicz, Alana; Golshan, Shah; Zisook, Sidney
The relationship between homelessness among veterans and mental illness and suicidality has not been clearly defined. To further examine this relationship, we compared rates of mental illness and suicidality among homeless and domiciled veterans seeking urgent psychiatric care at a US Department of Veterans Affairs (VA) facility. Information was collected by survey from 482 consecutive veterans seeking care at the Psychiatric Emergency Clinic (PEC) at the VA San Diego Healthcare System. A total of 73 homeless veterans were designated the homeless group and 73 domiciled veterans were randomly selected as the domiciled group. Suicidality and mental illnesses were assessed by self-assessment questionnaires and chart review of diagnoses. The homeless group had significantly higher rates of past suicide attempts (47% vs 27%) and recent reckless or self-harming behavior (33% vs 18%) compared with the domiciled group but significantly lower rates of depressive disorder (25% vs 44%), as diagnosed by a PEC physician. There were no differences between groups on the questionnaires for posttraumatic stress disorder (PTSD), depression, or alcohol abuse. Nor were there differences in diagnoses of bipolar disorder, PTSD, anxiety disorder, schizophrenia/schizoaffective disorder, or alcohol abuse. Veterans seeking help from a VA-based urgent psychiatric care clinic often are burdened by substantial depression, alcohol use disorders, PTSD, and both past and present suicide risk.
Mazzetti, Pilar; Silva-Paredes, Gustavo; Cornejo-Olivas, Mario
The regulation of clinical trials by the Government is a process of continuous change and adaptation, current challenge is to ensure the safety of participants and get balance of administrative procedures. Development and regulation of clinical trials in different countries vary according to the situation, context national or international execution, determining the insufficiency of national regulation requiring review of international regulation. The aim of this publication is to present a comprehensive overview of the role of Government in the regulation of clinical trials in different realities. It includes a review of the regulation in The European Union, The United States and some Latin American countries and finally the regulation in Peru. Contemporary trends in the regulation of clinical trials, are characterized by increasing standards of quality, ensuring the safety of the participants, promote transparency, lower bureaucratic processes and strengthening ethics IRB committees in the framework of open democratic processes, involving all stakeholders in dynamic processes based on current knowledge and changing tendencies. The challenge is to promote the development of clinical trials from the government institutions (universities, research centers, institutes, hospitals, etc.) priorizing local needs including orphan drugs, prevalent and neglected diseases, and therapeutic use of active components of local native plants.
Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.
Jones, Nicole Tuomi; McGill, Amanda C; Vogler, Jason E; Oxley, Stephen
The primary goals of compulsory, inpatient, psychiatric treatment are to decrease dangerous behaviors and help improve functioning so that a safe discharge to a less restrictive environment can be obtained. This study examined the aggression rates, levels of functioning, and treatment adherence for persons treated for schizophrenia (N = 506) compared with persons treated for borderline personality disorder (BPD) (N = 98) in an inpatient psychiatric facility. Over half of persons engaged in at least one incident of aggressive behavior during hospitalization. Differences in the types of aggression and functional deficits between these two clinical sub-groups were found. In addition, overall impairment increased the likelihood of aggressive behavior for persons diagnosed with schizophrenia, whereas irritability and social dependence increased the risk of aggression for persons diagnosed with BPD. Treatment interventions that target the improvement of these deficits may help reduce the intensity and severity of aggressive behaviors and help improve functioning and discharge readiness.
Truong, Tony H; Weeks, Jane C; Cook, E Francis; Joffe, Steven
Patients' motivations for participation in cancer clinical trials are incompletely understood. Even less is known about the factors that influence participants' motivations for enrolling in trials. We studied the reasons why adult patients and parents of pediatric patients agree to participate in cancer trials. We focused on the role of altruism across all phases of trial. We surveyed adult patients and parents of pediatric patients participating in phase I, II, or III cancer clinical trials. We asked respondents why they agreed to enroll, and examined correlates of altruistic motivation using univariate and multivariate analyses. Among 205 adults and 48 parents of children participating in cancer trials, 47% reported that altruistic motivations were 'very important' to their decisions to enroll. In multivariate analysis with phase III trial participants as the reference group, phase I trial participants least often identified altruism as a 'very important' motivation for enrolling (phase I OR 0.4, 95% CI (confidence interval) 0.2-0.8; phase II OR 0.9, 95% CI 0.5-1.5, overall P = 0.017). Thirty-three respondents (13%) reported being motivated primarily by altruism. In multivariate analysis, participants with poor prognoses-defined as an expected 5-year disease-free survival of ≤ 10%-reported altruism as their primary motivation less often than those with better prognoses (OR 0.2, 95% CI 0.1-0.5, P = 0.001). Altruistic motivations did not differ between adult patients and parents of pediatric participants. The data are derived from related academic medical centers in one city, and the study sample reflects limited sociodemographic diversity, thereby limiting generalizability to other settings. Although cancer trial participants commonly report that altruism contributed to their decision to enroll, it is rarely their primary motivation for study participation. Participants in early phase trials and those with poor prognoses are least often motivated by altruism.
A herbalist from Strand, Mr X, calls the plant unwele. (hair) and sells it to local traditional healers (isangoma) ... being contested and very fragile. In the making of an African medicine through clinical .... In a small number of cases ARVs can cause Immune. Reconstitution Inflammatory Syndrome, a life threatening condition.
APPLICATION FORM. Although a clinical research associate. (CRA) usually completes the applica- tion, it is incumbent upon the investigators (usually represented by the. 'principal' investigators) to ensure that the study is both scientifically and ethically sound, and that the application is logically completed. Many CRAs do.
Kieburtz, Karl; Olanow, C Warren
In the past several years, there have been several innovations in the design of clinical trials assessing new therapies for patients with movement disorders. These include attempts to address difficulties in conducting clinical trials in treated patients in the advanced stages of their illness, demonstrating disease-modifying effects or a reduction in the development of cumulative disability, and assessing the effects of interventions in patients in the premanifest state of their disease. In addition, there have been advances in clinical trial methodologies and changes in regulatory guidelines that permit the performance of more efficient studies, with a reduction in the cost and duration of the development period. These will be reviewed in the present article. © 2015 International Parkinson and Movement Disorder Society. © 2015 International Parkinson and Movement Disorder Society.
Sheldon, R; Rose, S
The time is ripe for adequately powered, randomized, placebo-controlled clinical trials in vasovagal syncope. Vasovagal syncope is a common syndrome, the symptoms of which can be troublesomely frequent. It is usually diagnosed by tilt-table testing, although this has persistent problems with both sensitivity and specificity. Patients with syncope and positive tilt tests have been the subjects of numerous studies of natural history, risk stratification, and treatment. This paper discusses studies of treatments for vasovagal syncope in the context of a classification of the levels of evidence that can be gleaned from clinical studies. The reasons for placebo-controlled trials are reviewed, as is the evidence for various methods of risk stratification. Data for power calculations are presented for the primary outcome, the time to the first syncope recurrence. Strengths and weakness of the four main types of outcomes for clinical trials are compared.
González-Moreno, María; Saborido, Cristian; Teira, David
Our goal in this paper is to articulate a precise concept of at least a certain kind of disease-mongering, showing how pharmaceutical marketing can commercially exploit certain diseases when their best definition is given through the success of a treatment in a clinical trial. We distinguish two types of disease-mongering according to the way they exploit the definition of the trial population for marketing purposes. We argue that behind these two forms of disease-mongering there are two well-known problems in the statistical methodology of clinical trials (the reference class problem and the distinction between statistical and clinical significance). Overcoming them is far from simple. Copyright © 2015 Elsevier Ltd. All rights reserved.
Garland, Eric L; Roberts-Lewis, Amelia; Tronnier, Christine D; Graves, Rebecca; Kelley, Karen
In many clinical settings, there is a high comorbidity between substance use disorders, psychiatric disorders, and traumatic stress. Novel therapies are needed to address these co-occurring issues efficiently. The aim of the present study was to conduct a pragmatic randomized controlled trial comparing Mindfulness-Oriented Recovery Enhancement (MORE) to group Cognitive-Behavioral Therapy (CBT) and treatment-as-usual (TAU) for previously homeless men residing in a therapeutic community. Men with co-occurring substance use and psychiatric disorders, as well as extensive trauma histories, were randomly assigned to 10 weeks of group treatment with MORE (n = 64), CBT (n = 64), or TAU (n = 52). Study findings indicated that from pre-to post-treatment MORE was associated with modest yet significantly greater improvements in substance craving, post-traumatic stress, and negative affect than CBT, and greater improvements in post-traumatic stress and positive affect than TAU. A significant indirect effect of MORE on decreasing craving and post-traumatic stress by increasing dispositional mindfulness was observed, suggesting that MORE may target these issues via enhancing mindful awareness in everyday life. This pragmatic trial represents the first head-to-head comparison of MORE against an empirically-supported treatment for co-occurring disorders. Results suggest that MORE, as an integrative therapy designed to bolster self-regulatory capacity, may hold promise as a treatment for intersecting clinical conditions. Copyright © 2015 Elsevier Ltd. All rights reserved.
Rogers, E Sally; Maru, Mihoko; Johnson, Gene; Cohee, Julie; Hinkel, Jennifer; Hashemi, Lobat
Given the proliferation of peer-delivered services and its growing but insufficient empirical base, we undertook a randomized trial to examine the effects of such services on individuals with severe psychiatric disabilities undergoing a civil commitment. We recruited n = 113 individuals who were civilly committed for inpatient treatment. Randomly assigned experimental participants were paired with a trained peer specialist to receive intensive 1-on-1 support to assist them with both their recovery and the conditions of their mandated court-ordered services. Individuals in the control group were invited to receive other supportive, peer-delivered services, such as social and group educational activities, but excluding individual peer support. We assessed a variety of outcomes including social supports, quality of life, recovery, symptoms, and functioning. Mounting a randomized trial in this setting and with participants who were court-ordered for inpatient treatment proved challenging in terms of recruitment, service provision, retention in the intervention, and attrition from the research. Intent-to-treat analyses revealed no significant differences in outcomes by study condition. As-treated analyses comparing high- and low-use peer support groups with control group participants found significant differences favoring peer support recipients in quality of life and functioning but no differences in other study outcomes. Difficulties with ensuring the quality of the peer support in this study may be in part responsible for our failure to see more-definitive and -positive results. As the peer support specialist profession evolves, an understanding of its effective ingredients and mechanisms must be elucidated to allow for more-rigorous studies. (PsycINFO Database Record (c) 2016 APA, all rights reserved).
McShane, Lisa M.; Korn, Edward L.
Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients. Definitive evaluation of the clinical utility of these biomarkers requires conducting large randomized clinical trials (RCTs). Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice, and a variety of designs have been proposed for this purpose. To guide design and interpretation of RCTs evaluating biomarkers, we present an in-depth comparison of advantages and disadvantages of the commonly used designs. Key aspects of the discussion include efficiency comparisons and special interim monitoring issues that arise because of the complexity of these RCTs. Important ongoing and completed trials are used as examples. We conclude that, in most settings, randomized biomarker-stratified designs (ie, designs that use the biomarker to guide analysis but not treatment assignment) should be used to obtain a rigorous assessment of biomarker clinical utility. PMID:20075367
Jacobsen, Pamela; Peters, Emmanuelle; Chadwick, Paul
Inpatient psychiatric care is a scarce and expensive resource in the National Health Service (NHS), with chronic bed shortages being partly driven by high re-admission rates. People often need to go into hospital when they have a mental health crisis due to overwhelming distressing psychotic symptoms, such as hearing voices (hallucinations) or experiencing unusual beliefs (delusions). Brief talking therapies may be helpful for people during an acute inpatient admission as an adjunct to medication in reducing re-admission rates, and despite promising findings from trials in the USA, there have not yet been any clinical trials on this kind of intervention within NHS settings. The amBITION study is a feasibility randomised controlled trial (RCT) of a manualised brief talking therapy (Mindfulness-Based Crisis Intervention; MBCI). Inpatients on acute psychiatric wards are eligible for the study if they report at least one positive psychotic symptom, and are willing and able to engage in a talking therapy. In addition to treatment as usual (TAU), participants will be randomly allocated to receive either MBCI or a control intervention (Social Activity Therapy; SAT) which will be based on doing activities on the ward with the therapist. The primary objective of the study is to find out whether it is possible to carry out this kind of trial successfully within UK inpatient settings and to find out whether patients and staff find it an acceptable intervention. The secondary objective is to collect pilot data on primary and secondary outcome measures, including re-admission rates at 6 month follow-up. This will provide information on the appropriateness of re-admission as the primary outcome measure for future efficacy trials, as well as data on the acceptability and utility of the clinical self-report measures. The results of the feasibility trial will indicate whether a subsequent efficacy pilot trial is warranted, and if so, will provide vital information for the planning
Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers. Copyright © 2010 Elsevier Inc. All rights reserved.
Full Text Available Purpose: To illustrate an approach to evidence-based medical practice by reporting the Collaborative Ocular Melanoma Study (COMS randomised clinical trials and cohort studies of choroidal melanoma. Methods: COMS randomised clinical trials of Iodine-125 (I-125 brachytherapy, adjunctive cohort study of visual acuity in eyes treated with brachytherapy and adjunctive natural history study. COMS randomised clinical trial of pre-enucleation radiation. Results: The COMS I-125 brachytherapy trial (N = 1,317 patients of medium-sized choroidal melanoma showed 5-year all-cause mortality of 18% [95% Confidence Interval (CI, 16-20%] and no statistically significant difference in mortality following 1-125 brachytherapy or enucleation. Adjunctive cohort natural history study (N-42 patients of patients eligible for the I-125 brachytherapy trial who deferred treatment or had no melanoma treatment had a 5-year all-cause mortality of 30% (95% CI, 18-47%. The COMS pre-enucleation radiation trial (N = 1,003 patients of large-sized choroidal melanoma showed 5-year all-cause mortality of 40% (95% CI, 37-44%. Conclusions: Evidence derived from randomised clinical trials and cohort studies shows the need for longterm ( 5 years follow-up to determine the efficacy of treatment for choroidal melanoma by any modality. The rather similar 5-year mortality for treated and untreated medium melanoma patients suggests that metastatic dissemination may occur at an early stage of choroidal melanoma. To increase longterm survival, ocular treatment of choroidal melanoma must strive for diagnosis and treatment of melanoma at an early stage when metastasis is less likely and be combined with measures to detect and treat micrometastasis
Full Text Available Bernardo Dell’Osso,1,2,* Umberto Albert,3,* Anna Rita Atti,4 Claudia Carmassi,5 Giuseppe Carrà,6 Fiammetta Cosci,7 Valeria Del Vecchio,8 Marco Di Nicola,9 Silvia Ferrari,10 Arianna Goracci,11 Felice Iasevoli,12 Mario Luciano,8 Giovanni Martinotti,13 Maria Giulia Nanni,14 Alessandra Nivoli,15,16 Federica Pinna,17 Nicola Poloni,18 Maurizio Pompili,19 Gaia Sampogna,8 Ilaria Tarricone,20 Sarah Tosato,21 Umberto Volpe,8 Andrea Fiorillo8 1Department of Psychiatry, University of Milan, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy; 2Bipolar Disorders Clinic, Stanford Medical School, Stanford University, CA, USA; 3Rita Levi Montalcini Department of Neuroscience, University of Turin, Torino, 4Department of Biomedical and NeuroMotor Sciences, University of Bologna, Bologna, 5Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; 6Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK; 7Department of Health Sciences, University of Florence, Florence, 8Department of Psychiatry, University of Naples SUN, Naples, 9Institute of Psychiatry and Psychology, Catholic University of Sacred Heart, Rome, 10Department of Diagnostic-Clinical Medicine and Public Health, University of Modena and Reggio Emilia, Modena, 11Department of Molecular Medicine and Clinical Department of Mental Health, University of Siena, Siena, 12Department of Neuroscience, Reproductive Sciences and Odontostomatology, University Federico II of Naples, Naples, 13Department of Neuroscience, Imaging, and Clinical Science, University G.d Annunzio, Chieti-Pescara, 14Section of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, 15Psychiatric Institute, Department of Clinical and Experimental Medicine, University of Sassari, Sassari, Italy; 16Bipolar Disorder Unit, CIBERSAM, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain; 17Department of
Ricardo-Ramírez, Carmenza; Álvarez-Gómez, Matilde; Rodríguez-Gázquez, María de los Ángeles
Mental disorders in the world affecting 15% to 30% in children and adolescents, altering its function and emotional, cognitive and social. Affect interpersonal relationships, school performance and increased substance use and the risk of suicide. describe the social-demographic characteristics and mental disorders of children and adolescents of psychiatric consultation. Retrospective descriptive study that analyzed all the histories of children and adolescents of both sexes from 5 to 16 years who attended for the first time outpatient psychiatry university clinic of Medellin, from July 2010 to July 2012. We studied 197 patients, the average age was 11±3.5 years, male sex was the most common 69%, 46.2% belonged to nuclear family. The most prevalent psychiatric disorders were 44.2% ADHD, depressive disorders 9.1% and 8.1% TOC. 61% had psychiatric comorbidity, the most frequent was oppositional defiant disorder with ADHD 35.6%. The frequency of mental disorders and comorbidities found in this study were similar to those reported by other researchers. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.
was highly dependent on the individual nurses' practical ability to participate in the game. Furthermore, the nurses colluded in their mutual communication to enable the collective display and sense of knowing that protected them against explicit signs of uncertainty about the clinic. The game of clinical...... knowledge influenced processes of clinical decision-making among the nurses as the game added to a distorted widening of a 'fictional distance' between patients and the representations produced by the nurses.......Nursing practices at psychiatric hospitals have changed significantly over the last decades. In this paper, everyday nursing practices were interpreted in light of these institutional changes. The objective was to examine how mental health nurses' production of clinical knowledge was influenced...
The aim of this article is to contribute to the analysis of the origins of psychiatric semiology, which by emphasizing subjectivity in clinical practice, gave birth to psychopathology as the scientific and intellectual enterprise of alienism. In other words, beyond simple anatomical and clinical observation, there was an effort to 'listen to' and 'read' the patient's delirium. In essence, the basic thesis which this short paper seeks to defend is that, despite a growing anatomical and clinical mind-set and a clear interest in physically locating mental illness within the body, during the Romantic period, psychiatry was able to construct a semiology largely based on the experience of the ego, on the inner world of the individual. This makes it possible to establish, from a clinical perspective, that the birth of alienism - of psychiatry - must be situated within the framework of a modernity in which the culture of subjectivity was one of its most characteristic features. © The Author(s) 2014.
Lo, Albert C
Rehabilitation robots are increasingly being tested and promoted for clinical neurorehabilitation. Compared with conventional and manual methods, robots allow for a variety of advantages, particularly in the areas of interventional control and the ability to provide a high volume of facilitated movement. Since 1997, there have been more than 60 clinical trials reporting the use of two dozen different robots for neurorehabilitation. Although there are a number of smaller pilot studies, there are only few larger clinical trials. There may be a number of reasons why pilot robot studies do not materialize into larger studies. Beyond devices that failed to perform as intended, what are the clinical design issues that have limited these studies? Some basic considerations include randomization, inclusion of a control group, power calculation based on a clinically meaningful outcome, and finally, reproducible descriptions of the intervention being tested. Although many of these issues are general challenges presented for all rehabilitation studies, there are clinical design features that would likely greatly improve interpretation of results and better position robot devices toward the next clinical trial step. On the other hand, the absence of these elements, even in the setting of a pilot study, may significantly hamper the interpretation of results and not yield sufficient information on treatment effects, adverse event rates, dropout rate, and so on, to allow further testing to proceed to follow-up Food and Drug Administration phase II and III studies. Development of rehabilitation robots for clinical use needs to occur hand in hand with well-conducted clinical trials to provide evidence of efficacy while also taking into account costs.
Abbas, Ismail; Rovira, Joan; Casanovas, Josep
The patient recruitment process of clinical trials is an essential element which needs to be designed properly. In this paper we describe different simulation models under continuous and discrete time assumptions for the design of recruitment in clinical trials. The results of hypothetical examples of clinical trial recruitments are presented. The recruitment time is calculated and the number of recruited patients is quantified for a given time and probability of recruitment. The expected delay and the effective recruitment durations are estimated using both continuous and discrete time modeling. The proposed type of Monte Carlo simulation Markov models will enable optimization of the recruitment process and the estimation and the calibration of its parameters to aid the proposed clinical trials. A continuous time simulation may minimize the duration of the recruitment and, consequently, the total duration of the trial.
The present study examines the building up of art classes in psychiatric hospitals in the thirties and forties of this century. Until 1950 the worldwide total of 34 art classes had come into being. The growing psychiatric interest in drawings of patients in the 19th century is related to changes in psychiatric theory moving from "moral treatment" to descriptive psychiatry at the turn of the century. All in all the installation of 11 artistic workshops for patients can be traced before the 1st world war. They were part of work therapy in german private clinics as a means to put patients of a higher social standing to a regular activity instead of field and garden work, which was medically indicated but socially unacceptable. During the course of development of a diagnostic interest since 1870 the drawings were all along considered to be the immediate expression of the patients inner world. Such a view had become possible, after in modern art the conceptions about the meaning of art had changed. Paradigmatically this connection can be shown in the work of Prinzhorn. First therapeutic attempts were then started by different psychoanalysts especially in the treatment of children. These formed an important basis for the establishment of art classes in psychiatric hospitals later on. Painting was now considered as a means to approach the hidden unconscious. The study continues to explain in which way the therapeutic applications of art therapy depended on the convergence of view points in esthetic and therapeutic theory.(ABSTRACT TRUNCATED AT 250 WORDS)
Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.
Full Text Available There is a growing awareness that research in primary care is needed to provide excellent clinical and population-based care, to develop effective health systems and policies, and to educate future primary care professionals and researchers. The relevance of research undertaken in primary care is unquestionable: the results of researches conducted in other settings has limited relevance because primary care encounters health problems rarely managed in other sectors of health care (i.e. low probability of major acute disease and high prevalence of comorbidity. From legislative aspects to limits and difficulties of application, the article underlines the importance of research in primary care in the Italian context, where this kind of activity is almost absent. An example, concerning the Genova ASL 3, is reported to suggest strategies to promote and improve research as an integral component of family doctors skills.
Full Text Available June Chen1, Stephen A Runyan1, Michael R Robinson21Department of Biological Sciences, 2Ophthalmology Clinical Research, Allergan, Inc, Irvine, CA, USAIntroduction: Glaucoma is a multifactorial disease characterized by progressive optic nerve injury and visual field defects. Elevated intraocular pressure (IOP is the most widely recognized risk factor for the onset and progression of open-angle glaucoma, and IOP-lowering medications comprise the primary treatment strategy. IOP elevation in glaucoma is associated with diminished or obstructed aqueous humor outflow. Pharmacotherapy reduces IOP by suppressing aqueous inflow and/or increasing aqueous outflow.Purpose: This review focuses on novel non-FDA approved ocular antihypertensive compounds being investigated for IOP reduction in ocular hypertensive and glaucoma patients in active clinical trials within approximately the past 2 years.Methods: The mode of IOP reduction, pharmacology, efficacy, and safety of these new agents were assessed. Relevant drug efficacy and safety trials were identified from searches of various scientific literature databases and clinical trial registries. Compounds with no specified drug class, insufficient background information, reformulations, and fixed-combinations of marketed drugs were not considered.Results: The investigational agents identified comprise those that act on the same targets of established drug classes approved by the FDA (ie, prostaglandin analogs and β-adrenergic blockers as well as agents belonging to novel drug classes with unique mechanisms of action. Novel targets and compounds evaluated in clinical trials include an actin polymerization inhibitor (ie, latrunculin, Rho-associated protein kinase inhibitors, adenosine receptor analogs, an angiotensin II type 1 receptor antagonist, cannabinoid receptor agonists, and a serotonin receptor antagonist.Conclusion: The clinical value of novel compounds for the treatment of glaucoma will depend
Walraven, I.; Aaronson, N.; Sonke, J.-J.; Verheij, M.; Belderbos, J.
Gita Thanarajasingam and colleagues' Article1 in The Lancet Oncology reports on a novel longitudinal approach for adverse event analysis and reporting. Comprehensive adverse event reporting in clinical oncology trials is essential to monitor tolerability of new cancer treatments. In view of the
Clinical therapeutic trials, or human experimentation with drugs, are abso- lutely necessary, because data gained from experiments on animals cannot always be directly extrapolated onto man as being applicable. Variations are also found in the different animal species. Tt is impossible to obtain data in animals regarding.
Baigent, Colin; Herrington, William G; Coresh, Josef
to detect treatment effects of a magnitude that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled "Challenges in the Conduct of Clinical Trials in Nephrology" to identify the key barriers to conducting...
Geller, Nancy L; Kim, Dong-Yun; Tian, Xin
This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research. Published by Elsevier Inc.
New treatments for lung cancer and aspects of joining a clinical trial are discussed in this 30-minute Facebook Live event, hosted by NCI’s Dr. Shakun Malik, head of thoracic oncology therapeutics, and Janet Freeman-Daily, lung cancer patient activist and founding member of #LCSM.
Buhmann, Christine Cæcilie Böck; Mortensen, Erik Lykke; Nordentoft, Merete
PURPOSE: To describe change in mental health after treatment with antidepressants and trauma-focused cognitive behavioral therapy. METHODS: Patients receiving treatment at the Psychiatric Trauma Clinic for Refugees in Copenhagen completed self-ratings of level of functioning, quality of life......, and symptoms of PTSD, depression and anxiety before and after treatment. Changes in mental state and predictors of change were evaluated in a sample that all received well-described and comparable treatment. RESULTS: 85 patients with PTSD or depression were included in the analysis. Significant improvement...
Knook, L.M.; Konijnenberg, A.Y.; Hoeven, J. van der; Kimpen, J.L.L.; Buitelaar, J.K.; Engeland, H. van; Graeff-Meeder, E.R. de
The prevalence of psychiatric disorders among children with unexplained chronic pain (UCP) is high in unselected populations and pain clinics, yet the clinical relevance of these disorders in children referred for unexplained pain is not known. This study assessed the prevalence of clinically
Roberta Katz Abela
Full Text Available The Dimensional Clinical Personality Inventory (IDCP was developed in Brazil for the assessment of pathological personality traits. This study aimed to seek validity evidence for the dimensions of IDCP based on external criteria, psychiatric diagnosis. We examined the profile in IDCP of 105 psychotherapy outpatients, previously diagnosed with personality disorders. The profiles were compared with the profile of the normative non-clinical sample and we conducted the repeated measures analysis to investigate whether the IDCP is able to discriminate consistent profiles for different diagnoses and compared the general population. The results suggest validity evidence based on external criteria for the IDCP dimensions and points to the clinical effectiveness of the instrument.
Gutmann, David H; Blakeley, Jaishri O; Korf, Bruce R; Packer, Roger J
Introduction The neurofibromatoses (neurofibromatosis type 1, NF1 and neurofibromatosis type 2, NF2) comprise the most common inherited conditions in which affected children and adults develop tumors of the central and peripheral nervous system. In this review, the authors discuss how the establishment of the Neurofibromatosis Clinical Trials Consortium (NFCTC) has positively impacted on the design and execution of treatment studies for individuals with NF1 and NF2. Areas covered Using an extensive PUBMED search in collaboration with select NFCTC members expert in distinct NF topics, the authors discuss the clinical features of NF1 and NF2, the molecular biology of the NF1 and NF2 genes, the development and application of clinically relevant Nf1 and Nf2 genetically engineered mouse models and the formation of the NFCTC to enable efficient clinical trial design and execution. Expert opinion The NFCTC has resulted in a more seamless integration of mouse preclinical and human clinical trials efforts. Leveraging emerging enabling resources, current research is focused on identifying subtypes of tumors in NF1 and NF2 to deliver the most active compounds to the patients most likely to respond to the targeted therapy. PMID:23425047
Schmal, Hagen; Bernstein, Anke; Feucht, Matthias J
Background. Intra-articular infections can rapidly lead to osteoarthritic degradation. The aim of this clinical biomarker analysis was to investigate the influence of inflammation on cartilage destruction and metabolism. Methods. Patients with acute joint infections were enrolled in a prospective...... clinical trial and the cytokine composition of effusions (n = 76) was analyzed. Characteristics of epidemiology and disease severity were correlated with levels of cytokines with known roles in cartilage turnover and degradation. Results. Higher synovial IL-1β concentrations were associated with clinical...
Hróbjartsson, A; Boutron, I
Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...... and empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used...
Full Text Available Deep brain stimulation (DBS of either the subthalamic nucleus (STN or the globus pallidus interna (GPi can reduce motor symptoms in patients with Parkinson's disease (PD and improve their quality of life. However, the effects of STN DBS and GPi DBS on cognitive functions and their psychiatric effects remain controversial. The present meta-analysis was therefore performed to clarify these issues.We searched the PUBMED, EMBASE, and the Cochrane Central Register of Controlled Trials databases. Other sources, including internet-based clinical trial registries and grey literature sources, were also searched. After searching the literature, two investigators independently performed literature screens to assess the quality of the included trials and to extract the data. The outcomes included the effects of STN DBS and GPi DBS on multiple cognitive domains, depression, anxiety, and quality of life.Seven articles related to four randomized controlled trials that included 521 participants were incorporated into the present meta-analysis. Compared with GPi DBS, STN DBS was associated with declines in selected cognitive domains after surgery, including attention, working memory and processing speed, phonemic fluency, learning and memory, and global cognition. However, there were no significant differences in terms of quality of life or psychiatric effects, such as depression and anxiety, between the two groups.A selective decline in frontal-subcortical cognitive functions is observed after STN DBS in comparison with GPi DBS, which should not be ignored in the target selection for DBS treatment in PD patients. In addition, compared to GPi DBS, STN DBS does not affect depression, anxiety, and quality of life.
Full Text Available Abstract Background There is a dearth of studies regarding chemical restraint in routine clinical psychiatric practice. There may be wide variations between different settings and countries. Methods A retrospective study on chemical restraint was performed in the 11-bed psychiatric ward of the General Hospital of Arta, in northwestern Greece. All admissions over a 2-year-period (from March 2008 to March 2010 were examined. Results Chemical restraint was applied in 33 cases (10.5% of total admissions. From a total of 82 injections, 22 involved a benzodiazepine and/or levomepromazine, whereas 60 injections involved an antipsychotic agent, almost exclusively haloperidol (96.7% of cases, usually in combination with a benzodiazepine (61.7% of cases. In 36.4% of cases the patient was further subjected to restraint or seclusion. Conclusions In our unit, clinicians prefer the combined antipsychotic/benzodiazepine regimen for the management of patients' acute agitation and violent behaviour. Conventional antipsychotics are administrated almost exclusively and in a significant proportion of cases further coercive measures are applied. Studies on the practice of chemical restraint should be regularly performed in clinical settings.
Pereira, Luis; Budovich, Aliaksandr; Claudio-Saez, Maria
Atypical antipsychotics are associated with metabolic complications that contribute to a higher risk of cardiovascular disease. Current evidence reveal suboptimal adherence to the complex and variable official recommendations on metabolic monitoring in the corresponding patient population. A study evaluating metabolic monitoring at guideline-recommended intervals may help identify areas for intervention. Describe the frequency of monitoring metabolic adverse effects in patients receiving atypical antipsychotics in an outpatient psychiatric clinic with respect to the specific guideline-recommended intervals. A retrospective chart review was conducted in the outpatient psychiatric clinic. The primary outcome measure was the percentage of patients monitored for metabolic parameters at the current guideline-recommended intervals. The secondary end points were the percentage of patients with documented primary care physician, untreated metabolic comorbidities, and treated metabolic comorbidities by disease state. The most assessed parameters were family history (98%), blood pressure (81%), and body mass index/body weight (83%) at the baseline interval. The least assessed parameters were lipids (14%) at the 12-week interval and waist circumference (0%) at any interval. Interventions are needed to encourage higher compliance with current recommendations. The complexity of the recommendations is the most likely reason for the suboptimal compliance.
Full Text Available Suicidal behavior (SB is a major, worldwide health concern. To date there is limited understanding of the associated motivational aspects which accompany this self-initiated conduct.To develop a method for identifying motivational features associated with SB by studying admitted psychiatric patients, and to examine their clinical relevance.By performing a factor analytic study using data obtained from a patient sample exhibiting high suicidality and a variety of SB methods, Motivations for SB Scale (MSBS was constructed to measure the features. Data included assessments of DSM-IV psychiatric and personality disorders, suicide intent, depressive symptomatology, overt aggression, recent life events (RLEs and methods of SB, collated from structured interviews. Association of identified features with clinical variables was examined by correlation analyses and MANCOVA.Factor analyses elicited a 4-factor solution composed of Interpersonal-testing (IT, Interpersonal-change (IC, Self-renunciation (SR and Self-sustenance (SS. These factors were classified according to two distinctions, namely interpersonal vs. intra-personal directedness, and the level of assumed influence by SB or the relationship to prevailing emotions. Analyses revealed meaningful links between patient features and clinical variables. Interpersonal-motivations (IT and IC were associated with overt aggression, low suicidality and RLE discord or conflict, while SR was associated with depression, high suicidality and RLE separation or death. Borderline personality disorder showed association with IC and SS. When self-strangulation was set as a reference SB method, self-cutting and overdose-taking were linked to IT and SS, respectively.The factors extracted in this study largely corresponded to factors from previous studies, implying that they may be useful in a wider clinical context. The association of these features with SB-related factors suggests that they constitute an integral part
Hayashi, Naoki; Igarashi, Miyabi; Imai, Atsushi; Yoshizawa, Yuka; Asamura, Kaori; Ishikawa, Yoichi; Tokunaga, Taro; Ishimoto, Kayo; Tatebayashi, Yoshitaka; Harima, Hirohiko; Kumagai, Naoki; Ishii, Hidetoki; Okazaki, Yuji
Suicidal behavior (SB) is a major, worldwide health concern. To date there is limited understanding of the associated motivational aspects which accompany this self-initiated conduct. To develop a method for identifying motivational features associated with SB by studying admitted psychiatric patients, and to examine their clinical relevance. By performing a factor analytic study using data obtained from a patient sample exhibiting high suicidality and a variety of SB methods, Motivations for SB Scale (MSBS) was constructed to measure the features. Data included assessments of DSM-IV psychiatric and personality disorders, suicide intent, depressive symptomatology, overt aggression, recent life events (RLEs) and methods of SB, collated from structured interviews. Association of identified features with clinical variables was examined by correlation analyses and MANCOVA. Factor analyses elicited a 4-factor solution composed of Interpersonal-testing (IT), Interpersonal-change (IC), Self-renunciation (SR) and Self-sustenance (SS). These factors were classified according to two distinctions, namely interpersonal vs. intra-personal directedness, and the level of assumed influence by SB or the relationship to prevailing emotions. Analyses revealed meaningful links between patient features and clinical variables. Interpersonal-motivations (IT and IC) were associated with overt aggression, low suicidality and RLE discord or conflict, while SR was associated with depression, high suicidality and RLE separation or death. Borderline personality disorder showed association with IC and SS. When self-strangulation was set as a reference SB method, self-cutting and overdose-taking were linked to IT and SS, respectively. The factors extracted in this study largely corresponded to factors from previous studies, implying that they may be useful in a wider clinical context. The association of these features with SB-related factors suggests that they constitute an integral part of the
Russo, Ethan B
This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration "Botanical Guidance." The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain.
Russo, Ethan B.
This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558
Ethan Budd Russo
Full Text Available This overview covers a wide range of cannabis topics, initially examining issue in dispensaries and self-administration, plus regulatory requirement for production of cannabis-based medicines, particularly the Food and Drug Administration Botanical Guidance. The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety and public health issues remain.
Jürgens, G; Jacobsen, C B; Rasmussen, H B
To describe clinical utility and adoption of routinely offered CYP2D6 and CYP2C19 genotyping (CYP test) in daily clinical practice of a psychiatric centre.......To describe clinical utility and adoption of routinely offered CYP2D6 and CYP2C19 genotyping (CYP test) in daily clinical practice of a psychiatric centre....
McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan
With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations. © The Author(s) 2015.
Martinez, Diego A; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L; Djulbegovic, Benjamin
The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time. The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength
Dal-Ré, Rafael; Moher, David; Gluud, Christian
Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....
Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N
Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
Patrick I Okonta
The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of c...
diseases and dry AMD; • Established patient databases at the University of Utah and University of Medicine and Dentistry of New Jersey CTECs, classified...clinical trial, 2) as many as 50% affected are missed if you don’t include those under the age of 18, and 3) while Stargardt’s lends itself to a pediatric ...population study, the risk should be assessed in an adult population prior to treating the pediatric population. Final Discussions: Suggestions
... Immunotherapy Shown Safe in Type 1 Diabetes Clinical Trial Next step is to see if it works ... Aug. 9, 2017 (HealthDay News) -- A small clinical trial showed an immune system therapy was safe for ...
Dichter Gabriel S
Full Text Available Abstract This review summarizes evidence of dysregulated reward circuitry function in a range of neurodevelopmental and psychiatric disorders and genetic syndromes. First, the contribution of identifying a core mechanistic process across disparate disorders to disease classification is discussed, followed by a review of the neurobiology of reward circuitry. We next consider preclinical animal models and clinical evidence of reward-pathway dysfunction in a range of disorders, including psychiatric disorders (i.e., substance-use disorders, affective disorders, eating disorders, and obsessive compulsive disorders, neurodevelopmental disorders (i.e., schizophrenia, attention-deficit/hyperactivity disorder, autism spectrum disorders, Tourette’s syndrome, conduct disorder/oppositional defiant disorder, and genetic syndromes (i.e., Fragile X syndrome, Prader–Willi syndrome, Williams syndrome, Angelman syndrome, and Rett syndrome. We also provide brief overviews of effective psychopharmacologic agents that have an effect on the dopamine system in these disorders. This review concludes with methodological considerations for future research designed to more clearly probe reward-circuitry dysfunction, with the ultimate goal of improved intervention strategies.
Tais Michele Minatogawa Chang
Full Text Available To assess the frequency of involuntary psychiatric hospitalizations from 2001 to 2008 and to determine associated clinical and socio-demographic characteristics, a retrospective cohort study was conducted. Adult admission data were collected from a university hospital in Brazil. Hospitalizations were classified as voluntary (VH or involuntary (IH. Groups were compared using chi-square test for categorical variables and Mann-Whitney test for continuous non-parametric variables. The relative risk of certain events was estimated by the odds ratio statistic. Of 2,289 admissions, 13.3% were IH. The proportion of IH increased from 2.5% to 21.2% during the eight year period. IH were more frequently associated with female gender, unmarried status, unemployment, and more than 9 years of schooling. Psychotic symptoms were more common among IH. There were no differences in age, duration of hospitalization, or rate of attendance at first appointment after hospital discharge. Understanding of the characteristics associated with IH is necessary to improve the treatment of psychiatric disorders.
Gelkopf, M; Kreitler, S; Sigal, M
The study was designed to explore the potential therapeutic effects of humor on hospitalized schizophrenics. For this purpose, in the first stage, we conducted a review of findings in regard to physical health, emotions, psychiatric state, and social behavior. In the second stage, we carried out an experiment with 34 resident patients in two chronic schizophrenic wards who were exposed to 70 movies during 3 months. The experimental group was exposed to humorous movies only, and the control group to different kinds of movies. Before and after the exposure to films for 3 months, both groups were tested on different health, emotional, social, and clinical measures using the Cognitive Orientation of Health Questionnaire, the Shalvata Symptom Rating Scale, blood pressure, heart rate, Perceived Verbal and Motor Aggression (rated by nurses), the Multiple Affect Adjective Check List, the Social Support Questionnaire 6, and the Brief Psychiatric Rating Scale (BPRS; rated by psychiatrists). Covariance analyses yielded significant reductions in Perceived Verbal Hostility, BPRS scales (total score, anxiety/depression), and significant increases in BPRS (activation) and degree of staff support experienced by the patients. The results indicate that the effects of exposure to humor may be mediated by the effects on the staff of the incidental exposure to humorous films.
Desai, Rani A; Harpaz-Rotem, Ilan; Najavits, Lisa M; Rosenheck, Robert A
Seeking Safety is a manualized cognitive-behavioral therapy intervention that is designed to treat clients with comorbid substance abuse and trauma histories. This study examined its effectiveness when used with homeless women veterans with psychiatric or substance abuse problems at 11 Department of Veterans Affairs medical centers that had Homeless Women Veterans Programs. The intervention consists of 25 sessions that cover topics to help build safety in clients' lives and is present-focused, offering psychoeducation and coping skills. A cohort of homeless women veterans (N=359) was recruited before Seeking Safety was implemented (phase I). After clinicians were trained and certified in Seeking Safety, a postimplementation cohort was recruited and offered Seeking Safety treatment (phase II, N=91). Phase I lasted from January 2000 to June 2003. Phase II lasted from June 2003 to December 2005. The intervention lasted for six months. All participants were interviewed every three months for one year and received intensive case management and other services during the study. Mixed models were used to compare one-year clinical outcomes across phases. There were few differences across groups at baseline. All women entering the Homeless Women Veterans Programs showed significant improvement on most clinical outcome measures over one year. The Seeking Safety cohort reported significantly better outcomes over one year in employment, social support, general symptoms of psychiatric distress, and symptoms of posttraumatic stress disorder, particularly in the avoidance and arousal clusters. However, the Seeking Safety cohort was significantly more likely to have used drugs in the past 30 days. Seeking Safety appears to have had a moderately beneficial impact on several clinical outcomes. Although the nonequivalent comparison groups and low follow-up rates limit the internal validity of these results, availability of Seeking Safety may be of benefit for homeless female veterans
Introduction Cultural Consultation is a clinical process that emerged from anthropological critiques of mental healthcare. It includes attention to therapeutic communication, research observations and research methods that capture cultural practices and narratives in mental healthcare. This essay describes the work of a Cultural Consultation Service (ToCCS) that improves service user outcomes by offering cultural consultation to mental health practitioners. The setting is a psychiatric service with complex and challenging work located in an ethnically diverse inner city urban area. Following a period of 18 months of cultural consultation, we gather the dominant narratives that emerged during our evaluation of our service. Results These narratives highlight how culture is conceptualized and acted upon in the day-to-day practices of individual health and social care professionals, specialist psychiatric teams and in care systems. The findings reveal common narratives and themes about culture, ethnicity, race and their perceived place and meaningfulness in clinical care. These narratives express underlying assumptions and covert rules for managing, and sometimes negating, dilemmas and difficulties when considering “culture” in the presentation and expression of mental distress. The narratives reveal an overall “culture of understanding cultural issues” and specific “cultures of care”. These emerged as necessary foci of intervention to improve service user outcomes. Conclusion Understanding the cultures of care showed that clinical and managerial over-structuring of care prioritises organisational proficiency, but it leads to inflexibility. Consequently, the care provided is less personalised and less accommodating of cultural issues, therefore, professionals are unable to see or consider cultural influences in recovery. PMID:23020856
Sekeres, Melanie; Gold, Jennifer L; Chan, An-Wen; Lexchin, Joel; Moher, David; Van Laethem, Marleen L P; Maskalyk, James; Ferris, Lorraine; Taback, Nathan; Rochon, Paula A
In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial
Di Lorenzo R
Full Text Available Rosaria Di Lorenzo,1 Nina Cimino,2 Elena Di Pietro,3 Gabriella Pollutri,4 Vittoria Neviani,5 Paola Ferri2 1Service of Psychiatric Diagnosis and Treatment, Department of Mental Health, AUSL Modena, Modena, 2School of Nursing, University of Modena and Reggio Emilia, 3School of Neuro-Psychiatry, 4School of Psychiatry, University of Modena and Reggio Emilia, 5 “The Medlar”, Villa Igea Hospital, Modena, Italy Background: Psychiatric emergencies of children and adolescents have greatly increased during the last years, but this phenomenon has not been studied in detail. The aim of this study was to analyze the correlation between acute psychiatric hospitalizations of adolescents and selected variables to highlight risk factors for psychiatric emergencies. Methods: This retrospective research was conducted in the acute psychiatric public ward, Service of Psychiatric Diagnosis and Treatment (SPDT, and in the residential facility for adolescents, “The Medlar”, located in Modena. The sample was constituted by all adolescent patients (n=101, age range 14–18 who had acute hospitalizations (n=140 in SPDT and had been successively transferred to “The Medlar” (n=83, from February 2, 2010 to January 31, 2015. From clinical charts, we extracted demographic and anamnestic characteristics of patients and clinical variables related to hospitalizations. Data were statistically analyzed. Results: Sixty-one percent of our patients lived with one divorced parent, with adoptive or immigrant family, or in institutions; 51% had experienced stressful events during childhood; 81% had a normal intellective level, but only 6% presented regular school performance. Parental psychiatric illness was negatively related, in a statistically significantly way, with onset age of adolescent mental disorders (coefficient -2.28, 95% confidence interval [CI]: -3.53 to 1.01, P<0.001, single linear regression; odds ratio: 4.39, 95% CI: 1.43–13.47, P<0.010, single logistic
Bartoli, E; Sorrentino, D; Trevisi, A
Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.
Santen, Gijs Willem Eduard
To fail or not to fail – Clinical trials in depression investigates the causes of the high failure rate of clinical trials in depression research. Apart from the difficulties in the search for new antidepressants during drug discovery, faulty clinical trial designs hinder their evaluation during
Henry, James A; Loovis, Carl; Montero, Melissa; Kaelin, Christine; Anselmi, Kathryn-Anne; Coombs, Rebecca; Hensley, June; James, Kenneth E
.... We conducted a randomized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinically significant tinnitus...
Välimäki, Maritta; Yang, Min; Normand, Sharon-Lise; Lorig, Kate R; Anttila, Minna; Lantta, Tella; Pekurinen, Virve; Adams, Clive E
People admitted to psychiatric hospitals with a diagnosis of schizophrenia may display behavioural problems. These may require management approaches such as use of coercive practices, which impact the well-being of staff members, visiting families and friends, peers, as well as patients themselves. Studies have proposed that not only patients' conditions, but also treatment environment and ward culture may affect patients' behaviour. Seclusion and restraint could possibly be prevented with staff education about user-centred, more humane approaches. Staff education could also increase collaboration between patients, family members and staff, which may further positively affect treatment culture and lower the need for using coercive treatment methods. This is a single-blind, two-arm cluster randomised controlled trial involving 28 psychiatric hospital wards across Finland. Units will be randomised to receive either a staff educational programme delivered by the team of researchers, or standard care. The primary outcome is the incidence of use of patient seclusion rooms, assessed from the local/national health registers. Secondary outcomes include use of other coercive methods (limb restraint, forced injection, and physical restraint), service use, treatment satisfaction, general functioning among patients, and team climate and employee turn-over (nursing staff). The study, designed in close collaboration with staff members, patients and their relatives, will provide evidence for a co-operative and user-centred educational intervention aiming to decrease the prevalence of coercive methods and service use in the units, increase the functional status of patients and improve team climate in the units. We have identified no similar trials. ClinicalTrials.gov NCT02724748 . Registered on 25th of April 2016.
Smuck, Bobbi; Bettello, Phyllis; Berghout, Koralee; Hanna, Tracie; Kowaleski, Brenda; Phippard, Lynda; Au, Diana; Friel, Kay
The Ontario Institute for Cancer Research supported the creation of a working group with the objective of developing a standard rating scale to evaluate clinical trial complexity and applying the scale to facilitate workload measurement for Ontario cancer research sites. The lack of a mechanism to measure the workload involved in a clinical trials protocol was identified and confirmed by a literature review. To collect information on how Ontario sites were assessing workload, a survey was distributed and evaluated. As a result, the working group developed the Ontario Protocol Assessment Level (OPAL), a protocol complexity rating scale designed to capture the workload involved in a clinical trial. After a training workshop on the application, OPAL was evaluated by 17 Ontario cancer centers to demonstrate its reliability and consistency during a 3-month pilot study. Twenty-seven protocols were reviewed by multiple sites, and the majority of the sites reported OPAL score differences between 0 and 1.5. OPAL provides clinical trials departments with an objective method of quantifying clinical trials activity on the basis of study protocol complexity. With consistent application of OPAL, sites can manage staffing objectively. The working group is continuing to monitor the application of OPAL in Ontario.
Full Text Available ATL is a distinct peripheral T-lymphocytic malignancy associated with human T-cell lymphotropic virus type I (HTLV-1. The diversity in clinical features and prognosis of patients with this disease has led to its subtype-classification into four categories, acute, lymphoma, chronic, and smoldering types, defined by organ involvement, and LDH and calcium values. In case of acute, lymphoma, or unfavorable chronic subtypes (aggressive ATL, intensive chemotherapy like the LSG15 regimen (VCAP-AMP-VECP is usually recommended if outside of clinical trials, based on the results of a phase 3 trial. In case of favorable chronic or smoldering ATL (indolent ATL, watchful waiting until disease progression has been recommended, although the long-term prognosis was inferior to those of, for instance, chronic lymphoid leukemia. Retrospective analysis suggested that the combination of interferon alpha and zidovudine was apparently promising for the treatment of ATL, especially for types with leukemic manifestation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT is also promising for the treatment of aggressive ATL possibly reflecting graft versus ATL effect. Several new agent trials for ATL are ongoing and in preparation, including a defucosylated humanized anti-CC chemokine receptor 4 monoclonal antibody, IL2-fused with diphtheria toxin, histone deacetylase inhibitors, a purine nucleoside phosphorylase inhibitor, a proteasome inhibitor, and lenalidomide.
Kobes, Marjolein H B M; Nijman, Henk H L I; Bulten, Erik B H
Accurate observation of aggressive behavior among forensic psychiatric patients requires valid instruments. This study examines the validity and clinical utility of combining the social dysfunction and aggression scale (SDAS) and staff observation aggression scale revised (SOAS-R). Nurses weekly obtained SDAS scores of 127 patients, resulting in 6.124 assessments. Aggressive incidents were documented by the SOAS-R. Internal consistency, subscale structure, interobserver reliability of the SDAS, and convergent validity with SOAS-R were analyzed. A three-factor solution was found. Interobserver reliability was moderate, and good convergent validity was found. The SDAS, in conjunction with the SOAS-R, monitors changes in aggressiveness and may contribute to the prevention of aggressive behavior. Copyright © 2012 Elsevier Inc. All rights reserved.
Full Text Available Abstract Background Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. Methods We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA, which measures mental health problems and their severity. We collected also data about the diagnoses, suicidal problems, family situations, and the involvement of the Child Protection Service. Predictions of outcome (change in HoNOSCA total score were analysed with a regression model. Results The sample comprised 192 adolescents admitted during one year (response rate 87%. Mean age was 15.7 years (range 10-18 and 70% were girls. Fifty-eight per cent had suicidal problems at intake and the mean intake HoNOSCA total score was 18.5 (SD 6.4. The largest groups of main diagnostic conditions were affective (28% and externalizing (26% disorders. Diagnoses and other patient characteristics at intake did not differ between units. Clinical psychiatric disorders and developmental disorders were associated with severity (on HoNOSCA at intake but not with outcome. Of adolescents ≥ 16 years, 33% were compulsorily admitted. Median length of stay was 8.5 days and 75% of patients stayed less than a month. Compulsory admissions and length of stay varied between units. Mean change (improvement in the HoNOSCA total score was 5.1 (SD 6.2, with considerable variation between units. Mean discharge score was close to the often-reported outpatient level, and self-injury and emotional symptoms were the most reduced symptoms during the stay. In a regression model, unit, high HoNOSCA total score at intake, or involvement of the Child Protection Service predicted improvement during admission
Kilian, Reinhold; Lauber, Christoph; Kalkan, Rana; Dorn, Wulf; Rössler, Wulf; Wiersma, Durk; van Buschbach, Jooske T; Fioritti, Angelo; Tomov, Toma; Catty, Jocelyn; Burns, Tom; Becker, Thomas
Positive relationships between employment and clinical status have been found in several studies. However, an unequivocal interpretation of these relationships is difficult on the basis of common statistical methods. In this analysis, a structural equation model approach for longitudinal data was applied to identify the direction of statistical relationships between hours worked, clinical status and days in psychiatric hospital in 312 persons with schizophrenia who participated in a multi-centre randomised controlled trial comparing the effectiveness of Individual Placement and Support (IPS) with conventional vocational services in six study settings across Europe. Data were analysed by an autoregressive cross-lagged effects model, an autoregressive cross-lagged model with random intercepts and an autoregressive latent trajectory model. Comparison of model fit parameters suggested the autoregressive cross-lagged effects model to be the best approach for the given data structure. All models indicated that patients who received an IPS intervention spent more hours in competitive employment and, due to indirect positive effects of employment on clinical status, spent fewer days in psychiatric hospitals than patients who received conventional vocational training. Results support the hypothesis that the IPS intervention has positive effects not only on vocational but also on clinical outcomes in patients with schizophrenia.
Kurbel, Sven; Mihaljević, Slobodan
Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials. © 2017 WILEY Periodicals, Inc.
Philip James Brittain
Full Text Available Progress in personalised psychiatry is dependent on researchers having access to systematic and accurately acquired symptom data across clinical diagnoses. We have developed a structured psychiatric assessment tool, OPCRIT+, that is being introduced into the electronic medical records system of the South London and Maudsley NHS Foundation Trust which can help to achieve this. In this report we examine the utility of the symptom data being collected with the tool. Cross-sectional mental state data from a mixed-diagnostic cohort of 876 inpatients was subjected to a principal components analysis (PCA. Six components, explaining 46% of the variance in recorded symptoms, were extracted. The components represented dimensions of mania, depression, positive symptoms, anxiety, negative symptoms and disorganization. As indicated by component scores, different clinical diagnoses demonstrated distinct symptom profiles characterized by wide-ranging levels of severity. When comparing the predictive value of symptoms against diagnosis for a variety of clinical outcome measures (e.g. 'Overactive, aggressive behaviour', symptoms proved superior in five instances (R(2 range: 0.06-0.28 whereas diagnosis was best just once (R(2:0.25. This report demonstrates that symptom data being routinely gathered in an NHS trust, when documented on the appropriate tool, have considerable potential for onward use in a variety of clinical and research applications via representation as dimensions of psychopathology.
Yvette M Nel
Full Text Available Background. Evidence suggests that the presence of mental illness may be associated with poorer adherence to antiretroviral therapy (ART. There is also a general understanding that patients initiated on ART as inpatients have poorer outcomes than those initiated as outpatients. Negative perceptions regarding future adherence may affect the clinical decision to initiate ART in hospitalised psychiatric patients. Attendance at clinic appointments is an indicator of medication adherence, and is easily measurable in a limited-resource setting. Objectives. The primary objective of this study was to examine the rate of attendance at the first clinic appointment post discharge from a period of psychiatric hospitalisation in HIV-positive psychiatric patients initiated on ART as inpatients. A secondary objective was to determine which factors, if any, were associated with clinic attendance. Methods. This study was a retrospective record review, conducted at the Luthando Neuropsychiatric HIV Clinic in Soweto, which is an integrated mental healthcare and ART clinic. Patients who were initiated on ART as psychiatric inpatients from 1 July 2009 to 31 December 2010, and subsequently discharged for outpatient follow-up at Luthando Clinic were included in the sample. Results. There were 98 patients included in the analysis. The sample was predominantly female. The rate of attendance was 80%. The attendant and non-attendant groups were similar in terms of demographic and clinical data. Significantly fewer non-attendant patients had disclosed their HIV status to their treatment supporter (p=0.01. Conclusion. Non-disclosure of HIV status needs to be further addressed in integrated psychiatric HIV treatment facilities in order to improve attendance. Female predominance in this setting should also be further investigated.
Halsteinli, Vidar; Kittelsen, Sverre A.C.; Magnussen, Jon
BACKGROUND: It is generally believed that 5 percent of the population under 18 years is in need of specialist psychiatric care. In 1998, however, services were delivered to only 2.1 percent of the Norwegian population. Access to services can be improved by increasing capacity, but also by increasing the utilization of existing capacity. Changing financial incentives has so far not been considered. Based on a relatively low number of registered consultations per therapist (1.1 per therapist day) the ministry has stipulated that productivity should increase by as much as 50 percent. AIMS OF THE STUDY: Measuring productivity in psychiatric care is difficult, but we believe that studies of productivity should be an important input in policy making. The aim of this paper is to provide such an analysis of the productive efficiency of psychiatric outpatient clinics for children and youths, and in particular to focus on three issues: (i) is an increase in productivity of 50 percent a realistic goal, (ii) are there economies of scale in the sector, and (iii) to what extent can differences in productivity be explained by differences in staff-mix and patient-mix? METHODS: We utilize an approach termed Data Envelopment Analysis (DEA) to estimate a best-practice production frontier. The potential for efficiency improvement is measured as the difference between actual and best-practice performance, while allowing for trade-offs between different staff groups and different mixes of service production. The DEA method gives estimates of efficiency and productivity for each clinic without the need for prices, and thus avoids the pitfalls of partial productivity ratios. The Kolmogorov-Smirnov statistic is used to compare efficiency distributions, providing tests of variable specification and scale properties. RESULTS: Based on 135 observations for the years 1997 to 1999, the tests lead to a model with two inputs, two outputs and variable returns to scale. The outputs are number of
It is necessary for us to reform the infrastructure for clinical trials in Japan in this new GCP era. Medical institutions for clinical trials should prepare to implement monitoring and auditing procedures for quality control and quality assurance of clinical trials. It is also necessary to ease the burden and improve the benefits of participating in clinical trials by subjects. Although there has been no effort to educate and train CRC/SC staff at all in Japan, future improvement in this area is needed to bring the quality of Japan's clinical trials up to international standards.
Farquhar, Cynthia M; Showell, Marian G; Showell, Emily A E; Beetham, Penny; Baak, Nora; Mourad, Selma; Jordan, Vanessa M B
What is the prevalence and source of prospectively and retrospectively registered and unregistered trials in fertility treatments? Trial registration is low and does not appear to be changing over the 5 years studied. Trial registration is associated with lower risk of bias than in unregistered trials. The Cochrane Gynaecology and Fertility Group's specialised register was searched on 5 November 2015 for randomised controlled trials (RCTs) published from January 2010 to December 2014. Eligible trials included randomised women or men for fertility treatments, were published in full text, and written in English. Two reviewers independently assessed trial registration status for each trial, by searching the publication, trial registries, and by contacting the original authors. Of 693 eligible RCTS, only 44% were registered trials. Of 309 registered trials, 21.7% were prospectively registered, 15.8% were registered within 6 months of first patient enrolment and 62.5% were retrospectively registered trials. Prospective trial registration by country varied from 0% to 100%. The highest frequency of prospective trial registration amongst the top 10 publishing countries was 31% in the Netherlands. Only English language trials were included in this review. Prospective trial registration is still low. Journals, funders and ethics committees could have a greater role to increase trial registration. University of Auckland. No competing interests.
DerSimonian, Rebecca; Laird, Nan
In this paper, we revisit a 1986 article we published in this Journal, Meta-Analysis in Clinical Trials, where we introduced a random-effects model to summarize the evidence about treatment efficacy from a number of related clinical trials. Because of its simplicity and ease of implementation, our approach has been widely used (with more than 12,000 citations to date) and the "DerSimonian and Laird method" is now often referred to as the 'standard approach' or a 'popular' method for meta-analysis in medical and clinical research. The method is especially useful for providing an overall effect estimate and for characterizing the heterogeneity of effects across a series of studies. Here, we review the background that led to the original 1986 article, briefly describe the random-effects approach for meta-analysis, explore its use in various settings and trends over time and recommend a refinement to the method using a robust variance estimator for testing overall effect. We conclude with a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases. Published by Elsevier Inc.
Bayés, M; Rabasseda, X; Prous, J R
Gateways to clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and devlopment protal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV-CF, adalimumab, ademetionine, afeletecan hydrochloride, agomelatine, alemtuzumab, almotriptan, amdoxovir, aplidine, aranose, arsenic sulfide, atazanavir, atlizumab; Bimatoprost, BMS-181176, BMS-188667, bortezomib, bryostatin 1; Combretastatin A-4 phosphate; Darbepoetin alfa, darusentan, deferasirox, desloratadine, DTaP-HBV-IPV/Hib-vaccine, DTI-0009; Eculizumab, edodekin alfa, emtricitabine, enfuvirtide, epoetin, esomeprazole magnesium etoricoxib; Fampridine, fenretinide, FR-146687; Galiximab, gamma-Hydroxybutyrate sodium, ganirelix acetate, gefitinib, Gemtuzumab ozogamicin, gimatecan; HEA125xOKT3, hIL-13-PE38QQR, HSV-2 theracine, Hu14.18-IL-2, human gammaglobulin; Idraparinux sodium, imatinib mesylate, IMiD3, insulin detemir, interleukin-4, irofulven, ISAtx-247; JT-1001; Levetiracetam, levosimendan, liposomal doxorubicin, liposomal vincristine sulfate, lixivaptan, lopinavir, lumiracoxib; Maxacalcitol, melatonin, midostaurin, MLN-518; Neridronic acid, nesiritide, nitronaproxen; Oblimersen sodium, oregovomab; PEG-filgrastim polyglutamate paclitaxel, prasterone, pregabalin; Rosuvastatin calcium, rotigotine hydrochloride; SGN-30; T-1249, tenofovir disoproxil fumarate, teriparatide, tiotropium bromide, tipranavir, TMC-114, trabectedin, transdermal selegiline; UK-427857; Valdecoxib, valganciclovir hydrochloride, vardenafil, vatalanib succinate, vincristine sulfate TCS; Zofenopril calcium.
Ramsey, Tam; Lai, Wanda; Guo, Eric; Svider, Peter F; Zuliani, Giancarlo; Eloy, Jean Anderson; Folbe, Adam J
To characterize trends in rhinosinusitis clinical trials to provide recommendations for therapeutic directions, highlight possible redundancy, and provide a framework for prioritization of future clinical trials. Database analysis. Data were collected from ClinicalTrials.gov including all clinical trials that focused on rhinosinusitis with the exclusion of trials withdrawn prior to enrollment. Variables recorded included study design, study population, pharmaceutical involvement, publication, and whether a trial was a medical or surgical intervention. Associated publications were identified using the PubMed, Embase, and Cochrane databases. There were 269 rhinosinusitis clinical trials, dating from 1993 to 2017, that met inclusion reauirements. Of the studies included in this analysis, 51.7% had at least one scientific publication, and of those with publications, 80.6% had positive results and 19.3% had negative results. Twenty-three clinical trials (8.5%) studied drugs already approved for rhinosinusitis, 113 (42.0%) trials studied drugs that were approved for other uses, 42 (15.6%) trials studied experimental drugs, and 102 (39.4%) studied surgical intervention. Of the trials studying drugs, the data showed many clinical trials that studied the same drug. The data demonstrate a steady decline in clinical trials with medical intervention and a rise in clinical trials with surgical intervention. This analysis is the first to characterize rhinosinusitis clinical trials, highlighting the over-representation of certain drugs and demonstrating an increased focus on clinical trials employing surgical intervention. We provide a framework to discuss prioritization of future studies to guide clinical and research practice. 4. Laryngoscope, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.
Van Laethem Marleen; Kalkar Sunila R; Wu Wei; Moher David; Ferris Lorraine E; Lexchin Joel; Hoey John; Sekeres Melanie; Rochon Paula A; Gruneir Andrea; Gold Jennifer; Maskalyk James; Streiner David L; Taback Nathan; Chan An-Wen
Abstract Background Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Methods Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct,...
Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G
Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.
Palermo, Tonya M; Beals-Erickson, Sarah; Bromberg, Maggie; Law, Emily; Chen, Maida
The majority of adolescents with chronic insomnia have physical health or psychiatric comorbidities; insomnia is also associated with greater negative daytime symptoms (e.g., depressive symptoms) and reduced overall health-related quality of life (HRQOL). However, to date, there has been limited attention to treatment of insomnia in this population. The purpose of this study was to determine the preliminary efficacy of a brief cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep, psychological symptoms, and HRQOL outcomes in adolescents with insomnia and co-occurring physical or psychiatric comorbidities. We conducted a single arm pilot trial in which 40 youth (mean age = 14.93, standard deviation = 1.89) with insomnia and physical or psychiatric comorbidities (e.g., depression, chronic pain, anxiety, gastrointestinal problems) received CBT-I in four individual treatment sessions over 4 to 6 w. Adolescents completed 7 days of wrist actigraphy and self-report measures of insomnia, sleep quality and behaviors, psychological symptoms, and HRQOL outcomes at pretreatment, immediate posttreatment, and 3-mo follow-up. CBT-I was associated with improvements in self-reported measures of sleep including insomnia symptoms, sleep quality, sleep hygiene, pre-sleep arousal, and sleep onset latency. Psychological symptoms and HRQOL also improved. Effects were generally sustained at 3-mo follow-up. CBT-I may be efficacious for adolescents with co-occurring physical and mental health comorbidities; future randomized controlled trials are needed to test the effect of CBT-I on sleep, psychological symptoms, and HRQOL and to evaluate maintenance of treatment effects over longer time periods.
Speer, Susan A; McPhillips, Rebecca
To explore transsexual patients' perceptions of communication with psychiatrists in a Gender Identity Clinic and advance understanding of patient centered communication (PCC) in psychiatric, 'gatekeeping' settings. 21 qualitative interviews with a convenience sample of clinic patients. Interviews were coded at a semantic level and subject to an inductive thematic analysis. Patients' perceptions clustered into three themes: (1) aspects of communication that patients described liking; (2) aspects of communication that patients described disliking; and (3) aspects of communication that patients deemed challenging but necessary or useful. Patients described liking or disliking aspects of communication that reflect existing understandings of PCC. However, a striking feature of their accounts was how they were able to rationalize and reflect pragmatically on their negative communication experiences, welcoming doctors' challenges as an opportunity to consider their life-changing decision to transition from their natal gender. In certain clinical settings, current operationalizations of PCC may not apply. Patients' perceptions of communication may be enhanced if an analysis of their experiences formed part of the professional training of doctors, who could be invited to consider the functional specificity of communication across settings and the consequences (both immediate and post hoc) of their communication practices. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
Jon O Ebbert
Full Text Available Jon O Ebbert, Kirk D Wyatt, Ali Zirakzadeh, Michael V Burke, JT HaysMayo Clinic College of Medicine, Mayo Clinic, Rochester, MN, USAAbstract: Chronic obstructive pulmonary disease (COPD is a costly and deadly disease afflicting an estimated 210 million people and accounting for 5% of all global deaths. Exposure to cigarette smoke is the greatest risk factor for COPD in the developed world. Smoking cessation improves respiratory symptoms and lung function and reduces mortality among patients with COPD. Cigarette smokers with COPD and other co-morbid conditions such as cardiovascular disease and psychiatric illnesses should receive comprehensive tobacco treatment interventions incorporating efficacious pharmacotherapies. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, is the newest and most effective drug currently available to promote smoking cessation. In conjunction with behavioral interventions and clinical monitoring for potential side effects, varenicline offers great hope for reducing smoking-attributable death and disability.Keywords: smoking cessation, chronic obstructive pulmonary disease, varenicline
DeCoux Hampton, Michelle
With the popularity of accelerated pre-licensure nursing programmes and the growth in nursing student enrolments, traditional clinical education continues to be a challenge to deliver. Nursing faculty members are required to develop and implement educational innovations that achieve effective learning outcomes, while using fewer resources. The purpose of this qualitative study was to explore the effectiveness of a constructivism-based learning project to achieve specific learning outcomes and to supplement approximately 30 clinical hours in a psychiatric-mental health nursing course. Students participated in a 10-week, multistage project that examined life histories, treatment resources, and evidence-based practice, as applied to a single individual with a mental illness. Students reported increased understanding of mental health and illness, developed personal relevance associated with the knowledge gained, and learned to problem solve with regard to nursing care of individuals diagnosed with mental illness. For many students, there also appeared to be a reduction in stigmatized attitudes towards mental illness. Constructivism-based learning is a promising alternative to supplement clinical hours, while effectively achieving learning outcomes. Future research is needed to further validate the use of this method for the learning of course content, as well as the reduction of stigma. © 2011 The Author. International Journal of Mental Health Nursing © 2011 Australian College of Mental Health Nurses Inc.
Andres E. Morales La Madrid
Full Text Available In spite of major recent advances in DIPG molecular characterization, this body of knowledge has not yet translated into better treatments.To date,more than 250 clinical trials evaluating radiotherapy along with conventional cytotoxic chemotherapy as well as newer biologic agents,have failed to improve the dismal outcome when compared to palliative radiation alone.The biology of DIPG remained unknown until recently when the neurosurgical expertise along with the recognition by the scientific and clinical community of the importance of tissue sampling at diagnosis;ideally in the context of a clinical trial and by trained neurosurgical teams to maximize patient safety.These pre-treatment tumor samples,and others coming from tissue obtained post-mortem,have yielded new insights into DIPG molecular biology.We now know that DIPG comprises a heterogeneous disease with variable molecular phenotypes, different from adult high grade glioma,other non-pontine pediatric high grade gliomas and even between pontine gliomas.The discovery of histone H3.3 or H3.1 mutations has been an important step forward in understanding tumor formation,maintenance and progression.Pharmacologic reversal of DIPG histone demethylation therefore offers an important potential intervention strategy for the treatment of DIPG.To date,clinical trials of newly diagnosed or progressive DIPG with epigenetic modifiers have been unsuccessful.Whether this failure represents limited activity of the agents used,their CNS penetration,redundant pathways within the tumor,or the possibility that histone mutations are necessary only to initiate DIPGs but not maintain their growth,suggest that a great deal still needs to be elucidated in both the underlying biology of these pathways,and the drugs designed to target them.In this review, we discuss the role of both epigenetic and genetic mutations within DIPG and the development of treatment strategies directed against the unique abnormalities
Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.
George, Melvin; Selvarajan, Sandhiya; S, Suresh-Kumar; Dkhar, Steven A; Chandrasekaran, Adithan
The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide.
Scherer-Rath, M.; Brand, J.A.M. van den; Straten, C. van; Modderkolk, L.; Terlouw, C.; Hoencamp, E.
This is a qualitative pilot study of congruence in narrative reconstruction of interpretations of life events by patients in a clinical psychiatric setting. It is based on the assumption that a coherent interpretive structure means that the interpretation of contingent life events by a person must
Cain, Nicole M; Pincus, Aaron L; Ansell, Emily B
This review documents two themes of emphasis found in phenotypic descriptions of pathological narcissism across clinical theory, social/personality psychology, and psychiatric diagnosis. Clinical theories of narcissism spanning 35 years consistently describe variations in the expression of pathological narcissism that emphasize either grandiosity or vulnerable affects and self-states. Recent research in social/personality psychology examining the structure of narcissistic personality traits consistently finds two broad factors representing Grandiosity-Exhibitionism and Vulnerability-Sensitivity-Depletion respectively. However, the majority of psychiatric criteria for narcissistic personality disorder (NPD) in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) emphasize expressions of grandiosity. By placing most of the diagnostic emphasis on overt grandiosity, DSM NPD has been limited by poor discriminant validity, modest levels of temporal stability, and the lowest prevalence rate on Axis II. Despite converging support for two phenotypic themes associated with pathological narcissism, psychiatric diagnosis and social/personality psychology research often focus only on grandiosity in the assessment of narcissism. In contrast, clinical theory struggles with a proliferation of labels describing these broad phenotypic variations. We conclude that the construct of pathological narcissism is at a crossroads and provide recommendations for diagnostic assessment, clinical conceptualization, and future research that could lead to a more integrated understanding of narcissistic personality and narcissistic personality pathology.
Xu, Jun; Zhang, Yaoyun; Wu, Yonghui; Wang, Jingqi; Dong, Xiao; Xu, Hua
In scientific writing, positive credits and negative criticisms can often be seen in the text mentioning the cited papers, providing useful information about whether a study can be reproduced or not. In this study, we focus on citation sentiment analysis, which aims to determine the sentiment polarity that the citation context carries towards the cited paper. A citation sentiment corpus was annotated first on clinical trial papers. The effectiveness of n-gram and sentiment lexicon features, and problem-specified structure features for citation sentiment analysis were then examined using the annotated corpus. The combined features from the word n-grams, the sentiment lexicons and the structure information achieved the highest Micro F-score of 0.860 and Macro-F score of 0.719, indicating that it is feasible to use machine learning methods for citation sentiment analysis in biomedical publications. A comprehensive comparison between citation sentiment analysis of clinical trial papers and other general domains were conducted, which additionally highlights the unique challenges within this domain.
In individually randomized controlled trials, in addition to the primary outcome, information is often available on a number of covariates prior to randomization. This information is frequently utilized to undertake adjustment for baseline characteristics in order to increase precision of the estimation of average treatment effects; such adjustment is usually performed via covariate adjustment in outcome regression models. Although the use of covariate adjustment is widely seen as desirable for making treatment effect estimates more precise and the corresponding hypothesis tests more powerful, there are considerable concerns that objective inference in randomized clinical trials can potentially be compromised. In this paper, we study an empirical likelihood approach to covariate adjustment and propose two unbiased estimating functions that automatically decouple evaluation of average treatment effects from regression modeling of covariate-outcome relationships. The resulting empirical likelihood estimator of the average treatment effect is as efficient as the existing efficient adjusted estimators(1) when separate treatment-specific working regression models are correctly specified, yet are at least as efficient as the existing efficient adjusted estimators(1) for any given treatment-specific working regression models whether or not they coincide with the true treatment-specific covariate-outcome relationships. We present a simulation study to compare the finite sample performance of various methods along with some results on analysis of a data set from an HIV clinical trial. The simulation results indicate that the proposed empirical likelihood approach is more efficient and powerful than its competitors when the working covariate-outcome relationships by treatment status are misspecified.
The purpose of sharing these ideas about the role of the psychiatric clinical specialist in the medical setting has been threefold: first, to stimulate the interest of others by communicating the needs for and the value of such a role in improving health care; secondly, to convey the variety of potential opportunities available in the role; and third, to share some ideas about specific activities which can be pursued in such a role. The clinical specialist who chooses to work in the medical setting will discover opportunities to develop creativeness, to explore innovative ideas, and to utilize the variety of one's personal resources and past learning experiences. It affords one with opportunities to serve as a change agent, to influence the quality of patient care, and to stimulate the growth of other nurses. It allows for on-going contact and exchange with other professional groups comprising the health care team, and finally, it provides the nurses with a high level of autonomy and challenge in defining their own roles.
Faustino, Patricia C.; Terreri, Maria Teresa R.A.; Rocha, Antonio J. da; Zappitelli, Marcelo C.; Lederman, Henrique M.; Hilario, Maria Odete E. [Universidade Federal de Sao Paulo, Sao Paulo (Brazil)
The objective of this study was to determine the clinical and laboratory characteristics, psychiatric manifestations and magnetic resonance imaging (MRI) findings in children and adolescents with Sydenham chorea (SyC). The imaging examination was repeated 1 year after the acute phase of SyC. There were 19 patients with a mean age of 11.7 years and a predominance of females (79%);68% had generalized chorea and 53% moderate chorea. SyC presented as an isolated manifestation in 74%. No association between SyC and obsessive-compulsive disorder was found. Mental health problems were present in 45% of the patients. MRI analysis revealed persistent alterations in the caudate nucleus in three patients (16%), who presented recurrent episodes of chorea during the study. In one patient, MRI revealed the presence of nodular heteropathy close to the caudate nucleus region. We conclude that attention problems can be associated with acute clinical features of SyC and persistent alterations in the basal nuclei, evidenced by MRI, can be found in some patients who tend to suffer prolonged attacks and a greater number of recurrences. (orig.)
Stuart J Pocock; Bernard J Gersh
.... Topics covered include the inadequacy of trial research on medical devices, problems with industry-sponsored trials, the lack of head-to-head trials of new effective treatments, the need for wiser...
Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana
Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.
Luís, H S; Morgado, I; Assunção, V; Bernardo, M F; Leroux, B; Martin, M D; DeRouen, T A; Leitão, J
Dental hygiene activities were developed as part of a randomized clinical trial designed to assess the safety of low-level mercury exposure from dental amalgam restorations. Along with dental-hygiene clinical work, a community programme was implemented after investigators noticed the poor oral hygiene habits of participants, and the need for urgent action to minimize oral health problems in the study population. Clinical and community activity goal was to promote oral health and prevent new disease. Community activities involved participants and their fellow students and were aimed at providing education on oral health in a school environment. Dental hygienists developed clinical work with prophylaxis, sealants application and topical fluoride and implemented the community programme with in-class sessions on oral health themes. Twice a month fluoride mouthrinses and bi-annual tooth brushing instructional activity took place. Participation at dental-hygiene activities, sealed teeth with no need of restoration and dental-plaque-index were measures used to evaluate success of the programme for the participants. Improvement in dental hygiene is shown by the decrease in dental plaque index scores (P teeth. 888 (13.7%) teeth with sealants had to be restored or were lost. Children participated actively on dental hygiene activities. Teachers became aware of the problem and included oral-health in school curricula. Dental hygiene activities have shown to be helpful to promote dental hygiene, promote oral health and to provide school-age children with education on habits that will be important for their future good health.
Full Text Available Clinical trial planning of candidate drugs is an important task for pharmaceutical companies. In this paper, we propose two new multistage stochastic programming formulations (CM1 and CM2 to determine the optimal clinical trial plan under uncertainty. Decisions of a clinical trial plan include which clinical trials to start and their start times. Its objective is to maximize expected net present value of the entire clinical trial plan. Outcome of a clinical trial is uncertain, i.e., whether a potential drug successfully completes a clinical trial is not known until the clinical trial is completed. This uncertainty is modeled using an endogenous uncertain parameter in CM1 and CM2. The main difference between CM1 and CM2 is an additional binary variable, which tracks both start and end time points of clinical trials in CM2. We compare the sizes and solution times of CM1 and CM2 with each other and with a previously developed formulation (CM3 using different instances of clinical trial planning problem. The results reveal that the solution times of CM1 and CM2 are similar to each other and are up to two orders of magnitude shorter compared to CM3 for all instances considered. In general, the root relaxation problems of CM1 and CM2 took shorter to solve, CM1 and CM2 yielded tight initial gaps, and the solver required fewer branches for convergence to the optimum for CM1 and CM2.
Liu, Katherine A; Mager, Natalie A Dipietro
The importance of considering the differences between the male and female sex in clinical decision-making is crucial. However, it has been acknowledged in recent decades that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have hindered the progress of understanding women's response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This review outlines the history and progress of women's inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue.
Dear, Rachel; Barratt, Alexandra; Askie, Lisa; McGeechan, Kevin; Arora, Sheena; Crossing, Sally; Currow, David; Tattersall, Martin
Clinical trials registries are now operating in the USA, Europe, Australia, China, and India and more are planned. Trial registries could be an excellent source of information about clinical trials for patients and others affected by cancer as well as health care professionals, but may be difficult for patients to navigate and use. An opportunity arose in Australia to develop a consumer friendly cancer clinical trials website (Australian Cancer Trials Online (ACTO), www.australiancancertrials.gov.au) using an automated data feed from two large clinical trial registries. In this article, we describe aspects of this new website, and explore ways in which such a website may add value to clinical trial data which are already collected and held by trial registries. The development of ACTO was completed by a Web company working in close association with staff at the Australian New Zealand Clinical Trials Registry (ANZCTR), and with consumer representatives. Data for the website were sourced directly and only from clinical trial registries, thus avoiding the creation of an additional trials database. It receives an automated, daily data feed of newly registered cancer clinical trials from both the ANZCTR and Clinical Trials.gov. The development of ACTO exemplifies the advantage of a local clinical trial registry working with consumers to provide accessible information about cancer clinical trials to meet consumers' information needs. We found that the inclusion of a lay summary added substantial value for consumers, and recommend that consideration be given to adding a lay summary to the mandatory data items collected by all trial registries. Furthermore, improved navigation, decision support tools, and consistency in data collection between clinical trial registries will also enable consumer websites to provide additional value for users. Clinical trial registration is not compulsory in Australia. If the additional cancer items (including a lay summary) are not provided
Soaham Dilip Desai
Full Text Available Background: Psychiatric disorders are common in patients attending neurology clinics with headache. Evaluation of psychiatric comorbidity in patients with headache is often missed in the busy neurology clinics. Aims: To assess the prevalence of Axis-I DSM-IV psychiatric disorders in patients with primary headache disorders in a rural-based tertiary neurology clinic in Western India. Settings and Design : A cross-sectional observation survey was conducting assessing all patients with migraine, tension-type headache and chronic daily headache attending the Neurology Clinic of Shree Krishna Hospital, a rural medical teaching hospital in Karamsad, in Gujarat in Western India. Materials and Methods: A total of 101 consecutive consenting adults with headache were interviewed using Mini International Neuropsychiatric Interview (M.I.N.I., a structured diagnostic clinical interview to assess prevalence of Axis-I DSM-IV psychiatric disorders. Statistical Analysis: Descriptive statistics were calculated using SPSS software version 16 and a binomial regression model was used to study the relationship of psychiatric co-morbidity with patient-related factors. Results: 49 out of 101 (48.5% patients with headache suffered from depressive disorders (dysthymia or depression or suicidality, 18 out of 101 patients with headache (17.90% suffered from anxiety related disorders (generalized anxiety disorder or agoraphobia or social phobia or panic disorder. Conclusions: Axis-I psychiatric disorders are a significant comorbidity among patients with headache disorders. M.I.N.I. can be used as a short, less time consuming instrument to assess all patients with headache disorders.
Unger, Joseph M; Hershman, Dawn L; Albain, Kathy S; Moinpour, Carol M; Petersen, Judith A; Burg, Kenda; Crowley, John J
Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ≥ 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.
Gadde, Kishore M; Pritham Raj, Y
This review provides an overview of the current state of drug therapy for obesity, with a focus on four new drug therapies-lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide 3.0 mg-which have been approved by the US Food and Drug Administration (FDA) for long-term management of obesity since 2012. Topics discussed in this paper include rationale for pharmacotherapy, history of antiobesity drugs, and efficacy and safety data from randomized controlled trials with implications for clinical practice. Weight loss achieved by currently approved drugs ranges from approximately 3 to 9%, above and beyond weight loss with lifestyle counseling alone, after a year. Response and attrition rates in clinical trials indicate that the benefits of pharmacotherapy range from substantial for some patients, modest for others, and no benefits for others still. Decisions regarding selection of a suitable drug from the available pharmacotherapy options and duration of treatment should be based on the expected and observed benefit-to-risk balance and tailored to the needs of each individual patient using the principles of shared decision-making.
Li, Ting-qian; Wang, Gang; Wang, Lei
To explore the problems and the strategies in clinical trials of traditional Chinese medicine (TCM), including the method and concealment of randomizing, equipoise of baseline, blindness and outcome measures, adverse reaction observation, statistical method and publication bias. The consolidated standard of reporting trials (CONSORT) is recommended to be applied in order to improve the quality of design and report of randomized controlled trials (RCTs) of TCM, and in case of human is taken as the subject of trial, according to the fundamental ethical principle, the clinical trial design should be censored by institutional review board (IRB), and the informed consent should be signed to protect the rights and interests of the trial participator.
Van Laethem Marleen
Full Text Available Abstract Background Financial conflicts of interest (fCOI can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Methods Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. Results 844 investigators responded (76% and 732 (66% provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively. Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%. Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43% and dissemination (53% to 64% stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85 or witnessed (n = 236 a fCOI; over 70% of these situations related to industry trials. Conclusion Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.
Rochon, Paula A; Sekeres, Melanie; Hoey, John; Lexchin, Joel; Ferris, Lorraine E; Moher, David; Wu, Wei; Kalkar, Sunila R; Van Laethem, Marleen; Gruneir, Andrea; Gold, Jennifer; Maskalyk, James; Streiner, David L; Taback, Nathan; Chan, An-Wen
Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. 844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials. Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.
Kertesz Stefan G
Full Text Available Abstract Background Comorbid psychiatric illness can undermine outcomes among homeless persons undergoing addiction treatment, and psychiatric specialty care is not always readily available. The prognosis for nonsubstance abuse psychiatric diagnoses among homeless persons receiving behaviorally-based addiction treatment, however, is little studied. Results Data from an addiction treatment trial for 95 cocaine-dependent homeless persons (1996–1998 were used to profile psychiatric diagnoses at baseline and 6 months, including mood-related disorders (e.g. depression and anxiety-related disorders (e.g. post-traumatic stress disorder. Treatment interventions, including systematic reinforcement for goal attainment, were behavioral in orientation. There was a 32% reduction in the prevalence of comorbid non-addiction psychiatric disorder from baseline to 6 months, with similar reductions in the prevalence of mood (-32% and anxiety-related disorders (-20% (p = 0.12. Conclusion Among cocaine-dependent homeless persons with psychiatric comorbidity undergoing behavioral addiction treatment, a reduction in comorbid psychiatric disorder prevalence was observed over 6 months. Not all participants improved, suggesting that even evidence-based addiction treatment will prove insufficient for a meaningful proportion of the dually diagnosed homeless population.
Griffioen, Brecht T; van der Vegt, Anna A; de Groot, Izaäk W; de Jongh, Ad
Although low self-esteem has been found to be an important factor in the development and maintenance of psychopathology, surprisingly little is known about its treatment. This study investigated the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy and Cognitive Behavioural Therapy (CBT), regarding their capacities in enhancing self-esteem in a general psychiatric secondary health care population. A randomized controlled trial with two parallel groups was used. Participants were randomly allocated to either 10 weekly sessions of EMDR (n = 15) or CBT (n = 15). They were assessed pre-treatment, after each session, post treatment and at 3 months follow-up on self-esteem (Rosenberg Self-esteem Scale and Credibility of Core Beliefs), psychological symptoms (Brief Symptom Inventory), social anxiety, and social interaction (Inventory of Interpersonal Situations) (IIS). The data were analyzed using repeated measures ANOVA for the complete cases (n = 19) and intention-to-treat (n = 30) to examine differences over time and between conditions. Both groups, EMDR as well as CBT, showed significant improvements on self-esteem, increasing two standard deviations on the main parameter (RSES). Furthermore, the results showed significant reductions in general psychiatric symptoms. The effects were maintained at 3 months follow-up. No between-group differences could be detected. Although the small sample requires to exercise caution in the interpretation of the findings, the results suggest that, when offering an adequate number of sessions, both EMDR and CBT have the potential to be effective treatments for patients with low self-esteem and a wide range of comorbid psychiatric conditions. This study was registered at www.trialregister.nl with identifier NTR4611.
Brecht T. Griffioen
Full Text Available Although low self-esteem has been found to be an important factor in the development and maintenance of psychopathology, surprisingly little is known about its treatment. This study investigated the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR therapy and Cognitive Behavioural Therapy (CBT, regarding their capacities in enhancing self-esteem in a general psychiatric secondary health care population. A randomized controlled trial with two parallel groups was used. Participants were randomly allocated to either 10 weekly sessions of EMDR (n = 15 or CBT (n = 15. They were assessed pre-treatment, after each session, post treatment and at 3 months follow-up on self-esteem (Rosenberg Self-esteem Scale and Credibility of Core Beliefs, psychological symptoms (Brief Symptom Inventory, social anxiety, and social interaction (Inventory of Interpersonal Situations (IIS. The data were analyzed using repeated measures ANOVA for the complete cases (n = 19 and intention-to-treat (n = 30 to examine differences over time and between conditions. Both groups, EMDR as well as CBT, showed significant improvements on self-esteem, increasing two standard deviations on the main parameter (RSES. Furthermore, the results showed significant reductions in general psychiatric symptoms. The effects were maintained at 3 months follow-up. No between-group differences could be detected. Although the small sample requires to exercise caution in the interpretation of the findings, the results suggest that, when offering an adequate number of sessions, both EMDR and CBT have the potential to be effective treatments for patients with low self-esteem and a wide range of comorbid psychiatric conditions. This study was registered at www.trialregister.nl with identifier NTR4611.
Griffioen, Brecht T.; van der Vegt, Anna A.; de Groot, Izaäk W.; de Jongh, Ad
Although low self-esteem has been found to be an important factor in the development and maintenance of psychopathology, surprisingly little is known about its treatment. This study investigated the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy and Cognitive Behavioural Therapy (CBT), regarding their capacities in enhancing self-esteem in a general psychiatric secondary health care population. A randomized controlled trial with two parallel groups was used. Participants were randomly allocated to either 10 weekly sessions of EMDR (n = 15) or CBT (n = 15). They were assessed pre-treatment, after each session, post treatment and at 3 months follow-up on self-esteem (Rosenberg Self-esteem Scale and Credibility of Core Beliefs), psychological symptoms (Brief Symptom Inventory), social anxiety, and social interaction (Inventory of Interpersonal Situations) (IIS). The data were analyzed using repeated measures ANOVA for the complete cases (n = 19) and intention-to-treat (n = 30) to examine differences over time and between conditions. Both groups, EMDR as well as CBT, showed significant improvements on self-esteem, increasing two standard deviations on the main parameter (RSES). Furthermore, the results showed significant reductions in general psychiatric symptoms. The effects were maintained at 3 months follow-up. No between-group differences could be detected. Although the small sample requires to exercise caution in the interpretation of the findings, the results suggest that, when offering an adequate number of sessions, both EMDR and CBT have the potential to be effective treatments for patients with low self-esteem and a wide range of comorbid psychiatric conditions. This study was registered at www.trialregister.nl with identifier NTR4611. PMID:29167649
Vandenheuvel, Dieter; Lavigne, Rob; Brüssow, Harald
Recently, a number of phage therapy phase I and II safety trials have been concluded, showing no notable safety concerns associated with the use of phage. Though hurdles for efficient treatment remain, these trials hold promise for future phase III clinical trials. Interestingly, most phage formulations used in these clinical trials are straightforward phage suspensions, and not much research has focused on the processing of phage cocktails in specific pharmaceutical dosage forms. Additional research on formulation strategies and the stability of phage-based drugs will be of key importance, especially with phage therapy advancing toward phase III clinical trials.
Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.
van Veen, Mark; Koekkoek, Bauke; Mulder, Niels; Postulart, Debby; Adang, Eddy; Teerenstra, Steven; Schoonhoven, Lisette; van Achterberg, Theo
This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders. Present care for this population has a limited evidence base, is often open ended, little effective, and expensive. Recent epidemiological data shows that 43.5% of the Dutch are affected by mental illness during their life. About 80% of all patients receiving mental health services (MHS) have one or more non-psychotic disorders. Particularly for this group, long-term treatment and care is poorly developed. Care As Usual (CAU) currently is a form of low-structured treatment/care. Interpersonal Community Psychiatric Treatment (ICPT) is a structured treatment for people with long-term, non-psychotic disorders, developed together with patients, professionals, and experts. ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study. Multi-centre cluster-randomized clinical trial: 36 professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12 months, and a follow-up of 6 months. 180 Patients between 18-65 years of age will be included, who have been diagnosed with a non-psychotic psychiatric disorder (depressive, anxiety, personality or substance abuse disorder), have long-term (>2 years) or high care use (>1 outpatient contact per week or >2 crisis contacts per year or >1 inpatient admission per year), and who receive treatment in a specialized mental health care setting. The primary outcome variable is quality of life; secondary outcomes are costs, recovery, general mental health, therapeutic alliance, professional-perceived difficulty of patient, care needs and social contacts. No RCT, nor cost-effectiveness study, has been conducted on ICPT so far. The empirical base for current CAU is weak, if not absent. This study will fill this void, and generate data needed to improve daily mental health care. Netherlands Trial Register (NTR): 3988 . Registered 13th of May
Sullivan, Patrick F; Agrawal, Arpana; Bulik, Cynthia M
into biologically, clinically, and therapeutically meaningful insights. The emerging findings suggest that we are entering a phase of accelerated genetic discovery for multiple psychiatric disorders. These findings are likely to elucidate the genetic portions of these truly complex traits, and this knowledge can...... then be mined for its relevance for improved therapeutics and its impact on psychiatric practice within a precision medicine framework. [AJP at 175: Remembering Our Past As We Envision Our Future November 1946: The Genetic Theory of Schizophrenia Franz Kallmann's influential twin study of schizophrenia in 691...
Bjørndal, Lars; Fransson, Helena; Bruun, Gitte
nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... between the carious lesion and the pulp. In this long-term study, 239 of 314 (76.2%) patients were analyzed. The stepwise removal group had a significantly higher proportion of success (60.2%) at 5-y follow-up compared with the nonselective carious removal to hard dentin group (46.3%) (P = 0.031) when......) in deep carious lesions in adults. In conclusion, the stepwise carious removal group had a significantly higher proportion of pulps with sustained vitality without apical radiolucency versus nonselective carious removal of deep carious lesions in adult teeth at 5-y follow-up (ClinicalTrials.gov NCT...
Bardach, Shoshana H; Holmes, Sarah D; Jicha, Gregory A
Alzheimer's disease (AD) research progress is impeded due to participant recruitment challenges. This study seeks to better understand, from the perspective of individuals engaged in clinical trials (CTs), research motivations. Participants, or their caregivers, from AD treatment and prevention CTs were surveyed about research motivators. The 87 respondents had a mean age of 72.2, were predominantly Caucasian, 55.2% were male, and 56.3% had cognitive impairment. An overwhelming majority rated the potential to help themselves or a loved one and the potential to help others in the future as important motivators. Relatively few respondents were motivated by free healthcare, monetary rewards, or to make others happy. Recruitment efforts should focus on the potential benefit for the individual, their loved ones, and others in the future rather than free healthcare or monetary rewards.
Sahlsten, Hanna; Taiminen, Tero; Karukivi, Max; Sjösten, Noora; Nikkilä, Johanna; Virtanen, Juuso; Paavola, Janika; Joutsa, Juho; Niinivirta-Joutsa, Katri; Takala, Mari; Holm, Anu; Rauhala, Esa; Löyttyniemi, Eliisa; Johansson, Reijo; Jääskeläinen, Satu K
Chronic tinnitus has been associated with several psychiatric disorders. Only few studies have investigated these disorders using validated diagnostic interviews. The aims were to diagnose psychiatric and personality disorders with structured interviews, to assess self-rated psychiatric symptoms and elucidate temporal relations between psychiatric disorders and tinnitus. Current and lifetime DSM-IV diagnoses of axis-I (psychiatric disorders) and axis-II (personality disorders) were assessed using structured clinical interviews (SCID-I and -II). Current subjective psychiatric symptoms were evaluated via self-rating instruments: the Symptom Check List-90 (SCL-90), the Beck Depression Inventory, and the Dissociative Experiences Scale (DES). 83 patients (mean age 51.7, 59% men) with chronic, disturbing tinnitus and a median Tinnitus Handicap Inventory score of 32. The rates of lifetime and current major depression were 26.5% and 2.4%. The lifetime rate of obsessive-compulsive personality disorder (type C) was 8.4%. None of the patients had cluster B personality disorder or psychotic symptoms. The SCL-90 subscales did not differ from the general population, and median DES score was low, 2.4. Tinnitus patients are prone to episodes of major depression and often also have obsessive-compulsive personality features. Psychiatric disorders seem to be comorbid or predisposing conditions rather than consequences of tinnitus. Clinical trial reference: ClinicalTrials.gov (ID NCT 01929837).
Full Text Available Abstract Background Previous research has shown positive effects of music therapy for people with schizophrenia and other mental disorders. In clinical practice, music therapy is often offered to psychiatric patients with low therapy motivation, but little research exists about this population. The aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes. An additional aim of the study is to examine the mechanisms of change through music therapy. Methods 144 adults with a non-organic mental disorder (ICD-10: F1 to F6 who have low therapy motivation and a willingness to work with music will be randomly assigned to an experimental or a control condition. All participants will receive standard care, and the experimental group will in addition be offered biweekly sessions of music therapy over a period of three months. Outcomes will be measured by a blind assessor before and 1, 3, and 9 months after randomisation. Discussion The findings to be expected from this study will fill an important gap in the knowledge of treatment effects for a patient group that does not easily benefit from treatment. The study's close link to clinical practice, as well as its size and comprehensiveness, will make its results well generalisable to clinical practice.
Baer, Susan; Bogusz, Elliot; Green, David A.
Objective: Computer and gaming-station use has become entrenched in the culture of our youth. Parents of children with psychiatric disorders report concerns about overuse, but research in this area is limited. The goal of this study is to evaluate computer/gaming-station use in adolescents in a psychiatric clinic population and to examine the relationship between use and functional impairment. Method: 102 adolescents, ages 11–17, from out-patient psychiatric clinics participated. Amount of computer/gaming-station use, type of use (gaming or non-gaming), and presence of addictive features were ascertained along with emotional/functional impairment. Multivariate linear regression was used to examine correlations between patterns of use and impairment. Results: Mean screen time was 6.7±4.2 hrs/day. Presence of addictive features was positively correlated with emotional/functional impairment. Time spent on computer/gaming-station use was not correlated overall with impairment after controlling for addictive features, but non-gaming time was positively correlated with risky behavior in boys. Conclusions: Youth with psychiatric disorders are spending much of their leisure time on the computer/gaming-station and a substantial subset show addictive features of use which is associated with impairment. Further research to develop measures and to evaluate risk is needed to identify the impact of this problem. PMID:21541096
Baer, Susan; Bogusz, Elliot; Green, David A
Computer and gaming-station use has become entrenched in the culture of our youth. Parents of children with psychiatric disorders report concerns about overuse, but research in this area is limited. The goal of this study is to evaluate computer/gaming-station use in adolescents in a psychiatric clinic population and to examine the relationship between use and functional impairment. 102 adolescents, ages 11-17, from out-patient psychiatric clinics participated. Amount of computer/gaming-station use, type of use (gaming or non-gaming), and presence of addictive features were ascertained along with emotional/functional impairment. Multivariate linear regression was used to examine correlations between patterns of use and impairment. Mean screen time was 6.7±4.2 hrs/day. Presence of addictive features was positively correlated with emotional/functional impairment. Time spent on computer/gaming-station use was not correlated overall with impairment after controlling for addictive features, but non-gaming time was positively correlated with risky behavior in boys. Youth with psychiatric disorders are spending much of their leisure time on the computer/gaming-station and a substantial subset show addictive features of use which is associated with impairment. Further research to develop measures and to evaluate risk is needed to identify the impact of this problem.
Elkum, Naser B; Myles, James D; Kumar, Pranesh
The human body exhibits a variety of biological rhythms. There are patterns that correspond, among others, to the daily wake / sleep cycle, a yearly seasonal cycle and, in women, the menstrual cycle. Sine/cosine functions are often used to model biological patterns for continuous data, but this model is not appropriate for analysis of biological rhythms in failure time data. We consider a method appropriate for analysis of biological rhythms in clinical trials. We present a method to provide an estimate and confidence interval of the time when the minimum hazard is achieved. A motivating example from a clinical trial of adjuvant of pre-menopausal breast cancer patients provides an important illustration of the methodology in practice. Adapting the Cosinor method to the Weibull proportional hazards model is proposed as useful way of modeling the biological rhythm data. It presents a method to estimate the time that achieves the minimum hazard along with its associated confidence interval. The application of this technique to the breast cancer data revealed that the optimal day for pre-resection incisional or excisional biopsy of 28-day cycle (i.e. the day associated with the lowest recurrence rate) is day 8 with 95% CI 5-10. We found that older age, fewer positive nodes, smaller tumor size, and experimental treatment are important prognostic factors of longer relapse-free survival. The analysis of biological/circadian rhythms is usually handled by Cosinor rhythmometry method. However, in FTD this is simply not possible. In this case, we propose to adapt the Cosinor method to the Weibull proportional hazard model. The advantage of the proposed method is its ability to model survival data. This method is not limited to breast cancer data, and may be applied to any biological rhythms linked to right censored data.
Vawdrey, David K; Hripcsak, George
To measure the rate of non-publication and assess possible publication bias in clinical trials of electronic health records. We searched ClinicalTrials.gov to identify registered clinical trials of electronic health records and searched the biomedical literature and contacted trial investigators to determine whether the results of the trials were published. Publications were judged as positive, negative, or neutral according to the primary outcome. Seventy-six percent of trials had publications describing trial results; of these, 74% were positive, 21% were neutral, and 4% were negative (harmful). Of unpublished studies for which the investigator responded, 43% were positive, 57% were neutral, and none were negative; the lower rate of positive results was significant (pelectronic health record studies is similar to that in other biomedical studies. There appears to be a bias toward publication of positive trials in this domain. Copyright © 2012 Elsevier Inc. All rights reserved.
Pocock, Stuart J; Clayton, Tim C; Stone, Gregg W
As a sequel to last week's paper on the fundamentals of clinical trial design, this paper tackles related controversial issues: noninferiority trials, the value of factorial designs, the importance and challenges of strategy trials, Data Monitoring Committees (including when to stop a trial early), and the role of adaptive designs. All topics are illustrated by relevant examples from cardiology trials. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Kerbage, Hala; El Chammay, Rabih; Richa, Sami
Mental health legislation represents an important mean of protecting the rights of persons with mental disabilities by preventing human rights violations and discrimination and by legally reinforcing the objectives of a mental health policy. The last decade has seen significant changes in the laws relating to psychiatric practice all over the world, especially with the implementation of the Convention for the Rights of People with Disabilities (CRPD). In this paper, we review the existing legislation in Lebanon concerning the following areas in mental health: treatment and legal protection of persons with mental disabilities, criminal laws in relation to offenders with mental disorders, and laws regulating incapacity. We will discuss these texts in comparison with international recommendations and standards on the rights of persons with disabilities, showing the recurrent contradiction between them. Throughout our article, we will address the clinical dilemmas that Lebanese psychiatrists encounter in practice, in the absence of a clear legislation that can orient their decisions and protect their patients from abuse. Copyright © 2015. Published by Elsevier Ltd.
Romeika Carla Ferreira de Sena
Full Text Available Introduction: The male population has a high probability of abandoning treatment, avoidance of health services, great exposure to violence, mainly due to abusive use of alcohol and other drugs, and high crime rates also associated with this problem. Objective: To characterize the sociodemographic and clinical profile of men admitted to a Psychiatric Detoxification Hospital Unit for alcohol and drug abuse. Method: It is a cross-sectional and retrospective study, with data collection in 2015, with a temporal cut in patients´ records between 2008 and 2014, reaching a sample of 1,152 medical records. The data collection instrument was composed of a structured form. The data were analyzed in a descriptive way. Results: Regarding the age, the age group between 21 and 50 years old had 30.73% between six and ten days hospitalized, and 11.98% had readmissions. The main diagnoses for this disorders were linked to the use of opiates, cannabinoids, sedatives and hypnotics. Conclusion: The profile of internal and assisted men was characterized such as adults of productive age, residents of the metropolitan area of the city, with long periods of hospitalization, generally with improved type discharge, low readmission and diagnoses of mental disorders related to the excessive use of alcohol and other drugs.
Sher, Leo; Siever, Larry J; Goodman, Marianne; McNamara, Margaret; Hazlett, Erin A; Koenigsberg, Harold W; New, Antonia S
Gender is an important variable in the study of mental health because of the actual and perceived differences between men and women. Relatively little is known how males and females differ in their manifestations of antisocial personality disorder (ASPD). Demographic and clinical features of 323 participants with ASPD were assessed and recorded. Women had fewer episodes of antisocial behavior involving or not involving police, higher scores on the Childhood Trauma Questionnaire (CTQ) and on Emotional Abuse and Sexual Abuse subscales of the CTQ compared to men. CTQ scores positively correlated with the number of episodes of antisocial behavior involving police in men but not in women. The percentage of patients with comorbid borderline and histrionic personality disorders was higher and the percentage of participants with cocaine use disorder was lower among women compared to men. Comorbid alcohol use disorder was frequent in both groups, while a higher percentage of women had comorbid mood disorders compared to men. Logistic regression analysis demonstrates that CTQ scores, histrionic personality disorder, and antisocial behavior involving the police drive the difference between the groups. Our findings indicate that treatment of individuals with ASPD should focus on the management of comorbid psychiatric disorders. Published by Elsevier Ireland Ltd.
Ewashen, Carol; Lane, Annette
Often, baccalaureate nursing students initially approach a psychiatric mental health practicum with uncertainty, and even fear. They may feel unprepared for the myriad complex practice situations encountered. In addition, memories of personal painful life events may be vicariously evoked through learning about and listening to the experiences of those diagnosed with mental disorders. When faced with such challenging situations, nursing students often seek counsel from the clinical and/or classroom faculty. Pedagogic boundaries may begin to blur in the face of student distress. For the nurse educator, several questions arise: Should a nurse educator provide counseling to students? How does one best negotiate the boundaries between 'counselor', and 'caring educator'? What are the limits of a caring and professional pedagogic relation? What different knowledges provide guidance and to what differential consequences for ethical pedagogic relationships? This paper offers a comparative analysis of three philosophical stances to examine differences in key assumptions, pedagogic positioning, relationships of power/knowledge, and consequences for professional ethical pedagogic practices. While definitive answers are difficult, the authors pose several questions for consideration in discerning how best to proceed and under what particular conditions.
Full Text Available Abstract Background Mental distress among medical students is often reported. Burnout has not been studied frequently and studies using interviewer-rated diagnoses as outcomes are rarely employed. The objective of this prospective study of medical students was to examine clinically significant psychiatric morbidity and burnout at 3rd year of medical school, considering personality and study conditions measured at 1st year. Methods Questionnaires were sent to 127 first year medical students who were then followed-up at 3rd year of medical school. Eighty-one of 3rd year respondents participated in a diagnostic interview. Personality (HP5-i and Performance-based self-esteem (PBSE-scale were assessed at first year, Study conditions (HESI, Burnout (OLBI, Depression (MDI at 1st and 3rd years. Diagnostic interviews (MINI were used at 3rd year to assess psychiatric morbidity. High and low burnout at 3rd year was defined by cluster analysis. Logistic regressions were used to identify predictors of high burnout and psychiatric morbidity, controlling for gender. Results 98 (77% responded on both occasions, 80 (63% of these were interviewed. High burnout was predicted by Impulsivity trait, Depressive symptoms at 1st year and Financial concerns at 1st year. When controlling for 3rd year study conditions, Impulsivity and concurrent Workload remained. Of the interviewed sample 21 (27% had a psychiatric diagnosis, 6 of whom had sought help. Unadjusted analyses showed that psychiatric morbidity was predicted by high Performance-based self-esteem, Disengagement and Depression at 1st year, only the later remained significant in the adjusted analysis. Conclusion Psychiatric morbidity is common in medical students but few seek help. Burnout has individual as well as environmental explanations and to avoid it, organisational as well as individual interventions may be needed. Early signs of depressive symptoms in medical students may be important to address. Students
Furniss, Tilman; Müller, Jörg M; Achtergarde, Sandra; Wessing, Ida; Averbeck-Holocher, Marlies; Postert, Christian
An increasing number of empirical studies indicate that infants, toddlers and preschoolers may suffer from non-transient mental illnesses featuring developmental psychopathology. A few innovative child psychiatric approaches have been developed to treat infants, toddlers and preschoolers and their families, but have not yet been conceptually presented and discussed in the framework of different healthcare systems. The organizational and clinical experience gained while developing specific approaches may be important across disciplines and guide future developments in psychiatric treatment of infants, toddlers, preschoolers and their families. This article introduces the Preschool Family Day Hospital for Infants, Toddlers and Preschoolers and their Families at Münster University Hospital, Germany. This hospital is unique in the German healthcare system with regard to its social-service institution division of labor. Specifically, it uses an intermittent treatment approach and an integrated interactional family psychiatric approach to treat children and their parents as separate patients. This multidisciplinary, developmentally and family-oriented approach includes components of group treatments with children and separate treatments with parents. Specific techniques include video-assisted treatments of the parent-child interaction, psychiatric and psychotherapeutic treatments for parents, and conjoint family therapies that include both parents and siblings. The Family Day Hospital for infants, toddlers and preschoolers and their families offers innovative family-oriented treatments for those who suffer from a wide range of severe child psychiatric disorders that cannot be sufficiently treated in outpatient settings. Treatment is based on the need for family-oriented approaches to the early psychiatric treatment of infants, toddlers and preschoolers. Family day hospitals are an innovative approach to preschool child psychiatry that requires further evaluation.
Dahlin, Marie E; Runeson, Bo
Mental distress among medical students is often reported. Burnout has not been studied frequently and studies using interviewer-rated diagnoses as outcomes are rarely employed. The objective of this prospective study of medical students was to examine clinically significant psychiatric morbidity and burnout at 3rd year of medical school, considering personality and study conditions measured at 1st year. Questionnaires were sent to 127 first year medical students who were then followed-up at 3rd year of medical school. Eighty-one of 3rd year respondents participated in a diagnostic interview. Personality (HP5-i) and Performance-based self-esteem (PBSE-scale) were assessed at first year, Study conditions (HESI), Burnout (OLBI), Depression (MDI) at 1st and 3rd years. Diagnostic interviews (MINI) were used at 3rd year to assess psychiatric morbidity. High and low burnout at 3rd year was defined by cluster analysis. Logistic regressions were used to identify predictors of high burnout and psychiatric morbidity, controlling for gender. 98 (77%) responded on both occasions, 80 (63%) of these were interviewed. High burnout was predicted by Impulsivity trait, Depressive symptoms at 1st year and Financial concerns at 1st year. When controlling for 3rd year study conditions, Impulsivity and concurrent Workload remained. Of the interviewed sample 21 (27%) had a psychiatric diagnosis, 6 of whom had sought help. Unadjusted analyses showed that psychiatric morbidity was predicted by high Performance-based self-esteem, Disengagement and Depression at 1st year, only the later remained significant in the adjusted analysis. Psychiatric morbidity is common in medical students but few seek help. Burnout has individual as well as environmental explanations and to avoid it, organisational as well as individual interventions may be needed. Early signs of depressive symptoms in medical students may be important to address. Students should be encouraged to seek help and adequate facilities
Kaló, Zoltán; Antal, János; Pénzes, Miklós; Pozsgay, Csilla; Szepezdi, Zsuzsanna; Nagyjánosi, László
To determine the contribution of clinical trials to the gross domestic product (GDP) in Hungary. An anonymous survey of pharmaceutical companies and clinical research organizations (CROs) was conducted to estimate their clinical trial-related employment and revenues. Clinical trial documents at the National Institute of Pharmacy (NIP) were analyzed to estimate trial-related revenues at health care institutions and the value of investigational medical products (IMPs) based on avoided drug costs. Financial benefits were calculated as 2010 US $ purchasing power parity (PPP) values. Clinical trials increased the revenue of Hungarian health care providers by 1 US $65.6 million. The value of IMPs was US $67.0 million. Clinical trial operation and management activities generated 900 jobs and US $166.9 million in revenue among CROs and pharmaceutical companies. The contribution of clinical trials to the Hungarian GDP in 2010 amounted to 0.2%. Participation in international clinical trials may result in health, financial, and intangible benefits that contribute to the sustainability of health care systems, especially in countries with severe resource constraints. Although a conservative approach was employed to estimate the economic benefits of clinical trials, further research is necessary to improve the generalizability of our findings.
Pariera, Katrina L; Murphy, Sheila T; Meng, Jingbo; McLaughlin, Margaret L
African-Americans and Hispanic-Americans are disproportionately affected by cancer, yet underrepresented in cancer clinical trials. Because of this, it is important to understand how attitudes and beliefs about clinical trials vary by ethnicity. A national, random sample of 860 adults was given an online survey about attitudes toward clinical trials. We examined willingness to participate in clinical trials, attitudes toward clinical trials, trust in doctors, attitudes toward alternative and complementary medicine, and preferred information channels. Results indicate that African-American and Hispanic-American participants have more negative attitudes about clinical trials, more distrust toward doctors, more interest in complementary and alternative medicine, and less willingness to participate in clinical trials than white/non-Hispanics, although specific factors affecting willingness to participate vary. The channels people turn to for information on clinical trials also varied by ethnicity. These results help explain the ethnic disparities in cancer clinical trial enrollment by highlighting some potential underlying causes and drawing attention to areas of importance to these groups.
Biedrzycki, Barbara A
To describe what is known about the factors that influence cancer clinical trial decision making. PubMed database and reference lists of identified articles. Variations in research design and methods, including sample characteristics, instrumentation, time between decision made and measurement of decision making, and response rates, have effects on what is known about decision making for cancer clinical trial participation. Communication, whether in the form of education about a cancer clinical trial or as a personal invitation to join, is an important factor influencing decision making. Personal and system factors influence the outcomes of decision making for cancer clinical trials. The process of decision making for cancer clinical trials is understudied. Nevertheless, the currently available cancer clinical trial decision-making literature suggests a multitude of factors that influence the outcomes of the decision to accept or decline clinical trial participation, as well as the psychosocial consequences of decisional regret, pressures, and satisfaction. The decision-making process of cancer clinical trials is a fertile area for research and, subsequently, evidence-based interventions. Oncology nurses are in a position to facilitate the process and to relieve the pressures patients perceive regarding decision making for cancer clinical trials that will benefit individuals and, ultimately, society.
Huc-Chabrolle, M; Barthez, M-A; Tripi, G; Barthélémy, C; Bonnet-Brilhault, F
issues. ADHD is the most frequent psychiatric disorder associated with dyslexia. Underpinnings of this link between the two disorders seem to rely on common cognitive and genetic factors. Some authors have proposed a candidate gene ADRA2A to determine the condition including ADHD and dyslexia. In addition, dyslexics are exposed to a higher risk of anxiodepressive and behavioural disorders. Dyslexic children experience three times more behavioural disorders and one third of children with behavioural problems turn out to be affected by dyslexia. The literature study reveals inconsistent findings about depressed mood among dyslexics, but evidence of a persistent increase in the rate of anxiety disorders. The authors put forward the impact of environmental factors to explain these psychiatric comorbidities. This review emphasizes dyslexia's comorbidities because they represent an important issue, both from a scientific and clinical point of view. Indeed, for clinicians, children showing multiple learning disabilities have specific reeducation and educational needs and dyslexics have a higher risk of emotional and behavioural disorders. On the other hand, dyslexia's comorbidity study provides a powerful method for researchers to investigate the still unknown physiopathology of dyslexia. 2009 L'Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.
Diefenbach, Catherine S; Connors, Joseph M; Friedberg, Jonathan W; Leonard, John P; Kahl, Brad S; Little, Richard F; Baizer, Lawrence; Evens, Andrew M; Hoppe, Richard T; Kelly, Kara M; Persky, Daniel O; Younes, Anas; Kostakaglu, Lale; Bartlett, Nancy L
The National Clinical Trials Network lymphoid malignancies Clinical Trials Planning Meeting (CTPM) occurred in November of 2014. The scope of the CTPM was to prioritize across the lymphoid tumors clinically significant questions and to foster strategies leading to biologically informed and potentially practice changing clinical trials. This review from the Hodgkin lymphoma (HL) subcommittee of the CTPM discusses the ongoing clinical challenges in HL, outlines the current standard of care for HL patients from early to advanced stage, and surveys the current science with respect to biomarkers and the landscape of ongoing clinical trials. Finally, we suggest areas of unmet need in HL and elucidate promising therapeutic strategies to guide future HL clinical trials planning across the NCTN. Published by Oxford University Press 2016. This work is written by US Government employees and is in the public domain in the US.
Hu, Min; Liu, Jian-Ping; Wu, Xiao-Ke
Acupuncture clinical trials are designed to provide reliable evidence of clinical efficacy, and SCI papers is one of the high-quality clinical efficacy of acupuncture research. To analyze these papers published in high impact factor journals on acupuncture clinical trials, we can study clinical trials from design to implementation, the efficacy of prevention and cure, combined with international standard practices to evaluate the effectiveness and safety of acupuncture. That is the core of acupuncture clinical trials, as well as a prerequisite for outstanding academic output. A scientific and complete acupuncture clinical trial should be topically novel, designed innovative, logically clear, linguistically refining, and the most important point lies in a great discovery and solving the pragmatic problem. All of these are critical points of papers to be published in high impact factor journal, and directly affect international evaluation and promotion of acupuncture.
Full Text Available Abstract Background The Juniper Asthma Specific Quality of Life Questionnaire (AQLQ(S is a questionnaire that allows measurement of disease specific quality of life. We wanted to examine correlations between the (AQLQ(S general and different subscale scores and both psychiatric morbidity and levels of psychological distress in individuals with occupational asthma (OA and to determine if results in the emotional function subscale allow identification of individuals with clinically significant psychological distress or current psychiatric disorders. Methods This was a cross-sectional study of individuals with OA who were assessed during a re-evaluation for permanent disability, after they were no longer exposed to the sensitizing agent. Patients underwent a general sociodemographic and medical history evaluation, a brief psychiatric interview (Primary Care Evaluation of Mental Disorders, PRIME-MD and completed a battery of questionnaires including the AQLQ(S, the St-Georges Respiratory Questionnaire (SGRQ, and the Psychiatric Symptom Index (PSI. Results There was good internal consistency (Cronbach alpha = 0.936 for the AQLQ(S total score and construct validity for the AQLQ(S (Spearman rho = -0.693 for the SGRQ symptom score and rho = -0.650 for the asthma severity score. There were medium to large correlations between the total score of the AQLQ(S and the SGRQ symptom score (r = -.693, and PSI total (r = -.619 and subscale scores (including depression, r = -.419; anxiety, r = -.664; anger, r = -.367; cognitive disturbances, r = -.419. A cut-off of 5.1 on the AQLQ(S emotional function subscale (where 0 = high impairment and 7 = no impairment had the best discriminative value to distinguish individuals with or without clinically significant psychiatric distress according to the PSI, and a cut-off of 4.7 best distinguished individuals with or without a current psychiatric disorder according to the PRIME-MD. Conclusions Impaired quality of life is
Luntz, S P; Gorbauch, T; Schröder, B; Seibert-Grafe, M
Coordination Centres for Clinical Trials (Koordinierungszentren für Klinische Studien, KKS) were set up to increase the quality and number of clinical trials in Germany as well as to establish clinical trial training programs in order to improve international recognition of German clinical research. Over the past 6 years, 12 KKS have been set up at the respective universities with a public grant from the Federal Ministry of Education and Research (BMBF). Many non-clinical services have been established to ensure successful co-operation in clinical trials with clinical scientists and industry. KKS help researchers to efficiently conduct commercial and non-commercial clinical trials in various disease areas. Their expertise and infrastructure allow the university to assume sponsor responsibility in non-commercial drug trials. Because of their professional work and education activities KKS are well accepted by industry and the scientific community. Central professional trial organisations such as the KKS have been shown to be the pre-requisite for meeting the growing, manifold and complex requirements for clinical trials. Therefore they are considered essential for progress and success in clinical research.
offered complimentary or valet parking to prostate cancer clinical trial participants, followed by 21% offering complimentary food or beverages ...Help with transportation (e.g. bus tickets or taxi vouchers) 1 2 3 c. Cash or gift cards/certificates 1 2 3 d. Complimentary food or beverages ...prostate in an operation.] 1 0 77 99 c. Internal Radiation Therapy or Brachytherapy? [PROBE: This is when a doctor places radioactive ‗ seeds ‘ or other
Joseph S Ross
Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data
Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida
: PubMed, Embase, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press, and Google Scholar. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised clinical trials with blinded and non-blinded assessment of the same binary outcome. RESULTS: We included 21 trials in the main...
Fors, Martha Maria; Viada, Carmen Elena; Gonzalez, Paloma
Recursive Partitioning Analysis (RPA) is a very flexible non parametric algorithm that allows classification of individuals according to certain criteria, particularly in clinical trials, the method is used to predict response to treatment or classify individuals according to prognostic factors. In this paper we examine how often RPA is used in clinical trials and in meta-analysis. We reviewed abstracts published between 1990 and 2016, and extracted data regarding clinical trial phase, year of publication, type of treatment, medical indication and main evaluated endpoints. One hundred and eighty three studies were identified; of these 43 were meta-analyses and 23 were clinical trials. Most of the studies were published between 2011 and 2016, for both clinical trials and meta-analyses of randomized clinical trials. The prediction of overall survival and progression free survival were the outcomes most evaluated, at 43.5% and 51.2% respectively. Regarding the use of RPA in clinical trials, the brain was the most common site studied, while for meta-analytic studies, other cancer sites were also studied. The combination of chemotherapy and radiation was seen frequently in clinical trials. Recursive partitioning analysis is a very easy technique to use, and it could be a very powerful tool to predict response in different subgroups of patients, although it is not widely used in clinical trials. Copyright© Bentham Science Publishers; For any queries, please email at email@example.com.
Tudur Smith, Catrin; Williamson, Paula; Jones, Ashley; Smyth, Alan; Hewer, Simon Langton; Gamble, Carrol
Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners. This paper describes the monitoring methods and procedures that are utilised by a non-commercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks. Monitoring activities and approaches should be selected to be proportionate to the risks identified within a trial. A risk-proportionate approach to monitoring is described giving details of methods that may be considered by clinical trial practitioners during the development of a trial monitoring plan. An example risk assessment and corresponding monitoring plan for a low risk (type A in the Medicines and Healthcare Products Regulatory Agency (MHRA) classification system) pediatric trial is provided for illustration. We present ideas for developing a monitoring plan for a clinical trial of an investigational medicinal product based on our experience. Alternative approaches may be relevant or preferable in other settings based on inherent risk.
Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...
Greenfield, Shelly F.; Rosa, Carmen; Putnins, Susan I.; Green, Carla A.; Brooks, Audrey J.; Calsyn, Donald A.; Cohen, Lisa R.; Erickson, Sarah; Gordon, Susan M.; Haynes, Louise; Killeen, Therese; Miele, Gloria; Tross, Susan; Winhusen, Theresa
Background The NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) was established to foster translation of research into practice in substance abuse treatment settings. The CTN provides a unique opportunity to examine in multi-site, translational clinical trials, the outcomes of treatment interventions targeting vulnerable sub-groups of women; the comparative effectiveness of gender-specific protocols to reduce risk behaviors; and gender differences in clinical outcomes. Objectives To review gender-related findings from published CTN clinical trials and related studies from January, 2000 through March, 2010. Methods CTN studies were selected for review if they focused on treatment outcomes or services for special populations of women with substance use disorders (SUDs) including those with trauma histories, pregnancy, co-occurring eating and other psychiatric disorders and HIV risk behaviors; or implemented gender-specific protocols. Results The CTN has randomized 11,500 participants (41% women) across 200 clinics in 24 randomized clinical trials in community settings, of which 4 have been gender-specific. This paper summarizes gender-related findings from CTN clinical trials and related studies, focusing on trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors. Conclusions These published studies have expanded the evidence base regarding interventions for vulnerable groups of women with SUDs as well as gender-specific interventions to reduce HIV risk behaviors in substance using men and women. The results also underscore the complexity of accounting for gender in the design of clinical trials and analysis of results. Scientific Relevance To fully understand the relevance of gender-specific moderators and mediators of outcome, it is essential that future translational studies adopt more sophisticated approaches to understanding and measuring gender-relevant factors and plan sample sizes that are
Mandel, Jacob J; Yust-Katz, Shlomit; Patel, Akash J; Cachia, David; Liu, Diane; Park, Minjeong; Yuan, Ying; Kent, Thomas A; de Groot, John F
Glioblastoma is the most common primary malignant brain tumor in adults, but effective therapies are lacking. With the scarcity of positive phase III trials, which are increasing in cost, we examined the ability of positive phase II trials to predict statistically significant improvement in clinical outcomes of phase III trials. A PubMed search was conducted to identify phase III clinical trials performed in the past 25 years for patients with newly diagnosed or recurrent glioblastoma. Trials were excluded if they did not examine an investigational chemotherapy or agent, if they were stopped early owing to toxicity, if they lacked prior phase II studies, or if a prior phase II study was negative. Seven phase III clinical trials in newly diagnosed glioblastoma and 4 phase III clinical trials in recurrent glioblastoma met the inclusion criteria. Only 1 (9%) phase III study documented an improvement in overall survival and changed the standard of care. The high failure rate of phase III trials demonstrates the urgent need to increase the reliability of phase II trials of treatments for glioblastoma. Strategies such as the use of adaptive trial designs, Bayesian statistics, biomarkers, volumetric imaging, and mathematical modeling warrant testing. Additionally, it is critical to increase our expectations of phase II trials so that positive findings increase the probability that a phase III trial will be successful.
The implementation of informed consent (IC) in clinical trials presents many challenges, especially in developing countries. This study explored the experiences and reported practices regarding the implementation of IC in clinical trials in South Africa. Data were gathered through semi-structured interviews with a range of ...
Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida
To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....
Objectives: To identify possible existence of therapeutic misconception and its effects on clinical trials in sub-Saharan Africa. Data source: Original research findings and reviews published in the English literature and author's professional experience with clinical trials in some East, Central and West African countries.
Lambers Heerspink, Hiddo Jan
Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious
Objective: To identify and highlight challenges related to informed consent process for clinical trials in sub-Saharan Africa. Data sources: Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. Design: Review ...
Grønbech, Bettina Ellen; Aagaard, Jørgen; Jensen, Svend Eggert
People with severe mental illness, such as schizophrenia have higher rates of mortality especially due to cardiovascular disease. We have established a clinical trial named “Coronary artery disease and schizophrenia”. However, patients with schizophrenia have cognitive disturbances, which make re...... recruitment of patients challenging. The purpose of this study is to understand which type of recruitment strategy is needed in clinical trials....
Marinakis, Yorgos; Harms, Rainer; Walsh, Steven Thomas
Under U.S. federal regulation 31 CFR §312, medical interventions must report on a series of clinical trials phases before being submitted for approval for release to the U.S. market. Clinical trials are now being performed on medical interventions that were constructed through additive
Smed, Marie; Getz, Kenneth A.
in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract...
Jakobsen, Jan Nyrop; Sørensen, Jens Benn
Malignant mesothelioma (MM) is an aggressive tumor of the serosal surfaces with a poor prognosis. Advances in the understanding of tumor biology have led to the development of several targeted treatments, which have been evaluated in clinical trials. This article is a comprehensive review of all...... clinical trials evaluating the effect of targeted treatments in MM....
Barnard, Kayla; Klimberg, V Suzanne
Numerous clinical trials reveal new innovations and therapies that continually change the treatment and prevention of breast cancer. Earlier trials have changed the standard of care from radical mastectomy to breast conservation therapy and individualized treatment based on tumor-specific biology. As research continues and long-term follow-up results become available, updated reviews on randomized clinics trials become exceedingly important in discerning the most effective and oncologically safe therapies to provide optimal outcomes. Published by Elsevier Inc.
Full Text Available Abstract Background What constitutes a "clinical trial" is inconsistently defined in the medical literature. With an initiative by Cancer Care Ontario (CCO to report institutional clinical trials activity across the province of Ontario, Canada, we sought to investigate the variability in the interpretation of the term by local oncology professionals. Methods A survey amongst the physicians and nurses at the Juravinski Cancer Centre at Hamilton Health Sciences, Ontario was conducted. The survey included 12 summaries of local clinical research studies, and respondents were asked which they believed represented a clinical trial. Subsequently, they were asked which of the same 12 studies they believed should be labeled as clinical trials when considering separate definitions provided by CCO and by the Ontario Cancer Research Network (OCRN. Results A total of 66 (54% of 123 surveys were completed; 32/46 (70% by physicians, 21/59 (36% by primary care nurses, and 13/18 (72% by clinical trial nurses. Without a standardized definition, all studies, 12/12, were considered to be clinical trials by at least 50% of respondents. When provided with the CCO definition only 6/12 studies were considered to be clinical trials by the majority of respondents, while with the OCRN definition it was 9/12 studies. Studies evaluating natural health products, non-traditional medical interventions, and non-randomized studies with standard interventions consistently ranked the lowest, regardless of the definition used. Conclusion Oncology professionals appear to have a broadly inclusive baseline definition of what constitutes a clinical trial. Establishing rigor and consistency in the definition of a clinical trial is important for any program, institutional or jurisdictional based comparisons of clinical trials activity, especially when used as a quality indicator of patient care.
Wright, James R; Kowaleski, Brenda; Sussman, Jonathan
What constitutes a "clinical trial" is inconsistently defined in the medical literature. With an initiative by Cancer Care Ontario (CCO) to report institutional clinical trials activity across the province of Ontario, Canada, we sought to investigate the variability in the interpretation of the term by local oncology professionals. A survey amongst the physicians and nurses at the Juravinski Cancer Centre at Hamilton Health Sciences, Ontario was conducted. The survey included 12 summaries of local clinical research studies, and respondents were asked which they believed represented a clinical trial. Subsequently, they were asked which of the same 12 studies they believed should be labeled as clinical trials when considering separate definitions provided by CCO and by the Ontario Cancer Research Network (OCRN). A total of 66 (54%) of 123 surveys were completed; 32/46 (70%) by physicians, 21/59 (36%) by primary care nurses, and 13/18 (72%) by clinical trial nurses. Without a standardized definition, all studies, 12/12, were considered to be clinical trials by at least 50% of respondents. When provided with the CCO definition only 6/12 studies were considered to be clinical trials by the majority of respondents, while with the OCRN definition it was 9/12 studies. Studies evaluating natural health products, non-traditional medical interventions, and non-randomized studies with standard interventions consistently ranked the lowest, regardless of the definition used. Oncology professionals appear to have a broadly inclusive baseline definition of what constitutes a clinical trial. Establishing rigor and consistency in the definition of a clinical trial is important for any program, institutional or jurisdictional based comparisons of clinical trials activity, especially when used as a quality indicator of patient care.
...: A Video Game About Clinical Trials SUMMARY: In compliance with the requirement of Section 3506(c)(2... Collection: Title: Clinical Mythteries: A Video Game About Clinical Trials. Type of Information Collection... video game'' for adolescents about clinical studies which: (1) Incorporates core learning objectives...
Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg
Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of
Buonansegna, Erika; Salomo, Søren; Maier, Anja
Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature...... has extensively investigated success factors in R&D projects, it has not directly addressed success factors in clinical trials, as the late testing stage of a NPD yet. The aim of this paper is to enhance our understanding of the clinical trial management by creating a new conceptual framework...... of success factors. This paper creates the new framework by combining success factors from NPD literature and from empirical evidence collected through 11 semi-structured interviews with experts in clinical trials. The framework of success factors provides managerial guidelines for practitioners to optimize...
Moustgaard, Helene; Bello, Segun; Miller, Franklin G
OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...
Drye, Lea T; Meinert, Jill L; Meinert, Curtis L
In 1993 Congress passed the NIH Revitalization Act, which instructed the Director of the NIH to ensure that phase III clinical trials are 'designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect females or members of minority groups, as the case may be, differently than other subjects in the trial.' The purpose of this article is to track the PubMed indexing of gender in clinical trial publications since 1991 with a view toward assessing the impact of the legislation on the number of gender specific trials. We searched PubMed for full-length publications from years 1991 to 2008 of research on humans indexed as publication type 'clinical trial', 'randomized clinical trial' and multicenter randomized trial ('multicenter study' AND 'randomized clinical trial'), and counted the number of trials indexed as male-only, female-only, male and female, and gender unknown in PubMed. The majority of trial publications were indexed in PubMed as including both genders. The proportion of publications indexed as including both genders has increased while the number of publications not indexed with respect to gender and the number of publications indexed as male-only have decreased. In 2005, approximately 13% of NIH expenditures were for female specific or related research compared to 6% for male specific or related research. The proportion of clinical trial publications that were indexed in PubMed as including females began to increase before the legislation so it is difficult to conclude that changes in the number of female-only or male-only trials are due to the legislation. PubMed listings do not include gender enrollment, so female and male enrollment totals could not be compared. The NIH policy should be rewritten to be made gender neutral to bring it in line with the principle of justice as embodied in the Belmont Report.
Mueser, Kim T.; Glynn, Shirley M.; Cather, Corrine; Xie, Haiyi; Zarate, Roberto; Smith, Lindy Fox; Clark, Robin E.; Gottlieb, Jennifer D.; Wolfe, Rosemarie; Feldman, James
Substance use disorders have a profound impact on the course of severe mental illnesses and on the family, but little research has evaluated the impact of family intervention for this population. To address this question, a randomized controlled trial was conducted comparing a brief (2–3 mo) Family Education (ED) program with a longer-term (9–18 mo) program that combined education with teaching communication and problem-solving skills, Family Intervention for Dual Disorders (FIDD). A total of 108 clients (77% schizophrenia-spectrum) and a key relative were randomized to either ED or FIDD and assessed at baseline and every 6 months for 3 years. Rates of retention of families in both programs were moderate. Intent-to-treat analyses indicated that clients in both programs improved in psychiatric, substance abuse, and functional outcomes, as did key relatives in knowledge of co-occurring disorders, burden, and mental health functioning. Clients in FIDD had significantly less severe overall psychiatric symptoms and psychotic symptoms and tended to improve more in functioning. Relatives in FIDD improved more in mental health functioning and knowledge of co-occurring disorders. There were no consistent differences between the programs in substance abuse severity or family burden. The findings support the utility of family intervention for co-occurring disorders, and the added benefits of communication and problem-solving training, but also suggest the need to modify these programs to retain more families in treatment in order to provide them with the information and skills they need to overcome the effects of these disorders. PMID:22282453
Kontio, Raija; Pitkänen, Anneli; Joffe, Grigori; Katajisto, Jouko; Välimäki, Maritta
The management of psychiatric inpatients exhibiting severely disturbed and aggressive behaviour is an important educational topic. Well structured, IT-based educational programmes (eLearning) often ensure quality and may make training more affordable and accessible. The aim of this study was to explore the impact of an eLearning course for personnel on the rates and duration of seclusion and mechanical restraint among psychiatric inpatients. In a cluster-randomized intervention trial, the nursing personnel on 10 wards were randomly assigned to eLearning (intervention) or training-as-usual (control) groups. The eLearning course comprised six modules with specific topics (legal and ethical issues, behaviour-related factors, therapeutic relationship and self-awareness, teamwork and integrating knowledge with practice) and specific learning methods. The rates (incidents per 1000 occupied bed days) and durations of the coercion incidents were examined before and after the course. A total of 1283 coercion incidents (1143 seclusions [89%] and 140 incidents involving the use of mechanical restraints [11%]) were recorded on the study wards during the data collection period. On the intervention wards, there were no statistically significant changes in the rates of seclusion and mechanical restraint. However, the duration of incidents involving mechanical restraints shortened from 36.0 to 4.0 h (median) (P eLearning course, the duration of incidents involving the use of mechanical restraints decreased. However, more studies are needed to ensure that the content of the course focuses on the most important factors associated with the seclusion-related elements. The eLearning course deserves further development and further studies. The duration of coercion incidents merits attention in future research.
Stockings, Emily A L; Bowman, Jenny A; Baker, Amanda L; Terry, Margarett; Clancy, Richard; Wye, Paula M; Knight, Jenny; Moore, Lyndell H; Adams, Maree F; Colyvas, Kim; Wiggers, John H
Persons with a mental disorder smoke at higher rates and suffer disproportionate tobacco-related burden compared with the general population. The aim of this study was to determine if a smoking cessation intervention initiated during a psychiatric hospitalization and continued postdischarge was effective in reducing smoking behaviors among persons with a mental disorder. A randomized controlled trial was conducted at an Australian inpatient psychiatric facility. Participants were 205 patient smokers allocated to a treatment as usual control (n = 101) or a smoking cessation intervention (n = 104) incorporating psychosocial and pharmacological support for 4 months postdischarge. Follow-up assessments were conducted at 1 week, 2, 4, and 6 months postdischarge and included abstinence from cigarettes, quit attempts, daily cigarette consumption, and nicotine dependence. Rates of continuous and 7-day point prevalence abstinence did not differ between treatment conditions at the 6-month follow-up; however, point prevalence abstinence was significantly higher for intervention (11.5%) compared with control (2%) participants at 4 months (OR = 6.46, p = .01). Participants in the intervention condition reported significantly more quit attempts (F[1, 202.5] = 15.23, p = .0001), lower daily cigarette consumption (F[4, 586] = 6.5, p < .001), and lower levels of nicotine dependence (F[3, 406] = 8.5, p < .0001) compared with controls at all follow-up assessments. Postdischarge cessation support was effective in encouraging quit attempts and reducing cigarette consumption up to 6 months postdischarge. Additional support strategies are required to facilitate longer-term cessation benefits for smokers with a mental disorder. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org.
There is dynamic opportunity to advance medical research and clinical trial innovation in the USA and throughout the world. Identified problems and solutions in the clinical research and clinical trial enterprise have emerged over recent years. Strategic plans, public reports, expertise panels and international agreements have been produced, and now is the time to move forward collectively. Recommendations should be reviewed, especially because global healthcare can take them. A robust and future medical research enterprise hinges on maximized clinical trial efficiency, both in the USA and abroad.
Shergis Johannah L
Full Text Available Abstract Conducting clinical trials of Chinese medicines (CM in hospitals presents challenges for researchers. The success of hospital-based CM clinical trials may be influenced by the protocol design, including the maintenance of CM theory in compliance with scientific rigour and hospital guidelines and justified treatment approaches with results that can translate into clinical practice. Other influences include personnel and resources such as a dedicated team open to CM with an established research culture and the ability to maximise participant recruitment. This article identifies the key challenges and limitations of conducting CM clinical trials in Australian hospitals.
Lindblad, Robert; Hu, Lian; Oden, Neal; Wakim, Paul; Rosa, Carmen; VanVeldhuisen, Paul
Most substance use disorders (SUD) treatment clinical trials are too short and small to reliably estimate the incidence of rare events like death. The aim of this study is to estimate the overall mortality rates among a SUD treatment-seeking population by pooling participants from multiple clinical trials conducted through the National Institute on Drug Abuse (NIDA)-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN). Drug and or alcohol users (N=9866) who sought treatment and participated in one of the twenty-two CTN trials. Data were collected through randomized clinical trials in national community treatment programs for SUD. Pooled analysis was performed to assess age- and gender-standardized mortality rate(s) (SM rate(s)), and mortality ratio(s) (SM ratio(s)) of CTN trial participants compared to the U.S. general population. The age- and gender-SM rate among CTN trials participants was 1403 (95% CI: 862-2074) per 100,000 person years (PY) compared to 542 (95% CI: 541-543) per 100,000 PY among the U.S. general population in 2005. By gender, age-adjusted SM ratio for female CTN trial participants was over five times (SM ratio=5.35, 95% CI: 3.31-8.19)), and for male CTN trial participants, it was over three times (SM ratio=3.39, 95% CI: 2.25-4.90) higher than their gender comparable peers in the U.S. general population. Age and gender-standardized mortality rates and ratios among NIDA CTN SUD treatment-seeking clinical trial participants are higher than the age and gender comparable U.S. general population. The overall mortality rates of CTN trial participants are similar to in-treatment mortality reported in large U.S. and non-U.S. cohorts of opioid users. Future analysis with additional CTN trial participants and risk times will improve the stability of estimates, especially within subgroups based on primary substance of abuse. These SUD mortality rates can be used to facilitate safety monitoring within SUD clinical trials. Copyright © 2016
Kannan, S; Gowri, S
Clinical trials are mandatory for evidence-based practice. Hardly, any data are available regarding the number of clinical trials and their methodological quality that are conducted in allied fields of medicine. The present study was envisaged to assess methodological quality of trials in allied medical fields. Registered clinical trials in World Health Organization International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/AdvSearch.aspx) in the following fields were extracted: Acupuncture; Ayurveda; biofeedback; complementary and alternate medicine; herbal; homeopathy; massage; naturopathy; Reiki; Siddha; Unani; and yoga. The eligible studies were assessed for the following key details: Type of sponsors; health condition in which the trial has been conducted; recruitment status; study design; if randomization was present, method of randomization and allocation concealment; single or multi-centric; retrospective or prospective registration; and publication status in case of completed studies. A total of 276 clinical trials were registered majority of which have been proposed to be conducted in the field of oncology and psychiatry. Most of the clinical trials were done in single centers (87.75%), and almost all the clinical trials were investigator-initiated with pharmaceutical company sponsored studies contributing to a maximum extent of 24.5%. A large majority of the study designs were interventional where almost 85% of the studies were randomized controlled trials. However, an appropriate method of randomization was mentioned only in 27.4%, and the rate of allocation concealment was found to be just 5.5%. Only 1-2% of the completed studies were published, and the average rate of retrospective registration was found to be 23.6% in various fields. The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these
Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira
To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (pcountries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.
Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under "ideal" conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under "usual" conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.
Alzayyat, Abdulkarim; Al-Gamal, Ekhlas
Training in psychiatric settings is stressful for nursing students. The purpose of this study was to examine the correlations between the students' characteristics, their stress degrees, stressors and types of coping strategies they experience during training in psychiatric course. A descriptive, correlational, longitudinal design was used. Sixty-five undergraduate nursing students were recruited randomly from five Jordanian universities. Self-report questionnaires were administered at the second semester of the 2012-2013 academic year. The findings showed that students who utilized avoidance or transference strategies reported high stress degrees. Moreover, the results showed that those students who were in the fourth year, with a low family income, who avoid extracurricular activities, with a low academic grade or who registered in other clinical course(s) reported high stress degrees. These findings present a worthy data for the clinical instructors that facilitate students training in psychiatric settings and promote their psychosocial well-being. Copyright © 2014 John Wiley & Sons, Ltd. Copyright © 2014 John Wiley & Sons, Ltd.
Mentz, Robert J; Hernandez, Adrian F; Berdan, Lisa G; Rorick, Tyrus; O'Brien, Emily C; Ibarra, Jenny C; Curtis, Lesley H; Peterson, Eric D
Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. Although the application of Good Clinical Practice principles generally led to improvements in the quality and consistency of trial operations, these principles have also contributed to increasing trial complexity and costs. Alternatively, the growing availability of electronic health record data has facilitated the possibility for streamlined pragmatic clinical trials. The central tenets of Good Clinical Practice and pragmatic clinical trials represent potential tensions in trial design (stringent quality and highly efficient operations). In the present article, we highlight potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggest strategies to streamline study conduct in an ethical manner to optimally perform clinical trials in the electronic age. © 2016 American Heart Association, Inc.
Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi
Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to
Pompili, Maurizio; Iliceto, Paolo; Luciano, Debora; Innamorati, Marco; Serafini, Gianluca; Del Casale, Antonio; Tatarelli, Roberto; Girardi, Paolo; Lester, David
The present study was designed to explore psychopathological correlates of self-deception in clinical and nonclinical individuals to ascertain whether self-deception was associated with higher hopelessness, a proxy of suicide risk. The patients were 58 consecutive psychiatric patients (30 men, 28 women) admitted to the Sant'Andrea Hospital's psychiatric ward in Rome. Controls were composed of a sample recruited from the general population (62 men and 80 women). All the participants completed the Beck Hopelessness Scale (BHS), and the Balanced Inventory of Desirable Responding-6 Form 40A (BIDR). More than 55% of the patients had BHS scores of 9 or higher indicating severe hopelessness, while only 32% of the control subjects reported scores of 9 or higher on the BHS (p suicide risk as individuals do not want to face self-awareness and get close to a highly negative self.
Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R
This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...
Klimt, C R
Some of the guiding principles as well as the pitfall of long-term randomized clinical trials are presented. Examples have been chosen from trials in the cardiovascular field. A typical long-term clinical trial is divided into five phases: planning, preparation, recruitment, clinical follow-up and termination, and finally analysis. Administrative, legal, and ethical aspects of a trial are discussed, as well as the cost of clinical trials. Organization patterns are described and some prevalent ones are criticized. Further, practical matters such as recruitment techniques, obtaining informed consent from the patients, determining drug dosage and formulation as well as the problem of interaction with nonstudy drugs are referred to. Adherence testing remains a problem, because of our inability to test for placebo adherence.
Welch, Elisabeth; Jangmo, Andreas; Thornton, Laura M; Norring, Claes; von Hausswolff-Juhlin, Yvonne; Herman, Barry K; Pawaskar, Manjiri; Larsson, Henrik; Bulik, Cynthia M
We linked extensive longitudinal data from the Swedish national eating disorders quality registers and patient registers to explore clinical characteristics at diagnosis, diagnostic flux, psychiatric comorbidity, and suicide attempts in 850 individuals diagnosed with binge-eating disorder (BED). Cases were all individuals who met criteria for BED in the quality registers (N = 850). We identified 10 controls for each identified case from the Multi-Generation Register matched on sex, and year, month, and county of birth. We evaluated characteristics of individuals with BED at evaluation and explored diagnostic flux across eating disorders presentations between evaluation and one-year follow-up. We applied conditional logistic regression models to assess the association of BED with each comorbid psychiatric disorder and with suicide attempts and explored whether risk for depression and suicide were differentially elevated in individuals with BED with or without comorbid obesity. BED shows considerable diagnostic flux with other eating disorders over time, carries high psychiatric comorbidity burden with other eating disorders (OR 85.8; 95 % CI: 61.6, 119.4), major depressive disorder (OR 7.6; 95 % CI: 6.2, 9.3), bipolar disorder (OR 7.5; 95 % CI: 4.8, 11.9), anxiety disorders (OR 5.2; 95 % CI: 4.2, 6.4), and post-traumatic stress disorder (OR 4.3; 95 % CI: 3.2, 5.7) and is associated with elevated risk for suicide attempts (OR 1.8; 95 % CI: 1.2, 2.7). Depression and suicide attempt risk were elevated in individuals with BED with and without comorbid obesity. Considerable flux occurs across BED and other eating disorder diagnoses. The high psychiatric comorbidity and suicide risk underscore the severity and clinical complexity of BED.
Dunn, Adam G; Day, Richard O; Mandl, Kenneth D; Coiera, Enrico
Open sharing of clinical trial data has been proposed as a way to address the gap between the production of clinical evidence and the decision-making of physicians. A similar gap was addressed in the software industry by their open-source software movement. Here, we examine how the social and technical principles of the movement can guide the growth of an open-source clinical trial community.
DeBruin, Debra A; Liaschenko, Joan; Fisher, Anastasia
Despite prevalent concerns about the ethical conduct of clinical trials, little is known about the day-to-day work of trials and the ethical challenges arising in them. This paper reports on a study designed to fill this gap and demonstrates a need to refine the oversight system for trials to reflect an understanding of this day-to-day work. It also illuminates ethical challenges that cannot be addressed by the oversight system and so necessitate a rethinking of the ethics of clinical trials.
Daradkeh, T; El-Rufaie, O; Younis, Y; Ghubash, R
This study examines the stability of ICD-10 diagnoses of patients admitted to Al Ain (United Arab Emirates) inpatients psychiatric unit during the period from November 1993 to August 1995. Diagnostic stability is a measure of the degree to which diagnoses remained unchanged at a later hospital admission. One hundred and seven patients were admitted more than once during this period, accounting for 168 readmissions. High levels of diagnostic stability were found for ICD-10 Fl-psychiatric disorders (100%), F2-schizophrenia (87%), F3-bipolar disorders (87%) and F3-depressive disorders (73%). A poor level of stability was found for patients with neurotic, stress related and adjustment disorders (F4), ranging from zero for somatoform disorders to 50% for generalized anxiety and panic disorders. Poor levels of stability were also found for other psychoses (excluding schizophrenia and affective psychoses) and personality disorders. We conclude that the introduction of ICD-10 as a formal diagnostic system has greatly improved the temporal stability of the most commonly encountered psychiatric disorders (ICD-10 Fl to F3 disorders), confirming the construct validity of those psychiatric disorders. Further investigations are required to evaluate the diagnostic stability of neurotic and other psychotic disorders.
Nov 11, 2005 ... Predominantly risperidone and haloperidol in combination with valproate were used in treatment and at relatively high dosages. Conclusion: Amongst HIV positive service users acute psychiatric symptoms almost exclusively consisted of associated psychosis or manic symptoms rather than depression.
Ertem, Melike Yonder; Kececi, Ayla
Objective: An effective interpersonal communication is an essential nursing skill required to help provide quality health care and meet the treatment objectives. The aim of this study was to investigate the communication between the psychiatric nurses and the patients in terms of Transactional Analysis Theory ego states. Methods: The quantitative and qualitative research methods were used. The descriptive statistics (frequency, percentage, mean, standard deviation) were used in the data analysis and Kendall’s Tau-c coefficient was used to assess the agreement among the observers. Results: Of the psychiatric nurses, 66.7% (n = 14) had served as a psychiatric nurse for 1-10 years. Among the nurses, 52.4% (n=11) had received training about communication from any institution/organization. The agreement among the opinions of the nurses, the researcher and the charge nurses about the psychiatric nurses’ ego states showed that there was a significant relationship between the researcher’s opinion of the nurses’ ego states and the charge nurses’ opinion of the nurses’ ego states in terms of Critical Parent, Nurturing Parent, Adult, Adapted Child and Natural Child ego states. Conclusion: It is suggested that training be offered in regards to raising awareness about ulterior transactions that can affect communication negatively, patient autonomy and therapeutic communication in particular, and patients requiring the use of special communication methods. PMID:27182267
Ranawaka, Udaya K; de Abrew, Ashwini; Wimalachandra, Manu; Samaranayake, Nithushi; Goonaratna, Colvin
We describe our experience of the first 10 years at the Sri Lanka Clinical Trials Registry (SLCTR). We analyzed all trial records of the SLCTR over the study period. We collected information regarding trial characteristics and completeness of data entry in the SLCTR data set. During the study period, 210 trials (63% of all applications) were registered with the SLCTR. The number of registered trials showed an increasing trend over the years. All trial registrations had complete entries for all the data fields studied. Only 17.6% of the trials were registered retrospectively. All the registered trials were interventional studies, and the majority (87.6%) were randomized controlled trials. A significant proportion of trials (28.6%) were on noncommunicable diseases, and 12.4% were on pregnancy and its outcomes. Several trials (9.5%) were international collaborative studies. A majority of the Principal Investigators (70.9%) were affiliated to a university. Most of the studies (41.9%) were self-funded by the investigators. Details of ethics review committee approval were available for 96.7% of registered trials. Over a third of the registered trials (37.1%) had completed recruitment at the time of analysis. A majority of the trials (72.8%) had updated trial data since registration. There is a steady increase in the number of trials registered at the SLCTR. Complete entries for all the data fields were seen in all trial registrations. The SLCTR has made a positive contribution to the emergence of a healthy clinical research environment in Sri Lanka. © 2018 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.
Utami, Dina; Bickmore, Timothy W; Barry, Barbara; Paasche-Orlow, Michael K
Several web-based search engines have been developed to assist individuals to find clinical trials for which they may be interested in volunteering. However, these search engines may be difficult for individuals with low health and computer literacy to navigate. The authors present findings from a usability evaluation of clinical trial search tools with 41 participants across the health and computer literacy spectrum. The study consisted of 3 parts: (a) a usability study of an existing web-based clinical trial search tool; (b) a usability study of a keyword-based clinical trial search tool; and (c) an exploratory study investigating users' information needs when deciding among 2 or more candidate clinical trials. From the first 2 studies, the authors found that users with low health literacy have difficulty forming queries using keywords and have significantly more difficulty using a standard web-based clinical trial search tool compared with users with adequate health literacy. From the third study, the authors identified the search factors most important to individuals searching for clinical trials and how these varied by health literacy level.
Tsanas, Athanasios; Saunders, Kate; Bilderbeck, Amy; Palmius, Niclas; Goodwin, Guy; De Vos, Maarten
We recently described a new questionnaire to monitor mood called mood zoom (MZ). MZ comprises 6 items assessing mood symptoms on a 7-point Likert scale; we had previously used standard principal component analysis (PCA) to tentatively understand its properties, but the presence of multiple nonzero loadings obstructed the interpretation of its latent variables. The aim of this study was to rigorously investigate the internal properties and latent variables of MZ using an algorithmic approach which may lead to more interpretable results than PCA. Additionally, we explored three other widely used psychiatric questionnaires to investigate latent variable structure similarities with MZ: (1) Altman self-rating mania scale (ASRM), assessing mania; (2) quick inventory of depressive symptomatology (QIDS) self-report, assessing depression; and (3) generalized anxiety disorder (7-item) (GAD-7), assessing anxiety. We elicited responses from 131 participants: 48 bipolar disorder (BD), 32 borderline personality disorder (BPD), and 51 healthy controls (HC), collected longitudinally (median [interquartile range, IQR]: 363  days). Participants were requested to complete ASRM, QIDS, and GAD-7 weekly (all 3 questionnaires were completed on the Web) and MZ daily (using a custom-based smartphone app). We applied sparse PCA (SPCA) to determine the latent variables for the four questionnaires, where a small subset of the original items contributes toward each latent variable. We found that MZ had great consistency across the three cohorts studied. Three main principal components were derived using SPCA, which can be tentatively interpreted as (1) anxiety and sadness, (2) positive affect, and (3) irritability. The MZ principal component comprising anxiety and sadness explains most of the variance in BD and BPD, whereas the positive affect of MZ explains most of the variance in HC. The latent variables in ASRM were identical for the patient groups but different for HC; nevertheless
Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P
Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials. © International & American Associations for Dental Research.
Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R
A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.
Flight, Laura; Julious, Steven A; Goodacre, Steve
Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N
Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.
Bylund, Carma L; Weiss, Elisa S; Michaels, Margo; Patel, Shilpa; D'Agostino, Thomas A; Peterson, Emily B; Binz-Scharf, Maria Christina; Blakeney, Natasha; McKee, M Diane
Cancer clinical trials give patients access to state-of-the-art treatments and facilitate the translation of findings into mainstream clinical care. However, patients from racial and ethnic minority groups remain underrepresented in clinical trials. Primary care physicians are a trusted source of information for patients, yet their role in decision-making about cancer treatment and referrals to trial participation has received little attention. The aim of this study was to determine physicians' knowledge, attitudes, and beliefs about cancer clinical trials, their experience with trials, and their interest in appropriate training about trials. A total of 613 physicians in the New York City area primarily serving patients from ethnic and racial minority groups were invited via email to participate in a 20-min online survey. Physicians were asked about their patient population, trial knowledge and attitudes, interest in training, and personal demographics. Using calculated scale variables, we used descriptive statistical analyses to better understand physicians' knowledge, attitudes, and beliefs about trials. A total of 127 physicians completed the survey. Overall, they had low knowledge about and little experience with trials. However, they generally had positive attitudes toward trials, with 41.4% indicating a strong interest in learning more about their role in trials, and 35.7% indicating that they might be interested. Results suggest that Black and Latino physicians and those with more positive attitudes and beliefs were more likely to be interested in future training opportunities. Primary care physicians may be an important group to target in trying to improve cancer clinical trial participation among minority patients. Future work should explore methods of educational intervention for such interested providers.
Conclusions: Clinical research coordinators were insightful about the needs of patients and took a meticulous approach to the phase I cancer clinical trial process, allowing time to connect with patients and to coordinate the inter-professional research team. Additionally, education in advanced oncology care was valuable for comforting participants in cancer clinical trials.
Leiter, Amanda; Sablinski, Tomasz; Diefenbach, Michael; Foster, Marc; Greenberg, Alex; Holland, John; Oh, William K; Galsky, Matthew D
Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: email@example.com.
Ohmann, Christian; Canham, Steve; Danielyan, Edgar; Robertshaw, Steve; Legré, Yannick; Clivio, Luca; Demotes, Jacques
Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.
Fazi, P; Grifoni, P; Luzi, D; Ricci, F L; Vignetti, M
The clinical trial has to be rigidly followed because it identifies a uniform clinical behaviour, which has to be adopted by the different physicians carrying out the test. The life cycle of the clinical trial is therefore based on a planning and definition phase, a next experimental phase connected with its diffusion to the involved centres and finally an evaluation phase of the results. An information system, which supports the users in the different phases of the clinical trial life cycle, has to take into account the different characteristics of each phase. The aim of this paper is to illustrate the role of WF technology as a component of an information system which supports the life cycle of a clinical trial also on the basis of the experience of the Italian Group for Haematological Disease of Adults (GIMEMA).
Swoboda, Kathryn J.; Kissel, John T.; Crawford, Thomas O.; Bromberg, Mark B.; Acsadi, Gyula; D'Anjou, Guy; Krosschell, Kristin J.; Reyna, Sandra P.; Schroth, Mary K.; Scott, Charles B.; Simard, Louise R.
Spinal muscular atrophy is one of the most heterogeneous of the single-gene neuromuscular disorders. The broad spectrum of severity, with onset from the prenatal period to adulthood, presents unique challenges in the design and implementation of clinical trials. The clinical classification of subjects into severe (type 1), intermediate (type 2), and mild (type 3) subtypes has proved useful both in enhancing communication among clinicians internationally and in forging the collaborative development of outcome measures for clinical trials. Ideally, clinical trial design in spinal muscular atrophy must take into account the spinal muscular atrophy type, patient age, severity-of-affection status, nature of the therapeutic approach, timing of the proposed intervention relative to disease progression, and relative homogeneity of the cohort to be studied. Following is an overview of the challenges and opportunities, current and future therapeutic strategies, and progress to date in clinical trials in spinal muscular atrophy. PMID:17761650
Full Text Available Abstract Novel immunotherapeutic agents targeting tumor-site microenvironment are revolutionizing cancer therapy. Chimeric antigen receptor (CAR-engineered T cells are widely studied for cancer immunotherapy. CD19-specific CAR-T cells, tisagenlecleucel, have been recently approved for clinical application. Ongoing clinical trials are testing CAR designs directed at novel targets involved in hematological and solid malignancies. In addition to trials of single-target CAR-T cells, simultaneous and sequential CAR-T cells are being studied for clinical applications. Multi-target CAR-engineered T cells are also entering clinical trials. T cell receptor-engineered CAR-T and universal CAR-T cells represent new frontiers in CAR-T cell development. In this study, we analyzed the characteristics of CAR constructs and registered clinical trials of CAR-T cells in China and provided a quick glimpse of the landscape of CAR-T studies in China.
Ballard, Elizabeth D; Wills, Kathleen; Lally, Níall; Richards, Erica M; Luckenbaugh, David A; Walls, Tessa; Ameli, Rezvan; Niciu, Mark J; Brutsche, Nancy E; Park, Lawrence; Zarate, Carlos A
Identifying clinical correlates associated with reduced suicidal ideation may highlight new avenues for the treatment of suicidal thoughts. Anhedonia occurs across psychiatric diagnoses and has been associated with specific neural circuits in response to rapid-acting treatments, such as ketamine. This analysis sought to evaluate whether reductions in suicidal ideation after ketamine administration were related to reduced levels of anhedonia, independent of depressive symptoms. This post-hoc analysis included treatment-resistant patients with either major depressive disorder (MDD) or bipolar disorder (BD) from several clinical trials of ketamine. Anhedonia was assessed using a subscale of the Beck Depression Inventory (BDI) and the Snaith-Hamilton Pleasure Scale (SHAPS). The outcome of interest was suicidal ideation, as measured by a subscale of the Scale for Suicide Ideation (SSI5), one day post-ketamine administration. Anhedonia, as measured by the SHAPS, was associated with suicidal thoughts independent of depressive symptoms both before and after ketamine administration. One day post-ketamine administration, improvements on the SHAPS accounted for an additional 13% of the variance in suicidal thought reduction, beyond the influence of depressive symptoms. The BDI anhedonia subscale was not significantly associated with suicidal thoughts after adjusting for depressive symptoms. Data were limited to patients experiencing a major depressive episode and may not be generalizable to patients experiencing an active suicidal crisis. Suicidal thoughts may be related to symptoms of anhedonia independent of other depressive symptoms. These results have implications for the potential mechanisms of action of ketamine on suicidal thoughts. Published by Elsevier B.V.
Eisenstein, Eric L; Nordo, Amy Harris; Zozus, Meredith Nahm
The continued escalation of clinical trial costs is becoming a public health concern. During the past decade, medical research funding peaked and there is growing concern that there may be insufficient resources to test many promising medical products. Recent changes in the regulatory environment create opportunities for the use of medical informatics to improve clinical trial operations and reduce costs. We report on a Medical Informatics Europe 2016 workshop conducted during the Health - Exploring Complexity (HEC) 2016 conference. We review presentation given on Secondary Data Use, eSource, and Data Quality in Clinical Trials and report on the workshop's discussions.
Mirroring everyday clinical practice in clinical trial design: a new concept to improve the external validity of randomized double-blind placebo-controlled trials in the pharmacological treatment of major depression
Full Text Available Abstract Background Randomized, double-blind, placebo-controlled trials constitute the gold standard in clinical research when testing the efficacy of new psychopharmacological interventions in the treatment of major depression. However, the blinded use of placebo has been found to influence clinical trial outcomes and may bias patient selection. Discussion To improve clinical trial design in major depression so as to reflect clinical practice more closely we propose to present patients with a balanced view of the benefits of study participation irrespective of their assignment to placebo or active treatment. In addition every participant should be given the option to finally receive the active medication. A research agenda is outlined to evaluate the impact of the proposed changes on the efficacy of the drug to be evaluated and on the demographic and clinical characteristics of the enrollment fraction with regard to its representativeness of the eligible population. Summary We propose a list of measures to be taken to improve the external validity of double-blind, placebo-controlled trials in major depression. The recommended changes to clinical trial design may also be relevant for other psychiatric as well as medical disorders in which expectations regarding treatment outcome may affect the outcome itself.
Embi, Peter J; Jain, Anil; Clark, Jeffrey; Bizjack, Susan; Hornung, Richard; Harris, C Martin
Failure to recruit a sufficient number of eligible subjects in a timely manner represents a major impediment to the success of clinical trials. Physician participation is vital to trial recruitment but is often limited. After 12 months of traditional recruitment to a clinical trial, we activated our electronic health record (EHR)-based clinical trial alert (CTA) system in selected outpatient clinics of a large, US academic health care system. When a patient's EHR data met selected trial criteria during the subsequent 4-month intervention period, the CTA prompted physician consideration of the patient's eligibility and facilitated secure messaging to the trial's coordinator. Subjects were the 114 physicians practicing at selected EHR-equipped clinics throughout our study. We compared differences in the number of physicians participating in recruitment and their recruitment rates before and after CTA activation. The CTA intervention was associated with significant increases in the number of physicians generating referrals (5 before and 42 after; P based CTA led to significant increases in physicians' participation in and recruitment rates to an ongoing clinical trial. Given the trend toward the EHR implementation in health care centers engaged in clinical research, this approach may represent a much-needed solution to the common problem of inadequate trial recruitment.
Hernandez, Maria-Elena; Carini, Simona; Storey, Margaret-Anne; Sim, Ida
Clinical questions are often studied by randomized clinical trials (RCTs) of heterogeneous design. Systematic reviewers and trial designers need to compare the design and results across these trials. If trial information is available in computer processable form, computer-based visualization techniques can provide cognitive support for such comparisons. CTeXplorer offers systematic reviewers and trial designers a tool to better and more quickly understand design heterogeneity in RCTs. CTeXplorer supports dynamic queries on eligibility criteria, interventions, and outcomes in three linked views. We tested CTeXplorer for displaying 12 RCTs on prevention of mother-to-child transmission of HIV. Three target users found the representation and organization of information intuitive and easy to learn. They were able to use CTeXplorer to achieve a quick cognitive overview of a heterogeneous group of RCTs. This work shows the benefit of capturing trial information in computable form. Future work includes leveraging ontologies to enhance CTeXplorer visualizations.
Mentz, Robert J.; Hernandez, Adrian F.; Berdan, Lisa G.; Rorick, Tyrus; O?Brien, Emily C.; Ibarra, Jenny C.; Curtis, Lesley H.; Peterson, Eric D.
Randomized clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice (GCP) guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human s...
Ruopp, Marcus; Chiswell, Karen; Thaden, Joshua T; Merchant, Kunal; Tsalik, Ephraim L
Respiratory tract infections are highly prevalent and variable, and confer considerable morbidity and mortality. There is a growing need for new treatments for such infections, particularly in the setting of worsening antibacterial resistance. We analyzed data from ClinicalTrials.gov to summarize activity in respiratory infection trials, identify gaps in research activity, and inform efforts to address disparities between antimicrobial resistance and development of new antibacterial drugs. We examined 69,779 interventional trials registered with ClinicalTrials.gov from 2007 to 2012, focusing on study conditions and interventions to identify respiratory infection-related trials. Programmatic identification with manual confirmation yielded 6,253 infectious disease trials, 1,377 respiratory infection trials, and 270 lower respiratory tract infection trials for analysis. The 1,377 respiratory infection trials accounted for 2% of all trials and 22% of infectious diseases trials. Such trials (54.8%) were more likely than either nonrespiratory infectious diseases trials (48.1%) or noninfectious disease trials (42.8%) to receive industry funding. Stratification of respiratory infection trials by registration year demonstrated declining industry funding: 181 (64.9%) in 2007-2008 to 110 (46.0%) in 2011-2012. Respiratory infection trials more frequently evaluated vaccines (52.7 vs. 15.5% of nonrespiratory tract infection trials). Lower respiratory tract infection trials (excluding tuberculosis) focused primarily on bacterial pathogens (78.5%) followed by viral (12.6%), fungal (5.6%), and nontuberculous mycobacterial (3.0%) pathogens. Approximately 40% of 120 lower respiratory tract infection trials that were completed or terminated published results in the literature. On multivariable logistic regression analysis, a treatment focus was associated with decreased odds of publishing results (odds ratio, 0.28; 95% confidence interval, 0.10-0.82; P = 0.02). There were also
The World Medical Association Declaration of Helsinki states that the use of a placebo in a clinical trial can only be justified ethically when no proven active treatment is available as a comparison. Despite this, placebos remain a popular choice as controls in clinical trials. Recent literature reviews have suggested that reliance on placebos may, in part, be because of methodological misconceptions about the need for placebos to control for the 'placebo effect'. This study aimed to assess doctors' understanding of the requirements for placebo use in clinical trials. Two hundred doctors working in tertiary hospitals in Melbourne, Australia were surveyed in regards to their understanding of the role of the placebo and placebo effects in clinical trials. There was a 72% response rate. Doctors were specifically asked if a placebo was required in a randomised clinical trial, in preference to another form of control, to control for the 'placebo effect'. The majority of respondents (62%) incorrectly believed that placebos are essential to control for the 'placebo effect' in a randomised clinical trial. Misconceptions about the methodological requirement for placebos in randomised controlled trials may influence researcher decisions to use placebo controls in unethical situations. © 2011 The Author. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).
Goodarzynejad, Hamidreza; Babamahmoodi, Abdolreza
A well-structured protocol for a clinical trial may be able to answer clinical questions, but it cannot be deemed enough to ensure success in the face of incompetent management of time as well as human and economic resources. To address this problem, in this article, we present our literature review on evidence as to how a good knowledge of proper management among researchers can enhance the likelihood of the success of clinical trial projects. Using multiple search strategies, we conducted a literature review on published studies in the English language from 2002 to 2012 by searching the Cochrane Database of Systematic Reviews, MEDLINE, Google Scholar, and EMBASE. Our review suggests that a successful trial requires a work plan or work scope as well as a timeline. The trial manager should subsequently manage the study in accordance with the plan and the timeline. Many research units have called for a clinical project manager with scientific background and regulatory skills to effect coordination among various aspects of a clinical trial. Project management may benefit both the managerial and scientific aspects of medical projects and reduce fund waste. However, little has been written to date on project management in the context of clinical research. The suggestions represent the views of the individual authors. To provide a high level of evidence in this regard, we recommend that a randomized controlled trial be performed to compare trial projects progressed with and without the use of project management.
Park, Subin; Kim, Jae-Won; Kim, Bung-Nyun; Bae, Jeong-Hoon; Shin, Min-Sup; Yoo, Hee-Jeong
Objective We aimed to examine the rates, correlates, methods, and precipitating factors of suicide attempts among adolescent patients admitted for psychiatric inpatient care from 1999 to 2010 in a university hospital in Korea. Methods The subjects consisted of 728 patients who were admitted for psychiatric inpatient care in a university hospital over a 12-year period and who were aged 10-19 years at the time of admission. We retrospectively investigated the information on suicidal behaviors and other clinical information by reviewing the subjects' electronic medical records. Whether these patients had completed their suicide on 31 December 2010 was determined by a link to the database of the National Statistical Office. Results Among 728 subjects, 21.7% had suicidal ideation at admission, and 10.7% admitted for suicidal attempts. Female gender, divorced/widowed parents, and the presence of mood disorders were associated with a significantly increased likelihood of suicide attempts. Most common method of suicide attempts was cutting, and most common reason for suicide attempts was relationship problems within the primary support group. A diagnosis of schizophrenia was associated with increased risk of death by suicide after discharge. Conclusion These results highlight the role of specific psychosocial factor (e.g., relational problems) and psychiatric disorders (e.g., mood disorders) in the suicide attempts of Korean adolescents, and the need for effective prevention strategies for adolescents at risk for suicide. PMID:25670943
Silverman, Michael J
The purpose of this study was to determine the effects of a songwriting intervention on psychiatric patients' knowledge of coping skills and working alliance. Participants were randomly assigned to scripted and manualized experimental (n=48) or control (n=41) conditions. The experimental condition was a group psychoeducational music therapy songwriting session concerning coping skills while the control condition was a group psychoeducational session concerning coping skills. Both conditions were single-session therapy with patients on an acute adult psychiatric unit. Results indicated no significant between group differences in measures of knowledge of coping skills, consumer working alliance, or perception of enjoyment (p>.05), although the experimental condition tended to have slightly higher mean scores than the control group for these measures. There was a significant between group difference in measures of therapist working alliance (pcoping skills can be as effective a psychosocial intervention as traditional talk-based psychoeducation to teach psychiatric inpatients how to proactively manage their illness. Additionally, music therapy can be as effective as talk-based psychoeducation in establishing working alliance. Implications for clinical practice, limitations, and suggestions for future research are provided.
de Bruijn, Berry; Carini, Simona; Kiritchenko, Svetlana; Martin, Joel; Sim, Ida
Clinical trials are one of the most valuable sources of scientific evidence for improving the practice of medicine. The Trial Bank project aims to improve structured access to trial findings by including formalized trial information into a knowledge base. Manually extracting trial information from published articles is costly, but automated information extraction techniques can assist. The current study highlights a single architecture to extract a wide array of information elements from full-text publications of randomized clinical trials (RCTs). This architecture combines a text classifier with a weak regular expression matcher. We tested this two-stage architecture on 88 RCT reports from 5 leading medical journals, extracting 23 elements of key trial information such as eligibility rules, sample size, intervention, and outcome names. Results prove this to be a promising avenue to help critical appraisers, systematic reviewers, and curators quickly identify key information elements in published RCT articles.
van Busschbach, J T; Swildens, W; Michon, H; Kroon, H; Koeter, M; Wiersma, D; van Os, J
In the Netherlands the Boston psychiatric rehabilitation approach (bpr) is one of the most widely implemented rehabilitation methods. So far, little research has been done on the efficacy of this approach. To investigate the effect of bpr on the attainment of personal rehabilitation goals, social functioning and empowerment and on care requirements and quality of life in persons with severe mental illness (smi) in the Netherlands. In a multicentre randomised controlled trial (rct: isrctn73683215) patients with smi were randomly assigned to bpr (n = 80) or 'care as usual' (cau; n = 76). The primary outcome was the attainment of the rehabilitation goal as formulated by the patient. The secondary outcomes were a change in the work situation and in the degree of independent living, in care requirements (Camberwell Assessment of Needs), in empowerment (Personal Empowerment Scale) and in the quality of life (who-qol). The effects were tested at 12 and 24 months. The degree of goal attainment was substantially higher in bpr at both 12 months (adjusted risk difference: 16%; 95%ci, 2 to 31; nnt = 7) and 24 months (adjusted risk difference: 21%, 95%ci, 4% to 38%; nnt = 5). The approach was also more effective in the area of societal participation (bpr: 21% adjusted increase, cau: 0% adjusted increase; nnt = 5), but not in the other secondary outcome measures. The results suggest that bpr is effective in supporting patients with smi to reach self-formulated rehabilitation goals and in enhancing their societal participation.
Claire Elizabeth Tacon
Full Text Available Clinical research bridges patients’ unmet medical need with innovative medicines, increases knowledge acquisition by clinicians, and creates solutions to improve the sustainability and quality of the Canadian health care system and economy. The Canadian Institutes of Health Research and the Canadian Lung Association have recently raised concerns over declining research activities within the Canadian respiratory community. While there are currently >3000 ongoing clinical trials in Canada, the number of trials investigating common respiratory diseases is unknown. The objective of the present study was to monitor the trends in industry- and non-industry-sponsored respiratory clinical trials in Canada from 2001 to 2011. Trialtrove 2012 (Citeline, an Informa UK business, a database containing summarized clinical trial information regarding pharmaceutical products, was searched using common chronic respiratory disease terms: “allergic rhinitis”, “asthma”, “chronic obstructive pulmonary disease (COPD”, “cystic fibrosis”, “respiratory infections”, “pulmonary fibrosis” and “smoking cessation”. Over the past 10 years, the number of respiratory clinical trials conducted in Canada has increased (4.49 per year; P=0.004. From 2001 to 2011, the majority of trials were performed in asthma, followed closely by respiratory infections and COPD. Over the past decade, the number of trials investigating COPD and respiratory infections increased (P<0.05, while asthma trials showed a declining trend since 2007. Of the clinical trials performed during this 10-year period, the majority were in phase III, with a significant increase in the number of phase II trials (2.49 per year; P=0.008. However, certain trends observed are concerning and warrant further monitoring in the coming years.
Lee Su Jin
Full Text Available Abstract Background In the past few years, the number of clinical trials has increased rapidly in East Asia, especially for gastric and hepatobiliary cancer that are prevalent in Asian populations. However, the actual degree of understanding or perceptions of clinical trials by cancer patients in East Asian countries have seldom been studied. Methods Between July 1st and November 30th of 2011, we conducted a prospective study to survey cancer patients regarding their awareness of, and willingness to participate in, a clinical trial. Patients with gastrointestinal/hepatobiliary cancer who visited the Hematology-Oncology outpatient clinic at Samsung Medical Center (SMC were enrolled. A total of 21 questions were asked including four questions which used the Visual analogue scale (VAS score. Results In this survey study, 1,000 patients were asked to participate and 675 patients consented to participate (67.5%. The awareness of clinical trials was substantially higher in patients who had a higher level of education (pp=0.004, and had a higher economic status (p=0.001. However, the willingness to participate in a clinical trial was not affected by the level of education or economic status of patients. The most influential factors for patient willingness to participate were a physician recommendation (n=181, 26.8%, limited treatment options (n=178, 26.4%, and expectations of effectiveness of new anti-cancer drugs (n=142, 21.0%. Patients with previous experience in clinical trials had a greater willingness to participate in clinical trials compared to patients without previous experience (p Conclusions This large patient cohort survey study showed that Korean cancer patients are more aware of clinical trials, but awareness did not translate into willingness to participate.
Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida
conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...
Current Open Clinical Trials If you are interested in learning more about the eligibility requirements for any of open studies listed below, please contact the nearest participating University or Christina Mazcko. To search studies being conducted by other groups please visit Vet Cancer Trials. This will allow you to search by location and tumor type.
Sturup, Joakim; Monahan, John; Kristiansson, Marianne
This study was designed to investigate the base rate of violent behavior, the predictive validity of the Classification of Violence Risk (COVR) software, and specific risk factors for violence among nonforensically involved psychiatric patients in Sweden. On discharge from two psychiatric hospitals in Stockholm, 331 patients were interviewed. Telephone interviews with the patients and supportive others, as well as data from a national criminal register, were used to measure violent behavior 20 weeks after discharge. After the baseline interview, patients were assigned to different risk groups by the COVR software. Predicted risk was compared with the occurrence of actual acts of violence during the follow-up. Gender differences in base rates of violent behavior among the general psychiatric population were not found during the 20 weeks of follow-up after discharge. Violent behavior was significantly predicted by young age of males and by level of anger, violent thoughts, and victimization of females. The predictive validity of the COVR software was comparable between females (area under the curve [AUC]=.78) and males (AUC=.76). Violent behavior was uncommon for all patients. Although several risk factors were significantly associated with violence by each gender, the COVR software could predict violence equally well for both genders.
Boland, M R; Miotto, R; Gao, J; Weng, C
When standard therapies fail, clinical trials provide experimental treatment opportunities for patients with drug-resistant illnesses or terminal diseases. Clinical Trials can also provide free treatment and education for individuals who otherwise may not have access to such care. To find relevant clinical trials, patients often search online; however, they often encounter a significant barrier due to the large number of trials and in-effective indexing methods for reducing the trial search space. This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. We decomposed 80 randomly selected stage III breast cancer clinical trials into a vector of eligibility features, which were organized into a hierarchy. We clustered trials based on their eligibility feature similarities. In a simulated search process, manually selected features were used to generate specific eligibility questions to filter trials iteratively. We extracted 1,437 distinct eligibility features and achieved an inter-rater agreement of 0.73 for feature extraction for 37 frequent features occurring in more than 20 trials. Using all the 1,437 features we stratified the 80 trials into six clusters containing trials recruiting similar patients by patient-characteristic features, five clusters by disease-characteristic features, and two clusters by mixed features. Most of the features were mapped to one or more Unified Medical Language System (UMLS) concepts, demonstrating the utility of named entity recognition prior to mapping with the UMLS for automatic feature extraction. It is feasible to develop feature-based indexing and clustering methods for clinical trials to identify trials with similar target populations and to improve trial search efficiency.
Gluud, C; Sørensen, T I
The urgent need for the performance of more, better designed, and better conducted randomised clinical trials is increasingly recognised. Based on structured interviews with leading persons of 43 outstanding organisations and units involved in clinical trials in Europe and North America during 1993......, ways of organising and staffing clinical trial units were investigated. The present proposal is based on this experience from which an attempt to extract a composite set of minimal requirements has been made regarding pertinent objectives and aims, organisational aspects, staffing, and estimated costs...... of establishing a clinical trial unit. The core staff is suggested to consist of two chief physicians, one statistician, one data manager, one project coordinator, and two secretaries. In order to fulfil the minimal requirements for running such a unit, it is calculated that about GBP 450,000 per year is needed...
U.S. Department of Health & Human Services — The National Database for Clinical Trials Related to Mental Illness (NDCT) is an extensible informatics platform for relevant data at all levels of biological and...
Pedersen, Allan Gorm; Petersen, O B; Wara, P
BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...
The mathematical formulations of Neyman-Pearson hypothesis testing and the Fisherian concept of significance tests are examined as alternative ways of applying statistical models to data from clinical trials.
Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael
Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. Availability http://www.rfdn.org/bioinfo/CTMS/ctms.html. PMID:21670796
Buhman, Cæcilie; Mortensen, Erik Lykke; Lundstrøm, Stine
OBJECTIVE: To characterize physical and mental health in trauma exposed refugees by describing a population of patients with regard to background, mental health history and current health problems; and to identify pre- and post-migratory predictors of mental health. METHOD: All patients receiving...... treatment at the Psychiatric Trauma Clinic for Refugees in Copenhagen from April 2008 to February 2010 completed self-rating inventories on symptoms of PTSD, depression and anxiety as well as level of functioning and quality of life before treatment. Then, associations of pre and post migratory factors...... of treatment effect should clarify all co-morbidities so that comparable populations can be included in treatment evaluation studies....
Solomon, P; Draine, J
This study sought to examine the rate of homelessness and the extent to which lifetime homelessness was associated with clinical factors, such as diagnosis and treatment history; or criminal factors, such as criminal behavior and arrest history, among psychiatric probationers and parolees. Nearly half of the clients screened had experienced homelessness in their lifetime. In a logistic regression model to explain lifetime homelessness, significant factors were younger age, less education, a greater number of lifetime arrests, a schizophrenia diagnosis, and reporting both an alcohol and drug problem. Implications for service delivery with this population are discussed.
BACKGROUND Arrhythmia is a cardiovascular disorder which can lead to several complications. Over the past decade the introduction of many new drugs has raised concerns about their questionable benefits and cost-effectiveness. Classification of antiarrhythmic drugs has not been fully resolved. Although numerous clinical trials have been conducted, the value of antiarrhythmic drugs in many indications remains controversial. Two meta-analyses of clinical trials addressing the indication of q...
Marrie, R. A.; Miller, A.; Sormani, M. P.; Thompson, A.; Waubant, E.; Trojano, M.; O Connor, P.; Reingold, S.; Cohen, J. A.
Objective: We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS). Methods: We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS. Results: We recommend establishing age- and sex-specific incidence estimates for comorbidities in t...
Osborne, J P; O'Callaghan, F J K
The current regulations for conducting non-commercial clinical trials in Europe are many and complex. These are explored from the perspective of a UK based non-commercial international clinical trial. The reasons for the difficulties encountered are discussed and suggestions made as to how best to overcome them. Improvements are suggested for our law makers and competent authorities. It is argued that the current regulatory environment could be considered unethical as it inhibits and delays research.
An, Feng-Rong; Sha, Sha; Zhang, Qing-E; Ungvari, Gabor S; Ng, Chee H; Chiu, Helen F K; Wu, Ping-Ping; Jin, Xin; Zhou, Jian-Song; Tang, Yi-Lang; Xiang, Yu-Tao
Physical restraint (PR) for patients is an ongoing controversial topic in psychiatry. This study examined the percentage of PR and its associations with clinical characteristics and the implementation of the National Mental Health Law (NMHL) in China. The study consecutively assessed a sample of 1364 psychiatric inpatients. Socio-demographic and clinical data including use of PR were collected from the medical records using a form designed for this study and confirmed via interview. Psychopathology and insight were measured using standardized instruments. The percentage of PR was 27.2% in the whole sample with 30.7% and 22.4% occurring respectively before and after the NMHL implementation (p=0.001). In multiple logistic regression analysis PR was positively associated with unemployment, lower income, aggression in the past month, being admitted before the NMHL implementation and poorer insight. The percentage of PR in Chinese psychiatric patients is associated with various clinical factors and appeared to decrease after the implementation of the NMHL. Focused and individualized care for patients who are unemployed, have low income, recent aggression and poor insight would be necessary at early stages of admission. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Roumiantseva, Dina; Carini, Simona; Sim, Ida; Wagner, Todd H
We examine the extent to which ClinicalTrials.gov is meeting its goal of providing oversight and transparency of clinical trials with human subjects. We analyzed the ClinicalTrials.gov database contents as of June 2011, comparing interventions, medical conditions, and trial characteristics by sponsor type. We also conducted a detailed analysis of incomplete data. Among trials with only government sponsorship (N=9252), 36% were observational and 64% interventional; in contrast, almost all (90%) industry-only sponsored trials were interventional. Industry-only sponsored interventional trials (N=30,036) were most likely to report a drug intervention (81%), followed by biologics (9%) and devices (8%). Government-only interventional trials (N=5886) were significantly more likely to test behavioral interventions (28%) and procedures (13%) than industry-only trials (p<0.001). Medical conditions most frequently studied in industry-only trials were cancer (19%), cardiovascular conditions (12%) and endocrine/metabolic disorders (11%). Government-only funded trials were more likely to study mental health (19% vs. 7% for industry, p<.001), and viral infections, including HIV (15% vs 7% for industry, p<.001). Government-funded studies are significantly more likely to be missing data about study design and intervention arms in the registry. For all studies, we report ambiguous and contradictory data entries. Industry-sponsored studies differ systematically from government-sponsored studies in study type, choice of interventions, conditions studied, and completeness of submitted information. Imprecise study design information, incomplete coding of conditions, out-of-date or unspecified enrollment numbers, and other missing data continue to hinder robust analyses of trials registered in ClinicalTrials.gov. Published by Elsevier Inc.
Conroy, Elizabeth J; Harman, Nicola L; Lane, J Athene; Lewis, Steff C; Murray, Gordon; Norrie, John; Sydes, Matt R; Gamble, Carrol
The Medical Research Council Guidelines for Good Clinical Practice outlines a three-committee trial oversight structure--the day-to-day Trial Management Group, the Data Monitoring Committee and the Trial Steering Committee. In this model, the Trial Steering Committee is the executive committee that oversees the trial and considers the recommendations from the Data Monitoring Committee. There is yet to be in-depth consideration establishing the Trial Steering Committee's role and functionality. A survey to establish Trial Steering Committee's current practices, role and the use and opinion on the Medical Research Council guidelines was undertaken within UK Clinical Research Collaborative registered Clinical Trials Units. Completed surveys were obtained from 38 of 47 fully and partially registered Units. Individual items in the survey were analysed and reported spanning current Trial Steering Committee practices including its role, requirement and experience required for membership; methods to identify members; and meeting frequency. Terms (a document describing the committee's remit, objectives and functionality) were obtained and analysed from 21 of 33 Units with documents in place at their Unit. A total of 20 responders suggested aspects of the current Medical Research Council Guidelines that need improvement. We present the first survey reporting on practices within UK Clinical Research Collaborative registered Clinical Trials Units on the experience and remits of Trial Steering Committees. We have identified a widespread adoption of Medical Research Council Guidelines for Trial Steering Committees in the United Kingdom, but limitations in this existing provision have been identified that need to be addressed. © The Author(s) 2015.
Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira
A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.
Andersen, Roger C.; Loebel, Nicolas G.; Andersen, Dane M.
Photodynamic therapy(PDT) has been demonstrated to effectively kill human periopathogens in vitro. To evaluate the efficacy of PDT in vivo a series of clinical trials was carried out in multiple centers and populations. Clinical parameters including clinical attachment level, pocket probing depth and bleeding on probing were all evaluated. All groups received the standard of care, scaling and root planing, and the treatment group additionally received a single treatment of PDT. Of the total 309 patients and over 40,000 pockets treated in these 5 trials it was determined that photodynamic therapy provided a statistically significant improvement in clinical parameters over scaling and root planing alone.
Landewé, R. B. M.; van der Heijde, D.
The assessment of disease in rheumatological diseases is rather complicated, because it may involve different contexts (clinical practice, clinical trials, observational studies, registries, etc.) as well as different domains (disease activity, physical function, radiographic damage, quality of
Feagan, Brian G
Although the randomized controlled trial has become the standard for regulatory approval of new drugs and devices in inflammatory bowel disease (IBD), the components of effective trial design and implementation are still evolving. While induction and maintenance of remission are the ultimate goals in the treatment of IBD, the conduct of trials intended to measure these outcomes has varied substantially over time, as have the definitions of disease remission. Significant progress has been made in recent years towards understanding patient- and disease-related factors that are essential considerations in clinical trial design. However, questions remain regarding the best methods for assessing disease activity, and importantly for establishing trial end points that are clinically relevant and likely to affect meaningful long-term improvements in disease outcomes. This chapter will discuss the current 'best methods' in IBD trial design and introduce potential future concepts for improving the efficiency of clinical trials as well as their utility to inform clinical practice management. 2014 Nestec Ltd., Vevey/S. Karger AG, Basel.
Concannon, Thomas W; Guise, Jeanne-Marie; Dolor, Rowena J; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A; Pace, Wilson D; Saltz, Joel; Hersh, William R; Michener, Lloyd; Carey, Timothy S
An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1-year learning network to identify high-priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three-stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1-day network meeting at the end of the year. The year-long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. © 2014 Wiley Periodicals, Inc.
Guise, Jeanne‐Marie; Dolor, Rowena J.; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A.; Pace, Wilson D.; Saltz, Joel; Hersh, William R.; Michener, Lloyd; Carey, Timothy S.
Abstract An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. PMID:24472114
Kjaergard, Lise L; Gluud, Christian
The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985......-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index...... that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality....
Condo, Jeanine; Kateera, Brenda; Mutimura, Eugene; Birungi, Francine; Ndagijimana, Albert; Jansen, Stefan; Kamwesiga, Julius; Forrest, Jamie I; Mills, Edward J; Binagwaho, Agnes
After the genocide in Rwanda, the country's healthcare system collapsed. Remarkable gains have since been made by the state to provide greater clinical service capacity and expand health policies that are grounded on locally relevant evidence. This commentary explores the challenges faced by Rwanda in building an infrastructure for clinical trials. Through local examples, we discuss how a clinical trial infrastructure can be constructed by (1) building educational capacity; (2) encouraging the testing of relevant interventions using appropriate and cost-effective designs; and, (3) promoting ethical and regulatory standards. The future is bright for clinical research in Rwanda and with a renewed appetite for locally generated evidence it is necessary that we discuss the challenges and opportunities in drawing up a clinical trials agenda.
Saijo, Hajime; Kasai, Hiroi; Takahashi, Hiromitu; Harigai, Masayoshi; Takase, Kozo
Along with continued efforts to improve data quality in clinical trials, it is imperative to make critical assessments about the recognition, traceability, and validation of the data on final outputs of clinical trials. The present study investigated protocols in 36 clinical trials and case report forms (CRFs) for 141 patients. CRFs were categorized as Book Type (BT), Visit Type (VT), and Separate binding Type (ST). The achievement of recognition, traceability, and validation of the data in CRFs was assessed using arbitrary grading scales. There were significant differences between the VT and BT conditions in terms of traceability and validation 1 (the integrity of clinical laboratory test data). No significant differences were observed among the three types of CRFs in terms of recognition and validation 2 (verification of test drug compliance). These findings indicate that the traceability and the integrity of clinical laboratory test data depend on the structure of the CRFs used, whereas recognition and verification of test drug compliance were more matters of protocol design. Therefore, of the three CRFs, the VT CRF is considered to be the best choice of format for collecting clinical trial data as it maximizes the quality of clinical trials until electronic document systems are adopted.
Lifson, A; Rahme, FS; Belloso, WH
PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...
Ni, Yizhao; Kennebeck, Stephanie; Dexheimer, Judith W; McAneney, Constance M; Tang, Huaxiu; Lingren, Todd; Li, Qi; Zhai, Haijun; Solti, Imre
(1) To develop an automated eligibility screening (ES) approach for clinical trials in an urban tertiary care pediatric emergency department (ED); (2) to assess the effectiveness of natural language processing (NLP), information extraction (IE), and machine learning (ML) techniques on real-world clinical data and trials. We collected eligibility criteria for 13 randomly selected, disease-specific clinical trials actively enrolling patients between January 1, 2010 and August 31, 2012. In parallel, we retrospectively selected data fields including demographics, laboratory data, and clinical notes from the electronic health record (EHR) to represent profiles of all 202795 patients visiting the ED during the same period. Leveraging NLP, IE, and ML technologies, the automated ES algorithms identified patients whose profiles matched the trial criteria to reduce the pool of candidates for staff screening. The performance was validated on both a physician-generated gold standard of trial-patient matches and a reference standard of historical trial-patient enrollment decisions, where workload, mean average precision (MAP), and recall were assessed. Compared with the case without automation, the workload with automated ES was reduced by 92% on the gold standard set, with a MAP of 62.9%. The automated ES achieved a 450% increase in trial screening efficiency. The findings on the gold standard set were confirmed by large-scale evaluation on the reference set of trial-patient matches. By exploiting the text of trial criteria and the content of EHRs, we demonstrated that NLP-, IE-, and ML-based automated ES could successfully identify patients for clinical trials. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association.
Nugent, Timothy; Upton, David; Cimpoesu, Mihai
The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.
Hindryckx, Pieter; Baert, Filip; Hart, Ailsa; Armuzzi, Alessandro; Panès, Julian; Peyrin-Biroulet, Laurent
It goes back to 1932 when Dr. Burrill Bernard Crohn and co-workers published their landmark paper, describing regional ileitis as a disease entity. However, clinical trial research has been developing rather slowly in luminal Crohn's disease. It took until the early seventies before the first randomized clinical trial was set up by the National Co-operative Crohn's Disease Study (NCCDS) group. Although the efforts of this group triggered a first wave of clinical trials in Crohn's disease, the lack of guidelines for conducting a clinical trial in this research area resulted in a variety of study designs and much criticism. Besides having a rather small sample size and a short follow-up time, they were often characterized by vague and subjective assessment of disease activity and treatment response. Following the advent of a new and very potent drug class in the late nineties, the anti-TNF agents, investigators started to re-think their study protocols and the first guidelines were set up by the regulatory authorities. Over the last 15years, clinical trials in luminal Crohn's disease have been evolving significantly. Inclusion criteria have been shifting from clinical scores such as Crohn's Disease Activity Index (CDAI) to more objective disease activity parameters such as biomarkers (C-reactive protein and faecal calprotectin) and endoscopic lesions. Primary endpoints have been developing from clinical response to corticosteroid-free remission and more ambitious end-points such as mucosal healing. In this paper, we will give a historical overview on clinical trials in luminal Crohn's disease, before and within the biologic era, and provide insight into how they have shaped our current understanding of trial designs in Crohn's disease. Copyright © 2014 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.
Kuchinke, Wolfgang; Aerts, J; Semler, S C; Ohmann, C
Our objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database. Based on own experiences with CDISC, existing implementations and future developments, CDISC standards were evaluated concerning requirements for archiving clinical studies. Trial master files of a small, medium and large clinical study were analyzed to collect specifications for electronic archiving of records. Two different ways of long-term storage exist for the clinical trial archive: document-oriented archival and data archiving of the study database. The trial master file has a highly complex structure; its different parts can vary greatly in size, depending of the working style of investigators, number of patients recruited, the number of adverse event reports and the number of queries. The CDISC standard ODM is especially suited for archiving clinical trials, because among other features it contains the entire clinical trial data and full audit trail information. On the other hand SDTM is a content standard suited for data warehouses. Two recent developments in CDISC will affect the archival of studies: the further development of ODM in the area of "eCRF submission" and the use of "Electronic Source Data". The complexity and size of the trial master file requires new solutions. Though ODM provides effective means to archive the study database, it shows still deficiencies, especially for the joint archiving of data and the complex documentation of the trial master file. A concept was developed in which the ODM standard is part of an integrated archiving of the trial data and documents. ODM archiving of the study database enables long-term storage which is GCP-compliant. Archiving of documents of the trial master file in PDF
Wilkes, Lesley; Jackson, Debra; Miranda, Charmaine; Watson, Roger
Over the past two decades, the number of clinical trials conducted globally has increased thereby increasing demand for nurses working as Clinical Trial Nurses (CTNs), sometimes known as Clinical Research Nurses. The role and professional issues for these nurses in Australia has not been empirically formulated. Sixty-seven clinical trial nurses were surveyed nationally using a modified version of the Clinical Trials Nursing Questionnaire (CTNQ). Findings revealed the complex CTN role can include the coordination of the trials on one or more sites. This involves all domains listed in the questionnaire from protocol development, ethics approval applications, recruitment and consenting of participants in trials, to administering or assisting with treatments within the bounds of their practice code and the evaluation of protocols. Professional issues documented were: being undervalued in the nursing workforce, having no formal educational preparation for the role and minimal recognition in publications emanating from research in which they were involved. These nurses bring their practice knowledge to benefit research outcomes that may contribute to improving patient/client care.
Marshall, Deborah A; Hux, Margaret
Clinical trials can offer a valuable and efficient opportunity to collect the health resource use and outcomes data for economic evaluation. However, economic and clinical studies differ fundamentally in the question they seek to answer. The design and analysis of trial-based cost-effectiveness studies require special consideration, which are reviewed in this article. Traditional randomized controlled trials, using an experimental design with a controlled protocol, are designed to measure safety and efficacy for product registration. Cost-effectiveness analysis seeks to measure effectiveness in the context of routine clinical practice, and requires collection of health care resources to allow estimation of cost over an equal timeframe for each treatment alternative. In assessing suitability of a trial for economic data collection, the comparator treatment and other protocol factors need to reflect current clinical practice and the trial follow-up must be sufficiently long to capture important costs and effects. The broadest available population and a measure of effectiveness reflecting important benefits for patients are preferred for economic analyses. Special analytical issues include dealing with missing and censored cost data, assessing uncertainty of the incremental cost-effectiveness ratio, and accounting for the underlying heterogeneity in patient subgroups. Careful consideration also needs to be given to data from multinational studies since practice patterns can differ across countries. Although clinical trials can be an efficient opportunity to collect data for economic evaluation, careful consideration of the suitability of the study design, and appropriate analytical methods must be applied to obtain rigorous results.
Clausen, J; Albrecht, H; Mathie, R T
Veterinary homeopathy has led a somewhat shadowy existence since its first introduction. Only in the last three decades has the number of clinical trials increased considerably. This literature is generally not well perceived, which may be partly a consequence of the diffuse and somewhat inaccessible nature of some of the relevant research publications. The Veterinary Clinical Research Database for Homeopathy (VetCR) was launched in 2006 to provide information on existing clinical research in veterinary homeopathy and to facilitate the preparation of systematic reviews. The aim of the present report is to provide an overview of this first database on clinical research in veterinary homeopathy, with a special focus on its content of placebo controlled clinical trials and summarising what is known about placebo effects in animals. In April 2012, the VetCR database contained 302 data records. Among these, 203 controlled trials were identified: 146 randomised and 57 non-randomised. In 97 of those 203 trials, the homeopathic medical intervention was compared to placebo. A program of formal systematic reviews of peer-reviewed randomised controlled trials in veterinary homeopathy is now underway; detailed findings from the program's data extraction and appraisal approach, including the assessment of trial quality (risk of bias), will be reported in due course. Copyright © 2012 Elsevier Ltd. All rights reserved.
Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341
A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom
The argument for 'evidence based medical practice' is compelling and the ideal protocol of randomized controlled studies to obtain higher level evidence is equally sound. However, some peculiarities of African countries make the conduct of standard control trials difficult and raise some serious ethical questions over ...
Patel, Roshni R; Hollins, Kathryn
Women who struggle with distressing pregnancy-related phobic anxiety disorders are regularly encountered in maternity services, and their management poses particular challenges. Early identification is crucial in order to offer an opportunity to treat and manage their fears and enable a positive birth experience. In this article, women with different phobias (tokophobia, emetophobia and ante-cubital fossa phobia) describe their first pregnancy experience, and the ways in which the Chelsea and Westminster Hospital offered them joint maternity and psychiatric care. A multidisciplinary hospital-based approach can be effective in managing mental health problems in pregnancy. Despite maternal preconceptions and professional misgivings, this approach can work for women with phobias and enable a good birth experience and successful mother and infant bonding. The lead obstetrician for mental health and perinatal psychiatrist describe their roles in enabling successful outcomes for both the current and subsequent pregnancies. The case is made for training of maternity staff in both the identification of severe pregnancy phobias and the prompt referral for shared psychiatric and maternity care. Even if previous treatments have failed, adequate coping strategies for childbirth may be achieved in a short time frame. Long-term improvements in the phobia itself may also be found.
In German and American law, clinical trials require a positive benefit-risk evaluation, free and informed consent, medical and scientific qualification of the doctor, and a written research protocol. American law requires a written consent, which is free of undue influence, the subject being instructed that he is free to withdraw from the trial. In German law, an orally given consent is sufficient for therapeutic trials. With minor or incompetent research subjects, informed consent to therapeutic clinical experimentation has to be given by their parents or guardians, the permissibility of which, in other trials, is controversial. In non-therapeutic trials, blind studies, double-bind studies, and trials involving placebos, special attention has to be paid to the risk-benefit analysis and to informed consent, which in these cases, even in Germany, must be written. The most outstanding feature of American law of clinical trial is that the experimentation is subject to previous control and approval by institutional review boards. The most interesting difference in German law is the investigator's duty to effect an insurance against the risks of the research subject's death or invalidity.
Politi, Mary C; Kuzemchak, Marie D; Kaphingst, Kimberly A; Perkins, Hannah; Liu, Jingxia; Byrne, Margaret M
Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website. Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions. Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention. This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research. ©AlphaMed Press.
Magnuson, Victoria; Wang, Yanpin; Schork, Nicholas
There is a growing interest in personalized and preventive medicine initiatives that leverage serious patient engagement, such as those initiated and pursued among participants in the quantified-self movement. However, many of the self-assessments that result are not rooted in good scientific practices, such as exploiting controls, dose escalation strategies, multiple endpoint monitoring, etc. Areas where individual monitoring and health assessments have great potential involve sleep and behavior, as there are a number of very problematic sleep and behavior-related conditions that are hard to treat without personalization. For example, winter depression or seasonal affective disorder (SAD) is a serious, recurrent, atypical depressive disorder impacting millions each year. In order to prevent yearly recurrence antidepressant drugs are used to prophylactically treat SAD. In turn, these antidepressant drugs can affect sleep patterns, further exacerbating the condition. Because of this, possibly unique combinatorial or 'polypharmaceutical' interventions involving sleep aids may be prescribed. However, little research into the effects of such polypharmacy on the long-term sleep quality of treated individuals has been pursued. Employing wireless monitoring in a patient-centered study we sought to gain insight into the influence of polypharmacy on sleep patterns and the optimal course of therapy for an individual being treated for SAD with duloxetine (Cymbalta) and temazepam. We analyzed continuous-time sleep data while dosages and combinations of these agents were varied. We found that the administration of Cymbalta led to an exacerbation of the subject's symptoms in a statistically significant way. We argue that such analyses may be necessary to effectively treat individuals with similar overall clinical manifestations and diagnosis, despite their having a unique set of symptoms, genetic profiles and exposure histories. We also consider the limitations of our study and
Zannad, Faiez; Pfeffer, Marc A; Bhatt, Deepak L; Bonds, Denise E; Borer, Jeffrey S; Calvo-Rojas, Gonzalo; Fiore, Louis; Lund, Lars H; Madigan, David; Maggioni, Aldo Pietro; Meyers, Catherine M; Rosenberg, Yves; Simon, Tabassome; Stough, Wendy Gattis; Zalewski, Andrew; Zariffa, Nevine; Temple, Robert
Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Mackiewicz, Jacek; Mackiewicz, Andrzej
Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate.
Gluud, C; Nikolova, D
Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qual...
Full Text Available Background: India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not commensurate with her healthcare needs. We carried out the present study to assess if clinical trials were in line with the health care needs of the country by auditing the clinical trials registry of India. Materials and Methods: All the clinical studies registered in CTRI between July 20, 2007 and December 31, 2015 were searched in the “Trial Search” section. The total number of studies, their phases of development, and therapeutic areas were assessed. Trials in each therapeutic area was compared with the disease burden (DALYs in that area taken from Global Health Estimates  Summary Tables of the WHO. The number of trials conducted per state in India was also compared with the population of that state [Census 2011]. Results: A total of 6474 studies were registered of which 3325 (51.4% were clinical trials. The state of Maharashtra had the highest number trials [16.4%] followed by Karnataka ( 11.6% and Tamil Nadu (10%. Populous states like Uttar Pradesh (5.3% and Bihar (1.4% had far fewer trials. The largest number of trials was in the area of cancer (16.4%, followed by diabetes (12.1% and cardiovascular diseases (10.1%. Infectious and parasitic diseases had the highest DALYs (82,681 and ranked first in disease burden but accounted for only 5% of the total trials and ranked 7th according to number of trials. Cancer ranked first in the number of trials (16.4%, but ranked 6th based on DALYs. Conclusion: Clinical trials conducted in India are not in consonance with her health care needs. Strengthening the capacity for conducting trials in the populous states and the north-eastern part of the country is necessary to allow a more equitable selection of participants. The government should introduce policies to encourage new drug development in areas where needed the most.
Bakker, Ton J E M; Duivenvoorden, Hugo J; van der Lee, Jacqueline; Olde Rikkert, Marcel G M; Beekman, Aartjan T F; Ribbe, Miel W
To test the effectiveness of an integrative psychotherapeutic nursing home program (integrative reactivation and rehabilitation [IRR]) to reduce multiple neuropsychiatry symptoms (MNPS) of cognitively impaired patients and caregiver burden (CB). Randomized controlled trial. Psychiatric-skilled nursing home (IRR) and usual care (UC), consisting of different types of nursing home care at home or in an institution. N = 168 (81 IRR and 87 UC). Patients had to meet classification of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition for dementia, amnestic disorders, or other cognitive disorders. Further inclusion criteria: Neuropsychiatric Inventory (NPI) ≥3; Mini-Mental State Examination ≥18 and ≤27; and Barthel Index (BI) ≥5 and ≤19. IRR consisted of a person-oriented integrative psychotherapeutic nursing home program to reduce MNPS of the patient and CB. UC consisted of different types of nursing home care at home or in an institution, mostly emotion oriented. Primary outcome variable was MNPS (number and sum-severity of NPI). Furthermore, burden and competence of caregiver were also measured. T1 (inclusion), T2 (end of treatment), T3 (after 6 months of follow-up). Cohen's d (Cd) was calculated for mean differences (intention to treat). For confounding, repeated measurement modeling (random regression modeling [RRM]) was applied. In the short term from the perspective of the caregiver, IRR showed up to 34% surplus effects on MNPS of the patients; NPI symptoms: 1.31 lower (Cd, -0.53); and NPI sum- severity: 11.16 lower (Cd, -0.53). In follow-up, the effects were sustained. However, from the perspective of the nursing team, these effects were insignificant, although the trend was in the same direction and correlated significantly with the caregiver results over time (at T3: r = 0.48). In addition, IRR showed surplus effects (up to 36%) on burden and competence of caregiver: NPI emotional distress: 3.78 (Cd, -0.44); CB: 17.69 (Cd, -0
Starren, Justin B; Payne, Philip R O; Kaufman, David R
Clinical trials increasingly rely upon web-based Clinical Trials Management Systems (CTMS). As with clinical care systems, Human Computer Interaction (HCI) issues can greatly affect the usefulness of such systems. Evaluation of the user interface of one web-based CTMS revealed a number of potential human-computer interaction problems, in particular, increased workflow complexity associated with a web application delivery model and potential usability problems resulting from the use of ambiguous icons. Because these design features are shared by a large fraction of current CTMS, the implications extend beyond this individual system.
Gluud, Christian; Nikolova, Dimitrinka
The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....