From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

[Teaching of clinical reasoning to medical students using prototypical clinical cases].

PubMed

Montaldo L, Gustavo; Herskovic L, Pedro

2013-07-01

Clinical reasoning is the most important competente in the training process of a physician. To develop a method for teaching clinical reasoning based on prototypes of clinical cases. The study was conducted on sixty-four third year medical students. The study and control groups attended lectures and tutorial sessions with patients. The study group attended additionally discussion seminars of prototypical clinical cases. A clinical reasoning test was applied at the start and end of the learning period to both groups. At the end of the study, the opinions of students of the study group were collected in a focus group. After the learning period, both groups significantly increased their clinical reasoning skills. However, the improvement in the study group was more than double than that of the control group. The absolute improvement in the study group was 30.9%. Students interviewed in the focus group were unanimous in expressing their satisfaction in each and every aspect discussed. The teaching of clinical reasoning to third year medical students by means of pattern recognition in seminars with clinical cases improved significantly their skills.

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Advances in clinical NK cell studies: Donor selection, manufacturing and quality control

PubMed Central

Koehl, U.; Kalberer, C.; Spanholtz, J.; Lee, D. A.; Miller, J. S.; Cooley, S.; Lowdell, M.; Uharek, L.; Klingemann, H.; Curti, A.; Leung, W.; Alici, E.

2016-01-01

ABSTRACT Natural killer (NK) cells are increasingly used in clinical studies in order to treat patients with various malignancies. The following review summarizes platform lectures and 2013–2015 consortium meetings on manufacturing and clinical use of NK cells in Europe and United States. A broad overview of recent pre-clinical and clinical results in NK cell therapies is provided based on unstimulated, cytokine-activated, as well as genetically engineered NK cells using chimeric antigen receptors (CAR). Differences in donor selection, manufacturing and quality control of NK cells for cancer immunotherapies are described and basic recommendations are outlined for harmonization in future NK cell studies. PMID:27141397

Outbreak of Tsukamurella species bloodstream infection among patients at an oncology clinic, West Virginia, 2011-2012.

PubMed

See, Isaac; Nguyen, Duc B; Chatterjee, Somu; Shwe, Thein; Scott, Melissa; Ibrahim, Sherif; Moulton-Meissner, Heather; McNulty, Steven; Noble-Wang, Judith; Price, Cindy; Schramm, Kim; Bixler, Danae; Guh, Alice Y

2014-03-01

To determine the source and identify control measures of an outbreak of Tsukamurella species bloodstream infections at an outpatient oncology facility. Epidemiologic investigation of the outbreak with a case-control study. A case was an infection in which Tsukamurella species was isolated from a blood or catheter tip culture during the period January 2011 through June 2012 from a patient of the oncology clinic. Laboratory records of area hospitals and patient charts were reviewed. A case-control study was conducted among clinic patients to identify risk factors for Tsukamurella species bloodstream infection. Clinic staff were interviewed, and infection control practices were assessed. Fifteen cases of Tsukamurella (Tsukamurella pulmonis or Tsukamurella tyrosinosolvens) bloodstream infection were identified, all in patients with underlying malignancy and indwelling central lines. The median age of case patients was 68 years; 47% were male. The only significant risk factor for infection was receipt of saline flush from the clinic during the period September-October 2011 (P = .03), when the clinic had been preparing saline flush from a common-source bag of saline. Other infection control deficiencies that were identified at the clinic included suboptimal procedures for central line access and preparation of chemotherapy. Although multiple infection control lapses were identified, the outbreak was likely caused by improper preparation of saline flush syringes by the clinic. The outbreak demonstrates that bloodstream infections among oncology patients can result from improper infection control practices and highlights the critical need for increased attention to and oversight of infection control in outpatient oncology settings.

Retention of blinding at follow-up in a randomized clinical study using a sham-control cervical manipulation procedure for neck pain: secondary analyses from a randomized clinical study.

PubMed

Vernon, Howard; Triano, John T; Soave, David; Dinulos, Maricelle; Ross, Kim; Tran, Steven

2013-10-01

Participants in clinical trials of spinal manipulation have not been rigorously blinded to group assignment. This study reports on secondary analyses of the retention of participant blinding beyond the immediate posttreatment time frame following a single-session, randomized clinical study. A novel control cervical manipulation procedure that has previously been shown to be therapeutically inert was contrasted with a typical manipulation procedure. A randomized clinical study of a single session of typical vs sham-control manipulation in patients with chronic neck pain was conducted. Findings of self-reported group registration at 24 to 48 hours posttreatment were computed. The Blinding Index (BI) of Bang et al was then applied to both the immediate and post-24- to 48-hour results. Twenty-four to 48 hours after treatment, 94% and 22% of participants in the typical and control groups, respectively, correctly identified their group assignment. When analyzed with the BI of Bang et al, the immediate posttreatment BI for the group receiving a typical manipulation was 0.22 (95% confidence interval [CI], -0.03 to 0.47); for the group receiving a control manipulation, it was 0.19 (95% CI, -0.06 to 0.43). The BI at post-24 hours was as follows: typical = 0.75 (95% CI, 0.59-0.91) and control = -0.34 (95% CI, -0.58 to -0.11). This study found that the novel sham-control cervical manipulation procedure may be effective in blinding sham group allocation up to 48 hours posttreatment. It appears that, at 48 hours posttreatment, the modified form of the typical cervical manipulation was not. The sham-control procedure appears to be a promising procedure for future clinical trials. © 2013. Published by National University of Health Sciences All rights reserved.

A case-control study of influenza vaccine effectiveness among Malaysian pilgrims attending the Haj in Saudi Arabia.

PubMed

Mustafa, Amal Nasir; Gessner, Bradford D; Ismail, Raman; Yusoff, Ahmad Faudzi; Abdullah, Nasuruddin; Ishak, Ilina; Abdullah, Norazmi; Merican, Mohd Ismail

2003-09-01

To determine influenza vaccine effectiveness against clinically defined influenza-like illness among Malaysian pilgrims attending the Haj in Saudi Arabia. During February and March 2000, the authors conducted an unmatched case-control study. Case patients were identified at one of five hotel clinics, while controls were residents of these hotels who had not attended a clinic. Among 820 case patients--84% of whom had received antibiotics--and 600 controls, the adjusted vaccine effectiveness against clinic visits for influenza-like illness was 77% (95% confidence interval: 69, 83), and that against receipt of antibiotics was 66% (95% confidence interval, 54, 75). The vaccine did not prevent clinic visits for non-influenza-like upper respiratory tract illness (adjusted vaccine effectiveness, 20%; 95% confidence interval: -24, 49). Influenza vaccine was effective in preventing clinic visits for influenza-like illness and antibiotic use. Pilgrims traveling to the Haj in Saudi Arabia should consider influenza vaccination use.

Are Common Skin Diseases among Norwegian Dermatological Outpatients Associated with Psychological Problems Compared with Controls? An Observational Study.

PubMed

Balieva, Flora; Lien, Lars; Kupfer, Jörg; Halvorsen, Jon Anders; Dalgard, Florence

2016-02-01

Dermatological disease has been shown to be associated with psychological comorbidity. The aim of this observational study is to describe the distribution of skin disease and the prevalence of depression, anxiety and stress among Norwegian dermatological outpatients. Thirteen percent of outpatients had clinical anxiety compared with 3.7% of healthy controls, and 5.8% had clinical depression compared with 0.9% of controls. Adjusted odds ratio for clinical anxiety was 4.53 in patients compared with controls, and for clinical depression 6.25, which is much higher than previously described in a larger European study. Patients with tumours had less depression. Chronic inflammatory skin conditions had an especially high impact on patient's psychological wellbeing and should not be undervalued relative to, for instance, skin cancer in health strategies. These results argue strongly for including skin disease prevention and treatment in future health strategies.

Out of sight, out of mind? Does terminating the physical presence of a geriatric consultant in the community clinic reduce the implementation rate for geriatric recommendations.

PubMed

Freud, Tamar; Punchik, Boris; Biderman, Aya; Peleg, Roni; Kagan, Ella; Barzak, Alex; Press, Yan

2016-01-01

To assess the effect of moving the geriatric consultation from the primary care clinic to another setting, on the rate of implementation of geriatric recommendations by family physicians. A retrospective review of the computerized medical records of elderly patients in four primary care clinics. The rate of implementation of geriatric recommendations was compared between clinics in which a geriatric consultant was physically present (control clinics) and a clinic where the consultation took place elsewhere (study clinic). In addition, the results of the present study were compared to a previous study in which the geriatric consultation was carried out in the study clinic and the family doctor was an active participant. 127 computerized files were reviewed in the study clinic and 133 in the control clinics. The mean age of the patients was 81.1±6.3 years and 63.1% were women. The overall implementation of geriatric recommendations by family doctors in the study clinic was 55.9%, a statistically significant decrease compared to the previous study where the rate was 73.9% (p<0.0001). In contrast, there was no change in the implementation rate in the control clinics at 65.0% in the present study and 59.9% in the previous one (p=0.205). Direct, person-to-person contact between the geriatric consultant and the family doctor has a beneficial effect on the implementation of geriatric recommendations. This should be considered by healthcare policy makers when planning geriatric services in the community. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

An Evaluation of a Clinical Pharmacy-Directed Intervention on Blood Pressure Control

PubMed Central

Kicklighter, Caroline E.; Nelson, Kent M.; Humphries, Tammy L.; Delate, Thomas

Objective To compare short and long term blood pressure control with clinical pharmacy specialist involvement to traditional physician management. Setting A non-profit health maintenance organization in the United States covering approximately 385,000 lives. Methods This analysis utilized a prospective parallel design. Adult patients with a baseline Blood pressure>140/90 mmHg and receiving at least one antihypertensive medication were eligible for the study. Eligible hypertension management patients at one medical office were referred to the office’s clinical pharmacy specialist (intervention cohort) while at another comparable medical office they received usual physician-directed care (control cohort). The primary outcome measure was achievement of a goal BP (<140/90 mmHg) during a six month follow-up. Medical records were also reviewed approximately 1.5 years post enrollment to assess long-term BP control after clinical pharmacy-managed patients returned to usual care. Multivariate analyses were performed to adjust for baseline cohort differences. Results One hundred-thirteen and 111 subjects in the intervention and control cohorts completed the study, respectively. At the end of the follow-up period, clinical pharmacy-managed subjects were more likely to have achieved goal BP (64.6%) and received a thiazide diuretic (68.1%) compared to control subjects (40.7% and 33.3%, respectively) (adjusted p=0.002 and p<0.001, respectively). The proportion of clinical pharmacy-managed subjects with controlled BP decreased to 22.2% after returning to usual care (p<0.001). Conclusion Clinical pharmacy involvement in hypertension management resulted in increased BP control. Loss of long-term control after discontinuation of clinical pharmacy management supports a change in care processes that prevent patients from being lost to follow-up. PMID:25214896

Use of the i2b2 research query tool to conduct a matched case-control clinical research study: advantages, disadvantages and methodological considerations.

PubMed

Johnson, Emilie K; Broder-Fingert, Sarabeth; Tanpowpong, Pornthep; Bickel, Jonathan; Lightdale, Jenifer R; Nelson, Caleb P

2014-01-30

A major aim of the i2b2 (informatics for integrating biology and the bedside) clinical data informatics framework aims to create an efficient structure within which patients can be identified for clinical and translational research projects.Our objective was to describe the respective roles of the i2b2 research query tool and the electronic medical record (EMR) in conducting a case-controlled clinical study at our institution. We analyzed the process of using i2b2 and the EMR together to generate a complete research database for a case-control study that sought to examine risk factors for kidney stones among gastrostomy tube (G-tube) fed children. Our final case cohort consisted of 41/177 (23%) of potential cases initially identified by i2b2, who were matched with 80/486 (17%) of potential controls. Cases were 10 times more likely to be excluded for inaccurate coding regarding stones vs. inaccurate coding regarding G-tubes. A majority (67%) of cases were excluded due to not meeting clinical inclusion criteria, whereas a majority of control exclusions (72%) occurred due to inadequate clinical data necessary for study completion. Full dataset assembly required complementary information from i2b2 and the EMR. i2b2 was critical as a query analysis tool for patient identification in our case-control study. Patient identification via procedural coding appeared more accurate compared with diagnosis coding. Completion of our investigation required iterative interplay of i2b2 and the EMR to assemble the study cohort.

Childrearing style in families of anxiety-disordered children: between-family and within-family differences.

PubMed

Lindhout, Ingeborg E; Markus, Monica Th; Borst, Sophie R; Hoogendijk, Thea H G; Dingemans, Peter M A J; Boer, Frits

2009-06-01

This study examined whether (1) parents of anxiety-disordered (AD) children differed from those of non-clinical controls in their childrearing style, and whether (2) the child-rearing style of parents towards AD children is different from that towards their siblings. A clinical sample of 25 AD children, age range 8-13 years, was compared with 25 siblings and a non-clinical control group (n = 25). Childrearing was assessed by means of parental self-report, child report and through an expressed emotion interview measure. AD children perceived more parental rejection than non-clinical control children or the AD children's siblings. High-expressed emotion was scored significantly more often towards AD children than non-clinical control children, or their siblings. On [Symbol: see text]care' and [Symbol: see text]control' parental self-report showed some differences regarding AD children on the one hand and non-clinical control children or siblings of AD children on the other. These results suggest that the rearing of AD children differs significantly both from the rearing of their siblings and that of non-clinical control children.

Knowledge, adherence and control among patients with hypertension attending a peri-urban primary health care clinic, KwaZulu-Natal

PubMed Central

2017-01-01

Background Despite hypertension being a common condition among patients attending primary health care (PHC) clinics, blood pressure (BP) control is often poor. Greater insight into patient-related factors that influence the control of hypertension will assist in the development of an intervention to address the issues identified. Aim The aim of the study was to assess patient-related variables associated with hypertension control among patients attending a peri-urban PHC clinic. Setting The setting for this study was a peri-urban PHC clinic in KwaZulu-Natal. Method This was an observational, descriptive and cross-sectional study with 348 patients selected over a 1-month period. A validated questionnaire was used to collect data on patients’ hypertension knowledge and self-reported adherence, and BP recordings from their medical record were recorded to ascertain control. Results Of the 348 participants, only 49% had good BP control and 44% (152/348) had concurrent diabetes mellitus. The majority of patients had moderate levels of knowledge on hypertension and exhibited moderate adherence. There was a significant relationship between knowledge and reported adherence, between reported adherence and control, but not between reported knowledge and control. Conclusion Despite over 90% of the study population having moderate knowledge, and 62% with moderate reported adherence, BP was well controlled in only less than 50% of the study population. These findings suggest a need to emphasise adherence and explore new ways of approaching adherence. PMID:29113443

Association between glioma and history of allergies, asthma, and eczema: a case-control study with three groups of controls

PubMed Central

Il’yasova, Dora; McCarthy, Bridget; Marcello, Jennifer; Schildkraut, Joellen M.; Moorman, Patricia G.; Krishnamachari, Bhuma; Ali-Osman, Francis; Bigner, Darell D.; Davis, Faith

2009-01-01

Because glioma etiology is largely unknown, the inverse association of glioma risk with atopic conditions is promising and deserves close scrutiny. We examined the association between a history of allergies, asthma, and eczema and glioma risk using sibling, friend, and clinic-based controls. This analysis included 388 incident glioma cases and 80 sibling, 191 friend, and 177 clinic-based controls. Each subject’s medical history was assessed via a web-based or telephone survey. Odds ratios (ORs) and their 95% confidence intervals for the associations with allergies, asthma, eczema, and the overall number of these conditions were calculated from conditional (for sibling and friend controls) and unconditional (for clinic-based controls) logistic models. Allergies were consistently inversely associated with the glioma: ORs were 0.53 (95% CI, 0.15–1.84), 0.54 (95% CI, 0.28–1.07), and 0.34 (95% CI, 0.23–0.50) with sibling, friend, and clinic-based controls, respectively. Asthma showed an inverse association only in the comparison with sibling controls (OR=0.43; 95% CI, 0.19–1.00). Eczema showed an inverse association only in the comparison with friend controls (OR=0.42; 95% CI, 0.15–1.18). The overall number of these conditions (ordinal score 0, 1, 2, 3) was inversely associated with glioma: The risk decreased 31–45% with each addition of an atopic condition. These estimates were the most stable when different control groups were considered. Comparing the prevalence of these conditions in the three control groups with published data, we note that clinic-based controls generally better approximate the prevalence data for population-based groups. These controls appear to present a reasonable choice for clinic-centered case-control studies. PMID:19336556

Clinical Characteristics of Impaired Trunk Control in Children with Spastic Cerebral Palsy

ERIC Educational Resources Information Center

Heyrman, Lieve; Desloovere, Kaat; Molenaers, Guy; Verheyden, Geert; Klingels, Katrijn; Monbaliu, Elegast; Feys, Hilde

2013-01-01

This study aimed to identify clinical characteristics of impaired trunk control in hundred children with spastic CP (mean age 11.4 [plus or minus] 2.1 years, range 8-15 years). Assessment of trunk control was performed with the Trunk Control Measurement Scale (TCMS). Trunk control was clearly impaired, indicated by a median total TCMS score of…

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

[Quality of health care for diabetic and hypertensive patients in primary care settings servicing Mexican Seguro Popular].

PubMed

Ortiz-Domínguez, Maki E; Garrido-Latorre, Francisco; Orozco, Ricardo; Pineda-Pérez, Dayana; Rodríguez-Salgado, Marlenne

2011-01-01

To assess health care quality provided to type-2 diabetic and hypertensive patients in primary care settings from the Mexican Ministry of Health and to evaluate whether accredited clinics providing services to the Mexican Seguro Popular performed better in terms of metabolic control of those patients compared to the non-accredited. Cross-sectional study performed on 2008. Previous year clinical measures were obtained from 5 444 diabetic and 5 827 hypertensive patient's clinical records. Adequate metabolic control (glucose <110 mg/dl for diabetes and blood pressure <140/90 mmHg for hypertension) associated factors were assessed by multiple-multilevel logistic regression methods. Patients attending accredited clinics were more likely to be controlled, however, metabolic control was not constant over time of accreditation. Additional efforts are required to monitor accredited clinics' performance in order to maintain both metabolic control and clinical assessment of patients.

Randomized clinical trial to evaluate the efficacy of a 5-day ceftiofur hydrochloride intramammary treatment on nonsevere gram-negative clinical mastitis.

PubMed

Schukken, Y H; Bennett, G J; Zurakowski, M J; Sharkey, H L; Rauch, B J; Thomas, M J; Ceglowski, B; Saltman, R L; Belomestnykh, N; Zadoks, R N

2011-12-01

The objective of this study was to evaluate the efficacy of intramammary treatment with ceftiofur hydrochloride of nonsevere, clinical coliform mastitis. One hundred four cases on 5 farms met the enrollment criteria for the study. Escherichia coli was the most common coliform species identified in milk samples from cows with mild to moderate clinical mastitis, followed by Klebsiella spp. and Enterobacter spp. At enrollment, a milk sample from the affected quarter was taken and used for on-farm culture or submitted to the laboratory. For cows in the treatment group, treatment was initiated with ceftiofur hydrochloride via intramammary infusion at 24-h intervals for 5 d according to label standards. Cows in the control group did not receive treatment. Culture results were available on the day after enrollment and only cows with coliform mastitis continued in the treatment and untreated control groups. Bacteriological cure was defined based on 2 posttreatment milk samples. Molecular typing was used for final definition of bacteriological cure. Treatment of nonsevere clinical gram-negative mastitis with ceftiofur hydrochloride resulted in a significant increase in bacteriological cure compared with nontreated controls in animals infected with E. coli or Klebsiella spp. Treated animals clinically improved significantly more compared with control cows. No significant differences were observed between treated and control animals in milk production or linear score before or after clinical mastitis. Treated animals left the study less frequently compared with control animals. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Family intervention to control type 2 diabetes: a controlled clinical trial.

PubMed

García-Huidobro, Diego; Bittner, Marcela; Brahm, Paulina; Puschel, Klaus

2011-02-01

Chilean patients with type 2 diabetes mellitus (T2DM) have a low rate of blood sugar control. We studied the effectiveness of a culturally sensitive family oriented intervention designed to improve metabolic control in primary care patients with uncontrolled T2DM. Patients with T2DM from three primary care clinics in Santiago, Chile were randomly selected for inclusion if they had a recent HbA1c ≥7%, were between 18 and 70 years old and lived with a family member. Patients from one clinic received the family oriented intervention; patients from the other two (control) clinics received standard care. The intervention involved family members in care and included family counselling during clinic visits, family meetings and home visits. The primary outcome was HbA1c, measured at 6 and 12 months. A total of 243 patients were enrolled and 209 (86%) completed the study. The intervention was fully administered to only 34% of patients in the intervention clinic. The reduction in the HbA1c from baseline to 12 months was not significantly different between clinics. During the second 6-month period, when the intervention was more intensive, the patients in the intervention clinic significantly improved their HbA1c (P < 0.001) compared to the control patients. A family intervention for the control of T2DM was associated with a significant reduction in HbA1c when the intervention was provided. Incomplete implementation, low statistical power and potential confounding variables between groups could be some of the main factors that explain the lack of difference between clinics in the 12-month period.

Asthma in pregnancy: association between the Asthma Control Test and the Global Initiative for Asthma classification and comparisons with spirometry.

PubMed

de Araujo, Georgia Véras; Leite, Débora F B; Rizzo, José A; Sarinho, Emanuel S C

2016-08-01

The aim of this study was to identify a possible association between the assessment of clinical asthma control using the Asthma Control Test (ACT) and the Global Initiative for Asthma (GINA) classification and to perform comparisons with values of spirometry. Through this cross-sectional study, 103 pregnant women with asthma were assessed in the period from October 2010 to October 2013 in the asthma pregnancy clinic at the Clinical Hospital of the Federal University of Pernambuco. Questionnaires concerning the level of asthma control were administered using the Global Initiative for Asthma classification, the Asthma Control Test validated for asthmatic expectant mothers and spirometry; all three methods of assessing asthma control were performed during the same visit between the twenty-first and twenty-seventh weeks of pregnancy. There was a significant association between clinical asthma control assessment using the Asthma Control Test and the Global Initiative for Asthma classification (p<0.001). There were also significant associations between the results of the subjective instruments of asthma (the GINA classification and the ACT) and evidence of lung function by spirometry. This study shows that both the Global Initiative for Asthma classification and the Asthma Control Test can be used for asthmatic expectant mothers to assess the clinical control of asthma, especially at the end of the second trimester, which is assumed to be the period of worsening asthma exacerbations during pregnancy. We highlight the importance of the Asthma Control Test as a subjective instrument with easy application, easy interpretation and good reproducibility that does not require spirometry to assess the level of asthma control and can be used in the primary care of asthmatic expectant mothers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

PubMed

Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

2016-07-06

Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

PubMed Central

2016-01-01

Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

Clinical inertia in the pharmacological management of hypertension: A systematic review and meta-analysis.

PubMed

Milman, Tal; Joundi, Raed A; Alotaibi, Naif M; Saposnik, Gustavo

2018-06-01

Clinical Inertia is defined as "failure of health care providers to initiate or intensify therapy according to current guidelines". This phenomenon is gaining increasing attention as a major cause of clinicians' failure to adequately manage hypertension, thus leading to an increased incidence of cardiovascular events. We performed a systematic review and meta-analysis of randomized controlled trials to determine whether interventions aimed at reducing clinical inertia in the pharmacological treatment of hypertension improve blood pressure (BP) control. MEDLINE, Embase, and Cochrane Database of Systematic Reviews were searched from the start of their database until October 3, 2017 for the MESH terms "Hypertension" or "Blood Pressure", their subheadings, and the keywords "Therapeutic Inertia" or "Clinical Inertia". Studies were included if they addressed pharmacologic hypertension management, clinical inertia, were randomized controlled trials, reported an outcome describing prescriber behavior, and were available in English. Data for the included studies was extracted by two independent observers. Quality of studies was analyzed using the Cochrane Risk of Bias Assessment. Data was pooled for statistical analysis using both fixed- and random-effects models. The primary study outcome was the percentage of patients achieving blood pressure control as defined by the Joint National Committee guidelines or study authors. Of 474 citations identified, ten met inclusion criteria comprising a total of 26,871 patients, and eight were selected for meta-analysis. Interventions included Physician Education, Physician Reminders, Patient Education, Patient Reminders, Ambulatory BP Monitoring, Digital Medication Offerings, Physician Peer Visits, and Pharmacist-led Counselling. Pooled event rates revealed more patients with controlled BP in the intervention group versus control (55%, 95% CI 46-63% versus 45%, 95% CI 37-53%) and interventions significantly improved the odds of BP control (OR = 1.19, 95% CI = 1.12-1.27, P < .001). Heterogeneity in the quantitative analysis was moderate. Addressing clinical inertia through physician reminders, ambulatory BP monitoring, and educational interventions for primary care providers was associated with an improvement in blood pressure control. Our findings encourage further research to investigate strategies at reducing clinical inertia in the management of hypertension.

[The effects of case-based learning using video on clinical decision making and learning motivation in undergraduate nursing students].

PubMed

Yoo, Moon-Sook; Park, Jin-Hee; Lee, Si-Ra

2010-12-01

The purpose of this study was to examine the effects of case-base learning (CBL) using video on clinical decision-making and learning motivation. This research was conducted between June 2009 and April 2010 as a nonequivalent control group non-synchronized design. The study population was 44 third year nursing students who enrolled in a college of nursing, A University in Korea. The nursing students were divided into the CBL and the control group. The intervention was the CBL with three cases using video. The controls attended a traditional live lecture on the same topics. With questionnaires objective clinical decision-making, subjective clinical decision-making, and learning motivation were measured before the intervention, and 10 weeks after the intervention. Significant group differences were observed in clinical decision-making and learning motivation. The post-test scores of clinical decision-making in the CBL group were statistically higher than the control group. Learning motivation was also significantly higher in the CBL group than in the control group. These results indicate that CBL using video is effective in enhancing clinical decision-making and motivating students to learn by encouraging self-directed learning and creating more interest and curiosity in learning.

Serum levels of leptin and adiponectin and clinical parameters in women with fibromyalgia and overweight/obesity.

PubMed

Paiva, Eduardo S; Andretta, Aline; Batista, Emmanuelle Dias; Lobo, Márcia Maria Marques Teles; Miranda, Renata Costa de; Nisihara, Renato; Schieferdecker, Maria Eliana Madalozzo; Boguszewski, César L

2017-01-01

The objectives of this study were to evaluate the serum levels of adipokines in women with fibromyalgia with and without overweight/obesity, and to correlate the adipokines levels with clinical parameters associated with fibromyalgia and adipose tissue mass (body fat). The study included 100 women divided into four groups: (a) fibromyalgia and overweight/obesity; (b) fibromyalgia and normal weight; (c) controls and overweight/obesity; and (d) controls and normal weight. Patients and controls were evaluated for clinical, anthropometric, and fibromyalgia-related parameters. Assessments included serum levels of leptin, adiponectin, monocyte chemoattractant protein-1 (MCP-1), and C-reactive protein (CRP). Levels of adipokines were further adjusted for fat mass. Fibromyalgia patients with overweight/obesity or normal weight had no differences in clinical parameters. Unadjusted leptin levels were lower in fibromyalgia patients than controls, a finding that was more remarkable in fibromyalgia patients with overweight/obesity. Leptin levels had no correlation with clinical parameters of fibromyalgia or inflammation markers (MCP-1 and CRP), and adiponectin levels showed no difference between groups. No correlation was observed between adjusted leptin levels and clinical parameters of fibromyalgia. Patients with fibromyalgia and overweight/obesity presented lower levels of leptin than controls with overweight/obesity.

The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study.

PubMed

Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus; Rasmussen, Maria Birkvad; Mogensen, Simon Skibsted; Jensen, Michael Kammer; Frost, Torben; Ringsted, Charlotte

2009-02-01

The impact of clinical experience on learning outcome from a resuscitation course has not been systematically investigated. To determine whether half a year of clinical experience before participation in an Advanced Life Support (ALS) course increases the immediate learning outcome and retention of learning. This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS-competence assessed using a validated composite test including assessment of skills and knowledge. The intervention was half a year of clinical work before an ALS course. The intervention group received the course after a half-year of clinical experience. The control group participated in an ALS course immediately following graduation. Invitation to participate was accepted by 154/240 (64%) graduates and 117/154 (76%) completed the study. There was no difference between the intervention and control groups with regard to the immediate learning outcome. The intervention group had significantly higher retention of learning compared to the control group, intervention group mean 82% (CI 80-83), control group mean 78% (CI 76-80), P=0.002. The magnitude of this difference was medium (effect size=0.57). Half a year of clinical experience, before participation in an ALS course had a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome.

Examining clinical supervision as a mechanism for changes in practice: a research protocol.

PubMed

Dilworth, Sophie; Higgins, Isabel; Parker, Vicki; Kelly, Brian; Turner, Jane

2014-02-01

This paper describes the research protocol for a study exploring if and how clinical supervision facilitates change in practice relating to psychosocial aspects of care for Health Professionals, who have been trained to deliver a psychosocial intervention to adults with cancer. There is a recognized need to implement care that is in line with clinical practice guidelines for the psychosocial care of adults with cancer. Clinical supervision is recommended as a means to support Health Professionals in providing the recommended psychosocial care. A qualitative design embedded within an experimental, stepped wedge randomized control trial. The study will use discourse analysis to analyse audio-recorded data collected in clinical supervision sessions that are being delivered as one element of a large randomized control trial. The sessions will be attended primarily by nurses, but including physiotherapists, radiation therapists, occupational therapists. The Health Professionals are participants in a randomized control trial designed to reduce anxiety and depression of distressed adults with cancer. The sessions will be facilitated by psychiatrists experienced in psycho-oncology and the provision of clinical supervision. The proposed research is designed specifically to facilitate exploration of the mechanisms by which clinical supervision enables Health Professionals to deliver a brief, tailored psychosocial intervention in the context of their everyday practice. This is the first study to use discourse analysis embedded within an experimental randomized control trial to explore the mechanisms of change generated within clinical supervision by analysing the discourse within the clinical supervision sessions. © 2013 John Wiley & Sons Ltd.

Impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes: Randomized controlled trial.

PubMed

Wishah, Ruba A; Al-Khawaldeh, Omar A; Albsoul, Abla M

2015-01-01

The primary aim of this study was to evaluate the impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes patients in Jordan. A randomized controlled clinical trial was conducted on 106 patients with uncontrolled type 2 diabetes seeking care in the diabetes clinics at Jordan University Hospital. Patients were randomly allocated into control and intervention group. The intervention group patients received pharmaceutical care interventions developed by the clinical pharmacist in collaboration with the physician while the control group patients received usual care without clinical pharmacist's input. Fasting blood glucose and HbA1c were measured at the baseline, at three months, and six months intervals for both intervention and control groups. After the six months follow-up, mean of HbA1c and FBS of the patients in the intervention group decreased significantly compared to the control group patients (P<0.05). Also, the results indicated that mean scores of patients' knowledge about medications, knowledge about diabetes and adherence to medications and diabetes self-care activities of the patients in the intervention group increased significantly compared to the control group (P<0.05). This study demonstrated an improvement in HbA1c, FBS, and lipid profile, in addition to self-reported medication adherence, diabetes knowledge, and diabetes self-care activities in patients with type 2 diabetes who received pharmaceutical care interventions. The results suggest the benefits of integrating clinical pharmacist services in multidisciplinary healthcare team and diabetes management in Jordan. Copyright © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.

PubMed

Felicitas-Perkins, Jamie Q; Palalay, Melvin Paul; Cuaresma, Charlene; Ho, Reginald Cs; Chen, Moon S; Dang, Julie; Loui, William S

2017-07-01

We conducted an experimental pilot study in an oncology clinic in Honolulu, Hawai'i to determine the effect of a culturally-tailored educational DVD on cancer clinical trial participation among Filipino cancer patients. Thirty-seven patients participated in the study, with 17 randomized into the control group (ie, usual education) and 20 into the intervention group (ie, usual education plus educational DVD). Participants completed pre- and post-educational questionnaires with items asking about understanding of several cancer topics, behavioral outcomes, and attitudes regarding several treatment and physician related topics. A Fisher's exact test was conducted to explore the association between enrollment into a clinical trial and group assignment. General linear models were created to determine significant differences between study groups in post-education response scores for each questionnaire item after controlling for age, gender, education, and pre-education response scores. Two participants from the control group and three participants from the intervention group enrolled into clinical trials. Results showed no significant association between clinical trial enrollment and study group assignment ( P > .99). A significant difference was found between study groups on surety of joining the clinical trial suggested to them ( P = .013). A multilingual educational DVD to supplement clinical trial education may positively influence Filipino cancer patients to move forward with the decision to join a cancer clinical trial. However, health literacy may serve as a major barrier to actual enrollment into the particular clinical trial available to a patient.

The relationship between simulation in nursing education and medication safety.

PubMed

Sears, Kimberley; Goldsworthy, Sandra; Goodman, William M

2010-01-01

This experimental study examined whether the use of clinical simulation in nursing education could help reduce medication errors. Fifty-four student volunteers were randomly assigned to an experimental (treatment) group (24 students) or a clinical control group (30 students). The treatment replaced some early-term clinical placement hours with a simulated clinical experience. The control group had all normally scheduled clinical hours. Treatment occurred prior to opportunities for medication administration. Copyright 2010, SLACK Incorporated.

Influence of occlusal loading on peri-implant clinical parameters. A pilot study

PubMed Central

Pellicer-Chover, Hilario; Viña-Almunia, José; Romero-Millán, Javier; Peñarrocha-Oltra, David; Peñarrocha-Diago, María

2014-01-01

Objectives: To investigate the relation between occlusal loading and peri-implant clinical parameters (probing depth, bleeding on probing, gingival retraction, width of keratinized mucosa, and crevicular fluid volume) in patients with implant-supported complete fixed prostheses in both arches. Material and Methods: This clinical study took place at the University of Valencia (Spain) dental clinic. It included patients attending the clinic for regular check-ups during at least 12 months after rehabilitation of both arches with implant-supported complete fixed ceramo-metallic prostheses. One study implant and one control implant were established for each patient using the T-Scan®III computerized system (Tesco, South Boston, USA). The maxillary implant closest to the point of maximum occlusal loading was taken as the study implant and the farthest (with least loading) as the control. Occlusal forces were registered with the T-Scan® III and then occlusal adjustment was performed to distribute occlusal forces correctly. Peri-implant clinical parameters were analyzed in both implants before and two and twelve months after occlusal adjustment. Results: Before occlusal adjustment, study group implants presented a higher mean volume of crevicular fluid (51.3±7.4 UP) than the control group (25.8±5.5 UP), with statistically significant difference. Two months after occlusal adjustment, there were no significant differences between groups (24.6±3.8 UP and 26±4.5 UP respectively) (p=0.977). After twelve months, no significant differences were found between groups (24.4±11.1 UP and 22.5±8.9 UP respectively) (p=0.323). For the other clinical parameters, no significant differences were identified between study and control implants at any of the study times (p>0.05). Conclusions: Study group implants receiving higher occlusal loading presented significantly higher volumes of crevicular fluid than control implants. Crevicular fluid volumes were similar in both groups two and twelve months after occlusal adjustment. Key words:Occlusal loading, crevicular fluid, peri-implant clinical parameters, T-Scan®. PMID:24316708

Comparison of gesture and conventional interaction techniques for interventional neuroradiology.

PubMed

Hettig, Julian; Saalfeld, Patrick; Luz, Maria; Becker, Mathias; Skalej, Martin; Hansen, Christian

2017-09-01

Interaction with radiological image data and volume renderings within a sterile environment is a challenging task. Clinically established methods such as joystick control and task delegation can be time-consuming and error-prone and interrupt the workflow. New touchless input modalities may have the potential to overcome these limitations, but their value compared to established methods is unclear. We present a comparative evaluation to analyze the value of two gesture input modalities (Myo Gesture Control Armband and Leap Motion Controller) versus two clinically established methods (task delegation and joystick control). A user study was conducted with ten experienced radiologists by simulating a diagnostic neuroradiological vascular treatment with two frequently used interaction tasks in an experimental operating room. The input modalities were assessed using task completion time, perceived task difficulty, and subjective workload. Overall, the clinically established method of task delegation performed best under the study conditions. In general, gesture control failed to exceed the clinical input approach. However, the Myo Gesture Control Armband showed a potential for simple image selection task. Novel input modalities have the potential to take over single tasks more efficiently than clinically established methods. The results of our user study show the relevance of task characteristics such as task complexity on performance with specific input modalities. Accordingly, future work should consider task characteristics to provide a useful gesture interface for a specific use case instead of an all-in-one solution.

ERPs and Psychopathology. I. Behavioral process issues.

PubMed

Roth, W T; Tecce, J J; Pfefferbaum, A; Rosenbloom, M; Callaway, E

1984-01-01

The clinical study of ERPs has an inherent defect--a self-selection of clinical populations that hampers equating of clinically defined groups on factors extraneous to the independent variables. Such ex post facto studies increase the likelihood of confounding variables in the interpretation of findings. Hence, the development of lawful relationships between clinical variables and ERPs is impeded and the fulfillment of description, explanation, prediction, and control in brain science is thwarted. Proper methodologies and theory development can increase the likelihood of establishing these lawful relationships. One methodology of potential value in the clinical application of ERPs, particularly in studies of aging, is that of divided attention. Two promising theoretical developments in the understanding of brain functioning and aging are the distraction-arousal hypothesis and the controlled-automatic attention model. The evaluation of ERPs in the study of brain-behavior relations in clinical populations might be facilitated by the differentiation of concurrent, predictive, content, and construct validities.

[Development and Effects of Assertiveness Training applying Dongsasub Training for Nursing Students in Clinical Practice].

PubMed

Kim, Myoungsuk

2016-08-01

This study was conducted to develop assertiveness training applying Dongsasub training for junior nursing students, and to verify effectiveness of the training on assertiveness behavior, self-esteem, clinical practice stress, and clinical competence. The study design was a non-equivalent control group non-synchronized design. Participants were 63 nursing students in clinical training (31 students in the experimental group and 32 students in the control group). The assertiveness training applying Dongsasub training consisted of four sessions. Outcome variables included assertiveness behavior, self-esteem, clinical practice stress, and clinical competence. Data were analyzed using Chi-square, Fisher's exact test and independent samples t-test with SPSS/WIN 21.0. Scores of assertiveness behavior (t=-2.49, p=.015), self-esteem (t=-4.80, p<.001) and clinical competence (t=-2.33, p=.023) were significantly higher and clinical practice stress (t=4.22, p<.001) was significantly lower in the experimental group compared to the control group. Results indicate that the assertiveness training applying Dongsasub training can be used as a nursing intervention to lower clinical practice stress and improve the clinical competence of nursing students.

ASSOCIATION BETWEEN URINARY MUTAGENICITY AND RISK OF COLORECTAL ADENOMAS IN A CLINIC-BASED CASE-CONTROL STUDY

EPA Science Inventory

ASSOCIATION BETWEEN URINARY MUTAGENICITY AND RISK OF COLORECTAL ADENOMAS IN A CLINIC-BASED CASE-CONTROL STUDY

Humans are exposed to a variety of mutagens from diet, smoking, or occupation. To explore if exposure to mutagens was related to the risk of colorectal adenomas i...

A meta-analysis of mammographic screening with and without clinical breast examination

PubMed Central

Hamashima, Chisato; Ohta, Koji; Kasahara, Yoshio; Katayama, Takafumi; Nakayama, Tomio; Honjo, Satoshi; Ohnuki, Koji

2015-01-01

Mammographic screening with clinical breast examination has been recommended in Japan since 2000. Although mammographic screening without clinical breast examination has not been recommended, its introduction is anticipated. The efficacies of mammographic screening with and without clinical breast examination were evaluated based on the results of randomized controlled trials. PubMed and other databases for studies published between 1985 and 2014 were searched. The study design was limited to randomized controlled trials to evaluate mortality reduction from breast cancer. Five studies were eligible for meta-analysis of mammographic screening without clinical breast examination. The relative risk for women aged 40–74 years was 0.75 (95% confidence interval, 0.67–0.83). Three studies evaluated the efficacy of mammographic screening with clinical breast examination. The relative risk for women aged 40–64 years was 0.87 (95% confidence interval, 0.77–0.98). The number needed to invite was always lower in mammographic screening without clinical breast examination than in mammographic screening with clinical breast examination. In both screening methods, the number needed to invite was higher in women aged 40–49 years than in women aged 50–70 years. These results suggest that mammographic screening without clinical breast examination can afford higher benefits to women aged 50 years and over. Although evidence of the efficacy of mammographic screening without clinical breast examination was confirmed based on the results of the randomized controlled trials, a Japanese study is needed to resolve local problems. PMID:25959787

Using Theater to Teach Clinical Empathy: A Pilot Study

PubMed Central

Leong, David; Anderson, Aaron; Wenzel, Richard P.

2007-01-01

Background Clinical empathy, a critical skill for the doctor–patient relationship, is infrequently taught in graduate medical education. No study has tested if clinical empathy can be taught effectively. Objective To assess whether medicine residents can learn clinical empathy techniques from theater professors. Design A controlled trial of a clinical empathy curriculum taught and assessed by 4 theater professors. Setting Virginia Commonwealth University, Richmond, Virginia, a large urban university and health system. Participants Twenty Internal Medicine residents: 14 in the intervention group, 6 in the control group. Intervention Six hours of classroom instruction and workshop time with professors of theater. Measurements Scores derived from an instrument with 6 subscores designed to measure empathy in real-time patient encounters. Baseline comparisons were made using two-sample T tests. A mixed-effects analysis of variance model was applied to test for significance between the control and intervention groups. Results The intervention group demonstrated significant improvement (p ≤ .011) across all 6 subscores between pre-intervention and post-intervention observations. Compared to the control group, the intervention group had better posttest scores in 5 of 6 subscores (p ≤ .01). Limitations The study was neither randomized nor blinded. Conclusions Collaborative efforts between the departments of theater and medicine are effective in teaching clinical empathy techniques. PMID:17486385

Improving glycaemic control self-efficacy and glycaemic control behaviour in Chinese patients with type 2 diabetes mellitus: randomised controlled trial.

PubMed

Shi, Qifang; Ostwald, Sharon K; Wang, Shaopeng

2010-02-01

To examine the effect of a hospital-based clinic intervention on glycaemic control self-efficacy and glycaemic control behaviour of Chinese patients with type 2 diabetes mellitus (DM). Self-efficacy expectations are related to self-management of diabetes and, in conjunction with environmental support, are better predictors of behaviour than are knowledge and skills. Enhancing self-efficacy in patients with DM has been shown to have a positive effect on behavioural change and positively influence long-term glycaemic control. A randomised controlled trial study consisting of two-group pretest-post-test. One hundred and fifty-seven patients with type 2 DM were randomly divided into two groups: (1) the experimental group (77 patients) receiving one-month hospital-based clinic intervention and (2) the control group (80 patients) receiving usual care. Data collection instruments used in this study were Diabetes Management Self-Efficacy Scale and Summary of Diabetes Self-Care Activities Measure. Outcomes were determined by changes in glycaemic control self-efficacy and glycaemic control behaviour of patients with type 2 DM. The findings revealed that the experimental group showed statistically significant improvement in glycaemic control self-efficacy and glycaemic control behaviour immediately and four months after the intervention (F = 26.888, df = 1, 155, p < 0.05 and F = 18.619, df = 1, 155, p < 0.05, respectively). One-month hospital-based clinic intervention could be useful in improving glycaemic control self-efficacy and glycaemic control behaviour. Nurses can learn and use the sources of self-efficacy to enhance patients' self-efficacy on their glycaemic control in clinical care. The health education is most important in nursing care and should be considered while organising the hospital-based clinic intervention.

The impact of a reproductive health franchise on client satisfaction in rural Nepal.

PubMed

Agha, Sohail; Karim, Ali Mehryar; Balal, Asma; Sosler, Steve

2007-09-01

This study evaluates the impact of a nurse and paramedic reproductive health franchise in rural Nepal on client satisfaction and utilization of services. A quasi-experimental study design, with baseline and follow-up measurements on nonequivalent control groups, was used to assess the effects of the intervention. The study collected data from exit interviews with male and female clients at clinics and from household interviews with married women. Our assessment covers the project's performance for about a year of actual implementation. Client satisfaction with the quality of services increased across a range of indicators at intervention clinics but not at control clinics. Overall satisfaction with services also increased only at intervention clinics but not at control clinics. Consistent with these changes, loyalty increased among clients of franchised clinics. The analysis showed a positive relationship between client satisfaction and loyalty. Although the project's implementation was examined over a relatively short period of time, there appears to have been a net positive effect of the intervention on obtaining family planning products from medical stores/pharmacies. The study shows that franchising reproductive health services increases a provider's interest in delivering better quality services in rural areas of a developing country.

[Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

PubMed

Inagaki, Osamu

2016-04-01

Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

[Dexpanthenol nasal spray as an effective therapeutic principle for treatment of rhinitis sicca anterior].

PubMed

Kehrl, W; Sonnemann, U

1998-09-01

Controlled clinical studies on medical treatment of rhinitis sicca anterior have not yet been published. Therapy recommendations are based on experiences but not on results of controlled clinical studies. The aim of this study was to examine the efficacy and tolerance of a new form of application of Dexpanthenol in physiologic saline solution (Nasicur). A randomized comparison of parallel groups was performed. One group was treated with the nasal spray while the control group received a placebo. The assessment of nasal breathing resistance and the extent of crust formation according to scores were defined as target parameters. Statistical analysis was carried out according to Wilcoxon at alpha < or = 0.05. Forty-eight outpatients diagnosed with rhinitis sicca anterior were included in this study. Twenty-four received the medication, and 29 were treated with a placebo. The superiority of the dexpanthenol nasal spray in comparison to the placebo medication was demonstrated for both target parameters as clinically relevant and statistically significant. The placebo spray showed clinical improvement of the other treatment outcome parameters. Dexpanthenol nasal spray showed no statistically significant difference in comparison to placebo. The clinically proven efficacy is emphasized by good tolerance of both treatments which was validated by the objective rhinoscopy findings. Good compliance was confirmed. The result of the controlled clinical study confirms that the dexpanthenol nasal spray is an effective medicinal treatment of rhinitis sicca anterior and is more effective than common medications.

Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case–control study in the UK

PubMed Central

Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

2014-01-01

Objective Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the UK in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. Design A prospective multicentre case–control study was conducted at six UK hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Methods Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Results Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. Conclusions This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. PMID:24687130

Demographic and Clinical Profile of Patients With Dementia Receiving Electroconvulsive Therapy: A Case-Control Study.

PubMed

Zhang, Qing-E; Sha, Sha; Ungvari, Gabor S; Chiu, Helen F K; Ng, Chee H; He, Hong-Bo; Forester, Brent P; Xiang, Yu-Tao

2016-09-01

Little is known about the clinical characteristics of patients with dementia receiving electroconvulsive therapy (ECT) for the treatment of behavioral symptoms. This study examined the demographic and clinical profile of patients with dementia receiving ECT in China. This was a retrospective, case-control study. The sample was composed of 23 patients with dementia treated with ECT and 71 sex- and age-matched controls treated for a period of 8 years (2007-2014) at the National Clinical Research Centre of Mental Disorders, China. Sociodemographic and clinical data were collected from the electronic chart management system. Multiple logistic regression analysis revealed that ECT was independently associated with high risk for suicide at admission. The recorded indications for ECT included both high risk for suicide and aggressive behavior. Most patients responded to ECT satisfactorily (56.5%) or partially (34.8%) with only mild-moderate transient memory impairment (30.4%). Although this is a preliminary study limited by the retrospective design and small sample size, findings suggest that ECT is an effective and safe therapeutic intervention to reduce the risk for suicide and aggressive behavior in dementia.

An analysis of clinical outcomes and costs of a long term acute care hospital.

PubMed

Votto, John J; Scalise, Paul J; Barton, Randall W; Vogel, Cristine A

2011-01-01

Compare clinical outcomes and costs in a study group of long-term acute care hospital (LTCH) patients with a control group of LTCH-eligible patients in an acute care hospital. LTCHs were created to provide post-acute care services not available at other post-acute settings. This is based on the premise that these patients would otherwise have stayed at acute care hospitals as high-cost outliers. The LTCH hospital is intended to deliver care to patients more efficiently, however, there are little documented clinical and financial data regarding the comparative clinical outcomes and costs for patients. Retrospective medical and billing record review of patients from the following groups: (1) LTCH study comprising patients admitted directly from an acute care hospital to the study LTCH and discharged from the LTCH from September 2004 through August 2006; (2) a control group of LTCH-eligible, medically complex patients treated and discharged from an acute care hospital in FY 2002. The control group was selected from approximately 500 patients who had at least one of the ten most common principle diagnosis DRGs of the study LTCH with >30-day length of stay at the referring hospital and met NALTH admitting guidelines. Discharge disposition is an important outcome measure of the quality of care of medically complex patients. The in-hospital mortality rate trended lower and home discharge was 3 times higher for the LTCH study group than for the control group. As a possible result, SNF discharge of LTCH patients was approximately half that of the control group. Both mean patient cost per day and mean total cost per patient were significantly higher in the control group than in the LTCH study group. The patients in the LTCH study group had both better clinical outcomes and lower cost of care than the control group.

A focused exercise regimen improves clinical measures of balance in patients with peripheral neuropathy.

PubMed

Richardson, J K; Sandman, D; Vela, S

2001-02-01

To determine the effect of a specific exercise regimen on clinical measures of postural stability and confidence in a population with peripheral neuropathy (PN). Prospective, controlled, single blind study. Outpatient clinic of a university hospital. Twenty subjects with diabetes mellitus and electrodiagnostically confirmed PN. Ten subjects underwent a 3-week intervention exercise regimen designed to increase rapidly available distal strength and balance. The other 10 subjects performed a control exercise regimen. Unipedal stance time, functional reach, tandem stance time, and score on the activities-specific balance and confidence (ABC) scale. The intervention subjects, but not the control subjects, showed significant improvement in all 3 clinical measures of balance and nonsignificant improvement on the ABC scale. A brief, specific exercise regimen improved clinical measures of balance in patients with diabetic PN. Further studies are needed to determine if this result translates into a lower fall frequency in this high-risk population.

Transdiagnostic mechanisms in depression and anxiety: The role of rumination and attentional control.

PubMed

Hsu, Kean J; Beard, Courtney; Rifkin, Lara; Dillon, Daniel G; Pizzagalli, Diego A; Björgvinsson, Thröstur

2015-12-01

Deficits in attentional control have been hypothesized to cause rumination, suggesting that the relationships between attentional control and clinical symptoms may be mediated in part by rumination. However, to date, no clinical study has examined these constructs transdiagnostically in a path analysis model. Fifty-one adults presenting for treatment completed measures of self-reported attentional control, rumination, and depression and anxiety symptoms. A bias-corrected path analysis-based approach was employed to test whether indirect (i.e., mediating) effects of rumination were significantly associated with the direct effects of attentional control on depression and anxiety symptoms. Separate models for depression and anxiety symptoms were tested along with reverse models using attentional control as a proposed mediator. The relationship between attentional control and clinical symptomatology (i.e., both depression and anxiety symptoms) was mediated by rumination. Poor attentional control was associated with more rumination and consequently more severe symptoms of depression and anxiety. The reverse relationship (i.e., attentional control mediating the relationship between rumination and depression or anxiety symptoms) was not significant. Study design did not allow testing of temporal precedence for the mediation models. All constructs were assessed via self-report. Attentional control appears to impact depression and anxiety symptoms through rumination. The pathway between poor attentional control and emotion dysregulation via rumination suggests that interventions targeting attentional control may decrease maladaptive ruminative processes, leading to improved emotion regulation and reduced clinical symptomatology. Future studies should examine the stability of this mediational relationship over time (and in the face of targeted interventions). Copyright © 2015 Elsevier B.V. All rights reserved.

Prospective study of bacteraemia in acute haemorrhagic diarrhoea syndrome in dogs.

PubMed

Unterer, S; Lechner, E; Mueller, R S; Wolf, G; Straubinger, R K; Schulz, B S; Hartmann, K

2015-03-21

In dogs with idiopathic acute haemorrhagic diarrhoea syndrome (AHDS), a serious loss of intestinal mucosal barrier integrity occurs. However, the incidence of bacterial translocation in dogs with idiopathic AHDS is not known. Thus, the objectives of this prospective study were to identify the incidence of bacteraemia, to evaluate the frequency of septic events and the influence of bacteraemia on various clinical and laboratory parameters, duration of hospitalisation and survival of dogs with idiopathic AHDS. The study included 87 dogs with idiopathic AHDS. Twenty-one healthy dogs served as control group. To evaluate clinical significance of bacterial translocation, blood culture results were compared between patients and controls. Clinical and laboratory parameters were compared between patients with positive and negative blood cultures. There was no significant difference in either incidence of bacteraemia between patients with idiopathic AHDS (11 per cent) and controls (14 per cent) or in severity of clinical signs, laboratory parameters, duration of hospitalisation or mortality between blood culture-positive and culture-negative dogs with idiopathic AHDS. The results of this study suggest that the incidence of bacteraemia in dogs with idiopathic AHDS is low and not different from that of healthy control dogs. Bacteraemia does not influence the clinical course or survival and thus antibiotic treatment is not indicated to prevent sepsis. British Veterinary Association.

Tuberculosis infection control measures in health care facilities offering tb services in Ikeja local government area, Lagos, South West, Nigeria.

PubMed

Kuyinu, Y A; Mohammed, A S; Adeyeye, O O; Odugbemi, B A; Goodman, O O; Odusanya, O O

2016-03-15

Tuberculosis infection among health care workers is capable of worsening the existing health human resource problems of low--and middle-income countries. Tuberculosis infection control is often weakly implemented in these parts of the world therefore, understanding the reasons for poor implementation of tuberculosis infection control guidelines are important. This study was aimed at assessing tuberculosis infection control practices and barriers to its implementation in Ikeja, Nigeria. A cross-sectional study in 20 tuberculosis care facilities (16 public and 4 private) in Ikeja, Lagos was conducted. The study included a facility survey to assess the availability of tuberculosis infection control guidelines, the adequacy of facilities to prevent transmission of tuberculosis and observations of practices to assess the implementation of tuberculosis infection control guidelines. Four focus group discussions were carried out to highlight HCWs' perceptions on tuberculosis infection control guidelines and barriers to its implementation. The observational study showed that none of the clinics had a tuberculosis infection control plan. No clinic was consistently screening patients for cough. Twelve facilities (60%) consistently provided masks to patients who were coughing. Ventilation in the waiting areas was assessed to be adequate in 60% of the clinics while four clinics (20%) possessed N-95 respirators. Findings from the focus group discussions showed weak managerial support, poor funding, under-staffing, lack of space and not wanting to be seen as stigmatizing against tuberculosis patients as barriers that hindered the implementation of TB infection control measures. Tuberculosis infection control measures were not adequately implemented in health facilities in Ikeja, Nigeria. A multi-pronged approach is required to address the identified barriers to the implementation of tuberculosis infection control guidelines.

The design and methodology of premature ejaculation interventional studies

PubMed Central

2016-01-01

Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. PMID:27652224

Overview of clinical research design.

PubMed

Hartung, Daniel M; Touchette, Daniel

2009-02-15

Basic concepts and terminology of clinical research design are presented for new clinical investigators. Clinical research, research involving human subjects, can be described as either observational or experimental. The findings of all clinical research can be threatened by issues of bias and confounding. Biases are systematic errors in how study subjects are selected or measured, which result in false inferences. Confounding is a distortion in findings that is attributable to mixing variable effects. Uncontrolled observation research is generally more prone to bias and confounding than experimental research. Observational research includes designs such as the cohort study, case-control study, and cross-sectional study, while experimental research typically involves a randomized controlled trial (RCT). The cohort study, which includes the RCT, defines subject allocation on the basis of exposure interest (e.g., drug, disease-management program) and follows the patients to assess the outcomes. The case-control study uses the primary outcome of interest (e.g., adverse event) to define subject allocation, and different exposures are assessed in a retrospective manner. Cross-sectional research evaluates both exposure and outcome concurrently. Each of these design methods possesses different strengths and weaknesses in answering research questions, as well as underlying many study subtypes. While experimental research is the strongest method for establishing causality, it can be difficult to accomplish under many scenarios. Observational clinical research offers many design alternatives that may be appropriate if planned and executed carefully.

Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

ERIC Educational Resources Information Center

Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

2016-01-01

Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

Cardiovascular self-management support program for preventing cardiovascular complication behaviors and clinical outcomes in the elderly with poorly controlled type 2 diabetes mellitus in Indonesia: A pilot study.

PubMed

Hisni, Dayan; Rukmaini, Rukmaini; Saryono, Saryono; Chinnawong, Tippamas; Thaniwattananon, Ploenpit

2018-03-06

The aim of the study was to determine the feasibility, and to evaluate the effect of, a cardiovascular self-management support program by applying the 5A's self-management support program on preventing cardiovascular complication behaviors and to assess the clinical outcomes in the elderly with poorly controlled type 2 diabetes mellitus (DM). This pilot study used a quasi-experimental study design. Twelve elderly persons with poorly controlled type 2 DM were assigned into either a control or experimental group, with six participants in each group. The Preventing Cardiovascular Complication Behaviors (PCCB) was measured by the Preventing Cardiovascular Complication Behaviors Questionnaire, while the clinical outcomes were measured by clinical devices that were provided. These measurements were conducted and compared at baseline and 6 weeks after the completion of the program. The self-management support program was a 6 week program with several implementation methods, based on the 5A's self-management support program. The participants who received the cardiovascular self-management support program reported a significant improvement in their PCCB and clinical outcomes, compared to those receiving the usual care. This study revealed that a cardiovascular self-management support program that applies the 5A's self-management support program is feasible for implementation. © 2018 Japan Academy of Nursing Science.

Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

ERIC Educational Resources Information Center

Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

2016-01-01

Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

Does the Primary Care Behavioral Health Model Reduce Emergency Department Visits?

PubMed

Serrano, Neftali; Prince, Ronald; Fondow, Meghan; Kushner, Kenneth

2018-04-16

To examine the impact of integrating behavioral health services using the primary care behavioral health (PCBH) model on emergency department (ED) utilization. Utilization data from three Dane County, Wisconsin hospitals and four primary care clinics from 2003 to 2011. We used a retrospective, quasi-experimental, controlled, pre-post study design. Starting in 2007, two clinics began integrating behavioral health into their primary care practices with a third starting in 2010. A fourth, nonimplementing, community clinic served as control. Change in emergency department and primary care utilization (number of visits) for patients diagnosed with mood and anxiety disorders was the outcomes of interest. Retrospective data were obtained from electronic patient records from the three main area hospitals along with primary care data from participating clinics. Following the introduction of the PCBH model, one clinic experienced a statistically significant (p < .01, 95 percent CI 6.3-16.3 percent), 11.3 percent decrease in the ratio of ED visits to primary care encounters, relative to a control site, but two other intervention clinics did not. The PCBH model may be associated with a reduction in ED utilization, but better-controlled studies are needed to confirm this result. © Health Research and Educational Trust.

Exploring Organizational Barriers to Strengthening Clinical Supervision of Psychiatric Nursing Staff: A Longitudinal Controlled Intervention Study.

PubMed

Gonge, Henrik; Buus, Niels

2016-05-01

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, and (b) To explore organizational constraints to implementation of these strengthened practices. Questionnaire responses and registration of participation in clinical supervision were registered prior and subsequent to the intervention consisting of an action learning oriented reflection on staff's existing clinical supervision practices. Major organizational changes in the intervention group during the study period obstructed the implementation of strengthened clinical supervision practices, but offered an opportunity for studying the influences of organizational constraints. The main findings were that a) diminishing experience of social support from colleagues was associated with reduced participation in clinical supervision, while b) additional quantitative demands were associated with staff reporting difficulties finding time for supervision. This probably explained a negative development in the experienced effectiveness of supervision. It is concluded that organizational support is an imperative for implementation of clinical supervision.

Knowledge translation interventions for critically ill patients: a systematic review*.

PubMed

Sinuff, Tasnim; Muscedere, John; Adhikari, Neill K J; Stelfox, Henry T; Dodek, Peter; Heyland, Daren K; Rubenfeld, Gordon D; Cook, Deborah J; Pinto, Ruxandra; Manoharan, Venika; Currie, Jan; Cahill, Naomi; Friedrich, Jan O; Amaral, Andre; Piquette, Dominique; Scales, Damon C; Dhanani, Sonny; Garland, Allan

2013-11-01

We systematically reviewed ICU-based knowledge translation studies to assess the impact of knowledge translation interventions on processes and outcomes of care. We searched electronic databases (to July, 2010) without language restrictions and hand-searched reference lists of relevant studies and reviews. Two reviewers independently identified randomized controlled trials and observational studies comparing any ICU-based knowledge translation intervention (e.g., protocols, guidelines, and audit and feedback) to management without a knowledge translation intervention. We focused on clinical topics that were addressed in greater than or equal to five studies. Pairs of reviewers abstracted data on the clinical topic, knowledge translation intervention(s), process of care measures, and patient outcomes. For each individual or combination of knowledge translation intervention(s) addressed in greater than or equal to three studies, we summarized each study using median risk ratio for dichotomous and standardized mean difference for continuous process measures. We used random-effects models. Anticipating a small number of randomized controlled trials, our primary meta-analyses included randomized controlled trials and observational studies. In separate sensitivity analyses, we excluded randomized controlled trials and collapsed protocols, guidelines, and bundles into one category of intervention. We conducted meta-analyses for clinical outcomes (ICU and hospital mortality, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay) related to interventions that were associated with improvements in processes of care. From 11,742 publications, we included 119 investigations (seven randomized controlled trials, 112 observational studies) on nine clinical topics. Interventions that included protocols with or without education improved continuous process measures (seven observational studies and one randomized controlled trial; standardized mean difference [95% CI]: 0.26 [0.1, 0.42]; p = 0.001 and four observational studies and one randomized controlled trial; 0.83 [0.37, 1.29]; p = 0.0004, respectively). Heterogeneity among studies within topics ranged from low to extreme. The exclusion of randomized controlled trials did not change our results. Single-intervention and lower-quality studies had higher standardized mean differences compared to multiple-intervention and higher-quality studies (p = 0.013 and 0.016, respectively). There were no associated improvements in clinical outcomes. Knowledge translation interventions in the ICU that include protocols with or without education are associated with the greatest improvements in processes of critical care.

[Controlling wound odor with metronidazole: a systematic review].

PubMed

Castro, Diana Lima Villela de; Santos, Vera Lúcia Conceição de Gouveia

2015-10-01

Verifying the evidence of therapeutic efficacy in the topical application of metronidazole for controlling wound odor. A systematic literature review, according to the Cochrane Collaboration recommendations. 329 articles were identified in the Cochrane, LILACS, SciELO, CINAHL and PubMed databases, with 14 of them being included in the final sample. Two of the studies were double-blind randomized clinical trial studies. The actual effectiveness of metronidazole in controlling wound odor cannot yet be evidenced due to the absence of strong evidence from studies on the subject, despite clinical practice recommending its benefits.

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms

PubMed Central

Gamon, Carla; Späth, Christina; Berger, Thomas; Meyer, Björn; Hohagen, Fritz; Hautzinger, Martin; Lutz, Wolfgang; Vettorazzi, Eik; Moritz, Steffen; Schröder, Johanna

2017-01-01

Objective This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. Design This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. Setting The study takes place in five diagnostic centres in Germany. Participants A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. Interventions This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). Main outcome measures The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). Results The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). Conclusion Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. Trial registration number ClinicalTrials.gov NCT01636752. PMID:28710212

Tissue Engineering of the Urethra: A Systematic Review and Meta-analysis of Preclinical and Clinical Studies.

PubMed

Versteegden, Luuk R M; de Jonge, Paul K J D; IntHout, Joanna; van Kuppevelt, Toin H; Oosterwijk, Egbert; Feitz, Wout F J; de Vries, Rob B M; Daamen, Willeke F

2017-10-01

Urethra repair by tissue engineering has been extensively studied in laboratory animals and patients, but is not routinely used in clinical practice. To systematically investigate preclinical and clinical evidence of the efficacy of tissue engineering for urethra repair in order to stimulate translation of preclinical studies to the clinic. A systematic search strategy was applied in PubMed and EMBASE. Studies were independently screened for relevance by two reviewers, resulting in 80 preclinical and 23 clinical studies of which 63 and 13 were selected for meta-analysis to assess side effects, functionality, and study completion. Analyses for preclinical and clinical studies were performed separately. Full circumferential and inlay procedures were assessed independently. Evaluated parameters included seeding of cells and type of biomaterial. Meta-analysis revealed that cell seeding significantly reduced the probability of encountering side effects in preclinical studies. Remarkably though, cells were only sparsely used in the clinic (4/23 studies) and showed no significant reduction of side effects. ln 21 out of 23 clinical studies, decellularized templates were used, while in preclinical studies other biomaterials showed promising outcomes as well. No direct comparison to current clinical practice could be made due to the limited number of randomized controlled studies. Due to a lack of controlled (pre)clinical studies, the efficacy of tissue engineering for urethra repair could not be determined. Meta-analysis outcome measures were similar to current treatment options described in literature. Surprisingly, it appeared that favorable preclinical results, that is inclusion of cells, were not translated to the clinic. Improved (pre)clinical study designs may enhance clinical translation. We reviewed all available literature on urethral tissue engineering to assess the efficacy in preclinical and clinical studies. We show that improvements to (pre)clinical study design is required to improve clinical translation of tissue engineering technologies. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial.

PubMed

Lai, Michelle Mei Yee; Roberts, Noel; Martin, Jenepher

2014-09-17

Oral feedback from clinical educators is the traditional teaching method for improving clinical consultation skills in medical students. New approaches are needed to enhance this teaching model. Multisource feedback is a commonly used assessment method for learning among practising clinicians, but this assessment has not been explored rigorously in medical student education. This study seeks to evaluate if additional feedback on patient satisfaction improves medical student performance. The Patient Teaching Associate (PTA) Feedback Study is a single site randomized controlled, double-blinded trial with two parallel groups.An after-hours general practitioner clinic in Victoria, Australia, is adapted as a teaching clinic during the day. Medical students from two universities in their first clinical year participate in six simulated clinical consultations with ambulatory patient volunteers living with chronic illness. Eligible students will be randomized in equal proportions to receive patient satisfaction score feedback with the usual multisource feedback and the usual multisource feedback alone as control. Block randomization will be performed. We will assess patient satisfaction and consultation performance outcomes at baseline and after one semester and will compare any change in mean scores at the last session from that at baseline. We will model data using regression analysis to determine any differences between intervention and control groups. Full ethical approval has been obtained for the study. This trial will comply with CONSORT guidelines and we will disseminate data at conferences and in peer-reviewed journals. This is the first proposed trial to determine whether consumer feedback enhances the use of multisource feedback in medical student education, and to assess the value of multisource feedback in teaching and learning about the management of ambulatory patients living with chronic conditions. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613001055796.

Antibiotic therapy as an adjunct to scaling and root planing in smokers: a systematic review and meta-analysis.

PubMed

Assem, Naida Zanini; Alves, Márcio Luiz Ferro; Lopes, Alessandra Barreto; Gualberto, Erivan Clementino; Garcia, Valdir Gouveia; Theodoro, Letícia Helena

2017-07-03

The aim of this study was to perform a systematic review and meta-analysis to examine the effect of systemic antibiotics in the periodontal treatment of smokers. The selection criteria were as follows: controlled randomized clinical trials; studies published in English; studies with smoker patients diagnosed with chronic periodontitis; patients without systemic diseases; studies that used systemic antibiotic therapy associated with periodontal treatment; studies that presented results for the test and control groups and assessments of clinical periodontal parameters, such as probing depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). The differences in average weights were calculated with a confidence interval (CI) of 95% for PD reduction, CAL gain and BOP. The means of the periodontal clinical parameters were compared between the baseline and post-treatment periods between the test groups and the control groups. The heterogeneity was assessed using the Cochran Q test (Q (df = 3), α = 5%). A total of 67 articles were found, and after the selection process, three randomized controlled trials were included in the meta-analysis. The results indicate that SRP associated with systemic antibiotics promoted additional benefits when compared to SRP alone, with a greater reduction of PD (p = 0.0359, CI = -0.42, -0.01) and a gain of CAL (p = 0.0161, CI = -0.39, -0.04). There was a modest PD reduction (PD, DM -0.21) and a modest CAL gain (CAL, DM -0.22). The results of our meta-analysis reveal the clinical benefits of systemic antibiotics as an adjunct to the non-surgical periodontal treatment of smokers. These clinical improvements, although statistically significant, appeared to be of little clinical relevance.

Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

PubMed

Sennerby, L; Gottlow, J

2008-06-01

Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

[Realization of design regarding experimental research in the clinical real-world research].

PubMed

He, Q; Shi, J P

2018-04-10

Real world study (RWS), a further verification and supplement for explanatory randomized controlled trial to evaluate the effectiveness of intervention measures in real clinical environment, has increasingly become the focus in the field of research on medical and health care services. However, some people mistakenly equate real world study with observational research, and argue that intervention and randomization cannot be carried out in real world study. In fact, both observational and experimental design are the basic designs in real world study, while the latter usually refers to pragmatic randomized controlled trial and registry-based randomized controlled trial. Other nonrandomized controlled and adaptive designs can also be adopted in the RWS.

[Safety evaluation and risk control measures of Cassiae Semen].

PubMed

Zhao, Yi-Meng; Wu, Li; Zhang, Shuo; Zhang, Li; Gao, Xue-Min; Sun, Xiao-Bo; Wang, Chun

2017-11-01

In this study, the authors reviewed domestic and foreign literatures, conducted the textual research on origin and development of Cassia Semen, studied records in ancient books and ancient and modern literatures, clinical adverse reactions and relevant experimental studies in recent years, and summarized the clinical features and influencing factors related to the safety of Cassiae Semen. According to the findings,Cassia Semen's safety risks are mainly liver and kidney system damages, with the main clinical features of fatigue, anorexia, disgusting of oil, yellow urine and gray stool; digestive system injury, with the main clinical features of diarrhea, abdominal distension, nausea and loose stool; reproductive system damage, with the main clinical features of vaginal bleeding. Allergic reactions and clinical adverse events, with the main clinical features for numb mouth, itching skin, nausea and vomiting, diarrhea, wheezing and lip cyanosis were also reported. The toxicological studies on toxic components of Cassiae Semen obtusifolia were carried out through acute toxicity test, subacute toxicity test, subchronic toxicity test and chronic toxicity test. Risk factors might include patients, compatibility and physicians. Physicians should strictly abide by the medication requirements in the Pharmacopoeia, pay attention to rational compatibility, appropriate dosage,correct usage and appropriate processing, control the dosage below 15 g to avoid excessive intake, strictly control the course of treatment to avoid accumulated poisoning caused by long-term administration. At the same time, clinicians should pay attention to the latest research progress, update the knowledge structure, quickly find the latest and useful materials from clinical practice, scientific research and drug information and other literatures, make evaluation and judgment for the materials, establish a traditional Chinese medicine intelligence information library, and strengthen the control over adverse effects with a pre-warning consciousness. The authors suggested standardizing clinical medication of Cassiae Semen, and avoiding misuse or excessive use; clinicians should prescribe it in strict accordance with there commended usage and dosage in the Pharmacopoeia, and focus on the safety signal accumulation in clinic, while strengthening studies for toxic substance basis and toxicity mechanism, in order to give full play to Cassiae Semen's clinical efficacy and reduce its adverse reactions. Copyright© by the Chinese Pharmaceutical Association.

The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries.

PubMed

Dalgard, Florence J; Gieler, Uwe; Tomas-Aragones, Lucia; Lien, Lars; Poot, Francoise; Jemec, Gregor B E; Misery, Laurent; Szabo, Csanad; Linder, Dennis; Sampogna, Francesca; Evers, Andrea W M; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Kupfer, Jörg

2015-04-01

The contribution of psychological disorders to the burden of skin disease has been poorly explored, and this is a large-scale study to ascertain the association between depression, anxiety, and suicidal ideation with various dermatological diagnoses. This international multicenter observational cross-sectional study was conducted in 13 European countries. In each dermatology clinic, 250 consecutive adult out-patients were recruited to complete a questionnaire, reporting socio-demographic information, negative life events, and suicidal ideation; depression and anxiety were assessed with the Hospital Anxiety and Depression Scale. A clinical examination was performed. A control group was recruited among hospital employees. There were 4,994 participants--3,635 patients and 1,359 controls. Clinical depression was present in 10.1% patients (controls 4.3%, odds ratio (OR) 2.40 (1.67-3.47)). Clinical anxiety was present in 17.2% (controls 11.1%, OR 2.18 (1.68-2.82)). Suicidal ideation was reported by 12.7% of all patients (controls 8.3%, OR 1.94 (1.33-2.82)). For individual diagnoses, only patients with psoriasis had significant association with suicidal ideation. The association with depression and anxiety was highest for patients with psoriasis, atopic dermatitis, hand eczema, and leg ulcers. These results identify a major additional burden of skin disease and have important clinical implications.

The Psychological Burden of Skin Diseases: A Cross-Sectional Multicenter Study among Dermatological Out-Patients in 13 European Countries

PubMed Central

Dalgard, Florence J; Gieler, Uwe; Tomas-Aragones, Lucia; Lien, Lars; Poot, Francoise; Jemec, Gregor B E; Misery, Laurent; Szabo, Csanad; Linder, Dennis; Sampogna, Francesca; Evers, Andrea W M; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Kupfer, Jörg

2015-01-01

The contribution of psychological disorders to the burden of skin disease has been poorly explored, and this is a large-scale study to ascertain the association between depression, anxiety, and suicidal ideation with various dermatological diagnoses. This international multicenter observational cross-sectional study was conducted in 13 European countries. In each dermatology clinic, 250 consecutive adult out-patients were recruited to complete a questionnaire, reporting socio-demographic information, negative life events, and suicidal ideation; depression and anxiety were assessed with the Hospital Anxiety and Depression Scale. A clinical examination was performed. A control group was recruited among hospital employees. There were 4,994 participants––3,635 patients and 1,359 controls. Clinical depression was present in 10.1% patients (controls 4.3%, odds ratio (OR) 2.40 (1.67–3.47)). Clinical anxiety was present in 17.2% (controls 11.1%, OR 2.18 (1.68–2.82)). Suicidal ideation was reported by 12.7% of all patients (controls 8.3%, OR 1.94 (1.33–2.82)). For individual diagnoses, only patients with psoriasis had significant association with suicidal ideation. The association with depression and anxiety was highest for patients with psoriasis, atopic dermatitis, hand eczema, and leg ulcers. These results identify a major additional burden of skin disease and have important clinical implications. PMID:25521458

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

PubMed

Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

2009-08-01

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

Circadian Genes and Risk for Prostate Cancer

DTIC Science & Technology

2011-09-01

placebo-controlled clinical trial to determine if finasteride (an inhibitor of androgen bioactivation) could prevent prostate cancer. In Year 3 of the...risk. Our study is nested within the Prostate Cancer Prevention Trial (PCPT), a randomized placebo-controlled clinical trial to determine if finasteride

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma.

PubMed

Woodcock, Ashley; Bakerly, Nawar Diar; New, John P; Gibson, J Martin; Wu, Wei; Vestbo, Jørgen; Leather, David

2015-12-10

Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings. The Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors. Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data. The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings. Clinicaltrials.gov, NCT01706198; 04 October 2012.

Impact of clinical pharmacist intervention in anticoagulation clinic in Sudan.

PubMed

Ahmed, Nahid Osman; Osman, Bashier; Abdelhai, Yassein Mohamed; El-Hadiyah, Tariq Muhammed Hashim

2017-08-01

Background Many trials have compared anticoagulation management provided by a pharmacist led anticoagulation clinic versus usual physician care showing the role for clinical pharmacist in the management of anticoagulant therapy, and demonstrating excellent outcomes. In Sudan, there is no published research evaluating the role of pharmacist in providing pharmaceutical care for patients taking warfarin. Objective The objective of the study is to assess the role of clinical pharmacist intervention in warfarin patients compared to usual medical care. Setting This study was conducted in Ahmed Gasim cardiac surgery and renal transplant center warfarin clinic. Methods One hundred thirty-five patients were randomly selected from adult patients on warfarin therapy The history of INR records, and adverse effects for the past year, were recorded. Then patients' warfarin dose adjustments according to INR, was done by the clinical pharmacist for one year. Patients received continuous verbal education and written information about warfarin. Main outcome measure The primary outcome for this study was the INR control, while the secondary outcomes were the bleeding events and hospitalization due to warfarin. Results After the clinical pharmacist intervention there was significant (P < 0.01) improvement in INR control and a significant (P < 0.05) reduction in incidence of bleeding after clinical pharmacist intervention. Hospitalization due to warfarin related complications (bleeding, high INR, low INR) was also significantly (P < 0.001) reduced. Conclusion Clinical pharmacists intervention in warfarin therapy improve INR control, reduce bleeding and hospitalization due to warfarin complications.

Supporting the patient's role in guideline compliance: a controlled study.

PubMed

Rosenberg, Stephen N; Shnaiden, Tatiana L; Wegh, Arnold A; Juster, Iver A

2008-11-01

Clinical messages alerting physicians to gaps in the care of specific patients have been shown to increase compliance with evidence-based guidelines. This study sought to measure any additional impact on compliance when alerting messages also were sent to patients. For alerts that were generated by computerized clinical rules applied to claims, compliance was determined by subsequent claims evidence (eg, that recommended tests were performed). Compliance was measured in the baseline year and the study year for 4 study group employers (combined membership >100,000) that chose to add patient messaging in the study year, and 28 similar control group employers (combined membership >700,000) that maintained physician messaging but did not add patient messaging. The impact of patient messaging was assessed by comparing changes in compliance from baseline to study year in the 2 groups. Multiple logistic regression was used to control for differences between the groups. Because a given member or physician could receive multiple alerts, generalized estimating equations with clustering by patient and physician were used. Controlling for differences in age, sex, and the severity and types of clinical alerts between the study and control groups, the addition of patient messaging increased compliance by 12.5% (P <.001). This increase was primarily because of improved responses to alerts regarding the need for screening, diagnostic, and monitoring tests. Supplementing clinical alerts to physicians with messages directly to their patients produced a statistically significant increase in compliance with the evidence-based guidelines underlying the alerts.

Integrating evidence-based teaching into to clinical practice should improve outcomes.

PubMed

Richards, Derek

2005-01-01

Sources used were Medline, Embase, the Education Resources Information Centre , Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, Health Technology Assessment database, Best Evidence, Best Evidence Medical Education and Science Citation Index, along with reference lists of known systematic reviews. Studies were chosen for inclusion if they evaluated the effects of postgraduate evidence-based medicine (EBM) or critical appraisal teaching in comparison with a control group or baseline before teaching, using a measure of participants' learning achievements or patients' health gains as outcomes. Articles were graded as either level 1 (randomised controlled trials (RCT)) or level 2 (non-randomised studies that either had a comparison with a control group), or a before and after comparison without a control group. Learning achievement was assessed separately for knowledge, critical appraisal skills, attitudes and behaviour. Because of obvious heterogeneity in the features of individual studies, their quality and assessment tools used, a meta-analysis could not be carried out. Conclusions were weighted by methodological quality. Twenty-three relevant studies were identified, comprising four RCT, seven non-RCT, and 12 before and after comparison studies. Eighteen studies (including two RCT) evaluated a standalone teaching method and five studies (including two RCT) evaluated a clinically integrated teaching method. Standalone teaching improved knowledge but not skills, attitudes or behaviour. Clinically integrated teaching improved knowledge, skills, attitudes and behaviour. Teaching of EBM should be moved from classrooms to clinical practice to achieve improvements in substantial outcomes.

A systematic review of interventions conducted in clinical or community settings to improve dual-task postural control in older adults.

PubMed

Agmon, Maayan; Belza, Basia; Nguyen, Huong Q; Logsdon, Rebecca G; Kelly, Valerie E

2014-01-01

Injury due to falls is a major problem among older adults. Decrements in dual-task postural control performance (simultaneously performing two tasks, at least one of which requires postural control) have been associated with an increased risk of falling. Evidence-based interventions that can be used in clinical or community settings to improve dual-task postural control may help to reduce this risk. THE AIMS OF THIS SYSTEMATIC REVIEW ARE: 1) to identify clinical or community-based interventions that improved dual-task postural control among older adults; and 2) to identify the key elements of those interventions. Studies were obtained from a search conducted through October 2013 of the following electronic databases: PubMed, CINAHL, PsycINFO, and Web of Science. Randomized and nonrandomized controlled studies examining the effects of interventions aimed at improving dual-task postural control among community-dwelling older adults were selected. All studies were evaluated based on methodological quality. Intervention characteristics including study purpose, study design, and sample size were identified, and effects of dual-task interventions on various postural control and cognitive outcomes were noted. Twenty-two studies fulfilled the selection criteria and were summarized in this review to identify characteristics of successful interventions. The ability to synthesize data was limited by the heterogeneity in participant characteristics, study designs, and outcome measures. Dual-task postural control can be modified by specific training. There was little evidence that single-task training transferred to dual-task postural control performance. Further investigation of dual-task training using standardized outcome measurements is needed.

Clinical, biomechanical and morphological assessment of anterior cruciate ligament Kevlar®-based artificial prosthesis in rabbit model.

PubMed

de la Garza-Castro, Santiago; González-Rivera, Carlos E; Vílchez-Cavazos, Félix; Morales-Avalos, Rodolfo; Barrera-Flores, Francisco J; Elizondo-Omaña, Rodrigo E; Soto-Dominguez, Adolfo; Acosta-Olivo, Carlos; Mendoza-Lemus, Oscar F

2017-07-27

The aim of this study was to evaluate the clinical, biomechanical and morphological characteristics of a Kevlar®-based prosthetic ligament as a synthetic graft of the anterior cruciate ligament (ACL) in an experimental animal model in rabbits. A total of 27 knees of rabbits randomly divided into 3 groups (control, ACL excision and ACL replacement with a Kevlar® prosthesis) were analyzed using clinical, biomechanical and morphological tests at 6, 12 and 18 weeks postprocedure. The mean displacement in mechanical testing was 0.73 ± 0.06 mm, 1.58 ± 0.19 mm and 0.94 ± 0.20 mm for the control, ACL excision and ACL replacement with synthetic prosthesis groups, respectively. The results showed an improvement in the stability of the knee with the use of the Kevlar® synthetic prosthesis in the biomechanical testing (p<0.05) compared with rabbits that underwent ACL excision, in addition to displacements that were larger but comparable to that in the control group (p>0.05), between the replacement group and the control group. The histological study revealed a good morphological adaptation of the synthetic material to the knee. This study proposes a new animal model for the placement and evaluation of Kevlar®-based synthetic ACL implants. The studied prosthesis showed promising behavior in the clinical and biomechanical tests and in the histological analysis. This study lays the foundation for further basic and clinical studies of artificial ACL prostheses using this material.

A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

PubMed

Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

2007-09-01

Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

Using a claims data-based sentinel system to improve compliance with clinical guidelines: results of a randomized prospective study.

PubMed

Javitt, Jonathan C; Steinberg, Gregory; Locke, Todd; Couch, James B; Jacques, Jeffrey; Juster, Iver; Reisman, Lonny

2005-02-01

To demonstrate the potential effect of deploying a sentinel system that scans administrative claims information and clinical data to detect and mitigate errors in care and deviations from best medical practices. Members (n = 39 462; age range, 12-64 years) of a midwestern managed care plan were randomly assigned to an intervention or a control group. The sentinel system was programmed with more than 1000 decision rules that were capable of generating clinical recommendations. Clinical recommendations triggered for subjects in the intervention group were relayed to treating physicians, and those for the control group were deferred to study end. Nine hundred eight clinical recommendations were issued to the intervention group. Among those in both groups who triggered recommendations, there were 19% fewer hospital admissions in the intervention group compared with the control group (P < .001). Charges among those whose recommendations were communicated were dollar 77.91 per member per month (pmpm) lower and paid claims were dollar 68.08 pmpm lower than among controls compared with the baseline values (P = .003 for both). Paid claims for the entire intervention group (with or without recommendations) were dollar 8.07 pmpm lower than those for the entire control group. In contrast, the intervention cost dollar 1.00 pmpm, suggesting an 8-fold return on investment. Ongoing use of a sentinel system to prompt clinically actionable, patient-specific alerts generated from administratively derived clinical data was associated with a reduction in hospitalization, medical costs, and morbidity.

Should we reconsider the routine use of placebo controls in clinical research?

PubMed

Avins, Andrew L; Cherkin, Daniel C; Sherman, Karen J; Goldberg, Harley; Pressman, Alice

2012-04-27

Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

Clinical symptoms in fibromyalgia are better associated to lipid peroxidation levels in blood mononuclear cells rather than in plasma.

PubMed

Cordero, Mario D; Alcocer-Gómez, Elísabet; Cano-García, Francisco J; De Miguel, Manuel; Carrión, Angel M; Navas, Plácido; Sánchez Alcázar, José A

2011-01-01

We examined lipid peroxidation (LPO) in blood mononuclear cells (BMCs) and plasma, as a marker of oxidative damage, and its association to clinical symptoms in Fibromyalgia (FM) patients. We conducted a case-control and correlational study comparing 65 patients and 45 healthy controls. Clinical parameters were evaluated using the Fibromyalgia Impact Questionnaire (FIQ), visual analogues scales (VAS), and the Beck Depression Inventory (BDI). Oxidative stress was determined by measuring LPO in BMCs and plasma. We found increased LPO levels in BMCs and plasma from FM patients as compared to normal control (P<0.001). A significant correlation between LPO in BMCs and clinical parameters was observed (r = 0.584, P<0.001 for VAS; r = 0.823, P<0.001 for FIQ total score; and r = 0.875, P<0.01 for depression in the BDI). We also found a positive correlation between LPO in plasma and clinical symptoms (r = 0.452, P<0.001 for VAS; r = 0.578, P<0.001 for FIQ total score; and r = 0.579, P<0.001 for depression in the BDI). Partial correlation analysis controlling for age and BMI, and sex, showed that both LPO in cells and plasma were independently associated to clinical symptoms. However, LPO in cells, but not LPO in plasma, was independently associated to clinical symptoms when controlling for depression (BDI scores). The results of this study suggest a role for oxidative stress in the pathophysiology of fibromyalgia and that LPO in BMCs rather than LPO in plasma is better associated to clinical symptoms in FM.

Clinical and economic impact of clinical pharmacy service on hyperlipidemic management in Hong Kong.

PubMed

Chung, Jennifer S T; Lee, Kenneth K C; Tomlinson, Brian; Lee, Vivian W Y

2011-03-01

To assess the clinical and economic outcomes of a clinical pharmacy service (CPS) in dyslipidemic management. This was a 24-month prospective controlled trial conducted at the lipid clinic of a public hospital in Hong Kong. In the intervention group, a clinical pharmacist assessed low-density lipoprotein cholesterol (LDL-C) levels and provided recommendations in accordance to the Adult Treatment Panel III (ATP III) guidelines. Medication compliance and the proper use of drugs were assessed. Education on healthy lifestyles was reinforced. Monthly telephone follow-ups were made to check on the progress of patients. In the control group, patients received usual medical care with no pharmacist intervention. Primary outcome was the percentage of patients achieving the ATP III LDL-C goal at the end of study. The estimated cost of such service was also evaluated. A total of 300 patients were recruited into the study (150 in intervention group and 150 in control group). In the intervention group, 58.7% patients achieved LDL-C goals compared with 45.3% in the control group (P < .05). The intervention group achieved 26.4%, 17.4%, and 30.0% mean reduction in LDL-C, total cholesterol (TC), and triglycerides (TG) levels, respectively, compared with 12.6%, 6.6%, and 11.5% in the control group (P < .05). The estimated cost for this clinical service was US$385/month for a total of 600 dyslipidemic patients seen per year. The results of this study demonstrate the positive impact CPS can have on achieving treatment goals in lipid management. Similar services for other problematic conditions such as hypertension and diabetes mellitus may also be benefited by similar CPSs.

77 FR 31027 - Submission for OMB Review; Comment Request; Web-Based Assessment of the Clinical Studies Support...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

...; Comment Request; Web-Based Assessment of the Clinical Studies Support Center (CSSC) Summary: Under the... current valid OMB control number. Proposed Collection: Title: Web-Based Assessment of the Clinical Studies... Operations and Procedures (MOP); coordinating meeting space and logistics for in-person meetings, Web...

Effectiveness of clinical pathways for total knee and total hip arthroplasty: literature review.

PubMed

Kim, Stephen; Losina, Elena; Solomon, Daniel H; Wright, John; Katz, Jeffrey N

2003-01-01

Although many hospitals have implemented clinical pathways to standardize the process of care, the effectiveness of clinical pathways for total hip and knee arthroplasties has not been reviewed critically. We searched for articles comparing outcomes of total hip or knee arthroplasty for patients who were treated using clinical pathways as opposed to patients treated without these pathways. Eleven studies met criteria for inclusion. Ten used historical controls, and 1 was a randomized trial. The studies had important methodological limitations. In general, the articles showed that patients treated using pathways experienced shorter hospital stays and lower costs, with comparable clinical outcomes as compared with patients treated without clinical pathways. We concluded that clinical pathways appear successful in reducing costs and length of stay in the acute care hospital, with no compromise in patient outcomes. However, interpretation of these studies is complicated by substantial methodological limitations, particularly the use of historical controls and failure to account for length of stay in rehabilitation facilities. Copyright 2003, Elsevier Science (USA). All rights reserved.

Translational medicine in the field of ablative fractional laser (AFXL)-assisted drug delivery: A critical review from basics to current clinical status.

PubMed

Haedersdal, Merete; Erlendsson, Andrés M; Paasch, Uwe; Anderson, R Rox

2016-05-01

Ablative fractional lasers enhance uptake of topical therapeutics and the concept of fractional laser-assisted drug delivery has now been taken into clinical practice. We systematically reviewed preclinical data and clinical evidence for fractional lasers to enhance drug uptake and improve clinical efficacy. We searched PubMed and Embase databases; 34 articles met the inclusion criteria. Studies were categorized into experimental preclinical studies and clinical trials, the latter graded according to level of evidence. All preclinical trials (n = 16) documented enhanced topical drug uptake into skin after ablative fractional laser treatment. Clinical evidence encompassed 18 studies, of which 9 were randomized controlled trials and 2 were controlled trials, examining neoplastic lesions, photodamaged skin, scars, onychomycosis, and topical anesthetics. The highest level of evidence was reached for actinic keratoses treated with methylaminolevulinate for photodynamic therapy (level IB, 5 randomized controlled trials), substantiating superior and long-lasting efficacy versus conventional photodynamic therapy. No adverse events were reported, but ablative fractional laser-assisted drug delivery implies risks of systemic drug absorption, especially when performed over large skin areas. Fractional laser-assisted drug delivery is beneficial in enhancing preclinical and clinical outcomes for certain skin conditions. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Clinical Trials of Aspirin Treatment After Desensitization in Aspirin-Exacerbated Respiratory Disease.

PubMed

Kowalski, Marek L; Wardzyńska, Aleksandra; Makowska, Joanna S

2016-11-01

The clinical efficacy of aspirin treatment after desensitization in patients with respiratory disease exacerbated by nonsteroidal anti-inflammatory drugs has been documented in observational studies and in double-blind placebo-controlled trials. There is no general agreement with regard to the optimal maintenance dose or duration of treatment with acetylsalicylic acid after desensitization, thus further studies are necessary to offer clear guidelines to clinicians. This article summarizes data from noncontrolled, active-control, and placebo-controlled trials assessing clinical effectiveness and reporting on safety of treatment with acetylsalicylic acid in desensitized patients with respiratory disease exacerbated by nonsteroidal anti-inflammatory drugs. Copyright © 2016 Elsevier Inc. All rights reserved.

The impact of gender on asthma in the daily clinical practice.

PubMed

Ciprandi, Giorgio; Gallo, Fabio

2018-03-01

It is up-to-date to consider the potential gender impact on a disease. There are few data about gender difference in asthma. Therefore, the present cross-sectional study tested this hypothesis in a real-life setting to investigate possible difference between genders. This study was cross-sectional, considering 554 consecutive outpatients suspected of asthma, who were referred for a first specialist visit. Clinical and functional parameters were evaluated. Females with asthma could have a worse perception of asthma control, assessed by asthma control test (ACT), and more anxiety than asthmatic males. However, there was no difference regarding asthma control grading, asthma severity, and asthma medication use between genders; the differences in lung function were without clinical relevance. In the daily clinical practice, it is relevant to consider gender in the management of asthma.

Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

2007-01-01

We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

Knowledge, compliance with good clinical practices and barriers to effective control of postoperative pain among nurses from hospitals with and without a "Hospital without Pain" certificate.

PubMed

Tomaszek, Lucyna; Dębska, Grażyna

2018-04-01

(i) To compare knowledge and compliance with good clinical practices regarding control of postoperative pain among nurses employed at hospitals with and without a "Hospital without Pain" certificate, (ii) to identify the determinants of nurses' knowledge and (iii) to define barriers to effective control of postoperative pain. Only a slight improvement in postoperative pain control has been observed recently, if any. Implementation of good clinical practices in the control of postoperative pain requires involvement of nurses. A cross-sectional study. The study included 257 nurses from hospitals with a "Hospital without Pain" certificate and 243 nurses from noncertified hospitals, with mean job seniority of 17.6 ± 9.6 years. All respondents answered 26 questions regarding postoperative pain control-related issues. Based on the answers, overall scores were calculated for (i) nurses' knowledge, (ii) compliance with good clinical practices and (iii) barriers to effective control of postoperative pain. Nurses from the certified hospitals presented with significantly higher levels of knowledge and compliance with good clinical practices and identified significantly more barriers to effective control of postoperative pain. Apart from certification of a hospital, better knowledge of postoperative pain control was determined by higher education, participation in postgraduate training programmes and other relevant courses, self-education from medical journals, employment at paediatric ward or intensive care unit. The most commonly reported barriers to effective control of pain included too low doses of painkillers prescribed by physicians and inability to modify the protocol of pain treatment by the nurse. Control of postoperative pain can be improved by enrolling nurses in various forms of continuous training and by providing them with greater autonomy in administering painkillers to surgical patients. Better quality of care offered to patients with postoperative pain can be achieved by continuous education of nurses and physicians, and greater compliance with relevant good clinical practices. © 2017 John Wiley & Sons Ltd.

Learning from high risk industries may not be straightforward: a qualitative study of the hierarchy of risk controls approach in healthcare.

PubMed

Liberati, Elisa G; Peerally, Mohammad Farhad; Dixon-Woods, Mary

2018-02-01

Though healthcare is often exhorted to learn from 'high-reliability' industries, adopting tools and techniques from those sectors may not be straightforward. We sought to examine the hierarchies of risk controls approach, used in high-risk industries to rank interventions according to supposed effectiveness in reducing risk, and widely advocated as appropriate for healthcare. Classification of risk controls proposed by clinical teams following proactive detection of hazards in their clinical systems. Classification was based on a widely used hierarchy of controls developed by the US National Institute for Occupational Safety and Health (NIOSH). A range of clinical settings in four English NHS hospitals. The four clinical teams in our study planned a total of 42 risk controls aimed at addressing safety hazards. Most (n = 35) could be classed as administrative controls, thus qualifying among the weakest type of interventions according to the HoC approach. Six risk controls qualified as 'engineering' controls, i.e. the intermediate level of the hierarchy. Only risk control qualified as 'substitution', classified as the strongest type of intervention by the HoC. Many risk controls introduced by clinical teams may cluster towards the apparently weaker end of an established hierarchy of controls. Less clear is whether the HoC approach as currently formulated is useful for the specifics of healthcare. Valuable opportunities for safety improvement may be lost if inappropriate hierarchical models are used to guide the selection of patient safety improvement interventions. Though learning from other industries may be useful, caution is needed. © The Author(s) 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

Impact on seniors of the patient-centered medical home: evidence from a pilot study.

PubMed

Fishman, Paul A; Johnson, Eric A; Coleman, Kathryn; Larson, Eric B; Hsu, Clarissa; Ross, Tyler R; Liss, David; Tufano, James; Reid, Robert J

2012-10-01

To assess the impact on health care cost and quality among seniors of a patient-centered medical home (PCMH) pilot at Group Health Cooperative, an integrated health care system in Washington State. A prospective before-and-after evaluation of the experience of seniors receiving primary care services at 1 pilot clinic compared with seniors enrolled at the remaining 19 primary care clinics owned and operated by Group Health. Analyses of secondary data on quality and cost were conducted for 1,947 seniors in the PCMH clinic and 39,396 seniors in the 19 control clinics. Patient experience with care was based on survey data collected from 487 seniors in the PCMH clinic and of 668 in 2 specific control clinics that were selected for their similarities in organization and patient composition to the pilot clinic. After adjusting for baseline, seniors in the PCMH clinic reported higher ratings than controls on 3 of 7 patient experience scales. Seniors in the PCMH clinic had significantly greater quality outcomes over time, but this difference was not significant relative to control. PCMH patients used more e-mail, phone, and specialist visits but fewer emergency services and inpatient admissions for ambulatory care sensitive conditions. At 1 and 2 years, the PCMH and control clinics did not differ significantly in overall costs. A PCMH redesign can be associated with improvements in patient experience and quality without increasing overall cost.

Effects of lifestyle education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial.

PubMed

Adachi, Misa; Yamaoka, Kazue; Watanabe, Mariko; Nishikawa, Masako; Hida, Eisuke; Kobayashi, Itsuro; Tango, Toshiro

2010-11-30

The number of patients with type 2 diabetes is drastically increasing worldwide. It is a serious health problem in Japan as well. Lifestyle interventions can reduce progression from impaired glucose tolerance to type 2 diabetes, and glycemic control has been shown to improve postprandial plasma glucose levels. Moreover, several studies have suggested that continuous interventions (combined diet and exercise) can improve the plasma glucose level and reduce dosage of hypoglycemic agents.Although many interventional studies of lifestyle education for persons with diabetes in hospitals have been reported, only a few have been clinic-based studies employing an evidence-based lifestyle education program. This article describes the design of a cluster randomized controlled trial of the effectiveness of lifestyle education for patients with type 2 diabetes in clinics by registered dietitians. In Japan, general practitioners generally have their own medical clinics to provide medical care for outpatients in the community, including those with type 2 diabetes. With the collaboration of such general practitioners, the study patients were enrolled in the present study. Twenty general practitioners were randomly allocated to each provide patients for entry into either an intervention group (10) or a control group (10). In total, 200 participants will be included in the study. The intervention group will receive intensive education on lifestyle improvement related to type 2 diabetes by registered dietitians in clinics. Lifestyle education will be conducted several times during the study period. The control group will receive information on dietary intake and standard advice on glycemic control by registered dietitians. The primary endpoint is the change from the baseline value of HbA1c at 6 months. Data on health behavior and related issues will be gathered continuously over a 6-month period. This is the first study to evaluate lifestyle education in clinics by a cluster randomization trial in Japan. The proposed study will provide practical information about the usefulness of the intensive lifestyle improvement education program in primary care settings. The study was started in September 2007 and entry of subjects was completed in December 2010. Data on the effect evaluation will be available in 2011. UMIN000004049.

The efficacy and safety of neoadjuvant chemotherapy +/- letrozole in postmenopausal women with locally advanced breast cancer: a randomized phase III clinical trial.

PubMed

Mohammadianpanah, Mohammad; Ashouri, Yaghoub; Hoseini, Sare; Amadloo, Niloofar; Talei, Abdolrasoul; Tahmasebi, Sedigheh; Nasrolahi, Hamid; Mosalaei, Ahmad; Omidvari, Shapour; Ansari, Mansour; Mosleh-Shirazi, Mohammad Amin

2012-04-01

This two-arm randomized clinical study aimed to evaluate the efficacy and safety of neoadjuvant concurrent chemotherapy and letrozole in postmenopausal women with locally advanced breast carcinoma. One hundred and one postmenopausal women aged 50-83 years with pathologically proven locally advanced (clinical stage T3, T4 and/or N2, N3) breast cancer were randomly assigned to receive neoadjuvant chemotherapy alone (control arm, n = 51) or neoadjuvant chemotherapy concurrent with letrozole 2.5 mg (study arm, n = 50). Chemotherapy consisted of a median 4 (range 3-5) cycles of intravenous 5-fluorouracil 600 mg/m(2), doxorubicin 60 mg/m(2), and cyclophosphamide 600 mg/m(2), every three weeks. All patients subsequently underwent modified radical mastectomy approximately two weeks after the last cycle of chemotherapy. Pathologic complete response rates were 25.5% and 10.2% in the study and the control group, respectively (P = 0.049). Similarly, clinical complete response rates were 27.6% and 10.2% in the study and the control group, respectively (P = 0.037). In the subgroup analysis of hormone receptor-positive cases, the complete response rates were more prominent in study group compared with control group. Common treatment-related side effects such as nausea, vomiting, bone marrow suppression, and mucositis were similar in both groups, but hot flush was more prevalent in study group compared with control group (P = 0.023). The addition of letrozole concurrently with neoadjuvant chemotherapy provides a higher clinical and pathologic response rates with acceptable toxicity compared with chemotherapy alone in postmenopausal women with locally advanced sensitive breast cancer.

Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

PubMed

Heisler, Michele; Hofer, Timothy P; Klamerus, Mandi L; Schmittdiel, Julie; Selby, Joe; Hogan, Mary M; Bosworth, Hayden B; Tremblay, Adam; Kerr, Eve A

2010-10-12

Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. The ClinicalTrials.gov registration number is NCT00495794.

The complexities of malaria disease manifestations with a focus on asymptomatic malaria

PubMed Central

2012-01-01

Malaria is a serious parasitic disease in the developing world, causing high morbidity and mortality. The pathogenesis of malaria is complex, and the clinical presentation of disease ranges from severe and complicated, to mild and uncomplicated, to asymptomatic malaria. Despite a wealth of studies on the clinical severity of disease, asymptomatic malaria infections are still poorly understood. Asymptomatic malaria remains a challenge for malaria control programs as it significantly influences transmission dynamics. A thorough understanding of the interaction between hosts and parasites in the development of different clinical outcomes is required. In this review, the problems and obstacles to the study and control of asymptomatic malaria are discussed. The human and parasite factors associated with differential clinical outcomes are described and the management and treatment strategies for the control of the disease are outlined. Further, the crucial gaps in the knowledge of asymptomatic malaria that should be the focus of future research towards development of more effective malaria control strategies are highlighted. PMID:22289302

Randomized and controlled clinical study of modified prescriptions of Simiao Pill in the treatment of acute gouty arthritis.

PubMed

Shi, Xin-de; Li, Guo-chun; Qian, Zu-xi; Jin, Ze-qiu; Song, Yan

2008-03-01

To investigate the compatibility of a modified prescription of Simiao Pill in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. A randomized and controlled clinical trial was designed based on clinical epidemiological principles. A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group I) included 27 patients taking gout prescription I; the second group (Group II) included 27 patients taking gout prescription II; the third group (Group III) included 28 patients taking gout prescription III; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured. The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%, significantly superior to that of the control group (68%, P<0.05). In terms of the improvement of main symptoms, the scores of four symptoms in all TCM treatment and control groups decreased after treatment, with statistically significant differences (P<0.05). Moreover, the scores markedly fell more so in the three Chinese herb groups than in the control group, and especially in Group III (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen. The modified prescriptions, based on the clinical research, clinical experience and traditional Chinese medicine theory, did show a better effect than Western medicine in this clinical study. Moreover, the prescriptions were precise, with the herbs inexpensive and readily available. The patients had good compliance with less adverse reactions noted. The modified prescription has a favorable prospect for future development and is worthy of further blind trials with larger samples.

Treatment of Focal Articular Cartilage Defects in the Knee

PubMed Central

Magnussen, Robert A.; Dunn, Warren R.; Carey, James L.

2008-01-01

We asked whether autologous chondrocyte implantation or osteochondral autograft transfer yields better clinical outcomes compared with one another or with traditional abrasive techniques for treatment of isolated articular cartilage defects and whether lesion size influences this clinical outcome. We performed a literature search and identified five randomized, controlled trials and one prospective comparative trial evaluating these treatment techniques in 421 patients. The operative procedures included autologous chondrocyte implantation, osteochondral autograft transfer, matrix-induced autologous chondrocyte implantation, and microfracture. Minimum followup was 1 year (mean, 1.7 years; range, 1–3 years). All studies documented greater than 95% followup for clinical outcome measures. No technique consistently had superior results compared with the others. Outcomes for microfracture tended to be worse in larger lesions. All studies reported improvement in clinical outcome measures in all treatment groups when compared with preoperative assessment; however, no control (nonoperative) groups were used in any of the studies. A large prospective trial investigating these techniques with the addition of a control group would be the best way to definitively address the clinical questions. Level of Evidence: Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18196358

T-lymphocyte Subsets as a Prognostic Factor in a Clinical Course of Chickenpox

PubMed Central

Baljic, Rusmir; Konjo, Hadzan; Hrustemovic, Dzenana; Gazibera, Belma; Katica, Amela; Hukic, Mirsada

2017-01-01

Objective: To investigate possible prognostic values of CD4+, CD8+ T-lymphocytes, CD4/CD8 ratio to clinical course of chickenpox in immunocompetent hosts. Materials and methods: We performed a prospective study which included 69 immunocompetent patients with chickenpox who were addmited to Clinic for infectious disease, Clinical Center University of Sarajevo, in a 18 month period. All patients were divided into two groups depending on clinical presentation on admission. Patients with mild clinical form were dedicated to „outpatient” group, and patients with moderate, severe or life-threatening clinical forms were dedicated to „hospitalized” group. Also 30 healthy volunteers are included in study as a control group. We analyzed values of CD4+, CD8+ percentage, CD4/CD8 ratio with comparison to clinical course of chickenpox. All specimens were taken in acute phase of illness. Results: Values of CD4+ percentage were significantly declined in a group of hospitalized patients, compared to group of outpatients and control group. Values of CD8+ percentage were higher in a group of hospitalized patients, while CD4/CD8 values were lower in comparison to a group of outpatients and control group. Conclusion: We found significant correlation between these parameters and clinical course of chickenpox. PMID:28484347

A Simple Composite Metric for the Assessment of Glycemic Status from Continuous Glucose Monitoring Data: Implications for Clinical Practice and the Artificial Pancreas.

PubMed

Hirsch, Irl B; Balo, Andrew K; Sayer, Kevin; Garcia, Arturo; Buckingham, Bruce A; Peyser, Thomas A

2017-06-01

The potential clinical benefits of continuous glucose monitoring (CGM) have been recognized for many years, but CGM is used by a small fraction of patients with diabetes. One obstacle to greater use of the technology is the lack of simplified tools for assessing glycemic control from CGM data without complicated visual displays of data. We developed a simple new metric, the personal glycemic state (PGS), to assess glycemic control solely from continuous glucose monitoring data. PGS is a composite index that assesses four domains of glycemic control: mean glucose, glycemic variability, time in range and frequency and severity of hypoglycemia. The metric was applied to data from six clinical studies for the G4 Platinum continuous glucose monitoring system (Dexcom, San Diego, CA). The PGS was also applied to data from a study of artificial pancreas comparing results from open loop and closed loop in adolescents and in adults. The new metric for glycemic control, PGS, was able to characterize the quality of glycemic control in a wide range of study subjects with various mean glucose, minimal, moderate, and excessive glycemic variability and subjects on open loop versus closed loop control. A new composite metric for the assessment of glycemic control based on CGM data has been defined for use in assessing glycemic control in clinical practice and research settings. The new metric may help rapidly identify problems in glycemic control and may assist with optimizing diabetes therapy during time-constrained physician office visits.

Randomized clinical trial comparing ceftiofur hydrochloride with a positive control protocol for intramammary treatment of nonsevere clinical mastitis in dairy cows.

PubMed

Cortinhas, Cristina Simões; Tomazi, Tiago; Zoni, Mário Sérgio Ferreira; Moro, Elio; Veiga Dos Santos, Marcos

2016-07-01

The objective of this study was to compare ceftiofur hydrochloride with a positive control protocol for intramammary treatment of nonsevere clinical mastitis in dairy cows. A total of 264 clinical mastitis cases on 11 commercial dairy farms were treated with intramammary infusions, once a day for 4 d using 1 of 2 treatments: (1) ceftiofur hydrochloride 125mg; or (2) control: tetracycline 200mg + neomycin 250mg + bacitracin 28mg + prednisolone 10mg. Streptococcus agalactiae was the most frequently isolated gram-positive pathogen from clinical mastitis, followed by Staphylococcus aureus. Klebsiella spp. and Escherichia coli were the most isolated gram-negative bacteria from clinical mastitis. No significant differences were observed between treatments regarding the overall clinical cure, bacteriological cure, and new infection. No effect of treatment regimen was observed when the bacterial group (gram-positive vs. gram-negative) was evaluated. The overall clinical cure was 0.79 for ceftiofur-treated cows and 0.74 for control-treated cows, whereas the overall bacteriological cure was 0.79 for ceftiofur-treated cows and 0.76 for control-treated cows. Furthermore, the new intramammary infection was 0.10 for cows treated with ceftiofur and 0.11 for cows treated with control. In conclusion, the use of intramammary ceftiofur hydrochloride for treatment of nonsevere clinical mastitis has similar efficacy as a treatment regimen with a combination of antimicrobial agents (tetracycline + neomycin + bacitracin). Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

A systematic review of interventions conducted in clinical or community settings to improve dual-task postural control in older adults

PubMed Central

Agmon, Maayan; Belza, Basia; Nguyen, Huong Q; Logsdon, Rebecca G; Kelly, Valerie E

2014-01-01

Background Injury due to falls is a major problem among older adults. Decrements in dual-task postural control performance (simultaneously performing two tasks, at least one of which requires postural control) have been associated with an increased risk of falling. Evidence-based interventions that can be used in clinical or community settings to improve dual-task postural control may help to reduce this risk. Purpose The aims of this systematic review are: 1) to identify clinical or community-based interventions that improved dual-task postural control among older adults; and 2) to identify the key elements of those interventions. Data sources Studies were obtained from a search conducted through October 2013 of the following electronic databases: PubMed, CINAHL, PsycINFO, and Web of Science. Study selection Randomized and nonrandomized controlled studies examining the effects of interventions aimed at improving dual-task postural control among community-dwelling older adults were selected. Data extraction All studies were evaluated based on methodological quality. Intervention characteristics including study purpose, study design, and sample size were identified, and effects of dual-task interventions on various postural control and cognitive outcomes were noted. Data synthesis Twenty-two studies fulfilled the selection criteria and were summarized in this review to identify characteristics of successful interventions. Limitations The ability to synthesize data was limited by the heterogeneity in participant characteristics, study designs, and outcome measures. Conclusion Dual-task postural control can be modified by specific training. There was little evidence that single-task training transferred to dual-task postural control performance. Further investigation of dual-task training using standardized outcome measurements is needed. PMID:24741296

Feasibility of studying brain morphology in major depressive disorder with structural magnetic resonance imaging and clinical data from the electronic medical record: A pilot study

PubMed Central

Hoogenboom, Wouter S.; Perlis, Roy H.; Smoller, Jordan W.; Zeng-Treitler, Qing; Gainer, Vivian S.; Murphy, Shawn N.; Churchill, Susanne E.; Kohane, Isaac S.; Shenton, Martha E.; Iosifescu, Dan V.

2012-01-01

For certain research questions related to long-term outcomes or to rare disorders, designing prospective studies is impractical or prohibitively expensive. Such studies could instead utilize clinical and magnetic resonance imaging data (MRI) collected as part of routine clinical care, stored in the electronic medical record (EMR). Using major depressive disorder (MDD) as a disease model, we examined the feasibility of studying brain morphology and associations with remission using clinical and MRI data exclusively drawn from the EMR. Advanced automated tools were used to select MDD patients and controls from the EMR who had brain MRI data, but no diagnosed brain pathology. MDD patients were further assessed for remission status by review of clinical charts. Twenty MDD patients (eight full-remitters, six partial-remitters, and six non-remitters), and fifteen healthy control subjects met all study criteria for advanced morphometric analyses. Compared to controls, MDD patients had significantly smaller right rostral-anterior cingulate volume, and level of non-remission was associated with smaller left hippocampus and left rostral-middle frontal gyrus volume. The use of EMR data for psychiatric research may provide a timely and cost-effective approach with the potential to generate large study samples reflective of the real population with the illness studied. PMID:23149041

Evaluation and implementation of highly challenging balance training in clinical practice for people with Parkinson's disease: protocol for the HiBalance effectiveness-implementation trial.

PubMed

Leavy, Breiffni; Kwak, Lydia; Hagströmer, Maria; Franzén, Erika

2017-02-07

If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented. The HiBalance program is systemically designed to target balance impairments in PD and has been shown effective at improving balance control and gait in a previous RCT. Study aims are to i) determine the effectiveness of the adapted HiBalance program on performance and self-rated outcomes such as balance control, gait and physical activity level ii) conduct a process evaluation of program implementation at the various clinics iii) determine barriers and facilitators to program implementation in these settings. This effectiveness-implementation type 1 hybrid study will use a non-randomized controlled design with consecutive inclusion of people with PD at multiple clinical sites. A mixed method approach will be used to collect clinical effectiveness data and process evaluation data which is both quantitative and qualitative in nature. The consolidated framework for implementation research (CFIR) will be used to guide the planning and collection of data concerning implementation barriers and facilitators. The HiBalance program will be provided by physical therapists as a part of standard rehabilitation care at the clinical sites, while the evaluation of the implementation process will be performed by the research group and funded by research grants. An effectiveness-implementation study design benefits patients by speeding up the process of translating findings from research settings to routine health care. Findings from this study will also be highly relevant for those working with neurological rehabilitation when faced with decisions concerning the translation of training programs from efficacy studies to everyday clinical practice. ClinicalTrials.gov march 2016, NCT02727478 .

Adjunctive Effects of A Piscean Collagen-Based Controlled-Release Chlorhexidine Chip in the Treatment of Chronic Periodontitis: A Clinical and Microbiological Study

PubMed Central

John, Priya; Lazarus, Flemingson; Selvam, Arul; Prabhuji, Munivenkatappa Lakshmaiah Venkatesh

2015-01-01

Introduction PerioChip a bovine origin gelatine based CHX chip has shown beneficial effects in the management of Chronic Periodontitis. A new fish collagen based CHX chip similar to PerioChip is currently available; however this product has not been thoroughly researched. Aim The aim of the present study was to evaluate the effectiveness of a new Piscean collagen-based controlled-release chlorhexidine chip (CHX chip) as an adjunctive therapy to scaling and root planing (SRP). Settings and Design The study was conducted as a randomised, split-mouth, controlled clinical trial at Krishnadevaraya College of Dental Sciences, Bangalore, India. Materials and Methods In a split–mouth study involving 20 sites in 10 patients with chronic periodontitis, control sites received scaling and root planing and test sites received scaling and root planing (SRP) and the intrapocket CHX chip placement as an adjunct. Subgingival plaque samples were collected from both control and test sites at baseline, 11 days and 11 weeks and the anaerobic colony count were assessed. Clinical parameters that were recorded at baseline and 11 weeks were gingival index, Plaque index, Probing pocket depth (PPD), and Clinical attachment level (CAL). Plaque index was recorded additionally at 11 days. Results In the test group there was a statistically significant reduction in the total anaerobic colony count, gingival index and plaque scores from baseline as compared to control sites at all time intervals. An additional 0.8mm reduction in mean probing pocket depth was noted in the test group. Gain in Clinical attachment level was comparable in both groups. Conclusion The adjunctive use of the new collagen-based CHX chip yielded significant antimicrobial benefit accompanied by a reduction in probing depth and a clinical attachment level gain as compared to SRP alone. This suggests that it may be a useful treatment option of nonsurgical periodontal treatment of chronic periodontitis. PMID:26155567

Impact of Clinical Factors on the Achievement of Target Blood Pressure in Hypertensive Patients from Ivanovo Region of Russia: Data of 2015.

PubMed

Kiselev, A R; Posnenkova, O M; Belova, O A; Romanchuk, S V; Popova, Y V; Prokhorov, M D; Gridnev, V I

2017-12-01

In Russia, blood pressure (BP) control is below the optimal. The little is known about regional features and barriers to adequate BP control in Russian primary care. To evaluate the impact of clinical factors on achieving the target BP in hypertensive patients in one region of Russia. Retrospective medical data of 2015 on 11,129 patients (31.4% male) with hypertension (Htn) from Ivanovo region of Russia were examined. Achievement of target BP was assessed in all patients. We study association between BP control and clinical factors. 45.9% of studied patients with Htn had controlled BP. The frequency of achieving the target BP in subsets of hypertensive patients was 37.8% in patients with diabetes, 39.5% in patients with coronary artery disease, and 29.9% in patients with chronic heart failure. The main clinical factors associated with achieving the target BP in studied hypertensive patients were the advice on alcohol consumption, advice on smoking cessation, and advice on weight reduction. Therapy with main antihypertensive drugs (in particular, beta-blockers and thiazide diuretics) were also factors of optimal BP control in these patients. Comorbidities (chronic heart failure and cardiovascular diseases requiring the prescription of aspirin and statins) and family history of coronary artery disease were associated with inadequate BP control. A negative effect of some antihypertensive drugs (potassium sparing diuretics, ARBs, ACE-Is, and dihydropyridine CCBs) on BP control that was found out in our study requires further investigation. Other studied factors had no influence on BP control in patients with Htn from Ivanovo region. We identified regional factors of BP control in hypertensive patients from Ivanovo region of Russia. It is shown that individual medical education (in particular, medical advices) is the most important factor of optimal BP control. The intervention with antihypertensive therapy (beta-blockers and thiazide diuretics) facilitates the achievement of target BP. Comorbidity and age reduce the frequency of achieving the target BP.

Usefulness of a topical combination of dinotefuran and pyriproxyfen for long-term control of clinical signs of allergic dermatitis in privately-owned cats in Ile-de-France region.

PubMed

Crosaz, Odile; Bonati, Silvia; Briand, Amaury; Chapelle, Elodie; Cochet-Faivre, Noëlle; Ka, Diane; Darmon-Hadjaje, Céline; Varloud, Marie; Guillot, Jacques

2017-08-23

The present study assessed the activity of a combination of dinotefuran and pyriproxyfen (Vectra® Felis) for long-term control (3 months) of allergic dermatitis (AD) in privately-owned cats under common household conditions in Ile-de-France region. This was an open pre-treatment vs post-treatment study. Twenty-eight client-owned cats with clinical signs of AD were enrolled in the study. They received topical application of the combination of dinotefuran and pyriproxyfen on days 0, 28, 56 and 84. Two parameters (clinical signs and pruritus severity) were used to assess the animals' condition on days 0, 28 and 84. Fleas were counted if they were observed. Of the 28 cats initially enrolled, 26 were presented on day 28 and 20 for the final evaluation on day 84. A significant improvement in clinical signs and pruritus was observed in cats for which fleas and/or flea feces were detected on day 0. Globally, the post-treatment AD clinical scores on days 28 and 84 were different from that of the pre-treatment on day 0, with a reduction of 30% and 71%, respectively. For cats with fleas and/or flea feces, the reduction on days 28 and 84 was 33% and 85%, respectively. The improvement of clinical signs and pruritus was not significant in cats with no visible fleas and no flea feces at the beginning of the trial (n = 8). The present study indicated that the treatment with a combination of dinotefuran and pyriproxyfen should be considered as useful in controlling fleas on cats without additional environmental treatment and useful for long-term control of clinical signs and pruritus in allergic cats.

Reduced Specificity of Autobiographical Memory and Depression

PubMed Central

Dalgleish, Tim; Williams, J. Mark G.; Golden, Ann-Marie J.; Perkins, Nicola; Barrett, Lisa Feldman; Barnard, Phillip J.; Yeung, Cecilia Au; Murphy, Victoria; Elward, Rachael; Tchanturia, Kate; Watkins, Edward

2007-01-01

It has been widely established that depressed mood states and clinical depression, as well as a range of other psychiatric disorders, are associated with a relative difficulty in accessing specific autobiographical information in response to emotion-related cue words on an Autobiographical Memory Test (AMT; J. M. G. Williams & K. Broadbent, 1986). In 8 studies the authors examined the extent to which this relationship is a function of impaired executive control associated with these mood states and clinical disorders. Studies 1–4 demonstrated that performance on the AMT is associated with performance on measures of executive control, independent of depressed mood. Furthermore, Study 1 showed that executive control (as measured by verbal fluency) mediated the relationship between both depressed mood and a clinical diagnosis of eating disorder and AMT performance. Using a stratified sample in Study 5, the authors confirmed the positive association between depressed mood and impaired performance on the AMT. Studies 6–8 involved experimental manipulations of the parameters of the AMT designed to further indicate that reduced executive control is to a significant extent driving the relationship between depressed mood and AMT performance. The potential role of executive control in accounting for other aspects of the AMT literature is discussed. PMID:17324083

Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study.

PubMed

Demarzo, Marcelo; Montero-Marin, Jesus; Puebla-Guedea, Marta; Navarro-Gil, Mayte; Herrera-Mercadal, Paola; Moreno-González, Sergio; Calvo-Carrión, Sandra; Bafaluy-Franch, Laura; Garcia-Campayo, Javier

2017-01-01

Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI) programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population. Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively). Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed. Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience. Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both programmes performed better than controls, with similar effect size (ES). The efficacy of abbreviated mindfulness programmes may be similar to that of a standard MBI programme, making them potentially more accessible for a larger number of populations. Nevertheless, further studies with more powerful designs to compare the non-inferiority of the abbreviated protocol and addressing clinical populations are warranted. Clinical Trials.gov Registration ID: NCT02643927.

Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study

PubMed Central

Demarzo, Marcelo; Montero-Marin, Jesus; Puebla-Guedea, Marta; Navarro-Gil, Mayte; Herrera-Mercadal, Paola; Moreno-González, Sergio; Calvo-Carrión, Sandra; Bafaluy-Franch, Laura; Garcia-Campayo, Javier

2017-01-01

Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI) programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population. Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively). Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed. Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience. Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both programmes performed better than controls, with similar effect size (ES). The efficacy of abbreviated mindfulness programmes may be similar to that of a standard MBI programme, making them potentially more accessible for a larger number of populations. Nevertheless, further studies with more powerful designs to compare the non-inferiority of the abbreviated protocol and addressing clinical populations are warranted. Clinical Trials.gov Registration ID: NCT02643927 PMID:28848465

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

PubMed

Klein, Jan Philipp; Gamon, Carla; Späth, Christina; Berger, Thomas; Meyer, Björn; Hohagen, Fritz; Hautzinger, Martin; Lutz, Wolfgang; Vettorazzi, Eik; Moritz, Steffen; Schröder, Johanna

2017-07-13

This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. The study takes place in five diagnostic centres in Germany. A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. ClinicalTrials.gov NCT01636752. © 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.

Neurocognitive function in clinically stable individuals with long-term bipolar I disorder: Comparisons with schizophrenia patients and controls.

PubMed

Lin, Pei-Yun; Wang, Peng-Wei; Chen, Cheng-Sheng; Yen, Cheng-Fang

2017-05-01

This study compared the levels of the five domains of neurocognitive function-executive function, attention, memory, verbal comprehension, and perceptual organization-among clinically stable individuals with long-term bipolar I disorder, individuals with long-term schizophrenia, and a group of controls. We recruited a total of 93 clinically stable individuals with bipolar I disorder, 94 individuals with schizophrenia, and 106 controls in this study. Their neurocognitive function was measured using a series of neurocognitive function tests: the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III), Line Cancellation Test, Visual Form Discrimination, Controlled Oral Word Association Test, Wisconsin Card Sorting Test, Continuous Performance Task, and Wechsler Memory Scale-Third Edition. Neurocognitive function was compared among the three groups through a multivariate analysis of variance. The results indicated that when the effect of age was controlled, clinically stable individuals with bipolar I disorder and those with schizophrenia demonstrated poor neurocognitive function on all tests except for the WAIS-III Similarity and Information and the Line Cancellation Test. The individuals with bipolar I disorder had similar levels of neurocognitive function compared with the schizophrenia group, but higher levels of neurocognitive function on the WAIS-III Comprehension, Controlled Oral Word Association Test, and Wechsler Memory Scale-Third Edition Auditory Immediate and Delayed Index and Visual Immediate and Delayed Index. The conclusions of this study suggest that compared with controls, individuals with long-term bipolar I disorder and those with long-term schizophrenia have poorer neurocognitive function, even when clinically stable. Individuals with long-term bipolar I disorder and those with long-term schizophrenia have similar levels of deficits in several domains of neurocognitive function. Copyright © 2017. Published by Elsevier Taiwan.

Multiple large solar lentigos on the upper back as clinical markers of past severe sunburn: a case-control study.

PubMed

Derancourt, C; Bourdon-Lanoy, E; Grob, J-J; Guillaume, J-C; Bernard, P; Bastuji-Garin, S

2007-01-01

Multiple solar lentigos commonly seen on the upper back and shoulders of adults are classically considered as a sign of photodamage, although epidemiological studies are scarce. To assess whether these lesions are clinical markers of past severe sunburn. A case-control study in two outpatient dermatology clinics in French university hospitals. Past episodes of moderate and severe sunburn were compared between 145 adult patients with multiple solar lentigos on the upper back and 145 matched controls. In multivariate analysis adjusted for potential confounders, recalled episodes of sunburn during childhood, adolescence and adulthood were independently associated with the presence of multiple solar lentigos (adjusted odds ratios, 95% confidence intervals: 2.3 (1.1-5.2) and 28.1 (10.4-75.6) for moderate and severe sunburn, respectively). Multiple solar lentigos on the upper back and shoulders of adults are potential clinical markers of past severe sunburn which may thus be used to identify a population at higher risk of developing cutaneous malignant melanoma.

Hypnosis for procedure-related pain and distress in pediatric cancer patients: a systematic review of effectiveness and methodology related to hypnosis interventions.

PubMed

Richardson, Janet; Smith, Joanna E; McCall, Gillian; Pilkington, Karen

2006-01-01

The aim of this study was to systematically review and critically appraise the evidence on the effectiveness of hypnosis for procedure-related pain and distress in pediatric cancer patients. A comprehensive search of major biomedical and specialist complementary and alternative medicine databases was conducted. Citations were included from the databases' inception to March 2005. Efforts were made to identify unpublished and ongoing research. Controlled trials were appraised using predefined criteria. Clinical commentaries were obtained for each study. Seven randomized controlled clinical trials and one controlled clinical trial were found. Studies report positive results, including statistically significant reductions in pain and anxiety/distress, but a number of methodological limitations were identified. Systematic searching and appraisal has demonstrated that hypnosis has potential as a clinically valuable intervention for procedure-related pain and distress in pediatric cancer patients. Further research into the effectiveness and acceptability of hypnosis for pediatric cancer patients is recommended.

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

PubMed

Pinto-Fraga, José; Blázquez Arauzo, Francisco; Urbano Rodríguez, Rubén; González-García, María J

2015-01-01

To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Twenty subjects (10 women, 10 men) (mean age, 27.7±5.6 years; range, 20-41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p=0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p=0.18). The study MPDS received higher rates in comfort (study: 8.14±1.09, control: 7.94±0.92; p=0.56) and satisfaction at day 30 (study: 8.63±0.91, control: 8.29±0.80; p=0.19), however the scores were not significantly different with the control MPDS. The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

Towards Evidence-Based Practice in Language Intervention for Bilingual Children

ERIC Educational Resources Information Center

Thordardottir, Elin

2010-01-01

Evidence-based practice requires that clinical decisions be based on evidence from rigorously controlled research studies. At this time, very few studies have directly examined the efficacy of clinical intervention methods for bilingual children. Clinical decisions for this population cannot, therefore, be based on the strongest forms of research…

Sustained effect of simulation-based ultrasound training on clinical performance: a randomized trial

PubMed Central

Tolsgaard, M G; Ringsted, C; Dreisler, E; Nørgaard, L N; Petersen, J H; Madsen, M E; Freiesleben, N L C; Sørensen, J L; Tabor, A

2015-01-01

Objective To study the effect of initial simulation-based transvaginal sonography (TVS) training compared with clinical training only, on the clinical performance of residents in obstetrics and gynecology (Ob-Gyn), assessed 2 months into their residency. Methods In a randomized study, new Ob-Gyn residents (n = 33) with no prior ultrasound experience were recruited from three teaching hospitals. Participants were allocated to either simulation-based training followed by clinical training (intervention group; n = 18) or clinical training only (control group; n = 15). The simulation-based training was performed using a virtual-reality TVS simulator until an expert performance level was attained, and was followed by training on a pelvic mannequin. After 2 months of clinical training, one TVS examination was recorded for assessment of each resident's clinical performance (n = 26). Two ultrasound experts blinded to group allocation rated the scans using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. Results During the 2 months of clinical training, participants in the intervention and control groups completed an average ± SD of 58 ± 41 and 63 ± 47 scans, respectively (P = 0.67). In the subsequent clinical performance test, the intervention group achieved higher OSAUS scores than did the control group (mean score, 59.1% vs 37.6%, respectively; P < 0.001). A greater proportion of the intervention group passed a pre-established pass/fail level than did controls (85.7% vs 8.3%, respectively; P < 0.001). Conclusion Simulation-based ultrasound training leads to substantial improvement in clinical performance that is sustained after 2 months of clinical training. © 2015 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology. PMID:25580809

Effects of controlled-release formulations of atypical antipsychotics on functioning and quality of life of schizophrenic individuals.

PubMed

Ruiu, Stefania; Casu, Maria Antonietta; Casu, Gianluca; Piras, Sara; Marchese, Giorgio

2012-08-01

Controlled-release formulations of atypical antipsychotics have recently been introduced into clinical practice. Clinical studies have indicated that these new therapies induce meaningful improvements in the functioning and quality of life of schizophrenic individuals. The present analysis makes an attempt to address the clinical relevance of these studies and their contribution to the understanding of the mechanisms of action of these new drugs. A Medline search was done using the keywords 'antipsychotic', 'plasma level', 'quality of life' and 'functioning'. After reviewing the literature, it seems that symptom control and side effects may play a role in modulating the functioning and quality of life of schizophrenic individuals treated with controlled-release formulations of atypical antipsychotics. The analysis also highlights that these new drugs may possess peculiarities and similarities in regulating patient functioning. However, the low number of clinical analyses that have focused on these aspects of antipsychotic therapy limits the interpretation of the results. Additional comparative clinical trials are needed to evaluate how the pharmacokinetic/pharmacodynamic properties of antipsychotic drugs may modulate the functioning and quality of life of schizophrenic individuals, as well as to establish whether new clinical benefits may come from the use of these drugs in schizophrenia therapy.

Design and validity of a clinic-based case-control study on the molecular epidemiology of lymphoma

PubMed Central

Cerhan, James R; Fredericksen, Zachary S; Wang, Alice H; Habermann, Thomas M; Kay, Neil E; Macon, William R; Cunningham, Julie M; Shanafelt, Tait D; Ansell, Stephen M; Call, Timothy G; Witzig, Thomas E; Slager, Susan L; Liebow, Mark

2011-01-01

We present the design features and implementation of a clinic-based case-control study on the molecular epidemiology of lymphoma conducted at the Mayo Clinic (Rochester, Minnesota, USA), and then assess the internal and external validity of the study. Cases were newly diagnosed lymphoma patients from Minnesota, Iowa and Wisconsin seen at Mayo and controls were patients from the same region without lymphoma who had a pre-scheduled general medical examination, frequency matched on age, sex and residence. Overall response rates were 67% for cases and 70% for controls; response rates were lower for cases and controls over age 70 years, cases with more aggressive disease, and controls from the local area, although absolute differences were modest. Cases and controls were well-balanced on age, sex, and residence characteristics. Demographic and disease characteristics of NHL cases were similar to population-based cancer registry data. Control distributions were similar to population-based data on lifestyle factors and minor allele frequencies of over 500 SNPs, although smoking rates were slightly lower. Associations with NHL in the Mayo study for smoking, alcohol use, family history of lymphoma, autoimmune disease, asthma, eczema, body mass index, and single nucleotide polymorphisms in TNF (rs1800629), LTA (rs909253), and IL10 (rs1800896) were at a magnitude consistent with estimates from pooled studies in InterLymph, with history of any allergy the only directly discordant result in the Mayo study. These data suggest that this study should have strong internal and external validity. This framework may be useful to others who are designing a similar study. PMID:21686124

Pharmacological Treatment of Cannabis Dependence

PubMed Central

Weinstein, A.M.; Gorelick, David A.

2011-01-01

Cannabis is the most frequently used illegal psychoactive substance in the world. There is a significant increase in the number of treatment admissions for cannabis use disorders in the past few years, and the majority of cannabis-dependent individuals who enter treatment have difficulty in achieving and maintaining abstinence. Thus, there is increased need for medications that can be used to treat this population. So far, no medication has been shown broadly and consistently effective; none has been approved by any national regulatory authority. Medications studied have included those that alleviate symptoms of cannabis withdrawal (e.g., dysphoric mood, irritability), those that directly affect endogenous cannabinoid receptor function, and those that have shown efficacy in treatment of other drugs of abuse or psychiatric conditions. Buspirone is the only medication to date that has shown efficacy for cannabis dependence in a controlled clinical trial. Results from controlled human laboratory studies and small open-label clinical trials suggest that dronabinol, the COMT inhibitor entacapone, and lithium may warrant further study. Recent pre-clinical studies suggest the potential of fatty acid amide hydrolase (FAAH) inhibitors such as URB597, endocannabinoid-metabolizing enzymes, and nicotinic alpha7 receptor antagonists such as methyllycaconitine (MLA). Controlled clinical trials are needed to evaluate the clinical efficacy of these medications and to validate the laboratory models being used to study candidate medications. PMID:21524266

Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case-control study in the U.K.

PubMed

Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

2014-06-01

Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the U.K. in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. A prospective multicentre case-control study was conducted at six U.K. hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management.

PubMed

Gottrup, F; Apelqvist, J; Price, P

2010-06-01

While there is a consensus that clinical practice should be evidence based, this can be difficult to achieve due to confusion about the value of the various approaches to wound management. To address this, the European Wound Management Association (EWMA) set up a Patient Outcome Group whose remit was to produce recommendations on clinical data collection in wound care. This document, produced by the group and disseminated by JWC, identifies criteria for producing rigorous outcomes in both randomised controlled trials and clinical studies, and describes how to ensure studies are consistent and reproducible.

Symptoms of Anxiety, Depression, and Aggression in Non-Clinical Children: Relationships with Self-Report and Performance-Based Measures of Attention and Effortful Control

ERIC Educational Resources Information Center

Muris, Peter; van der Pennen, Els; Sigmond, Rianne; Mayer, Birgit

2008-01-01

This study investigated the relation between the regulative trait of effortful control, and in particular attention control, and psychopathological symptoms in a sample of 207 non-clinical children aged 8-12 years. For this purpose, children completed self-report scales for measuring regulative traits and various types of psychopathological…

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

PubMed

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

Wearable Sensors in Huntington Disease: A Pilot Study.

PubMed

Andrzejewski, Kelly L; Dowling, Ariel V; Stamler, David; Felong, Timothy J; Harris, Denzil A; Wong, Cynthia; Cai, Hang; Reilmann, Ralf; Little, Max A; Gwin, Joseph T; Biglan, Kevin M; Dorsey, E Ray

2016-06-18

The Unified Huntington's Disease Rating Scale (UHDRS) is the principal means of assessing motor impairment in Huntington disease but is subjective and generally limited to in-clinic assessments. To evaluate the feasibility and ability of wearable sensors to measure motor impairment in individuals with Huntington disease in the clinic and at home. Participants with Huntington disease and controls were asked to wear five accelerometer-based sensors attached to the chest and each limb for standardized, in-clinic assessments and for one day at home. A second chest sensor was worn for six additional days at home. Gait measures were compared between controls, participants with Huntington disease, and participants with Huntington disease grouped by UHDRS total motor score using Cohen's d values. Fifteen individuals with Huntington disease and five controls completed the study. Sensor data were successfully captured from 18 of the 20 participants at home. In the clinic, the standard deviation of step time (time between consecutive steps) was increased in Huntington disease (p < 0.0001; Cohen's d = 2.61) compared to controls. At home with additional observations, significant differences were observed in seven additional gait measures. The gait of individuals with higher total motor scores (50 or more) differed significantly from those with lower total motor scores (below 50) on multiple measures at home. In this pilot study, the use of wearable sensors in clinic and at home was feasible and demonstrated gait differences between controls, participants with Huntington disease, and participants with Huntington disease grouped by motor impairment.

[Clinical or subclinical hypothyroidism and thyroid autoantibody before 20 weeks pregnancy and risk of preterm birth: a systematic review].

PubMed

Wang, Shaowei; Li, Min; Chu, Defa; Liang, Lin; Zhao, Xiaodong; Zhang, Junrong

2014-11-01

To evaluate the relationship between clinical or subclinical hypothyroidism and positive thyroid autoantibody before 20 weeks pregnancy and risk of preterm birth. Literature search was done in PubMed, EMBASE, Wanfang Medical Database, China Academic Journal Network Publishing Database and China Biology Medicine disc databases from January 1st, 1980 to December 31th, 2013. The following search terms were used:hypothyroidism, subclinical hypothyroidism, hypothyroxinnism, thyroid antibody, preterm labor, preterm birth, etc. (1) Criteria for inclusion:cohort studies and clinical studies were included; only articles that described at least 10 patients were eligible;the exposure was clinical or subclinical hypothyroidism and positive thyroid autoantihody, and outcome was preterm birth. (2) The excluded subjects were articles that described less than 10 patients; controls were pregnant women without eurothyrodisim. Meta-analysis was performed by RevMan 5. The relationship between clinical or subclinical hypothyroidism and positive thyroid autoantibody and risk of preterm birth was evaluated by OR or RR. (1) Twenty cohort studies were enrolled. A total of 39 596 cases of preterm birth occurred among 498 418 pregnant women. The controls in these studies were pregnant women with eurothyrodisim. (2) Clinical hypothyroidism in pregnancy: eight studies were included, reported data on 478 418 pregnant women (5 473 women with clinical hypothyroidism and 472 945 euthyroid pregnant women). The risk of preterm birth in pregnant women with clinical hypothyroidism was higher than those eurothyroid pregnant women in control group (OR = 1.25, 95% CI:1.15-1.36, P < 0.01). (3) Subclinical hypothyroidism in pregnancy: ten studies were included, reported data on 277 531 pregnant women (5 257 women with subclinical hypothyroidism and 272 274 euthyroid pregnant women). The risk of preterm birth in pregnant women with subclinical hypothyroidism was higher than those in control group by random effects analysis (OR = 1.25, 95% CI:1.14-1.36, P < 0.01). (4) Thyroid autoantibodys positive in pregnancy:eleven studies were included, reported data on 28 781 pregnant women (3 036 women with thyroid autoanti body positive and 25 745 euthyroid pregnant women). The risk of preterm birth in pregnant women with positive thyroid autoantibody was higher than those negative thyroid autoantibody in control group (OR = 1.47, 95% CI: 1.27- 1.70, P < 0.01). The funnel plots presented symmetrical graphics, indicating that there was no publication bias. Clinical or subclinical hypothyroidism and positive thyroid autoantibody in pregnant women is risk factors of preterm birth.

Clinical Symptoms in Fibromyalgia Are Better Associated to Lipid Peroxidation Levels in Blood Mononuclear Cells Rather than in Plasma

PubMed Central

Cano-García, Francisco J.; De Miguel, Manuel; Carrión, Angel M.; Navas, Plácido; Sánchez Alcázar, José A.

2011-01-01

Background We examined lipid peroxidation (LPO) in blood mononuclear cells (BMCs) and plasma, as a marker of oxidative damage, and its association to clinical symptoms in Fibromyalgia (FM) patients. Methods We conducted a case–control and correlational study comparing 65 patients and 45 healthy controls. Clinical parameters were evaluated using the Fibromyalgia Impact Questionnaire (FIQ), visual analogues scales (VAS), and the Beck Depression Inventory (BDI). Oxidative stress was determined by measuring LPO in BMCs and plasma. Results We found increased LPO levels in BMCs and plasma from FM patients as compared to normal control (P<0.001). A significant correlation between LPO in BMCs and clinical parameters was observed (r = 0.584, P<0.001 for VAS; r = 0.823, P<0.001 for FIQ total score; and r = 0.875, P<0.01 for depression in the BDI). We also found a positive correlation between LPO in plasma and clinical symptoms (r = 0.452, P<0.001 for VAS; r = 0.578, P<0.001 for FIQ total score; and r = 0.579, P<0.001 for depression in the BDI). Partial correlation analysis controlling for age and BMI, and sex, showed that both LPO in cells and plasma were independently associated to clinical symptoms. However, LPO in cells, but not LPO in plasma, was independently associated to clinical symptoms when controlling for depression (BDI scores). Discussion The results of this study suggest a role for oxidative stress in the pathophysiology of fibromyalgia and that LPO in BMCs rather than LPO in plasma is better associated to clinical symptoms in FM. PMID:22046409

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Predicting healthcare employees' participation in an office redesign program: attitudes, norms and behavioral control.

PubMed

Mohr, David C; VanDeusen Lukas, Carol; Meterko, Mark

2008-11-02

The study examined the extent to which components based on a modified version of the theory of planned behavior explained employee participation in a new clinical office program designed to reduce patient waiting times in primary care clinics. We regressed extent of employee participation on attitudes about the program, group norms, and perceived behavioral control along with individual and clinic characteristics using a hierarchical linear mixed model. Perceived group norms were one of the best predictors of employee participation. Attitudes about the program were also significant, but to a lesser degree. Behavioral control, however, was not a significant predictor. Respondents with at least one year of clinic tenure, or who were team leaders, first line supervisor, or managers had greater participation rates. Analysis at the clinic level indicated clinics with scores in the highest quartile clinic scores on group norms, attitudes, and behavioral control scores were significantly higher on levels of overall participation than clinics in the lowest quartile. Findings suggest that establishing strong norms and values may influence employee participation in a change program in a group setting. Supervisory level was also significant with greater responsibility being associated with greater participation.

Comparison of virtual patient simulation with mannequin-based simulation for improving clinical performances in assessing and managing clinical deterioration: randomized controlled trial.

PubMed

Liaw, Sok Ying; Chan, Sally Wai-Chi; Chen, Fun-Gee; Hooi, Shing Chuan; Siau, Chiang

2014-09-17

Virtual patient simulation has grown substantially in health care education. A virtual patient simulation was developed as a refresher training course to reinforce nursing clinical performance in assessing and managing deteriorating patients. The objective of this study was to describe the development of the virtual patient simulation and evaluate its efficacy, by comparing with a conventional mannequin-based simulation, for improving the nursing students' performances in assessing and managing patients with clinical deterioration. A randomized controlled study was conducted with 57 third-year nursing students who were recruited through email. After a baseline evaluation of all participants' clinical performance in a simulated environment, the experimental group received a 2-hour fully automated virtual patient simulation while the control group received 2-hour facilitator-led mannequin-based simulation training. All participants were then re-tested one day (first posttest) and 2.5 months (second posttest) after the intervention. The participants from the experimental group completed a survey to evaluate their learning experiences with the newly developed virtual patient simulation. Compared to their baseline scores, both experimental and control groups demonstrated significant improvements (P<.001) in first and second post-test scores. While the experimental group had significantly lower (P<.05) second post-test scores compared with the first post-test scores, no significant difference (P=.94) was found between these two scores for the control group. The scores between groups did not differ significantly over time (P=.17). The virtual patient simulation was rated positively. A virtual patient simulation for a refreshing training course on assessing and managing clinical deterioration was developed. Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation, both simulations have demonstrated to be effective refresher learning strategies for improving nursing students' clinical performance. Given the greater resource requirements of mannequin-based simulation, the virtual patient simulation provides a more promising alternative learning strategy to mitigate the decay of clinical performance over time.

Fear-avoidance beliefs and temporal summation of evoked thermal pain influence self-report of disability in patients with chronic low back pain.

PubMed

George, Steven Z; Wittmer, Virgil T; Fillingim, Roger B; Robinson, Michael E

2006-03-01

Quantitative sensory testing has demonstrated a promising link between experimentally determined pain sensitivity and clinical pain. However, previous studies of quantitative sensory testing have not routinely considered the important influence of psychological factors on clinical pain. This study investigated whether measures of thermal pain sensitivity (temporal summation, first pulse response, and tolerance) contributed to clinical pain reports for patients with chronic low back pain, after controlling for depression or fear-avoidance beliefs about work. Consecutive patients (n=27) with chronic low back pain were recruited from an interdisciplinary pain rehabilitation program in Jacksonville, FL. Patients completed validated self-report questionnaires for depression, fear-avoidance beliefs, clinical pain intensity, and clinical pain related disability. Patients also underwent quantitative sensory testing from previously described protocols to determine thermal pain sensitivity (temporal summation, first pulse response, and tolerance). Hierarchical regression models investigated the contribution of depression and thermal pain sensitivity to clinical pain intensity, and fear-avoidance beliefs and thermal pain sensitivity to clinical pain related disability. None of the measures of thermal pain sensitivity contributed to clinical pain intensity after controlling for depression. Temporal summation of evoked thermal pain significantly contributed to clinical pain disability after controlling for fear-avoidance beliefs about work. Measures of thermal pain sensitivity did not contribute to pain intensity, after controlling for depression. Fear-avoidance beliefs about work and temporal summation of evoked thermal pain significantly influenced pain related disability. These factors should be considered as potential outcome predictors for patients with work-related low back pain. This study supported the neuromatrix theory of pain for patients with CLBP, as cognitive-evaluative factor contributed to pain perception, and cognitive-evaluative and sensory-discriminative factors uniquely contributed to an action program in response to chronic pain. Future research will determine if a predictive model consisting of fear-avoidance beliefs and temporal summation of evoked thermal pain has predictive validity for determining clinical outcome in rehabilitation or vocational settings.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

PubMed

Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

2013-05-22

The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. ClinicalTrials.gov: NCT01815710.

Cerebrovascular accidents in elderly people treated with antipsychotic drugs: a systematic review.

PubMed

Sacchetti, Emilio; Turrina, Cesare; Valsecchi, Paolo

2010-04-01

After 2002, an association between stroke and antipsychotic use was reported in clinical trials and large database studies. This review considers previous quantitative reviews, newly published clinical trials, and recent observational cohort and case-control studies, and focuses on the clinical significance of the risk for stroke, the difference between typical and atypical antipsychotics, the possible at-risk patient profile and the timing of stroke after exposure. A search of MEDLINE covering the period from 1966 to June 2009 was carried out using selected keywords. Inclusion criteria were (i) quantitative reviews on stroke and antipsychotics; (ii) double-blind, placebo-controlled clinical trials involving patients with dementia treated with antipsychotics; and (iii) observational database cohort studies and observational case-control studies investigating the association between stroke and antipsychotics. Clinical trials were excluded if they were single-blind or if patients were affected by dementia and/or other neurological illnesses. Four reviews with aggregate data, 2 meta-analyses, 13 randomized, double-blind, controlled trials, 7 observational cohort studies and 4 observational case-control studies were selected and analysed. The incidence of cerebrovascular accidents (CVAs) was found to be very low in aggregate reviews and meta-analyses (2-4%). When the number collected was sufficiently high, or different drug treatments were grouped together, the higher rate in subjects exposed to antipsychotics was statistically significant. Inspection of other randomized controlled clinical trials, not included in aggregate reviews and meta-analyses, reported similar rates of CVAs. The majority of observational cohort studies compared typical and atypical antipsychotics and no significant class differences were found. A comparison with non-users was carried out in some cohort studies. In case-control studies, the probability of CVAs in users compared with non-users was in the range of 1.3- to 2-fold greater. Preliminary data also indicate that the highest risk of stroke is related to the first weeks of treatment, and a risk profile for stroke is emerging, such as older age, cognitive impairment and vascular illness. Different pathophysiological pathways may be involved, ranging from the facilitation of thrombosis, pre-existing cardiovascular factors, sedation and a common diathesis for stroke of dementia, schizophrenia and affective illness. Before prescribing an antipsychotic, clinicians should weigh all the risk factors for a given patient and consider not only the indications as provided by the regulatory agencies, but also the overall effectiveness of typical and atypical antipsychotics.

Effect of Intranasal Oxytocin Administration on Psychiatric Symptoms: A Meta-Analysis of Placebo-Controlled Studies

PubMed Central

Hofmann, Stefan G.; Fang, Angela; Brager, Daniel N.

2015-01-01

Clinical trials of intranasal administration of oxytocin for treating psychiatric problems have yielded mixed results. To conduct a quantitative review of placebo-controlled clinical trials of intranasally-administered oxytocin (OT) for psychiatric symptoms, manual and electronic searches using PubMed and PsycINFO were conducted. Of 1,828 entries, 16 placebo-controlled studies totaling 330 participants were included in the analysis. The overall placebo-controlled effect size was moderately strong (Hedges’ g = 0.67) and robust as suggested by the fail-safe N and funnel plot analysis. OT reduced symptoms of depression, anxiety, autism/repetitive behaviors, psychotic symptoms, and general psychopathology. In the combined sample, symptom reduction was moderated by frequency of administration. Publication year and diagnostic category did not moderate the effect of OT on the clinical outcome measures. We conclude that intranasal administration of OT is a potentially useful intervention for reducing psychiatric symptoms. However, more studies are needed to determine the best treatment target and to identify the mechanism of treatment change. PMID:26094200

Computer-generated reminders and quality of pediatric HIV care in a resource-limited setting.

PubMed

Were, Martin C; Nyandiko, Winstone M; Huang, Kristin T L; Slaven, James E; Shen, Changyu; Tierney, William M; Vreeman, Rachel C

2013-03-01

To evaluate the impact of clinician-targeted computer-generated reminders on compliance with HIV care guidelines in a resource-limited setting. We conducted this randomized, controlled trial in an HIV referral clinic in Kenya caring for HIV-infected and HIV-exposed children (<14 years of age). For children randomly assigned to the intervention group, printed patient summaries containing computer-generated patient-specific reminders for overdue care recommendations were provided to the clinician at the time of the child's clinic visit. For children in the control group, clinicians received the summaries, but no computer-generated reminders. We compared differences between the intervention and control groups in completion of overdue tasks, including HIV testing, laboratory monitoring, initiating antiretroviral therapy, and making referrals. During the 5-month study period, 1611 patients (49% female, 70% HIV-infected) were eligible to receive at least 1 computer-generated reminder (ie, had an overdue clinical task). We observed a fourfold increase in the completion of overdue clinical tasks when reminders were availed to providers over the course of the study (68% intervention vs 18% control, P < .001). Orders also occurred earlier for the intervention group (77 days, SD 2.4 days) compared with the control group (104 days, SD 1.2 days) (P < .001). Response rates to reminders varied significantly by type of reminder and between clinicians. Clinician-targeted, computer-generated clinical reminders are associated with a significant increase in completion of overdue clinical tasks for HIV-infected and exposed children in a resource-limited setting.

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

PubMed

Jones, Jennifer D

2006-01-01

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

Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

PubMed

Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

2000-08-01

Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

Increased levels of circulating CD34+ cells in neovascular age-related macular degeneration: relation with clinical and OCT features.

PubMed

Kara, Caner; Özdal, Pınar Ç; Beyazyıldız, Emrullah; Özcan, Nurgül E; Teke, Mehmet Y; Vural, Gülden; Öztürk, Faruk

2018-01-01

To investigate the levels of circulating CD34+ stem cells in patients with neovascular type age-related macular degeneration (AMD) and its relation with clinical and optical coherence tomography (OCT) findings. The study consisted of 55 patients: 28 patients (18 male and 10 female) with neovascular type AMD as a study group and 27 patients (12 male and 15 female) scheduled for cataract surgery as a control group. The level of CD34+ stem cells was measured by flow cytometry. Demographic and clinical data were recorded. The mean ages of patients in the study and control groups were 71 ± 8 and 68 ± 6 years, respectively. There was no statistically significant difference in terms of age, sex, or systemic disease association between study and control groups. However, smoking status was significantly higher in the study group (67.9% vs 37.0%; p = 0.02). Stem cell levels were significantly higher in the study group (1.5 ± 0.9 vs 0.5 ± 0.3; p<0.001), but there was no relation between stem cell levels and clinical and OCT findings. Increased circulating CD34+ stem cell levels were observed in patients with choroidal neovascular membrane associated with AMD, but no significant relation was found between cell levels and clinical and OCT findings.

[Prevention of intramammary infections in dairy cows by the use of a premilking teat dip method with a foaming iodophor dip agent].

PubMed

Falkenberg, U; Tenhagen, B A; Baumgärtner, B; Heuwieser, W

2002-10-01

In this study we investigated the efficacy of premilking teat dipping with a foaming iodophor teat dip in a negative controlled field study. Incidence of new intramammary infections (IMI), incidence of clinical mastitis, influence on somatic cell count (SCC) and the characteristics of udder tissue and teats were used as parameters to evaluate clinical efficacy. Predipping was compared with a negative control using a split-udder experimental design. Right teats were predipped with a foaming disinfectant containing 0.27% iodine while left teats served as controls. The latter were conventionally cleaned with damp cloth towels and dried manually with disposable paper towels ("best cleaning practice"). All teats were dipped after milking with the same dip. There were no differences between treated and control quarters with respect to incidence of new IMI during the study period (treated quarters: 6.6% vs. untreated: 6.95%), incidence of clinical mastitis (30 cases in the treatment group vs. 39 cases in the control group) and geometric mean of SCC of quarter milk samples. Spectrum of detected pathogens was also comparable. Condition of udder tissue and teat ducts did not differ between treated and control quarters.

Bruxism in craniocervical dystonia: a prospective study.

PubMed

Borie, Laetitia; Langbour, Nicolas; Guehl, Dominique; Burbaud, Pierre; Ella, Bruno

2016-09-01

Bruxism pathophysiology remains unclear, and its occurrence has been poorly investigated in movement disorders. The aim of this study was to compare the frequency of bruxism in patients with craniocervical dystonia vs. normal controls and to determine its associated clinical features. This is a prospective-control study. A total of 114 dystonic subjects (45 facial dystonia, 69 cervical dystonia) and 182 controls were included. Bruxism was diagnosed using a hetero-questionnaire and a clinical examination performed by trained dentists. Occurrence of bruxism was compared between the different study populations. A binomial logistic regression analysis was used to determine which clinical features influenced bruxism occurrence in each population. The frequency of bruxism was significantly higher in the dystonic group than in normal controls but there was no difference between facial and cervical dystonia. It was also higher in women than in men. Bruxism features were similar between normal controls and dystonic patients except for a higher score of temporomandibular jaw pain in the dystonic group. The higher frequency of bruxism in dystonic patients suggests that bruxism is increased in patients with basal ganglia dysfunction but that its nature does not differ from that seen in bruxers from the normal population.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

PubMed

Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

2013-10-24

Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Clinical Trials NCT01740635.

Verbal Memory Impairment in Polydrug Ecstasy Users: A Clinical Perspective.

PubMed

Kuypers, Kim P C; Theunissen, Eef L; van Wel, Janelle H P; de Sousa Fernandes Perna, Elizabeth B; Linssen, Anke; Sambeth, Anke; Schultz, Benjamin G; Ramaekers, Johannes G

2016-01-01

Ecstasy use has been associated with short-term and long-term memory deficits on a standard Word Learning Task (WLT). The clinical relevance of this has been debated and is currently unknown. The present study aimed at evaluating the clinical relevance of verbal memory impairment in Ecstasy users. To that end, clinical memory impairment was defined as decrement in memory performance that exceeded the cut-off value of 1.5 times the standard deviation of the average score in the healthy control sample. The primary question was whether being an Ecstasy user (E-user) was predictive of having clinically deficient memory performance compared to a healthy control group. WLT data were pooled from four experimental MDMA studies that compared memory performance during placebo and MDMA intoxication. Control data were taken from healthy volunteers with no drug use history who completed the WLT as part of a placebo-controlled clinical trial. This resulted in a sample size of 65 E-users and 65 age- and gender-matched healthy drug-naïve controls. All participants were recruited by similar means and were tested at the same testing facilities using identical standard operating procedures. Data were analyzed using linear mixed-effects models, Bayes factor, and logistic regressions. Findings were that verbal memory performance of placebo-treated E-users did not differ from that of controls, and there was substantial evidence in favor of the null hypothesis. History of use was not predictive of memory impairment. During MDMA intoxication of E-users, verbal memory was impaired. The combination of the acute and long-term findings demonstrates that, while clinically relevant memory impairment is present during intoxication, it is absent during abstinence. This suggests that use of Ecstasy/MDMA does not lead to clinically deficient memory performance in the long term. Additionally, it has to be investigated whether the current findings apply to more complex cognitive measures in diverse 'user categories' using a combination of genetics, imaging techniques and neuropsychological assessments.

Clinically observed chickenpox and the risk of childhood-onset multiple sclerosis.

PubMed

Mikaeloff, Yann; Caridade, Guillaume; Suissa, Samy; Tardieu, Marc

2009-05-15

The authors conducted a population-based case-control study to investigate whether clinically observed chickenpox, linked with a level of intensity for clinical expression, increases the risk of multiple sclerosis (MS) in childhood. The cases were MS patients whose disease onset occurred between 1994 and 2003, before age 16 years, in France. Each case was matched for age, sex, and geographic origin with as many as 12 controls randomly selected from the general population. Information about clinically observed chickenpox in cases and controls before the index date regarding onset of MS was collected with a standardized questionnaire and was checked against health certificates. Conditional logistic regression was used to estimate the odds ratio for an association between MS and chickenpox. The 137 MS cases were matched with 1,061 controls. Clinically observed chickenpox had occurred in 76.6% of the cases and 84.9% of their matched controls. The adjusted odds ratio of MS onset associated with chickenpox occurrence was 0.58 (95% confidence interval: 0.36, 0.92). The authors concluded that clinically observed chickenpox was associated with a lower risk of childhood-onset MS in a French population.

Impact of clinical pharmacist-based parenteral nutrition service for bone marrow transplantation patients: a randomized clinical trial.

PubMed

Mousavi, Maryam; Hayatshahi, Alireza; Sarayani, Amir; Hadjibabaie, Molouk; Javadi, Mohammadreza; Torkamandi, Hassan; Gholami, Kheirollah; Ghavamzadeh, Ardeshir

2013-12-01

Parenteral nutrition (PN) is a well-documented supportive care which maintains the nutritional status of patients. Clinical pharmacists are often involved in providing PN services; however, few studies have investigated the effect of a clinical pharmacy-based PN service in resource-limited settings. We designed a randomized clinical trial to compare the clinical pharmacist-based PN service (intervention group) with the conventional method (control group) for adult patients undergoing hematopoietic stem cell transplantation in Shariati Hospital, Tehran, Iran (2011-2012). In the intervention group, the clinical pharmacists implemented standard guidelines of nutrition support. The conventional method was a routine nutrition support protocol which was pursued for all patients in the bone marrow transplantation wards. Main study outcomes included nutritional status (weight, albumin, total protein, pre-albumin, and nitrogen balance), length of hospital stay, time to engraftment, rate of graft versus host disease, and mortality rate. Patients were followed for 3 months. Fifty-nine patients were randomly allocated to a study group. The overall intake (oral and parenteral) in the control group was significantly lower than standard daily needed calories (P < 0.01). Patients in the intervention group received fewer days of PN (10.7 ± 4.2 vs. 18.4 ± 5.5 days, P < 0.01). All nutritional outcomes were either preserved or improved in the intervention group while the nutritional status in the control group was deteriorated (P values < 0.01). Length of hospital stay was significantly shorter in the intervention group (P < 0.01). Regarding PN complications, hyperglycemia was observed more frequently in the intervention group (34.5 %, P = 0.01). Two patients in the control group expired due to graft versus host disease at the 3-month follow-up. A clinical pharmacist-based nutrition support service significantly improved nutritional status and clinical outcomes in comparison with the suboptimal conventional method. Future studies should assess the cost effectiveness of clinical pharmacists' PN services.

Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis.

PubMed

Yu, Ashley M; Balasubramanaiam, Bannuya; Offringa, Martin; Kelly, Lauren E

2018-06-13

In pediatric medicine, the usual treatment received by children ("standard of care") varies across centers. Evaluations of new treatments often compare to the existing "standard of care" to determine if a treatment is more effective, has a better safety profile, or costs less. The objective of our study was to evaluate intervention and "standard of care" control arms reported in published pediatric clinical trials. Pediatric clinical trials, published in 2014, reporting the use of a "standard of care" control arm were included. Duplicate assessment of reporting completeness was done using the 12-item TIDieR (Template for Intervention Description and Replication) checklist for both the "standard of care" control arms and intervention arms within the same published study. Following screening, 214 pediatric trials in diverse therapeutic areas were included. Several different terms were used to describe "standard of care." There was a significant difference between the mean reported TIDieR checklist items of "standard of care" control arms (5.81 (SD 2.13) and intervention arms (8.45 (SD 1.39, p < 0.0001). Reporting of intervention and "standard of care" control arms in pediatric clinical trials should be improved as current "standard of care" reporting deficiencies limit reproducibility of research and may ultimately contribute to research waste.

Virtual-reality-based system for controlled study of cataplexy

NASA Astrophysics Data System (ADS)

Augustine, Kurt E.; Cameron, Bruce M.; Camp, Jon J.; Krahn, Lois E.; Robb, Richard A.

2002-05-01

Cataplexy is a sudden loss of voluntary muscle control experienced by narcolepsy patients. It is usually triggered by strong, spontaneous emotions and is more common in times of stress. The Sleep Disorders Unit and the Biomedical Imaging Resource at Mayo Clinic are developing interactive display technology for reliably inducing cataplexy during clinical monitoring. The project is referred to as the Cataplexy/Narcolepsy Activation Program, or CatNAP. We have developed an automobile driving simulation that introduces humorous, surprising, and stress-inducing events and objects as the patient attempts to navigate a vehicle through a virtual town. The patient wears a head-mounted display and controls the vehicle via a driving simulator steering wheel and pedal cluster. As the patient attempts to drive through the town, various objects, sounds or conditions occur that distract, startle, frustrate or amuse. These responses may trigger a cataplectic episode, which can then be clinically evaluated. We believe CatNAP is a novel and innovative example of the effective application of virtual reality technology to study an important clinical problem that has resisted previous approaches. An evaluation phase with volunteer patients previously diagnosed with cataplexy has been completed. The prototype system is being prepared for a full clinical study.

The effect of a clinical medical librarian on in-patient care outcomes.

PubMed

Esparza, Julia M; Shi, Runhua; McLarty, Jerry; Comegys, Marianne; Banks, Daniel E

2013-07-01

The research sought to determine the effect of a clinical medical librarian (CML) on outcomes of in-patients on the internal medicine service. A prospective study was performed with two internal medicine in-patient teams. Team 1 included a CML who accompanied the team on daily rounds. The CML answered questions posed at the point of care immediately or in emails post-rounds. Patients on Team 2, which did not include a CML, as well as patients who did not require consultation by the CML on Team 1, served as the control population. Numerous clinical and library metrics were gathered on each question. Patients on Team 1 who required an answer to a clinical question were more ill and had a longer length of stay, higher costs, and higher readmission rates compared to those in the control group. Using a matched pair analysis, we showed no difference in clinical outcomes between the intervention group and the control group. This study is the largest attempt to prospectively measure changes in patient outcomes when physicians were accompanied by a CML on rounds. This approach may serve as a model for further studies to define when and how CMLs are most effective.

The clinical application of teaching people about pain.

PubMed

Louw, Adriaan; Zimney, Kory; O'Hotto, Christine; Hilton, Sandra

2016-07-01

Teaching people about the neurobiology and neurophysiology of their pain experience has a therapeutic effect and has been referred to as pain neuroscience education (PNE). Various high-quality randomized controlled trials and systematic reviews have shown increasing efficacy of PNE decreasing pain, disability, pain catastrophization, movement restrictions, and healthcare utilization. Research studies, however, by virtue of their design, are very controlled environments and, therefore, in contrast to the ever-increasing evidence for PNE, little is known about the clinical application of this emerging therapy. In contrast, case studies, case series, and expert opinion and perspectives by authorities in the world of pain science provide clinicians with a glimpse into potential "real" clinical application of PNE in the face of the ever-increasing chronic pain epidemic. By taking the material from the randomized controlled trials, systematic reviews, case series, case studies, and expert opinion, this article aims to provide a proposed layout of the clinical application of PNE. The article systematically discusses key elements of PNE including examination, educational content, and delivery methods, merging of PNE with movement, goal setting, and progression. This perspectives article concludes with a call for research into the clinical application of PNE.

Prevalence and Spectrum of Gastro Esophageal Reflux Disease in Bronchial Asthma.

PubMed

Rameschandra, Sahoo; Acharya, Vishak; Kunal; Vishwanath, Tantry; Ramkrishna, Anand; Acharya, Preetam

2015-10-01

There exists a complex interplay between asthma and gastroesophageal reflux disease. Both these diseases are known to aggravate each other and amelioration of one is necessary for the control of the other. There is a paucity of studies in Indian population on this subject. To evaluate the clinical features and the endoscopic findings of the upper gastrointestinal tract in patients with bronchial asthma. Study was conducted at KMC group of hospitals, Mangalore in the Department of chest medicine in association with Department of gastroenterology. Subjects included 50 cases of bronchial asthma and controls were 58 non asthmatic patients with allergic rhinitis and chronic urticaria. All patients were queried about presence or absence of symptoms of upper gastro intestinal tract disorders by gastro oesophageal reflux disease (GERD) questionnaire and all the included patients underwent upper gastro intestinal endoscopy. The study showed that symptoms of gastroesophageal reflux were significantly more in asthmatics (52%) as compared to the controls (28%). The common presenting features of gastroesophageal reflux in asthmatics were heartburn (40%) retrosternal pain (24%), nocturnal cough (18%), dyspepsia (16%) and regurgitation (14%) and the above symptoms were significantly more common in asthmatics as compared to controls. Gastroesophageal reflux disease was found to be significantly more common in the asthmatics (58%) as compared to the control group where it was present in 32.75% of the subjects. Clinical or endoscopic evidence of any upper gastrointestinal disorder was found in 68% of the asthmatics as compared to 37.93% of the controls. This difference was found to be statistically significant. The study showed that gastroesophageal reflux disease was significantly more in asthmatics as compared to the controls. Upper gastrointestinal symptoms were more common in asthmatics as against controls. Clinical or endoscopic evidence of upper gastrointestinal disorder and gastroesophageal reflux disease was found in significantly higher proportion of the asthmatics as compared to the controls. Clinically silent gastroesophageal reflux disease was however seen in both control and asthmatic groups equally with a lower prevalence.

High-dose levofloxacin in community-acquired pneumonia: a randomized, open-label study.

PubMed

Lee, Jin Hwa; Kim, Seo Woo; Kim, Ji Hye; Ryu, Yon Ju; Chang, Jung Hyun

2012-09-01

The conventional treatment for community-acquired pneumonia (CAP) involves combination therapy consisting of a β-lactam penicillin or a cephalosporin with a macrolide. Alternatively, high-dose levofloxacin treatment has been used as single-agent therapy for treating CAP, covering atypical pathogens. This study compared the clinical efficacy and safety of high-dose levofloxacin with combined ceftriaxone and azithromycin for the treatment of CAP. This phase IV, prospective, randomized, open-label trial enrolled patients admitted to a tertiary referral hospital for CAP treatment from 2010 to 2011. Hospital admission was decided based on clinical judgement and the pneumonia severity index. Forty subjects were enrolled and assigned to two treatment arms using a random numbers table. The 20 subjects in the experimental group were given levofloxacin 750 mg intravenously once daily, followed by the same dose of oral levofloxacin at discharge when clinically improved and the 20 subjects in the control group were given ceftriaxone 2.0 g intravenously once daily plus oral azithromycin 500 mg for 3 consecutive days, followed by oral cefpodoxime 200 mg per day at discharge after clinical improvement. The primary outcome was the clinical success rate. Secondary outcomes were the microbiological success rate and adverse events during the study. Of the 40 subjects enrolled, 36 completed the study: 17 in the experimental group and 19 in the control group. The groups did not differ in terms of demographic factors or clinical findings at baseline. The clinical success rate (cured + improved) was 94% in the experimental (levofloxacin) group and 84% in the control group (p > 0.05). The microbiological success rate and overall adverse events were also similar in both groups. Single-agent, high-dose levofloxacin treatment exhibited excellent clinical and microbiological efficacy with a safety profile comparable to that of ceftriaxone plus azithromycin therapy. Large-scale clinical trials are required to verify these results. WHO International Clinical Trials Registry: KCT0000374; Daiichi-Sankyo Korea study code: T11-13-V1.

Clinical outcomes research in gynecologic oncology.

PubMed

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

2017-09-01

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

Conjugated Equine Estrogens and Breast Cancer Risk in the Women’s Health Initiative Clinical Trial and Observational Study

PubMed Central

Prentice, Ross L.; Chlebowski, Rowan T.; Stefanick, Marcia L.; Manson, JoAnn E.; Langer, Robert D.; Pettinger, Mary; Hendrix, Susan L.; Hubbell, F. Allan; Kooperberg, Charles; Kuller, Lewis H.; Lane, Dorothy S.; McTiernan, Anne; O’Sullivan, Mary Jo; Rossouw, Jacques E.; Anderson, Garnet L.

2009-01-01

The Women’s Health Initiative randomized controlled trial found a trend (p = 0.09) toward a lower breast cancer risk among women assigned to daily 0.625-mg conjugated equine estrogens (CEEs) compared with placebo, in contrast to an observational literature that mostly reports a moderate increase in risk with estrogenalone preparations. In 1993–2004 at 40 US clinical centers, breast cancer hazard ratio estimates for this CEE regimen were compared between the Women’s Health Initiative clinical trial and observational study toward understanding this apparent discrepancy and refining hazard ratio estimates. After control for prior use of postmenopausal hormone therapy and for confounding factors, CEE hazard ratio estimates were higher from the observational study compared with the clinical trial by 43% (p = 0.12). However, after additional control for time from menopause to first use of postmenopausal hormone therapy, the hazard ratios agreed closely between the two cohorts (p = 0.82). For women who begin use soon after menopause, combined analyses of clinical trial and observational study data do not provide clear evidence of either an overall reduction or an increase in breast cancer risk with CEEs, although hazard ratios appeared to be relatively higher among women having certain breast cancer risk factors or a low body mass index. PMID:18448442

Prenatal Pregnancy Complications and Psychiatric Symptoms: Children with ASD versus Clinic Controls

ERIC Educational Resources Information Center

Tudor, Megan E.; DeVincent, Carla J.; Gadow, Kenneth D.

2012-01-01

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.…

Radiosurgery of Glomus Jugulare Tumors: A Meta-Analysis

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

Guss, Zachary D.; Batra, Sachin; Limb, Charles J.

2011-11-15

Purpose: During the past two decades, radiosurgery has arisen as a promising approach to the management of glomus jugulare. In the present study, we report on a systematic review and meta-analysis of the available published data on the radiosurgical management of glomus jugulare tumors. Methods and Materials: To identify eligible studies, systematic searches of all glomus jugulare tumors treated with radiosurgery were conducted in major scientific publication databases. The data search yielded 19 studies, which were included in the meta-analysis. The data from 335 glomus jugulare patients were extracted. The fixed effects pooled proportions were calculated from the data whenmore » Cochrane's statistic was statistically insignificant and the inconsistency among studies was <25%. Bias was assessed using the Egger funnel plot test. Results: Across all studies, 97% of patients achieved tumor control, and 95% of patients achieved clinical control. Eight studies reported a mean or median follow-up time of >36 months. In these studies, 95% of patients achieved clinical control and 96% achieved tumor control. The gamma knife, linear accelerator, and CyberKnife technologies all exhibited high rates of tumor and clinical control. Conclusions: The present study reports the results of a meta-analysis for the radiosurgical management of glomus jugulare. Because of its high effectiveness, we suggest considering radiosurgery for the primary management of glomus jugulare tumors.« less

[Clinical and endoscopic efficacy of vedolizumab in patients with ulcerative colitis].

PubMed

Varvarynets, Antonina V; Chopei, Ivan V; Chubirko, Kseniya I

2018-01-01

Introduction: Ulcerative colitis (UC) is a chronic recurrent idiopathic inflammatory bowel disease that is characterized by a continuous or wave-like course with multifactorial etiopathogenesis. In recent decades, the number of patients with this pathology has been steadily increasing. Therefore, timely detection of UC at the diagnostic stage for the further qualified assistance providing is one of the most important tasks in modern gastroenterology. In recent years, a new group of drugs that can be an alternative to the surgical method of treatment has appeared. These are biological drugs, one of which is vedolizumab. The aim: to study the changes in clinical and endoscopic parameters in patients with ulcerative colitis, in response to the biological therapy with vedolizumab. Materials and methods: 38 patients with ulcerative colitis were included in this study that lasted 52 weeks. 15 patients of the control group received standard therapy with 5-aminosalicylic acid (5-ASA). 23 patients in the study group received the vedolizumab infusions. Results: Clinical response was observed in 16 (69.6%) and 23 (100.0%) patients of the study group at the 6th and 52nd weeks respectively. In control group the clinical response was present in 5 (33.3%) and 9 (60,0%) patients at the 6th and 52nd weeks respectively. Mucosal healing at the 52nd week was observed in 22 (95.7%) patients in the study group and 7 (46.7%) patients in the control group. Conclusions: Patients who were treated with vedolizumab experienced significant improvement in clinical and endoscopic parameters 52 weeks after treatment initiation compared to the control group.

Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature.

PubMed

Kennelty, Korey A; Polgreen, Linnea A; Carter, Barry L

2018-01-18

We review studies published since 2014 that examined team-based care strategies and involved pharmacists to improve blood pressure (BP). We then discuss opportunities and challenges to sustainment of team-based care models in primary care clinics. Multiple studies presented in this review have demonstrated that team-based care including pharmacists can improve BP management. Studies highlighted the cost-effectiveness of a team-based pharmacy intervention for BP control in primary care clinics. Little information was found on factors influencing sustainability of team-based care interventions to improve BP control. Future work is needed to determine the best populations to target with team-based BP programs and how to implement team-based approaches utilizing pharmacists in diverse clinical settings. Future studies need to not only identify unmet clinical needs but also address reimbursement issues and stakeholder engagement that may impact sustainment of team-based care interventions.

Risk factors for clinical coronary heart disease in systemic lupus erythematosus: the lupus and atherosclerosis evaluation of risk (LASER) study.

PubMed

Haque, Sahena; Gordon, Caroline; Isenberg, David; Rahman, Anisur; Lanyon, Peter; Bell, Aubrey; Emery, Paul; McHugh, Neil; Teh, Lee Suan; Scott, David G I; Akil, Mohamed; Naz, Sophia; Andrews, Jacqueline; Griffiths, Bridget; Harris, Helen; Youssef, Hazem; McLaren, John; Toescu, Veronica; Devakumar, Vinodh; Teir, Jamal; Bruce, Ian N

2010-02-01

Accelerated atherosclerosis and premature coronary heart disease (CHD) are recognized complications of systemic lupus erythematosus (SLE), but the exact etiology remains unclear and is likely to be multifactorial. We hypothesized that SLE patients with CHD have increased exposure to traditional risk factors as well as differing disease phenotype and therapy-related factors compared to SLE patients free of CHD. Our aim was to examine risk factors for development of clinical CHD in SLE in the clinical setting. In a UK-wide multicenter retrospective case-control study we recruited 53 SLE patients with verified clinical CHD (myocardial infarction or angina pectoris) and 96 SLE patients without clinical CHD. Controls were recruited from the same center as the case and matched by disease duration. Charts were reviewed up to time of event for cases, or the same "dummy-date" in controls. SLE patients with clinical CHD were older at the time of event [mean (SD) 53 (10) vs 42 (10) yrs; p < 0.001], more likely to be male [11 (20%) vs 3 (7%); p < 0.001], and had more exposure to all classic CHD risk factors compared to SLE patients without clinical CHD. They were also more likely to have been treated with corticosteroids (OR 2.46; 95% CI 1.03, 5.88) and azathioprine (OR 2.33; 95% CI 1.16, 4.67) and to have evidence of damage on the pre-event SLICC damage index (SDI) (OR 2.20; 95% CI 1.09, 4.44). There was no difference between groups with regard to clinical organ involvement or autoantibody profile. Our study highlights the need for clinical vigilance to identify modifiable risk factors in the clinical setting and in particular with male patients. The pattern of organ involvement did not differ in SLE patients with CHD events. However, the higher pre-event SDI, azathioprine exposure, and pattern of damage items (disease-related rather than therapy-related) in cases suggests that a persistent active lupus phenotype contributes to CHD risk. In this regard, corticosteroids and azathioprine may not control disease well enough to prevent CHD. Clinical trials are needed to determine whether classic risk factor modification will have a role in primary prevention of CHD in SLE patients and whether new therapies that control disease activity can better reduce CHD risk.

CoYoT1 Clinic: Home Telemedicine Increases Young Adult Engagement in Diabetes Care.

PubMed

Reid, Mark W; Krishnan, Subramanian; Berget, Cari; Cain, Cindy; Thomas, John Fred; Klingensmith, Georgeanna J; Raymond, Jennifer K

2018-05-01

Young adults with type 1 diabetes (T1D) experience poor glycemic control, disengagement in care, and are often lost to the medical system well into their adult years. Diabetes providers need a new approach to working with the population. The goal of this study was to determine whether an innovative shared telemedicine appointment care model (CoYoT1 Clinic [pronounced as "coyote"; Colorado Young Adults with T1D]) for young adults with T1D improves care engagement, satisfaction, and adherence to American Diabetes Association (ADA) guidelines regarding appointment frequency. CoYoT1 Clinic was designed to meet the diabetes care needs of young adults (18-25 years of age) with T1D through home telemedicine. Visits occurred every 3 months over the 1-year study (three times by home telemedicine and one time in-person). Outcomes were compared to patients receiving treatment as usual (control). Compared with controls, CoYoT1 patients attended significantly more clinic visits (P < 0.0001) and increased their number of clinic visits from the year before the intervention. Seventy-four percent of CoYoT1 patients were seen four times over the 12-month study period, meeting ADA guidelines, but none in the control group met the ADA recommendation. CoYoT1 patients used diabetes technologies more frequently and reported greater satisfaction with care compared with controls. Delivering diabetes care by home telemedicine increases young adults' adherence to ADA guidelines and usage of diabetes technologies, and improves retention in care when compared to controls. Home telemedicine may keep young adults engaged in their diabetes care during this challenging transition period.

Offering Annual Fecal Occult Blood Tests at Annual Flu Shot Clinics Increases Colorectal Cancer Screening Rates

PubMed Central

Potter, Michael B.; Phengrasamy, La; Hudes, Esther S.; McPhee, Stephen J.; Walsh, Judith M.E.

2009-01-01

PURPOSE We wanted to determine whether providing home fecal occult blood test (FOBT) kits to eligible patients during influenza inoculation (flu shot) clinics can contribute to higher colorectal cancer screening (CRCS) rates. METHODS The study was time randomized. On 8 dates of an annual flu shot clinic at the San Francisco General Hospital, patients were offered flu shots as usual (control group) and on 9 other dates, patients were offered both flu shots and FOBT kits (intervention group). RESULTS The study included 514 patients aged 50 to 79 years, with 246 in the control group and 268 in the intervention group. At the conclusion of flu season, FOBT screening rates increased by 4.4 percentage points from 52.9% at baseline to 57.3% (P = .07) in the control group, and increased by 29.8 percentage points from 54.5% to 84.3% (P <.001) in the intervention group, with the change among intervention participants 25.4 percentage points greater than among control participants (P value for change difference <.001). Among patients initially due for CRCS, 20.7% in the control group and 68.0% in the intervention group were up-to-date at the conclusion of the study (P <.001). In multivariate analyses, the odds ratio for becoming up-to-date with screening in the intervention group (vs the control group) was 11.3 (95% CI, 5.8–22.0). CONCLUSIONS Offering FOBT kits during flu shot clinics dramatically increased the CRCS rate for flu shot clinic attendees. Pairing home FOBT kits with annual flu shots may be a useful strategy to improve CRCS rates in other primary care or public health settings. PMID:19139445

Development and Clinical Assessment of a Comprehensive Product for Pigmentation Control in Multiple Ethnic Populations.

PubMed

Makino, Elizabeth T; Kadoya, Kuniko; Sigler, Monya L; Hino, Peter D; Mehta, Rahul C

2016-12-01

Pigmentary changes in people of different ethnic origins are controlled by slight variations in key biological pathways leading to different outcomes from the same treatment. It is important to develop and test products for desired outcomes in varying ethnic populations. To develop a comprehensive product (LYT2) that affects all major biological pathways controlling pigmentation and test for clinical efficacy and safety in different ethnic populations. A thorough analysis of biological pathways was used to identify ingredient combinations for LYT2 that provided optimal melanin reduction in a 3-D skin model. Expression of four key genes for melanogenesis, TYR, TYRP-1, DCT, and MITF was analyzed by qPCR. Clinical study was conducted to compare the efficacy and tolerability of LYT2 against 4% hydroquinone (HQ). Average melanin suppression by LYT2 in 7 independent experiments was 45%. All four key genes show significant down- regulation of expression. LYT2 provided statistically significant reductions in mean overall hyperpigmentation grades as early as week 2 compared to baseline, with continued significant improvements through week 12 in all ethnic groups tested. We have successfully combined management of 6 categories of pathways related to melanogenesis: melanocyte activation, melanosome development, melanin production, melanin distribution, keratinocyte turnover, and barrier function to create a comprehensive HQ-free product. The outcome clearly shows greater pigmentation control with LYT2 compared to other HQ-free products in skin tissue models and earlier control in clinical studies compared to 4% HQ. Clinical study shows pigmentation control benefits of LYT2 in people of Caucasian, Hispanic, and African ethnic origins. J Drugs Dermatol. 2016;15(12):1562-1570.

Effect of teaching motivational interviewing via communication coaching on clinician and patient satisfaction in primary care and pediatric obesity-focused offices.

PubMed

Pollak, Kathryn I; Nagy, Paul; Bigger, John; Bilheimer, Alicia; Lyna, Pauline; Gao, Xiaomei; Lancaster, Michael; Watkins, R Chip; Johnson, Fred; Batish, Sanjay; Skelton, Joseph A; Armstrong, Sarah

2016-02-01

Studies indicate needed improvement in clinician communication and patient satisfaction. Motivational interviewing (MI) helps promote patient behavior change and improves satisfaction. In this pilot study, we tested a coaching intervention to teach MI to all clinic staff to improve clinician and patient satisfaction. We included four clinics (n=29 staff members). In the intervention clinics (one primary care and one pediatric obesity-focused), we trained all clinic staff in MI through meetings as a group seven times, directly observing clinicians in practice 4-10 times, and providing real-time feedback on MI techniques. In all clinics, we assessed patient satisfaction via anonymous surveys and also assessed clinician burnout and self-rated MI skills. Clinicians in the intervention clinics reported improvements in burnout scores, self-rated MI skills, and perceived cohesion whereas clinicians in the control clinic reported worse scores. Patient satisfaction improved in the intervention clinics more than in the control clinics. This is the first study to find some benefit of training an entire clinic staff in MI via a coaching model. It might help to train staff in MI to improve clinician satisfaction, team cohesion, perceived skills, and patient satisfaction. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Blood Pressure Control in Hypertensive Patients, Cardiovascular Risk Profile and the Prevalence of Masked Uncontrolled Hypertension (MUCH).

PubMed

Naser, Nabil; Dzubur, Alen; Durak, Azra; Kulic, Mehmed; Naser, Nura

2016-07-27

The term masked hypertension (MH) should be used for untreated individuals who have normal office blood pressure but elevated ambulatory blood pressure. For treated patients, this condition should be termed masked uncontrolled hypertension (MUCH). Masked uncontrolled hypertension (MUCH) has gone unrecognized because few studies have used 24-h ABPM to determine the prevalence of suboptimal BP control in seemingly well-treated patients, and there are few such studies in large cohorts of treated patients attending usual clinical practice. This is important because masked hypertension is associated with a high risk of cardiovascular events. This study was conducted to obtain more information about the association between hypertension and other CV risk factors, about office and ambulatory blood pressure (BP) control as well as on cardiovascular (CV) risk profile in treated hypertensive patients, also to define the prevalence and characteristics of masked uncontrolled hypertension (MUCH) among treated hypertensive patients in routine clinical practice. In this study 2514 male and female patients were included during a period of 5 years follow up. All patients have ambulatory blood pressure monitoring (ABPM) for at least 24h. We identified patients with treated and controlled BP according to current international guidelines (clinic BP, 140/90mmHg). Cardiovascular risk assessment was based on personal history, clinic BP values, as well as target organ damage evaluation. Masked uncontrolled hypertension (MUCH) was diagnosed in these patients if despite controlled clinic BP, the mean 24-h ABPM average remained elevated (24-h systolic BP ≥130mmHg and/or 24-h diastolic BP ≥80mmHg). Patients had a mean age of 60.2+10 years, and the majority of them (94.6%) were followed by specialist physicians. Average clinic BP was 150.4+16/89.9+12 mmHg. About 70% of patients displayed a very high-risk profile. Ambulatory blood pressure monitoring (ABPM) was performed in all recruited patients for at least 24h. Despite the combined medical treatment (78% of the patients), clinic control (<140/90 mmHg) was achieved in only 26.2% of patients, the corresponding control rate for ambulatory BP (<130/80 mmHg) being 32.7%. From 2514 patients with treated BP, we identified 803 with treated and controlled office BP control (<140/90 mmHg), of whom 258 patients (32.1%) had MUCH according to 24-h ABPM criteria (mean age 57.2 years, 54.7% men). The prevalence of MUCH was slightly higher in males, patients with borderline clinic and office BP (130-139/80-89 mmHg), and patients at high cardiovascular risk (smokers, diabetes, obesity). Masked uncontrolled hypertension (MUCH) was most often due to poor control of nocturnal BP, with the proportion of patients in whom MUCH was solely attributable to an elevated nocturnal BP almost double that solely attributable to daytime BP elevation (22.3 vs. 10.1%, P 0.001). The prevalence of masked suboptimal BP control in patients with treated and well-controlled clinic BP is high. The characteristics of patients with MUCH (male, longer duration of hypertension, obesity, smoking history, and diabetes) indicate that this is a higher-risk group with most to gain from improved BP.

Effects of team-based learning on problem-solving, knowledge and clinical performance of Korean nursing students.

PubMed

Kim, Hae-Ran; Song, Yeoungsuk; Lindquist, Ruth; Kang, Hee-Young

2016-03-01

Team-based learning (TBL) has been used as a learner-centered teaching strategy in efforts to improve students' problem-solving, knowledge and practice performance. Although TBL has been used in nursing education in Korea for a decade, few studies have studied its effects on Korean nursing students' learning outcomes. To examine the effects of TBL on problem-solving ability and learning outcomes (knowledge and clinical performance) of Korean nursing students. Randomized controlled trial. 63 third-year undergraduate nursing students attending a single university were randomly assigned to the TBL group (n=32), or a control group (n=31). The TBL and control groups attended 2h of class weekly for 3weeks. Three scenarios with pulmonary disease content were employed in both groups. However, the control group received lectures and traditional case study teaching/learning strategies instead of TBL. A questionnaire of problem-solving ability was administered at baseline, prior to students' exposure to the teaching strategies. Students' problem-solving ability, knowledge of pulmonary nursing care, and clinical performance were assessed following completion of the three-week pulmonary unit. After the three-week educational interventions, the scores on problem-solving ability in the TBL group were significantly improved relative to that of the control group (t=10.89, p<.001). In addition, there were significant differences in knowledge, and in clinical performance with standardized patients between the two groups (t=2.48, p=.016, t=12.22, p<.001). This study demonstrated that TBL is an effective teaching strategy to enhance problem-solving ability, knowledge and clinical performance. More research on other specific learning outcomes of TBL for nursing students is recommended. Copyright © 2015 Elsevier Ltd. All rights reserved.

Theory of Mind in Schizophrenia: Associations With Clinical and Cognitive Insight Controlling for Levels of Psychopathology.

PubMed

Popolo, Raffaele; Dimaggio, Giancarlo; Luther, Lauren; Vinci, Giancarlo; Salvatore, Giampaolo; Lysaker, Paul H

2016-03-01

Poor insight in schizophrenia is a risk factor for both poor outcomes and treatment adherence. Accordingly, interest in identifying causes of poor insight has increased. This study explored whether theory of mind (ToM) impairments are linked to poor clinical and cognitive insight independent of psychopathology. Participants with schizophrenia (n = 37) and control subjects (n = 40) completed assessments of ToM with the Hinting Task and the Brüne Picture Sequencing Task, clinical insight and psychopathology with the Positive and Negative Syndrome Scale, and cognitive insight with the Beck Cognitive Insight Scale. Results indicated that the schizophrenia group had greater impairments in ToM relative to control subjects. In the schizophrenia group, the Hinting Task performance was related to both cognitive and clinical insight, with only the relationship with cognitive insight persisting after controlling for psychopathology. Picture Sequencing Task performance was related to cognitive insight only. Future research directions and clinical implications are discussed.

Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review

PubMed Central

Zhang, Claire Shuiqing; Tan, Hsiewe Ying; Zhang, George Shengxi; Zhang, Anthony Lin; Xue, Charlie Changli; Xie, Yi Min

2015-01-01

While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and blinding credibility. PMID:26536619

Interrelationships of Hormones, Diet, Body Size and Breast Cancer Among Hispanic Women

DTIC Science & Technology

2006-09-01

faculty, and 2) to design and conduct a clinic-based case-control study to include completion of a questionnaire, anthropometry and a blood draw...clinic-based case- control study to include completion of a questionnaire, anthropometry and a blood draw, 3) to disseminate findings to the Texas...Psychosocial stress, coping and prostate cancer. Ethnicity Dis (In Press). Sanderson M, Coker AL, Perez A, Du XL , Peltz G, Fadden MK. A

Case-controlled clinical and histopathological study of conjunctivochalasis.

PubMed

Francis, I C; Chan, D G; Kim, P; Wilcsek, G; Filipic, M; Yong, J; Coroneo, M T

2005-03-01

Conjunctivochalasis, a secondary cause of the watery eye, is frequently seen in the older age group as an elevation of the bulbar conjunctiva lying along the lateral or central lower lid margin. A prospective, interventional, case-controlled clinical and histopathological study was conducted. The relevant features of 18 patients (29 eyes) who had their conjunctivochalasis resected as part of the surgical management of their watery eye syndrome were examined. In the control group, tissue was obtained from an age matched series of 24 normal subjects undergoing routine cataract surgery. 24 controls (24 specimens) and 18 patients (29 specimens) had conjunctival strip biopsies, taken from the usual lid margin level bulbar conjunctiva in line with the inferior limbus (controls), and the clinically apparent conjunctivochalasis (patients). These were submitted for histological study. 23 of 24 control sections demonstrated normal conjunctival variation. Four of 29 patient specimens demonstrated a chronic non-granulomatous conjunctivitis, while three eyes of the patient group (two patients) demonstrated features of elastosis. Of the four patients who had the inflammatory infiltrates, three had functional nasolacrimal duct obstructions (FNLDOs) and one had a primary acquired nasolacrimal duct obstruction (PANDO). Of the two patients who had elastosis, one had an FNLDO and the other had normal lacrimal drainage and was Jones 1 positive. Six of 18 patients--that is, seven of 29 specimens of conjunctivochalasis demonstrated signs of elastosis or of chronic non-granulomatous inflammation. Clinically, patients had a spectrum of aetiologies of their watery eye syndrome.

Spinal and temporo-mandibular disorders in male workers of the State Police.

PubMed

Sancini, Angela; Tomei, Francesco; Tomei, Gianfranco; Caciari, Tiziana; Capozzella, Assunta; Di Famiani, Manuela; Samperi, Ilaria; Scala, Barbara; Fiaschetti, Maria; Cetica, Carlotta; Ciarrocca, Manuela

2013-01-01

The aims of this study are to evaluate the prevalence of disorders of the lumbar region and the temporo-mandibular district co-morbidity in drivers and workers of the State Police employed for different office activities. The study population included 103 drivers as cases and 100 police officers as controls. The study was carried out through questionnaire and clinical evaluation of the spine and temporo-mandibular region. At clinical examination, the drivers were found to have a higher prevalence (p < 0.05) of both symptoms and clinical signs at the spine and temporo-mandibular joint (TMJ), when compared with the controls. The results also showed a higher prevalence (p < 0.05) of co-morbidity in the two districts among the drivers, when compared with the controls. These results confirm that morbidity related to back and TMJ and increase in co-morbidity between the two districts are higher in professional drivers.

A randomised controlled trial of clinics in secondary schools for adolescents with asthma.

PubMed Central

Salisbury, Chris; Francis, Caia; Rogers, Chris; Parry, Kate; Thomas, Huw; Chadwick, Stephanie; Turton, Pat

2002-01-01

AIM: To compare a nurse-led clinic in schools versus care in general practice for adolescents with asthma. DESIGN OF STUDY: Randomised controlled trial in four schools; parallel observational study in two schools. SETTING: Six comprehensive schools. METHOD: In the randomised trial, pupils were invited to attend asthma review at a nurse-led clinic either in school, or in general practice. The parallel observational study compared pupils invited to practice care within and outside the randomised trial. Primary outcome measures were attendance for asthma review, symptom control, and quality of life. Secondary outcomes were knowledge, attitudes, inhaler technique, use of steroids, school absence, peak flow rate, preference for future care, health service utilisation, and costs. RESULTS: School clinic pupils were more likely to attend an asthma review than those randomised to practice care (90.8% versus 51.0% overall [P < 0.001, not consistent across schools]). No differences were observed in symptom control (P = 0.42) or quality of life (P = 0.63). Pupils attending school clinics had greater knowledge of asthma (difference = +0.38, 95% CI = 0.19 to 0.56), more positive attitudes (difference = +0.21, 95% CI = 0.05 to 0.36), and better inhaler technique (P < 0.001, not consistent across all schools). No differences were observed in school absence or peak flow rate. A majority (63%) of those who had received care at school preferred this model in future. Median costs of providing care at school and at the practice were 32.10 Pounds and 19.80 Pounds, respectively. No differences were observed between the groups in the observational comparison on any outcome. CONCLUSIONS: The schools asthma clinic increased uptake of asthma reviews. There were improvements in various process measures, but not in clinical outcomes. PMID:12528584

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes.

PubMed

Tauschmann, Martin; Hovorka, Roman

2017-12-01

Nocturnal glucose control remains challenging in children and adolescents with type 1 diabetes due to highly variable overnight insulin requirements. The issue may be addressed by glucose responsive insulin delivery based on real-time continuous glucose measurements. Areas covered: This review outlines recent developments of glucose responsive insulin delivery systems from a paediatric perspective. We cover threshold-based suspend application, predictive low glucose suspend, and more advanced single hormone and dual-hormone closed-loop systems. Approaches are evaluated in relation to nocturnal glucose control particularly during outpatient randomised controlled trials. Expert opinion: Significant progress translating research from controlled clinical centre settings to free-living unsupervised home studies have been achieved over the past decade. Nocturnal glycaemic control can be improved whilst reducing the risk of hypoglycaemia with closed-loop systems. Following the US regulatory approval of the first hybrid closed-loop system in non-paediatric population, large multinational closed-loop clinical trials and pivotal studies including paediatric populations are underway or in preparation to facilitate the use of closed-loop systems in clinical practice.

Effects of nursing process-based simulation for maternal child emergency nursing care on knowledge, attitude, and skills in clinical nurses.

PubMed

Kim, Sunghee; Shin, Gisoo

2016-02-01

Since previous studies on simulation-based education have been focused on fundamental nursing skills for nursing students in South Korea, there is little research available that focuses on clinical nurses in simulation-based training. Further, there is a paucity of research literature related to the integration of the nursing process into simulation training particularly in the emergency nursing care of high-risk maternal and neonatal patients. The purpose of this study was to identify the effects of nursing process-based simulation on knowledge, attitudes, and skills for maternal and child emergency nursing care in clinical nurses in South Korea. Data were collected from 49 nurses, 25 in the experimental group and 24 in the control group, from August 13 to 14, 2013. This study was an equivalent control group pre- and post-test experimental design to compare the differences in knowledge, attitudes, and skills for maternal and child emergency nursing care between the experimental group and the control group. The experimental group was trained by the nursing process-based simulation training program, while the control group received traditional methods of training for maternal and child emergency nursing care. The experimental group was more likely to improve knowledge, attitudes, and skills required for clinical judgment about maternal and child emergency nursing care than the control group. Among five stages of nursing process in simulation, the experimental group was more likely to improve clinical skills required for nursing diagnosis and nursing evaluation than the control group. These results will provide valuable information on developing nursing process-based simulation training to improve clinical competency in nurses. Further research should be conducted to verify the effectiveness of nursing process-based simulation with more diverse nurse groups on more diverse subjects in the future. Copyright © 2015 Elsevier Ltd. All rights reserved.

The prevalence and moderators of clinical pain in people with schizophrenia: a systematic review and large scale meta-analysis.

PubMed

Stubbs, Brendon; Mitchell, Alex J; De Hert, Marc; Correll, Christoph U; Soundy, Andy; Stroobants, Marc; Vancampfort, Davy

2014-12-01

People with schizophrenia frequently have physical comorbidities that can cause pain. Experimental studies report reduced pain sensitivity among schizophrenia patients, but it remains unclear if clinically relevant pain is less prevalent in schizophrenia. We systematically searched major electronic databases from inception till 03/2014. Articles were included that reported the prevalence of clinical pain in people with schizophrenia. Two independent authors conducted searches, completed methodological quality assessment and extracted data. A random effects relative risks (RR) meta-analysis was conducted to determine the prevalence of all-cause and specific pain in schizophrenia, and the relative prevalence compared to the general population, and to assess moderators. Altogether, 14 studies were included encompassing 242,703 individuals with schizophrenia (30.2-55.8 years) and 4,259,221 controls. Different types of pain were considered. The overall pooled prevalence of clinical pain in people with schizophrenia was 34.7% (95% CI=23.6-46.6). In the comparative analysis involving 7 studies with controls, the RR was 0.99 (95% CI=0.83-1.19). The pooled prevalence of headache among 94,043 individuals with schizophrenia was 29.9% (95% CI=3-69%) and the RR compared to 4,248,284 controls was 1.32 (95% CI=0.85-2.07). In moderator analyses, neither age, sex, study quality or pain assessment method influenced pain prevalence. Clinical pain affects a third of people with schizophrenia and levels are similar with age- and sex-comparable controls. Future research is needed to determine if similar clinical pain prevalences in schizophrenia occur despite having more painful conditions, resulting from under-reporting, higher pain thresholds or lower help seeking behaviours. Copyright © 2014 Elsevier B.V. All rights reserved.

Serum Lipase as Clinical Laboratory Index for Chronic Renal Failure Diagnosis.

PubMed

Zhu, Ying; Dong, Jing; Wang, Ping; Huang, Huifang; Jin, Xiaohua; Zhou, Jingou; Shi, Jingfang; Gu, Guohao; Chen, Jun; Xu, Jun; Song, Yanhui

2016-07-01

Measuring the level of serum lipase has been used for the clinical diagnosis of acute pancreatitis. Reports showed that the serum lipase level increased in patients of clinical renal failure. In this study, we aimed to measure the change of serum lipase levels in chronic kidney diseases and determine whether it could serve as a clinical laboratory index for clinical renal failure diagnosis. Materials: The OLYMPUS AU5400 automatic biochemical analyzer was used to determine the serum levels of lipase and creatinine. The study included 120 cases in the clinical renal failure group, 76 cases in the nephrotic syndrome group, 81 cases in the chronic nephritis group, and 80 healthy controls from our hospital volunteers in the same period. We then compared the lipase levels and conducted statistical analyses among these groups. The serum lipase levels were 15.3 U/L, 79.8 U/L, 45.1 U/L, and 51.0 U/L in the normal control, clinical renal failure, nephrotic syndrome, and chronic nephritis groups, respectively. The lipase levels in the groups with diseases were significantly different compared with that of the normal control group (p < 0.01). The lipase level of the clinical renal failure group was significantly higher than that of the nephrotic syndrome group and chronic nephritis group (p < 0.01). However, no statistically significant difference between the nephrotic syndrome and chronic nephritis group (p > 0.05) was observed. Moreover, an association of the serum lipase with disease progression was observed in the study. Serum lipase is an effective serological index which can reflect the clinical changes in the clinical renal failure and tends to increase through the progression of renal dysfunction.

Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial.

PubMed

González-Ortega, Itxaso; Echeburúa, Enrique; García-Alocén, Adriana; Vega, Patricia; González-Pinto, Ana

2016-07-29

The high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation). This is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group. This study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder. NCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014.

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

PubMed

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

2018-05-10

Stem cell therapy has been applied in the treatment of acute-on-chronic liver failure (ACLF). However, its clinical efficiency is still debatable. The aim of this systematic review and meta-analysis is to evaluate the clinical efficiency of stem cell therapy in the treatment of ACLF. The Cochrane Library, OVID, EMBASE, and PUBMED were searched to December 2017. Both randomized and non-randomized studies, assessing stem cell therapy in patients with ACLF, were included. The outcome measures were total bilirubin (TBIL), alanine transaminase (ALT), international normalized ratio (INR), albumin (ALB), and the model for end-stage liver disease (MELD) score. The quality of evidence was assessed by GRADEpro. Four randomized controlled trials and six non-randomized controlled trials were included. The TBIL levels significantly decreased at 1-, 3-, 12-month after the stem cell therapy (p = 0.0008; p = 0.04; p = 0.007). The ALT levels decreased significantly compared with the control group in the short-term (p < 0.00001). There was no obvious change in the INR level compared with the control groups (p = 0.64). The ALB levels increased markedly as compared with the control groups (p < 0.0001). The significant difference can be found in MELD score between stem cell therapy and control groups (p = 0.008). Further subgroup analysis for 3-month clinical performance according to the stem cell types have also been performed. This study suggests that the clinical outcomes of stem cell therapy were satisfied in patients with ACLF in the short-term. MSCs may be better than BM-MNCs in the stem cells transplantation of ACLF. However, more attention should focus on clinical trials in large-volume centers.

Efficacy of botulinum toxins on bruxism: an evidence-based review.

PubMed

Long, Hu; Liao, Zhengyu; Wang, Yan; Liao, Lina; Lai, Wenli

2012-02-01

The objective of this study was to assess the efficacy of botulinum toxins on bruxism. Electronic databases (PubMed, Embase and Science Citation Index), websites (Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) and the literature database of SIGLE (System for Information on Grey Literature in Europe) were searched from January 1990 to April 2011 for randomised controlled trials or nonrandomised studies assessing the efficacy of botulinum toxins on bruxism. There was no language restriction. Through a predefined search strategy, we retrieved 28 studies from PubMed, 94 from Embase, 60 from the Science Citation Index, two ongoing clinical trials and two from the Cochrane Central Register of Controlled Trials. Of these, only four studies met our inclusion criteria and were finally included. Of the four included studies, two were randomised controlled trials and two were controlled before-and-after studies. These studies showed that botulinum toxin injections can reduce the frequency of bruxism events, decrease bruxism-induced pain levels and satisfy patients' self-assessment with regard to the effectiveness of botulinum toxins on bruxism. In comparison with oral splint, botulinum toxins are equally effective on bruxism. Furthermore, botulinum toxin injections at a dosage of <100 U are safe for otherwise healthy patients. Botulinum toxin injections are effective on bruxism and are safe to use. Therefore, they can be used clinically for otherwise healthy patients with bruxism. © 2012 FDI World Dental Federation.

21 CFR 862.3280 - Clinical toxicology control material.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

21 CFR 862.3280 - Clinical toxicology control material.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

21 CFR 862.3280 - Clinical toxicology control material.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

21 CFR 862.3280 - Clinical toxicology control material.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

21 CFR 862.3280 - Clinical toxicology control material.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

Use of case-based reasoning to enhance intensive management of patients on insulin pump therapy.

PubMed

Schwartz, Frank L; Shubrook, Jay H; Marling, Cynthia R

2008-07-01

This study was conducted to develop case-based decision support software to improve glucose control in patients with type 1 diabetes mellitus (T1DM) on insulin pump therapy. While the benefits of good glucose control are well known, achieving and maintaining good glucose control remains a difficult task. Case-based decision support software may assist by recalling past problems in glucose control and their associated therapeutic adjustments. Twenty patients with T1DM on insulin pumps were enrolled in a 6-week study. Subjects performed self-glucose monitoring and provided daily logs via the Internet, tracking insulin dosages, work, sleep, exercise, meals, stress, illness, menstrual cycles, infusion set changes, pump problems, hypoglycemic episodes, and other events. Subjects wore a continuous glucose monitoring system at weeks 1, 3, and 6. Clinical data were interpreted by physicians, who explained the relationship between life events and observed glucose patterns as well as treatment rationales to knowledge engineers. Knowledge engineers built a prototypical system that contained cases of problems in glucose control together with their associated solutions. Twelve patients completed the study. Fifty cases of clinical problems and solutions were developed and stored in a case base. The prototypical system detected 12 distinct types of clinical problems. It displayed the stored problems that are most similar to the problems detected, and offered learned solutions as decision support to the physician. This software can screen large volumes of clinical data and glucose levels from patients with T1DM, identify clinical problems, and offer solutions. It has potential application in managing all forms of diabetes.

Using clinical indicators to facilitate quality improvement via the accreditation process: an adaptive study into the control relationship.

PubMed

Chuang, Sheuwen; Howley, Peter P; Hancock, Stephen

2013-07-01

The aim of the study was to determine accreditation surveyors' and hospitals' use and perceived usefulness of clinical indicator reports and the potential to establish the control relationship between the accreditation and reporting systems. The control relationship refers to instructional directives, arising from appropriately designed methods and efforts towards using clinical indicators, which provide a directed moderating, balancing and best outcome for the connected systems. Web-based questionnaire survey. Australian Council on Healthcare Standards' (ACHS) accreditation and clinical indicator programmes. Seventy-three of 306 surveyors responded. Half used the reports always/most of the time. Five key messages were revealed: (i) report use was related to availability before on-site investigation; (ii) report use was associated with the use of non-ACHS reports; (iii) a clinical indicator set's perceived usefulness was associated with its reporting volume across hospitals; (iv) simpler measures and visual summaries in reports were rated the most useful; (v) reports were deemed to be suitable for the quality and safety objectives of the key groups of interested parties (hospitals' senior executive and management officers, clinicians, quality managers and surveyors). Implementing the control relationship between the reporting and accreditation systems is a promising expectation. Redesigning processes to ensure reports are available in pre-survey packages and refined education of surveyors and hospitals on how to better utilize the reports will support the relationship. Additional studies on the systems' theory-based model of the accreditation and reporting system are warranted to establish the control relationship, building integrated system-wide relationships with sustainable and improved outcomes.

A randomized, open-label, standard controlled, parallel group study of efficacy and safety of baclofen, and chlordiazepoxide in uncomplicated alcohol withdrawal syndrome.

PubMed

Girish, K; Vikram Reddy, K; Pandit, Lakshmi V; Pundarikaksha, H P; Vijendra, R; Vasundara, K; Manjunatha, R; Nagraj, Moulya; Shruthi, R

2016-02-01

Alcohol withdrawal syndrome (AWS) is a distressing condition, generally controlled by benzodiazepines (BZD's). Baclofen, a gamma-aminobutyric acid-B (GABAB) agonist, has also shown promising results in controlling AWS. As there are few studies comparing the efficacy and tolerability of chlordiazepoxide with baclofen, the present study was taken up. The objective of this study was to compare efficacy and tolerability of baclofen with chlordiazepoxide in uncomplicated AWS. Sixty subjects with uncomplicated AWS were randomized into two groups of 30 each, to receive baclofen (30 mg) or chlordiazepoxide (75 mg) in decremented fixed dose regime for 9 days. Clinical efficacy was assessed by Clinical Institute Withdrawal Assessment for Alcohol-Revised Scale (CIWA-Ar) and tolerability by the nature and severity of adverse events. Lorazepam was used as rescue medication. Secondary efficacy parameters were Clinical Global Impression scores, symptom-free days, and subject satisfaction as assessed by visual analog scale. This study was registered with Clinical Trial Registry-India (CTRI/2013/04/003588), also subsequently registered with WHO's ICTRP clinical trial portal. Both baclofen and chlordiazepoxide showed a consistent reduction in the total CIWA-Ar scores. However, chlordiazepoxide showed a faster and a more effective control of anxiety and agitation requiring lesser lorazepam supplementation, and also showed a better subject satisfaction compared to baclofen. Both the drugs showed good tolerability with mild self-limiting adverse events. The present study demonstrates that baclofen is not as good as chlordiazepoxide in the treatment of uncomplicated AWS. However, baclofen might be considered as an alternative. Copyright © 2016 Chang Gung University. Published by Elsevier B.V. All rights reserved.

Promoting oral cancer examinations to medical primary care providers: a cluster randomized trial.

PubMed

Wee, Alvin G; Zimmerman, Lani M; Anderson, James R; Nunn, Martha E; Loberiza, Fausto R; Sitorius, Michael A; Pullen, Carol H

2016-09-01

To compare the percentage of patients who had an oral cancer examination (OCE) by their primary care provider (PCP) in medical clinics participating in a web-based education with poster reminder intervention to that of patients in control clinics. To also determine the effects for PCPs in medical clinics participating in the web-based education with poster reminder intervention as compared with those in control clinics regarding: a) index of knowledge of oral cancer risk factors (RiskOC) and b) index of knowledge of oral cancer diagnostic procedures (DiagOC). Six medical clinics were recruited to participate in this study and randomly assigned to an intervention group or a control group. PCPs (physicians, physician assistants, and advanced practice registered nurses) took a pretest; 2 weeks later, they participated in the web-based educational program, including a posttest (intervention group) or took a posttest only (control group). In each clinic, 1 week following completion of the PCPs' posttests, 94 patients were recruited to complete a one-page survey. The intervention clinics were found to be a significant factor for the PCPs to perform patient OCEs, after controlling for significant covariates, that is, age, main reason for clinic visit, OCE for patient in the past year, clinic's mean DiagOC score, and clinic's mean RiskOC score. The intervention also resulted in the PCPs increasing their pretest to posttest RiskOC scores. The use of intervention has the potential to increase PCPs' short-term knowledge and to increase the frequency of PCPs' routine, nonsymptomatic opportunistic OCE on patients. © 2016 American Association of Public Health Dentistry.

Association between Low-density lipoprotein cholesterol and occipital periventricular hyperintensities in a group of Chinese patients: an observational study.

PubMed

Duan, Dazhi; Shen, Lin; Cui, Chun; Shu, Tongsheng; Zheng, Jian

2017-02-27

While occipital periventricular hyperintensities (OPVHs) are among the most common mild white matter hyperintensities, the clinical factors associated with OPVHs remain unclear. In this study, we investigated the role of clinical factors in development of pure OPVHs. This study included 97 patients with OPVHs and 73 healthy controls. Univariate analysis of clinical factors in OPVH patients and controls was followed by binomial logistic regression analysis to identify clinical factors significantly associated with OPVHs. Univariate analysis indicated that age, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein-B (Apo-B) levels differed significantly between the OPVH patients and controls (p < 0.05). Age and gender were correlated with OPVH scores (p < 0.05), while LDL-C, triglycerides, Apo-B and TC were anti-correlated with OPVHs scores (p < 0.05). Multivariate analysis indicated that LDL-C is negatively correlated with OPVHs (p < 0.05), and age is positively correlated with OPVHs (p < 0.001). In summary, LDL-C was negatively and age was positively associated with OPVHs among Chinese patients in a hospital.

[A Structural Equation Model of Pressure Ulcer Prevention Action in Clinical Nurses].

PubMed

Lee, Sook Ja; Park, Ok Kyoung; Park, Mi Yeon

2016-08-01

The purpose of this study was to construct and test a structural equation model for pressure ulcer prevention action by clinical nurses. The Health Belief Model and the Theory of Planned Behavior were used as the basis for the study. A structured questionnaire was completed by 251 clinical nurses to analyze the relationships between concepts of perceived benefits, perceived barriers, attitude, subjective norm, perceived control, intention to perform action and behavior. SPSS 22.0 and AMOS 22.0 programs were used to analyze the efficiency of the hypothesized model and calculate the direct and indirect effects of factors affecting pressure ulcer prevention action among clinical nurses. The model fitness statistics of the hypothetical model fitted to the recommended levels. Attitude, subjective norm and perceived control on pressure ulcer prevention action explained 64.2% for intention to perform prevention action. The major findings of this study indicate that it is essential to recognize improvement in positive attitude for pressure ulcer prevention action and a need for systematic education programs to increase perceived control for prevention action.

Evaluation of Glycemic Control, Lifestyle and Clinical Characteristics in Patients with Type 2 Diabetes Treated at King Abdullah University Hospital in Jordan.

PubMed

Al-Eitan, Laith N; Nassar, Ahmad M; Saadeh, Nesreen A; Almomani, Basima A

2016-12-01

The study aimed to assess glycemic control in a Jordanian population with type 2 diabetes and to explore the sociodemographic, clinical and medication-related factors as well as the anthropometric indexes and laboratory values associated with and possibly contributing to unsatisfactory glycemic control. We included 237 patients previously diagnosed as having type 2 diabetes. Data were collected through direct interviews. Sociodemographic and clinical details were collected using a questionnaire designed for the purpose of the study, anthropometric measurements were obtained at the time of the interviews, and laboratory data were extracted from the medical records of King Abdullah University Hospital. Of the participants, 60.8% were found to have unsatisfactory glycemic control (glycated hemoglobin levels ≥7%). Unsatisfactory glycemic control was associated with younger ages at diabetes diagnosis, higher mean weights and higher prevalences of diabetic neuropathy. No relationships were found among glycemic control and body mass index, waist circumference or central obesity. Patients with adequate control were more likely to have health insurance and to have hypothyroidism as a comorbidity. Insulin use and medication plans containing insulin were associated with unsatisfactory control. Patients with unsatisfactory control had higher mean levels of low-density lipoproteins and triglycerides and lower mean levels of high-density lipoproteins. Moreover, elevated triglycerides (≥150 mg/dL) and dyslipidemia were associated with unsatisfactory glycemic control. More than half of the participants had unsatisfactory glycemic control, highlighting the need for a change in the approach and strategies used for patients with diabetes in Jordan. Factors associated with glycemic control that were found in this study should be further studied and used in the prevention and management of diabetes. Copyright © 2016 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

A group randomized trial using an appointment system to improve adherence to ART at reproductive and child health clinics implementing Option B+ in Tanzania

PubMed Central

Liana, Jafary; Kajoka, Mwikemo Deborah; Valimba, Richard; Kimatta, Suleiman; Dillip, Angel; Vialle-Valentin, Catherine; Embrey, Martha; Lieber, Rachel; Johnson, Keith

2017-01-01

Introduction In October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic. Methods We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment tracking and community outreach systems on the rate of missed appointments and number of days covered by dispensed antiretroviral medications among women previously established on antiretroviral therapy. We used interrupted time series analysis to assess study outcomes. Clinic staff and patients in intervention clinics were aware of the intervention because of change in clinic procedures; data collectors knew the study group assignment. Results Three months pre-intervention, we identified 1924 and 1226 patients established on antiretroviral therapy for six months or more in intervention and control clinics, respectively, of whom 83.4% and 86.9% had one or more post-intervention visits. The unadjusted rate of missed visits declined from 36.5% to 34.4% in intervention clinics and increased from 38.9% to 45.5% in control clinics following the intervention. Interrupted time series analyses demonstrated a net decrease of 13.7% (95% CI [-15.4,-12.1]) for missed visits at six months post-intervention. Similar differential changes were observed for visits missed by 3, 7, 15, or 60 days. Conclusion Appointment-tracking and community outreach significantly improved appointment-keeping for women on antiretroviral therapy. The facility staff controlled their workload better, identified missing patients rapidly, and worked with existing community organizations. There is now enough evidence to scale up this approach to all antiretroviral therapy and Option B+ reproductive and child health clinics in Tanzania as well as to evaluate the intervention in medical clinics that treat other chronic health conditions. Trial registration Registry for International Development Impact Evaluations ID-55310280d8757 PMID:28957381

The effect of platelet-rich plasma on clinical outcomes in lateral epicondylitis.

PubMed

Ahmad, Zafar; Brooks, Roger; Kang, Sertaz-Niel; Weaver, Holly; Nunney, Ian; Tytherleigh-Strong, Graham; Rushton, Neil

2013-11-01

To evaluate the evidence for application of platelet-rich plasma (PRP) in lateral epicondylitis. We carried out a systematic review of the current evidence on the effects of PRP in lateral epicondylitis on clinical outcomes. We performed a comprehensive search of the PubMed, Medline, Cochrane, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase databases using various combinations of the commercial names of each PRP preparation and "lateral epicondylitis" (with its associated terms), looking specifically at human studies. Data validity was assessed and collected on clinical outcome. Nine studies met the inclusion criteria, of which 5 were randomized controlled trials. Two cohort studies showed that PRP improved clinical satisfaction scores. One case-control study showed that PRP yielded a significantly greater improvement in symptoms compared with bupivacaine. Two randomized controlled trials compared the effect of injections of PRP and blood. Only 1 of the studies noted a significant difference at the 6-week time point. Three randomized controlled trials compared corticosteroids with PRP. Two of the smaller trials, which had follow-up periods of 6 weeks and 3 months, showed no significant difference between treatment groups. The largest randomized controlled trial found that PRP had significant benefit compared with corticosteroids with regard to pain and Disabilities of the Arm, Shoulder and Hand scores at 1- and 2-year time points. This review highlights the limited but evolving evidence for the use of PRP in lateral epicondylitis; however, further research is required to understand the concentration and preparation that facilitate the best clinical outcome. Characterizing the timing of the intervention would optimize the health economics behind the decision to treat for the patient and health care provider. Level III, systematic review of Level I to III studies. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

Analysis of Clinical Cohort Data Using Nested Case-control and Case-cohort Sampling Designs. A Powerful and Economical Tool.

PubMed

Ohneberg, K; Wolkewitz, M; Beyersmann, J; Palomar-Martinez, M; Olaechea-Astigarraga, P; Alvarez-Lerma, F; Schumacher, M

2015-01-01

Sampling from a large cohort in order to derive a subsample that would be sufficient for statistical analysis is a frequently used method for handling large data sets in epidemiological studies with limited resources for exposure measurement. For clinical studies however, when interest is in the influence of a potential risk factor, cohort studies are often the first choice with all individuals entering the analysis. Our aim is to close the gap between epidemiological and clinical studies with respect to design and power considerations. Schoenfeld's formula for the number of events required for a Cox' proportional hazards model is fundamental. Our objective is to compare the power of analyzing the full cohort and the power of a nested case-control and a case-cohort design. We compare formulas for power for sampling designs and cohort studies. In our data example we simultaneously apply a nested case-control design with a varying number of controls matched to each case, a case cohort design with varying subcohort size, a random subsample and a full cohort analysis. For each design we calculate the standard error for estimated regression coefficients and the mean number of distinct persons, for whom covariate information is required. The formula for the power of a nested case-control design and the power of a case-cohort design is directly connected to the power of a cohort study using the well known Schoenfeld formula. The loss in precision of parameter estimates is relatively small compared to the saving in resources. Nested case-control and case-cohort studies, but not random subsamples yield an attractive alternative for analyzing clinical studies in the situation of a low event rate. Power calculations can be conducted straightforwardly to quantify the loss of power compared to the savings in the num-ber of patients using a sampling design instead of analyzing the full cohort.

Repurposing historical control clinical trial data to provide safety context.

PubMed

Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

2016-02-01

Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluating the impact of a pre-rotation workshop on student preparation for clinical advanced pharmacy practice experiences.

PubMed

Medina, Melissa S; Stark, Jennifer E; Vesta, Kimi S; Lockhart, Staci M

2008-10-01

This pilot study was designed to evaluate the impact of a pre-rotation workshop (PRW) on pharmacy students' clinical skills and preparation for clinical Advanced Pharmacy Practice Experiences (APPE) involving direct patient care. Randomized controlled trial of an educational intervention with Institutional Review Board approval. PRW activities designed to simulate rotation activities around five competencies, patient charts, medication histories, SOAP notes, patient presentations, and professionalism. Endpoints were evaluated using clinical rotation preceptors' evaluation of performance and students' performance on objective structured clinical exams (OSCE). Eight fourth-year students and eight GPA matched controls (20% of the total class) were selected to voluntarily participate. The PRW demonstrated a positive impact on students' clinical skills and preparation for rotations by improving OSCE performance. However, no significant differences were found between groups when comparing preceptor evaluations of skills on rotations. These results are limited by the small sample size, potential OSCE "test-wiseness" effects, lack of OSCE evaluator blinding to study groups, potential case specificity effects due to the limited number of cases used on the OSCE and possible lack of sensitivity of the rotation evaluation tool to capture true differences among the experimental and control group participants. The PRW was successful at advancing students' clinical skills and preparation for rotations and may be considered as a tool to help bridge didactic to clinical experiences in the Pharm.D. curriculum.

Control of OSA During Automatic Positive Airway Pressure Titration in a Clinical Case Series: Predictors and Accuracy of Device Download Data

PubMed Central

Huang, Hsin-Chia Carol; Hillman, David R.; McArdle, Nigel

2012-01-01

Study Objectives: To investigate the factors associated with physiologic control of obstructive sleep apnea (OSA) during automatic positive airway pressure (APAP) titration in a clinical series. To also assess the usefulness of apnea-hypopnea index (AHI) data downloaded from the APAP device (Dev AHI). Design: Retrospective review of a consecutive series of patients with OSA who underwent APAP titration (Autoset Spirit, ResMed, Bella Vista, New South Wales, Australia ) with simultaneous polysomnographic (PSG) monitoring in the sleep laboratory. Setting: Tertiary sleep clinic. Participants: There were 190 consecutive patients with OSA referred for APAP titration. Measurements and Results: There were 58% of patients who achieved optimal or good control of OSA (titration PSG AHI < 10, or at least 50% reduction in AHI if diagnostic AHI < 15/hr) during APAP titration. The independent predictors of titration PSG AHI were a history of cardiac disease and elevated central apnea and arousal indices during the diagnostic study. Although the median and interquartile range (IQR) AHI from the device (7.0, 3.9-11.6 events/hr) was only slightly less than the PSG AHI (7.8, 3.9-14.4 events/hr, P = 0.04) during titration, case-by-case agreement between the two measures was poor (chi-square < 0.001). Conclusion: In a clinical sample control of OSA during APAP titration is often poor, and close clinical follow-up is particularly needed in patients with a history of cardiac disease or with high arousal or central apnea indices on the diagnostic study. Device AHI does not reliably assess control during APAP titration, and PSG assessment may be required if clinical response to treatment is poor. The findings relate to the ResMed AutoSet device and may not apply to other devices. Citation: Huang HCC; Hillman DR; McArdle N. Control of OSA during automatic positive airway pressure titration in a clinical case series: predictors and accuracy of device download data. SLEEP 2012;35(9):1277–1283. PMID:22942506

Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes.

PubMed

Riddell, M A; Dunbar, J A; Absetz, P; Wolfe, R; Li, H; Brand, M; Aziz, Z; Oldenburg, B

2016-08-24

The 2013 Global Burden of Disease Study demonstrated the increasing burden of diabetes and the challenge it poses to the health systems of all countries. The chronic and complex nature of diabetes requires active self-management by patients in addition to clinical management in order to achieve optimal glycaemic control and appropriate use of available clinical services. This study is an evaluation of a "real world" peer support program aimed at improving the control and management of type 2 diabetes (T2DM) in Australia. The trial used a randomised cluster design with a peer support intervention and routine care control arms and 12-month follow up. Participants in both arms received a standardised session of self-management education at baseline. The intervention program comprised monthly community-based group meetings over 12 months led by trained peer supporters and active encouragement to use primary health care and other community resources and supports related to diabetes. Clinical, behavioural and other measures were collected at baseline, 6 and 12 months. The primary outcome was the predicted 5 year cardiovascular disease risk using the United Kingdom Prospective Diabetes Study (UKPDS) Risk Equation at 12 months. Secondary outcomes included clinical measures, quality of life, measures of support, psychosocial functioning and lifestyle measures. Eleven of 12 planned groups were successfully implemented in the intervention arm. Both the usual care and the intervention arms demonstrated a small reduction in 5 year UKPDS risk and the mean values for biochemical and anthropometric outcomes were close to target at 12 months. There were some small positive changes in self-management behaviours. The positive changes in self-management behaviours among intervention participants were not sufficient to reduce cardiovascular risk, possibly because approximately half of the study participants already had quite well controlled T2DM at baseline. Future research needs to address how to enhance community based programs so that they reach and benefit those most in need of resources and supports to improve metabolic control and associated clinical outcomes. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000469213 . Registered 16 June 2009.

Maintenance of a smoking cessation program in public health clinics beyond the experimental evaluation period.

PubMed Central

Manfredi, C.; Crittenden, K.; Cho, Y. I.; Engler, J.; Warnecke, R.

2001-01-01

OBJECTIVES: As phase 3 of a study to evaluate a smoking cessation program in public health practice, the authors assess the maintenance and impact of the It's Time smoking cessation program in seven public maternal and child health clinics in Chicago. METHODS: The authors interviewed 404 clinic patients in the study's baseline phase (prior to introduction of the It's Time intervention program), and 610 in the program maintenance phase (in the year after experimental evaluation had ended) to assess exposure to smoking cessation interventions offered at the clinic, and smoking cessation outcomes (quit, actions toward quitting, scores on action, motivation, readiness, and confidence scales). The authors controlled for clustering of smokers within clinics, smokers' characteristics prior to clinic visit, and type of clinic service. They compared outcomes by study group (control or intervention) to which each clinic had been assigned in the earlier experimental phase. RESULTS: Compared to baseline, smokers in the maintenance phase had greater exposure to posters, provider advice and booklet, and better outcomes on seven of eight smoking cessation measures, including quitting. These improvements were larger for clinics with prior experience implementing It's Time. CONCLUSION: Participation in the experimental evaluation of the It's Time program prepared and possibly motivated the clinics to continue the program. Continuing the program resulted in greater delivery of interventions and improved smoking cessation outcomes for smokers in the clinics. PMID:11889280

The natural history of subjective tinnitus in adults: A systematic review and meta-analysis of no-intervention periods in controlled trials.

PubMed

Phillips, John S; McFerran, Don J; Hall, Deborah A; Hoare, Derek J

2018-01-01

Tinnitus is a prevalent condition, but little has been published regarding the natural history of the condition. One technique for evaluating the long-term progression of the disease is to examine what happens to participants in the no-intervention control arm of a clinical trial. The aim of this study was to examine no-intervention or waiting-list data reported in trials, in which participants on the active arm received any form of tinnitus intervention. CINAHL, PsychINFO, EMBASE, ASSIA, PubMed, Web of Science, Science Direct, EBSCO Host, and Cochrane. Inclusion criteria followed the PICOS principles: Participants, adults with tinnitus; Intervention, none; Control, any intervention for alleviating tinnitus; Outcomes, a measure assessing tinnitus symptoms using a multi-item patient-reported tinnitus questionnaire. Secondary outcome measures included multi-item patient-reported questionnaires of mood and health-related quality of life and measures that quantified change in tinnitus loudness; Study design, randomized controlled trials or observational studies utilizing a no-intervention or waiting-list control group. Data were extracted and standardized mean difference was calculated for each study to enable meta-analysis. The evidence strongly favored a statistically significant decrease in the impact of tinnitus over time, though there was significant heterogeneity and clinical significance cannot be interpreted. Outcome data regarding secondary measures did not demonstrate any clinically significant change. Participants allocated to the no-intervention or waiting-list control arm of clinical trials for a tinnitus intervention show a small but significant improvement in self-reported measures of tinnitus with time; the clinical significance of this finding is unknown. There is, however, considerable variation across individuals. These findings support previous work and can cautiously be used when counseling patients. Laryngoscope, 128:217-227, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

77 FR 37059 - Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0419... who conduct studies using active controls and have a basic understanding of statistical principles... clinical investigators who conduct studies using active controls and have a basic understanding of...

Comparative clinical study using laser and LED-therapy for orofacial pain relief: dentin hypersensitivity and cervicogenic headache

NASA Astrophysics Data System (ADS)

Lizarelli, Rosane F. Z.; Pizzo, Renata C. A.; Florez, Fernando L. E.; Grecco, Clovis; Speciali, Jose G.; Bagnato, Vanderlei S.

2015-06-01

Considering several clinical situations, low intensity laser therapy has been widely applied in pain relief or analgesia mechanism. With the advent of new LED-based (light emitting diode) light sources, the need of further clinical experiments aiming to compare the effectiveness among them is paramount. The LED system therapeutic use can be denominated as LEDT - Light Emitting Diode Therapy. This study proposed two clinical evaluations of pain relief effect: to dentin hypersensitivity and to cervicogenic headache using different sources of lasers (low and high intensity) and light emitting diodes (LEDs), one emitting at the spectral band of red (630+/- 5nm) and the other one at infrared band (880+/- 5nm). Two different clinical studies were performed and presented interesting results. Considering dentin hypersensitivity, red and infrared led were so effective than the control group (high intensity laser system); by the other side, considering cervicogenic headache, control group (infrared laser) was the best treatment in comparison to red and infrared led system.

Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.

PubMed

Juraskova, I; Butow, P; Bonner, C; Bell, M L; Smith, A B; Seccombe, M; Boyle, F; Reaby, L; Cuzick, J; Forbes, J F

2014-07-08

Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.

Attachment styles, memories of parental rearing and therapeutic bond: a study with eating disordered patients, their parents and therapists.

PubMed

Tereno, Susana; Soares, Isabel; Martins, Carla; Celani, Mariana; Sampaio, Daniel

2008-01-01

Patients diagnosed with anorexia nervosa (n = 30) and bulimia nervosa (n = 27), their parents and therapists were recruited for this study aimed at examining differences between clinical groups and a control group (n = 35) in terms of attachment styles and perceptions of memories of parental rearing. Within the clinical groups, relations among these variables and therapeutic bond were explored. In addition, parents' and their daughters' attachment styles were compared. The results showed differences between clinical and control groups: the daughters in the control group reported lower levels of attachment anxiety compared to those of the clinical groups; their mothers exhibited higher security than mothers of anorectic patients and lower avoidance than mothers of bulimic patients. For the anorectic group, therapeutic bond was associated to higher father's emotional support and lower rejection; in the bulimic group, therapeutic bond was related to higher maternal emotional support and lower rejection as well as to lower paternal overprotection.

Mini-implants for orthodontic anchorage.

PubMed

Reynders, Reint Meursinge; Ladu, Luisa

2017-10-27

Data sourcesPubmed, Embase, Cochrane Central Register of Controlled Trials and the Web of Science databases. Hand searches of the journals European Journal of Orthodontics, Journal of Orthodontics, Journal of Clinical Orthodontics, Seminars in Orthodontics, American Journal of Orthodontics & Dentofacial Orthopaedics and Angle Orthodontist.Study selectionTwo reviewers independently selected studies. Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of orthodontic patients requiring extraction of the maxillary first premolars and closure of the spaces without anchorage loss were considered.Data extraction and synthesisData extraction and risk of bias assessment were carried out independently by two reviewers. Meta-analysis and sensitivity analysis were conducted.ResultsFourteen studies; seven RCTS and seven CCTs were included. In total 303 patients received TISADs with 313 control patients. Overall the quality of the studies was considered to be moderate. Overall the TISAD group had significantly less anchorage loss than the control group. On average, TISADs enabled 1.86mm more anchorage preservation than did conventional methods.ConclusionsThe results of the meta-analysis showed that TISADs are more effective than conventional methods of anchorage reinforcement. The average difference of 2mm seems not only statistically but also clinically significant. However, the results should be interpreted with caution because of the moderate quality of the included studies. More high-quality studies on this issue are necessary to enable drawing more reliable conclusions.

Clinical follow-up after cessation of chronic electrical neuromodulation in patients with severe coronary artery disease: a prospective randomized controlled study on putative involvement of sympathetic activity.

PubMed

Jessurun, G A; DeJongste, M J; Hautvast, R W; Tio, R A; Brouwer, J; van Lelieveld, S; Crijns, H J

1999-10-01

The present study assessed the reoccurrence of myocardial ischemia after withholding electrical neurostimulation. After randomization, in the study or withdrawal group, spinal cord stimulation (SCS) was set active during the first 4 weeks, followed by 4 weeks of withholding stimulation. In the control group, SCS was switched off during 4 weeks before the end of the study. The control group had no crossover period. Measurements were done at baseline, then after 4 and 8 weeks. The first periods at 4 weeks of each sequence of both groups were compared. In addition, a comparison of clinical variables was performed between the study group 4 weeks after withholding stimulation and the control group 4 weeks following randomization. A total number of 24 patients with refractory angina and an implanted spinal cord stimulator were included in the study (n = 12) and control group. Angina pectoris complaints, nitroglycerin intake, ischemia, and heart rate variability using 48-hour ambulatory electrocardiographic monitoring were assessed. In addition, neurohormonal status and symptom-limited aerobic capacity were evaluated. There was no increase of anginal complaints or ischemia after withholding stimulation. Neurohormonal levels and aerobic capacity were not altered. We conclude that there is no adverse clinical rebound phenomenon after withholding neurostimulation in patients with refractory angina pectoris.

Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

PubMed

Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

2017-08-01

This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. I. Main results of the studies].

PubMed

Jermendy, György

2018-04-01

The effect of antihyperglycaemic (antidiabetic) treatment on the late diabetic complications is one of the most important research areas in clinical diabetology. The relationship between glycaemic control and late micro- and macrovascular complications was highlighted by the results of the DCCT (Diabetes Control and Complications Trial) with type 1 and by the UKPDS (United Kingdom Prospective Diabetes Study) with type 2 diabetic patients. In these studies, observational follow-up investigations were also performed after the close-out of the randomized phase of the trial. In addition to these landmark studies, other randomized, controlled efficacy trials were also performed with observational follow-up investigations resulting in the development of the concept of metabolic memory or metabolic legacy. In this article, the main results of the studies are summarized. Orv Hetil. 2018; 159(15): 575-582.

Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial.

PubMed

Colombel, Jean-Frederic; Panaccione, Remo; Bossuyt, Peter; Lukas, Milan; Baert, Filip; Vaňásek, Tomas; Danalioglu, Ahmet; Novacek, Gottfried; Armuzzi, Alessandro; Hébuterne, Xavier; Travis, Simon; Danese, Silvio; Reinisch, Walter; Sandborn, William J; Rutgeerts, Paul; Hommes, Daniel; Schreiber, Stefan; Neimark, Ezequiel; Huang, Bidan; Zhou, Qian; Mendez, Paloma; Petersson, Joel; Wallace, Kori; Robinson, Anne M; Thakkar, Roopal B; D'Haens, Geert

2018-12-23

Biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein, have been recommended for monitoring patients with Crohn's disease, but whether their use in treatment decisions improves outcomes is unknown. We aimed to compare endoscopic and clinical outcomes in patients with moderate to severe Crohn's disease who were managed with a tight control algorithm, using clinical symptoms and biomarkers, versus patients managed with a clinical management algorithm. CALM was an open-label, randomised, controlled phase 3 study, done in 22 countries at 74 hospitals and outpatient centres, which evaluated adult patients (aged 18-75 years) with active endoscopic Crohn's disease (Crohn's Disease Endoscopic Index of Severity [CDEIS] >6; sum of CDEIS subscores of >6 in one or more segments with ulcers), a Crohn's Disease Activity Index (CDAI) of 150-450 depending on dose of prednisone at baseline, and no previous use of immunomodulators or biologics. Patients were randomly assigned at a 1:1 ratio to tight control or clinical management groups, stratified by smoking status (yes or no), weight (<70 kg or ≥70 kg), and disease duration (≤2 years or >2 years) after 8 weeks of prednisone induction therapy, or earlier if they had active disease. In both groups, treatment was escalated in a stepwise manner, from no treatment, to adalimumab induction followed by adalimumab every other week, adalimumab every week, and lastly to both weekly adalimumab and daily azathioprine. This escalation was based on meeting treatment failure criteria, which differed between groups (tight control group before and after random assignment: faecal calprotectin ≥250 μg/g, C-reactive protein ≥5mg/L, CDAI ≥150, or prednisone use in the previous week; clinical management group before random assignment: CDAI decrease of <70 points compared with baseline or CDAI >200; clinical management group after random assignment: CDAI decrease of <100 points compared with baseline or CDAI ≥200, or prednisone use in the previous week). De-escalation was possible for patients receiving weekly adalimumab and azathioprine or weekly adalimumab alone if failure criteria were not met. The primary endpoint was mucosal healing (CDEIS <4) with absence of deep ulcers 48 weeks after randomisation. Primary and safety analyses were done in the intention-to-treat population. This trial has been completed, and is registered with ClinicalTrials.gov, number NCT01235689. Between Feb 11, 2011, and Nov 3, 2016, 244 patients (mean disease duration: clinical management group, 0·9 years [SD 1·7]; tight control group, 1·0 year [2·3]) were randomly assigned to monitoring groups (n=122 per group). 29 (24%) patients in the clinical management group and 32 (26%) patients in the tight control group discontinued the study, mostly because of adverse events. A significantly higher proportion of patients in the tight control group achieved the primary endpoint at week 48 (56 [46%] of 122 patients) than in the clinical management group (37 [30%] of 122 patients), with a Cochran-Mantel-Haenszel test-adjusted risk difference of 16·1% (95% CI 3·9-28·3; p=0·010). 105 (86%) of 122 patients in the tight control group and 100 (82%) of 122 patients in the clinical management group reported treatment-emergent adverse events; no treatment-related deaths occurred. The most common adverse events were nausea (21 [17%] of 122 patients), nasopharyngitis (18 [15%]), and headache (18 [15%]) in the tight control group, and worsening Crohn's disease (35 [29%] of 122 patients), arthralgia (19 [16%]), and nasopharyngitis (18 [15%]) in the clinical management group. CALM is the first study to show that timely escalation with an anti-tumour necrosis factor therapy on the basis of clinical symptoms combined with biomarkers in patients with early Crohn's disease results in better clinical and endoscopic outcomes than symptom-driven decisions alone. Future studies should assess the effects of such a strategy on long-term outcomes such as bowel damage, surgeries, hospital admissions, and disability. AbbVie. Copyright © 2017 Elsevier Ltd. All rights reserved.

Using low-cost Android tablets and instructional videos to teach clinical skills to medical students in Kenya: a prospective study.

PubMed

O'Donovan, James; Ahn, Roy; Nelson, Brett D; Kagan, Calvin; Burke, Thomas F

2016-08-01

To assess the feasibility and impact of using a low-cost Android tablet to deliver clinical skills training to third-year medical students in Kenya. A prospective study using a low cost tablet called 'connecTAB', which was designed and manufactured specifically for areas with low bandwidth. Instructional video tutorials demonstrating techniques of cardiovascular and abdominal clinical examinations were pre-loaded onto the tablet. Maseno University School of Medicine, Western Kenya. Fifty-one third-year medical students from Maseno University School of Medicine were subjects in the study. Twenty-five students were assigned to the intervention group and 26 to the control group. At the start of the study, students from both groups completed an Observed Structured Clinical Examination (OSCE) of the cardiovascular and abdominal evaluations. Students who were allocated to the intervention group then received the connecTAB, whereas students in the control group did not. After a period of three weeks, students from both groups completed a post-study OSCE for both the cardiovascular and abdominal evaluations. There were significantly higher improvements in the scores for both cardiovascular and abdominal examinations (p < 0.001) within the group who received the e-tablets as compared to the control group. The study suggests that access to connecTAB improves clinical education and efficacy and holds promise for international training in both medical and allied healthcare professional spheres in resource-limited settings.

Randomized controlled trials in mild cognitive impairment

PubMed Central

Thomas, Ronald G.; Aisen, Paul S.; Mohs, Richard C.; Carrillo, Maria C.; Albert, Marilyn S.

2017-01-01

Objective: To examine the variability in performance among placebo groups in randomized controlled trials for mild cognitive impairment (MCI). Methods: Placebo group data were obtained from 2 National Institute on Aging (NIA) MCI randomized controlled trials, the Alzheimer's Disease Cooperative Study (ADCS) MCI trial and the Alzheimer's Disease Neuroimaging Initiative (ADNI), which is a simulated clinical trial, in addition to industry-sponsored clinical trials involving rivastigmine, galantamine, rofecoxib, and donepezil. The data were collated for common measurement instruments. The performance of the placebo participants from these studies was tracked on the Alzheimer's Disease Assessment Scale–cognitive subscale, Mini-Mental State Examination, and Clinical Dementia Rating–sum of boxes, and for progression on these measures to prespecified clinical study endpoints. APOE status, where available, was also analyzed for its effects. Results: The progression to clinical endpoints varied a great deal among the trials. The expected performances were seen for the participants in the 2 NIA trials, ADCS and ADNI, with generally worsening of performance over time; however, the industry-sponsored trials largely showed stable or improved performance in their placebo participants. APOE4 carrier status influenced results in an expected fashion on the study outcomes, including rates of progression and cognitive subscales. Conclusions: In spite of apparently similar criteria for MCI being adopted by the 7 studies, the implementation of the criteria varied a great deal. Several explanations including instruments used to characterize participants and variability among study populations contributed to the findings. PMID:28381516

The application of disease management to clinical trial designs.

PubMed

Puterman, Jared; Alter, David A

2009-08-01

The utilization of disease management (DM) as a minimum standard of care is believed to facilitate pronounced benefits in overall patient outcome and cost management. Randomized clinical trials remain the gold standard evaluative tool in clinical medicine. However, the extent to which contemporary cardiovascular clinical trials incorporate DM components into their treatment or control arms is unknown. Our study is the first to evaluate the extent to which clinical trials incorporate DM as a minimum standard of care for both the intervention and control groups. In total, 386 clinical trials published in 3 leading medical journals between 2003 and 2006 were evaluated. For each study, elements related to DM care, as defined using the American Heart Association Taxonomy, were abstracted and characterized. Our results demonstrate that while the application of DM has increased over time, only 3.4% of the clinical trials examined incorporated all 8 DM elements (and only 11% of such trials incorporated 4 DM elements). A significant association was found between study year and the inclusion of more than 3 elements of DM (chi(2) = 10.10 (3); p = 0.018). In addition, associations were found between study objective and DM criteria, as well as between cohort type and domains described. Our study serves as a baseline reference for the tracking of DM within, and its application to, randomized clinical trials. Moreover, our results underscore the need for broader implementation and evaluation of DM as a minimum care standard within clinical trial research.

eHealth and the use of individually tailored information: A systematic review.

PubMed

Conway, Nicholas; Webster, Clare; Smith, Blair; Wake, Deborah

2017-09-01

Tailored messages are those that specifically target individuals following an assessment of their unique characteristics. This systematic review assesses the evidence regarding the effectiveness of tailoring within eHealth interventions aimed at chronic disease management. OVID Medline/Embase databases were searched for randomised control trials, controlled clinical, trials, before -after studies, and time series analyses from inception - May 2014. Objectively measured clinical processes/outcomes were considered. Twenty-two papers were eligible for inclusion: 6/22 used fully tailored messaging and 16/22 used partially tailored messages. Two studies isolated tailoring as the active component. The remainder compared intervention with standard care. In all, 12/16 studies measuring clinical processes and 2/6 studies reporting clinical outcomes showed improvements, regardless of target group. Study quality was low and design did not allow for identification of interventions' active component. Heterogeneity precluded meta-analysis. This review has demonstrated that there is a lack of evidence to suggest that tailoring within an eHealth context confers benefit over non-tailored eHealth interventions.

Implementation of GINA guidelines in Ho Chi Minh City: a model for Viet Nam.

PubMed

Tho, N V; Loan, H T H; Thao, N T P; Dung, N T T; Lan, L T T

2012-12-21

The Global Initiative for Asthma (GINA) guidelines have not been implemented effectively in primary care settings in Viet Nam. To estimate the proportion of patients with controlled asthma and the direct health care costs of managing asthma according to GINA guidelines at four out-patient clinics in Ho Chi Minh City (HCMC), Viet Nam. One hundred and six patients with asthma were treated and followed up according to GINA guidelines for 12 months. Clinical and pulmonary function responses and direct health care costs were evaluated every 3 months during the study. The proportion of patients with controlled asthma rose from 1.0% at the start of the study to 36.8% by the end of the study (P < 0.0001). The proportion of patients who had at least one hospitalisation per year decreased significantly, from 32.1% to 5.7% (P < 0.0001). The annual per patient median direct health care cost was US$169. Using asthma controllers continuously gave better asthma control than using them intermittently (OR 12.9, 95%CI 4.7-35.7). The implementation of GINA guidelines at out-patient clinics in HCMC, Viet Nam, improved asthma control with modest direct health care costs.

[Clinical applications of dosing algorithm in the predication of warfarin maintenance dose].

PubMed

Huang, Sheng-wen; Xiang, Dao-kang; An, Bang-quan; Li, Gui-fang; Huang, Ling; Wu, Hai-li

2011-12-27

To evaluate the feasibility of clinical application for genetic based dosing algorithm in the predication of warfarin maintenance dose in Chinese population. The clinical data were collected and blood samples harvested from a total of 126 patients undergoing heart valve replacement. The genotypes of VKORC1 and CYP2C9 were determined by melting curve analysis after PCR. They were divided randomly into the study and control groups. In the study group, the first three doses of warfarin were prescribed according to the predicted warfarin maintenance dose while warfarin was initiated at 2.5 mg/d in the control group. The warfarin doses were adjusted according to the measured international normalized ratio (INR) values. And all subjects were followed for 50 days after an initiation of warfarin therapy. At the end of a 50-day follow-up period, the proportions of the patients on a stable dose were 82.4% (42/51) and 62.5% (30/48) for the study and control groups respectively. The mean durations of reaching a stable dose of warfarin were (27.5 ± 1.8) and (34.7 ± 1.8) days and the median durations were (24.0 ± 1.7) and (33.0 ± 4.5) days in the study and control groups respectively. Significant differences existed in the durations of reaching a stable dose between the two groups (P = 0.012). Compared with the control group, the hazard ratio (HR) for the duration of reaching a stable dose was 1.786 in the study group (95%CI 1.088 - 2.875, P = 0.026). The predicted dosing algorithm incorporating genetic and non-genetic factors may shorten the duration of achieving efficiently a stable dose of warfarin. And the present study validates the feasibility of its clinical application.

Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial

PubMed Central

Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

2016-01-01

[Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

PubMed

Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

2016-03-01

[Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists.

Adaptation of an evidence-based intervention to promote colorectal cancer screening: a quasi-experimental study

PubMed Central

2014-01-01

Background To accelerate the translation of research findings into practice for underserved populations, we investigated the adaptation of an evidence-based intervention (EBI), designed to increase colorectal cancer (CRC) screening in one limited English-proficient (LEP) population (Chinese), for another LEP group (Vietnamese) with overlapping cultural and health beliefs. Methods Guided by Diffusion of Innovations Theory, we adapted the EBI to achieve greater reach. Core elements of the adapted intervention included: small media (a DVD and pamphlet) translated into Vietnamese from Chinese; medical assistants distributing the small media instead of a health educator; and presentations on CRC screening to the medical assistants. A quasi-experimental study examined CRC screening adherence among eligible Vietnamese patients at the intervention and control clinics, before and after the 24-month intervention. The proportion of the adherence was assessed using generalized linear mixed models that account for clustering under primary care providers and also within-patient correlation between baseline and follow up. Results Our study included two cross-sectional samples: 1,016 at baseline (604 in the intervention clinic and 412 in the control clinic) and 1,260 post-intervention (746 in the intervention and 514 in the control clinic), including appreciable overlaps between the two time points. Pre-post change in CRC screening over time, expressed as an odds ratio (OR) of CRC screening adherence by time, showed a marginally-significant greater increase in CRC screening adherence at the intervention clinic compared to the control clinic (the ratio of the two ORs = 1.42; 95% CI 0.95, 2.15). In the sample of patients who were non-adherent to CRC screening at baseline, compared to the control clinic, the intervention clinic had marginally-significant greater increase in FOBT (adjusted OR = 1.77; 95% CI 0.98, 3.18) and a statistically-significantly greater increase in CRC screening adherence (adjusted OR = 1.70; 95% CI 1.05, 2.75). Conclusions Theoretically guided adaptations of EBIs may accelerate the translation of research into practice. Adaptation has the potential to mitigate health disparities for hard-to-reach populations in a timely manner. PMID:24989083

Collaborative Approach in the Development of High‐Performance Brain–Computer Interfaces for a Neuroprosthetic Arm: Translation from Animal Models to Human Control

PubMed Central

Collinger, Jennifer L.; Kryger, Michael A.; Barbara, Richard; Betler, Timothy; Bowsher, Kristen; Brown, Elke H. P.; Clanton, Samuel T.; Degenhart, Alan D.; Foldes, Stephen T.; Gaunt, Robert A.; Gyulai, Ferenc E.; Harchick, Elizabeth A.; Harrington, Deborah; Helder, John B.; Hemmes, Timothy; Johannes, Matthew S.; Katyal, Kapil D.; Ling, Geoffrey S. F.; McMorland, Angus J. C.; Palko, Karina; Para, Matthew P.; Scheuermann, Janet; Schwartz, Andrew B.; Skidmore, Elizabeth R.; Solzbacher, Florian; Srikameswaran, Anita V.; Swanson, Dennis P.; Swetz, Scott; Tyler‐Kabara, Elizabeth C.; Velliste, Meel; Wang, Wei; Weber, Douglas J.; Wodlinger, Brian

2013-01-01

Abstract Our research group recently demonstrated that a person with tetraplegia could use a brain–computer interface (BCI) to control a sophisticated anthropomorphic robotic arm with skill and speed approaching that of an able‐bodied person. This multiyear study exemplifies important principles in translating research from foundational theory and animal experiments into a clinical study. We present a roadmap that may serve as an example for other areas of clinical device research as well as an update on study results. Prior to conducting a multiyear clinical trial, years of animal research preceded BCI testing in an epilepsy monitoring unit, and then in a short‐term (28 days) clinical investigation. Scientists and engineers developed the necessary robotic and surgical hardware, software environment, data analysis techniques, and training paradigms. Coordination among researchers, funding institutes, and regulatory bodies ensured that the study would provide valuable scientific information in a safe environment for the study participant. Finally, clinicians from neurosurgery, anesthesiology, physiatry, psychology, and occupational therapy all worked in a multidisciplinary team along with the other researchers to conduct a multiyear BCI clinical study. This teamwork and coordination can be used as a model for others attempting to translate basic science into real‐world clinical situations. PMID:24528900

Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

PubMed

Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

2015-11-01

To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

Management Control Systems and Clinical Experience of Managers in Public Hospitals

PubMed Central

Naranjo-Gil, David

2018-01-01

Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector. PMID:29673192

Management Control Systems and Clinical Experience of Managers in Public Hospitals.

PubMed

Lunkes, Rogério Joao; Naranjo-Gil, David; Lopez-Valeiras, Ernesto

2018-04-17

Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector.

A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics.

PubMed

Koethe, John R; Westfall, Andrew O; Luhanga, Dora K; Clark, Gina M; Goldman, Jason D; Mulenga, Priscilla L; Cantrell, Ronald A; Chi, Benjamin H; Zulu, Isaac; Saag, Michael S; Stringer, Jeffrey S A

2010-03-12

The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree). Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months. From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites. A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings. Clinicaltrials.gov NCT00929604.

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses☆

PubMed Central

Pinto-Fraga, José; Blázquez Arauzo, Francisco; Urbano Rodríguez, Rubén; González-García, María J.

2014-01-01

Purpose To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. Methods This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Results Twenty subjects (10 women, 10 men) (mean age, 27.7 ± 5.6 years; range, 20–41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p = 0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p = 0.18). The study MPDS received higher rates in comfort (study: 8.14 ± 1.09, control: 7.94 ± 0.92; p = 0.56) and satisfaction at day 30 (study: 8.63 ± 0.91, control: 8.29 ± 0.80; p = 0.19), however the scores were not significantly different with the control MPDS. Conclusions The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. PMID:25649640

Polyamidoamine Dendrimers for Enhanced Solubility of Small Molecules and Other Desirable Properties for Site Specific Delivery: Insights from Experimental and Computational Studies.

PubMed

Shadrack, Daniel M; Swai, Hulda S; Munissi, Joan J E; Mubofu, Egid B; Nyandoro, Stephen S

2018-06-12

Clinical applications of many small molecules are limited due to poor solubility and lack of controlled release besides lack of other desirable properties. Experimental and computational studies have reported on the therapeutic potential of polyamidoamine (PAMAM) dendrimers as solubility enhancers in pre-clinical and clinical settings. Besides formulation strategies, factors such as pH, PAMAM dendrimer generation, PAMAM dendrimer concentration, nature of the PAMAM core, special ligand and surface modifications of PAMAM dendrimer have an influence on drug solubility and other recommendable pharmacological properties. This review, therefore, compiles the recently reported applications of PAMAM dendrimers in pre-clinical and clinical uses as enhancers of solubility and other desirable properties such as sustained and controlled release, bioavailability, bio-distribution, toxicity reduction or enhancement, and targeted delivery of small molecules with emphasis on cancer treatment.

Effectiveness of pre-travel consultation in the prevention of travel-related diseases: a retrospective cohort study.

PubMed

Tafuri, Silvio; Guerra, Rocco; Gallone, Maria Serena; Cappelli, Maria Giovanna; Lanotte, Serafina; Quarto, Michele; Germinario, Cinzia

2014-01-01

This study aims to evaluate the effectiveness of pre-travel counselling carried out in Travel Clinics. This is a retrospective cohort. Three hundred international travellers were enrolled; 150 people were from users of Bari Travel Clinic, 150 were users of a travel agency. Enrolled subjects were interviewed using a questionnaire. The average age of the enrolled subjects was 37.5 ± 13.9, without statistically significant differences between the two groups. 86% of cases and 19.3% of the controls reported the use of anti-malaria prophylaxis (p < 0.0001). Vaccination against cholera was given to 62% of cases and 7.3% of the controls (p < 0.001). Travel Clinic users, 6% reported diarrhoea and these figures were 27% in the control group (p < 0.0001). The proportion of those interviewed who reported fever (3.7) or insomnia (1.3) did not differ between the two groups. Mosquito bites were reported by 8% of cases and 20% of the controls (p = 0.003). Three cases of malaria were reported among the controls but no cases were detected among the cases (chi-square = 3.03; p = 0.08). Our study demonstrated the effectiveness of pre-travel counselling; in the future, new studies must investigate the cost-effectiveness of pre-travel prevention measures.

Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial.

PubMed

Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Yusof, Barakatun-Nisak Mohd

2016-02-27

Type 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls. This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy. The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes. ClinicalTrials.gov identifier: NCT02322268.

Outcomes Among Chronically Ill Adults in a Medical Home Prototype

PubMed Central

Liss, David T.; Fishman, Paul A.; Rutter, Carolyn M.; Grembowski, David; Ross, Tyler R.; Johnson, Eric A.; Reid, Robert J.

2014-01-01

Objectives To compare quality, utilization, and cost outcomes for patients with selected chronic illnesses at a patient-centered medical home (PCMH) prototype site with outcomes for patients with the same chronic illnesses at 19 nonintervention control sites. Study Design Nonequivalent pretest-posttest control group design. Methods PCMH redesign results were investigated for patients with preexisting diabetes, hypertension, and/or coronary heart disease. Data from automated databases were collected for eligible enrollees in an integrated healthcare delivery system. Multivariable regression models tested for adjusted differences between PCMH patients and controls during the baseline and follow-up periods. Dependent measures under study included clinical processes and, outcomes, monthly healthcare utilization, and costs. Results Compared with controls over 2 years, patients at the PCMH prototype clinic had slightly better clinical outcome control in coronary heart disease (2.20 mg/dL lower mean low-density lipoprotein cholesterol; P <.001). PCMH patients changed their patterns of primary care utilization, as reflected by 86% more secure electronic message contacts (P <.001), 10% more telephone contacts (P = .003), and 6% fewer in-person primary care visits (P <.001). PCMH patients had 21% fewer ambulatory care–sensitive hospitalizations (P <.001) and 7% fewer total inpatient admissions (P = .002) than controls. During the 2-year redesign, we observed 17% lower inpatient costs (P <.001) and 7% lower total healthcare costs (P <.001) among patients at the PCMH prototype clinic. Conclusions A clinic-level population-based PCMH redesign can decrease downstream utilization and reduce total healthcare costs in a subpopulation of patients with common chronic illnesses. PMID:24304182

A single-blinded, randomized, parallel group superiority trial investigating the effects of footwear and custom foot orthoses versus footwear alone in individuals with patellofemoral joint osteoarthritis: a phase II pilot trial protocol.

PubMed

Wyndow, Narelle; Crossley, Kay M; Vicenzino, Bill; Tucker, Kylie; Collins, Natalie J

2017-01-01

Patellofemoral joint osteoarthritis is a common condition, yet information regarding conservative management is lacking. Foot orthoses are an effective intervention for improving pain and function in younger individuals with patellofemoral pain and may be effective in those with patellofemoral osteoarthritis. This pilot study will seek to establish the feasibility of a phase III randomised controlled trial to investigate whether foot orthoses worn in prescribed motion controlled footwear are superior to prescribed motion control footwear alone in the management of patellofemoral osteoarthritis. This phase II pilot clinical trial is designed as a randomized, single-blind, parallel group, two arm, superiority trial. The trial will recruit 44 participants from Queensland and Tasmania, Australia. Volunteers aged 40 years and over must have clinical symptoms and radiographic evidence of patellofemoral osteoarthritis to be eligible for inclusion. Those eligible will be randomized to receive either foot orthoses and prescribed motion control shoes, or prescribed motion control shoes alone, to be worn for a period of 4 months. The feasibility of a phase III clinical trial will be evaluated by assessing factors such as recruitment rate, number of eligible participants, participant compliance with the study protocol, adverse events, and drop-out rate. A secondary aim of the study will be to determine completion rates and calculate effect sizes for patient reported outcome measures such as knee-related symptoms, function, quality of life, kinesiophobia, self-efficacy, general and mental health, and physical activity at 2 and 4 months. Primary outcomes will be reported descriptively while effect sizes and 95% confidence intervals will be calculated for the secondary outcome measures. Data will be analysed using an intention-to-treat principle. The results of this pilot trial will help determine the feasibility of a phase III clinical trial investigating whether foot orthoses plus motion control footwear are superior to motion control footwear alone in individuals with patellofemoral osteoarthritis. A Phase III clinical trial will help guide footwear and foot orthoses recommendations in the clinical management of this disorder. Retrospectively registered with the Australian New Zealand Clinical Trials Registry: ACTRN12615000002583. Date registered: 07/01/15.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for ‘point of care’ management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. Design/methods We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma—the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis—the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. Discussion This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. Trial registration ClinicalTrials.gov: NCT01815710 PMID:23692634

Diagnostic ultrasound imaging for lateral epicondylalgia: a case-control study.

PubMed

Heales, Luke James; Broadhurst, Nathan; Mellor, Rebecca; Hodges, Paul William; Vicenzino, Bill

2014-11-01

Lateral epicondylalgia (LE) is clinically diagnosed as pain over the lateral elbow that is provoked by gripping. Usually, LE responds well to conservative intervention; however, those who fail such treatment require further evaluation, including musculoskeletal ultrasound. Previous studies of musculoskeletal ultrasound have methodological flaws, such as lack of assessor blinding and failure to control for participant age, sex, and arm dominance. The purpose of this study was to assess the diagnostic use of blinded ultrasound imaging in people with clinically diagnosed LE compared with that in a control group matched for age, sex, and arm dominance. Participants (30 with LE and 30 controls) underwent clinical examination as the criterion standard test. Unilateral LE was defined as pain over the lateral epicondyle, which was provoked by palpation, resisted wrist and finger extension, and gripping. Controls without symptoms were matched for age, sex, and arm dominance. Ultrasound investigations were performed by two sonographers using a standardized protocol. Grayscale images were assessed for signs of tendon pathology and rated on a four-point ordinal scale. Power Doppler was used to assess neovascularity and rated on a five-point ordinal scale. The combination of grayscale and power Doppler imaging revealed an overall sensitivity of 90% and specificity of 47%. The positive and negative likelihood ratios for combined grayscale and power Doppler imaging were 1.69 and 0.21, respectively. Although ultrasound imaging helps confirm the absence of LE, when findings are negative for tendinopathic changes, the high prevalence of tendinopathic changes in pain-free controls challenges the specificity of the measure. The validity of ultrasound imaging to confirm tendon pathology in clinically diagnosed LE requires further study with strong methodology.

The effect of a clinical medical librarian on in-patient care outcomes*

PubMed Central

Esparza, Julia M.; Shi, Runhua; McLarty, Jerry; Comegys, Marianne; Banks, Daniel E.

2013-01-01

Objective: The research sought to determine the effect of a clinical medical librarian (CML) on outcomes of in-patients on the internal medicine service. Methods: A prospective study was performed with two internal medicine in-patient teams. Team 1 included a CML who accompanied the team on daily rounds. The CML answered questions posed at the point of care immediately or in emails post-rounds. Patients on Team 2, which did not include a CML, as well as patients who did not require consultation by the CML on Team 1, served as the control population. Numerous clinical and library metrics were gathered on each question. Results: Patients on Team 1 who required an answer to a clinical question were more ill and had a longer length of stay, higher costs, and higher readmission rates compared to those in the control group. Using a matched pair analysis, we showed no difference in clinical outcomes between the intervention group and the control group. Conclusions: This study is the largest attempt to prospectively measure changes in patient outcomes when physicians were accompanied by a CML on rounds. This approach may serve as a model for further studies to define when and how CMLs are most effective. PMID:23930088

[The clinical effectiveness of a post milking teat disinfection method with a foaming iodophor teat dip].

PubMed

Falkenberg, U; Tenhagen, B A; Heuwieser, W; Kalbe, P; Klünder, G; Baumgärtner, B

2003-02-01

The effect of postmilking teat dipping with a foaming iodophor agent on incidence of intramammary infections (IMI), incidence of clinical mastitis, somatic cell count and the characteristics of udder tissue and teat was investigated in a positively controlled field study. Two groups of animals were compared. Teats were dipped with a foaming iodophor in the treatment group (TG, 122 animals) while teats in the control group (CG, 121 animals) were dipped with a conventional iodophor teat dip with the same iodine content. A bacteriological examination of quarter milk samples divided the study period in two parts. The incidence of new IMI did not differ between the groups (1st part of trial: TG vs. CG: 6.84% vs. 9.16%, 2nd part of trial: 7.78% vs. 7.82%). There were no differences between the treatment groups regarding incidence of clinical mastitis. We detected 0.64 clinical cases per 100 days in the treatment group vs. 0.50 in the control group. The development of SCC was comparable in both groups. Teat skin and teat duct conditions showed variation during the study period. Clinical efficacy of postmilking teat disinfection with a foaming iodophor was comparable to the treatment with a conventional iodophor product.

The topical 5% lidocaine medicated plaster in localized neuropathic pain: a reappraisal of the clinical evidence

PubMed Central

de León-Casasola, Oscar A; Mayoral, Victor

2016-01-01

Topical 5% lidocaine medicated plasters represent a well-established first-line option for the treatment of peripheral localized neuropathic pain (LNP). This review provides an updated overview of the clinical evidence (randomized, controlled, and open-label clinical studies, real-life daily clinical practice, and case series). The 5% lidocaine medicated plaster effectively provides pain relief in postherpetic neuralgia, and data from a large open-label controlled study indicate that the 5% lidocaine medicated plaster is as effective as systemic pregabalin in postherpetic neuralgia and painful diabetic polyneuropathy but with an improved tolerability profile. Additionally, improved analgesia and fewer side effects were experienced by patients treated synchronously with the 5% lidocaine medicated plaster, further demonstrating the value of multimodal analgesia in LNP. The 5% lidocaine medicated plaster provides continued benefit after long-term (≤7 years) use and is also effective in various other LNP conditions. Minor application-site reactions are the most common adverse events associated with the 5% lidocaine medicated plaster; there is minimal risk of systemic adverse events and drug–drug interactions. Although further well-controlled studies are warranted, the 5% lidocaine medicated plaster is efficacious and safe in LNP and may have particular clinical benefit in elderly and/or medically compromised patients because of the low incidence of adverse events. PMID:26929664

Difference of Success Rates of Mineral Trioxide Aggregate Pulpotomies Performed Both by Undergraduate Dental Students and by an Expert Operator: A Retrospective Study.

PubMed

Pasini, Marco; Giuca, Maria Rita; Gatto, Roberto; Caruso, Silvia

2017-01-01

The aim of this retrospective study was to evaluate the clinical and radiographic success of pulpotomy on primary molars performed by dental students compared to that performed by an expert operator. The study was conducted on 142 second primary molars in 102 children. The patients were randomly selected from the available records. The test group (treated by dental students) included 51 subjects (28 males and 23 females, mean age: 7.2 ± 1) and the control group included 51 children (29 males and 22 females, mean age: 7.4 ± 1.2 years). After pulpotomy, a clinical and radiographic evaluation after 12 months was performed. Chi-square test and odds ratio were calculated and significance level was set at p < 0.05. The success rate was significantly lower, 81.6% ( p < 0.05), in the test group than in the control group (93%). The test group showed less clinical and radiographic success (86% and 80%, resp.) compared to the control group (97.2% for clinical success and 93% for radiographic success). Pulpotomy with MTA is an effective method that ensures a good percentage of success. The clinical experience of the operator is a contributing factor.

Clinical studies of fiber posts: a literature review.

PubMed

Cagidiaco, Maria C; Goracci, Cecilia; Garcia-Godoy, Franklin; Ferrari, Marco

2008-01-01

This literature review aimed to find answers to relevant questions regarding the clinical outcome of endontically treated teeth restored with fiber posts. All clinical studies published since 1990 in journals indexed in MEDLINE were retrieved by searching PubMed with the query terms "fiber posts and clinical studies." The reference list of the collected articles was also screened for further relevant citations. The strength of the evidence provided by the reviewed papers was assessed according to the criteria of evidence-based dentistry. Five randomized controlled trials (RCTs) on fiber posts have been published in peer-reviewed journals. A meta-analysis is not applicable to these studies since they do not address the same specific clinical question. Retrospective and prospective trials without controls are also available. Two RCTs indicate that fiber-reinforced composite posts outperform metal posts in the restoration of endontically treated teeth. However, this evidence cannot be considered as conclusive. Longer-term RCTs would be desirable. The placement of a fiber-reinforced composite post protects against failure, especially under conditions of extensive coronal destruction. The most common type of failure with fiber-reinforced composite posts is debonding.

Feedback intervention to doctors improves patient satisfaction among outpatients in Inner Mongolia Autonomous Region, China.

PubMed

Qiao, T; Geater, A F; Chongsuvivatwong, V; Fan, Y; Guo, Z

2017-11-01

The doctor-patient relationship (DPR) in China is known to be tense. We tested whether an intervention program providing individualized feedback to doctors by patients could improve patients' satisfaction in an outpatient setting. A non-randomized controlled prepost intervention study in a tertiary hospital. Six surgery clinics were chosen as the intervention group and eight internal medicine clinics as the control group. Before the program started, patients attending each group of clinics were asked to fill in the Short-Form Patient Satisfaction Questionnaire (PSQ-18). In the experimental period, patients attending the intervention clinics were requested to rate their perception of the doctor's quality of care in various domains on an 8-question feedback card immediately after exiting from the examination room and to drop the completed card into the feedback box for the particular doctor. The cards were then collected by the doctor confidentially at the end of each day. There was no feedback in the control clinics. After the experimental period ended, the doctors in both groups of clinics were reassessed by a new series of patients using PSQ-18. The PSQ-18 scores were compared within the same group of clinics over time, and the changes in satisfaction score compared between intervention and control clinics. There were 189 and 190 responders in the intervention group and 190 and 200 in the control group, before and after the intervention period, respectively. Scores in all domains increased significantly (P < 0.001) in the intervention group but not in the control group. Significant improvement in the patient satisfaction scores in the intervention clinics compared with the control clinics was confirmed by mixed-effects linear regression controlling for the effects of gender, age, marital status, education, and household income in the domains of general satisfaction, technical quality, communication, and accessibility and convenience. Timely feedback to doctors of patients' perception of quality of care received can improve outpatient satisfaction in a Chinese hospital. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Neurologic effects of exogenous saccharides: A review of controlled human, animal, and in vitro studies

PubMed Central

Nelson, Erika D.; Ramberg, Jane E.; Best, Talitha; Sinnott, Robert A.

2012-01-01

Objectives Current research efforts are centered on delineating the novel health benefits of naturally derived saccharides, including growing interest in their abilities to influence neurologic health. We performed a comprehensive review of the literature to consolidate all controlled studies assessing various roles of exogenous saccharide compounds and polysaccharide-rich extracts from plants, fungi, and other natural sources on brain function, with a significant focus on benefits derived from oral intake. Methods Studies were identified by conducting electronic searches on PubMed and Google Scholar. Reference lists of articles were also reviewed for additional relevant studies. Only articles published in English were included in this review. Results Six randomized, double-blind, placebo-controlled clinical studies were identified in which consumption of a blend of plant-derived polysaccharides showed positive effects on cognitive function and mood in healthy adults. A separate controlled clinical study observed improvements in well-being with ingestion of a yeast beta-glucan. Numerous animal and in vitro studies have demonstrated the ability of individual saccharide compounds and polysaccharide-rich extracts to modify behavior, enhance synaptic plasticity, and provide neuroprotective effects. Discussion Although the mechanisms by which exogenous saccharides can influence brain function are not well understood at this time, the literature suggests that certain naturally occurring compounds and polysaccharide-rich extracts show promise, when taken orally, in supporting neurologic health and function. Additional well-controlled clinical studies on larger populations are necessary, however, before specific recommendations can be made. PMID:22417773

Evaluating a health care provider delivered intervention to reduce intimate partner violence and mitigate associated health risks: study protocol for a randomized controlled trial in Mexico City.

PubMed

Falb, Kathryn L; Diaz-Olavarrieta, Claudia; Campos, Paola A; Valades, Jimena; Cardenas, Roosebelinda; Carino, Giselle; Gupta, Jhumka

2014-07-30

Intimate partner violence (IPV) victimization is a prevalent issue among women residing in Mexico City. Comprehensive and integrated health care provider (HCP) delivered programs in clinic-settings are needed, yet few have been evaluated in Latin America, including Mexico. In addition, there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics. The current randomized controlled trial seeks to increase midlevel HCPs' capacity, specifically nurses, who are often the first point of contact in this setting, to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation. Specific outcomes include changes in past-year IPV (physical and/or sexual), reproductive coercion, safety planning, use of community resources, and quality of life. Forty-two public health clinics in Mexico City were randomized to treatment or control clinics. Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV, providing supportive referrals, and assessing for health and safety risks. Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women. Women were screened for eligibility (currently experiencing abuse in a heterosexual relationship, 18-44 years of age, non-pregnant or in first trimester) by research assistants in private areas of waiting rooms in health clinics. Consenting women completed a baseline survey and received the study protocol for that clinic. In treatment clinics, women received the nurse delivered session at baseline and received a follow-up counseling session after three months. Surveys are conducted at baseline, three months, and fifteen months from baseline. This study will provide important insight into whether a nurse-delivered program can assist women currently experiencing abuse in a Latin American context. Findings can be used to inform IPV programs and policies in Mexico City's public health clinics. NCT01661504.

A theory of eu-estrogenemia: a unifying concept

PubMed Central

Turner, Ralph J.; Kerber, Irwin J.

2017-01-01

Abstract Objective: The aim of the study was to propose a unifying theory for the role of estrogen in postmenopausal women through examples in basic science, randomized controlled trials, observational studies, and clinical practice. Methods: Review and evaluation of the literature relating to estrogen. Discussion: The role of hormone therapy and ubiquitous estrogen receptors after reproductive senescence gains insight from basic science models. Observational studies and individualized patient care in clinical practice may show outcomes that are not reproduced in randomized clinical trials. The understanding gained from the timing hypothesis for atherosclerosis, the critical window theory in neurosciences, randomized controlled trials, and numerous genomic and nongenomic actions of estrogen discovered in basic science provides new explanations to clinical challenges that practitioners face. Consequences of a hypo-estrogenemic duration in women's lives are poorly understood. The Study of Women Across the Nation suggests its magnitude is greater than was previously acknowledged. We propose that the healthy user bias was the result of surgical treatment (hysterectomy with oophorectomy) for many gynecological maladies followed by pharmacological and physiological doses of estrogen to optimize patient quality of life. The past decade of research has begun to demonstrate the role of estrogen in homeostasis. Conclusions: The theory of eu-estrogenemia provides a robust framework to unify the timing hypothesis, critical window theory, randomized controlled trials, the basic science of estrogen receptors, and clinical observations of patients over the past five decades. PMID:28562489

Teaching metacognition in clinical decision-making using a novel mnemonic checklist: an exploratory study

PubMed Central

Chew, Keng Sheng; Durning, Steven J; van Merriënboer, Jeroen JG

2016-01-01

INTRODUCTION Metacognition is a cognitive debiasing strategy that clinicians can use to deliberately detach themselves from the immediate context of a clinical decision, which allows them to reflect upon the thinking process. However, cognitive debiasing strategies are often most needed when the clinician cannot afford the time to use them. A mnemonic checklist known as TWED (T = threat, W = what else, E = evidence and D = dispositional factors) was recently created to facilitate metacognition. This study explores the hypothesis that the TWED checklist improves the ability of medical students to make better clinical decisions. METHODS Two groups of final-year medical students from Universiti Sains Malaysia, Malaysia, were recruited to participate in this quasi-experimental study. The intervention group (n = 21) received educational intervention that introduced the TWED checklist, while the control group (n = 19) received a tutorial on basic electrocardiography. Post-intervention, both groups received a similar assessment on clinical decision-making based on five case scenarios. RESULTS The mean score of the intervention group was significantly higher than that of the control group (18.50 ± 4.45 marks vs. 12.50 ± 2.84 marks, p < 0.001). In three of the five case scenarios, students in the intervention group obtained higher scores than those in the control group. CONCLUSION The results of this study support the use of the TWED checklist to facilitate metacognition in clinical decision-making. PMID:26778635

Aromatherapy Massage for Neuropathic Pain and Quality of Life in Diabetic Patients.

PubMed

Gok Metin, Zehra; Arikan Donmez, Ayse; Izgu, Nur; Ozdemir, Leyla; Arslan, Ismail Emre

2017-07-01

This study aimed to examine the effects of aromatherapy massage on neuropathic pain severity and quality of life (QoL) in patients suffering from painful diabetic neuropathy. This open-label randomized controlled clinical study was conducted in a university hospital endocrine outpatient clinic in Turkey. The study sample consisted of 46 patients, randomly allocated to an intervention group (n = 21) and a control group (n = 25). The intervention group received aromatherapy massage three times per week for a period of 4 weeks. The control group received only routine care. Data were collected from patients using the Douleur Neuropathique questionnaire, the visual analog scale, and the Neuropathic Pain Impact on Quality of Life questionnaire. Neuropathic pain scores significantly decreased in the intervention group compared with the control group in the fourth week of the study. Similarly, QoL scores significantly improved in the intervention group in the fourth week of the study. Aromatherapy massage is a simple and effective nonpharmacological nursing intervention that can be used to manage neuropathic pain and improve QoL in patients with painful neuropathy. Aromatherapy massage is a well-tolerated, feasible, and safe nonpharmacological method that can be readily integrated into clinical settings by nursing staff. The essential oils rosemary, geranium, lavender, eucalyptus, and chamomile can be safely used by nurses in the clinical setting, if applicable. However, training and experience of nurses in aromatherapy massage is critical to achieving positive results. © 2017 Sigma Theta Tau International.

A systematic review of reboxetine for treating patients with attention deficit hyperactivity disorder.

PubMed

Ghanizadeh, Ahmad

2015-05-01

No published systematic review has ever assessed the efficacy and safety of reboxetine for treating of patients with attention deficit hyperactivity disorder (ADHD). This systematic review aimed to review the available evidence regarding the efficacy of reboxetine for treating ADHD. The databases of Pubmed/Medline, Google scholar, SCOPUS and Web of Science were searched using the Keywords: "reboxetine", "ADHD" and "attention deficit hyperactivity disorder". The reference lists of the included studies were screened to find any possible other relevant articles. All the non-controlled and controlled clinical trials were included. The current evidence mainly consists of un-controlled studies, such as case series. Only three of 33 studies were controlled clinical trials. They are from single sites and included a sub-sample of patients with ADHD. Non-controlled studies and controlled trials support the promising effect of reboxetine for treating ADHD in a sub-sample of patients that are without co-morbid psychiatric disorder and mental retardation. Reboxetine is tolerated well. However, more controlled trials are needed to reach any firm conclusion.

Management of Chronic Periodontitis Using Subgingival Irrigation of Ozonized Water: A Clinical and Microbiological Study.

PubMed

Issac, Annie V; Mathew, Jayan Jacob; Ambooken, Majo; Kachappilly, Arun Jose; Pk, Ajithkumar; Johny, Thomas; Vk, Linith; Samuel, Anju

2015-08-01

Adjunctive use of professional subgingival irrigation with scaling and root planing (SRP) has been found to be beneficial in eradicating the residual microorganisms in the pocket. To evaluate the effect of ozonized water subgingival irrigation on microbiologic parameters and clinical parameters namely Gingival index, probing pocket depth, and clinical attachment level. Thirty chronic periodontitis patients with probing pocket depth ≥6mm on at least one tooth on contra lateral sides of opposite arches were included in the study. The test sites were subjected to ozonized water subgingival irrigation with subgingival irrigation device fitted with a modified subgingival tip. Control sites were subjected to scaling and root planing only. The following clinical parameters were recorded initially and after 4 weeks at the test sites and control sites. Plaque Index, Gingival Index, probing pocket depth, clinical attachment level. Microbiologic sampling was done for the test at the baseline, after scaling, immediately after ozonized water subgingival irrigation and after 4 weeks. In control sites microbiologic sampling was done at the baseline, after scaling and after 4 weeks. The following observations were made after 4 weeks. The results were statistically analysed using independent t-test and paired t-test. Test sites showed a greater reduction in pocket depth and gain in clinical attachment compared to control sites. The total anaerobic counts were significantly reduced by ozonized water subgingival irrigation along with SRP compared to SRP alone. Ozonized water subgingival irrigation can improve the clinical and microbiological parameters in patients with chronic periodontitis when used as an adjunct to scaling and root planing.

Predoctoral Dental Students' Perceptions of Dental Implant Training: Effect of Preclinical Simulation and Clinical Experience.

PubMed

Prasad, Soni; Bansal, Naveen

2017-04-01

The aims of this study were to assess 1) differences in perceptions of dental implant training between dental students who received didactic training alone (control group) and those who received didactic plus simulation training (test group); 2) differences in response between students with and without clinical experience in implant dentistry; and 3) the interaction effect of simulation training and clinical experience on students' satisfaction. A survey was distributed to the control group in 2014 and to the test group in 2015; both groups were at the same U.S. dental school. Data were collected on confidence levels with various implant restorative procedures along with overall satisfaction and number of implant restorations performed by each student. The response rate was 78.7% in the control group and 81.3% in the test group. In the control group, 85.7% of students reported being satisfied with implant training compared to 90.8% of students in the test group. The interaction effect of simulation training and clinical experience on overall student satisfaction was OR=1.5 at 95% CI: 0.8, 3.0. The students who had clinical experience with implant restorative procedures had significantly greater satisfaction than those who did not (OR=4.8, 95% CI: 2.1, 11.1, p<0.01). This study found that both the simulation and clinical experience affected these students' confidence and satisfaction levels with implant education: they were almost five times more satisfied with implant training when clinical experience in implant restorative procedures was a part of their implant education.

Vasopressin, cortisol, and catecholamine concentrations in dogs with dilated cardiomyopathy.

PubMed

Tidholm, Anna; Häggström, Jens; Hansson, Kerstin

2005-10-01

To evaluate plasma concentrations and urinary excretion of vasopressin and cortisol and urinary excretion of catecholamines in dogs with dilated cardiomyopathy (DCM). 15 dogs with clinical signs of DCM, 15 dogs with preclinical DCM, and 15 control dogs. Physical examinations, thoracic radiography, ECG, and echocardiography were performed on all dogs. Blood and urine samples were collected. Plasma concentration of vasopressin and the urine cortisol-to-urine creatinine ratio were significantly increased in dogs with clinical signs of DCM and dogs with preclinical DCM, compared with control dogs. Plasma vasopressin concentration was significantly higher in dogs with clinical signs of DCM, compared with dogs with preclinical DCM. Urine vasopressin-to-urine creatinine ratio was significantly increased in dogs with clinical signs of DCM, compared with dogs with preclinical DCM and control dogs. Urine epinephrine-to-urine creatinine ratio and urine norepinephrine-to-urine creatinine ratio were significantly increased in dogs with clinical signs of DCM, compared with control dogs. Plasma concentration of cortisol and urine dopamine-to-urine creatinine ratio did not differ significantly among groups. According to this study, the neuroendocrine pattern is changed in dogs with preclinical DCM. These changes are even more pronounced in dogs with clinical signs of DCM. Analysis of concentrations of vasopressin, cortisol, and catecholamines may aid in identification of the clinical stages of DCM. These findings may also provide a basis for additional studies of the possible beneficial effects of vasopressin antagonists and beta-adrenergic receptor antagonists in the treatment of dogs with congestive heart failure and DCM.

Systematic Review and Meta-Analysis of the Clinical Efficacy and Adverse Effects of Chinese Herbal Decoction for the Treatment of Gout

PubMed Central

Liu, Xiaoyu; Chen, Pinyi; Liu, Ling; Zhang, Yanqi; Wu, Yazhou; Pettigrew, Julia Christine; Cheng, Dixiang; Yi, Dong

2014-01-01

Background In East Asia, numerous reports describe the utilization of traditional Chinese herbal decoctions to treat gout. However, the reported clinical effects vary. Objectives In this study, we reviewed and analyzed a large number of randomized controlled clinical trials to systematically assess the clinical efficacy and adverse reactions of Chinese herbal decoctions for treating gout. Methods We performed a comprehensive search of databases, such as PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese biomedical literature database, et al. In addition, we manually searched the relevant meeting information in the library of the Third Military Medical University. Results Finally, 17 randomized controlled trials with a sample size of 1,402 cases met the criteria and were included in the study. The results of the meta-analysis showed that when gout had progressed to the stage of acute arthritis, there was no significant difference in clinical efficacy between Chinese herbal decoctions and traditional Western medicine, as indicated based on the following parameters: serum uric acid (standardized mean difference (SMD):0.35, 95% confidence interval (CI): 0.03 to 0.67), C reactive protein (SMD: 0.25, 95% CI: −0.18 to 0.69), erythrocyte sedimentation rate (SMD: 0.21, 95% CI: −0.02 to 0.45) and overall clinical response (relative risk (RR): 1.05, 95% CI: 1.01 to 1.10). However, the Chinese herbal decoction was significantly better than traditional Western medicine in controlling adverse drug reactions (RR: 0.06, 95% CI: 0.03 to 0.13). Conclusions Through a systematic review of the clinical efficacy and safety of Chinese herbal decoctions and traditional Western medicine for the treatment of gout, we found that Chinese herbal decoction and traditional Western medicine led to similar clinical efficacy, but the Chinese herbal decoctions were superior to Western medicine in terms of controlling adverse drug reactions. PMID:24465466

Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma?

PubMed

Koenig, Steven M; Murray, John J; Wolfe, James; Andersen, Leslie; Yancey, Steve; Prillaman, Barbara; Stauffer, John; Dorinsky, Paul

2008-05-01

Little is known about the use of biomarkers in guiding treatment decisions in routine asthma management. The objective of this study was to determine whether adding a LABA to an ICS would control bronchial hyperresponsiveness (BHR) at an overall lower dose of ICS when titration of medication was based upon the assessment of routine clinical measures with or without the measurement of BHR. After a 2-week run-in period, subjects (> or = 12 years) were randomized to one of three treatment groups. Two groups followed a BHR treatment strategy (based on clinical parameters [lung function, asthma symptoms, and bronchodilator use] and BHR) and were treated with either fluticasone propionate/salmeterol (FSC(BHR) group) or fluticasone propionate (FP(BHR) group) (n=156 each). The third group followed a clinical treatment algorithm (based on clinical parameters alone) and were treated with fluticasone propionate (FP(REF) group; n=154). All treatments were administered via Diskus. Treatment doses were adjusted as needed every 8 weeks for 40 weeks according to the subject's derived severity class, which was based on clinical measures of asthma control with or without BHR. The mean total daily inhaled corticosteroids (ICS) dose during the double-blind treatment period was lower, although not statistically significant, in the FSC(BHR) group compared with the FP(BHR) group (a difference of -42.9 mcg; p=0.07). Compared with the FP(REF) group, the mean total daily ICS dose was higher in the FSC(BHR) group (a difference of 85.2 mcg) and was significantly higher in the FP(BHR) group (a difference of 131.2 mcg, p=0.037). This study demonstrated that for most subjects, control of BHR was maintained when treatment was directed toward control of clinical parameters. In addition, there was a trend towards control of BHR and clinical measures at a lower dose of ICS when used concurrently with salmeterol.

Effects of an intensive clinical skills course on senior nursing students' self-confidence and clinical competence: A quasi-experimental post-test study.

PubMed

Park, Soohyun

2018-02-01

To foster nursing professionals, nursing education requires the integration of knowledge and practice. Nursing students in their senior year experience considerable stress in performing the core nursing skills because, typically, they have limited opportunities to practice these skills in their clinical practicum. Therefore, nurse educators should revise the nursing curricula to focus on core nursing skills. To identify the effect of an intensive clinical skills course for senior nursing students on their self-confidence and clinical competence. A quasi-experimental post-test study. A university in South Korea during the 2015-2016 academic year. A convenience sample of 162 senior nursing students. The experimental group (n=79) underwent the intensive clinical skills course, whereas the control group (n=83) did not. During the course, students repeatedly practiced the 20 items that make up the core basic nursing skills using clinical scenarios. Participants' self-confidence in the core clinical nursing skills was measured using a 10-point scale, while their clinical competence with these skills was measured using the core clinical nursing skills checklist. Independent t-test and chi-square tests were used to analyze the data. The mean scores in self-confidence and clinical competence were higher in the experimental group than in the control group. This intensive clinical skills courses had a positive effect on senior nursing students' self-confidence and clinical competence for the core clinical nursing skills. This study emphasizes the importance of reeducation using a clinical skills course during the transition from student to nursing professional. Copyright © 2017. Published by Elsevier Ltd.

Outcomes of videotape instruction in clinic waiting area.

PubMed

Oermann, Marilyn H; Webb, Sue A; Ashare, Jo Ann

2003-01-01

The purpose of our study was to examine the effectiveness of general health-promotion teaching for patients in the waiting room of a clinic, using focused videotape instruction. An experimental design was used. Subjects were patients (N = 215) in the waiting rooms of clinics in a university medical center in the Midwest. Patients were randomly assigned to two groups: focused videotape instruction in the clinic (n = 106) and control (no instruction in the clinic waiting area) (n = 109). The outcome measures included patient learning about a health education topic and patient satisfaction with overall care, explanations by the provider, and education received during the clinic visit. There was a significant gain in knowledge for patients who viewed the videotape in the waiting room (t = 5.43, df = 213, p < .0001), and they were more satisfied with their education compared with the control group (t = 4.73, df = 213, p < .0001). This study supports focused video instruction as an effective and efficient teaching intervention for disseminating health information in the waiting area.

Vitamin E in human skin: organ-specific physiology and considerations for its use in dermatology.

PubMed

Thiele, Jens J; Ekanayake-Mudiyanselage, Swarna

2007-01-01

Vitamin E has been used for more than 50 years in experimental and clinical dermatology. While a large number of case reports were published in this time, there is still a lack of controlled clinical studies providing a rationale for well defined dosages and clinical indications. In contrast, advances in basic research on the physiology, mechanism of action, penetration, bioconversion and photoprotection of vitamin E in human skin has led to the development of numerous new formulations for use in cosmetics and skin care products. This article reviews basic mechanisms and possible cosmetic as well as clinical implications of the recent advances in cutaneous vitamin E research. Experimental evidence suggests that topical and oral vitamin E has antitumorigenic, photoprotective, and skin barrier stabilizing properties. While the current use of vitamin E is largely limited to cosmetics, controlled clinical studies for indications such as atopic dermatitis or preventions of photocarcinogenesis are needed to evaluate the clinical benefit of vitamin E.

A Tale of Smoking Cessation Promotion: The Utilization of a Children's Book to Increase Screening and Counseling in the Pediatric Clinic.

PubMed

Thomas, Katharine E H; Kisely, Steve; Urrego, Fernando

2017-10-01

The rate at which pediatricians promote smoking cessation in clinical settings is low. The literature demonstrates that interventions paired with tangible health promotion materials may significantly increase screening rates to the pediatric office. The aim of this study was to investigate whether the addition of a children's book in the pediatric clinic could result in an increase in the rate in which pediatricians screened for secondhand smoke exposure (SHSe) and counseled caregivers to stop smoking. This randomized controlled study was performed at 7 pediatric clinics. Seven pediatric clinic sites were randomly assigned to either an intervention or control group. Pediatricians in the intervention group were given children's books about SHSe to distribute to their patients while the control group did not receive any materials. At baseline, there was no difference between the control group and intervention group in rates at which pediatricians screened for SHSe ( P = .8728) and counseled caregivers to stop smoking ( P = .29). After the intervention, screening for SHSe and counseling caregivers to stop smoking were statistically significantly greater in the intervention group, when compared to controls ( P < .01 and P < .001, respectively). The use of a health promotion children's book in the pediatric setting can increase the rate at which pediatricians screen for SHSe and counsel caregivers to stop smoking. Future research should examine the effect of the storybook on various parameters of smoking cessation and future smoking behaviors.

The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial.

PubMed

Kuru, Tuğba; Yeldan, İpek; Dereli, E Elçin; Özdinçler, Arzu R; Dikici, Fatih; Çolak, İlker

2016-02-01

To compare the efficacy of three-dimensional (3D) Schroth exercises in patients with adolescent idiopathic scoliosis. A randomised-controlled study. An outpatient exercise-unit and in a home setting. Fifty-one patients with adolescent idiopathic scoliosis. Forty-five patients with adolescent idiopathic scoliosis meeting the inclusion criteria were divided into three groups. Schroth's 3D exercises were applied to the first group in the clinic and were given as a home program for the second group; the third group was the control. Scoliosis angle (Cobb method), angle of rotation (scoliometer), waist asymmetry (waist - elbow distance), maximum hump height of the patients and quality of life (QoL) (SRS-23) were assessed pre-treatment and, at the 6(th), 12(th) and 24(th) weeks. The Cobb (-2.53°; P=0.003) and rotation angles (-4.23°; P=0.000) significantly decreased, which indicated an improvement in the clinic exercise group compared to the other groups. The gibbosity (-68.66mm; P=0.000) and waist asymmetry improved only in the clinic exercise group, whereas the results of the other groups worsened. QoL did not change significantly in either group. According to the results of this study the Schroth exercise program applied in the clinic under physiotherapist supervision was superior to the home exercise and control groups; additionally, we observed that scoliosis progressed in the control group, which received no treatment. © The Author(s) 2015.

Factors influencing adherence to psychopharmacological medications in psychiatric patients: a structural equation modeling approach.

PubMed

De Las Cuevas, Carlos; de Leon, Jose; Peñate, Wenceslao; Betancort, Moisés

2017-01-01

To evaluate pathways through which sociodemographic, clinical, attitudinal, and perceived health control variables impact psychiatric patients' adherence to psychopharmacological medications. A sample of 966 consecutive psychiatric outpatients was studied. The variables were sociodemographic (age, gender, and education), clinical (diagnoses, drug treatment, and treatment duration), attitudinal (attitudes toward psychopharmacological medication and preferences regarding participation in decision-making), perception of control over health (health locus of control, self-efficacy, and psychological reactance), and level of adherence to psychopharmacological medications. Structural equation modeling was applied to examine the nonstraightforward relationships and the interactive effects among the analyzed variables. Structural equation modeling demonstrated that psychiatric patients' treatment adherence was associated: 1) negatively with cognitive psychological reactance (adherence decreased as cognitive psychological reactance increased), 2) positively with patients' trust in their psychiatrists (doctors' subscale), 3) negatively with patients' belief that they are in control of their mental health and that their mental health depends on their own actions (internal subscale), and 4) positively (although weakly) with age. Self-efficacy indirectly influenced treatment adherence through internal health locus of control. This study provides support for the hypothesis that perceived health control variables play a relevant role in psychiatric patients' adherence to psychopharmacological medications. The findings highlight the importance of considering prospective studies of patients' psychological reactance and health locus of control as they may be clinically relevant factors contributing to adherence to psychopharmacological medications.

[THERAPEUTIC AND DIETARY CORRECTION OF PROTEIN-ENERGY DEFICIENCY WITH A DRY PROTEIN COMPOSITE FORMULA IN PATIENTS WITH PULMONARY TUBERCULOSIS IN A TUBERCULOSIS HOSPITAL].

PubMed

2010-01-01

The time course of changes in the degree of tuberculous intoxication syndrome (scores), body mass deficiency (body mass index), routine clinical X-ray data on 300 first detected patients with tuberculosis treated at the Regional Clinical Tuberculosis Hospital (n = 160) and the clinic of the I. M. Sechenov Moscow Medical Academy (n = 140) was assessed to evaluate the efficiency of using a dry protein composite formula in the package of therapeutic measures in inpatients with pulmonary tuberculosis. A study group included 200 patients whose basic diet comprised the dry protein composite formula DISOO Nutrinor. A control group consisted of 100 patients receiving standard antituberculosis treatment and basic diet without using the above formula. In the vast majority of study group patients (n = 152), intoxication symptoms substantially reduced 1.6 months after the start of treatment whereas this occurred noticeably later (following 2.5 months) in the control group (n = 80). Better positive changes in weight gain were found during dietary therapy with the dry protein composite formula in the study group than in the control group. During correction of a dietary protein component, the monthly body weight gain in the study group was 2.2 kg on average greater than that in the control group. The study group patients were also found to have a more significant resolution of infiltrative and focal lung changes on control X-ray studies than the control patients. Also, the study group patients showed a trend for more frequent cessation of bacterial excretion than did the controls. The rate of adverse reactions to chemotherapy was 5% (10 subjects) in the study group and thrice higher than that in the control group (15%, 15 subjects) in the control group. The findings prove the efficiency and urgency of correction of protein-energy deficiency in patients with active pulmonary tuberculosis, by supplementing the dry protein composite formula to the basic diet.

Does the therapy manual or the therapist matter most in treatment of obsessive-compulsive disorder? A randomized controlled trial of exposure with response or ritual prevention in 118 patients.

PubMed

van Oppen, Patricia; van Balkom, Anton J L M; Smit, Johannes H; Schuurmans, Josien; van Dyck, Richard; Emmelkamp, Paul M G

2010-09-01

The importance of the therapist's education and experience for the successful behavior treatment of obsessive-compulsive disorder (OCD) has not been investigated. Data on the relative effectiveness of self-controlled versus therapist-controlled in vivo exposure with response or ritual prevention (ERP) have yielded conflicting results. The present study compared the effectiveness of 4 different modes of delivery of ERP in a referred sample of OCD patients. Of the 146 eligible OCD outpatients, 118 patients enrolled in this randomized controlled trial and were randomly assigned to (1) therapist-controlled ERP performed by experienced behavior therapists; (2) therapist-controlled ERP performed by master's students of clinical psychology; (3) self-controlled ERP performed by experienced behavior therapists; and (4) self-controlled ERP performed by master's students of clinical psychology. This trial was performed from January 1999 to January 2005. Our analyses revealed no significant differences in clinical outcome between any of the different modes of delivery of ERP at posttreatment. The different ERP modes of delivery were associated with significant pretreatment to posttreatment improvement on all measurements, with large effect sizes on the primary outcome measure, the Yale-Brown Obsessive Compulsive Scale. Our results indicate that clinically inexperienced master's students with no postgraduate training can be as capable as experienced and certified behavior therapists in treating OCD patients, as long as therapists adhere to a standardized treatment manual and adequate training and supervision is provided. In contrast to other studies, we did not find a supposed benefit of therapist-controlled ERP versus self-controlled ERP in patients with OCD. www.trialregister.nl Identifier: NTR1444. © Copyright 2010 Physicians Postgraduate Press, Inc.

Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study.

PubMed

Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

2015-01-01

Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p < 0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs' abilities to apply EBP knowledge and skills when supervising students.

Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study

PubMed Central

Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

2015-01-01

Background and Purpose Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. Methods We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. Results In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p<0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. Conclusions A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs’ abilities to apply EBP knowledge and skills when supervising students. PMID:25894559

What Is Different About Worker’s Compensation Patients?

PubMed Central

Atlas, Steven J.; Tosteson, Tor D.; Hanscom, Brett; Blood, Emily A.; Pransky, Glenn S.; Abdu, William A.; Andersson, Gunnar B.; Weinstein, James N.

2010-01-01

Study Design Combined analysis of 2 prospective clinical studies. Objective To identify socioeconomic characteristics associated with workers’ compensation in patients with an intervertebral disc herniation (IDH) or spinal stenosis (SpS). Summary of Background Data Few studies have compared socioeconomic differences between those receiving or not receiving workers’ compensation with the same underlying clinical conditions. Methods Patients were identified from the Spine Patient Outcomes Research Trial (SPORT) and the National Spine Network (NSN) practice-based outcomes study. Patients with IDH and SpS within NSN were identified satisfying SPORT eligibility criteria. Information on disability and work status at baseline evaluation was used to categorize patients into 3 groups: workers’ compensation, other disability compensation, or work-eligible controls. Enrollment rates of patients with disability in a clinical efficacy trial (SPORT) and practice-based network (NSN) were compared. Independent socioeconomic predictors of baseline workers’ compensation status were identified in multivariate logistic regression models controlling for clinical condition, study cohort, and initial treatment designation. Results Among 3759 eligible patients (1480 in SPORT and 2279 in NSN), 564 (15%) were receiving workers’ compensation, 317 (8%) were receiving other disability compensation, and 2878 (77%) were controls. Patients receiving workers’ compensation were less common in SPORT than NSN (9.2% vs. 18.8%, P < 0.001), but patients receiving other disability compensation were similarly represented (8.9% vs. 7.7%, P = 0.19). In univariate analyses, many socioeconomic characteristics significantly differed according to baseline workers’ compensation status. In multiple logistic regression analyses, gender, educational level, work characteristics, legal action, and expectations about ability to work without surgery were independently associated with receiving workers’ compensation. Conclusion Clinical trials involving conditions commonly seen in patients with workers’ compensation may need special efforts to ensure adequate representation. Socioeconomic characteristics markedly differed between patients receiving and not receiving workers’ compensation. Identifying the independent effects of workers’ compensation on outcomes will require controlling for these baseline characteristics and other clinical features associated with disability status. PMID:17700451

A Systematic Review of Experimental and Clinical Acupuncture in Chemotherapy-Induced Peripheral Neuropathy

PubMed Central

Franconi, Giovanna; Schröder, Sven; Marchetti, Paolo; Robinson, Nicola

2013-01-01

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect that can be very disabling and can limit or delay the dose of chemotherapy that can be administered. Acupuncture may be effective for treating peripheral neuropathy. The aim of this study was to review the available literature on the use of acupuncture for CIPN. The systematic literature search was performed using MEDLINE, Google Scholar, Cochrane Database, CINHAL, and ISI Proceedings. Hand searching was conducted, and consensus was reached on all extracted data. Only papers in the English language were included, irrespective of study design. From 3989 retrieved papers, 8 relevant papers were identified. One was an experimental study which showed that electroacupuncture suppressed CIPN pain in rats. In addition, there were 7 very heterogeneous clinical studies, 1 controlled randomised study using auricular acupuncture, 2 randomized controlled studies using somatic acupuncture, and 3 case series/case reports which suggested a positive effect of acupuncture in CIPN. Conclusions. Only one controlled randomised study demonstrated that acupuncture may be beneficial for CIPN. All the clinical studies reviewed had important methodological limitations. Further studies with robust methodology are needed to demonstrate the role of acupuncture for treating CIPN resulting from cancer treatment. PMID:23983788

Cigarette smoking and risk of pancreatic cancer: a clinic-based case-control study in the San Francisco Bay Area.

PubMed

Lea, C Suzanne; Holly, Elizabeth A; Bracci, Paige M

2015-11-01

Cigarette smoking is an established risk factor for pancreatic cancer (PC). We examined the association between cigarette smoking and PC in a San Francisco Bay Area clinic-based, case-control study. A total of 536 cases and sex and age frequency-matched controls (n = 869) were recruited predominately from the University of California San Francisco (UCSF) medical clinics between 2006 and 2011. Participants were interviewed in-person using structured questionnaires. Adjusted odds ratios (ORs) were computed. Forty-eight percent of cases and controls reported never having smoked cigarettes; 39% of cases and 40% of controls were former smokers; 13% of cases and 12% of controls were current smokers. No association was found for either former (OR = 0.85, 95% confidence interval [CI] = 0.66-1.1) or current cigarette smoking (men: OR = 1.0, 95% CI = 0.60-1.7; women: OR = 1.2, 95% CI = 0.73-2.1). No dose-response relationships were detected with number of cigarettes/day, smoking intensity, duration, or years since last smoked. Comparisons with a 1995-1999 population-based UCSF study demonstrated a significantly increased proportion of never smokers in this study (P < .001). This study revealed no significant associations between cigarette smoking and PC in the San Francisco Bay Area during 2006-2011. Data suggest a reduction in the duration of smoking within the referral population. Copyright © 2015 Elsevier Inc. All rights reserved.

Consanguinity and family clustering of male factor infertility in Lebanon.

PubMed

Inhorn, Marcia C; Kobeissi, Loulou; Nassar, Zaher; Lakkis, Da'ad; Fakih, Michael H

2009-04-01

To investigate the influence of consanguineous marriage on male factor infertility in Lebanon, where rates of consanguineous marriage remain high (29.6% among Muslims, 16.5% among Christians). Clinic-based, case-control study, using reproductive history, risk factor interview, and laboratory-based semen analysis. Two IVF clinics in Beirut, Lebanon, during an 8-month period (January-August 2003). One hundred twenty infertile male patients and 100 fertile male controls, distinguished by semen analysis and reproductive history. None. Standard clinical semen analysis. The rates of consanguineous marriage were relatively high among the study sample. Patients (46%) were more likely than controls (37%) to report first-degree (parental) and second-degree (grandparental) consanguinity. The study demonstrated a clear pattern of family clustering of male factor infertility, with patients significantly more likely than controls to report infertility among close male relatives (odds ratio = 2.58). Men with azoospermia and severe oligospermia showed high rates of both consanguinity (50%) and family clustering (41%). Consanguineous marriage is a socially supported institution throughout the Muslim world, yet its relationship to infertility is poorly understood. This study demonstrated a significant association between consanguinity and family clustering of male factor infertility cases, suggesting a strong genetic component.

Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial.

PubMed

Cardaropoli, Daniele; Tamagnone, Lorenzo; Roffredo, Alessandro; Gaveglio, Lorena

2012-03-01

Connective tissue graft (CTG) plus coronally advanced flap (CAF) is the reference therapy for root coverage. The aim of the present study is to evaluate the use of a porcine collagen matrix (PCM) plus CAF as an alternative to CTG+CAF for the treatment of gingival recessions (REC), in a prospective randomized, controlled clinical trial. Eighteen adult patients participated in this study. The patients presented 22 single Miller's Class I or II REC, randomly assigned to the test (PCM+CAF) or control (CTG+CAF) group. REC, probing depth, clinical attachment level (CAL), and width of keratinized tissue (KG) were evaluated at 12 months. In addition, the gingival thickness (GT) was measured 1mm apical to the bottom of the sulcus. At 12 months, mean REC was 0.23 mm for test sites and 0.09 mm for control sites (P <0.01), whereas percentage of root coverage was 94.32% and 96.97%, respectively. CAL gain was 2.41 mm in test sites and 2.95 mm in control sites (P <0.01). KG gain was 1.23 mm in the test group and 1.27 mm in the control group (P <0.01). In test sites, GT changed from 0.82 to 1.82 mm, and in control sites, from 0.86 to 2.09 mm (P <0.01). Within the limits of the study, both treatment procedures resulted in significant reduction in REC at 12 months. No statistically significant differences were found between PCM+CAF and CTG+CAF with regard to any clinical parameter. The collagen matrix represents a possible alternative to CTG.

Application of Standard Project Management Tools to Research--A Case Study from a Multi-National Clinical Trial

ERIC Educational Resources Information Center

Gist, Peter; Langley, David

2007-01-01

PRINCE2, which stands for Projects in Controlled Environments, is a project management method covering the organisation, management, and control of projects and is widely used in both government and commercial IT and building projects in the UK. This paper describes the application of PRINCE2 to the management of large clinical trials…

Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1—Psychometric Characteristics of 5 Paradigms

PubMed Central

Reddy, L. Felice; Horan, William P.; Barch, Deanna M.; Buchanan, Robert W.; Dunayevich, Eduardo; Gold, James M.; Lyons, Naomi; Marder, Stephen R.; Treadway, Michael T.; Wynn, Jonathan K.; Young, Jared W.; Green, Michael F.

2015-01-01

Impairments in willingness to exert effort contribute to the motivational deficits characteristic of the negative symptoms of schizophrenia. The current study evaluated the psychometric properties of 5 new or adapted paradigms to determine their suitability for use in clinical trials of schizophrenia. This study included 94 clinically stable participants with schizophrenia and 40 healthy controls. The effort-based decision-making battery was administered twice to the schizophrenia group (baseline, 4-week retest) and once to the control group. The 5 paradigms included 1 that assesses cognitive effort, 1 perceptual effort, and 3 that assess physical effort. Each paradigm was evaluated on (1) patient vs healthy control group differences, (2) test-retest reliability, (3) utility as a repeated measure (ie, practice effects), and (4) tolerability. The 5 paradigms showed varying psychometric strengths and weaknesses. The Effort Expenditure for Rewards Task showed the best reliability and utility as a repeated measure, while the Grip Effort Task had significant patient-control group differences, and superior tolerability and administration duration. The other paradigms showed weaker psychometric characteristics in their current forms. These findings highlight challenges in adapting effort and motivation paradigms for use in clinical trials. PMID:26142081

Plasma metabolic profiling of dairy cows affected with clinical ketosis using LC/MS technology.

PubMed

Li, Y; Xu, C; Xia, C; Zhang, Hy; Sun, Lw; Gao, Y

2014-01-01

Ketosis in dairy cattle is an important metabolic disorder. Currently, the plasma metabolic profile of ketosis as determined using liquid chromatography-mass spectrometry (LC/MS) has not been reported. To investigate plasma metabolic profiles from cows with clinical ketosis in comparison to control cows. Twenty Holstein dairy cows were divided into two groups based on clinical signs and plasma β-hydroxybutyric acid and glucose concentrations 7-21 days postpartum: clinical ketosis and control cows. Plasma metabolic profiles were analyzed using LC/MS. Data were processed using principal component analysis and orthogonal partial least-squares discriminant analysis. Compared to control cows, the levels of valine, glycine, glycocholic, tetradecenoic acid, and palmitoleic acid increased significantly in clinical ketosis. On the other hand, the levels of arginine, aminobutyric acid, leucine/isoleucine, tryptophan, creatinine, lysine, norcotinine, and undecanoic acid decreased markedly. Our results showed that the metabolic changes in cows with clinical ketosis involve complex metabolic networks and signal transduction. These results are important for future studies elucidating the pathogenesis, diagnosis, and prevention of clinical ketosis in dairy cows.

HLA-B27 and clinical features of acute anterior uveitis in Cuba.

PubMed

Torres, Sylvia; Borges, Sandra; Artiles, Adriana

2013-04-01

There are few data about the epidemiology of acute anterior uveitis (AAU) from Latin America. In Cuba, the genetic admixture of the population could modify the HLA-B27-AAU association. In this study, the authors compared the distribution of the HLA-B27 allele in patients and controls and described some clinical outcomes. The clinical features of patients were collected from their medical records. HLA-B27 genotyping was performed using the polymerase chain reaction. HLA-B27 allele distribution was compared between patients and controls. HLA-B27 allele was present in 55.4% of the patients and 0.87% of the controls. AAU HLA-B27 positivity was associated with males, frequent episodes, and a systemic disease. There is no difference in ocular complications between HLA-B27-positive and -negative patients. Results from this study are similar to data described in other countries. HLA-B27 allele distribution in controls is lower than other reports in Caucasian populations.

Brain Immune Interactions as the Basis of Gulf War Illness: Gulf War Illness Consortium (GWIC)

DTIC Science & Technology

2015-10-01

August to train all clinical staff and to ensure proper quality control measures are in place for the clinical studies. This has been followed up by...clinical and preclinical studies Training for researchers and clinical staff was completed at in-person meeting in Boston in August 2014 and continued to...Catechol-O- methyl transferase ( COMT ). COMT is associated with synaptic catecholamine neurotransmitters. COMT helps regulate cortical dopamine in the

Health services utilization under Qassam rocket attacks.

PubMed

Goldberg, Lital; Dreiher, Jacob; Friger, Michael; Levin, Alexander; Shvartzman, Pesach

2013-08-01

The Qassam rocket attacks on southern Israel during the years 2000-2007 created a unique situation of life undera continuous threat. The effect of this unique situation on health services utilization has not been previously examined. To evaluate health utilization patterns in two primary care clinics in southern Israel: one under continuous attacks of Qassam rockets as compared with a similar clinic not under a rocket threat. We conducted a retrospective cross-sectional study in two primary care clinics in southern Israel, with 11,630 persons listed in the two clinics during the entire study period. The primary outcome measures were total annual number of visits per person to the clinic and for specific diagnoses, and the number of drug prescriptions issued, emergency room (ER) visits, hospitalization days, cardiac catheterizations and coronary bypass surgeries. In both clinics there was an increase over time in the mean annual number of visits per person. During the years of severe attacks there was an increase in visits with a chief complaint of depression and anxiety and an increase in the number of anxiolytic prescriptions in the study clinic compared with the control. During the same period there was a decrease in the number of ER visits in the study clinic compared with the control. The population under continuous life-threatening events showed more depression and anxiety problems. Under severe bombardment, the residents prefer not to leave home, unless necessary.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. Methods A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. Discussion The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Trial registration Clinical Trials NCT01740635. PMID:24156396

[Potential therapeutic usefulness of cannabis and cannabinoids].

PubMed

Lorenzo Fernández, P

2000-01-01

Diseases in which Cannabis and cannabinoids have demonstrated some medicinal putative properties are: nausea and vomiting associated with cancer chemotherapy, muscle spasticity (multiple sclerosis, movement disorders), pain, anorexia, epilepsy, glaucoma, bronchial asthma, neuroegenerative diseases, cancer, etc. Although some of the current data comes from clinical controlled essays, the majority are based on anecdotic reports. Basic pharmacokinetic and pharmacodynamic studies and more extensive controlled clinical essays with higher number of patients and long term studies are necessary to consider these compounds useful since a therapeutical point of view.

A study to enhance clinical end-user MEDLINE search skills: design and baseline findings.

PubMed

McKibbon, K A; Haynes, R B; Johnston, M E; Walker, C J

1991-01-01

To determine if a preceptor and timely, individualized feedback improves the performance of physicians in searching MEDLINE using GRATEFUL MED in clinical settings. Randomized controlled trial. A 300 bed primary to tertiary care teaching hospital. Computers were installed in wards and clinics of 6 major clinical services, and the emergency room, intensive care and neonatal intensive care units. All physicians and physicians-in-training from the departments of Medicine, Family Medicine, Surgery, Psychiatry, Pediatrics, and Obstetrics and Gynecology were included if they made patient care decisions for at least 8 weeks during the study period. All participants were given a 1-hour training class and 1 hour of individualized searching with 1 of the 2 study librarians. After training, participants were randomized to a control group who received no further intervention or to an intervention group in which each person chose a clinical preceptor experienced in MEDLINE searching and received individualized feedback by a study librarian on their first 10 searches, indicating search quality and providing suggestions for improvement. Feedback was mailed the first week day after the search was done. Baseline characteristics by study group, department and level of training, study participation rates, and searching rates. 308 of 392 eligible physicians joined the study. Participation was almost 80% with some variation by department and level of training. Excellent balance in the baseline characteristics was achieved for the 2 groups, as well as for the number who did first searches. Intervention group participants searched MEDLINE more often than did controls (3.5 searches per month vs 2.5 per month for controls, P = 0.046). The recall and precision for first searches for both groups was significantly less than that of librarians. The analysis of study data will be completed by September 1991. Clinicians are willing to do self-service searching of MEDLINE in clinical settings but their precision and recall are less than a trained librarian at baseline. Search skills enhancements are needed and the effect of feedback and preceptors is being tested. U.S. National Library of Medicine and Ontario Ministry of Health.

Multidisciplinary COPD disease management program: impact on clinical outcomes.

PubMed

Morganroth, Melvin; Pape, Ginger; Rozenfeld, Yelena; Heffner, John E

2016-01-01

We hypothesized performance improvement interventions would improve COPD guideline-recommended care and decrease COPD exacerbations in primary care clinic practices. We initiated a performance improvement project in 12 clinics to improve COPD outcomes incorporating physician education, case management, web-based decision support (CareManager(TM)), and performance feedback. We collected baseline and one-year follow up data on 242 patients who had COPD with acute exacerbations. We analyzed data by two methods. First, the 12 clinics were cluster randomized to 4 intervention (117 patients) and 8 control (125 patients) clinics which all had access to CareManager(TM) but only intervention clinic physicians received case management, academic detailing, and decision support assistance. Exacerbation rates and guideline adherence were compared. Second, data from all 12 clinics were pooled in a quasi-experimental design comparing baseline and post-implementation of CareManager(TM) to determine the value of system-wide performance improvement during the study period. In the randomized analysis, baseline demographics were similar. No differences (p = 0.79) occurred in exacerbation rates between intervention and control clinics although both groups had decreased numbers of exacerbations from baseline to follow up (p < 0.05). The pooled data from all 12 clinics demonstrated a reduction (p < 0.05) in mean exacerbations/patient from 2.3 (CI 2.0-2.6) during baseline to 1.4 (CI 1.1-1.7) at one-year follow up. Emergency department visits and hospitalizations/patient decreased (p = 0.003). Patients naïve at study start to depression screening, pneumococcal vaccination, inhaled control medications or smoking cessation had fewer (p < 0.05) exacerbations after these interventions. We observed no difference in exacerbation rates between clinics receiving case management, academic detailing, and ongoing assistance with decision support and controls. Implementation of a web-based disease management system (CareManager(TM)) along with health system-wide COPD performance improvement efforts was associated with fewer COPD exacerbations and increased adherence to guideline recommendations.

Verbal Memory Impairment in Polydrug Ecstasy Users: A Clinical Perspective

PubMed Central

Kuypers, Kim P. C.; Theunissen, Eef L.; van Wel, Janelle H. P.; de Sousa Fernandes Perna, Elizabeth B.; Linssen, Anke; Sambeth, Anke; Schultz, Benjamin G.; Ramaekers, Johannes G.

2016-01-01

Background Ecstasy use has been associated with short-term and long-term memory deficits on a standard Word Learning Task (WLT). The clinical relevance of this has been debated and is currently unknown. The present study aimed at evaluating the clinical relevance of verbal memory impairment in Ecstasy users. To that end, clinical memory impairment was defined as decrement in memory performance that exceeded the cut-off value of 1.5 times the standard deviation of the average score in the healthy control sample. The primary question was whether being an Ecstasy user (E-user) was predictive of having clinically deficient memory performance compared to a healthy control group. Methods WLT data were pooled from four experimental MDMA studies that compared memory performance during placebo and MDMA intoxication. Control data were taken from healthy volunteers with no drug use history who completed the WLT as part of a placebo-controlled clinical trial. This resulted in a sample size of 65 E-users and 65 age- and gender-matched healthy drug-naïve controls. All participants were recruited by similar means and were tested at the same testing facilities using identical standard operating procedures. Data were analyzed using linear mixed-effects models, Bayes factor, and logistic regressions. Results Findings were that verbal memory performance of placebo-treated E-users did not differ from that of controls, and there was substantial evidence in favor of the null hypothesis. History of use was not predictive of memory impairment. During MDMA intoxication of E-users, verbal memory was impaired. Conclusion The combination of the acute and long-term findings demonstrates that, while clinically relevant memory impairment is present during intoxication, it is absent during abstinence. This suggests that use of Ecstasy/MDMA does not lead to clinically deficient memory performance in the long term. Additionally, it has to be investigated whether the current findings apply to more complex cognitive measures in diverse ‘user categories’ using a combination of genetics, imaging techniques and neuropsychological assessments. PMID:26907605

Theory of mind correlates with clinical insight but not cognitive insight in patients with schizophrenia.

PubMed

Zhang, Qi; Li, Xu; Parker, Giverny J; Hong, Xiao-Hong; Wang, Yi; Lui, Simon S Y; Neumann, David L; Cheung, Eric F C; Shum, David H K; Chan, Raymond C K

2016-03-30

Research on the relationship between insight and social cognition, in particular Theory of Mind (ToM), in schizophrenia has yielded mixed findings to date. Very few studies, however, have assessed both clinical insight and cognitive insight when examining their relationships with ToM in schizophrenia. The current study thus investigated the relationship between clinical insight, cognitive insight, and ToM in a sample of 56 patients with schizophrenia and 30 healthy controls. Twenty-seven patients were classified as low in clinical insight according to their scores on the 'insight' item (G12) of the Positive and Negative Syndrome Scale (PANSS). Moreover, cognitive insight and ToM were assessed with the Beck Cognitive Insight Scale (BCIS) and the Yoni task, respectively. The results indicated that patients with poor clinical insight performed worse on tasks of second-order cognitive and affective ToM, while the ToM performance of patients with high clinical insight was equivalent to that of healthy controls. Furthermore, while clinical insight was correlated with ToM and clinical symptoms, cognitive insight did not correlate with clinical insight, ToM, or clinical symptoms. Clinical insight thus appears to be an important factor related to ToM in schizophrenia. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Toxoplasma gondii seroprevalence and association with equine protozoal myeloencephalitis: A case-control study of Californian horses.

PubMed

James, K E; Smith, W A; Packham, A E; Conrad, P A; Pusterla, N

2017-06-01

While toxoplasmosis is not commonly considered a clinical disease of equines, previous seroprevalence studies have reported differing background rates of Toxoplasma gondii infection in horses globally. The objective of this study was to evaluate possible associations between T. gondii seroprevalence and clinical signs of equine protozoal myeloencephalitis (EPM) in horses. Using a case-control study design, 720 Californian horses with neurologic signs compatible with EPM were compared to healthy, non-neurologic horses for the presence of T. gondii antibodies (using indirect fluorescent antibody tests [IFAT]). Toxoplasma gondii seroprevalence among cases and controls was determined at standard serum cut-offs: 40, 80, 160, 320, and 640. At a T. gondii titre cut-off of 320, horses with clinical signs compatible with EPM had 3.55 times the odds of a seropositive test compared to those without clinical signs (P<0.01) when adjusted for covariates. When restricted to the autumn season and at the same titre cut-off, an EPM suspect horse had 6.4 times the odds of testing seropositive to T. gondii, compared to non-neurologic horses. The association between high T. gondii titres and clinical signs compatible with EPM is potentially reflective of toxoplasmosis in equines. Serologic testing of cerebrospinal fluid and isolation of T. gondii in EPM suspect cases should be considered. Future studies investigating the relationship between T. gondii and EPM are warranted. Copyright © 2017 Elsevier Ltd. All rights reserved.

The clinical effectiveness of cognitive behaviour therapy for chronic insomnia: implementation and evaluation of a sleep clinic in general medical practice.

PubMed

Espie, C A; Inglis, S J; Tessier, S; Harvey, L

2001-01-01

Chronic insomnia is a very common clinical condition which may respond well to non-pharmacological treatment. Indeed, the literature supports the efficacy of cognitive behaviour therapy (CBT). However, there has been no substantial study of clinical effectiveness. Since insomniacs typically present in general medical practice this is a crucial gap in the outcome research. This study, therefore, specifically investigated the clinical effectiveness of CBT delivered by Health Visitors (primary care nurses) trained as therapists. One hundred and thirty-nine insomniacs (mean age 51 yr) were randomised to CBT or Self-Monitoring Control (SMC) in a controlled trial. CBT comprised six group sessions (n=4 to 6 patients). After the controlled phase, SMC patients entered deferred treatment (CBT-DEF), allowing both treatment replication and long-term outcome to be investigated for a sizeable, treated sample. Repeated measures ANOVAs demonstrated superiority of CBT over SMC in substantially reducing sleep latency and wakefulness during the night. CBT-DEF replicated similar effects and maintained improvement was observed in both groups one year later. Furthermore, total sleep increased significantly during follow-up and 84% of patients initially using hypnotics remained drug-free. Results suggest that CBT administered by Health Visitors offers a clinically effective treatment for insomnia.

Association between drug insurance cost sharing strategies and outcomes in patients with chronic diseases: a systematic review.

PubMed

Mann, Bikaramjit S; Barnieh, Lianne; Tang, Karen; Campbell, David J T; Clement, Fiona; Hemmelgarn, Brenda; Tonelli, Marcello; Lorenzetti, Diane; Manns, Braden J

2014-01-01

Prescription drugs are used in people with hypertension, diabetes, and cardiovascular disease to manage their illness. Patient cost sharing strategies such as copayments and deductibles are often employed to lower expenditures for prescription drug insurance plans, but the impact on health outcomes in these patients is unclear. To determine the association between drug insurance and patient cost sharing strategies on medication adherence, clinical and economic outcomes in those with chronic diseases (defined herein as diabetes, hypertension, hypercholesterolemia, coronary artery disease, and cerebrovascular disease). Studies were included if they examined various cost sharing strategies including copayments, coinsurance, fixed copayments, deductibles and maximum out-of-pocket expenditures. Value-based insurance design and reference based pricing studies were excluded. Two reviewers independently identified original intervention studies (randomized controlled trials, interrupted time series, and controlled before-after designs). MEDLINE, EMBASE, Cochrane Library, CINAHL, and relevant reference lists were searched until March 2013. Two reviewers independently assessed studies for inclusion, quality, and extracted data. Eleven studies, assessing the impact of seven policy changes, were included: 2 separate reports of one randomized controlled trial, 4 interrupted time series, and 5 controlled before-after studies. Outcomes included medication adherence, clinical events (myocardial infarction, stroke, death), quality of life, healthcare utilization, or cost. The heterogeneity among the studies precluded meta-analysis. Few studies reported the impact of cost sharing strategies on mortality, clinical and economic outcomes. The association between patient copayments and medication adherence varied across studies, ranging from no difference to significantly lower adherence, depending on the amount of the copayment. Lowering cost sharing in patients with chronic diseases may improve adherence, but the impact on clinical and economic outcomes is uncertain.

Information Technology-Based Interventions to Improve Drug-Drug Interaction Outcomes: A Systematic Review on Features and Effects.

PubMed

Nabovati, Ehsan; Vakili-Arki, Hasan; Taherzadeh, Zhila; Saberi, Mohammad Reza; Medlock, Stephanie; Abu-Hanna, Ameen; Eslami, Saeid

2017-01-01

The purpose of this systematic review was to identify features and effects of information technology (IT)-based interventions on outcomes related to drug-drug interactions (DDI outcomes). A literature search was conducted in Medline, EMBASE, and the Cochrane Library for published English-language studies. Studies were included if a main outcome was related to DDIs, the intervention involved an IT-based system, and the study design was experimental or observational with controls. Study characteristics, including features and effects of IT-based interventions, were extracted. Nineteen studies comprising five randomized controlled trials (RCT), five non-randomized controlled trials (NRCT) and nine observational studies with controls (OWC) were included. Sixty-four percent of prescriber-directed interventions, and all non-prescriber interventions, were effective. Each of the following characteristics corresponded to groups of studies of which a majority were effective: automatic provision of recommendations within the providers' workflow, intervention at the time of decision-making, integration into other systems, and requiring the reason for not following the recommendations. Only two studies measured clinical outcomes: an RCT that showed no significant improvement and an OWC that showed improvement, but did not statistically assess the effect. Most studies that measured surrogate outcomes (e.g. potential DDIs) and other outcomes (e.g. adherence to alerts) showed improvements. IT-based interventions improve surrogate clinical outcomes and adherence to DDI alerts. However, there is lack of robust evidence about their effectiveness on clinical outcomes. It is recommended that researchers consider the identified features of effective interventions in the design of interventions and evaluate the effectiveness on DDI outcomes, particularly clinical outcomes.

Impact of the clinical Pilates exercises and verbal education on exercise beliefs and psychosocial factors in healthy women.

PubMed

Küçük, Fadime; Livanelioglu, Ayşe

2015-11-01

[Purpose] Exercise is one of the most important components of a healthy life. The purpose of this study was to analyze exercise beliefs and psychosocial factors in sedentary and active healthy women and observe the changes in these parameters resulting from clinical Pilates exercises and verbal education in healthy women. [Subjects and Methods] Sixty-six healthy women were included in the study. Participants were divided into clinical Pilates (n=21), verbal education (n=25), and control groups (n=20). Prior to and at the end of the study, demographic information, body mass index, waist-hip circumference, exercise beliefs, physical activity index, and psychosocial factors (Rosenberg self-esteem scale, Body Cathexis Index, SF-36 quality of life, Beck Depression Scale, visual analog scale for tiredness) of the subjects were recorded. [Results] Meaningful changes for all the parameters took place in the clinical Pilates and verbal education groups. Our analyses indicated that the changes in the clinical Pilates group were more meaningful than those in the verbal education group. When the data of the study groups were compared with those of the control group, the clinical Pilates group showed meaningful differences. [Conclusion] The result of this study indicate that both clinical Pilates and verbal education are effective in changing exercise beliefs and physical and psychosocial parameters.

The clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial

PubMed Central

Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Dean, Madeleine; Green, John; Jones, Rachael; Leurent, Baptiste; Sweeting, Michael J; Touquet, Robin; Greene, Linda; Tyrer, Peter; Ward, Helen; Lingford-Hughes, Anne

2015-01-01

Objectives To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics. Methods Two-arm, parallel group, assessor blind, pragmatic, randomised controlled trial. 802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment. Brief advice consisted of feedback on alcohol and health, written information and an offer of an appointment with an Alcohol Health Worker. Control participants received a leaflet on health and lifestyle. The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation. The main secondary outcome was unprotected sex during this period. Results Among the 402 randomised to brief advice, 397 (99%) received it. The adjusted mean difference in alcohol consumption at 6 months was −2.33 units per week (95% CI −4.69 to 0.03, p=0.053) among those in the active compared to the control arm of the trial. Unprotected sex was reported by 154 (53%) of those who received brief advice, and 178 (59%) controls (adjusted OR=0.89, 95% CI 0.63 to 1.25, p=0.496). There were no significant differences in costs between study groups at 6 months. Conclusions Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. Trial registration number Current Controlled Trials ISRCTN 99963322. PMID:24936090

The effect of an educational intervention, based on clinical simulation, on the diagnosis of rheumatoid arthritis and osteoarthritis.

PubMed

Fernández-Ávila, Daniel G; Ruiz, Álvaro J; Gil, Fabián; Mora, Sergio A; Tobar, Carlos; Gutiérrez, Juan M; Rosselli, Diego

2018-03-01

The aim of the present study was to evaluate the effectiveness of an educational tool for general physicians, based on rheumatological clinical simulation, for the diagnosis of rheumatoid arthritis and osteoarthritis. A randomized clinical study was carried out, in which the physician research subjects were assigned to one of two groups: the experimental group (educational intervention for rheumatoid arthritis with clinical simulation) or the control group (educational intervention for the basic aspects of the diagnosis and treatment of osteoporosis). Four weeks after the educational intervention, the members of both groups completed an examination that included four clinical cases with real patients, two clinical cases with two clinical simulation models and six virtual clinical cases. In this examination, the participants noted clinical findings, established a diagnosis and defined the complementary tests they would request, if necessary, to corroborate their diagnosis. A total of 160 doctors participated (80 in the active educational intervention for rheumatoid arthritis and 80 in the control group), of whom 89 were women (56%). The mean age was 35 (standard deviation 7.7) years. Success was defined as a physician correctly diagnosing at least 10 of the 12 cases presented. A significant difference of 81.3% (95% confidence interval 72-90%; p < 0.001) in success was found in favour of the active group (88.8% versus 7.5%). A greater number of correct answers was found in the active group compared with the control group in the detection of clinical findings and in the number of complementary tests requested (p < 0.001). The study showed the effectiveness of an educational intervention based on clinical simulation to improve the diagnostic approach to rheumatoid arthritis and osteoarthritis. The results open a new horizon in the teaching of rheumatology. Copyright © 2017 John Wiley & Sons, Ltd.

Risk Factors for SARS among Persons without Known Contact with SARS Patients, Beijing, China

PubMed Central

Wu, Jiang; Xu, Fujie; Zhou, Weigong; Feikin, Daniel R.; Lin, Chang-Ying; He, Xiong; Zhu, Zonghan; Liang, Wannian; Chin, Daniel P.

2004-01-01

Most cases of severe acute respiratory syndrome (SARS) have occurred in close contacts of SARS patients. However, in Beijing, a large proportion of SARS cases occurred in persons without such contact. We conducted a case-control study in Beijing that compared exposures of 94 unlinked, probable SARS patients with those of 281 community-based controls matched for age group and sex. Case-patients were more likely than controls to have chronic medical conditions or to have visited fever clinics (clinics at which possible SARS patients were separated from other patients), eaten outside the home, or taken taxis frequently. The use of masks was strongly protective. Among 31 case-patients for whom convalescent-phase (>21 days) sera were available, 26% had immunoglobulin G to SARS-associated coronavirus. Our finding that clinical SARS was associated with visits to fever clinics supports Beijing’s strategy of closing clinics with poor infection-control measures. Our finding that mask use lowered the risk for disease supports the community’s use of this strategy. PMID:15030685

Effects of low-dose aspirin on clinic and ambulatory blood pressure in treated hypertensive patients. Collaborative Group of the Primary Prevention Project (PPP)--Hypertension study.

PubMed

Avanzini, F; Palumbo, G; Alli, C; Roncaglioni, M C; Ronchi, E; Cristofari, M; Capra, A; Rossi, S; Nosotti, L; Costantini, C; Pietrofeso, R

2000-06-01

Nonsteroidal antiinflammatory drugs may affect blood pressure (BP) control in hypertensive patients receiving drug treatment, but data on the effects of low-dose aspirin are scanty. This study assessed the effects of chronic treatment with low doses of aspirin (100 mg/day) on clinic and ambulatory systolic (SBP) and diastolic (DBP) BP in hypertensives on chronic, stable antihypertensive therapy. The study was conducted in the framework of the Primary Prevention Project (PPP), a randomized, controlled factorial trial on the preventive effect of aspirin or vitamin E in people with one or more cardiovascular risk factors. Fifteen Italian hypertension units studied 142 hypertensive patients (76 men, 66 women; mean age 59 +/- 5.9 years) treated with different antihypertensive drugs: 71 patients were randomized to aspirin and 71 served as controls. All patients underwent a clinic BP evaluation with an automatic sphygmomanometer and a 24-h ambulatory BP monitoring, at baseline and after 3 months of aspirin treatment. At the end of the study the changes in clinic SBP and DBP were not statistically different in treated and untreated subjects. Ambulatory SBP and DBP after 3 months of aspirin treatment were similar to baseline: deltaSBP -0.5 mmHg (95% confidence intervals [CI] from -1.9 to +2.9 mm Hg) and deltaDBP -1.1 mm Hg (95% CI from -2.5 to +0.3 mm Hg). The pattern was similar in the control group. No interaction was found between aspirin and the most used antihypertensive drug classes (angiotensin converting enzyme inhibitors and calcium antagonists). Despite the relatively small sample size our results seem to exclude any significant influence of low-dose aspirin on BP control in hypertensives under treatment.

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial.

PubMed

Pontes, Caridad; Gratacós, Jordi; Torres, Ferran; Avendaño, Cristina; Sanz, Jesús; Vallano, Antoni; Juanola, Xavier; de Miguel, Eugenio; Sanmartí, Raimon; Calvo, Gonzalo

2015-08-20

Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. EudraCT 2011-005871-18 (21 December 2011).

Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial.

PubMed

Ring, Howard; Gilbert, Nakita; Hook, Roxanne; Platt, Adam; Smith, Christopher; Irvine, Fiona; Donaldson, Cam; Jones, Elizabeth; Kelly, Joanna; Mander, Adrian; Murphy, Caroline; Pennington, Mark; Pullen, Angela; Redley, Marcus; Rowe, Simon; Wason, James

2016-06-24

In adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive clinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe and to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with expertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life outcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also aims to establish whether any perceived benefits represent good value for money. The EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy management versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and drug-resistant epilepsy. Participants are randomly assigned either to a 'treatment as usual' control or a 'defined epilepsy nurse role' active arm, according to the cluster site at which they are treated. The active intervention utilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with ID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention (novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is seizure severity, including associated injuries and the level of distress manifest by the patient in the preceding 4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects. Descriptive measures include demographic and clinical descriptors of participants and clinical services in which they receive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with clinicians and participants' carers are also undertaken. The EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a nurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and epilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting these are discussed. International Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.

Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

PubMed

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

Prevalence and Spectrum of Gastro Esophageal Reflux Disease in Bronchial Asthma

PubMed Central

Rameschandra, Sahoo; Kunal; Vishwanath, Tantry; Ramkrishna, Anand; Acharya, Preetam

2015-01-01

Background There exists a complex interplay between asthma and gastroesophageal reflux disease. Both these diseases are known to aggravate each other and amelioration of one is necessary for the control of the other. There is a paucity of studies in Indian population on this subject. Aim To evaluate the clinical features and the endoscopic findings of the upper gastrointestinal tract in patients with bronchial asthma. Materials and Methods Study was conducted at KMC group of hospitals, Mangalore in the Department of chest medicine in association with Department of gastroenterology. Subjects included 50 cases of bronchial asthma and controls were 58 non asthmatic patients with allergic rhinitis and chronic urticaria. All patients were queried about presence or absence of symptoms of upper gastro intestinal tract disorders by gastro oesophageal reflux disease (GERD) questionnaire and all the included patients underwent upper gastro intestinal endoscopy. Results The study showed that symptoms of gastroesophageal reflux were significantly more in asthmatics (52%) as compared to the controls (28%). The common presenting features of gastroesophageal reflux in asthmatics were heartburn (40%) retrosternal pain (24%), nocturnal cough (18%), dyspepsia (16%) and regurgitation (14%) and the above symptoms were significantly more common in asthmatics as compared to controls. Gastroesophageal reflux disease was found to be significantly more common in the asthmatics (58%) as compared to the control group where it was present in 32.75% of the subjects. Clinical or endoscopic evidence of any upper gastrointestinal disorder was found in 68% of the asthmatics as compared to 37.93% of the controls. This difference was found to be statistically significant. Conclusion The study showed that gastroesophageal reflux disease was significantly more in asthmatics as compared to the controls. Upper gastrointestinal symptoms were more common in asthmatics as against controls. Clinical or endoscopic evidence of upper gastrointestinal disorder and gastroesophageal reflux disease was found in significantly higher proportion of the asthmatics as compared to the controls. Clinically silent gastroesophageal reflux disease was however seen in both control and asthmatic groups equally with a lower prevalence. PMID:26557556

Treatment of adenoviral keratoconjunctivitis with a combination of povidone-iodine 1.0% and dexamethasone 0.1% drops: a clinical prospective controlled randomized study.

PubMed

Kovalyuk, Natalya; Kaiserman, Igor; Mimouni, Michael; Cohen, Ornit; Levartovsky, Shmuel; Sherbany, Hilda; Mandelboim, Michal

2017-12-01

To determine the efficacy of combination povidone-iodine (PVP-I) 1.0% eyedrops and dexamethasone 0.1% eyedrops in the treatment of adenoviral keratoconjunctivitis. In a prospective, randomized, controlled, double-blinded clinical trial patients with recent adenoviral keratoconjunctivitis (diagnosed clinically and confirmed by PCR), we randomly divided into three treatment groups: study group - received PVP-I 1.0% and dexamethasone 0.1%, control 1 group - received dexamethasone 0.1% and control 2 group - received lubricating eyedrops (hypromellose 0.3%). The treatment was administered four times a day in each group. All patients were examined and filled a questionnaire before treatment and on the 3rd, 5th and 7th days of treatment. We included in the study 78 eyes (26 in each group). Adenovirus type 8 was the most common pathogen (83% of cases). The fastest improvement in patients red eyes, discharge, superficial punctate keratitis and pseudomembranes was observed in the study group (p < 0.001). Those patients reached a near complete recovery in 5-7 days, which was also confirmed by reduction in Adenovirus titres by PCR. The slowest improvement was in the control 2 group. Subepithelial infiltrates (SEI) were observed in 44% of the control 1 group, 20% of the control 2 group and in 0% of the study group. The rate of reduction in Adenovirus titres was the slowest in the control 1 group. The combination of PVP-I 1.0% and dexamethasone 0.1% four times a day can reduce symptoms and expedite recovery in epidemic keratoconjunctivitis patients. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Understanding health economic analysis in critical care: insights from recent randomized controlled trials.

PubMed

Sud, Sachin; Cuthbertson, Brian H

2011-10-01

The article reviews the methods of health economic analysis (HEA) in clinical trials of critically ill patients. Emphasis is placed on the usefulness of HEA in the context of positive and 'no effect' studies, with recent examples. The need to control costs and promote effective spending in caring for the critically ill has garnered considerable attention due to the high cost of critical illness. Many clinical trials focus on short-term mortality, ignoring costs and quality of life, and fail to change clinical practice or promote efficient use of resources. Incorporating HEA into clinical trials is a possible solution. Such studies have shown some interventions, although expensive, provide good value, whereas others should be withdrawn from clinical practice. Incorporating HEA into randomized controlled trials (RCTs) requires careful attention to collect all relevant costs. Decision trees, modeling assumptions and methods for collecting costs and measuring outcomes should be planned and published beforehand to minimize bias. Costs and cost-effectiveness are potentially useful outcomes in RCTs of critically ill patients. Future RCTs should incorporate parallel HEA to provide both economic outcomes, which are important to the community, alongside patient-centered outcomes, which are important to individuals.

Control of OSA during automatic positive airway pressure titration in a clinical case series: predictors and accuracy of device download data.

PubMed

Huang, Hsin-Chia Carol; Hillman, David R; McArdle, Nigel

2012-09-01

To investigate the factors associated with physiologic control of obstructive sleep apnea (OSA) during automatic positive airway pressure (APAP) titration in a clinical series. To also assess the usefulness of apnea-hypopnea index (AHI) data downloaded from the APAP device (Dev AHI). Retrospective review of a consecutive series of patients with OSA who underwent APAP titration (Autoset Spirit, ResMed, Bella Vista, New South Wales, Australia ) with simultaneous polysomnographic (PSG) monitoring in the sleep laboratory. Tertiary sleep clinic. There were 190 consecutive patients with OSA referred for APAP titration. There were 58% of patients who achieved optimal or good control of OSA (titration PSG AHI < 10, or at least 50% reduction in AHI if diagnostic AHI < 15/hr) during APAP titration. The independent predictors of titration PSG AHI were a history of cardiac disease and elevated central apnea and arousal indices during the diagnostic study. Although the median and interquartile range (IQR) AHI from the device (7.0, 3.9-11.6 events/hr) was only slightly less than the PSG AHI (7.8, 3.9-14.4 events/hr, P = 0.04) during titration, case-by-case agreement between the two measures was poor (chi-square < 0.001). In a clinical sample control of OSA during APAP titration is often poor, and close clinical follow-up is particularly needed in patients with a history of cardiac disease or with high arousal or central apnea indices on the diagnostic study. Device AHI does not reliably assess control during APAP titration, and PSG assessment may be required if clinical response to treatment is poor. The findings relate to the ResMed AutoSet device and may not apply to other devices.

Impact of bariatric surgery on clinical depression. Interrupted time series study with matched controls.

PubMed

Booth, Helen; Khan, Omar; Prevost, A Toby; Reddy, Marcus; Charlton, Judith; Gulliford, Martin C

2015-03-15

Obesity is associated with depression. This study aimed to evaluate whether clinical depression is reduced after bariatric surgery (BS). Obese adults who received BS procedures from 2002 to 2014 were sampled from the UK Clinical Practice Research Datalink. An interrupted time series design, with matched controls, was conducted from three years before, to a maximum of seven years after surgery. Controls were matched for body mass index (BMI), age, gender and year of procedure. Clinical depression was defined as a medical diagnosis recorded in year, or an antidepressant prescribed in year to a participant ever diagnosed with depression. Adjusted odds ratios (AOR) were estimated. There were 3045 participants (mean age 45.9; mean BMI 44.0kg/m(2)) who received BS, including laparoscopic gastric banding in 1297 (43%), gastric bypass in 1265 (42%), sleeve gastrectomy in 477 (16%) and six undefined. Before surgery, 36% of BS participants, and 21% of controls, had clinical depression; between-group AOR, 2.02, 95%CI 1.75-2.33, P<0.001. In the second post-operative year 32% had depression; AOR, compared to time without surgery, 0.83 (0.76-0.90, P<0.001). By the seventh year, the prevalence of depression increased to 37%; AOR 0.99 (0.76-1.29, P=0.959). Despite matching there were differences in depression between BS and control patients, representing the highly selective nature of BS. Depression is frequent among individuals selected to undergo bariatric surgery. Bariatric surgery may be associated with a modest reduction in clinical depression over the initial post-operative years but this is not maintained. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Impact of innate immunity in a subset of children with autism spectrum disorders: a case control study.

PubMed

Jyonouchi, Harumi; Geng, Lee; Cushing-Ruby, Agnes; Quraishi, Huma

2008-11-21

Among patients with autism spectrum disorders (ASD) evaluated in our clinic, there appears to be a subset that can be clinically distinguished from other ASD children because of frequent infections (usually viral) accompanied by worsening behavioural symptoms and/or loss/decrease in acquired skills. This study assessed whether these clinical features of this ASD subset are associated with atopy, asthma, food allergy (FA), primary immunodeficiency (PID), or innate immune responses important in viral infections. This study included the ASD children described above (ASD test, N = 26) and the following controls: ASD controls (N = 107), non-ASD controls with FA (N = 24), non-ASD controls with chronic rhinosinusitis/recurrent otitis media (CRS/ROM; N = 38), and normal controls (N = 43). We assessed prevalence of atopy, asthma, FA, CRS/ROM, and PID. Innate immune responses were assessed by measuring production of proinflammatory and counter-regulatory cytokines by peripheral blood mononuclear cells (PBMCs) in response to agonists of Toll-like receptors (TLRs), with or without pre-treatment of lipopolysaccharide (LPS), a TLR4 agonist. Non-IgE mediated FA was equally prevalent in both ASD test and ASD control groups, occurring at higher frequency than in the non-ASD controls. Allergic rhinitis, atopic/non-atopic asthma, and atopic dermatitis were equally prevalent among the study groups except for the CRS/ROM group in which non-atopic asthma was more prevalent (52.6%). CRS/ROM and specific polysaccharide antibody deficiency (SPAD) were more prevalent in the ASD test group than in the ASD control, FA, and normal control groups: 23.1% vs. < 5% for CRS/ROS and 19.2% vs. < 1% for SPAD. However, CRS/ROM patients had the highest prevalence of SPAD (34.2%). When compared to ASD and normal case controls, PBMCs from 19 non-SPAD, ASD test group children produced: 1) less IL-1beta with a TLR7/8 agonist, less IL-10 with a TLR2/6 agonist, and more IL-23 with a TLR4 agonist without LPS pre-treatment, and 2) less IL-1beta with TLR4/7/8 agonists with LPS pre-treatment. These are cytokines associated with the neuro-immune network. Clinical features of the ASD test group were not associated with atopy, asthma, FA, or PID in our study but may be associated with altered TLR responses mediating neuro-immune interactions.

Participants with schizophrenia retain the information necessary for informed consent during clinical trials

PubMed Central

Fischer, Bernard A.; McMahon, Robert P.; Meyer, Walter A.; Slack, Daniel J.; Appelbaum, Paul S.; Carpenter, William T.

2015-01-01

Objective Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge--including assessment of therapeutic misconception--in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks. Method Individuals enrolling in one of seven clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not re-reviewed at any follow-up visit. Results Fifty-nine participants were enrolled; analysis included 52 participants with at least one follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44= 3.43, p= 0.001). Retention of study knowledge was not related to symptoms, but had a weak correlation with cognitive capacity (R= 0.28, p= 0.07). Performance did not differ between participants from research clinics and those from community mental health centers. Conclusions Clinically-stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely re-evaluate participants during this type of clinical trial. PMID:23842013

Importance of placebo effect in cough clinical trials.

PubMed

Eccles, Ron

2010-01-01

Cough is a unique symptom because, unlike sneeze and other symptoms, it can be under voluntary control and this complicates clinical trials on cough medicines. All over-the-counter cough medicines (OTC) are very effective treatments because of their placebo effect. The placebo effect is enhanced by expectancy related to advertising, brand, packaging, and formulation. This placebo effect creates a problem for the conduct of clinical trials on OTC cough medicines that attempt to demonstrate the efficacy of a pharmacological agent above that of any placebo effect. Up to 85% of the efficacy of some cough medicines can be attributed to a placebo effect. The placebo effect apparent in clinical trials consists of several components: natural recovery, regression of cough response toward mean, demulcent effect, effect of sweetness, voluntary control, and effects related to expectancy and meaning of the treatment. The placebo effect has been studied most in the pain model, and placebo analgesia is reported to depend on the activation of endogenous opioid systems in the brain; this model may be applicable to cough. A balanced placebo design may help to control for the placebo effect, but this trial design may not be acceptable due to deception of patients. The placebo effect in clinical trials may be controlled by use of a crossover design, where feasible, and the changes in the magnitude of the placebo effect in this study design are discussed.

Serological analysis of patients treated with a new surgical hemostat containing bovine proteins and autologous plasma.

PubMed

Nelson, P A; Powers, J N; Estridge, T D; Elder, E A; Alea, A D; Sidhu, P K; Sehl, L C; DeLustro, F A

2001-01-01

A randomized, controlled clinical study of the management of diffuse bleeding with CoStasis surgical hemostat, a new hemostat containing bovine thrombin and collagen with the patient's own plasma, included patients undergoing cardiac, hepatic, iliac, and general surgery. Sera from 92 patients treated with CoStasis and 84 control patients were collected preoperatively and at a post surgical follow-up of 8 weeks. Among the control group, 57 patients were treated with Instat collagen sponge in noncardiac indications. Results showed that antibody responses in the CoStasis clinical study were similar to the reported literature for all antigens screened and were not associated with any adverse reactions. The bovine thrombin preparations in CoStasis and other commercially available thrombins were compared with the use of SDS-PAGE and Western blot analyses. Within this clinical study, CoStasis was shown to be a safe and effective hemostatic product containing bovine thrombin and bovine collagen and no pooled human blood products. Copyright 2001 John Wiley & Sons, Inc.

A double-blind, placebo-controlled study of preventive immunotherapy with E.P.D., in the treatment of seasonal allergic disease.

PubMed

Di Stanislao, C; Di Berardino, L; Bianchi, I; Bologna, G

1997-02-01

Control of seasonal symptoms by means of a preventive and easy to use (only one intradermal injection eight weeks before the pollen peak) immunotherapy, is recommended nowadays. We verified the clinical efficacy of E.P.D. (Enzyme Potentiated Desensibilization) in a double-blind, placebo-controlled study. This particular immunotherapy consists of an intradermal injection mix, made up of allergenic extracts at extremely low doses and an enzyme called beta-glucuronidase. The vaccine is administered once a year, eight weeks before pollen peaks. We studied a group of 40 patients allergic to grass pollen. The results, analysed statistically on the basis of a symptoms score, showed good clinical efficacy and a significant reduction of drug consumption during the high pollen period. Due to the clinical effectiveness, easy administration (only on injection) and excellent tolerance of the immunotherapy, E.P.D. is particularly suited for the prevention of seasonal symptoms in patients allergic to grass pollen.

Adherence and retention in clinical trials: a community-based approach.

PubMed

Fouad, Mona N; Johnson, Rhoda E; Nagy, M Christine; Person, Sharina D; Partridge, Edward E

2014-04-01

The Community Health Advisor (CHA) model has been widely used to recruit rural and low-income, mostly African American women into clinical and behavioral research studies. However, little is known about its effectiveness in promoting retention and adherence of such women in clinical trials. The Community-Based Retention Intervention Study evaluated the effectiveness of a community-based intervention strategy using the CHA model and the empowerment theory to improve the retention and adherence of minority and low-income women in clinical trials. The research strategy included the training and use of the volunteer CHAs as research partners. The target population included women participating in the University of Alabama at Birmingham clinical site of the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), a multicenter, randomized clinical trial. Two communities in Jefferson County, Alabama, that were matched according to population demographics were identified and randomly assigned to either an intervention group or a control group. Thirty community volunteers were recruited to be CHAs and to implement the intervention with the ALTS trial participants. In total, 632 ALTS participants agreed to participate in the project, including 359 in the intervention group, which received CHA care, and 273 in the control group, which received standard care. Adherence rates for scheduled clinic visits were significantly higher in the intervention group (80%) compared with the control group (65%; P < .0001). The results indicate that volunteer CHAs can be trained to serve as research partners and can be effective in improving the retention and adherence of minority and low-income women in clinical trials. © 2014 American Cancer Society.

[Clinical study on the effect of anti-gingivitis IgY toothpaste in control of gingivitis and dental plaque].

PubMed

Zhang, Wei; Feng, Xi-Ping; Tao, Dan-Ying; Chen, Jian-Fen

2016-08-01

To observe the effect of anti-gingivitis IgY toothpaste in control of gingivitis and plaque. The study was a double-blind, randomized, parallel-controlled clinical trail with a total of 100 subjects who were divided into two groups, experimental group and control group. The subjects in experimental group used anti-gingivitis IgY toothpaste to brush twice daily for 3 minutes, and the subjects in control group used none anti-gingivitis IgY toothpaste. The examiner recorded GI, PI and BOP index of all subjects at the baseline, 6-weeks and 12-weeks. SPSS21.0 software package was used for statistical analysis. Twelve weeks later, there were significant differences in GI and BOP between the two groups. Yet no significant difference was found in PI. Anti-gingivitis IgY toothpaste is effective in control of gingivitis.

[Study on "multi-dimensional structure and process dynamics quality control system" of Danshen infusion solution based on component structure theory].

PubMed

Feng, Liang; Zhang, Ming-Hua; Gu, Jun-Fei; Wang, Gui-You; Zhao, Zi-Yu; Jia, Xiao-Bin

2013-11-01

As traditional Chinese medicine (TCM) preparation products feature complex compounds and multiple preparation processes, the implementation of quality control in line with the characteristics of TCM preparation products provides a firm guarantee for the clinical efficacy and safety of TCM preparation products. Danshen infusion solution is a preparation commonly used in clinic, but its quality control is restricted to indexes of finished products, which can not guarantee its inherent quality. Our study group has proposed "multi-dimensional structure and process dynamics quality control system" on the basis of "component structure theory", for the purpose of controlling the quality of Danshen infusion solution at multiple levels and in multiple links from the efficacy-related material basis, the safety-related material basis, the characteristics of dosage form to the preparation process. This article, we bring forth new ideas and models to the quality control of TCM preparation products.

Nutritional status in patients with cutaneous leishmaniasis and a study of the effects of zinc supplementation together with antimony treatment.

PubMed

Guzman-Rivero, Miguel; Rojas, Ernesto; Verduguez-Orellana, Aleida; Pardo, Henry; Torrico, Mary Cruz; Cloetens, Lieselotte; Akesson, Björn; Sejas, Edgar

2014-01-01

The role of micronutrient status for the incidence and clinical course of cutaneous leishmaniasis is not much studied. Still zinc supplementation in leishmaniasis has shown some effect on the clinical recovery, but the evidence in humans is limited. To compare biochemical nutritional status in cutaneous leishmaniasis patients with that in controls and to study the effects of zinc supplementation for 60 days. Twenty-nine patients with cutaneous leishmaniasis were treated with antimony for 20 days. Fourteen of them got 45 mg zinc daily and 15 of them got placebo. Biomarkers of nutritional and inflammatory status and changes in size and characteristics of skin lesions were measured. The level of transferrin receptor was higher in patients than in controls but otherwise no differences in nutritional status were found between patients and controls. No significant effects of zinc supplementation on the clinical recovery were observed as assessed by lesion area reduction and characteristics or on biochemical parameters. It is concluded that nutritional status was essentially unaffected in cutaneous leishmaniasis and that oral zinc supplementation administered together with intramuscular injection of antimony had no additional clinical benefit.

The Clinical Interview Schedule-Revised (CIS-R)-Malay Version, Clinical Validation.

PubMed

Subramaniam, Kavitha; Krishnaswamy, Saroja; Jemain, Abdul Aziz; Hamid, Abdul; Patel, Vikram

2006-01-01

Use of instruments or questionnaires in different cultural settings without proper validation can result in inaccurate results. Issues like reliability, validity, feasibility and acceptability should be considered in the use of an instrument. The study aims to determine the usefulness of the CIS-R Malay version in detecting common mental health problems specifically to establish the validity. The CIS-R instrument (PROQSY* format) was translated through the back translation process into Malay. Inter rater reliability was established for raters who were medical students. Cases and controls for the study were psychiatric in patients, out patient and relatives or friends accompanying the patients to the clinic or visiting the inpatients. The Malay version of CIS-R was administered to all cases and controls. All cases and controls involved in the study were rated by psychiatrists for psychiatric morbidity using the SCID as a guideline. Specificity and sensitivity of the CIS-R to the assessment by the psychiatrist were determined. The Malay version of CIS-R showed 100% sensitivity and 96.15% specificity at a cut off score of 9. The CIS-R can be a useful instrument for clinical and research use in the Malaysian population for diagnosing common mental disorders like depression and anxiety.

Clinical profile of Monomelic Amyotrophy (MMA) and role of persistent viral infection.

PubMed

Vibha, Deepti; Behari, Madhuri; Goyal, Vinay; Shukla, Garima; Bhatia, Rohit; Srivastava, Achal Kumar; Vivekanandhan, S

2015-12-15

The objective of our study was to describe the clinical characteristics, electrophysiology, MRI features and conduct viral assays in patients with Monomelic Amyotrophy (MMA) and follow them up over one year. Consecutive patients with MMA who attended the Neurology services from April 2013 to March 2014 were included. Age and sex matched controls were taken for the purpose of viral assay analysis. The clinical evaluation was repeated at six months and one year. 109 cases and 109 controls were included in the study. The patients were predominantly males (98.2%; n=107/109) and had involvement of upper limbs (83.5%; n=91/109). 26 (23.8%) patients with clinically unilateral involvement had bilateral neurogenic changes in the electromyography. Serological assays of Japanese E, West Nile Virus, and Poliovirus 1, 2 and 3, HIV 1 and 2 were negative in all the cases and controls. Patients with MMA are predominantly young males with upper limb wasting and weakness. MRI of the cervical cord is normal in most of the patients (67.9%). The present study did not find any evidence of the association of viral infection in MMA. Copyright © 2015 Elsevier B.V. All rights reserved.

Gut microbiota and probiotics: Focus on diabetes mellitus.

PubMed

Bordalo Tonucci, Livia; Dos Santos, Karina Maria Olbrich; De Luces Fortes Ferreira, Celia Lucia; Ribeiro, Sonia Machado Rocha; De Oliveira, Leandro Licursi; Martino, Hercia Stampini Duarte

2017-07-24

The characterization of gut microbiota has become an important area of research in several clinical conditions, including type 2 diabetes (T2DM). Changes in the composition and/or metabolic activity of the gut microbiota can contribute to human health. Thus, this review discusses the effects of probiotics and gut microbiota on metabolic control in these individuals. Relevant studies were obtained from electronic databases such as PubMed/Medline and ISI Web of Science. The main probiotics used in these studies belonged to the genera Lactobacillus and Bifidobacterium. The authors found seven randomized placebo-controlled clinical trials and 13 experimental studies directly related to the effect of probiotics on metabolic control in the context of T2DM. The hypothesis that gut microbiota plays a role in the development of diabetes indicates an important beginning, and the potential of probiotics to prevent and reduce the severity of T2DM is better observed in animal studies. In clinical trials, the use of probiotics in glycemic control presented conflicting results, and only few studies have attempted to evaluate factors that justify metabolic changes, such as markers of oxidative stress, inflammation, and incretins. Thus, further research is needed to assess the effects of probiotics in the metabolism of diabetic individuals, as well as the main mechanisms involved in this complex relationship.

Multicentre Double-Blind Placebo-Controlled Food Challenge Study in Children Sensitised to Cashew Nut.

PubMed

van der Valk, Johanna P M; Gerth van Wijk, Roy; Dubois, Anthony E J; de Groot, Hans; Reitsma, Marit; Vlieg-Boerstra, Berber; Savelkoul, Huub F J; Wichers, Harry J; de Jong, Nicolette W

2016-01-01

Few studies with a limited number of patients have provided indications that cashew-allergic patients may experience severe allergic reactions to minimal amounts of cashew nut. The objectives of this multicentre study were to assess the clinical relevance of cashew nut sensitisation, to study the clinical reaction patterns in double-blind placebo-controlled food challenge tests and to establish the amount of cashew nuts that can elicit an allergic reaction. A total of 179 children were included (median age 9.0 years; range 2-17 years) with cashew nut sensitisation and a clinical history of reactions to cashew nuts or unknown exposure. Sensitised children who could tolerate cashew nuts were excluded. The study included three clinical visits and a telephone consultation. During the first visit, the medical history was evaluated, physical examinations were conducted, blood samples were drawn and skin prick tests were performed. The children underwent a double-blind placebo-controlled food challenge test with cashew nut during the second and third visits. The study showed that 137 (76.5%) of the sensitised children suspected of allergy to cashew nut had a positive double-blind placebo-controlled food challenge test, with 46% (63) manifesting subjective symptoms to the lowest dose of 1 mg cashew nut protein and 11% (15) developing objective symptoms to the lowest dose. Children most frequently had gastro-intestinal symptoms, followed by oral allergy and skin symptoms. A total of 36% (49/137) of the children experienced an anaphylactic reaction and 6% (8/137) of the children were treated with epinephrine. This prospective study demonstrated a strikingly high percentage of clinical reactions to cashew nut in this third line population. Severe allergic reactions, including anaphylaxis requiring epinephrine, were observed. These reactions were to minimal amounts of cashew nut, demonstrated the high potency of this allergens. www.ncbi.nlm.nih.gov/pubmed NTR3572.

Multicentre Double-Blind Placebo-Controlled Food Challenge Study in Children Sensitised to Cashew Nut

PubMed Central

van der Valk, Johanna P. M.; Gerth van Wijk, Roy; Dubois, Anthony E. J.; de Groot, Hans; Reitsma, Marit; Vlieg-Boerstra, Berber; Savelkoul, Huub F. J.; Wichers, Harry J.; de Jong, Nicolette W.

2016-01-01

Background Few studies with a limited number of patients have provided indications that cashew-allergic patients may experience severe allergic reactions to minimal amounts of cashew nut. The objectives of this multicentre study were to assess the clinical relevance of cashew nut sensitisation, to study the clinical reaction patterns in double-blind placebo-controlled food challenge tests and to establish the amount of cashew nuts that can elicit an allergic reaction. Methods and Findings A total of 179 children were included (median age 9.0 years; range 2–17 years) with cashew nut sensitisation and a clinical history of reactions to cashew nuts or unknown exposure. Sensitised children who could tolerate cashew nuts were excluded. The study included three clinical visits and a telephone consultation. During the first visit, the medical history was evaluated, physical examinations were conducted, blood samples were drawn and skin prick tests were performed. The children underwent a double-blind placebo-controlled food challenge test with cashew nut during the second and third visits. The study showed that 137 (76.5%) of the sensitised children suspected of allergy to cashew nut had a positive double-blind placebo-controlled food challenge test, with 46% (63) manifesting subjective symptoms to the lowest dose of 1 mg cashew nut protein and 11% (15) developing objective symptoms to the lowest dose. Children most frequently had gastro-intestinal symptoms, followed by oral allergy and skin symptoms. A total of 36% (49/137) of the children experienced an anaphylactic reaction and 6% (8/137) of the children were treated with epinephrine. Conclusion This prospective study demonstrated a strikingly high percentage of clinical reactions to cashew nut in this third line population. Severe allergic reactions, including anaphylaxis requiring epinephrine, were observed. These reactions were to minimal amounts of cashew nut, demonstrated the high potency of this allergens. Trial Registration www.ncbi.nlm.nih.gov/pubmed NTR3572 PMID:26967158

Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

PubMed

Gaus, Wilhelm; Muche, Rainer

2013-05-01

Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinical studies of the effectiveness and safety of antivenoms.

PubMed

Williams, David J; Habib, Abdulrazaq G; Warrell, David A

2018-05-07

In the 1890s, hyperimmune sera proved effective in animals against challenge by the snake venom against which they had been raised. They were first used, apparently successfully, in a human patient in about 1895. Since then, antivenoms have become accepted as the only reliable specific treatment for snake-bite envenoming. Despite decades of accumulated clinical experience and a number of published randomized comparative and observational studies, the clinical effectiveness and safety of some antivenoms remain open to question, due to a lack of robust randomized controlled trial data. Antivenoms in some poorly regulated markets may have high rates of potentially fatal adverse effects and their use must be balanced by demonstrable effectiveness. Even those manufactured to strict regulatory requirements may pose a rare risk of severe adverse reactions. Most antivenoms currently marketed around the world were registered without first being studied clinically. There is increasing pressure to subject antivenoms, even those that are long-established, to the same protocols of rigorous pre-clinical and clinical assessment that are standard regulatory requirements for other drugs. Conventional clinical testing progresses through Phases I, II, III to IV. Most authorities consider antivenoms too dangerous to be used in Phase I studies in healthy volunteers. An alternative method for preliminary estimation of safety, dose-finding and effectiveness, is proposed - the "3 + 3" dose escalation or de-escalation design, in volunteer patients, as used in oncology to test cytotoxic drugs. Antivenoms are so widely used and well trusted, that there are few ethical justifications for placebo controls. However, placebo might be ethically justified if there were no proven effective treatment and or if withholding or delaying treatment posed acceptably negligible risks to the participants. Antivenom trials are most urgently needed in low-to middle-income countries where there are many practical, logistical and funding challenges. Basic requirements for clinical trials include identification of the biting species of snake in every case; the use of objective, clinically-relevant endpoints, such as restoration of blood coagulability; definition of inclusion, exclusion and withdrawal criteria; assurance of antivenom safety; ethical considerations; inclusion of one or more control (comparator) groups; and analysis based on intention to treat. The highest quality evidence comes from Phase II and larger Phase III studies that have been designed as statistically powerful, randomized, controlled trials (RCTs), ideally with blinding of patients and investigators to avoid bias. Because of the challenges to carrying out clinical trials of antivenoms, Phase IV trials (post-marketing surveillance) are potentially more important and useful than for most other drugs. Copyright © 2018 Elsevier Ltd. All rights reserved.

Clinical Utility of Cancellation on the WISC-IV

ERIC Educational Resources Information Center

Zhu, Jianjun; Chen, Hsinyi

2013-01-01

This study examined empirical evidence for clinical utility of the Wechsler Intelligence Scale for Children, fourth edition (WISC-IV) cancellation subtest by comparing data from 597 clinical and 597 matched control children. The results of dependent t and sequential logistic regression analyses demonstrated that (a) children with intellectual…

Periocular mexametric melanin and erythema indexes in adult glaucoma patients treated with topical prostaglandin analogs.

PubMed

Duman, Nilay; Duman, Reşat; Yavaş, Güliz Fatma; Doğruk Kaçar, Seval; Özuğuz, Pınar; Çetinkaya, Ersan

2017-03-01

Although topical prostaglandin analogs (PGAs) have been previously associated with periocular skin hyperpigmentation, studies using objective clinical methods are lacking. Furthermore changes in periocular skin erythema indexes associated with topical PGAs have not been reported previously. The purpose of the present study was to evaluate periocular melanin and erythema indexes in patients treated with topical PGA using an objective clinical method - Mexameter. About 45 glaucoma patients treated with topical PGA therapy, and 30 age-, and sex-matched controls were enrolled in the study. Demographic data, medical history including duration of therapy, PGA type, involved eye (unilateral, bilateral) were noted, and skin phototypes were evaluated. Melanin and erythema indexes on medial and lateral upper and lower eyelids, and normal skin from the upper cheeks were measured using Mexameter MX-18. The index of difference for lower/upper eyelid was calculated. Reading results of patients and controls were compared. Melanin and erythema indexes of upper/lower eyelids, and the index of differences for upper/lower eyelids were significantly higher in patients despite similar clinical findings (p < 0.05). Duration of therapy and type of PGA were not associated with skin changes (p > 0.05). Both periocular melanin and erythema indexes increased in both upper and lower eyelids due to PGA therapy compared to controls, despite similar clinical findings. Mexametric evaluation is more sensitive than clinical evaluation, and may be used as an objective, sensitive clinical method to evaluate periocular skin changes, even smallest changes, in such patients.

Using low-cost Android tablets and instructional videos to teach clinical skills to medical students in Kenya: a prospective study

PubMed Central

Ahn, Roy; Nelson, Brett D; Kagan, Calvin; Burke, Thomas F

2016-01-01

Objectives To assess the feasibility and impact of using a low-cost Android tablet to deliver clinical skills training to third-year medical students in Kenya. Design A prospective study using a low cost tablet called ‘connecTAB’, which was designed and manufactured specifically for areas with low bandwidth. Instructional video tutorials demonstrating techniques of cardiovascular and abdominal clinical examinations were pre-loaded onto the tablet. Setting Maseno University School of Medicine, Western Kenya. Participants Fifty-one third-year medical students from Maseno University School of Medicine were subjects in the study. Twenty-five students were assigned to the intervention group and 26 to the control group. Main outcome measures At the start of the study, students from both groups completed an Observed Structured Clinical Examination (OSCE) of the cardiovascular and abdominal evaluations. Students who were allocated to the intervention group then received the connecTAB, whereas students in the control group did not. After a period of three weeks, students from both groups completed a post-study OSCE for both the cardiovascular and abdominal evaluations. Results There were significantly higher improvements in the scores for both cardiovascular and abdominal examinations (p < 0.001) within the group who received the e-tablets as compared to the control group. Conclusion The study suggests that access to connecTAB improves clinical education and efficacy and holds promise for international training in both medical and allied healthcare professional spheres in resource-limited settings. PMID:27540487

Brain White Matter Shape Changes in Amyotrophic Lateral Sclerosis (ALS): A Fractal Dimension Study

PubMed Central

Allexandre, Didier; Zhang, Luduan; Wang, Xiao-Feng; Pioro, Erik P.; Yue, Guang H.

2013-01-01

Amyotrophic lateral sclerosis (ALS) is a fatal progressive neurodegenerative disorder. Current diagnosis time is about 12-months due to lack of objective methods. Previous brain white matter voxel based morphometry (VBM) studies in ALS reported inconsistent results. Fractal dimension (FD) has successfully been used to quantify brain WM shape complexity in various neurological disorders and aging, but not yet studied in ALS. Therefore, we investigated WM morphometric changes using FD analyses in ALS patients with different clinical phenotypes. We hypothesized that FD would better capture clinical features of the WM morphometry in different ALS phenotypes than VBM analysis. High resolution MRI T1-weighted images were acquired in controls (n = 11), and ALS patients (n = 89). ALS patients were assigned into four subgroups based on their clinical phenotypes.VBM analysis was carried out using SPM8. FD values were estimated for brain WM skeleton, surface and general structure in both controls and ALS patients using our previously published algorithm. No significant VBM WM changes were observed between controls and ALS patients and among the ALS subgroups. In contrast, significant (p<0.05) FD reductions in skeleton and general structure were observed between ALS with dementia and other ALS subgroups. No significant differences in any of the FD measures were observed between control and ALS patients. FD correlated significantly with revised ALS functional rating scale (ALSFRS-R) score a clinical measure of function. Results suggest that brain WM shape complexity is more sensitive to ALS disease process when compared to volumetric VBM analysis and FD changes are dependent on the ALS phenotype. Correlation between FD and clinical measures suggests that FD could potentially serve as a biomarker of ALS pathophysiology, especially after confirmation by longitudinal studies. PMID:24040000

Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper

PubMed Central

Ryu, Borim; Kim, Nari; Heo, Eunyoung; Yoo, Sooyoung; Lee, Keehyuck; Hwang, Hee; Kim, Jeong-Whun; Kim, Yoojung; Lee, Joongseek

2017-01-01

Background Personal health record (PHR)–based health care management systems can improve patient engagement and data-driven medical diagnosis in a clinical setting. Objective The purpose of this study was (1) to demonstrate the development of an electronic health record (EHR)–tethered PHR app named MyHealthKeeper, which can retrieve data from a wearable device and deliver these data to a hospital EHR system, and (2) to study the effectiveness of a PHR data-driven clinical intervention with clinical trial results. Methods To improve the conventional EHR-tethered PHR, we ascertained clinicians’ unmet needs regarding PHR functionality and the data frequently used in the field through a cocreation workshop. We incorporated the requirements into the system design and architecture of the MyHealthKeeper PHR module. We constructed the app and validated the effectiveness of the PHR module by conducting a 4-week clinical trial. We used a commercially available activity tracker (Misfit) to collect individual physical activity data, and developed the MyHealthKeeper mobile phone app to record participants’ patterns of daily food intake and activity logs. We randomly assigned 80 participants to either the PHR-based intervention group (n=51) or the control group (n=29). All of the study participants completed a paper-based survey, a laboratory test, a physical examination, and an opinion interview. During the 4-week study period, we collected health-related mobile data, and study participants visited the outpatient clinic twice and received PHR-based clinical diagnosis and recommendations. Results A total of 68 participants (44 in the intervention group and 24 in the control group) completed the study. The PHR intervention group showed significantly higher weight loss than the control group (mean 1.4 kg, 95% CI 0.9-1.9; P<.001) at the final week (week 4). In addition, triglyceride levels were significantly lower by the end of the study period (mean 2.59 mmol/L, 95% CI 17.6-75.8; P=.002). Conclusions We developed an innovative EHR-tethered PHR system that allowed clinicians and patients to share lifelog data. This study shows the effectiveness of a patient-managed and clinician-guided health tracker system and its potential to improve patient clinical profiles. Trial Registration ClinicalTrials.gov NCT03200119; https://clinicaltrials.gov/ct2/show/NCT03200119 (Archived by WebCite at http://www.webcitation.org/6v01HaCdd) PMID:29217503

Patient-oriented randomisation: A new trial design applied in the Neuroleptic Strategy Study.

PubMed

Schulz, Constanze; Timm, Jürgen; Cordes, Joachim; Gründer, Gerhard; Mühlbauer, Bernd; Rüther, Eckart; Heinze, Martin

2016-06-01

The 'gold standard' for clinical studies is a randomised controlled trial usually comparing specific treatments. If the scientific study expands to strategy comparison with each strategy including various treatments, the research problems are increasingly complicated. The strategy debate in the psychiatric community is the starting point for the development of our new design. It is widely accepted that second-generation antipsychotics are the therapy of choice in the treatment of schizophrenia. However, their general superiority over first-generation antipsychotics could not be demonstrated in recent randomised controlled trials. Furthermore, we are becoming increasingly aware that the experimental conditions of randomised controlled trials, as in the European First Episode Schizophrenia Trial and Clinical Antipsychotic Trials of Intervention Effectiveness Phase 1 studies, may be inappropriate for psychiatric treatments. The high heterogeneity in the patient population produces discrepancies between daily clinical perception and randomised controlled trials results. The patient-oriented approach in the Cost Utility of the Latest Antipsychotic drugs in Schizophrenia Study reflects everyday clinical practice. The results, however, are highly dependent on the physicians' preferences. The goal of the design described here is to take an intermediate path between randomised controlled trials and clinical studies such as Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study, combining the advantages of both study types. The idea is to randomise two treatment pairs each consisting of one first-generation antipsychotic and one second-generation antipsychotic in a first step and subsequently, to involve the investigators in deciding for a pair most appropriate to the patients' needs and then to randomise the allocation to one drug (first-generation antipsychotic or second-generation antipsychotic) of that chosen pair. This idea was first implemented in the clinical trial, the Neuroleptic Strategy Study, with a randomised design comparing efficacy and safety of two different strategies: either to use first-generation antipsychotics (haloperidol and flupentixol) or second-generation antipsychotics (olanzapine, aripiprazole and quetiapine) in patients suffering from schizophrenia. In the course of the Neuroleptic Strategy Study, feasibility of this design was demonstrated. All aspects of the new design were implemented: randomisation process, documentation of responses from investigators as well as patients and drug logistic experience. In implementing the design, furthermore, we could investigate its theoretical properties. The physicians' preferences for specific drugs used for the respective patients were analysed. The idea of patient-oriented randomisation can be generalised. In light of the heterogeneity and complexity of patient-drug interaction, this design should prove particularly useful. © The Author(s) 2016.

Effectiveness of nurse-led cardiac clinics in adult patients with a diagnosis of coronary heart disease.

PubMed

Page, Tamara; Lockwood, Craig; Conroy-Hiller, Tiffany

2005-02-01

Background  Coronary heart disease is the major cause of illness and death in Western countries and this is likely to increase as the average age of the population rises. Consumers with established coronary heart disease are at the highest risk of experiencing further coronary events. Lifestyle measures can contribute significantly to a reduction in cardiovascular mortality in established coronary heart disease. Improved management of cardiac risk factors by providing education and referrals as required has been suggested as one way of maintaining quality care in patients with established coronary heart disease. There is a need to ascertain whether or not nurse-led clinics would be an effective adjunct for patients with coronary heart disease to supplement general practitioner advice and care. Objectives  The objective of this review was to present the best available evidence related to nurse-led cardiac clinics. Inclusion criteria  This review considered any randomised controlled trials that evaluated cardiac nurse-led clinics. In the absence of randomised controlled trials, other research designs such as non-randomised controlled trials and before and after studies were considered for inclusion. Participants were adults (18 years and older) with new or existing coronary heart disease. The interventions of interest to the review included education, assessment, consultation, referral and administrative structures. Outcomes measured included adverse event rates, readmissions, admissions, clinical and cost effectiveness, consumer satisfaction and compliance with therapy. Results  Based on the search terms used, 80 papers were initially identified and reviewed for inclusion; full reports of 24 of these papers were retrieved. There were no papers included that addressed cost effectiveness or adverse events; and none addressed the outcome of referrals. A critical appraisal of the 24 remaining papers identified a total of six randomised controlled trials that met the inclusion criteria. Two studies addressed nurse-led clinics for patients diagnosed with angina, one looked at medication administration and the other looked at educational plans. A further four studies compared secondary preventative care with a nurse-led clinic and general practitioner clinic. One specifically compared usual care versus shared care introduced by nurses for patients awaiting coronary artery bypass grafting. Of the remaining three studies, two have been combined in the results section, as they are an interim report and a final report of the same study. Because of inconsistencies in reporting styles and outcome measurements, meta-analysis could not be performed on all outcomes. However, a narrative summary of each study and comparisons of specific outcomes assessed from within each study has been developed. Although not all outcomes obtained statistical significance, nurse-led clinics were at least as effective as general practitioner clinics for most outcomes. Recommendations  The following recommendations are made: • The use of nurse-led clinics is recommended for patients with coronary heart disease (Level II). • Utilise nurse-led clinics to increase clinic attendance and follow-up rates (Level II). • Nurse-led clinics are recommended for patients who require lifestyle changes to decrease their risk of adverse outcomes associated with coronary heart disease (Level II).

Predictive factors for the placebo effect in clinical trials for dry eye: a pooled analysis of three clinical trials.

PubMed

Imanaka, Takahiro; Sato, Izumi; Tanaka, Shiro; Kawakami, Koji

2017-11-01

Placebo effect is one of the methodological difficulties in dry eye clinical trials. If we could elucidate the tendencies of the placebo response and find predictors, we could reduce the placebo response in clinical trials for dry eye. In this study, we investigated the predictive factors for the placebo effect in dry eye clinical trials. A total of 205 patients with dry eye assigned to the placebo arms of three placebo-controlled randomised clinical trials were analysed by simple and multivariable regression analysis. The corneal fluorescein (FL) staining score and dry eye symptoms were studied at week 4. The variables of interest included gender, age, complications of Sjögren's syndrome, Schirmer's test I value, tear break-up time and conjunctival hyperaemia score. We also conducted a stratified analysis according to the patients' age. Among all the studied endpoints, the baseline scores were significantly related to the corresponding placebo response. In addition, for the FL score and the dryness score, age was a significant predictor of the placebo response (p=0.04 and p<0.0001, respectively). Stratified analysis by age showed that patients more than 40 years of age are more likely to have a stronger placebo response in the FL and dryness scores. The baseline scores and age were predictive factors of the placebo response in frequently used endpoints, such as FL score or dryness symptoms. These patient characteristics can be controlled by study design, and our findings enable the design of more efficient placebo-controlled studies with good statistical power. © 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.

Effectiveness of computerized clinical decision support systems for asthma and chronic obstructive pulmonary disease in primary care: a systematic review.

PubMed

Fathima, Mariam; Peiris, David; Naik-Panvelkar, Pradnya; Saini, Bandana; Armour, Carol Lyn

2014-12-02

The use of computerized clinical decision support systems may improve the diagnosis and ongoing management of chronic diseases, which requires recurrent visits to multiple health professionals, disease and medication monitoring and modification of patient behavior. The aim of this review was to systematically review randomized controlled trials evaluating the effectiveness of computerized clinical decision systems (CCDSS) in the care of people with asthma and COPD. Randomized controlled trials published between 2003 and 2013 were searched using multiple electronic databases Medline, EMBASE, CINAHL, IPA, Informit, PsychINFO, Compendex, and Cochrane Clinical Controlled Trials Register databases. To be included, RCTs had to evaluate the role of the CCDSSs for asthma and/or COPD in primary care. Nineteen studies representing 16 RCTs met our inclusion criteria. The majority of the trials were conducted in patients with asthma. Study quality was generally high. Meta-analysis was not conducted because of methodological and clinical heterogeneity. The use of CCDSS improved asthma and COPD care in 14 of the 19 studies reviewed (74%). Nine of the nineteen studies showed statistically significant (p < 0.05) improvement in the primary outcomes measured. The majority of the studies evaluated health care process measures as their primary outcomes (10/19). Evidence supports the effectiveness of CCDSS in the care of people with asthma. However there is very little information of its use in COPD care. Although there is considerable improvement in the health care process measures and clinical outcomes through the use of CCDSSs, its effects on user workload and efficiency, safety, costs of care, provider and patient satisfaction remain understudied.

'The trial is owned by the team, not by an individual': a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology.

PubMed

Strong, Sean; Paramasivan, Sangeetha; Mills, Nicola; Wilson, Caroline; Donovan, Jenny L; Blazeby, Jane M

2016-04-26

Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was to explore how teamwork influences recruitment to a multicentre randomised controlled trial (RCT) involving interventions delivered by different clinical specialties. Semi-structured interviews were conducted in three centres with a purposeful sample of members of the surgical, oncology and research teams recruiting to a feasibility RCT comparing definitive chemoradiotherapy with chemoradiotherapy and surgery for oesophageal squamous cell carcinoma. Interviews explored factors known to influence healthcare team effectiveness and were audio-recorded and thematically analysed. Sampling, data collection and analysis were undertaken iteratively and concurrently. Twenty-one interviews were conducted. Factors that influenced how team working impacted upon trial recruitment were centred on: (1) the multidisciplinary team (MDT) meeting, (2) leadership of the trial, and (3) the recruitment process. The weekly MDT meeting was reported as central to successful recruitment and formed the focus for creating a 'study team', bringing together clinical and research teams. Shared study leadership positively influenced healthcare professionals' willingness to participate. Interviewees perceived their clinical colleagues to have strong treatment preferences which led to scepticism regarding whether the treatments were being described to patients in a balanced manner. This study has highlighted a number of aspects of team functioning that are important for recruitment to RCTs that span different clinical specialties. Understanding these issues will aid the production of guidance on team-relevant issues that should be considered in trial management and the development of interventions that will facilitate teamwork and improve recruitment to these challenging RCTs. International Standard Randomised Controlled Trial Number (ISRCTN): ISRCTN89052791 .

Randomised clinical simulation designed to evaluate the effect of telemedicine using Google Glass on cardiopulmonary resuscitation (CPR).

PubMed

Pérez Alonso, Nuria; Pardo Rios, Manuel; Juguera Rodriguez, Laura; Vera Catalan, Tomas; Segura Melgarejo, Francisca; Lopez Ayuso, Belen; Martí Nez Riquelme, Carolina; Lasheras Velasco, Joaquin

2017-11-01

Through a clinical simulation, this study aims to assess the effect of telematics support through Google Glass (GG) from an expert physician on performance of cardiopulmonary resuscitation (CPR) performed by a group of nurses, as compared with a control group of nurses receiving no assistance. This was a randomised study carried out at the Catholic University of Murcia (November 2014-February 2015). Nursing professionals from the Emergency Medical Services in Murcia (Spain) were asked to perform in a clinical simulation of cardiac arrest. Half of the nurses were randomly chosen to receive coaching from physicians through GG, while the other half did not receive any coaching (controls). The main outcome of the study expected was successful defibrillation, which restores sinus rhythm. Thirty-six nurses were enrolled in each study group. Statistically significant differences were found in the percentages of successful defibrillation (100% GG vs 78% control; p=0005) and CPR completion times: 213.91 s for GG and 250.31 s for control (average difference=36.39 s (95% CI 12.03 to 60.75), p=0.004). Telematics support by an expert through GG improves success rates and completion times while performing CPR in simulated clinical situations for nurses in simulated scenarios. © 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.

Prevalence of prescription opioid use disorder among chronic opioid therapy patients after health plan opioid dose and risk reduction initiatives.

PubMed

Von Korff, Michael; Walker, Rod L; Saunders, Kathleen; Shortreed, Susan M; Thakral, Manu; Parchman, Michael; Hansen, Ryan N; Ludman, Evette; Sherman, Karen J; Dublin, Sascha

2017-08-01

No studies have assessed the comparative effectiveness of guideline-recommended interventions to reduce risk of prescription opioid use disorder among chronic opioid therapy (COT) patients. We compared the prevalence of prescription opioid use disorder among COT patients from intervention clinics that had implemented opioid dose and risk reduction initiatives for more than 4 years relative to control clinics that had not. After a healthcare system in Washington State implemented interventions to reduce opioid dose and risks, we surveyed 1588 adult primary care COT patients to compare the prevalence of prescription opioid use disorder among COT patients from the intervention and control clinics. Intervention clinics managed COT patients at lower COT doses and with more consistent use of risk reduction practices. Control clinics cared for similar COT patients but prescribed higher opioid doses and used COT risk reduction practices inconsistently. Prescription opioid use disorder was assessed with the Psychiatric Research Interview for Substance and Mental Disorders. The prevalence of prescription opioid use disorder was 21.5% (95% CI=18.9% to 24.4%) among COT patients in the intervention clinics and 23.9% (95% CI=20.5% to 27.6%) among COT patients in the control clinics. The adjusted relative risk of prescription opioid use disorder was 1.08 (95% CI=0.89, 1.32) among the control clinic patients relative to the intervention clinic patients. Long-term implementation of opioid dose and risk reduction initiatives was not associated with lower rates of prescription opioid use disorder among prevalent COT patients. Extreme caution should be exercised by clinicians considering COT for patients with chronic non-cancer pain until benefits of this treatment and attendant risks are clarified. Copyright © 2017 Elsevier B.V. All rights reserved.

The Effects of Focused Attention on Inhibition and State Regulation in Children with and without Attention Deficit Hyperactivity Disorder

ERIC Educational Resources Information Center

Ketch, Karen M.; Brodeur, Darlene A.; McGee, Robin

2009-01-01

This study investigated the effects of response rate and attention focusing on performance of ADHD, clinical-control (CRNA) and non-clinical control children in response inhibition tasks. All children completed the "Go-NoGo" task, a computer-based task of attention and impulsivity. Focused attention on this task was manipulated using a priming…

Economic analysis of temperature-controlled laminar airflow (TLA) for the treatment of patients with severe persistent allergic asthma.

PubMed

Brazier, Peter; Schauer, Uwe; Hamelmann, Eckard; Holmes, Steve; Pritchard, Clive; Warner, John O

2016-01-01

Chronic asthma is a significant burden for individual sufferers, adversely impacting their quality of working and social life, as well as being a major cost to the National Health Service (NHS). Temperature-controlled laminar airflow (TLA) therapy provides asthma patients at BTS/SIGN step 4/5 an add-on treatment option that is non-invasive and has been shown in clinical studies to improve quality of life for patients with poorly controlled allergic asthma. The objective of this study was to quantify the cost-effectiveness of TLA (Airsonett AB) technology as an add-on to standard asthma management drug therapy in the UK. The main performance measure of interest is the incremental cost per quality-adjusted life year (QALY) for patients using TLA in addition to usual care versus usual care alone. The incremental cost of TLA use is based on an observational clinical study monitoring the incidence of exacerbations with treatment valued using NHS cost data. The clinical effectiveness, used to derive the incremental QALY data, is based on a randomised double-blind placebo-controlled clinical trial comprising participants with an equivalent asthma condition. For a clinical cohort of asthma patients as a whole, the incremental cost-effectiveness ratio (ICER) is £8998 per QALY gained, that is, within the £20 000/QALY cost-effectiveness benchmark used by the National Institute for Health and Care Excellence (NICE). Sensitivity analysis indicates that ICER values range from £18 883/QALY for the least severe patients through to TLA being dominant, that is, cost saving as well as improving quality of life, for individuals with the most severe and poorly controlled asthma. Based on our results, Airsonett TLA is a cost-effective addition to treatment options for stage 4/5 patients. For high-risk individuals with more severe and less well controlled asthma, the use of TLA therapy to reduce incidence of hospitalisation would be a cost saving to the NHS.

Clinical effects of carvedilol and trimetazidine for the treatmentof alcoholic myocardiopathy.

PubMed

Li, Hui; Liu, Fu-Yuan; Li, Xiao-Lan; Li, Xiao-Mei; Zhu, Lei

2016-08-01

The aim of the study was to compare the clinical effects of carvedilol and trimetazidine for the treatment of alcoholic cardiomyopathy. A total of 60 patients diagnosed with alcoholic cardiomyopathy were enrolled in the study. The patients were randomly divided into the carvedilol (n=20), trimetazidine (n=20) and control (n=20) groups. The patients in the control, carvedilol and trimetazidine groups were treated with conventional drugs, conventional drugs + carvedil and conventional drugs + trimetazidine respectively, for 12 weeks. The patients were compared for their heart functions [left ventricular ejection fraction (LVEF), C-reactive protein (CRP) and 6 min walking], heart rate, blood pressure and heart enlargement (cardiothoracic proportion and left ventricular diameter) before and after treatment. The parameters studied for heart functions, heart rate, blood pressure, heart enlargement, clinical effects before and after treatment were statistically insignificant (p>0.05). After treatment, the carvedilol and trimetazidine groups showed higher LVEF and CRP, longer walking distance in 6 min, as well as lower heart rate and blood pressure (both systolic and diastolic) compared to the control group. Similarly, the cardiothoracic proportion and left ventricular internal diameter for the carvedilol and trimetazidine groups was lower than those of the control group, with better clinical effects (p<0.05). In conclusion, the curative effects of the carvedilol and trimetazidine groups of alcoholic myocardiopathy similar. Both are safe agents that may improve the cardiac function and heart expansion of patients.

Improving decision making about clinical trial participation – a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial

PubMed Central

Juraskova, I; Butow, P; Bonner, C; Bell, M L; Smith, A B; Seccombe, M; Boyle, F; Reaby, L; Cuzick, J; Forbes, J F

2014-01-01

Background: Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. Methods: The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). Results: Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS–DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. Conclusions: This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation. PMID:24892447

Association of α-, β-, and γ-Synuclein With Diffuse Lewy Body Disease

PubMed Central

Nishioka, Kenya; Wider, Christian; Vilariño-Güell, Carles; Soto-Ortolaza, Alexandra I.; Lincoln, Sarah J.; Kachergus, Jennifer M.; Jasinska-Myga, Barbara; Ross, Owen A.; Rajput, Alex; Robinson, Christopher A.; Ferman, Tanis J.; Wszolek, Zbigniew K.; Dickson, Dennis W.; Farrer, Matthew J.

2016-01-01

Objective To determine the association of the genes that encode α-, β-, and γ-synuclein (SNCA, SNCB, and SNCG, respectively) with diffuse Lewy body disease (DLBD). Design Case-control study. Subjects A total of 172 patients with DLBD consistent with a clinical diagnosis of Parkinson disease dementia/dementia with Lewy bodies and 350 clinically and 97 pathologically normal controls. Interventions Sequencing of SNCA, SNCB, and SNCG and genotyping of single-nucleotide polymorphisms performed on an Applied Biosystems capillary sequencer and a Sequenom MassArray pLEX platform, respectively. Associations were determined using χ2 or Fisher exact tests. Results Initial sequencing studies of the coding regions of each gene in 89 patients with DLBD did not detect any pathogenic substitutions. Nevertheless, genotyping of known polymorphic variability in sequence-conserved regions detected several single-nucleotide polymorphisms in the SNCA and SNCG genes that were significantly associated with disease (P=.05 to <.001). Significant association was also observed for 3 single-nucleotide polymorphisms located in SNCB when comparing DLBD cases and pathologically confirmed normal controls (P=.03-.01); however, this association was not significant for the clinical controls alone or the combined clinical and pathological controls (P>.05). After correction for multiple testing, only 1 single-nucleotide polymorphism in SNCG (rs3750823) remained significant in all of the analyses (P=.05-.009). Conclusion These findings suggest that variants in all 3 members of the synuclein gene family, particularly SNCA and SNCG, affect the risk of developing DLBD and warrant further investigation in larger, pathologically defined data sets as well as clinically diagnosed Parkinson disease/dementia with Lewy bodies case-control series. PMID:20697047

Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project.

PubMed

Fisher, Jeffrey D; Amico, K Rivet; Fisher, William A; Cornman, Deborah H; Shuper, Paul A; Trayling, Cynthia; Redding, Caroline; Barta, William; Lemieux, Anthony F; Altice, Frederick L; Dieckhaus, Kevin; Friedland, Gerald

2011-11-01

We evaluated the efficacy of LifeWindows, a theory-based, computer-administered antiretroviral (ARV) therapy adherence support intervention, delivered to HIV + patients at routine clinical care visits. 594 HIV + adults receiving HIV care at five clinics were randomized to intervention or control arms. Intervention vs. control impact in the intent-to-treat sample (including participants whose ARVs had been entirely discontinued, who infrequently attended care, or infrequently used LifeWindows) did not reach significance. Intervention impact in the On Protocol sample (328 intervention and control arm participants whose ARVs were not discontinued, who attended care and were exposed to LifeWindows regularly) was significant. On Protocol intervention vs. control participants achieved significantly higher levels of perfect 3-day ACTG-assessed adherence over time, with sensitivity analyses maintaining this effect down to 70% adherence. This study supports the utility of LifeWindows and illustrates that patients on ARVs who persist in care at clinical care sites can benefit from adherence promotion software.

Clinical, virologic, and immunologic outcomes in lymphoma survivors and in cancer-free, HIV-1-infected patients: a matched cohort study.

PubMed

Spagnuolo, Vincenzo; Travi, Giovanna; Galli, Laura; Cossarini, Francesca; Guffanti, Monica; Gianotti, Nicola; Salpietro, Stefania; Lazzarin, Adriano; Castagna, Antonella

2013-08-01

The objective of this study was to compare immunologic, virologic, and clinical outcomes between living human immunodeficiency virus (HIV)-infected individuals who had a diagnosis of lymphoma versus outcomes in a control group of cancer-free, HIV-infected patients. In this matched cohort study, patients in the case group were survivors of incident lymphomas that occurred between 1997 and June 2010. Controls were living, cancer-free, HIV-infected patients who were matched to cases at a 4:1 ratio by age, sex, nadir CD4 cell count, and year of HIV diagnosis. The date of lymphoma diagnosis served as the baseline in cases and in the corresponding controls. In total, 62 patients (cases) who had lymphoma (20 with Hodgkin disease [HD] and 42 with non-Hodgkin lymphoma [NHL]) were compared with 211 controls. The overall median follow-up was 4.8 years (interquartile range, 2.0-7.9 years). The CD4 cell count at baseline was 278 cells/mm³ (interquartile range, 122-419 cells/mm³) in cases versus 421 cells/mm³ (interquartile range, 222-574 cells/mm³) in controls (P = .003). At the last available visit, the CD4 cell count was 412 cells/mm³ (range, 269-694 cells/mm³) in cases versus 518 cells/mm³ (interquartile range, 350-661 cells/mm³) in controls (P = .087). The proportion of patients who achieved virologic success increased from 30% at baseline to 74% at the last available visit in cases (P = .008) and from 51% to 81% in controls (P = .0286). Patients with HD reached higher CD4 cell counts at their last visit than patients with NHL (589 cells/mm³ [range, 400-841 cells/mm³] vs 332 cells/mm³ [interquartile range, 220-530 cells/mm³], respectively; P = .003). Virologic success was similar between patients with HD and patients with NHL at the last visit. Forty cases (65%) and 76 controls (36%) experienced at least 1 clinical event after baseline (P < .0001); cases were associated with a shorter time to occurrence of the first clinical event compared with controls (P < .0001). HIV-infected lymphoma survivors experienced more clinical events than controls, especially during the first year of follow-up, but they reached similar long-term immunologic and virologic outcomes. © 2013 American Cancer Society.

Use of Statins to Augment Progenitor Cell Function in Preclinical and Clinical Studies of Regenerative Therapy: a Systematic Review.

PubMed

Park, Angela; Barrera-Ramirez, Juliana; Ranasinghe, Indee; Pilon, Sophie; Sy, Richmond; Fergusson, Dean; Allan, David S

2016-06-01

Mesenchymal stromal cells (MSCs) and endothelial progenitor cells (EPCs) are used in cell-based regenerative therapy. HMG CoA reductase inhibitors (statins) appear promising in blocking apoptosis, prolonging progenitor cell survival and improving their capacity to repair organ function. We performed a systematic review of preclinical and clinical studies to clarify whether statins can improve cell-based repair of organ injury. MEDLINE, EMBASE, and PUBMED databases were searched (1947 to June 25, 2013). Controlled clinical and pre-clinical studies were included that evaluated statin therapy used alone or in combination with MSCs or EPCs in patients or animals with organ injury. After screening 771 citations, 100 records underwent full eligibility screening of which 38 studies met eligibility and were included in the review: Studies were grouped into pre-clinical studies that involved statin treatment in combination with cell therapy (18 studies), preclinical studies of statin therapy alone (13 studies) and clinical studies of statin therapy (7 studies). Studies addressed cardiac injury (14 studies), vascular disorders (15 studies), neurologic conditions (8 studies) and bone fractures (1 study). Pre-clinical studies of statins in combination with MSC infusion (15 studies) or EPC therapy (3 studies) were described and despite marked heterogeneity in reporting outcomes of cellular analysis and organ function, all of these cell-based pre-clinical studies reported improved organ recovery with the addition of statin therapy. Moreover, 13 pre-clinical studies involved the administration of a statin drug alone to animals. An increase in EPC number and/or function (no studies of MSCs) was reported in 11 of these studies (85 %) and improved organ function in 12 studies (92 %). We also identified 7 clinical studies and none involved the administration of cells but described an increased number and/or function of EPCs (no studies of MSCs) and improved organ function with statin therapy (1.2-fold to 35-fold improvement over controls) in all 7 studies. Our systematic review provides a foundation of encouraging results that support further study of statins in regenerative therapy to augment the number and/or function of MSCs used in cell-based repair and to augment the number and function of EPCs in vivo to repair damaged tissues. Larger studies are needed to ensure safety and confirm clinical benefits.

Application of the Stable Isotope Label Approach in Clinical Development-Supporting Dissolution Specifications for a Commercial Tablet Product with Tafenoquine, a Long Half-life Compound.

PubMed

Goyal, Navin; Mohamed, Khadeeja; Rolfe, Katie; Sahota, Satty; Ernest, Terry; Duparc, Stephan; Taylor, Maxine; Casillas, Linda; Koh, Gavin C K W

2018-06-04

Bioavailability/bioequivalence studies supporting clinical drug development or commercial supply of drug formulations are often time, cost, and resource intensive. The drug's pharmacokinetic (PK) variability, systemic half-life, and safety issues may pose additional challenges. The stable isotope label (SIL) approach provides a useful tool to significantly reduce the study size in clinical PK studies. Tafenoquine (TQ) is an 8-aminoquinoline under development for preventing Plasmodium vivax malaria relapse. This SIL study assessed the impact of differences in the in vitro dissolution profiles on in vivo exposure of TQ tablets. Fourteen healthy volunteers received a single dose of 300 mg TQ Intermediate Aged or 300 mg TQ Control formulations in this single-center, two-arm, randomized, open-label, parallel-group study. Endpoints included the geometric means ratio of the area under the concentration-time curve (AUC (0-t) and AUC (0-∞) ; primary endpoint) and maximum plasma concentration (C max ) for Intermediate Aged versus Control TQ; correlation of PK parameters for venous versus peripheral (via microsample) blood samples; and safety and tolerability endpoints. Geometric mean ratios for PK parameters (AUC and C max ) and their 90% confidence intervals fell well within standard bioequivalence limits (0.80-1.25). Only one mild adverse event (skin abrasion) was reported. In summary, this SIL methodology-based study demonstrates that the observed differences in the in vitro dissolution profiles between the Control and Intermediate Aged TQ tablets have no clinically relevant effect on systemic TQ exposure. The SIL approach was successfully implemented to enable the setting of a clinically relevant dissolution specification. This study (GSK study number 201780) is registered at clinicaltrials.gov with identifier NCT02751294.

Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

PubMed

Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

2014-01-01

This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

Target controlled infusion for kids: trials and simulations.

PubMed

Mehta, Disha; McCormack, Jon; Fung, Parry; Dumont, Guy; Ansermino, J

2008-01-01

Target controlled infusion (TCI) for Kids is a computer controlled system designed to administer propofol for general anesthesia. A controller establishes infusion rates required to achieve a specified concentration at the drug's effect site (C(e)) by implementing a continuously updated pharmacokinetic-pharmacodymanic model. This manuscript provides an overview of the system's design, preclinical tests, and a clinical pilot study. In pre-clinical tests, predicted infusion rates for 20 simulated procedures displayed complete convergent validity between two software implementations, Labview and Matlab, at computational intervals of 5, 10, and 15s, but diverged with 20s intervals due to system rounding errors. The volume of drug delivered by the TCI system also displayed convergent validity with Tivatrainer, a widely used TCI simulation software. Further tests, were conducted for 50 random procedures to evaluate discrepancies between volumes reported and those actually delivered by the system. Accuracies were within clinically acceptable ranges and normally distributed with a mean of 0.08 +/- 0.01 ml. In the clinical study, propofol pharmacokinetics were simulated for 30 surgical procedures involving children aged 3 months to 9 years. Predicted C(e) values during standard clinical practice, the accuracy of wake-up times predicted by the system, and potential correlations between patient wake-up times, C(e), and state entropy (SE) were assessed. Neither Ce nor SE was a reliable predictor of wake-up time in children, but the small sample size of this study does not fully accommodate the noted variation in children's response to propofol. A C(e) value of 1.9 mug/ml was found to best predict emergence from anesthesia in children.

Antibiotics for acute maxillary sinusitis in adults.

PubMed

Ahovuo-Saloranta, Anneli; Rautakorpi, Ulla-Maija; Borisenko, Oleg V; Liira, Helena; Williams, John W; Mäkelä, Marjukka

2014-02-11

Sinusitis is one of the most common diagnoses among adults in ambulatory care, accounting for 15% to 21% of all adult outpatient antibiotic prescriptions. However, the role of antibiotics for sinusitis is controversial. To assess the effects of antibiotics in adults with acute maxillary sinusitis by comparing antibiotics with placebo, antibiotics from different classes and the side effects of different treatments. We searched CENTRAL 2013, Issue 2, MEDLINE (1946 to March week 3, 2013), EMBASE (1974 to March 2013), SIGLE (OpenSIGLE, later OpenGrey (accessed 15 January 2013)), reference lists of the identified trials and systematic reviews of placebo-controlled studies. We also searched for ongoing trials via ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). We imposed no language or publication restrictions. Randomised controlled trials (RCTs) comparing antibiotics with placebo or antibiotics from different classes for acute maxillary sinusitis in adults. We included trials with clinically diagnosed acute sinusitis, confirmed or not by imaging or bacterial culture. Two review authors independently screened search results, extracted data and assessed trial quality. We calculated risk ratios (RRs) for differences between intervention and control groups in whether the treatment failed or not. All measures are presented with 95% confidence intervals (CIs). We conducted the meta-analyses using either the fixed-effect or random-effects model. In meta-analyses of the placebo-controlled studies, we combined data across antibiotic classes. Primary outcomes were clinical failure rates at 7 to 15 days and 16 to 60 days follow-up. We used GRADEpro to assess the quality of the evidence. We included 63 studies in this updated review; nine placebo-controlled studies involving 1915 participants (seven of the studies clearly conducted in primary care settings) and 54 studies comparing different classes of antibiotics (10 different comparisons). Five studies at low risk of bias comparing penicillin or amoxicillin to placebo provided information on the main outcome: clinical failure rate at 7 to 15 days follow-up, defined as a lack of full recovery or improvement, for participants with symptoms lasting at least seven days. In these studies antibiotics decreased the risk of clinical failure (pooled RR of 0.66, 95% CI 0.47 to 0.94, 1084 participants randomised, 1058 evaluated, moderate quality evidence). However, the clinical benefit was small. Cure or improvement rates were high in both the placebo group (86%) and the antibiotic group (91%) in these five studies. When clinical failure was defined as a lack of full recovery (n = five studies), results were similar: antibiotics decreased the risk of failure (pooled RR of 0.73, 95% CI 0.63 to 0.85, high quality evidence) at 7 to 15 days follow-up.Adverse effects in seven of the nine placebo-controlled studies (comparing penicillin, amoxicillin, azithromycin or moxicillin to placebo) were more common in antibiotic than in placebo groups (median of difference between groups 10.5%, range 2% to 23%). However, drop-outs due to adverse effects were rare in both groups: 1.5% in antibiotic groups and 1% in control groups.In the 10 head-to-head comparisons, none of the antibiotic preparations were superior to another. However, amoxicillin-clavulanate had significantly more drop-outs due to adverse effects than cephalosporins and macrolides. There is moderate evidence that antibiotics provide a small benefit for clinical outcomes in immunocompetent primary care patients with uncomplicated acute sinusitis. However, about 80% of participants treated without antibiotics improved within two weeks. Clinicians need to weigh the small benefits of antibiotic treatment against the potential for adverse effects at both the individual and general population levels.

Mechanisms of change in control group drinking in clinical trials of brief alcohol intervention: implications for bias toward the null.

PubMed

Bernstein, Judith A; Bernstein, Edward; Heeren, Timothy C

2010-09-01

Reductions in control group consumption over time that are possibly related to research design affect the impact of brief alcohol interventions (BAI) in clinical settings. We conducted a systematic review to identify research design factors that may contribute to control group change, strategies to limit these effects and implications for researchers. Studies with control group n > 30 were selected if they published baseline and outcome consumption data, conducted trials in clinical settings in Anglophone countries and did not censor gender or age. Among 38 studies cited in 20 reviews through October 2009, 16 met criteria (n = 31-370). In 54%, controls received alcohol specific handouts, advice and/or referral. Both the number and depth of assessments were highly variable. The percentage change in consumption ranged from-0.10 to-0.84 (mean-0.32), and effect size from 0.04 to 0.70 (mean 0.37). Published data were insufficient for meta-analysis. Researchers should consider strategies to reduce the impact of research design factors, such as procedures to enhance sample diversity, blind subjects to study purpose to limit social desirability bias, reduce the number and depth of instruments (assessment reactivity), and finally, analytic techniques to decrease the impact of outliers and regression to the mean. This review identifies problems with retrospective analysis of predictors of control group change, and underscores the need to design prospective studies to permit identification, quantification and adjustment for potential sources of bias in BAI trials.

Facilitating Case Studies in Massage Therapy Clinical Education

PubMed Central

Baskwill, Amanda

2013-01-01

The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

Silk sericin ameliorates wound healing and its clinical efficacy in burn wounds.

PubMed

Aramwit, Pornanong; Palapinyo, Sirinoot; Srichana, Teerapol; Chottanapund, Suthat; Muangman, Pornprom

2013-09-01

The aim of this study was to evaluate the effect of silk sericin, a protein from silkworm cocoon, on scratch wound healing in vitro. For applicable result in clinical use, we also study the efficacy of sericin added to a standard antimicrobial cream, silver zinc sulfadiazine, for open wound care in the treatment of second-degree burn wounds. In vitro scratch assays show that sericin at concentration 100 μg/mL can promote the migration of fibroblast L929 cells similar to epidermal growth factor (positive control) at 100 μg/mL. After 1 day of treatment, the length of scratch in wounds treated with sericin was significantly shorter than the length of negative control wounds (culture medium without sericin). For clinical study, a total of 29 patients with 65 burn wounds which covered no less than 15 % of total body surface area were randomly assigned to either control (wounds treated with silver zinc sulfadiazine cream) or treatment (wounds treated with silver zinc sulfadiazine with added sericin cream) group in this randomized, double-blind, standard-controlled study. The results showed that the average time to reach 70 % re-epithelialization of the burned surface and complete healing in the treatment group was significantly shorter, approximately 5-7 days, than in the control group. Regarding time for complete healing, control wounds took approximately 29.28 ± 9.27 days, while wounds treated with silver zinc sulfadiazine with added sericin cream took approximately 22.42 ± 6.33 days, (p = 0.001). No infection or severe reaction was found in any wounds. This is the first clinical study to show that silk sericin is safe and beneficial for burn wound treatment when it is added to silver sulfadiazine cream.

Role of Adult Asthma Education in Improving Asthma Control and Reducing Emergency Room Utilization and Hospital Admissions in an Inner City Hospital

PubMed Central

Mishra, Rashmi; Venkatram, Sindhaghatta; George, Teresa; Luo, Kristina; Diaz-Fuentes, Gilda

2017-01-01

Objective. Asthma education programs have been shown to decrease healthcare utilization and improve disease control and management. The purpose of our study was to evaluate the impact of an outpatient adult asthma education program in an inner city hospital caring for patients with low socioeconomic and educational status. Methods. An asthma education program was implemented in September 2014. Patients who received education from September 2014 to July 2015 were evaluated. Outcomes were compared for the same group of patients before and after education. Primary outcomes were emergency room (ER) visits and hospital admissions. Secondary outcomes were change in Asthma Control Test (ACT) score and number of pulmonary clinic visits. Results. Asthma education significantly decreased number of patients requiring ER visits and hospital admissions (p = 0.0005 and p = 0.0015, resp.). Asthma control as per ACT score ≥ 20 improved with education (p = 0.0001) with an increase in clinic visits (p = 0.0185). Conclusions. Our study suggests that implementation of a structured asthma education program in an inner city community hospital has a positive impact on reduction of ER visits and hospital admissions with improvement in asthma control. Institutional Review Board Clinical Study registration number is 01081507. PMID:28546781

Management of Chronic Periodontitis Using Subgingival Irrigation of Ozonized Water: A Clinical and Microbiological Study

PubMed Central

Mathew, Jayan Jacob; Ambooken, Majo; Kachappilly, Arun Jose; PK, Ajithkumar; Johny, Thomas; VK, Linith; Samuel, Anju

2015-01-01

Introduction Adjunctive use of professional subgingival irrigation with scaling and root planing (SRP) has been found to be beneficial in eradicating the residual microorganisms in the pocket. Objective To evaluate the effect of ozonized water subgingival irrigation on microbiologic parameters and clinical parameters namely Gingival index, probing pocket depth, and clinical attachment level. Materials and Methods Thirty chronic periodontitis patients with probing pocket depth ≥6mm on at least one tooth on contra lateral sides of opposite arches were included in the study. The test sites were subjected to ozonized water subgingival irrigation with subgingival irrigation device fitted with a modified subgingival tip. Control sites were subjected to scaling and root planing only. The following clinical parameters were recorded initially and after 4 weeks at the test sites and control sites. Plaque Index, Gingival Index, probing pocket depth, clinical attachment level. Microbiologic sampling was done for the test at the baseline, after scaling, immediately after ozonized water subgingival irrigation and after 4 weeks. In control sites microbiologic sampling was done at the baseline, after scaling and after 4 weeks. The following observations were made after 4 weeks. The results were statistically analysed using independent t-test and paired t-test. Result Test sites showed a greater reduction in pocket depth and gain in clinical attachment compared to control sites. The total anaerobic counts were significantly reduced by ozonized water subgingival irrigation along with SRP compared to SRP alone. Conclusion Ozonized water subgingival irrigation can improve the clinical and microbiological parameters in patients with chronic periodontitis when used as an adjunct to scaling and root planing. PMID:26436042

What is different about workers' compensation patients? Socioeconomic predictors of baseline disability status among patients with lumbar radiculopathy.

PubMed

Atlas, Steven J; Tosteson, Tor D; Hanscom, Brett; Blood, Emily A; Pransky, Glenn S; Abdu, William A; Andersson, Gunnar B; Weinstein, James N

2007-08-15

Combined analysis of 2 prospective clinical studies. To identify socioeconomic characteristics associated with workers' compensation in patients with an intervertebral disc herniation (IDH) or spinal stenosis (SpS). Few studies have compared socioeconomic differences between those receiving or not receiving workers' compensation with the same underlying clinical conditions. Patients were identified from the Spine Patient Outcomes Research Trial (SPORT) and the National Spine Network (NSN) practice-based outcomes study. Patients with IDH and SpS within NSN were identified satisfying SPORT eligibility criteria. Information on disability and work status at baseline evaluation was used to categorize patients into 3 groups: workers' compensation, other disability compensation, or work-eligible controls. Enrollment rates of patients with disability in a clinical efficacy trial (SPORT) and practice-based network (NSN) were compared. Independent socioeconomic predictors of baseline workers' compensation status were identified in multivariate logistic regression models controlling for clinical condition, study cohort, and initial treatment designation. Among 3759 eligible patients (1480 in SPORT and 2279 in NSN), 564 (15%) were receiving workers' compensation, 317 (8%) were receiving other disability compensation, and 2878 (77%) were controls. Patients receiving workers' compensation were less common in SPORT than NSN (9.2% vs. 18.8%, P < 0.001), but patients receiving other disability compensation were similarly represented (8.9% vs. 7.7%, P = 0.19). In univariate analyses, many socioeconomic characteristics significantly differed according to baseline workers' compensation status. In multiple logistic regression analyses, gender, educational level, work characteristics, legal action, and expectations about ability to work without surgery were independently associated with receiving workers' compensation. Clinical trials involving conditions commonly seen in patients with workers' compensation may need special efforts to ensure adequate representation. Socioeconomic characteristics markedly differed between patients receiving and not receiving workers' compensation. Identifying the independent effects of workers' compensation on outcomes will require controlling for these baseline characteristics and other clinical features associated with disability status.

Disease history and medication use as risk factors for the clinical manifestation of type 1 diabetes in children and young adults: an explorative case control study.

PubMed

Fazeli Farsani, Soulmaz; Souverein, Patrick C; van der Vorst, Marja M J; Mantel-Teeuwisse, Aukje K; Knibbe, Catherijne A J; de Boer, Anthonius

2014-01-01

There is a highly variable asymptomatic period of beta cell destruction prior to the clinical presentation of type1 diabetes. It is not well known what triggers type 1 diabetes to become a clinically overt disease. This explorative study aimed to identify the association between disease history/medication use and the clinical manifestation of type 1 diabetes. An explorative case control study was conducted in the Dutch PHARMO Record Linkage System. Cases (n = 1,107) were younger than 25 years and had at least 2 insulin prescriptions between 1999 and 2009. For each case, up to 4 controls (without any prescription for the glucose lowering medications (n = 4,424)) were matched by age and sex. Conditional logistic regression analysis was used to evaluate the association between disease history/medication use in the year prior to the diagnosis of type 1 diabetes and clinical manifestation of this disease. Type1 diabetes was significantly associated with a history of mental disorder (odds ratio (OR) 8.0, 95% confidence interval (CI) 1.5-43.7), anemia (OR 5.1, 95% CI 1.1-22.9), and disease of digestive system (OR 2.6, 95% CI 1.2-5.5). The following drug exposures were significantly associated with the clinical manifestation of type 1 diabetes: "systemic hormonal preparations" (OR 1.7, 95% CI 1.1-2.6), medications for "blood and blood forming organs" (OR 1.6, 95% CI 1.1-2.6), "alimentary tract and metabolism" (OR 1.3, 95% CI 1.1-1.6), and "anti-infectives for systemic use" (OR 1.2, 95% CI 1.01-1.4). Our explorative study demonstrated that in the year prior to the presentation of type 1 diabetes in children and young adults, hospitalization for a diverse group of diseases and drug exposures were significantly more prevalent compared with age- and sex-matched diabetes-free controls.

Drugs affecting blood pressure variability: an update.

PubMed

Hocht, Christian; Del Mauro, Julieta Sofia; Bertera, Facundo Martín; Taira, Carlos Alberto

2015-01-01

Blood pressure variability (BPV) is considered nowadays a novel risk factor for cardiovascular disease. Clinical evidences support that short-term and long-term BPV independently contribute to target organ damage, cardiovascular events and mortality in patients with hypertension or diabetes. Attenuation of excessive fluctuations of systolic and diastolic BPV has been suggested as an additional therapeutic target in cardiovascular prevention. A growing number of preclinical and clinical studies have focused in the assessment of drug effects or other interventions on the different types of BPV and their contribution in the prevention of cardiovascular events. Prospective clinical trials have shown that antihypertensive classes differ in their ability to control excessive BP fluctuations with an impact in clinical outcomes. Current evidences suggest that calcium channel blockers are more effective than other blood pressure lowering drugs for the reduction of short-term, mid-term and long-term BPV. In order to increase actual knowledge regarding the therapeutic significance of BPV in cardiovascular disease, there is a need for additional clinical studies specifically designed for the study of the relevance of short-term and long-term BPV control by antihypertensive drugs.

Clinical performance of a new blood control peripheral intravenous catheter: A prospective, randomized, controlled study.

PubMed

Seiberlich, Laura E; Keay, Vanessa; Kallos, Stephane; Junghans, Tiffany; Lang, Eddy; McRae, Andrew D

2016-03-01

The performance of a new safety peripheral intravenous catheter (PIVC) that contains a blood control feature in the hub (blood control) was compared against the current hospital standard without blood control (standard). In this prospective, non-blinded trial, patients were randomized 1:1 to receive either device. Insertions were performed and rated by emergency room nurses. Primary endpoints included clinical acceptability, incidence of blood leakage, and risk of blood exposure. Secondary endpoints were digital compression, insertion success, and usability. 15 clinicians performed 152 PIVC insertions (73 blood control, 79 standard). Clinical acceptability of the blood control device (100%) was non-inferior to the standard (98.7%) (p < 0.0001). The blood control device had a lower incidence of blood leakage (14.1% vs 68.4%), was superior in eliminating the risk of blood exposure (93.9% vs 19.1%) and the need for digital compression (95.3% vs 19.1%), while maintaining non-inferior insertion success rates (95.9% vs 93.7%) and usability ratings (p < 0.0001). In comparison with the hospital-standard, the new safety PIVC with integrated blood control valve had similar clinical acceptability ratings yet demonstrated superior advantages to both clinicians and patients to decrease blood leakage and the clinician's risk of blood exposure, during the insertion process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Attitudes towards the Infection Prevention and Control Nurse: an interview study.

PubMed

Ward, Deborah J

2012-07-01

A study was undertaken involving nursing students and nurse mentors to investigate the experiences and learning needs of nursing students in relation to infection prevention. One of the objectives was to consider the views of both nursing students and mentors towards the Infection Prevention and Control Nurse (IPCN) as an important staff member in infection prevention and control. Infection prevention and control is a national and international priority but compliance with precautions can be low. One reason for this is staff attitudes. Infection Prevention and Control Nurses have an important role to play in the management of patient care through clinical staff and it is therefore important that they are seen as approachable and effective in their role. Using a qualitative approach, data were obtained through semistructured interviews with 31 nursing students and 32 nurse mentors. Interviews were recorded, transcribed and analysed using framework analysis. Three themes emerged: attitudes towards the IPCN, effects of the presence of the IPCN and preferred qualities in IPCNs. Areas for future research are identified and recommendations made to address areas where attitudes may affect both clinical practice and the education of nursing students in clinical placements. Nurse specialists or practitioners, who are often seen within a management role, need to consider how they work with clinical staff in order to foster more collaborative relationships. © 2012 Blackwell Publishing Ltd.

Saccharomyces boulardii for prevention of necrotizing enterocolitis in preterm infants: a randomized, controlled study.

PubMed

Demirel, Gamze; Erdeve, Omer; Celik, Istemi Han; Dilmen, Ugur

2013-12-01

To evaluate the efficacy of orally administered Saccharomyces boulardii (S. boulardii) for reducing the incidence and severity of necrotizing enterocolitis (NEC) in very low-birth-weight (VLBW) infants. A prospective, randomised controlled trial was conducted in infants with gestational age ≤32 weeks and birth weight ≤1500 g. The study group received S. boulardii supplementation, and the control group did not. The primary outcomes were death or NEC (Bell's stage ≥2), and secondary outcomes were feeding intolerance and clinical or culture-proven sepsis. A total of 271 infants were enrolled in the study, 135 in the study group and 136 in the control group. There was no significant difference in the incidence of death (3.7% vs. 3.6%, 95% CI of the difference, -5.20-5.25; p = 1.0) or NEC (4.4% vs. 5.1%, 95% CI, -0.65-5.12; p = 1.0) between the groups. However, feeding intolerance and clinical sepsis were significantly lower in the probiotic group compared with control. Although Saccharomyces boulardii supplementation at a dose of 250 mg/day was not effective at reducing the incidence of death or NEC in VLBW infants, it improved feeding tolerance and reduced the risk of clinical sepsis. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Clinical characteristics and pregnancy outcomes of Syrian refugees: a case-control study in a tertiary care hospital in Istanbul, Turkey.

PubMed

Erenel, Hakan; Aydogan Mathyk, Begum; Sal, Veysel; Ayhan, Isil; Karatas, Suat; Koc Bebek, Arzu

2017-01-01

We aimed to compare the clinical characteristics and pregnancy outcomes in women who are Syrian refugees and Turkish women who are non-refugees at a maternity center in Istanbul, Turkey. A total of 600 singleton pregnancies who delivered at Sisli Hamidiye Etfal Training and Research Hospital were included in the study. Demographic data, obstetrical history, clinical findings, obstetrical and neonatal outcomes were compared between 300 Syrian refugees and 300 control patients. The Syrian refugee patients were significantly younger than Turkish patients. The percentage of adolescents aged 12-19 years were significantly higher in the Syrian patients (14.3 vs. 5.3 %, p < 0,001). 41.3 % of the refugee patients had no antenatal care. However, this ratio was only 7.7 % for the control group (p < 0.001). Preterm birth rates showed no difference between the groups, however, postterm birth rates were significantly higher in the control group. Low Birthweight (<2500 gr), oligohydramnios, stillbirth and fetal anomaly rates were not different between the two groups. In comparison to non-refugee control patients, refugee women in our study had poor antenatal care but no adverse perinatal outcomes were observed. Further larger multicenter studies may provide more convincing data about obstetric outcomes in the Syrian refugee population as well as adolescent pregnancies in this population.

The selective treatment of clinical mastitis based on on-farm culture results: I. Effects on antibiotic use, milk withholding time, and short-term clinical and bacteriological outcomes.

PubMed

Lago, A; Godden, S M; Bey, R; Ruegg, P L; Leslie, K

2011-09-01

The objective of this multi-state, multi-herd clinical trial was to evaluate the efficacy of using an on-farm culture system to guide strategic treatment decisions in cows with clinical mastitis. The study was conducted in 8 commercial dairy farms ranging in size from 144 to 1,795 cows from Minnesota, Wisconsin, and Ontario, Canada. A total of 422 cows affected with mild or moderate clinical mastitis in 449 quarters were randomly assigned to either (1) a positive-control treatment program or (2) an on-farm, culture-based treatment program. Quarter cases assigned to the positive-control group received immediate on-label intramammary treatment with cephapirin sodium. Quarters assigned to the culture-based treatment program were cultured on-farm and treated with cephapirin sodium after 18 to 24h of incubation if they had gram-positive growth or a mixed infection. Quarters with gram-negative or no growth did not receive intramammary therapy. The proportion of quarter cases assigned to positive-control and culture-based treatments that received intramammary antibiotic therapy because of study assignment was 100 and 44%, respectively; the proportion of cases that received secondary antibiotic therapy was 36 and 19%, respectively; and the proportion of cases that received intramammary antibiotic therapy because of study assignment or secondary therapy was 100 and 51%, respectively. A tendency existed for a decrease in the number of days in which milk was discarded from cows assigned to the culture-based treatment program versus cows assigned to the positive-control group (5.9 vs. 5.2 d). No statistically significant differences existed between cases assigned to the positive-control and cases assigned to the culture-based treatment program in days to clinical cure (2.7 vs. 3.2 d), bacteriological cure risk within 21 d of enrollment (71 vs. 60%), new intramammary infection risk within 21 d of enrollment (50 vs. 50%), and treatment failure risk (presence of infection, secondary treatment, clinical mastitis recurrence, or removal from herd within 21 d after enrollment; 81 vs. 78%). In summary, the use of an on-farm culture system to guide the strategic treatment of clinical mastitis reduced intramammary antibiotic use by half and tended to decrease milk withholding time by 1 d, without significant differences in days to clinical cure, bacteriological cure risk, new intramammary infection risk, and treatment failure risk within 21 d after the clinical mastitis event. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Efficacy of Platelet-Rich Fibrin After Mandibular Third Molar Extraction: A Systematic Review and Meta-Analysis.

PubMed

Al-Hamed, Faez Saleh; Tawfik, Mohamed Abdel-Monem; Abdelfadil, Ehab; Al-Saleh, Mohammed A Q

2017-06-01

To assess the effect of platelet-rich fibrin (PRF) on the healing process of the alveolar socket after surgical extraction of the mandibular third molars. PubMed, the Cochrane Central Register of Controlled Trials, Scopus, and relevant journals were searched using a combination of specific keywords ("platelet-rich fibrin," "oral surgery," and "third molar"). The final search was conducted on November 2, 2015. Randomized controlled clinical trials, as well as controlled clinical trials, aimed at comparing the effect of PRF versus natural healing after extraction of mandibular third molars were included. Five randomized controlled trials and one controlled clinical trial were included. There were 335 extractions (168 with PRF and 167 controls) in 183 participants. Considerable heterogeneity in study characteristics, outcome variables, and estimated scales was observed. Positive results were generally recorded for pain, trismus, swelling, periodontal pocket depth, soft tissue healing, and incidence of localized osteitis, but not in all studies. However, no meta-analysis could be conducted for such variables because of the different measurement scales used. The qualitative and meta-analysis results showed no significant improvement in bone healing with PRF-treated sockets compared with the naturally healing sockets. Within the limitations of the available evidence, PRF seems to have no beneficial role in bone healing after extraction of the mandibular third molars. Future standardized randomized controlled clinical trials are required to estimate the effect of PRF on socket regeneration. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C.

PubMed

Bruix, Jordi; Poynard, Thierry; Colombo, Massimo; Schiff, Eugene; Burak, Kelly; Heathcote, Elizabeth J L; Berg, Thomas; Poo, Jorge-Luis; Mello, Carlos Brandao; Guenther, Rainer; Niederau, Claus; Terg, Ruben; Bedossa, Pierre; Boparai, Navdeep; Griffel, Louis H; Burroughs, Margaret; Brass, Clifford A; Albrecht, Janice K

2011-06-01

Several studies have reported that low doses of interferon can delay the development of hepatocellular carcinoma (HCC) and progression of chronic hepatitis C. We investigated the incidence of clinical events among participants of the Evaluation of PegIntron in Control of Hepatitis C Cirrhosis (EPIC)3 program. Data were analyzed from an open-label randomized study of patients with chronic hepatitis C who had failed to respond to interferon alfa plus ribavirin. All patients had compensated cirrhosis with no evidence of HCC. Patients received peginterferon alfa-2b (0.5 μg/kg/week; n=311) or no treatment (controls, n=315) for a maximum period of 5 years or until 98 patients had a clinical event (hepatic decompensation, HCC, death, or liver transplantation). The primary measure of efficacy was time until the first clinical event. There was no significant difference in time to first clinical event among patients who received peginterferon alfa-2b compared with controls (hazard ratio [HR], 1.452; 95% confidence interval [CI]: 0.880-2.396). There was no decrease in the development of HCC with therapy. The time to disease progression (clinical events or new or enlarged varices) was significantly longer for patients who received peginterferon alfa-2b compared with controls (HR, 1.564; 95% CI: 1.130-2.166). In a prospectively defined subanalysis of patients with baseline portal hypertension, peginterferon alfa-2b significantly increased the time to first clinical event compared with controls (P=.016). There were no new safety observations. Maintenance therapy with peginterferon alfa-2b is not warranted in all patients and does not prevent HCC. However, there is a potential clinical benefit of long-term suppressive therapy in patients with preexisting portal hypertension. Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

[Comparative study of two treatment methods for acute periodontal abscess].

PubMed

Jin, Dong-mei; Wang, Wei-qian

2012-10-01

The aim of this short-term study was to compare the clinical efficacy of 2 different methods to treat acute periodontal abscesses. After patient selection, 100 cases of acute periodontal abscess were randomly divided into two groups. The experimental group was treated by supra- and subgingival scaling, while the control group was treated by incision and drainage. A clinical examination was carried out to record the following variables: subjective clinical variables including pain, edema, redness and swelling; objective clinical variables including gingival index(GI), bleeding index(BI), probing depth(PD),suppuration, lymphadenopathy and tooth mobility. The data was analyzed with SPSS 19.0 software package. RESULES: Subjective clinical variables demonstrated statistically significant improvements with both methods from the first day after treatment and lasted for at least 30 days(P<0.05), but the results of experimental group showed much better than the control group 1 day and 7 days after treatment. 30 days after treatment, there was no significant difference between the two groups in pain and swelling improvement(P>0.05), but the experimental group showed more improvement in edema and redness than the control group(P<0.05).On improving objective variables, the experimental group showed significant improvement in GI,BI,PD and suppuration 1 day after treatment(P<0.05).After 7 days, all objective clinical variables in the experimental group improved significantly(P<0.05) in the control group, there were significant improvements in GI,suppuration,lymphadenopathy and tooth mobility(P<0.05) but the four variables of the experimental group showed more improvement than the control group(P<0.05).After 30 days, all objective clinical variables improved significantly in both groups as compared to baseline, but in the experimental group, improvements were more significant regarding to GI,BI,PD,suppuration and tooth mobility(P<0.05). The method of supra- and subgingival scaling was rapid and effective in treatment of acute periodontal abscesses.

Bayesian analysis of a mastitis control plan to investigate the influence of veterinary prior beliefs on clinical interpretation.

PubMed

Green, M J; Browne, W J; Green, L E; Bradley, A J; Leach, K A; Breen, J E; Medley, G F

2009-10-01

The fundamental objective for health research is to determine whether changes should be made to clinical decisions. Decisions made by veterinary surgeons in the light of new research evidence are known to be influenced by their prior beliefs, especially their initial opinions about the plausibility of possible results. In this paper, clinical trial results for a bovine mastitis control plan were evaluated within a Bayesian context, to incorporate a community of prior distributions that represented a spectrum of clinical prior beliefs. The aim was to quantify the effect of veterinary surgeons' initial viewpoints on the interpretation of the trial results. A Bayesian analysis was conducted using Markov chain Monte Carlo procedures. Stochastic models included a financial cost attributed to a change in clinical mastitis following implementation of the control plan. Prior distributions were incorporated that covered a realistic range of possible clinical viewpoints, including scepticism, enthusiasm and uncertainty. Posterior distributions revealed important differences in the financial gain that clinicians with different starting viewpoints would anticipate from the mastitis control plan, given the actual research results. For example, a severe skeptic would ascribe a probability of 0.50 for a return of < 5 UK pounds per cow in an average herd that implemented the plan, whereas an enthusiast would ascribe this probability for a return of > 20 UK pounds per cow. Simulations using increased trial sizes indicated that if the original study was four times as large, an initial skeptic would be more convinced about the efficacy of the control plan but would still anticipate less financial return than an initial enthusiast would anticipate after the original study. In conclusion, it is possible to estimate how clinicians' prior beliefs influence their interpretation of research evidence. Further research on the extent to which different interpretations of evidence result in changes to clinical practice would be worthwhile.

Anodal transcranial direct current stimulation of the left dorsolateral prefrontal cortex enhances emotion recognition in depressed patients and controls.

PubMed

Brennan, Sean; McLoughlin, Declan M; O'Connell, Redmond; Bogue, John; O'Connor, Stephanie; McHugh, Caroline; Glennon, Mark

2017-05-01

Transcranial direct current stimulation (tDCS) can enhance a range of neuropsychological functions but its efficacy in addressing clinically significant emotion recognition deficits associated with depression is largely untested. A randomized crossover placebo controlled study was used to investigate the effects of tDCS over the left dorsolateral prefrontal cortex (L-DLPFC) on a range of neuropsychological variables associated with depression as well as neural activity in the associated brain region. A series of computerized tests was administered to clinical (n = 17) and control groups (n = 20) during sham and anodal (1.5 mA) stimulation. Anodal tDCS led to a significant main effect for overall emotion recognition (p = .02), with a significant improvement in the control group (p = .04). Recognition of disgust was significantly greater in the clinical group (p = .01). Recognition of anger was significantly improved for the clinical group (p = .04) during anodal stimulation. Differences between groups for each of the six emotions at varying levels of expression found that at 40% during anodal stimulation, happy recognition significantly improved for the clinical group (p = .01). Anger recognition at 80% during anodal stimulation significantly improved for the clinical group (p = .02). These improvements were observed in the absence of any change in psychomotor speed or trail making ability during anodal stimulation. Working memory significantly improved during anodal stimulation for the clinical group but not for controls (p = .03). The tentative findings of this study indicate that tDCS can have a neuromodulatory effect on a range of neuropsychological variables. However, it is clear that there was a wide variation in responses to tDCS and that individual difference and different approaches to testing and stimulation have a significant impact on final outcomes. Nonetheless, tDCS remains a promising tool for future neuropsychological research.

Comparison of Efficacy Between Endoscopic Cyclophotocoagulation and Alternative Surgeries in Refractory Glaucoma

PubMed Central

Yang, Yangfan; Zhong, Jing; Dun, Zhongjun; Liu, Xiao-an; Yu, Minbin

2015-01-01

Abstract Refractory glaucoma refers to uncontrolled intraocular pressure (IOP) despite anti-glaucoma medication and surgical treatment, which remains a challenge to be treated. The objective of this study is to evaluate and statistically compare the clinical efficacy between endoscopic cyclophotocoagulation (ECP) and alternative surgical techniques in the treatment of refractory glaucoma in this article, as a meta-analysis. Data sources are China Biomedical Database (Sinomed, online version), China National Knowledge Infrastructure (CNKI), Cqvip, Wanfang database, and PubMed. The randomized controlled trial (RCT) and case–control study literatures evaluating the clinical efficacy between ECP and other surgical techniques were searched electronically from public databases. The methodology quality of the retrieved articles was evaluated according to the RCT or case–control study criteria. The success rate of treatment, intraocular pressure (IOP) and visual acuity were statistically compared. RevMan 5.3 software was used for the meta-analysis. In total, 6 relevant control studies were selected in this study with a total sampling of 429 cases (429 eyes), including 204 eyes in the ECP group and 225 in the non-ECP group. Meta-analysis demonstrated that the clinical efficacy did not significantly differ between 2 groups (P > 0.05). Postoperative IOP was dramatically reduced in both groups. However, it was difficult to evaluate the combined influence of ECP and non-ECP therapies upon IOP reduction. In conclusion, ECP and non-ECP treatment yielded almost equivalent clinical efficacy in treating refractory glaucoma. The IOP-lowering degree, safety, and incidence of complications remain to be further elucidated by RCTs with a larger sample size. PMID:26426659

The applications of regenerative medicine in sinus lift procedures: A systematic review.

PubMed

Correia, Francisco; Pozza, Daniel Humberto; Gouveia, Sónia; Felino, António; Faria E Almeida, Ricardo

2018-04-01

Findings in regenerative medicine applied to the sinus lift procedures. Evaluate the effectiveness of regenerative medicine in sinus lift. An extensive search for manuscripts were performed by using different combinations of keywords and MeSH terms (Pub-med; Embase; Scopus; Web of Science Core Collection; Medline; Current Contents Connect; Derwent Innovations Index; Scielo Citation Index; Cochrane library). The full text selected articles are written in English, Portuguese, Spanish, Italian, German, or French, and published until 28 of November 2016. Inclusion criteria were: implant osteointegration, radiographic, histologic, and/or histomorphometric analysis, clinical studies in humans using of regenerative medicine. This systematic review was performed by selecting only randomized controlled clinical trials and controlled clinical trials. Eighteen published studies (11 CT and 7 RCT) were considered eligible for inclusion in the present systematic review. These studies demonstrated considerable variation of biomaterial and cell technics used, study design, sinus lift technic, outcomes, follow-up, and results. Only few studies have demonstrated potential of regenerative medicine in sinus lift; further randomized clinical trials are needed to achieve more accurate results. © 2017 Wiley Periodicals, Inc.

A quick behavioral dichotic word test is prognostic for clinical response to cognitive therapy for depression: A replication study.

PubMed

Bruder, Gerard E; Haggerty, Agnes; Siegle, Greg J

2017-02-01

There are no commonly used clinical indicators of whether an individual will benefit from cognitive therapy (CT) for depression. A prior study found right ear (left hemisphere) advantage for perceiving dichotic words predicted CT response. This study replicates this finding at a different research center in clinical trials that included clinically representative samples and community therapists. Right-handed individuals with unipolar major depressive disorder who subsequently received 12-14 weeks of CT at the University of Pittsburgh were tested on dichotic fused words and complex tones tests. Responders to CT showed twice the mean right ear advantage in dichotic fused words performance than non-responders. Patients with a right ear advantage greater than the mean for healthy controls had an 81% response rate to CT, whereas those with performance lower than the mean for controls had a 46% response rate. Individuals with a right ear advantage, indicative of strong left hemisphere language dominance, may be better at utilizing cognitive processes and left frontotemporal cortical regions critical for success of CT for depression. Findings at two clinical research centers suggest that verbal dichotic listening may be a clinically disseminative brief, inexpensive and easily automated test prognostic for response to CT across diverse clinical settings. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Clinical Characteristics of Voice, Speech, and Swallowing Disorders in Oromandibular Dystonia

ERIC Educational Resources Information Center

Kreisler, Alexandre; Vepraet, Anne Caroline; Veit, Solène; Pennel-Ployart, Odile; Béhal, Hélène; Duhamel, Alain; Destée, Alain

2016-01-01

Purpose: To better define the clinical characteristics of idiopathic oromandibular dystonia, we studied voice, speech, and swallowing disorders and their impact on activities of daily living. Method: Fourteen consecutive patients with idiopathic oromandibular dystonia and 14 matched, healthy control subjects were included in the study. Results:…

Monolingual or Bilingual Intervention for Primary Language Impairment? A Randomized Control Trial

ERIC Educational Resources Information Center

Thordardottir, Elin; Cloutier, Geneviève; Ménard, Suzanne; Pelland-Blais, Elaine; Rvachew, Susan

2015-01-01

Purpose: This study investigated the clinical effectiveness of monolingual versus bilingual language intervention, the latter involving speech-language pathologist-parent collaboration. The study focuses on methods that are currently being recommended and that are feasible within current clinical contexts. Method: Bilingual children with primary…

Is caffeine intake a risk factor leading to infertility? A protocol of an epidemiological systematic review of controlled clinical studies.

PubMed

Cao, Huijuan; Ren, Jun; Feng, Xue; Yang, Guoyan; Liu, Jianping

2016-03-15

Previous studies showed that high dose of caffeine intake may induce some specific human reproductive system diseases, even lead to infertility. In consideration of the high consumption of caffeine according to the latest population-based survey, this review is aimed to systematically review the evidence from all controlled clinical studies of caffeine intake for infertility. Relevant randomized/quasi-randomized controlled trials, non-randomized clinical studies, cohort studies, and case-control studies will be included in this review. Participants will be either those without a history of infertility who are willing to have a baby (for prospective studies) or infertile patients with confirmed diagnosis (for retrospective studies). Caffeine or caffeine-containing beverage will be observed as the exposure factor. The key outcome will be the diagnosis of infertility in participants. All relevant published/unpublished or ongoing studies will be searched from seven databases and four online systems until December 2015. Two authors will screen the literatures and extract the data independently. Methodological quality of the included studies will be assessed by two authors according to either Risk of Bias Assessment or Newcastle-Ottawa Scale. We will use R software to analyze the data. Dose of caffeine will be quantified on a daily basis, and relative risk with their 95 % confidence interval will be measured. If data permit, meta-analysis and dose-response analysis will be conducted. Summary of findings tables will be generated using Guideline Development Tool online. PROSPERO CRD42015015714.

painACTION-back pain: a self-management website for people with chronic back pain.

PubMed

Chiauzzi, Emil; Pujol, Lynette A; Wood, Mollie; Bond, Kathleen; Black, Ryan; Yiu, Elizabeth; Zacharoff, Kevin

2010-07-01

To determine whether an interactive self-management Website for people with chronic back pain would significantly improve emotional management, coping, self-efficacy to manage pain, pain levels, and physical functioning compared with standard text-based materials. The study utilized a pretest-posttest randomized controlled design comparing Website (painACTION-Back Pain) and control (text-based material) conditions at baseline and at 1-, 3, and 6-month follow-ups. Two hundred and nine people with chronic back pain were recruited through dissemination of study information online and at a pain treatment clinic. The 6-month follow-up rates for the Website and control groups were 73% and 84%, respectively. Measures were based on the recommendations of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials and included measures of pain intensity, physical functioning, emotional functioning, coping, self-efficacy, fear-avoidance, perceived improvement with treatment, self-efficacy, and catastrophizing. Compared with controls, painACTION-Back Pain participants reported significantly: 1) lower stress; 2) increased coping self-statements; and 3) greater use of social support. Comparisons between groups suggested clinically significant differences in current pain intensity, depression, anxiety, stress, and global ratings of improvement. Among participants recruited online, those using the Website reported significantly: 1) lower "worst" pain; 2) lower "average" pain; and 3) increased coping self-statements, compared with controls. Participants recruited through the pain clinic evidenced no such differences. An online self-management program for people with chronic back pain can lead to improvements in stress, coping, and social support, and produce clinically significant differences in pain, depression, anxiety, and global rates of improvement.

Diagnostic accuracy in Family Medicine residents using a clinical decision support system (DXplain): a randomized-controlled trial.

PubMed

Martinez-Franco, Adrian Israel; Sanchez-Mendiola, Melchor; Mazon-Ramirez, Juan Jose; Hernandez-Torres, Isaias; Rivero-Lopez, Carlos; Spicer, Troy; Martinez-Gonzalez, Adrian

2018-05-07

Clinical reasoning is an essential skill in physicians, required to address the challenges of accurate patient diagnoses. The goal of the study was to compare the diagnostic accuracy in Family Medicine residents, with and without the use of a clinical decision support tool (DXplain http://www.mghlcs.org/projects/dxplain). A total of 87 first-year Family Medicine residents, training at the National Autonomous University of Mexico (UNAM) Postgraduate Studies Division in Mexico City, participated voluntarily in the study. They were randomized to a control group and an intervention group that used DXplain. Both groups solved 30 clinical diagnosis cases (internal medicine, pediatrics, gynecology and emergency medicine) in a multiple-choice question test that had validity evidence. The percent-correct score in the Diagnosis Test in the control group (44 residents) was 74.1±9.4 (mean±standard deviation) whereas the DXplain intervention group (43 residents) had a score of 82.4±8.5 (p<0.001). There were significant differences in the four knowledge content areas of the test. Family Medicine residents have appropriate diagnostic accuracy that can improve with the use of DXplain. This could help decrease diagnostic errors, improve patient safety and the quality of medical practice. The use of clinical decision support systems could be useful in educational interventions and medical practice.

Effects of sleep bruxism on functional and occlusal parameters: a prospective controlled investigation

PubMed Central

Alicia Ommerborn, Michelle; Giraki, Maria; Schneider, Christine; Michael Fuck, Lars; Handschel, Jörg; Franz, Matthias; Hans-Michael Raab, Wolfgang; Schäfer, Ralf

2012-01-01

This study was conducted to verify the results of a preceding retrospective pilot study by means of a prospective controlled investigation including a larger sample size. Therefore, the aim of this clinical investigation was to analyze the relationship between sleep bruxism and several functional and occlusal parameters. The null hypothesis of this study was that there would be no differences among sleep bruxism subjects and non-sleep bruxism controls regarding several functional and occlusal parameters. Fifty-eight sleep bruxism subjects and 31 controls participated in this study. The diagnosis sleep bruxism was based on clinical criteria of the American Academy of Sleep Medicine. Sixteen functional and occlusal parameters were recorded clinically or from dental study casts. Similar to the recently published retrospective pilot study, with a mean slide of 0.77 mm (s.d., 0.69 mm) in the sleep bruxism group and a mean slide of 0.4 mm (s.d., 0.57 mm) in the control group, the evaluation of the mean comparison between the two groups demonstrated a larger slide from centric occlusion to maximum intercuspation in sleep bruxism subjects (Mann–Whitney U-test; P=0.008). However, following Bonferroni adjustment, none of the 16 occlusal and functional variables differed significantly between the sleep bruxism subjects and the non-sleep bruxism controls. The present study shows that the occlusal and functional parameters evaluated do not differ between sleep bruxism subjects and non-sleep bruxism subjects. However, as the literature reveals a possible association between bruxism and certain subgroups of temporomandibular disorders, it appears advisable to incorporate the individual adaptive capacity of the stomatognathic system into future investigations. PMID:22935746

A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.

PubMed

Ezenwa, Miriam O; Yao, Yingwei; Engeland, Christopher G; Molokie, Robert E; Wang, Zaijie Jim; Suarez, Marie L; Wilkie, Diana J

2016-06-01

To test feasibility of a guided audio-visual relaxation intervention protocol for reducing stress and pain in adults with sickle cell disease. Sickle cell pain is inadequately controlled using opioids, necessitating further intervention such as guided relaxation to reduce stress and pain. Attention-control, randomized clinical feasibility pilot study with repeated measures. Randomized to guided relaxation or control groups, all patients recruited between 2013-2014 during clinical visits, completed stress and pain measures via a Galaxy Internet-enabled Android tablet at the Baseline visit (pre/post intervention), 2-week posttest visit and also daily at home between the two visits. Experimental group patients were asked to use a guided relaxation intervention at the Baseline visit and at least once daily for 2 weeks. Control group patients engaged in a recorded sickle cell discussion at the Baseline visit. Data were analysed using linear regression with bootstrapping. At baseline, 27/28 of consented patients completed the study protocol. Group comparison showed that guided relaxation significantly reduced current stress and pain. At the 2-week posttest, 24/27 of patients completed the study, all of whom reported liking the study. Patients completed tablet-based measures on 71% of study days (69% in control group, 72% in experiment group). At the 2-week posttest, the experimental group had significantly lower composite pain index scores, but the two groups did not differ significantly on stress intensity. This study protocol appears feasible. The tablet-based guided relaxation intervention shows promise for reducing sickle cell pain and warrants a larger efficacy trial. The ClinicalTrials.gov Identifier is: NCT02501447. © 2016 John Wiley & Sons Ltd.

Effects of sleep bruxism on functional and occlusal parameters: a prospective controlled investigation.

PubMed

Ommerborn, Michelle Alicia; Giraki, Maria; Schneider, Christine; Fuck, Lars Michael; Handschel, Jörg; Franz, Matthias; Hans-Michael Raab, Wolfgang; Schäfer, Ralf

2012-09-01

This study was conducted to verify the results of a preceding retrospective pilot study by means of a prospective controlled investigation including a larger sample size. Therefore, the aim of this clinical investigation was to analyze the relationship between sleep bruxism and several functional and occlusal parameters. The null hypothesis of this study was that there would be no differences among sleep bruxism subjects and non-sleep bruxism controls regarding several functional and occlusal parameters. Fifty-eight sleep bruxism subjects and 31 controls participated in this study. The diagnosis sleep bruxism was based on clinical criteria of the American Academy of Sleep Medicine. Sixteen functional and occlusal parameters were recorded clinically or from dental study casts. Similar to the recently published retrospective pilot study, with a mean slide of 0.77 mm (s.d., 0.69 mm) in the sleep bruxism group and a mean slide of 0.4 mm (s.d., 0.57 mm) in the control group, the evaluation of the mean comparison between the two groups demonstrated a larger slide from centric occlusion to maximum intercuspation in sleep bruxism subjects (Mann-Whitney U-test; P=0.008). However, following Bonferroni adjustment, none of the 16 occlusal and functional variables differed significantly between the sleep bruxism subjects and the non-sleep bruxism controls. The present study shows that the occlusal and functional parameters evaluated do not differ between sleep bruxism subjects and non-sleep bruxism subjects. However, as the literature reveals a possible association between bruxism and certain subgroups of temporomandibular disorders, it appears advisable to incorporate the individual adaptive capacity of the stomatognathic system into future investigations.

Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial.

PubMed

Lewandowski, Kathryn Eve; Sperry, Sarah H; Ongur, Dost; Cohen, Bruce M; Norris, Lesley A; Keshavan, Matcheri S

2016-03-12

Cognitive dysfunction is a major feature of bipolar disorder with psychosis and is strongly associated with functional outcomes. Computer-based cognitive remediation has shown promise in improving cognition in patients with schizophrenia. However, despite similar neurocognitive deficits between patients with schizophrenia and bipolar disorder, few studies have extended neuroscience-based cognitive remediation programs to this population. The Treatment to Enhance Cognition in Bipolar Disorder study is an investigator-initiated, parallel group, randomized, blinded clinical trial of an Internet-based cognitive remediation protocol for patients with bipolar disorder I with psychosis (n = 100). We also describe the development of our dose-matched active control paradigm. Both conditions involve 70 sessions of computer-based activities over 24 weeks. The control intervention was developed to mirror the treatment condition in dose and format but without the neuroplasticity-based task design and structure. All participants undergo neuropsychological and clinical assessment at baseline, after approximately 25 hours of study activities, post treatment, and after 6 months of no study contact to assess durability. Neuroimaging at baseline and post treatment are offered in an "opt-in" format. The primary outcomes are scores on the MATRICS battery; secondary and exploratory outcomes include measures of clinical symptoms, community functioning, and neuroimaging changes. Associations between change in cognitive measures and change in community functioning will be assessed. Baseline predictors of treatment response will be examined. The present study is the first we are aware of to implement an Internet-based cognitive remediation program in patients with bipolar disorder with psychosis and to develop a comparable web-based control paradigm. The mixed online and study-site format allows accessible treatment while providing weekly staff contact and bridging. Based on user-provided feedback, participant blinding is feasible. ClinicalTrials.gov NCT01470781 ; 11 July 2011.

Fuzzy control for closed-loop, patient-specific hypnosis in intraoperative patients: a simulation study.

PubMed

Moore, Brett L; Pyeatt, Larry D; Doufas, Anthony G

2009-01-01

Research has demonstrated the efficacy of closed-loop control of anesthesia using bispectral index (BIS) as the controlled variable, and the recent development of model-based, patient-adaptive systems has considerably improved anesthetic control. To further explore the use of model-based control in anesthesia, we investigated the application of fuzzy control in the delivery of patient-specific propofol-induced hypnosis. In simulated intraoperative patients, the fuzzy controller demonstrated clinically acceptable performance, suggesting that further study is warranted.

The RooPfs study to assess whether improved housing provides additional protection against clinical malaria over current best practice in The Gambia: study protocol for a randomized controlled study and ancillary studies.

PubMed

Pinder, Margaret; Conteh, Lesong; Jeffries, David; Jones, Caroline; Knudsen, Jakob; Kandeh, Balla; Jawara, Musa; Sicuri, Elisa; D'Alessandro, Umberto; Lindsay, Steve W

2016-06-03

In malaria-endemic areas, residents of modern houses have less malaria than those living in traditional houses. This study will determine if modern housing provides incremental protection against clinical malaria over the current best practice of long-lasting insecticidal nets (LLINs) and prompt treatment in The Gambia, determine the incremental cost-effectiveness of the interventions, and analyze the housing market in The Gambia. A two-armed, household, cluster-randomized, controlled study will be conducted to assess whether improved housing and LLINs combine to provide better protection against clinical malaria in children than LLINs alone in The Gambia. The unit of randomization will be the household, defined as a house and its occupants. A total of 800 households will be enrolled and will receive LLINs, and 400 will receive improved housing before clinical follow-up. One child aged 6 months to 13 years will be enrolled from each household and followed for clinical malaria using active case detection to estimate malaria incidence for two malaria transmission seasons. Episodes of clinical malaria will be the primary endpoint. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection, parasite density, and the prevalence of anemia. Exposure to malaria parasites will be assessed using light traps, followed by detection of Anopheles gambiae species and sporozoite infection. Ancillary economic and social science studies will undertake a cost-effectiveness analysis and use qualitative and participatory methods to explore the acceptability of the housing modifications and to design strategies for scaling-up housing interventions. The study is the first of its kind to measure the efficacy of housing on reducing clinical malaria, assess the incremental cost-effectiveness of improved housing, and identify mechanisms for scaling up housing interventions. Trial findings will help inform policy makers on improved housing for malaria control in sub-Saharan Africa. ISRCTN Registry, ISRCTN02622179 . Registered on 23 September 2014.

Patient Expectancy as a Mediator of Placebo Effects in Antidepressant Clinical Trials.

PubMed

Rutherford, Bret R; Wall, Melanie M; Brown, Patrick J; Choo, Tse-Hwei; Wager, Tor D; Peterson, Bradley S; Chung, Sarah; Kirsch, Irving; Roose, Steven P

2017-02-01

Causes of placebo effects in antidepressant trials have been inferred from observational studies and meta-analyses, but their mechanisms have not been directly established. The goal of this study was to examine in a prospective, randomized controlled trial whether patient expectancy mediates placebo effects in antidepressant studies. Adult outpatients with major depressive disorder were randomly assigned to open or placebo-controlled citalopram treatment. Following measurement of pre- and postrandomization expectancy, participants were treated with citalopram or placebo for 8 weeks. Independent samples t tests determined whether patient expectancy differed between the open and placebo-controlled groups, and mixed-effects models assessed group effects on Hamilton Depression Rating Scale (HAM-D) scores over time while controlling for treatment assignment. Finally, mediation analyses tested whether between-group differences in patient expectancy mediated the group effect on HAM-D scores. Postrandomization expectancy scores were significantly higher in the open group (mean=12.1 [SD=2.1]) compared with the placebo-controlled group (mean=11.0 [SD=2.0]). Mixed-effects modeling revealed a significant week-by-group interaction, indicating that HAM-D scores for citalopram-treated participants declined at a faster rate in the open group compared with the placebo-controlled group. Patient expectations postrandomization partially mediated group effects on week 8 HAM-D. Patient expectancy is a significant mediator of placebo effects in antidepressant trials. Expectancy-related interventions should be investigated as a means of controlling placebo responses in antidepressant clinical trials and improving patient outcome in clinical treatment.

Hydrogen Gas Inhalation Treatment in Acute Cerebral Infarction: A Randomized Controlled Clinical Study on Safety and Neuroprotection.

PubMed

Ono, Hirohisa; Nishijima, Yoji; Ohta, Shigeo; Sakamoto, Masaki; Kinone, Kazunori; Horikosi, Tohru; Tamaki, Mituyuki; Takeshita, Hirosi; Futatuki, Tomoko; Ohishi, Wataru; Ishiguro, Taichi; Okamoto, Saori; Ishii, Shou; Takanami, Hiroko

2017-11-01

Molecular hydrogen (H 2 ) acts as a therapeutic antioxidant. Inhalation of H 2 gas (1-4%) was effective for the improvement of cerebral infarction in multiple animal experiments. Thus, for actual applications, a randomized controlled clinical study is desired to evaluate the effects of inhalation of H 2 gas. Here, we evaluate the H 2 treatment on acute cerebral infarction. Through this randomized controlled clinical study, we assessed the safety and effectiveness of H 2 treatment in patients with cerebral infarction in an acute stage with mild- to moderate-severity National Institute of Health Stroke Scale (NIHSS) scores (NIHSS = 2-6). We enrolled 50 patients (25 each in the H 2 group and the control group) with a therapeutic time window of 6 to 24 hours. The H 2 group inhaled 3% H 2 gas (1 hour twice a day), and the control group received conventional intravenous medications for the initial 7 days. The evaluations included daily vital signs, NIHSS scores, physical therapy indices, weekly blood chemistry, and brain magnetic resonance imaging (MRI) scans over the 2-week study period. The H 2 group showed no significant adverse effects with improvements in oxygen saturation. The following significant effects were found: the relative signal intensity of MRI, which indicated the severity of the infarction site, NIHSS scores for clinically quantifying stroke severity, and physical therapy evaluation, as judged by the Barthel Index. H 2 treatment was safe and effective in patients with acute cerebral infarction. These results suggested a potential for widespread and general application of H 2 gas. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Bloodstream infections in pediatric oncology outpatients: a new healthcare systems challenge.

PubMed

Smith, Theresa L; Pullen, Gregg T; Crouse, Vonda; Rosenberg, Jon; Jarvis, William R

2002-05-01

To investigate a perceived increase in central venous catheter (CVC)-associated bloodstream infections (BSIs) among pediatric hematology-oncology outpatients. A case-control study. A pediatric hematology-oncology outpatient clinic at Fresno Children's Hospital. Pediatric hematology-oncology clinic outpatients with CVCs at Fresno Children's Hospital between November 1994 and October 1997. A case-patient was defined as any hematology-oncology outpatient with a CVC-associated BSI at Fresno Children's Hospital from November 1996 to October 1997 (study period) without a localizable infection. To identify case-patients, we reviewed Fresno Children's Hospital records for all hematology-oncology clinic patients, those with CVCs and those with CVCs and BSIs. Control-patients were randomly selected hematology-oncology outpatients with a CVC but no BSI during the study period. Case-patient and control-patient demographics, diagnoses, caretakers, catheter types, catheter care, and water exposure were compared. Twenty-five case-patients had 42 CVC-associated BSIs during the study period. No significant increase in CVC-associated BSI rates occurred among pediatric hematology-oncology patients. However, there was a statistically significant increase in nonendogenous, gram-negative (eg, Pseudomonas species) BSIs during summer months (May-October) compared with the rest of the year. Case-patients and control-patients differed only in catheter type; case-patients were more likely than control-patients to have a transcutaneous CVC. Summertime recreational water exposures were similar and high in the two groups. Hematology-oncology clinic patients with transcutaneous CVCs are at greater risk for CVC-associated BSI, particularly during the summer. Caretakers should be instructed on proper care of CVCs, particularly protection of CVCs during bathing and recreational summer water activities, to reduce the risk of nonendogenous, gram-negative BSIs.

Detecting At-Risk Alzheimer's Disease Cases.

PubMed

Fladby, Tormod; Pålhaugen, Lene; Selnes, Per; Waterloo, Knut; Bråthen, Geir; Hessen, Erik; Almdahl, Ina Selseth; Arntzen, Kjell-Arne; Auning, Eirik; Eliassen, Carl Fredrik; Espenes, Ragna; Grambaite, Ramune; Grøntvedt, Gøril Rolfseng; Johansen, Krisztina Kunszt; Johnsen, Stein Harald; Kalheim, Lisa Flem; Kirsebom, Bjørn-Eivind; Müller, Kai Ivar; Nakling, Arne Exner; Rongve, Arvid; Sando, Sigrid Botne; Siafarikas, Nikias; Stav, Ane Løvli; Tecelao, Sandra; Timon, Santiago; Bekkelund, Svein Ivar; Aarsland, Dag

2017-01-01

While APOEɛ4 is the major genetic risk factor for Alzheimer's disease (AD), amyloid dysmetabolism is an initial or early event predicting clinical disease and is an important focus for secondary intervention trials. To improve identification of cases with increased AD risk, we evaluated recruitment procedures using pathological CSF concentrations of Aβ42 (pAβ) and APOEɛ4 as risk markers in a multi-center study in Norway. In total, 490 subjects aged 40-80 y were included after response to advertisements and media coverage or memory clinics referrals. Controls (n = 164) were classified as normal controls without first-degree relatives with dementia (NC), normal controls with first-degree relatives with dementia (NCFD), or controls scoring below norms on cognitive screening. Patients (n = 301) were classified as subjective cognitive decline or mild cognitive impairment. Subjects underwent a clinical and cognitive examination and MRI according to standardized protocols. Core biomarkers in CSF from 411 and APOE genotype from 445 subjects were obtained. Cases (both self-referrals (n = 180) and memory clinics referrals (n = 87)) had increased fractions of pAβ and APOEɛ4 frequency compared to NC. Also, NCFD had higher APOEɛ4 frequencies without increased fraction of pAβ compared to NC, and cases recruited from memory clinics had higher fractions of pAβ and APOEɛ4 frequency than self-referred. This study shows that memory clinic referrals are pAβ enriched, whereas self-referred and NCFD cases more frequently are pAβ negative but at risk (APOEɛ4 positive), suitable for primary intervention.

The effect of mentoring on clinical perioperative competence in operating room nursing students.

PubMed

Mirbagher Ajorpaz, Neda; Zagheri Tafreshi, Mansoureh; Mohtashami, Jamileh; Zayeri, Farid; Rahemi, Zahra

2016-05-01

The aim of this study was to investigate the effects of mentoring on the clinical perioperative competence of nursing operating room students in Iran. Mentoring is an essential part of clinical education, which has been studied in different populations of students. However, there is a need to assess its effectiveness in operating room students' competence. A randomised controlled trial was performed. Sixty nursing operating room students were randomly assigned to experimental and control groups. Both the control and experimental groups had routine training in the form of faculty supervision. The experimental group had an additional mentoring program. Using the Persian Perceived Perioperative Competence Scale-Revised, clinical competence was compared between the two groups, before and after the intervention. Using SPSS 19, descriptive and inferential statistics, including chi-square and t-tests, were conducted. In the experimental group, the difference between the mean scores of clinical competence before (19·43 ± 2·80) and after (27·86 ± 1·87) the intervention was significant (p ≤ 0·001). After intervention, the difference between the mean scores of the control (3·9 ± 0·15) and experimental (8·61 ± 0·68) groups was significant (p ≤ 0·003). Findings affirmed the positive effect of mentorship programmes on clinical competence in nursing operating room students. Mentoring is an effective method for preparing nursing students in practice. Health care systems may improve as a result of staff-student relationships that ultimately increase the quality care for patients. © 2016 John Wiley & Sons Ltd.

The effects of a spiritual learning program on improving spiritual health and clinical practice stress among nursing students.

PubMed

Hsiao, Ya-Chu; Chiang, Hui-Ying; Lee, Hsiang-Chun; Chen, Su-Hui

2012-12-01

Numerous studies have indicated an association between spirituality and health outcomes. However, little information is available about interventions that have been shown to enhance spiritual health and decrease stress. This study examined the effects of a spiritual learning program (SLP) on nursing student-perceived spiritual health and clinical practice stress. A convenience sample of nursing students currently enrolled at a nursing school in northern Taiwan were recruited to participate in this quasiexperimental study as participants to experimental and control groups via simple random sampling. Results from a spiritual health scale and a perceived clinical practice stress scale, together with the score for clinical nursing practice, were compared between the groups. Baseline data were collected from all participants. The experimental group participated in 8 weeks of 50-minute per week SLP, which included lectures, discussion, reflection, and spiritual practices. A second data set was collected from all participants after the intervention. A third data set was collected after all participants had performed 4 weeks of nursing clinical practice. Participants were all women. Average age was 19.4 years (SD = 1.3 years). Generalized estimating equation analysis showed SLP to have a significant short-term effect on improving the total score for spiritual health (p < .01). Significantly greater improvement in clinical practice stress scores was also seen in the experimental group as compared with the control group (all p < .05). The experimental group obtained a higher score of the final clinical practice than the control group (t = 3.771, p < .001). The SLP may encourage participants to see stressors as meaningful events that are connected to individual life purposes. The program developed in this study may be used to improve spiritual health and reduce stress in nursing students' clinical practice. This SLP may be referenced when designing similar spirituality-related courses and applied to nursing student counseling.

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial.

PubMed

Dobson, Rosie; Whittaker, Robyn; Jiang, Yannan; Shepherd, Matthew; Maddison, Ralph; Carter, Karen; Cutfield, Richard; McNamara, Catherine; Khanolkar, Manish; Murphy, Rinki

2016-04-02

Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial. A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction. This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment. Australian New Zealand Clinical Trials Registry: ACTRN12614001232628 .

Clinical and Immunological Changes of Immunotherapy in Patients with Atopic Dermatitis: Randomized Controlled Trial

PubMed Central

Sánchez Caraballo, Jorge Mario; Cardona Villa, Ricardo

2012-01-01

Background. Immunotherapy has proven to be an useful tool in the management of allergic respiratory diseases; however, little has been studied in atopic dermatitis. Objective. To evaluate the clinical and immunological impact of immunotherapy with mites allergen extracts in atopic dermatitis. Methods. Patients with atopic dermatitis were assigned with computer-generated randomization to either of the following groups: (a) controls received only topical treatment with steroids and/or tacrolimus and (b) actively treated patients received topical treatment plus immunotherapy. Levels of serum total IgE, mites-specific IgE and IgG4 were assessed at study start and after one year of immunotherapy. Results. 31 patients in the active group and 29 in the control group completed the study. Symptoms and medication scores were significantly reduced in the active group after six months. Three patients in the control group showed new sensitizations to mites, while 3 patients in the active group showed neosensitization to shrimp with negative oral food challenge. We observed significant increase of mites-specific IgG4 levels in active group. Conclusion. Specific allergen immunotherapy induced a tolerogenic IgG4 response to mite allergens associated with favorable clinical effects in atopic dermatitis patients. PMID:23724240

Effects of structured written feedback by cards on medical students' performance at Mini Clinical Evaluation Exercise (Mini-CEX) in an outpatient clinic.

PubMed

Haghani, Fariba; Hatef Khorami, Mohammad; Fakhari, Mohammad

2016-07-01

Feedback cards are recommended as a feasible tool for structured written feedback delivery in clinical education while effectiveness of this tool on the medical students' performance is still questionable.  The purpose of this study was to compare the effects of structured written feedback by cards as well as verbal feedback versus verbal feedback alone on the clinical performance of medical students at the Mini Clinical Evaluation Exercise (Mini-CEX) test in an outpatient clinic. This is a quasi-experimental study with pre- and post-test comprising four groups in two terms of medical students' externship. The students' performance was assessed through the Mini-Clinical Evaluation Exercise (Mini-CEX) as a clinical performance evaluation tool. Structured written feedbacks were given to two experimental groups by designed feedback cards as well as verbal feedback, while in the two control groups feedback was delivered verbally as a routine approach in clinical education. By consecutive sampling method, 62 externship students were enrolled in this study and seven students were excluded from the final analysis due to their absence for three days. According to the ANOVA analysis and Post Hoc Tukey test,  no statistically significant difference was observed among the four groups at the pre-test, whereas a statistically significant difference was observed between the experimental and control groups at the post-test  (F = 4.023, p =0.012). The effect size of the structured written feedbacks on clinical performance was 0.19. Structured written feedback by cards could improve the performance of medical students in a statistical sense. Further studies must be conducted in other clinical courses with longer durations.

The alfa and beta of tumours: a review of parameters of the linear-quadratic model, derived from clinical radiotherapy studies.

PubMed

van Leeuwen, C M; Oei, A L; Crezee, J; Bel, A; Franken, N A P; Stalpers, L J A; Kok, H P

2018-05-16

Prediction of radiobiological response is a major challenge in radiotherapy. Of several radiobiological models, the linear-quadratic (LQ) model has been best validated by experimental and clinical data. Clinically, the LQ model is mainly used to estimate equivalent radiotherapy schedules (e.g. calculate the equivalent dose in 2 Gy fractions, EQD 2 ), but increasingly also to predict tumour control probability (TCP) and normal tissue complication probability (NTCP) using logistic models. The selection of accurate LQ parameters α, β and α/β is pivotal for a reliable estimate of radiation response. The aim of this review is to provide an overview of published values for the LQ parameters of human tumours as a guideline for radiation oncologists and radiation researchers to select appropriate radiobiological parameter values for LQ modelling in clinical radiotherapy. We performed a systematic literature search and found sixty-four clinical studies reporting α, β and α/β for tumours. Tumour site, histology, stage, number of patients, type of LQ model, radiation type, TCP model, clinical endpoint and radiobiological parameter estimates were extracted. Next, we stratified by tumour site and by tumour histology. Study heterogeneity was expressed by the I 2 statistic, i.e. the percentage of variance in reported values not explained by chance. A large heterogeneity in LQ parameters was found within and between studies (I 2  > 75%). For the same tumour site, differences in histology partially explain differences in the LQ parameters: epithelial tumours have higher α/β values than adenocarcinomas. For tumour sites with different histologies, such as in oesophageal cancer, the α/β estimates correlate well with histology. However, many other factors contribute to the study heterogeneity of LQ parameters, e.g. tumour stage, type of LQ model, TCP model and clinical endpoint (i.e. survival, tumour control and biochemical control). The value of LQ parameters for tumours as published in clinical radiotherapy studies depends on many clinical and methodological factors. Therefore, for clinical use of the LQ model, LQ parameters for tumour should be selected carefully, based on tumour site, histology and the applied LQ model. To account for uncertainties in LQ parameter estimates, exploring a range of values is recommended.

Subjective memory complaints, depressive symptoms and cognition in patients attending a memory outpatient clinic.

PubMed

Lehrner, J; Moser, D; Klug, S; Gleiß, A; Auff, E; Dal-Bianco, P; Pusswald, G

2014-03-01

The goals of this study were to establish prevalence of subjective memory complaints (SMC) and depressive symptoms (DS) and their relation to cognitive functioning and cognitive status in an outpatient memory clinic cohort. Two hundred forty-eight cognitively healthy controls and 581 consecutive patients with cognitive complaints who fulfilled the inclusion criteria were included in the study. A statistically significant difference (p < 0.001) between control group and patient group regarding mean SMC was detected. 7.7% of controls reported a considerable degree of SMC, whereas 35.8% of patients reported considerable SMC. Additionally, a statistically significant difference (p < 0.001) between controls and patient group regarding Beck depression score was detected. 16.6% of controls showed a clinical relevant degree of DS, whereas 48.5% of patients showed DS. An analysis of variance revealed a statistically significant difference across all four groups (control group, SCI group, naMCI group, aMCI group) (p < 0.001). Whereas 8% of controls reported a considerable degree of SMC, 34% of the SCI group, 31% of the naMCI group, and 54% of the aMCI group reported considerable SMC. A two-factor analysis of variance with the factors cognitive status (controls, SCI group, naMCI group, aMCI group) and depressive status (depressed vs. not depressed) and SMC as dependent variable revealed that both factors were significant (p < 0.001), whereas the interaction was not (p = 0.820). A large proportion of patients seeking help in a memory outpatient clinic report considerable SMC, with an increasing degree from cognitively healthy elderly to aMCI. Depressive status increases SMC consistently across groups with different cognitive status.

A meta-analysis of randomized controlled trials of azilsartan therapy for blood pressure reduction.

PubMed

Takagi, Hisato; Mizuno, Yusuke; Niwa, Masao; Goto, Shin-Nosuke; Umemoto, Takuya

2014-05-01

Although there have been a number of azilsartan trials, no meta-analysis of the findings has been conducted to date. We performed the first meta-analysis of randomized controlled trials of azilsartan therapy for the reduction of blood pressure (BP) in patients with hypertension. MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched from the beginning of the records through March 2013 using web-based search engines (PubMed and OVID). Eligible studies were prospective randomized controlled trials of azilsartan (including azilsartan medoxomil) vs. any control therapy that reported clinic or 24-h mean BP as an outcome. For each study, data for the changes from baseline to final clinic systolic BP (SBP) and diastolic BP (DBP) in both the azilsartan group and the control group were used to generate mean differences and 95% confidence intervals (CIs). Of 27 potentially relevant articles screened initially, 7 reports of randomized trials of azilsartan or azilsartan medoxomil therapy enrolling a total of 6152 patients with hypertension were identified and included. Pooled analysis suggested a significant reduction in BP changes among patients randomized to 40 mg of azilsartan vs. control therapy (clinic SBP: -4.20 mm Hg; 95% CI: -6.05 to -2.35 mm Hg; P<0.00001; clinic DBP: -2.58 mm Hg; 95% CI: -3.69 to -1.48 mm Hg; P<0.00001; 24-h mean SBP: -3.33 mm Hg; 95% CI: -4.74 to -1.93 mm Hg; P<0.00001; 24-h mean DBP: -2.12 mm Hg; 95% CI: -2.74 to -1.49 mm Hg; P<0.00001). In conclusion, azilsartan therapy appears to provide a greater reduction in BP than control therapy in patients with hypertension.

Cautionary tales in the interpretation of observational studies of effects of clinical interventions.

PubMed

Scott, I A; Attia, J

2017-02-01

Observational studies of the effectiveness of clinical interventions are proliferating as more 'real-world' clinical data (so called 'big data') are gathered from clinical registries, administrative datasets and electronic health records. While well-conducted randomised controlled trials (RCT) remain the scientific standard in assessing the efficacy of clinical interventions, well-designed observational studies may add to the evidence base of effectiveness in situations where RCT are of limited value or very difficult to perform. Rather than dismissing observational studies, we need to determine what circumstances may justify doing an observational study and when the study is sufficiently rigorous to be considered reasonably trustworthy. This article proposes criteria by which users of the literature might make such determinations. © 2016 Royal Australasian College of Physicians.

Medication adherence and blood pressure control amongst adults with primary hypertension attending a tertiary hospital primary care clinic in Eastern Nigeria

PubMed Central

Ofoedu, John N.; Njoku, Patrick U.; Amadi, Agwu N.; Godswill-Uko, Ezinne U.

2013-01-01

Abstract Background As the case detection rates of hypertension increase in adult Nigerians, achieving target blood pressure (BP) control has become an important management challenge. Objectives To describe medication adherence and BP control amongst adult Nigerians with primary hypertension attending a primary care clinic of a tertiary hospital in a resource-poor environment in Eastern Nigeria. Methods A cross-sectional study was carried out in 140 adult patients with primary hypertension who have been on treatment for at least 6 months at the primary care clinic of Federal Medical Centre, Umuahia. A patient was said to have achieved goal BP control if the BP was < 140 per 90 mmHg. Adherence was assessed in the previous 30 days using a pretested researcher-administered questionnaire on 30 days of self-reported therapy. Adherence was graded using an ordinal scoring system of 0–4; an adherent patient was one who scored 4 points in the previous 30 days. Reasons for non-adherence were documented. Results Adherence to medication and BP control rates were 42.9% and 35.0% respectively. BP control was significantly associated with medication adherence (p = 0.03), antihypertensive medication duration ≥3 years (p = 0.042), and taking ≥ one form of antihypertensive medication (p = 0.04). BP at the recruitment visit was significantly higher than at the end of the study (p = 0.036). The most common reason for non-adherence was forgetfulness (p = 0.046). Conclusions The rate of BP control amongst the study population was low, which may be connected with low medication adherence. This study urges consideration of factors relating to adherence alongside other factors driving goal BP control.

[Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

PubMed

Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

2011-10-01

To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

Bringing antiretroviral therapy (ART) closer to the end-user through mobile clinics and home-based ART: systematic review shows more evidence on the effectiveness and cost effectiveness is needed.

PubMed

Mdege, Noreen Dadirai; Chindove, Stanley

2014-01-01

Home-based antiretroviral therapy (ART) and ART through mobile clinics can potentially increase access to ART for large numbers of people, including hard-to-reach populations. We reviewed literature on the effectiveness and cost implications of the home-based ART and mobile clinic ART models. We searched Medline, Embase, PsycInfo, CINAHL, Cochrane Library, Web of Knowledge and Current Controlled Trials Register for articles published up to March 2012. We included non-randomised and randomised controlled clinical trials that recruited HIV/AIDS positive adults with or without prior exposure to ART. Six studies were included in the review, with only four effectiveness studies (all evaluating home-based ART and none for mobile clinic ART) and four studies reporting on the cost implications. The evidence suggests home-based ART is as effective as health facility-based ART, including on clinical outcomes, viral load and CD4+ count. However, three of these studies were very small. Studies suggest health facility-based ART is the most cost-effective, followed by mobile-clinic ART, with home-based ART being the least cost-effective. Evidence on the effectiveness and cost implications of mobile clinic and home-based ART is currently limited. Although the few available studies suggest home-based ART can potentially be as effective as health facility-based ART, there is need for more research before robust conclusions can be made. Results from the few available studies also suggest that health facility-based ART is the most cost-effective. Copyright © 2013 John Wiley & Sons, Ltd.

Efficiency and effectiveness of the use of an acenocoumarol pharmacogenetic dosing algorithm versus usual care in patients with venous thromboembolic disease initiating oral anticoagulation: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Hemorrhagic events are frequent in patients on treatment with antivitamin-K oral anticoagulants due to their narrow therapeutic margin. Studies performed with acenocoumarol have shown the relationship between demographic, clinical and genotypic variants and the response to these drugs. Once the influence of these genetic and clinical factors on the dose of acenocoumarol needed to maintain a stable international normalized ratio (INR) has been demonstrated, new strategies need to be developed to predict the appropriate doses of this drug. Several pharmacogenetic algorithms have been developed for warfarin, but only three have been developed for acenocoumarol. After the development of a pharmacogenetic algorithm, the obvious next step is to demonstrate its effectiveness and utility by means of a randomized controlled trial. The aim of this study is to evaluate the effectiveness and efficiency of an acenocoumarol dosing algorithm developed by our group which includes demographic, clinical and pharmacogenetic variables (VKORC1, CYP2C9, CYP4F2 and ApoE) in patients with venous thromboembolism (VTE). Methods and design This is a multicenter, single blind, randomized controlled clinical trial. The protocol has been approved by La Paz University Hospital Research Ethics Committee and by the Spanish Drug Agency. Two hundred and forty patients with VTE in which oral anticoagulant therapy is indicated will be included. Randomization (case/control 1:1) will be stratified by center. Acenocoumarol dose in the control group will be scheduled and adjusted following common clinical practice; in the experimental arm dosing will be following an individualized algorithm developed and validated by our group. Patients will be followed for three months. The main endpoints are: 1) Percentage of patients with INR within the therapeutic range on day seven after initiation of oral anticoagulant therapy; 2) Time from the start of oral anticoagulant treatment to achievement of a stable INR within the therapeutic range; 3) Number of INR determinations within the therapeutic range in the first six weeks of treatment. Discussion To date, there are no clinical trials comparing pharmacogenetic acenocoumarol dosing algorithm versus routine clinical practice in VTE. Implementation of this pharmacogenetic algorithm in the clinical practice routine could reduce side effects and improve patient safety. Trial registration Eudra CT. Identifier: 2009-016643-18. PMID:23237631

Invited review: A systematic review and qualitative analysis of treatments other than conventional antimicrobials for clinical mastitis in dairy cows.

PubMed

Francoz, D; Wellemans, V; Dupré, J P; Roy, J P; Labelle, F; Lacasse, P; Dufour, S

2017-10-01

Clinical mastitis is an important disease in dairies. Its treatment is mainly based on the use of antimicrobial drugs. Numerous non-antimicrobial drugs and treatment strategies have already been reported for clinical mastitis treatment, but data on their efficacy have never been collated in a systematic way. The objective of this systematic review was to identify treatments other than conventional antimicrobials for the treatment of clinical mastitis in lactating dairy cows. A systematic review was performed with studies written in English or French selected from CAB Abstracts, PubMed, and Web of Science from January 1970 to June 2014. Controlled clinical trials, observational studies, and experimental challenges were retained. Lactating dairy cows with clinical mastitis were the participant of interest. All treatments other than conventional antimicrobials for clinical mastitis during lactation were retained. Only studies comparing the treatment under investigation to a negative or positive control, or both, were included. Outcomes evaluated were clinical and bacteriological cure rates and milk production. Selection of the study, data extraction, and assessment of risk of bias was performed by 3 reviewers. Assessment of risk of bias was evaluated using the Cochrane Collaboration tool for systematic review of interventions. A total of 2,451 manuscripts were first identified and 39 manuscripts corresponding to 41 studies were included. Among these, 22 were clinical trials, 18 were experimental studies, and 1 was an observational study. The treatments evaluated were conventional anti-inflammatory drugs (n = 14), oxytocin with or without frequent milk out (n = 5), biologics (n = 9), homeopathy (n = 5), botanicals (n = 4), probiotics (n = 2), and other alternative products (n = 2). All trials had at least one unclear or high risk of bias. Most trials (n = 13) did not observe significant differences in clinical or bacteriological cure rates in comparison with negative or positive controls. Few studies evaluated the effect of treatment on milk yield. In general, the power of the different studies was very low, thus precluding conclusions on noninferiority or nonsuperiority of the treatments investigated. No evidence-based recommendations could be given for the use of an alternative or non-antimicrobial conventional treatment for clinical mastitis. However, probiotics and oxytocin with or without frequent milk out should not be recommended. We concluded that homeopathic treatments are not efficient for management of clinical mastitis. The Authors. Published by the Federation of Animal Science Societies and Elsevier Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

The Effects of an 8-Week Stabilization Exercise Program on Lumbar Multifidus Muscle Thickness and Activation as Measured With Ultrasound Imaging in Patients With Low Back Pain: An Exploratory Study.

PubMed

Larivière, Christian; Gagnon, Dany H; Henry, Sharon M; Preuss, Richard; Dumas, Jean-Pierre

2018-05-01

Lumbar stabilization exercise programs (LSEP) produce positive effects on clinical outcomes, but the underlying mechanisms remain relatively unexplored. Psychological and neuromuscular mechanisms can be involved, such as a better activation of the lumbar multifidus, which represents one possibility. To determine the following: (1) the effect of an LSEP on lumbar multifidus muscle thickness and activation, as measured with rehabilitative ultrasound imaging (RUSI), in patients with low back pain (LBP); (2) the correlation between RUSI measures and any change in clinical outcomes following the LSEP; and (3) the reliability of RUSI measures in control subjects over 8 weeks. One-arm clinical trial with healthy subjects as a control group; reliability study. LSEP delivered in a clinical setting; outcomes measured in a laboratory setting. A total of 34 patients with nonacute LBP and 28 healthy control subjects. Outcomes were measured before and after an 8-week LSEP in patients with LBP, and at the same time interval (without treatment, to assess reliability) in control subjects. Pain numeric rating scale, Oswestry Disability Index (function), as well as RUSI measures for the lumbar multifidus (LM) muscles at 3 vertebral levels (L5-S1, L4-5, and L3-4) during rest (static) and dynamic contractions (percent thickness change). Patients did not show systematic changes in RUSI measures relative to controls, even though RUSI impairments were observed at baseline (dynamic measure at L5-S1) and even though patients had significant improvements in pain and disability. Correlational analyses with these clinical outcomes suggested that patients had reduced muscle thickness at baseline that was associated with a greater reduction in disability following LSEP; however, LM activation measured at baseline showed the opposite. Static RUSI measures showed excellent reliability at the L4-5 and L3-4 levels, whereas dynamic measures were not reliable. Patients showed less muscle activation than controls at baseline (L5-S1 level), but the LSEP did not normalize this impairment. The links between RUSI measures and the change in clinical outcomes during LSEP should be further explored. This clinical trial has been recorded in the International Standard Registered Clinical/soCial sTudy Number (ISRCTN) registry (ID: ISRCTN94152969). II. Copyright © 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

The effect of internal teat sealant products (Teatseal and Orbeseal) on intramammary infection, clinical mastitis, and somatic cell counts in lactating dairy cows: a meta-analysis.

PubMed

Rabiee, A R; Lean, I J

2013-01-01

The objective of this study was to assess the efficacy of internal teat sealant products containing bismuth subnitrate (Teatseal and Orbeseal; Pfizer Animal Health, West Ryde, Australia) when used alone, or in the presence of antibiotic dry cow therapy (ADCT), before or at drying off on the incidence of new intramammary infections (IMI), clinical mastitis, and milk somatic cell count (SCC) during lactation. The literature search identified 18 English-language publications on the use of Teatseal in dairy cattle. A total of 12 studies with 17 subtrials or comparisons including 13 positive control subtrials (internal teat sealant and ADCT vs. ADCT) and 4 negative control subtrials (internal teat sealant vs. untreated) examining IMI were included in the analysis. Internal teat sealants, alone or in the presence of ADCT, reduced the risk of acquiring new IMI after calving by 25% [risk ratio (RR)=0.75; 95% confidence interval (CI): 0.67 to 0.83]. Internal teat sealants reduced the risk of IMI by 73% compared with untreated cows (RR=0.27; 95% CI: 0.13 to 0.55). The results of both meta-analyses of IMI, with positive and negative controls, were heterogeneous [I(2) (a statistic that describes the proportion of total variation in study effect estimates that is due to heterogeneity)=65.4 and 92.1%]. No farm or cow factors studied significantly contributed to the heterogeneity of the results. A total of 16 studies (21 subtrials), including 14 positive control subtrials and 7 negative control subtrials, examining clinical mastitis were included in the analysis. Internal teat sealants alone and in the presence of ADCT reduced the risk of clinical mastitis after calving in lactating cows by 29% (RR=0.71; 95% CI: 0.62 to 0.82), and 48% (RR=0.52; 95% CI: 0.37 to 0.75), respectively. The results of the meta-analysis on clinical mastitis with positive controls were homogeneous (I(2)=33.6%), whereas the results of studies with negative controls were heterogeneous (I(2)=60.4%). No farm or cow factors studied that had sufficient data to evaluate significantly contributed to the heterogeneity of the results. The estimated linear score (LS) of milk SCC after calving in published studies (n=3) and for studies that provided raw data (n=2), was significantly lower for cattle treated with internal teat sealants and ADCT in 3 studies than for cattle treated with internal teat sealants only. The estimated LS of pooled raw data of 3 studies from 32 herds showed that the LS of cows treated with internal teat sealant and ADCT was not significantly different than those treated with ADCT only. This study found that the application of internal teat sealants in the presence of ADCT or the use of internal teat sealants alone at dry off significantly reduced the incidence of IMI and clinical mastitis in lactating dairy cows compared with respective control groups. Further studies are needed to investigate the effect of internal teat sealants on postpartum milk SCC in lactating dairy cows. Copyright © 2013 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Comparison of pregnancy rates between patients with and without local endometrial scratching before intrauterine insemination.

PubMed

Senocak, G C; Yapca, O E; Borekci, B

2017-11-01

To determine the implantation success of local endometrial injury in patients undergoing intrauterine insemination following ovulation induction with gonadotropins as an infertility treatment. In this prospective randomized controlled trial, ovulation induction was performed with gonadotropins in 80 patients following intrauterine insemination. In 40 patients, local endometrial injury (scratch) was performed in the midluteal phase of the cycle preceding ovarian stimulation with a Novak curette to the posterior side of the endometrial cavity. Fifteen pregnancies (37.5%) and 11 clinical pregnancies (27.5%) occurred in the intervention group, whereas eight pregnancies (20%) and five clinical pregnancies (12.5%) occurred in the control group. Although the pregnancy rates and clinical pregnancy rates were increased in the intervention group, no statistically significant difference was found between the intervention and control groups (pregnancy rates: P=0.084; clinical pregnancy rates: P=0.094). Performing local endometrial injury (scratch) in the cycle preceding ovulation induction in patients with a diagnosis of infertility and indication for intrauterine insemination increased the pregnancy and clinical pregnancy rates. This increase was not, however, statistically significant. More randomized, controlled, prospective studies with larger patient numbers are required before the use of iatrogenic induction of local endometrial injury can be recommended in routine clinical practice. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Appointment Wait Time, Primary Care Provider Status, and Patient Demographics are Associated With Nonattendance at Outpatient Gastroenterology Clinic.

PubMed

Shrestha, Manish P; Hu, Chengcheng; Taleban, Sasha

2016-09-22

We intended to identify the factors associated with missed appointments at a gastroenterology (GI) clinic in an academic setting. Missed clinic appointments reduce clinic efficiency, waste resources, and increase costs. Limited data exist on subspecialty clinic attendance. We performed a case-control study using data from the electronic health record of patients scheduled for an appointment at the adult GI clinic at the Banner University Medical Center between March and October of 2014. Patients who missed their appointment during the study period served as cases. Controls were randomly selected from patients who completed their appointment during the study period. Analysis included univariate and multivariate logistic regression analysis. Of 2331 scheduled clinic appointments, 195 (8.4%) were missed appointments. Longer waiting time from referral to scheduled appointment was significantly associated with missed appointment (AOR=1.014; 95% CI, 1.01-1.02; P<0.001). Patients with primary care providers (PCPs) were less likely to miss their appointment than those without PCPs (AOR=0.35; 95% CI, 0.18-0.66; P=0.001). Among patient demographic characteristics, ethnicity and marital status were associated with missed appointment. Wait time, ethnicity, marital status, and PCP status were associated with missed GI clinic appointments. Further investigations are needed to assess the effects of intervention strategies directed at reducing appointment wait time and increasing PCP-based care.

The data management of a phase III efficacy trial of an 11-valent pneumococcal conjugate vaccine and related satellite studies conducted in the Philippines

PubMed Central

2012-01-01

Background A large phase III placebo-controlled, randomized efficacy trial of an investigational 11-valent pneumococcal conjugate vaccine against pneumonia in children less than 2 years of age was conducted in the Philippines from July 2000 to December 2004. Clinical data from 12,194 children who were given either study vaccine or placebo was collected from birth up to two years of age for the occurrence of radiologically proven pneumonia as the primary endpoint, and for clinical pneumonia and invasive pneumococcal disease as the secondary endpoints. Several tertiary endpoints were also explored. Along the core trial, several satellite studies on herd immunity, cost-effectiveness of the study vaccine, acute otitis media, and wheezing were conducted. Results We describe here in detail how the relevant clinical records were managed and how quality control procedures were implemented to ensure that valid data were obtained respectively for the core trial and for the satellite studies. We discuss how the task was achieved, what the challenges were and what might have been done differently. Conclusions There were several factors that made the task of data management doable and efficient. First, a pre-trial data management system was available. Secondly, local committed statisticians, programmers and support staff were available and partly familiar to clinical trials. Thirdly, the personnel had undergone training during trial and grew with the task they were supposed to do. Thus the knowledge needed to develop and operate clinical data system was fully transferred to local staff. Trial registration Current Controlled Trials ISRCTN62323832 PMID:22676626

Challenges in the Clinical Application of the American Society of Clinical Oncology Value Framework: A Medicare Cost-Benefit Analysis in Chronic Lymphocytic Leukemia.

PubMed

Seymour, Erlene K; Schiffer, Charles A; de Souza, Jonas A

2017-12-01

The ASCO Value Framework calculates the value of cancer therapies. Given costly novel therapeutics for chronic lymphocytic leukemia, we used the framework to compare net health benefit (NHB) and cost within Medicare of all regimens listed in the National Comprehensive Cancer Network (NCCN) guidelines. The current NCCN guidelines for chronic lymphocytic leukemia were reviewed. All referenced studies were screened, and only randomized controlled prospective trials were included. The revised ASCO Value Framework was used to calculate NHB. Medicare drug pricing was used to calculate the cost of therapies. Forty-nine studies were screened. The following observations were made: only 10 studies (20%) could be evaluated; when comparing regimens studied against the same control arm, ranking NHB scores were comparable to their preference in guidelines; NHB scores varied depending on which variables were used, and there were no clinically validated thresholds for low or high values; treatment-related deaths were not weighted in the toxicity scores; and six of the 10 studies used less potent control arms, ranked as the least-preferred NCCN-recommended regimens. The ASCO Value Framework is an important initial step to quantify value of therapies. Essential limitations include the lack of clinically relevant validated thresholds for NHB scores and lack of incorporation of grade 5 toxicities/treatment-related mortality into its methodology. To optimize its application for clinical practice, we urge investigators/sponsors to incorporate and report the required variables to calculate the NHB of regimens and encourage trials with stronger comparator arms to properly quantify the relative value of therapies.

The data management of a phase III efficacy trial of an 11-valent pneumococcal conjugate vaccine and related satellite studies conducted in the Philippines.

PubMed

Sanvictores, Diozele Hazel M; Lucero, Marilla G; Nohynek, Hanna; Tallo, Veronica L; Tanskanen, Antti; Nillos, Leilani T; Williams, Gail

2012-06-07

A large phase III placebo-controlled, randomized efficacy trial of an investigational 11-valent pneumococcal conjugate vaccine against pneumonia in children less than 2 years of age was conducted in the Philippines from July 2000 to December 2004. Clinical data from 12,194 children who were given either study vaccine or placebo was collected from birth up to two years of age for the occurrence of radiologically proven pneumonia as the primary endpoint, and for clinical pneumonia and invasive pneumococcal disease as the secondary endpoints. Several tertiary endpoints were also explored. Along the core trial, several satellite studies on herd immunity, cost-effectiveness of the study vaccine, acute otitis media, and wheezing were conducted. We describe here in detail how the relevant clinical records were managed and how quality control procedures were implemented to ensure that valid data were obtained respectively for the core trial and for the satellite studies. We discuss how the task was achieved, what the challenges were and what might have been done differently. There were several factors that made the task of data management doable and efficient. First, a pre-trial data management system was available. Secondly, local committed statisticians, programmers and support staff were available and partly familiar to clinical trials. Thirdly, the personnel had undergone training during trial and grew with the task they were supposed to do. Thus the knowledge needed to develop and operate clinical data system was fully transferred to local staff. Current Controlled Trials ISRCTN62323832.

[Evaluation of the treatment with fenfluramine of autism in children].

PubMed

de Villard, R; Ceillier-Hoppenot, B; Flachaire, E; Dalery, J; Rebaud, B; Maillet, J; Revol, O; Mamelle, J C; Quincy, C

1988-01-01

The effects of fenfluramine were studied in a group of 44 children with the autistic syndrome and in 26 non autistic children with behavior abnormalities, mostly hyperkinetic children, as a control group. The mean daily dosage was 0.65 mg/kg/day. There were 75% positive results in the autistic children and 77% in the control group. The clinical improvement appears to be mainly related to the control of the hyperactive behavior in the autistic children. Platelet serotonin levels were studied in both groups, showing a clear cut decrease during fenfluramine therapy with no significant differences between the 2 groups and no correlation between the clinical effects and the magnitude of the decrease.

[Discussion on developing a data management plan and its key factors in clinical study based on electronic data capture system].

PubMed

Li, Qing-na; Huang, Xiu-ling; Gao, Rui; Lu, Fang

2012-08-01

Data management has significant impact on the quality control of clinical studies. Every clinical study should have a data management plan to provide overall work instructions and ensure that all of these tasks are completed according to the Good Clinical Data Management Practice (GCDMP). Meanwhile, the data management plan (DMP) is an auditable document requested by regulatory inspectors and must be written in a manner that is realistic and of high quality. The significance of DMP, the minimum standards and the best practices provided by GCDMP, the main contents of DMP based on electronic data capture (EDC) and some key factors of DMP influencing the quality of clinical study were elaborated in this paper. Specifically, DMP generally consists of 15 parts, namely, the approval page, the protocol summary, role and training, timelines, database design, creation, maintenance and security, data entry, data validation, quality control and quality assurance, the management of external data, serious adverse event data reconciliation, coding, database lock, data management reports, the communication plan and the abbreviated terms. Among them, the following three parts are regarded as the key factors: designing a standardized database of the clinical study, entering data in time and cleansing data efficiently. In the last part of this article, the authors also analyzed the problems in clinical research of traditional Chinese medicine using the EDC system and put forward some suggestions for improvement.

Cavum Septum Pellucidum in Retired American Pro-Football Players.

PubMed

Gardner, Raquel C; Hess, Christopher P; Brus-Ramer, Marcel; Possin, Katherine L; Cohn-Sheehy, Brendan I; Kramer, Joel H; Berger, Mitchel S; Yaffe, Kristine; Miller, Bruce; Rabinovici, Gil D

2016-01-01

Previous studies report that cavum septum pellucidum (CSP) is frequent among athletes with a history of repeated traumatic brain injury (TBI), such as boxers. Few studies of CSP in athletes, however, have assessed detailed features of the septum pellucidum in a case-control fashion. This is important because prevalence of CSP in the general population varies widely (2% to 85%) between studies. Further, rates of CSP among American pro-football players have not been described previously. We sought to characterize MRI features of the septum pellucidum in a series of retired pro-football players with a history of repeated concussive/subconcussive head traumas compared with controls. We retrospectively assessed retired American pro-football players presenting to our memory clinic with cognitive/behavioral symptoms in whom structural MRI was available with slice thickness ≤2 mm (n=17). Each player was matched to a memory clinic control patient with no history of TBI. Scans were interpreted by raters blinded to clinical information and TBI/football history, who measured CSP grade (0-absent, 1-equivocal, 2-mild, 3-moderate, 4-severe) and length according to a standard protocol. Sixteen of 17 (94%) players had a CSP graded ≥2 compared with 3 of 17 (18%) controls. CSP was significantly higher grade (p<0.001) and longer in players than controls (mean length±standard deviation: 10.6 mm±5.4 vs. 1.1 mm±1.3, p<0.001). Among patients presenting to a memory clinic, long high-grade CSP was more frequent in retired pro-football players compared with patients without a history of TBI.

Clinical and neurobiological effects of aerobic exercise in dental phobia: A randomized controlled trial.

PubMed

Lindenberger, Brigitt L; Plag, Jens; Schumacher, Sarah; Gaudlitz, Katharina; Bischoff, Sophie; Bobbert, Thomas; Dimeo, Fernando; Petzold, Moritz B; Kirschbaum, Clemens; Dudás, Zsuzsa; Ströhle, Andreas

2017-11-01

Physical activity has shown to be effective in anxiety disorders. For specific phobia, no studies are available that systematically examined the effects of an aerobic exercise intervention on phobic fear within a randomized-controlled design. Therefore, we investigated the acute effect of a standardized aerobic training on clinical symptoms of dental phobia as well as on stress-related neurobiological markers. Within a crossover design, 30 patients with dental phobia (mean age: 34.1 years; mean score of the Dental Anxiety Scale: 18.8) underwent two minor dental interventions separated by 7 days. Dental treatment was performed after 30 min of physical activity at either 20% VO 2 max (control) or 70% VO 2 max (intervention), respectively. To control for habituation, patients were randomly assigned to one of the two conditions prior to the first intervention. Moreover, saliva samples were collected at five times in order to determine changes in salivary cortisol (sC) and alpha-amylase (sAA) due to treatment. In comparison to baseline, aerobic exercise within 70% VO 2 max significantly reduced clinical anxiety and sC concentrations before, during, and after the dental treatment. In contrast, the control condition led to decreased sAA levels at different time points of measurement. Habituation occurred at the second study day, independent of the order. Our study provides evidence for an effect of moderate-intense exercise on clinical symptoms and sC in patients with dental phobia. Therefore, acute aerobic exercise might be a simple and low-cost intervention to reduce disorder-specific phobic fear. © 2017 Wiley Periodicals, Inc.

A Randomized Trial Testing the Impact of Narrative Vignettes vs. Guideline Summaries on Provider Response to a Professional Organization Clinical Policy for Safe Opioid Prescribing

PubMed Central

Meisel, Zachary F.; Metlay, Joshua P.; Sinnenberg, Lauren; Kilaru, Austin S.; Grossestreuer, Anne; Barg, Frances K.; Shofer, Frances S.; Rhodes, Karin V.; Perrone, Jeanmarie

2016-01-01

Background Clinical guidelines are known to be underused by practitioners. In response to the challenges of treating pain amidst a prescription opioid epidemic, the American College of Emergency Physicians published an evidence-based clinical policy for opioid prescribing in 2012. Evidence-based narratives, an effective method of communicating health information in a variety of settings, offer a novel strategy for disseminating guidelines to physicians and engaging providers with clinical evidence. Objectives To compare whether narrative vignettes embedded in the American College of Emergency Physician (ACEP) daily e-newsletter improved dissemination of the clinical policy to ACEP members, and engagement of members with the clinical policy, compared to traditional summary text. Methods A prospective randomized controlled study, entitled Stories to Promote Information using Narrative (SPIN) trial, was performed. Derived from qualitative interviews with 61 ACEP physicians, 4 narrative vignettes were selected and refined, using a consensus panel of clinical and implementation experts. All ACEP members were then block randomized by state of residence to receive alternative versions of a daily emailed newsletter for a total of 24 days during a 9 week period. Narrative newsletters contained a selection of vignettes that referenced opioid prescription dilemmas. Control newsletters contained a selection of descriptive text about the clinical policy using similar length and appearance to the narrative vignettes. Embedded in the newsletters were web links to the complete vignette or traditional summary text, as well as additional links to the full ACEP clinical policy and a website providing assistance with prescription drug monitoring program enrollment. The newsletters were otherwise identical. Outcomes measured were the percentage of subjects who visited any of the web pages that contained additional guideline related information and the odds of any unique physician visiting these web pages during the study. Results 27,592 physicians were randomized and 21,226 received the newsletter during the study period. When counting each physician once over the study period, there were 509 unique visitors in the narrative group and 173 unique visitors in the control group (4.8% vs. 1.6%, difference 3.2% 95%CI 2.7%-3.7%). There were 744 gross visits from the e-newsletter to any of the three web pages in the narrative group compared to 248 in the control group (7.0% vs. 2.3%, OR 3.2 (95% CI 2.7-3.6). Over the course of the study, the odds ratio of any physician in the narrative group visiting one of the three informational web sites compared to the control group was 3.1 (95% CI 2.6-3.6). Conclusion Among a national sample of emergency physicians, narrative vignettes outperformed traditional guideline text in promoting engagement with an evidence-based clinical guideline related to opioid prescriptions. PMID:27133392

Is diabetes a risk factor for a severe clinical presentation of dengue?--review and meta-analysis.

PubMed

Htun, Nan Shwe Nwe; Odermatt, Peter; Eze, Ikenna C; Boillat-Blanco, Noémie; D'Acremont, Valérie; Probst-Hensch, Nicole

2015-04-01

The mean age of acute dengue has undergone a shift towards older ages. This fact points towards the relevance of assessing the influence of age-related comorbidities, such as diabetes, on the clinical presentation of dengue episodes. Identification of factors associated with a severe presentation is of high relevance, because timely treatment is the most important intervention to avert complications and death. This review summarizes and evaluates the published evidence on the association between diabetes and the risk of a severe clinical presentation of dengue. A systematic literature review was conducted using the MEDLINE database to access any relevant association between dengue and diabetes. Five case-control studies (4 hospital-based, 1 population-based) compared the prevalence of diabetes (self-reported or abstracted from medical records) of persons with dengue (acute or past; controls) and patients with severe clinical manifestations. All except one study were conducted before 2009 and all studies collected information towards WHO 1997 classification system. The reported odds ratios were formally summarized by random-effects meta-analyses. A diagnosis of diabetes was associated with an increased risk for a severe clinical presentation of dengue (OR 1.75; 95% CI: 1.08-2.84, p = 0.022). Large prospective studies that systematically and objectively obtain relevant signs and symptoms of dengue fever episodes as well as of hyperglycemia in the past, and at the time of dengue diagnosis, are needed to properly address the effect of diabetes on the clinical presentation of an acute dengue fever episode. The currently available epidemiological evidence is very limited and only suggestive. The increasing global prevalence of both dengue and diabetes justifies further studies. At this point, confirmation of dengue infection as early as possible in diabetes patients with fever if living in dengue endemic regions seems justified. The presence of this co-morbidity may warrant closer observation for glycemic control and adapted fluid management to diminish the risk for a severe clinical presentation of dengue.

A Comparison of In-service Teaching Methods on Clinical Aspesis for Dental Personnel.

ERIC Educational Resources Information Center

Fotos, Pete G.; And Others

1990-01-01

Results of a study with dental assistants and hygienists, clinic clerks, supply and sterilization personnel, receptionists, and housekeeping and secretarial staff (n=80) suggest that inservice training programs on infection control and clinical asepsis procedures may be better accomplished by practical demonstration than by lecture or seminar.…

78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

..., choosing a study population, using a control group and blinding, dose selection, treatment plans...] Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular... document entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

Psychosocial and individual characteristics and musculoskeletal complaints among clinical laboratory workers.

PubMed

Sadeghian, Farideh; Kasaeian, Amir; Noroozi, Pirasteh; Vatani, Javad; Taiebi, Seiyed Hassan

2014-01-01

Musculoskeletal disorders (MSDs) are an important health problem among healthcare workers, including clinical laboratory ones. The aim of the present study was to investigate the prevalence of MSDs and individual and psychosocial risk factors among clinical laboratory workers. A cross-sectional study was carried out among 156 workers of 30 clinical laboratories in 3 towns of Iran. The Nordic questionnaire with individual and psychosocial risk factors was used to collect data. Multiple logistic regression analysis was performed. The prevalence of reported MSDs among the study population was 72.4% in the past 12 months. The most prevalent MSDs were pain in the lower back and neck; 42.7% and 33.3%, respectively. Significant relations were found between MSDs and age, gender, heavy work at home and job control (p < .05). MSDs among laboratory workers were high and associated with age, gender, heavy work at home and job control. More research into measuring these factors and workplace physical demands is suggested.

[POLYGYNAX IN THE TREATMENT OF VAGINAL INFECTIONS IN PREGNANT AND NON-PREGNANT WOMEN--CLINICAL EXPERIENCE].

PubMed

Popovski, N; Popovski, K; Nedelkovski, V

2016-01-01

Vaginal infections /VI/ represent some of the most common diseases by infection of FGS. The aim of this study is to analyze clinical and bacteriological efficacy of Polygynax in the treatment of vaginal infections and to take into account the correlation between the results of microbiological controls and reduction of clinical symptoms. The study included 100 patients, including 50 pregnant and non-pregnant 50 for a period of 3 months. All of them was diagnosed with vaginitis clinical examination, taken material from vagina for microbiological testing. The studied women was conducted targeted therapy Polygynax 12 capsules, in the form of vaginal capsules for 12 days, after which the sample control microbiology. Behind the subjective complaints of the patient and to reduce them as a result of treatment. The effective implementation of Polygynax 12 capsules is equally good as in non-pregnant and pregnant women. In a summary of the survey data to make relevant analyzes and conclusions from the results.

[The Contribution of GMP-grade Hospital Preparation to Translational Research].

PubMed

Yonezawa, Atsushi; Kajiwara, Moto; Minami, Ikuko; Omura, Tomohiro; Nakagawa, Shunsaku; Matsubara, Kazuo

2015-01-01

Translational research is important for applying the outcomes of basic research studies to practical medical treatments. In exploratory early-phase clinical trials for an innovative therapy, researchers should generally manufacture investigational agents by themselves. To provide investigational agents with safety and high quality in clinical studies, appropriate production management and quality control are essential. In the Department of Pharmacy of Kyoto University Hospital, a manufacturing facility for sterile drugs was established, independent of existing manufacturing facilities. Manuals on production management and quality control were developed according to Good Manufacturing Practices (GMP) for Investigational New Drugs (INDs). Advanced clinical research has been carried out using investigational agents manufactured in our facility. These achievements contribute to both the safety of patients and the reliability of clinical studies. In addition, we are able to do licensing-out of our technique for the manufacture of investigational drugs. In this symposium, we will introduce our GMP grade manufacturing facility for sterile drugs and discuss the role of GMP grade hospital preparation in translational research.

Vitamin K for upper gastrointestinal bleeding in people with acute or chronic liver diseases.

PubMed

Martí-Carvajal, Arturo J; Solà, Ivan

2015-06-09

Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. Several treatments are used for upper gastrointestinal bleeding in people with liver diseases. One of them is vitamin K administration, but it is not known whether it benefits or harms people with acute or chronic liver disease and upper gastrointestinal bleeding. This is an update of this Cochrane review. To assess the beneficial and harmful effects of vitamin K for people with acute or chronic liver disease and upper gastrointestinal bleeding. We searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), and LILACS (1982 to 25 February 2015). We sought additional randomised trials from two registries of clinical trials: the World Health Organization Clinical Trials Search Portal and the metaRegister of Controlled Trials. We looked through the reference lists of the retrieved publications and review articles. Randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. We considered observational studies for assessment of harms only. \\We aimed to summarise data from randomised clinical trials using Standard Cochrane methodology and assess them according to the GRADE approach. We found no randomised trials on vitamin K for upper gastrointestinal bleeding in people with liver diseases assessing benefits and harms of the intervention. We identified no quasi-randomised studies, historically controlled studies, or observational studies assessing harms. This updated review found no randomised clinical trials of vitamin K for upper gastrointestinal bleeding in people with liver diseases. The benefits and harms of vitamin K need to be tested in randomised clinical trials. Until randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute the use of vitamin K for upper gastrointestinal bleeding in people with liver diseases.

Hydrocortisone concentration influences time to clinically significant healing of acute inflammation of the ocular surface and adnexa - results from a double-blind randomized controlled trial.

PubMed

Sergiyenko, Nikolay; Sukhina, Ludmila; Bezdetko, Pavel; Kovalenko, Yuriy; Nikitin, Nikolai; Merzbacher, Matthias; Gross, Dorothea; Kohnen, Ralf

2014-05-10

The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations, such as drug concentration.The aim of this study was to confirm that hydrocortisone acetate (HC-ac) ophthalmic ointments of 2.5% and 1% are more effective than a 0.5% eye ointment. In this randomized, double-blind, placebo-controlled, parallel-group clinical study, the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 subjects. Median time to clinically relevant response as estimated by 50% reduction in clinical signs and symptoms (CSS) total score over the entire trial was similar for subjects treated with HC-ac 2.5% (73.5 h) and for subjects treated with HC-ac 1.0% (67.7 h) and was considerably and significantly longer for subjects treated with HC-ac 0.5% (111.8 h) [p < 0.001 for both dosages]. All trial medications were safe and well tolerated. Hydrocortisone acetate 2.5% and Hydrocortisone acetate 1% eye ointments are efficacious and safe treatments for acute inflammations of the ocular surface or adnexa, and showed significantly better efficacy than a control group treated with Hydrocortisone acetate 0.5% therapy. Current Controlled Trials ISRCTN15464650.

Prevalence of Small Intestinal Bacterial Overgrowth among Chronic Pancreatitis Patients: A Case-Control Study

PubMed Central

Bouchard, Simon; Sidani, Sacha

2016-01-01

Background. Patients with chronic pancreatitis (CP) exhibit numerous risk factors for the development of small intestinal bacterial overgrowth (SIBO). Objective. To determine the prevalence of SIBO in patients with CP. Methods. Prospective, single-centre case-control study conducted between January and September 2013. Inclusion criteria were age 18 to 75 years and clinical and radiological diagnosis of CP. Exclusion criteria included history of gastric, pancreatic, or intestinal surgery or significant clinical gastroparesis. SIBO was detected using a standard lactulose breath test (LBT). A healthy control group also underwent LBT. Results. Thirty-one patients and 40 controls were included. The patient group was significantly older (53.8 versus 38.7 years; P < 0.01). The proportion of positive LBTs was significantly higher in CP patients (38.7 versus 2.5%: P < 0.01). A trend toward a higher proportion of positive LBTs in women compared with men was observed (66.6 versus 27.3%; P = 0.056). The subgroups with positive and negative LBTs were comparable in demographic and clinical characteristics, use of opiates, pancreatic enzymes replacement therapy (PERT), and severity of symptoms. Conclusion. The prevalence of SIBO detected using LBT was high among patients with CP. There was no association between clinical features and the risk for SIBO. PMID:27446865

Prevalence of Small Intestinal Bacterial Overgrowth among Chronic Pancreatitis Patients: A Case-Control Study.

PubMed

Therrien, Amelie; Bouchard, Simon; Sidani, Sacha; Bouin, Mickael

2016-01-01

Background. Patients with chronic pancreatitis (CP) exhibit numerous risk factors for the development of small intestinal bacterial overgrowth (SIBO). Objective. To determine the prevalence of SIBO in patients with CP. Methods. Prospective, single-centre case-control study conducted between January and September 2013. Inclusion criteria were age 18 to 75 years and clinical and radiological diagnosis of CP. Exclusion criteria included history of gastric, pancreatic, or intestinal surgery or significant clinical gastroparesis. SIBO was detected using a standard lactulose breath test (LBT). A healthy control group also underwent LBT. Results. Thirty-one patients and 40 controls were included. The patient group was significantly older (53.8 versus 38.7 years; P < 0.01). The proportion of positive LBTs was significantly higher in CP patients (38.7 versus 2.5%: P < 0.01). A trend toward a higher proportion of positive LBTs in women compared with men was observed (66.6 versus 27.3%; P = 0.056). The subgroups with positive and negative LBTs were comparable in demographic and clinical characteristics, use of opiates, pancreatic enzymes replacement therapy (PERT), and severity of symptoms. Conclusion. The prevalence of SIBO detected using LBT was high among patients with CP. There was no association between clinical features and the risk for SIBO.

Blood pressure control with cilnidipine treatment in Japanese post-stroke hypertensive patients: The CA-ATTEND study.

PubMed

Aoki, Shiro; Hosomi, Naohisa; Nezu, Tomohisa; Teshima, Tsukasa; Sugii, Hitoshi; Nagahama, Shinobu; Kurose, Yoshiki; Maruyama, Hirofumi; Matsumoto, Masayasu

2017-01-01

Blood pressure control is important in post-stroke hypertensive patients and antihypertensive treatment is recommended for such patients. Ca-channel blockers are recommended as the medications of choice for the treatment of post-stroke patients. Here, we report the results of a large-scale prospective post-marketing surveillance study of post-stroke hypertensive patients (n = 2667, male 60.4%, 69.0 ± 10.9 years) treated with cilnidipine, with regard to blood pressure control and adverse reactions. Cilnidipine treatment caused a decrease in both clinic and home blood pressures 2 months after the beginning of treatment, and the decreased blood pressure was maintained until the end of 12 months' observation. The proportion of patients in whom clinic blood pressure was well controlled (<140/90 mmHg) increased from 21.5% to 65.3% in cilnidipine treatment, with no differences in effectiveness among the various clinical subtypes of stroke. In total, 346 adverse events occurred, with an overall incidence of 8.9% (238 of 2667 patients). In the elderly group, specifically, a fall and a hip fracture each occurred in 1 (0.1%) patient. These results indicate that cilnidipine was effective in treating uncontrolled blood pressure and was well tolerated in Japanese post-stroke hypertensive patients in a real-world clinical setting.

Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1—Psychometric Characteristics of 5 Paradigms.

PubMed

Reddy, L Felice; Horan, William P; Barch, Deanna M; Buchanan, Robert W; Dunayevich, Eduardo; Gold, James M; Lyons, Naomi; Marder, Stephen R; Treadway, Michael T; Wynn, Jonathan K; Young, Jared W; Green, Michael F

2015-09-01

Impairments in willingness to exert effort contribute to the motivational deficits characteristic of the negative symptoms of schizophrenia. The current study evaluated the psychometric properties of 5 new or adapted paradigms to determine their suitability for use in clinical trials of schizophrenia. This study included 94 clinically stable participants with schizophrenia and 40 healthy controls. The effort-based decision-making battery was administered twice to the schizophrenia group (baseline, 4-week retest) and once to the control group. The 5 paradigms included 1 that assesses cognitive effort, 1 perceptual effort, and 3 that assess physical effort. Each paradigm was evaluated on (1) patient vs healthy control group differences, (2) test-retest reliability, (3) utility as a repeated measure (ie, practice effects), and (4) tolerability. The 5 paradigms showed varying psychometric strengths and weaknesses. The Effort Expenditure for Rewards Task showed the best reliability and utility as a repeated measure, while the Grip Effort Task had significant patient-control group differences, and superior tolerability and administration duration. The other paradigms showed weaker psychometric characteristics in their current forms. These findings highlight challenges in adapting effort and motivation paradigms for use in clinical trials. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center 2015.

[Research activity in clinical biochemistry].

PubMed

Jørgensen, Henrik L; Larsen, Birger; Ingwersen, Peter; Rehfeld, Jens F

2008-09-01

Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched control group from other medical specialities in Denmark. A list of all physicians registered in Denmark (23,127 persons) was drawn from the database "Laeger.dk". Of these, 5,202 were generalists (not included) while 11,691 were from other specialities. Of the 126 specialists from Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained. 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry compared to 51 for the control group. The number of citations per specialist was 1,844 for Clinical Biochemistry compared to 816 for the control group. The top ten H-indices (of which 8 were in Clinical Biochemistry) ranged from 30 to 69. Both the number of papers and the number of citations were higher for Clinical Biochemistry than for the control group. The difference was most pronounced among professors.

A Comparison of Clinical and Non-Clinical Samples Using the Concepts of: Individual Personality, Family Structure, Family of Origin Perception, Sexuality, and Adjustment/Adaptability To Determine Family Risk for Father Daughter Incest.

ERIC Educational Resources Information Center

Utesch, William E.

Father-daughter incest is more traumatic than any other type of child-sexual molestation. This study examines some of the factors which may lead to father-daughter incest. The author divided 40 Caucasian couples into three groups: (1) clinical incest group; (2) clinical non-incest group (to control for clinical status); and (3) non-clinical group.…

Maternity leave in normal pregnancy.

PubMed

Leduc, Dean

2011-08-01

To assist maternity care providers in recognizing and discussing health- and illness-related issues in pregnancy and their relationship to maternity benefits. Published literature was retrieved through searches of PubMed or Medline, CINAHL, and The Cochrane Library in 2009 using appropriate controlled vocabulary (e.g., maternity benefits) and key words (e.g., maternity, benefits, pregnancy). Results were restricted to systematic reviews, randomized controlled trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to December 2009. Grey (unpublished) literature was identified through searching the web sites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.

How informative are open-label studies for youth with bipolar disorder? A meta-analysis comparing open-label versus randomized, placebo-controlled clinical trials.

PubMed

Biederman, Joseph; Petty, Carter R; Woodworth, K Yvonne; Lomedico, Alexandra; O'Connor, Katherine B; Wozniak, Janet; Faraone, Stephen V

2012-03-01

To examine the informativeness of open-label trials toward predicting results in subsequent randomized, placebo-controlled clinical trials of psychopharmacologic treatments for pediatric bipolar disorder. We searched journal articles through PubMed at the National Library of Medicine using bipolar disorder, mania, pharmacotherapy, treatment and clinical trial as keywords. This search was supplemented with scientific presentations at national and international scientific meetings and submitted manuscripts from our group. Selection criteria included (1) enrollment of children diagnosed with DSM-IV bipolar disorder; (2) prospective assessment of at least 3 weeks; (3) monotherapy of a pharmacologic treatment for bipolar disorder; (4) use of a randomized placebo-controlled design or an open-label design for the same therapeutic compound; and (5) repeated use of the Young Mania Rating Scale (YMRS) as an outcome. The following information and data were extracted from 14 studies: study design, name of medication, class of medication, dose of medication, sample size, age, sex, trial length, and YMRS mean and standard deviation baseline and follow-up scores. For both study designs, the pooled effect size was statistically significant (open-label studies, z = 8.88, P < .001; randomized placebo-controlled studies, z = 13.75, P < .001), indicating a reduction in the YMRS from baseline to endpoint in both study designs. In a meta-analysis regression, study design was not a significant predictor of mean change in the YMRS. We found similarities in the treatment effects between open-label and randomized placebo-controlled studies in youth with bipolar disorder indicating that open-label studies are useful predictors of the potential safety and efficacy of a given compound in the treatment of pediatric bipolar disorder. © Copyright 2012 Physicians Postgraduate Press, Inc.

Extended acute toxicity study of (188) Re-liposome in rats.

PubMed

Chi-Mou, Liu; Chia-Che, Tsai; Chia-Yu, Yu; Wan-Chi, Lee; Chung-Li, Ho; Tsui-Jung, Chang; Chih-Hsien, Chang; Te-Wei, Lee

2013-09-01

Liposomes can selectively target cancer sites and carry payloads, thereby improving diagnostic and therapeutic effectiveness as well as reducing toxicity. To evaluate therapeutic strategies, it is essential to use animal models reflecting important safety aspects before clinical application. As our previous study found that a high dosage (185 of MBq) of (188) Re-N,N-bis (2-mercaptoethyl)-N',N'-diethylethylenediamine-labeled pegylated liposomes ((188) Re-liposome) induced a decrease in white blood cell (WBC) count in Sprague-Dawley rats 7 days postinjection, the objective of the present study was to investigate extended acute radiotoxicity of (188) Re-liposome. Rats were administered via intravenous (i.v.) injection with (188) Re-liposome (185, 55.5 and 18.5 MBq), normal saline as a blank control or non-radioactive liposome as a vehicle control. Mortality, clinical signs, food consumption, body weights, urinary, biochemical and hematological analyzes were examined. In addition, gross necropsy and histopathological examinations were also performed at the end of the follow-up period. None of the rats died and no clinical sign was observed during the 28-day study period. Only male rats receiving (188) Re-liposome at a high dosage (185 MBq) displayed a slight weight loss compared with the control rats. In both male and female rats, the WBC counts of both high-dose and medium-dose (55.5 MBq) groups reduced significantly 7 days postinjection, but recovered to the normal range on Study Day 29. There was no significant difference in urinary analyzes, biochemical parameters and histopathological assessments between the (188) Re-liposome-treated and control groups. The information generated from the present study on extended acute toxicity of (188) Re-liposome will serve as a safety reference for radiopharmaceuticals in early-phase clinical trials. Copyright © 2012 John Wiley & Sons, Ltd.

Effects of Clinical Pathways for Common Outpatient Infections on Antibiotic Prescribing

PubMed Central

Jenkins, Timothy C.; Irwin, Amy; Coombs, Letoynia; DeAlleaume, Lauren; Ross, Stephen E.; Rozwadowski, Jeanne; Webster, Brian; Dickinson, L. Miriam; Sabel, Allison L.; MacKenzie, Thomas D.; West, David R.; Price, Connie S.

2013-01-01

Background Antibiotic overuse in the primary care setting is common. Our objective was to evaluate the effect of a clinical pathway-based intervention on antibiotic use. Methods Eight primary care clinics were randomized to receive clinical pathways for upper respiratory infection, acute bronchitis, acute rhinosinusitis, pharyngitis, acute otitis media, urinary tract infection, skin infections, and pneumonia and patient education materials (study group) versus no intervention (control group). Generalized linear mixed effects models were used to assess trends in antibiotic prescriptions for non-pneumonia acute respiratory infections and broad-spectrum antibiotic use for all eight conditions during a 2-year baseline and 1-year intervention period. Results In the study group, antibiotic prescriptions for non-pneumonia acute respiratory infections decreased from 42.7% of cases at baseline to 37.9% during the intervention period (11.2% relative reduction) (p <.0001) and from 39.8% to 38.7%, respectively, in the control group (2.8% relative reduction) (p=0.25). Overall use of broad-spectrum antibiotics in the study group decreased from 26.4% to 22.6% of cases, respectively, (14.4% relative reduction) (p <.0001) and from 20.0% to 19.4%, respectively, in the control group (3.0% relative reduction) (p=0.35). There were significant differences in the trends of prescriptions for acute respiratory infections (p<.0001) and broad-spectrum antibiotic use (p=0.001) between the study and control groups during the intervention period, with greater declines in the study group. Conclusions This intervention was associated with declining antibiotic prescriptions for non-pneumonia acute respiratory infections and use of broad-spectrum antibiotics over the first year. Evaluation of the impact over a longer study period is warranted. PMID:23507206

Extracorporeal shock wave therapy as an adjunct wound treatment: a systematic review of the literature.

PubMed

Dymarek, Robert; Halski, Tomasz; Ptaszkowski, Kuba; Slupska, Lucyna; Rosinczuk, Joanna; Taradaj, Jakub

2014-07-01

Standard care procedures for complex wounds are sometimes supported and reinforced by physical treatment modalities such as extracorporeal shock wave therapy (ESWT). To evaluate available evidence of ESWT effectiveness in humans, a systematic review of the literature was conducted using MEDLINE, PubMed, Scopus, EBSCOhost, and PEDro databases. Of the 393 articles found, 13 met the publication date (year 2000-2013), study type (clinical study), language (English only), and abstract availability (yes) criteria. The 13 studies (n = 919 patients with wounds of varying etiologies) included seven randomized controlled trials that were evaluated using Cochrane Collaboration Group standards. Only studies with randomization, well prepared inclusion/exclusion criteria protocol, written in English, and full version available were analyzed. An additional six publications reporting results of other clinical studies including a total of 523patients were identified and summarized. ESWT was most commonly applied once or twice a week using used low or medium energy, focused or defocused generator heads (energy range 0.03 to 0.25 mJ/mm2; usually 0.1 mJ/mm2), and electrohydraulic or electromagnetic sources. Few safety concerns were reported, and in the controlled clinical studies statistically significant differences in rates of wound closure were reported compared to a variety of standard topical treatment modalities, sham ESWT treatment, and hyperbaric oxygen therapy. Based on this analysis, ESWT can be characterized as noninvasive, mostly painless, and safe. Controlled, randomized, multicenter, blind clinical trials still are required to evaluate the efficacy and cost-effectiveness of ESWT compared to sham control, other adjunctive treatments, and commonly used moisture-retentive dressings. In the future, ESWT may play an important role in wound care once evidence-based practice guidelines are developed.

[A clinical study of gelatamp colloidal silver gelatin sponge on preventing the complication of teeth extraction].

PubMed

Cai, Yong-hai; Lu, Chang-shou

2008-10-01

To study the clinical effect of Gelatamp colloidal silver gelatin sponge on preventing the complication of teeth extraction. 672 teeth were divided into experimental group and control group semi-randomly. All teeth were extracted after local anesthesia and sockets were cleaned. Gelatamp colloidal silver gelatin sponge was implanted into socket in experimental group and nothing was implanted into alveolar socket in control group. The complication of teeth extraction was observed on 0.5 h, 2 d and 7 d after extraction. The incidence rate of complication was calculated. The incidence rate of complication of teeth extraction in experimental group was 7.72%, which was lower than that of control group (24.43%). There was significant difference in the incidence rates of complication between experimental group and control group (P < 0.05). The incidence rate of bleeding, infection, pain, swelling and dry socket after teeth extraction in experimental group was lower than those of control group, and the difference between them was statistically significant (P < 0.05). The results demonstrate that Gelatamp colloidal silver gelatin sponge can prevent the occurrence of complication of teeth extraction, this can be used in clinic.

A Randomized Comparative Study of Two Techniques to Optimize the Root Coverage Using a Porcine Collagen Matrix.

PubMed

Reino, Danilo Maeda; Maia, Luciana Prado; Fernandes, Patrícia Garani; Souza, Sergio Luis Scombatti de; Taba Junior, Mario; Palioto, Daniela Bazan; Grisi, Marcio Fermandes de Moraes; Novaes, Arthur Belém

2015-10-01

The aim of this randomized controlled clinical study was to compare the extended flap technique (EFT) with the coronally advanced flap technique (CAF) using a porcine collagen matrix (PCM) for root coverage. Twenty patients with two bilateral gingival recessions, Miller class I or II on non-molar teeth were treated with CAF+PCM (control group) or EFT+PCM (test group). Clinical measurements of probing pocket depth (PPD), clinical attachment level (CAL), recession height (RH), keratinized tissue height (KTH), keratinized mucosa thickness (KMT) were determined at baseline, 3 and 6 months post-surgery. At 6 months, the mean root coverage for test group was 81.89%, and for control group it was 62.80% (p<0.01). The change of recession depth from baseline was statistically significant between test and control groups, with an mean of 2.21 mm gained at the control sites and 2.84 mm gained at the test sites (p=0.02). There were no statistically significant differences for KTH, PPD or CAL comparing the two therapies. The extended flap technique presented better root coverage than the coronally advanced flap technique when PCM was used.

Diagnosis of neglected tropical diseases among patients with persistent digestive disorders (diarrhoea and/or abdominal pain ≥14 days): Pierrea multi-country, prospective, non-experimental case-control study.

PubMed

Polman, Katja; Becker, Sören L; Alirol, Emilie; Bhatta, Nisha K; Bhattarai, Narayan R; Bottieau, Emmanuel; Bratschi, Martin W; Burza, Sakib; Coulibaly, Jean T; Doumbia, Mama N; Horié, Ninon S; Jacobs, Jan; Khanal, Basudha; Landouré, Aly; Mahendradhata, Yodi; Meheus, Filip; Mertens, Pascal; Meyanti, Fransiska; Murhandarwati, Elsa H; N'Goran, Eliézer K; Peeling, Rosanna W; Ravinetto, Raffaella; Rijal, Suman; Sacko, Moussa; Saye, Rénion; Schneeberger, Pierre H H; Schurmans, Céline; Silué, Kigbafori D; Thobari, Jarir A; Traoré, Mamadou S; van Lieshout, Lisette; van Loen, Harry; Verdonck, Kristien; von Müller, Lutz; Yansouni, Cédric P; Yao, Joel A; Yao, Patrick K; Yap, Peiling; Boelaert, Marleen; Chappuis, François; Utzinger, Jürg

2015-08-18

Diarrhoea still accounts for considerable mortality and morbidity worldwide. The highest burden is concentrated in tropical areas where populations lack access to clean water, adequate sanitation and hygiene. In contrast to acute diarrhoea (<14 days), the spectrum of pathogens that may give rise to persistent diarrhoea (≥14 days) and persistent abdominal pain is poorly understood. It is conceivable that pathogens causing neglected tropical diseases play a major role, but few studies investigated this issue. Clinical management and diagnostic work-up of persistent digestive disorders in the tropics therefore remain inadequate. Hence, important aspects regarding the pathogenesis, epidemiology, clinical symptomatology and treatment options for patients presenting with persistent diarrhoea and persistent abdominal pain should be investigated in multi-centric clinical studies. This multi-country, prospective, non-experimental case-control study will assess persistent diarrhoea (≥14 days; in individuals aged ≥1 year) and persistent abdominal pain (≥14 days; in children/adolescents aged 1-18 years) in up to 2000 symptomatic patients and 2000 matched controls. Subjects from Côte d'Ivoire, Indonesia, Mali and Nepal will be clinically examined and interviewed using a detailed case report form. Additionally, each participant will provide a stool sample that will be examined using a suite of diagnostic methods (i.e., microscopic techniques, rapid diagnostic tests, stool culture and polymerase chain reaction) for the presence of bacterial and parasitic pathogens. Treatment will be offered to all infected participants and the clinical treatment response will be recorded. Data obtained will be utilised to develop patient-centred clinical algorithms that will be validated in primary health care centres in the four study countries in subsequent studies. Our research will deepen the understanding of the importance of persistent diarrhoea and related digestive disorders in the tropics. A diversity of intestinal pathogens will be assessed for potential associations with persistent diarrhoea and persistent abdominal pain. Different diagnostic methods will be compared, clinical symptoms investigated and diagnosis-treatment algorithms developed for validation in selected primary health care centres. The findings from this study will improve differential diagnosis and evidence-based clinical management of digestive syndromes in the tropics. ClinicalTrials.gov; identifier: NCT02105714 .

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

PubMed

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

2010-11-16

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

Learning the futility of the thought suppression enterprise in normal experience and in obsessive compulsive disorder.

PubMed

Najmi, Sadia; Reese, Hannah; Wilhelm, Sabine; Fama, Jeanne; Beck, Celeste; Wegner, Daniel M

2010-01-01

The belief that we can control our thoughts is not inevitably adaptive, particularly when it fuels mental control activities that have ironic unintended consequences. The conviction that the mind can and should be controlled can prompt people to suppress unwanted thoughts, and so can set the stage for the intrusive return of those very thoughts. An important question is whether or not these beliefs about the control of thoughts can be reduced experimentally. One possibility is that behavioral experiments aimed at revealing the ironic return of suppressed thoughts might create a lesson that could reduce unrealistic beliefs about the control of thoughts. The present research assessed the influence of the thought suppression demonstration on beliefs about the control of thoughts in a non-clinical sample, and among individuals with obsessive-compulsive disorder (OCD). In Study 1, we assessed the effect of the thought suppression demonstration on beliefs about the control of thoughts among low and high obsessive individuals in the non-clinical population (N = 62). In Study 2, we conducted a similar study with individuals with OCD (N = 29). Results suggest that high obsessive individuals in the non-clinical population are able to learn the futility of suppression through the thought suppression demonstration and to alter their faulty beliefs about the control of thoughts; however, for individuals with OCD, the demonstration may be insufficient for altering underlying beliefs. For individuals with OCD, the connection between suppressing a neutral thought in the suppression demonstration and suppressing a personally relevant obsession may need to be stated explicitly in order to affect their obsessive beliefs.

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

PubMed

Silverman, Stuart L

2010-11-01

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

Better cancer biomarker discovery through better study design.

PubMed

Rundle, Andrew; Ahsan, Habibul; Vineis, Paolo

2012-12-01

High-throughput laboratory technologies coupled with sophisticated bioinformatics algorithms have tremendous potential for discovering novel biomarkers, or profiles of biomarkers, that could serve as predictors of disease risk, response to treatment or prognosis. We discuss methodological issues in wedding high-throughput approaches for biomarker discovery with the case-control study designs typically used in biomarker discovery studies, especially focusing on nested case-control designs. We review principles for nested case-control study design in relation to biomarker discovery studies and describe how the efficiency of biomarker discovery can be effected by study design choices. We develop a simulated prostate cancer cohort data set and a series of biomarker discovery case-control studies nested within the cohort to illustrate how study design choices can influence biomarker discovery process. Common elements of nested case-control design, incidence density sampling and matching of controls to cases are not typically factored correctly into biomarker discovery analyses, inducing bias in the discovery process. We illustrate how incidence density sampling and matching of controls to cases reduce the apparent specificity of truly valid biomarkers 'discovered' in a nested case-control study. We also propose and demonstrate a new case-control matching protocol, we call 'antimatching', that improves the efficiency of biomarker discovery studies. For a valid, but as yet undiscovered, biomarker(s) disjunctions between correctly designed epidemiologic studies and the practice of biomarker discovery reduce the likelihood that true biomarker(s) will be discovered and increases the false-positive discovery rate. © 2012 The Authors. European Journal of Clinical Investigation © 2012 Stichting European Society for Clinical Investigation Journal Foundation.

Effectiveness of 23-valent pneumococcal polysaccharide vaccine and seasonal influenza vaccine for pneumonia among the elderly - Selection of controls in a case-control study.

PubMed

Kondo, Kyoko; Suzuki, Kanzo; Washio, Masakazu; Ohfuji, Satoko; Fukushima, Wakaba; Maeda, Akiko; Hirota, Yoshio

2017-08-24

We conducted a case-control study to elucidate associations between pneumonia in elderly individuals and 23-valent pneumococcal polysaccharide vaccine (PPSV23) and seasonal influenza vaccine (influenza vaccine). Here, we examined selection of controls in our study using an analytic epidemiology approach. The study period was from October 1, 2009 through September 30, 2014. Cases comprised ≥65-year-old patients newly diagnosed with pneumonia. For every case with pneumonia, two patients with other diseases (one respiratory medicine, one non-respiratory medicine) who were sex-, age-, visit date- and visit hospital-matched were selected as controls. Odds ratios (ORs) and 95% confidence intervals (CIs) of vaccination for pneumonia were calculated using conditional logistic regression model. Similar analyses were also conducted based on the clinical department of controls. Analysis was conducted in 234 cases and 438 controls. Effectiveness of pneumococcal vaccination or influenza vaccination against pneumonia was not detected. Proportions of either vaccination in controls were greater among respiratory medicine (pneumococcal vaccine, 38%; influenza vaccine, 55%) than among non-respiratory medicine (23%; 48%). Analysis using controls restricted to respiratory medicine showed marginally significant effectiveness of pneumococcal vaccination (OR, 0.59; 95%CI, 0.34-1.03; P=0.064) and influenza vaccination (0.64; 0.40-1.04; 0.072). However, this effectiveness might have been overestimated by selection bias of controls, as pneumonia cases are not necessarily respiratory medicine patients. In the analysis using controls restricted to non-respiratory medicine, OR of pneumococcal vaccination for pneumonia was close to 1, presumably because the proportion of pneumococcal vaccination was higher in cases than in controls. Because pneumococcal vaccine was not routinely administered during the study period, differences in recommendations of vaccination by physician in different clinical departments might have greatly affected vaccination proportions. When we select controls, we should consider the background factors (underlying diseases, clinical department, etc.) which affect physicians' recommendation of vaccination. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Improved local and regional control with radiotherapy for Merkel cell carcinoma of the head and neck.

PubMed

Strom, Tobin; Naghavi, Arash O; Messina, Jane L; Kim, Sungjune; Torres-Roca, Javier F; Russell, Jeffery; Sondak, Vernon K; Padhya, Tapan A; Trotti, Andy M; Caudell, Jimmy J; Harrison, Louis B

2017-01-01

We hypothesized that radiotherapy (RT) would improve both local and regional control with Merkel cell carcinoma of the head and neck. A single-institution institutional review board-approved study was performed including 113 patients with nonmetastatic Merkel cell carcinoma of the head and neck. Postoperative RT was delivered to the primary tumor bed (71.7% cases) ± draining lymphatics (33.3% RT cases). Postoperative local RT was associated with improved local control (3-year actuarial local control 89.4% vs 68.1%; p = .005; Cox hazard ratio [HR] 0.18; 95% confidence interval [CI] = 0.06-0.55; p = .002). Similarly, regional RT was associated with improved regional control (3-year actuarial regional control 95.0% vs 66.7%; p = .008; Cox HR = 0.09; 95% CI = 0.01-0.69; p = .02). Regional RT played an important role for both clinical node-negative patients (3-year regional control 100% vs 44.7%; p = .03) and clinical/pathological node-positive patients (3-year regional control 90.9% vs 55.6%; p = .047). Local RT was beneficial for all patients with Merkel cell carcinoma of the head and neck, whereas regional RT was beneficial for clinical node-negative and clinical/pathological node-positive patients. © 2016 Wiley Periodicals, Inc. Head Neck 39: 48-55, 2017. © 2016 Wiley Periodicals, Inc.

Motivation and academic performance of medical students from ethnic minorities and majority: a comparative study.

PubMed

Isik, Ulviye; Wouters, Anouk; Ter Wee, Marieke M; Croiset, Gerda; Kusurkar, Rashmi A

2017-11-28

Medical students from ethnic minorities underperform in knowledge and skills assessments both in pre-clinical and clinical education compared to the ethnic majority group. Motivation, which influences learning and academic performance of medical students, might play an important role in explaining these differences, but is under-investigated. This study aimed to compare two types of motivation (autonomous and controlled) of ethnic minority (Western and non-Western) and majority (Dutch) students, and their association with academic performance. In a cross-sectional study, all students of a Dutch medical school were invited to complete a survey including the Academic Self-Regulation Questionnaire, measuring autonomous and controlled motivation, in the academic year 2015-2016. Motivation was compared using Kruskal-Wallis test and performance was compared using One-Way ANOVA. Linear regression analysis was used to determine the association between motivation and performance (grade point average; GPA). The response rate was 38.6% (n = 947). Autonomous motivation (AM) of non-Western students was higher than that of Dutch students in pre-clinical and clinical education (p < 0.05). Controlled motivation was higher in Western students than in Dutch students (pre-clinical education; p < 0.05). AM was associated with a higher GPA for Dutch (pre-clinical education; β = 0.33, p < 0.05) and Western students (clinical education; β = 0.57, p < 0.05) only. Our results show significant differences in the type of motivation between the ethnic majority and minority groups. The association of motivation with performance also differs between ethnic groups. We found that AM has a positive influence on GPA. Further research is needed to uncover the underlying mechanisms.

Bupropion for the treatment of apathy in Huntington’s disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial

PubMed Central

Gelderblom, Harald; Wüstenberg, Torsten; McLean, Tim; Mütze, Lisanne; Fischer, Wilhelm; Saft, Carsten; Hoffmann, Rainer; Süssmuth, Sigurd; Schlattmann, Peter; van Duijn, Erik; Landwehrmeyer, Bernhard; Priller, Josef

2017-01-01

Objective To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD). Methods In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy—Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI). Results At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator. Conclusion Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD. Trial registration ClinicalTrials.gov 01914965 PMID:28323838

Clinical profile of patients with type 2 diabetes mellitus treated with sodium- glucose cotransporter-2 inhibitors and experience in real-world clinical practice in Spain.

PubMed

Cuatrecasas, Gabriel; Goñi-Goicoechea, Fernando

2016-11-01

The main aim of the treatment of type 2 diabetes is overall control of cardiovascular risk factors. Almost 50% of patients with type 2 diabetes do not achieve glycaemic targets, and a much higher percentage do not achieve weight and blood pressure targets, despite the therapeutic arsenal that has appeared in the last decade for the treatment of this disease. In addition, antidiabetic secretatogues and insulin are associated with weight gain and an increased risk of hyperglycaemic episodes. Clinical practice guidelines recommend sodium-glucose cotransporter-2 inhibitors (SGLT2i) as an alternative in the same therapeutic step as the other options after initiation of metformin therapy. The present study reviews the most appropriate patient profile for SGLT2i therapy, based on their safety and efficacy demonstrated in controlled clinical trials. The article discusses which patients are at risk of experiencing the possible secondary effects due to the mechanism of action of this new therapeutic class, in whom SGLT2i should be used with caution. These considerations on the profile of patients suitable for SGLT2i therapy are contrasted with the results obtained in daily clinical practice, both in retrospective studies from other countries and from real-world experiences in Spain. This article presents a selection of studies performed in distinct centres with a minimum follow-up of 6 months and compares their results with those from clinical trials. SGLT2i are used in clinical practice in any therapeutic step and the efficacy results are very similar to those reported by controlled clinical trials, with a slightly higher proportion of genitourinary infections and a low dropout rate. Half the reported patients are diabetics receiving insulin therapy plus a gliflozin, showing the wide uptake of this therapeutic strategy by clinicians. SGLT2i are especially attractive due to their additional effectiveness in weight and blood pressure control and the possibility of using them in association with other antidiabetic agents or in monotherapy in patients at any stage of type 2 diabetes. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

ANTIPLAQUE AND ANTIGINGIVITIS EFFECT OF LIPPIA SIDOIDES. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

PubMed Central

Rodrigues, Ítalo Sarto Carvalho; Tavares, Vinícius Nascimento; Pereira, Sérgio Luís da Silva; da Costa, Flávio Nogueira

2009-01-01

Objectives: The antiplaque and antigingivitis effect of Lippia Sidoides (LS) was evaluated in this in vivo investigation. Material and Methods: Twenty-three subjects participated in a cross-over, double-blind clinical study, using 21-day partial-mouth experimental model of gingivitis. A toothshield was constructed for each volunteer, avoiding the brushing of the 4 experimental posterior teeth in the lower left quadrant. The subjects were randomly assigned initially to use either the placebo gel (control group) or the test gel, containing 10% LS (test group). Results: The clinical results showed statistically significant differences for plaque index (PLI) (p<0.01) between days 0 and 21 in both groups, however only the control group showed statistically significant difference (p<0.01) for the bleeding (IB) and gingival (GI) index within the experimental period of 21 days. On day 21, the test group presented significantly better results than the control group with regard to the GI (p<0.05). Conclusions: The test gel containing 10% LS was effective in the control of gingivitis. PMID:19936516

[Computer-assisted education in problem-solving in neurology; a randomized educational study].

PubMed

Weverling, G J; Stam, J; ten Cate, T J; van Crevel, H

1996-02-24

To determine the effect of computer-based medical teaching (CBMT) as a supplementary method to teach clinical problem-solving during the clerkship in neurology. Randomized controlled blinded study. Academic Medical Centre, Amsterdam, the Netherlands. 103 Students were assigned at random to a group with access to CBMT and a control group. CBMT consisted of 20 computer-simulated patients with neurological diseases, and was permanently available during five weeks to students in the CBMT group. The ability to recognize and solve neurological problems was assessed with two free-response tests, scored by two blinded observers. The CBMT students scored significantly better on the test related to the CBMT cases (mean score 7.5 on a zero to 10 point scale; control group 6.2; p < 0.001). There was no significant difference on the control test not related to the problems practised with CBMT. CBMT can be an effective method for teaching clinical problem-solving, when used as a supplementary teaching facility during a clinical clerkship. The increased ability to solve problems learned by CBMT had no demonstrable effect on the performance with other neurological problems.

The effect of a toothpaste containing aloe vera on established gingivitis.

PubMed

Namiranian, Homa; Serino, Giovanni

2012-01-01

The aim of the study was to evaluate the effect of a toothpaste containing high concentrations of Aloe vera on the reduction of plaque and gingivitis in patients attending regular dental care by a dental hygienist. Fifteen subjects participated in this randomized, double-blind, intra-individual and controlled clinical study. Participants were non-smokers, with signs of gingivitis (bleeding index 30%) and no signs of periodontitis. Subjects were followed for three 6-month periods during which they used either their own toothpaste, or an Aloe vera or a control toothpaste. Plaque and gingival indices were recorded atthe start and end of each period. There was a statistically and clinically significant reduction of about 20% of the plaque and gingivitis indices at the end of the clinical trial compared to baseline values, but no differences between the Aloe vera and the control toothpaste. It may be concluded that in patients motivated to improve their oral hygiene habits, the use of a toothpaste containing Aloe Vera showed no additional effect on plaque and gingivitis compared to a control toothpaste.

The Subthalamic Nucleus, Limbic Function, and Impulse Control.

PubMed

Rossi, P Justin; Gunduz, Aysegul; Okun, Michael S

2015-12-01

It has been well documented that deep brain stimulation (DBS) of the subthalamic nucleus (STN) to address some of the disabling motor symptoms of Parkinson's disease (PD) can evoke unintended effects, especially on non-motor behavior. This observation has catalyzed more than a decade of research concentrated on establishing trends and identifying potential mechanisms for these non-motor effects. While many issues remain unresolved, the collective result of many research studies and clinical observations has been a general recognition of the role of the STN in mediating limbic function. In particular, the STN has been implicated in impulse control and the related construct of valence processing. A better understanding of STN involvement in these phenomena could have important implications for treating impulse control disorders (ICDs). ICDs affect up to 40% of PD patients on dopamine agonist therapy and approximately 15% of PD patients overall. ICDs have been reported to be associated with STN DBS. In this paper we will focus on impulse control and review pre-clinical, clinical, behavioral, imaging, and electrophysiological studies pertaining to the limbic function of the STN.

What Are Women Told When Requesting Family Planning Services at Clinics Associated with Catholic Hospitals? A Mystery Caller Study.

PubMed

Guiahi, Maryam; Teal, Stephanie B; Swartz, Maryke; Huynh, Sandy; Schiller, Georgia; Sheeder, Jeanelle

2017-12-01

Catholic Church directives restrict family planning service provision at Catholic health care institutions. It is unclear whether obstetrics and gynecology clinics that are owned by or have business affiliations with Catholic hospitals offer family planning appointments. Mystery callers phoned 144 clinics nationwide that were found on Catholic hospital websites between December 2014 and February 2016, and requested appointments for birth control generally, copper IUD services specifically, tubal ligation and abortion. Chi-square and Fisher's exact tests assessed potential correlates of appointment availability, and multivariable logistic regressions were computed if bivariate testing suggested multiple correlates. Although 95% of clinics would schedule birth control appointments, smaller proportions would schedule appointments for copper IUDs (68%) or tubal ligation (58%); only 2% would schedule an abortion. Smaller proportions of Catholic-owned than of Catholic-affiliated clinics would schedule appointments for birth control (84% vs. 100%), copper IUDs (4% vs. 97%) and tubal ligation (29% vs. 72%); for birth control and copper IUD services, no other clinic characteristics were related to appointment availability. Multivariable analysis confirmed that tubal ligation appointments were less likely to be offered at Catholic-owned than at Catholic-affiliated clinics (odds ratio. 0.1); location and association with one of the top 10 Catholic health care systems also were significant. Adherence to church directives is inconsistent at Catholic-associated clinics. Women visiting such clinics who want highly effective methods may need to rely on less effective methods or delay method uptake while seeking services elsewhere. Copyright © 2017 by the Guttmacher Institute.

Human Heredity and Health (H3) in Africa Kidney Disease Research Network: A Focus on Methods in Sub-Saharan Africa.

PubMed

Osafo, Charlotte; Raji, Yemi Raheem; Burke, David; Tayo, Bamidele O; Tiffin, Nicki; Moxey-Mims, Marva M; Rasooly, Rebekah S; Kimmel, Paul L; Ojo, Akinlolu; Adu, Dwomoa; Parekh, Rulan S

2015-12-07

CKD affects an estimated 14% of adults in sub-Saharan Africa, but very little research has been done on the cause, progression, and prevention of CKD there. As part of the Human Heredity and Health in Africa (H3Africa) Consortium, the H3Africa Kidney Disease Research Network was established to study prevalent forms of kidney disease in sub-Saharan Africa and increase the capacity for genetics and genomics research. The study is performing comprehensive phenotypic characterization and analyzing environmental and genetic factors from nine clinical centers in four African countries (Ghana, Nigeria, Ethiopia, and Kenya) over a 5-year period. Approximately 4000 participants with specified kidney disease diagnoses and 4000 control participants will be enrolled in the four African countries. In addition, approximately 50 families with hereditary glomerular disease will be enrolled. The study includes both pediatric and adult participants age <1 to 74 years across a broad spectrum of kidney diseases secondary to hypertension-attributed nephropathy, diabetes, HIV infection, sickle cell disease, biopsy-proven glomerular disease, and CKD of unknown origin. Clinical and demographic data with biospecimens are collected to assess clinical, biochemical, and genetic markers of kidney disease. As of March 2015, a total of 3499 patients and controls have been recruited and 1897 had complete entry data for analysis. Slightly more than half (50.2%) of the cohort is female. Initial quality control of clinical data collection and of biosample and DNA analysis is satisfactory, demonstrating that a clinical research infrastructure can be successfully established in Africa. This study will provide clinical, biochemical, and genotypic data that will greatly increase the understanding of CKD in sub-Saharan Africa. Copyright © 2015 by the American Society of Nephrology.

Genome-wide association study of clinically defined gout identifies multiple risk loci and its association with clinical subtypes

PubMed Central

Matsuo, Hirotaka; Yamamoto, Ken; Nakaoka, Hirofumi; Nakayama, Akiyoshi; Sakiyama, Masayuki; Chiba, Toshinori; Takahashi, Atsushi; Nakamura, Takahiro; Nakashima, Hiroshi; Takada, Yuzo; Danjoh, Inaho; Shimizu, Seiko; Abe, Junko; Kawamura, Yusuke; Terashige, Sho; Ogata, Hiraku; Tatsukawa, Seishiro; Yin, Guang; Okada, Rieko; Morita, Emi; Naito, Mariko; Tokumasu, Atsumi; Onoue, Hiroyuki; Iwaya, Keiichi; Ito, Toshimitsu; Takada, Tappei; Inoue, Katsuhisa; Kato, Yukio; Nakamura, Yukio; Sakurai, Yutaka; Suzuki, Hiroshi; Kanai, Yoshikatsu; Hosoya, Tatsuo; Hamajima, Nobuyuki; Inoue, Ituro; Kubo, Michiaki; Ichida, Kimiyoshi; Ooyama, Hiroshi; Shimizu, Toru; Shinomiya, Nariyoshi

2016-01-01

Objective Gout, caused by hyperuricaemia, is a multifactorial disease. Although genome-wide association studies (GWASs) of gout have been reported, they included self-reported gout cases in which clinical information was insufficient. Therefore, the relationship between genetic variation and clinical subtypes of gout remains unclear. Here, we first performed a GWAS of clinically defined gout cases only. Methods A GWAS was conducted with 945 patients with clinically defined gout and 1213 controls in a Japanese male population, followed by replication study of 1048 clinically defined cases and 1334 controls. Results Five gout susceptibility loci were identified at the genome-wide significance level (p<5.0×10−8), which contained well-known urate transporter genes (ABCG2 and SLC2A9) and additional genes: rs1260326 (p=1.9×10−12; OR=1.36) of GCKR (a gene for glucose and lipid metabolism), rs2188380 (p=1.6×10−23; OR=1.75) of MYL2-CUX2 (genes associated with cholesterol and diabetes mellitus) and rs4073582 (p=6.4×10−9; OR=1.66) of CNIH-2 (a gene for regulation of glutamate signalling). The latter two are identified as novel gout loci. Furthermore, among the identified single-nucleotide polymorphisms (SNPs), we demonstrated that the SNPs of ABCG2 and SLC2A9 were differentially associated with types of gout and clinical parameters underlying specific subtypes (renal underexcretion type and renal overload type). The effect of the risk allele of each SNP on clinical parameters showed significant linear relationships with the ratio of the case–control ORs for two distinct types of gout (r=0.96 [p=4.8×10−4] for urate clearance and r=0.96 [p=5.0×10−4] for urinary urate excretion). Conclusions Our findings provide clues to better understand the pathogenesis of gout and will be useful for development of companion diagnostics. PMID:25646370

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial

PubMed Central

2013-01-01

Background Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. Methods/Design This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. Discussion This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. Trial registration NCT01695850 PMID:24180235

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial.

PubMed

Zhong, Linda L D; Cheng, Chung Wah; Chan, Yawen; Chan, King Hong; Lam, Ting Wa; Chen, Xiao Rui; Wong, Chi Tak; Wu, Justin C Y; Bian, Zhao Xiang

2013-11-04

Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. NCT01695850.

Propofol versus thiopental sodium for the treatment of refractory status epilepticus.

PubMed

Prabhakar, Hemanshu; Bindra, Ashish; Singh, Gyaninder Pal; Kalaivani, Mani

2012-08-15

Failure to respond to antiepileptic drugs in uncontrolled seizure activity such as refractory status epilepticus (RSE) has led to the use of anaesthetic drugs. Coma is induced with anaesthetic drugs to achieve complete control of seizure activity. Thiopental sodium and propofol are popularly used for this purpose. Both agents have been found to be effective. However, there is substantial lack of evidence as to which of the two drugs is better in terms of clinical outcome. To compare the efficacy, adverse effects, and short- and long-term outcomes of RSE treated with one of the two anaesthetic agents, thiopental sodium or propofol. We searched the Cochrane Epilepsy Group Specialized Register (10 May 2012), the Cochrane Central Register of Controlled Trials (CENTRAL Issue 4 of 12, The Cochrane Library 2012), and MEDLINE (1946 to May week 1, 2012). We also searched (10 May 2012) ClinicalTrials.gov, The South Asian Database of Controlled Clinical Trials, and IndMED (a bibliographic database of Indian Medical Journals). All randomised or quasi-randomised controlled studies (regardless of blinding) of control of RSE using either thiopental sodium or propofol. Two review authors screened the search results and reviewed abstracts of relevant and eligible trials before retrieving the full text publications. One study was available for review. This study was a small, single-blind, multicentre trial studying adults with RSE and receiving either propofol or thiopental sodium for the control of seizure activity (Rossetti 2011). This study showed a wide confidence interval suggesting that the drugs may differ in efficacy up to more than two-fold. There was no evidence of a difference between the drugs with respect to the outcome measures such as control of seizure activity and functional outcome at three months. There is lack of robust and randomised controlled evidence that can clarify the efficacy of propofol and thiopental sodium over each other in the treatment of RSE. There is a need for large, randomised controlled trials for this serious condition.

Volumetric upper airway changes after rapid maxillary expansion: a systematic review and meta-analysis.

PubMed

Buck, Lloyd M; Dalci, Oyku; Darendeliler, M Ali; Papageorgiou, Spyridon N; Papadopoulou, Alexandra K

2017-10-01

Although Rapid Maxillary Expansion (RME) has been used for over a century, its effect on upper airways has not yet adequately been assessed in an evidence-based manner. To investigate the volumetric changes in the upper airway spaces following RME in growing subjects by means of acoustic rhinometry, three-dimensional radiography and digital photogrammetry. Literature search of electronic databases and additional manual searches up to February 2016. Randomized clinical trials, prospective or retrospective controlled clinical trials and cohort clinical studies of at least eight patients, where the RME appliance was left in place for retention, and a maximum follow-up of 8 months post-expansion. After duplicate data extraction and assessment of the risk of bias, the mean differences and 95 per cent confidence intervals (CIs) of upper airway volume changes were calculated with random-effects meta-analyses, followed by subgroup analyses, meta-regressions, and sensitivity analyses. Twenty studies were eligible for qualitative synthesis, of which 17 (3 controlled clinical studies and 14 cohort studies) were used in quantitative analysis. As far as total airway volume is concerned patients treated with RME showed a significant increase post-expansion (5 studies; increase from baseline: 1218.3mm3; 95 per cent CI: 702.0 to 1734.6mm3), which did not seem to considerably diminish after the retention period (11 studies; increase from baseline: 1143.9mm3; 95 per cent CI: 696.9 to 1590.9mm3). However, the overall quality of evidence was judged as very low, due to methodological limitations of the included studies, absence of untreated control groups, and inconsistency among studies. RME seems to be associated with an increase in the nasal cavity volume in the short and in the long term. However, additional well-conducted prospective controlled clinical studies are needed to confirm the present findings. None. Australian Society of Orthodontics Foundation for Research and Education Inc. © The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

The maternal health clinic: an initiative for cardiovascular risk identification in women with pregnancy-related complications.

PubMed

Cusimano, Maria C; Pudwell, Jessica; Roddy, Michelle; Cho, Chan-Kyung Jane; Smith, Graeme N

2014-05-01

Women who develop certain common pregnancy complications have a greater chance of developing cardiovascular disease (CVD) later in life. However, most health care providers do not provide postpartum cardiovascular risk counselling or follow-up. The Maternal Health Clinic was established to address this gap in care. It targets women at increased risk of CVD to inspire lifestyle changes, encourage long-term follow-up, and initiate primary prevention. Here, we summarize results from the first 17 months of completed clinic visits. Patients experiencing at least one relevant complication in their index pregnancy were referred to the Maternal Health Clinic through standard postpartum order sheets. Patients underwent a complete assessment including screening history, physical examination, fasting bloodwork, and urinalysis. Lifetime and 30-year CVD risk estimates, along with a metabolic syndrome calculation, were determined for each patient. Complications most commonly leading to referral were gestational diabetes or impaired glucose tolerance (32.7%), preeclampsia (29.3%), preterm birth (29.3%), and gestational hypertension (19.6%). The clinic analysis group (n = 92) was compared with a healthy control group from the PreEclampsia New Emerging Team study (n = 118). Patients in the clinic analysis group had significantly increased lifetime and 30-year CVD risk estimates compared with healthy controls (P < .0001). Furthermore, 17.4% of the clinic analysis group had metabolic syndrome, compared with 6.78% of healthy controls (P < .05). This study demonstrates that the Maternal Health Clinic accurately identifies postpartum patients that have underlying cardiovascular risks which make them susceptible to CVD. The clinic may serve as an effective primary prevention strategy. Copyright © 2014 Mosby, Inc. All rights reserved.

Does specific psychopathology predict development of psychosis in ultra high-risk (UHR) patients?

PubMed

Thompson, Andrew; Nelson, Barnaby; Bruxner, Annie; O'Connor, Karen; Mossaheb, Nilufar; Simmons, Magenta B; Yung, Alison

2013-04-01

Studies have attempted to identify additional risk factors within the group identified as 'ultra high risk' (UHR) for developing psychotic disorders in order to characterise those at highest risk. However, these studies have often neglected clinical symptom types as additional risk factors. We aimed to investigate the relationship between baseline clinical psychotic or psychotic-like symptoms and the subsequent transition to a psychotic disorder in a UHR sample. A retrospective 'case-control' methodology was used. We identified all individuals from a UHR clinic who had subsequently developed a psychotic disorder (cases) and compared these to a random sample of individuals from the clinic who did not become psychotic within the sampling time frame (controls). The sample consisted of 120 patients (60 cases, 60 controls). An audit tool was used to identify clinical symptoms reported at entry to the clinic (baseline) using the clinical file. Diagnosis at transition was assessed using the Operational Criteria for Psychotic Illness (OPCRIT) computer program. The relationship between transition to a psychotic disorder and baseline symptoms was explored using survival analysis. Presence of thought disorder, any delusions and elevated mood significantly predicted transition to a psychotic disorder. When other symptoms were adjusted for, only the presence of elevated mood significantly predicted subsequent transition (hazard ratio 2.69, p = 0.002). Thought disorder was a predictor of transition to a schizophrenia-like psychotic disorder (hazard ratio 3.69, p = 0.008). Few individual clinical symptoms appear to be predictive of transition to a psychotic disorder in the UHR group. Clinicians should be cautious about the use of clinical profile alone in such individuals when determining who is at highest risk.

The quality of veterinary in-clinic and reference laboratory biochemical testing.

PubMed

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

PubMed

Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

2008-06-01

To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial

PubMed Central

2013-01-01

Background Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA. Methods/design The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group. The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the Geriatric Oral Health Assessment Index) will also be compared between the two groups. Discussion Evidence-based management of potential aggravating factors in subjects with active RA could be of clinical importance, yet there are few randomized controlled trials on the effect of periodontal treatment on the clinical parameters of RA. The ESPERA trial is designed to determine if non-surgical periodontal treatment could improve clinical outcomes in patients with active RA, and the quality of life of these patients. Trial registration The ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06. PMID:23945051

Early exposure to probiotics in a canine model of atopic dermatitis has long-term clinical and immunological effects.

PubMed

Marsella, Rosanna; Santoro, Domenico; Ahrens, Kim

2012-04-15

Probiotics modulate the immune response and may have protective effects against atopic dermatitis (AD). Clinical trials using dogs with spontaneous disease are limited by confounding factors such as different diets, environments and sensitizations while a more controlled evaluation is possible using experimental models. A validated model of canine AD showed that early exposure to Lactobacillus rhamnosus GG (LGG) significantly decreases allergen-specific IgE and partially prevents AD in the first 6 months of life. This study is a follow-up three years after discontinuation of LGG. Clinical signs were evaluated after allergen challenge with ragweed, timothy, Dermatophagoides farinae. Allergen-specific IgE, IL-10 and TGF-β were measured on the 1st day of challenge, before allergen exposure. Normal dogs were included as controls. Analyses included seven dogs in the non-probiotic and nine in the probiotic litter. For clinical scores, a 2-Group × 9-Time Analysis of Variance showed significant effects of group (p=0.0003, probiotic

[Clinical and epidemiological differences between Bordetella pertussis and respiratory syncytial virus infections in infants: a matched case control study].

PubMed

Giménez-Sánchez, Francisco; Cobos-Carrascosa, Elena; Sánchez-Forte, Miguel; López-Sánchez, María Ángeles; González-Jiménez, Yolanda; Azor-Martínez, Ernestina

2014-01-01

An increase in cases of pertussis, mainly in young infants, has been reported in the last few years. The clinical presentation of this disease is very similar to that produced by respiratory syncytial virus (RSV), which makes the diagnosis difficult. To compare the clinical and epidemiological characteristics between Bordetella pertussis and RSV infections in infants admitted to hospital. An analytical matched case-control study was conducted during the period 2008-2011. Cases were defined as infants admitted with pertussis confirmed by PCR in nasopharyngeal aspirate. Each case was matched by age, sex and date of admission to two controls defined as patients with RSV infection detected by immunochromatography in nasal aspirate. Demographic, clinical, laboratory data were compared. Seventy eight patients (26 cases of pertussis and 52 controls RSV+) were included. Sociodemographic characteristics were similar in both groups. Cases had more days of symptoms prior to admission, longer hospital stays, and increased frequency of epidemic family environment. Apnoea and cyanosis were more frequent. Cases of pertussis were more likely to have apnoea, cyanosis, and lymphocytosis while RSV infections had more frequent fever, vomiting and respiratory distress. The clinical presentations of pertussis and RSV infection are similar, but there are some characteristics that can help to distinguish between them. Copyright © 2013 Elsevier España, S.L. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Diabetes quality improvement in Department of Veterans Affairs Ambulatory Care Clinics: a group-randomized clinical trial.

PubMed

Reiber, Gayle E; Au, David; McDonell, Mary; Fihn, Stephan D

2004-05-01

To conduct a group-randomized clinical trial to determine whether regular feedback to primary care providers of synthesized information on patients' health, function, and satisfaction would demonstrate improved outcomes for their patients with diabetes. Patients in General Internal Medicine Clinics Department of Veterans Affairs (VA) Medical Centers were randomized into seven intervention or control firms. Patient self-reported information was collected by mail on general health, diabetes, and up to five other chronic conditions. Patients with diabetes received the Seattle Diabetes Questionnaire, the 36-item Medical Outcomes Study short form (SF-36), and a validated patient satisfaction questionnaire at regular intervals. Data from self-report, clinical, pharmacy, and laboratory sources were synthesized into patient-specific feedback reports that intervention providers received before patients' visits. The timely delivery to primary care providers of state-of-the-art patient-feedback reports that identified patient issues and areas for improvement did not result in significant improvements in patient outcomes between the intervention and control firms. Outcomes in diabetic patients whose providers received synthesized patient data before visits were no better than in those receiving care from control firms. Future studies may benefit from substantial involvement in patients discussing, problem solving, and goal setting in addition to use of timely synthesized patient data.

A comparative, randomized, controlled study on clinical efficacy and dental staining reduction of a mouthwash containing Chlorhexidine 0.20% and Anti Discoloration System (ADS).

PubMed

Marrelli, Massimo; Amantea, Massimiliano; Tatullo, Marco

2015-01-01

A good control of bacterial plaque is an essential factor for the success of periodontal therapy, therefore it is the main objective that the clinician together with the patient must get to have a healthy periodontium. The plaque control with mouthwashes is the most important home therapy as it helps to reduce the formation of plaque between the mechanical removal with a toothbrush. Authors analyzed the clinical data from a trial carried out with 3 different mouthwashes containing 0.2% Chlorhexidine (CHX). In addition, the ADS (Anti Discoloration System - Curaden Healthcare) was tested in comparison with the other mouthwashes without this system. We tested antiplaque activity showed by 3 of the most commercialized mouthwashes, moreover, we tested the ability in reducing the dental staining related to the oral assumption of Chlorhexidine. Our results demonstrated the clinical efficacy of the 3 mouthwashes with CHX. Particularly performing was the anti discoloration system (Curaden Healthcare), with a clinical detection of dental stainings significantly less than the others tested. This study demonstrated the clinical efficacy of ADS system in the reduction of tooth staining, without a loss of antiplaque activity with respect to the competing mouthwashes containing CHX.

Clinical verification of a unilateral otolith test

NASA Astrophysics Data System (ADS)

Wetzig, J.; Hofstetter-Degen, K.; Maurer, J.; von Baumgarten, R. J.

In a previous study 13 we reported promising results for a new test to differentiate in vivo unilateral otolith functions. That study pointed to a need for further validation on known pathological cases. In this presentation we will detail the results gathered on a group of clinically verified vestibular defectives (verum) and a normal (control) group. The subjects in the verum group were former patients of the ENT clinic of the university hospital. These subjects had usually suffered from neurinoma of the VIIth cranial nerve or inner ear infections. All had required surgical intervention including removal of the vestibular system. The patients were contacted usually two or more years postoperatively. A group of students from the pre- and clinical phase of medical training served as control. Both groups were subjected to standardized clinical tests. These tests served to reconfirm the intra- or postoperative diagnosis of unilateral vestibular loss in the verum group. In the control group they had to establish the normalcy of the responses of the vestibular system. Both groups then underwent testing on our exccentric rotary chair in the manner described before 13. Preliminary results of the trials indicate that this test may indeed for the first time offer a chance to look at isolated otolith apparati in vivo.

Subcortical volumetric differences between clinical stages of young people with affective and psychotic disorders.

PubMed

Eggins, Peta S; Hatton, Sean N; Hermens, Daniel F; Hickie, Ian B; Lagopoulos, Jim

2018-01-30

The aim of this study was to investigate differences in subcortical and hippocampal volumes between healthy controls, young people at an early stage of affective and psychotic disorders and those in more advanced stages, to identify markers associated with functional outcomes and illness severity. Young people presenting to youth mental health services with admixtures of depressive, manic and psychotic symptoms (n = 141), and healthy counterparts (n = 49), aged 18-25 were recruited. Participants underwent magnetic resonance imaging, clinical assessments and were rated as to their current clinical stage. Eighty-four patients were classified at the attenuated syndrome stage (Stage 1b) and 57 were classified as having discrete and persistent disorders (Stage 2+). Automated segmentation was performed using NeuroQuant® to determine volumes of subcortical and hippocampus structures which were compared between groups and correlated with clinical and functional outcomes. Compared to healthy controls, Stage 2+ patients showed significantly reduced right amygdala volumes. Whereas Stage 1b patients showed significantly reduced left caudate volumes compared to healthy controls. Smaller left caudate volume correlated with greater psychological distress and impaired functioning. This study shows a clinical application for an automated program to identify and track subcortical changes evident in young people with emerging psychopathology. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

Novel method for evaluation of eye movements in patients with narcolepsy.

PubMed

Christensen, Julie A E; Kempfner, Lykke; Leonthin, Helle L; Hvidtfelt, Mathias; Nikolic, Miki; Kornum, Birgitte Rahbek; Jennum, Poul

2017-05-01

Narcolepsy causes abnormalities in the control of wake-sleep, non-rapid-eye-movement (non-REM) sleep and REM sleep, which includes specific eye movements (EMs). In this study, we aim to evaluate EM characteristics in narcolepsy as compared to controls using an automated detector. We developed a data-driven method to detect EMs during sleep based on two EOG signals recorded as part of a polysomnography (PSG). The method was optimized using the manually scored hypnograms from 36 control subjects. The detector was applied on a clinical sample with subjects suspected for central hypersomnias. Based on PSG, multiple sleep latency test and cerebrospinal fluid hypocretin-1 measures, they were divided into clinical controls (N = 20), narcolepsy type 2 (NT2, N = 19), and narcolepsy type 1 (NT1, N = 28). We investigated the distribution of EMs across sleep stages and cycles. NT1 patients had significantly less EMs during wake, N1, and N2 sleep and more EMs during REM sleep compared to clinical controls, and significantly less EMs during wake and N1 sleep compared to NT2 patients. Furthermore, NT1 patients showed less EMs during NREM sleep in the first sleep cycle and more EMs during NREM sleep in the second sleep cycle compared to clinical controls and NT2 patients. NT1 patients show an altered distribution of EMs across sleep stages and cycles compared to NT2 patients and clinical controls, suggesting that EMs are directly or indirectly controlled by the hypocretinergic system. A data-driven EM detector may contribute to the evaluation of narcolepsy and other disorders involving the control of EMs. Copyright © 2016 Elsevier B.V. All rights reserved.

What's in a Trial? On the Importance of Distinguishing Between Experimental Lab Studies and Randomized Controlled Trials: The Case of Cognitive Bias Modification and Alcohol Use Disorders.

PubMed

Wiers, Reinout W; Boffo, Marilisa; Field, Matt

2018-05-01

Recently, the National Institutes of Health (NIH) redefined clinical trials to include any study involving behavioral or biomedical interventions. In line with a general framework from experimental medicine, we argue that it is crucial to distinguish between experimental laboratory studies aimed at revealing psychological mechanisms underlying behavior and randomized controlled trials (RCTs) in clinical samples aimed at testing the efficacy of an intervention. As an illustration, we reviewed the current state of the evidence on the efficacy of cognitive bias modification (CBM) interventions in alcohol use disorders. A recent meta-analysis "cast serious doubts on the clinical utility of CBM interventions for addiction." That analysis combined experimental laboratory studies and RCTs. We demonstrated that, when studies are differentiated regarding study type (experimental laboratory study or RCT), mode of delivery (controlled experiment or Internet), and population (healthy volunteers or patients), the following effects are found: (a) short-lived effects of CBM on drinking behavior in experimental laboratory studies in students, but only when the bias is successfully manipulated; (b) small but robust effects of CBM on treatment outcome when administered as an adjunct to established treatments in clinical settings in RCTs with alcohol-dependent patients; and (c) nonspecific effects (reduced drinking irrespective of condition) in RCTs of CBM administered online to problem drinkers. We discuss how CBM might be improved when it is better integrated into regular treatment, especially cognitive behavioral therapy, and we conclude that disregarding the difference between experimental laboratory studies and RCTs can lead to invalid conclusions.

B-cell depletion in SLE: clinical and trial experience with rituximab and ocrelizumab and implications for study design.

PubMed

Reddy, Venkat; Jayne, David; Close, David; Isenberg, David

2013-01-01

B cells are believed to be central to the disease process in systemic lupus erythematosus (SLE), making them a target for new therapeutic intervention. In recent years there have been many publications regarding the experience in SLE of B-cell depletion utilising rituximab, an anti-CD20 mAb that temporarily depletes B cells,reporting promising results in uncontrolled open studies and in routine clinical use. However, the two large randomised controlled trials in extra-renal lupus (EXPLORER study) and lupus nephritis (LUNAR study) failed to achieve their primary endpoints. Based on the clinical experience with rituximab this failure was somewhat unexpected and raised a number of questions and concerns, not only into the true level of benefit of B-cell depletion in a broad population but also how to test the true level of effectiveness of an investigational agent as we seek to improve the design of therapeutic trials in SLE. A better understanding of what went wrong in these trials is essential to elucidate the underlying reasons for the disparate observations noted in open studies and controlled trials. In this review, we focus on various factors that may affect the ability to accurately and confidently establish the level of treatment effect of the investigational agent, in this case rituximab, in the tw studies and explore hurdles faced in the randomised controlled trials investigating the efficacy of ocrelizumab, the humanised anti-CD20 mAb, in SLE. Further, based on the lessons learned from the clinical trials, we make suggestions that could be implemented in future clinical trial design to overcome the hurdles faced.

Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

PubMed

Becker, Jan; Beutel, Manfred E; Gerzymisch, Katharina; Schulz, Dirk; Siepmann, Martin; Knickenberg, Rudolf J; Schmädeke, Stefan; Ferdinand, Peter; Zwerenz, Rüdiger

2016-06-13

Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation. All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to log in to the study platform together with the usual clinic information leaflet. Patients will receive the study information and informed consent upon login and will be randomized into the intervention or the control group. The intervention group (n = 394) will get access to our virtual online clinic, containing several videos about inpatient rehabilitation, until their admission to inpatient rehabilitation. The control group (n = 394) will receive no special treatment preparation. Questionnaires will be given at study inclusion (T0), two weeks before admission to (T1), and at the end of (T2) inpatient rehabilitation. The primary outcome is the outcome expectancy measured with the Credibility Expectancy Questionnaire at T1. Secondary outcomes include treatment motivation, mental health, work ability, depression, anxiety, and satisfaction with and usage of the Internet platform. We expect the intervention group to benefit from the additional preparation concerning their outcome expectancy. If successful, this approach could be used in the future to enhance the efficacy of inpatient rehabilitation. ClinicalTrials.gov: NCT02532881 . Registered on 25 August 2015.

Limited association between perceived control and health-related quality of life in patients with heart failure.

PubMed

Banerjee, Teesta; Lee, Kyoung Suk; Browning, Steven R; Hopenhayn, Claudia; Westneat, Susan; Biddle, Martha J; Arslanian-Engoren, Cynthia; Eastwood, Jo-Ann; Mudd, Gia; Moser, Debra K

2014-01-01

Perceived control has been suggested as a modifiable factor associated with health-related quality of life (HRQOL). However, the relationship between perceived control and HRQOL has not been evaluated in patients with heart failure (HF). The purpose of this study was to determine whether perceived control independently predicts HRQOL in HF patients. A total of 423 HF patients were included. Hierarchical linear regression was performed to determine the independent association of perceived control to HRQOL after controlling for covariates. Higher levels of perceived control were associated with better HRQOL in univariate analysis. However, this relationship was strongly attenuated after controlling for relevant demographic, clinical, and psychological factors; the variance in HRQOL explained by the addition of perceived control to this model was small (1.4%). We found only a weak relationship between perceived control and HRQOL when considered in the presence of demographic, clinical, and psychological factors.

Using simulation pedagogy to teach clinical education skills: A randomized trial.

PubMed

Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

2016-05-01

Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

Clinical study of the effectiveness of the "water of the 3 sulfates" on balanitis and balanoposthitis.

PubMed

Gonzalvo, V; Polo, A; Serrallach, F; Gutiérrez, A; Peyri, E

2015-03-01

Despite scientific literature mentions the application of "water of the 3 sulfates" (copper sulphate, zinc sulphate and alum) as a treatment for acute balanitis and balanoposthitis, no clinical trials evaluating its efficacy have been found. In our study we evaluate the efficacy of this solution in acute balanitis and balanoposthitis. A double-blind randomized study was designed to compare the efficacy of "water of the 3 sulfates" (intervention) with saline solution (control) in 50 patients (30 patients and 20 patients, respectively) who suffer from acute balanitis or balanoposthitis. Exudate, erythema, oedema, burning, and itching were the clinical parameters assessed. for all clinical parameters assessed, the outcomes obtained with "water of the 3 sulfates" are higher than control, although significant differences only have been found for exudate. in our study, the "water of the 3 sulfates" is significantly more effective than saline solution for removing exudates in acute balanitis and balanoposthitis. Tolerability was excellent in both treatments. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Feasibility trial of a Spanish-language multimedia educational intervention.

PubMed

Wells, Kristen J; McIntyre, Jessica; Gonzalez, Luis E; Lee, Ji-Hyun; Fisher, Kate J; Jacobsen, Paul B; Meade, Cathy; Muñoz-Antonia, Teresita; Quinn, Gwendolyn P

2013-10-01

Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results may not generalize to other Hispanic populations. In the pilot project, we demonstrated the feasibility of delivering multimedia information to patients in medical oncology clinics. Because delivery in a clinical setting was found to be feasible, a larger study should be conducted to evaluate the efficacy of the multimedia intervention with respect to promoting accrual of Hispanic patients to clinical trials.

Clinical effects of internal fixation for ulnar styloid fractures associated with distal radius fractures: A matched case-control study.

PubMed

Sawada, Hideyoshi; Shinohara, Takaaki; Natsume, Tadahiro; Hirata, Hitoshi

2016-11-01

Ulnar styloid fractures are often associated with distal radius fractures. However, controversy exists regarding whether to treat ulnar styloid fractures. This study aimed to evaluate clinical effects of internal fixation for ulnar styloid fractures after distal radius fractures were treated with the volar locking plate system. We used prospectively collected data of distal radius fractures. 111 patients were enrolled in this study. A matched case-control study design was used. We selected patients who underwent fixation for ulnar styloid fractures (case group). Three control patients for each patient of the case group were matched on the basis of age, sex, and fracture type of distal radius fractures from among patients who did not undergo fixation for ulnar styloid fractures (control group). The case group included 16 patients (7 men, 9 women; mean age: 52.6 years; classification of ulnar styloid fractures: center, 3; base, 11; and proximal, 2). The control group included 48 patients (15 men, 33 women; mean age: 61.1 years; classification of ulnar styloid fractures: center, 10; base, 31; and proximal, 7). For radiographic examination, the volar tilt angle, radial inclination angle, and ulnar variance length were measured, and the union of ulnar styloid fractures was judged. For clinical examination, the range of motions, grip strength, Hand20 score, and Numeric Rating Scale score were evaluated. There was little correction loss for each radiological parameter of fracture reduction, and these parameters were not significantly different between the groups. The bone-healing rate of ulnar styloid fractures was significantly higher in the case group than in the control group, but the clinical results were not significantly different. We revealed that there was no need to fix ulnar styloid fractures when distal radius fractures were treated via open reduction and internal fixation with a volar locking plate system. Copyright © 2016 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

Lack of association between the Trp719Arg polymorphism in kinesin-like protein 6 and coronary artery disease in 19 case-control studies

PubMed Central

Assimes, Themistocles L; Hólm, Hilma; Kathiresan, Sekar; Reilly, Muredach P; Thorleifsson, Gudmar; Voight, Benjamin F; Erdmann, Jeanette; Willenborg, Christina; Vaidya, Dhananjay; Xie, Changchun; Patterson, Chris C; Morgan, Thomas M; Burnett, Mary Susan; Li, Mingyao; Hlatky, Mark A; Knowles, Joshua W; Thompson, John R; Absher, Devin; Iribarren, Carlos; Go, Alan; Fortmann, Stephen P; Sidney, Stephen; Risch, Neil; Tang, Hua; Myers, Richard M; Berger, Klaus; Stoll, Monika; Shah, Svati H.; Thorgeirsson, Gudmundur; Andersen, Karl; Havulinna, Aki S; Herrera, J. Enrique; Faraday, Nauder; Kim, Yoonhee; Kral, Brian G.; Mathias, Rasika; Ruczinski, Ingo; Suktitipat, Bhoom; Wilson, Alexander F; Yanek, Lisa R.; Becker, Lewis C; Linsel-Nitschke, Patrick; Lieb, Wolfgang; König, Inke R; Hengstenberg, Christian; Fischer, Marcus; Stark, Klaus; Reinhard, Wibke; Winogradow, Janina; Grassl, Martina; Grosshennig, Anika; Preuss, Michael; Eifert, Sandra; Schreiber, Stefan; Wichmann, H-Erich; Meisinger, Christa; Yee, Jean; Friedlander, Yechiel; Do, Ron; Meigs, James B; Williams, Gordon; Nathan, David M; MacRae, Calum A; Qu, Liming; Wilensky, Robert L; Matthai, William H.; Qasim, Atif N; Hakonarson, Hakon; Pichard, Augusto D; Kent, Kenneth M; Satler, Lowell; Lindsay, Joseph M; Waksman, Ron; Knouff, Christopher W; Waterworth, Dawn M; Walker, Max C; Mooser, Vincent; Marrugat, Jaume; Lucas, Gavin; Subirana, Isaac; Sala, Joan; Ramos, Rafael; Martinelli, Nicola; Olivieri, Oliviero; Trabetti, Elisabetta; Malerba, Giovanni; Pignatti, Pier Franco; Guiducci, Candace; Mirel, Daniel; Parkin, Melissa; Hirschhorn, Joel N; Asselta, Rosanna; Duga, Stefano; Musunuru, Kiran; Daly, Mark J; Purcell, Shaun; Braund, Peter S; Wright, Benjamin J; Balmforth, Anthony J; Ball, Stephen G; Ouwehand, Willem H; Deloukas, Panos; Scholz, Michael; Cambien, Francois; Huge, Andreas; Scheffold, Thomas; Salomaa, Veikko; Girelli, Domenico; Granger, Christopher B.; Peltonen, Leena; McKeown, Pascal P; Altshuler, David; Melander, Olle; Devaney, Joseph M; Epstein, Stephen E; Rader, Daniel J; Elosua, Roberto; Engert, James C; Anand, Sonia S; Hall, Alistair S; Ziegler, Andreas; O’Donnell, Christopher J; Spertus, John A; Siscovick, David; Schwartz, Stephen M; Becker, Diane; Thorsteinsdottir, Unnur; Stefansson, Kari; Schunkert, Heribert; Samani, Nilesh J; Quertermous, Thomas

2011-01-01

Objectives We sought to replicate the association between the kinesin-like protein 6 (KIF6) Trp719Arg polymorphism (rs20455) and clinical coronary artery disease (CAD). Background Recent prospective studies suggest that carriers of the 719Arg allele in KIF6 are at increased risk of clinical CAD compared with non-carriers. Methods The KIF6 Trp719Arg polymorphism (rs20455) was genotyped in nineteen case-control studies of non-fatal CAD either as part of a genome-wide association study or in a formal attempt to replicate the initial positive reports. Results Over 17 000 cases and 39 000 controls of European descent as well as a modest number of South Asians, African Americans, Hispanics, East Asians, and admixed cases and controls were successfully genotyped. None of the nineteen studies demonstrated an increased risk of CAD in carriers of the 719Arg allele compared with non-carriers. Regression analyses and fixed effect meta-analyses ruled out with high degree of confidence an increase of ≥2% in the risk of CAD among European 719Arg carriers. We also observed no increase in the risk of CAD among 719Arg carriers in the subset of Europeans with early onset disease (<50 years of age for males and <60 years for females) compared with similarly aged controls as well as all non-European subgroups. Conclusions The KIF6 Trp719Arg polymorphism was not associated with the risk of clinical CAD in this large replication study. PMID:20933357

Effect of cooling of cooked white rice on resistant starch content and glycemic response.

PubMed

Sonia, Steffi; Witjaksono, Fiastuti; Ridwan, Rahmawati

2015-01-01

Cooling of cooked starch is known to cause starch retrogradation which increases resistant starch content. This study aimed to determine the effect of cooling of cooked white rice on resistant starch content and glycemic response in healthy subjects. Resistant starch contents were analyzed on freshly cooked white rice (control rice), cooked white rice cooled for 10 hours at room temperature (test rice I), and cooked white rice cooled for 24 hours at 4°C then reheated (test rice II). The results showed that resistant starch contents in control rice, test rice I, and test rice II were 0.64 g/100 g, 1.30 g/100 g, and 1.65 g/100 g, respectively. Test rice II had higher resistant starch content than test rice I, hence used in the clinical study along with control rice to characterize glycemic response in 15 healthy adults. The clinical study was a randomized, single-blind crossover study. In the clinical study, test rice II significantly lowered glycemic response compared with control rice (125±50.1 vs 152±48.3 mmol.min/L, respectively; p=0.047). In conclusion, cooling of cooked white rice increased resistant starch content. Cooked white rice cooled for 24 hours at 4°C then reheated lowered glycemic response compared with freshly cooked white rice.

The efficacy of cetirizine hydrochloride on the pruritus of cats with atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Wildermuth, Kerstin; Zabel, Sonja; Rosychuk, Rod A W

2013-12-01

Various antihistamines have been used in the management of feline atopic dermatitis, with variable reported benefit. To date, there have been no randomized, double-blind, placebo-controlled, crossover clinical trials on the use of this drug class in cats. To evaluate the clinical efficacy of cetirizine hydrochloride for the control of pruritus and dermatitis in cats diagnosed with atopic dermatitis. In this randomized, double-blind, placebo-controlled crossover clinical trial, 21 client-owned cats diagnosed with mild to moderate nonseasonal atopic dermatitis were randomly assigned to two groups. Cats in each group received either 1 mg/kg cetirizine hydrochloride or placebo once daily per os for 28 days followed by a 14 day wash-out period. Treatments were then crossed over, and cats received placebo or cetirizine hydrochloride for another 28 days. Owners marked a pruritus severity scale before inclusion in the study and weekly throughout the entire study period. Lesions were scored by the clinician using a Canine Atopic Dermatitis Extent and Severity Index (CADESI)-03 modified for the cat before enrolment and at day 28 of each treatment. Nineteen cats completed the study. There were no statistically significant differences between treatment with cetirizine hydrochloride and placebo for modified CADESI-03 or pruritus scores. This study suggests that cetirizine hydrochloride cannot be recommended for the management of feline atopic dermatitis. © 2013 ESVD and ACVD.

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

PubMed

Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

2016-11-14

The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Venous Thrombosis Risk after Cast Immobilization of the Lower Extremity: Derivation and Validation of a Clinical Prediction Score, L-TRiP(cast), in Three Population-Based Case–Control Studies

PubMed Central

Nemeth, Banne; van Adrichem, Raymond A.; van Hylckama Vlieg, Astrid; Bucciarelli, Paolo; Martinelli, Ida; Baglin, Trevor; Rosendaal, Frits R.; le Cessie, Saskia; Cannegieter, Suzanne C.

2015-01-01

Background Guidelines and clinical practice vary considerably with respect to thrombosis prophylaxis during plaster cast immobilization of the lower extremity. Identifying patients at high risk for the development of venous thromboembolism (VTE) would provide a basis for considering individual thromboprophylaxis use and planning treatment studies. The aims of this study were (1) to investigate the predictive value of genetic and environmental risk factors, levels of coagulation factors, and other biomarkers for the occurrence of VTE after cast immobilization of the lower extremity and (2) to develop a clinical prediction tool for the prediction of VTE in plaster cast patients. Methods and Findings We used data from a large population-based case–control study (MEGA study, 4,446 cases with VTE, 6,118 controls without) designed to identify risk factors for a first VTE. Cases were recruited from six anticoagulation clinics in the Netherlands between 1999 and 2004; controls were their partners or individuals identified via random digit dialing. Identification of predictor variables to be included in the model was based on reported associations in the literature or on a relative risk (odds ratio) > 1.2 and p ≤ 0.25 in the univariate analysis of all participants. Using multivariate logistic regression, a full prediction model was created. In addition to the full model (all variables), a restricted model (minimum number of predictors with a maximum predictive value) and a clinical model (environmental risk factors only, no blood draw or assays required) were created. To determine the discriminatory power in patients with cast immobilization (n = 230), the area under the curve (AUC) was calculated by means of a receiver operating characteristic. Validation was performed in two other case–control studies of the etiology of VTE: (1) the THE-VTE study, a two-center, population-based case–control study (conducted in Leiden, the Netherlands, and Cambridge, United Kingdom) with 784 cases and 523 controls included between March 2003 and December 2008 and (2) the Milan study, a population-based case–control study with 2,117 cases and 2,088 controls selected between December 1993 and December 2010 at the Thrombosis Center, Fondazione IRCCS Ca’ Granda–Ospedale Maggiore Policlinico, Milan, Italy. The full model consisted of 32 predictors, including three genetic factors and six biomarkers. For this model, an AUC of 0.85 (95% CI 0.77–0.92) was found in individuals with plaster cast immobilization of the lower extremity. The AUC for the restricted model (containing 11 predictors, including two genetic factors and one biomarker) was 0.84 (95% CI 0.77–0.92). The clinical model (consisting of 14 environmental predictors) resulted in an AUC of 0.77 (95% CI 0.66–0.87). The clinical model was converted into a risk score, the L-TRiP(cast) score (Leiden–Thrombosis Risk Prediction for patients with cast immobilization score), which showed an AUC of 0.76 (95% CI 0.66–0.86). Validation in the THE-VTE study data resulted in an AUC of 0.77 (95% CI 0.58–0.96) for the L-TRiP(cast) score. Validation in the Milan study resulted in an AUC of 0.93 (95% CI 0.86–1.00) for the full model, an AUC of 0.92 (95% CI 0.76–0.87) for the restricted model, and an AUC of 0.96 (95% CI 0.92–0.99) for the clinical model. The L-TRiP(cast) score resulted in an AUC of 0.95 (95% CI 0.91–0.99). Major limitations of this study were that information on thromboprophylaxis was not available for patients who had plaster cast immobilization of the lower extremity and that blood was drawn 3 mo after the thrombotic event. Conclusions These results show that information on environmental risk factors, coagulation factors, and genetic determinants in patients with plaster casts leads to high accuracy in the prediction of VTE risk. In daily practice, the clinical model may be the preferred model as its factors are most easy to determine, while the model still has good predictive performance. These results may provide guidance for thromboprophylaxis and form the basis for a management study. PMID:26554832

An evidence-based review of pregabalin for the treatment of fibromyalgia.

PubMed

Arnold, Lesley M; Choy, Ernest; Clauw, Daniel J; Oka, Hiroshi; Whalen, Ed; Semel, David; Pauer, Lynne; Knapp, Lloyd

2018-04-16

Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in the United States, Japan, and 37 other countries. The purpose of this article was to provide an in-depth, evidence-based summary of pregabalin for FM as demonstrated in randomized, placebo-controlled clinical studies, including open-label extensions, meta-analyses, combination studies and post-hoc analyses of clinical study data. PubMed was searched using the term "pregabalin AND fibromyalgia" and the Cochrane Library with the term "pregabalin". Both searches were conducted on 2 March 2017 with no other date limits set. Eleven randomized, double-blind, placebo-controlled clinical studies were identified including parallel group, two-way crossover and randomized withdrawal designs. One was a neuroimaging study. Five open-label extensions were also identified. Evidence of efficacy was demonstrated across the studies identified with significant and clinically relevant improvements in pain, sleep quality and patient status. The safety and tolerability profile of pregabalin is consistent across all the studies identified, including in adolescents, with dizziness and somnolence the most common adverse events reported. These efficacy and safety data are supported by meta-analyses (13 studies). Pregabalin in combination with other pharmacotherapies (7 studies) is also efficacious. Post-hoc analyses have demonstrated the onset of pregabalin efficacy as early as 1-2 days after starting treatment, examined the effect of pregabalin on other aspects of sleep beyond quality, and shown it is effective irrespective of the presence of a wide variety of patient demographic and clinical characteristics. Pregabalin is a treatment option for FM; its clinical utility has been comprehensively demonstrated.

Electron microscopic changes of detrusor in benign enlargement of prostate and its clinical correlation.

PubMed

Yadav, Sher Singh; Bhattar, Rohit; Sharma, Lokesh; Banga, Gautam; Sadasukhi, Trilok Chandra

2017-01-01

To study the ultra structural changes in bladder musculature in cases of BPE and their clinical relevance. In this descriptive longitudinal, controlled, observational study patients were enrolled into three groups, group 1, group 2A and group 2B. Control group (group-1) consisted of age matched normal male patients, who underwent surveillance or diagnostic cystoscopy for microscopic hematuria or irritative symptoms. Case group (group-2) comprised of patients with BPE, undergoing TURP. Case group (group-2) was further classified into: Category 2A (patients not on catheter) and cat-egory 2B (patients on catheter). All relevant clinical parameters like IPSS, prostate size, Qmax, PVR were recorded. Cystoscopy and bladder biopsy were performed in all patients. Various ultrastructural parameters like myocytes, fascicular pattern, interstitial tissue, nerve hypertrophy and cell junction pattern were analyzed under electron microscope and they were clinically correlated using appropriate statistical tests. Control group had significant difference as compared to case group in terms of baseline parameters like IPSS, flow rate and prostate size, both preoperatively and postoperatively, except for PVR, which was seen only preoperatively. There was statistically significant difference in ultrastructural patterns between case and control group in all five electron microscopic patterns. However, no significant difference was found between the subcategories of case groups. BPE is responsible for ultra structural changes in detrusor muscle and these changes remain persistent even after TURP. Nerve hypertrophy, which was not thoroughly discussed in previous studies, is also one of the salient feature of this study. Copyright® by the International Brazilian Journal of Urology.

Symptoms of anxiety and depression among adolescents with seizures in Irbid, Northern Jordan.

PubMed

Alwash, R H; Hussein, M J; Matloub, F F

2000-09-01

In Jordan, individuals with epilepsy commonly attend neuropsychiatric clinics. The objective of this study was to assess the psychosocial outcome of epilepsy among adolescents. The study included 101 epileptic adolescents who attended the neurology clinic at the Princess Basma Teaching Hospital in Northern Jordan and 101 non-epileptic controls. Sociodemographic characteristics and all relevant clinical data were collected through interviewing the cases and controls. Identification of the symptoms of anxiety and depression was made according to DSM-IV criteria. The patients were age and sex matched with the controls. The controls had achieved a significantly better education (> 12 years education) than the patients with epilepsy. The adolescents with epilepsy were also shown to be disadvantaged in their living circumstances. Some of them were dependent on their parents in some daily physical activities, such as bathing, which might be a sign of overprotection by their parents. Those with epilepsy had a significantly higher tendency to develop symptoms of anxiety and depression than the control group. Moreover these psychiatric symptoms, especially anxiety symptoms, were more likely to happen when seizures had not been properly medically controlled. Overprotective parental behaviour towards their ill children could also delay their psychosocial maturation. Therefore, counselling of patients and parents about epilepsy is an important factor in the control of seizures and their sequelae. Copyright 2000 BEA Trading Ltd.

Brief review of published alprazolam clinical studies

PubMed Central

Straw, R. N.

1985-01-01

1 The clinical efficacy of alprazolam has been evaluated in both anxiety states and depressive disorders. In anxiety neurosis, studies have been conducted vs placebo and/or other benzodiazepine tranquilizers. Reports, to date, with regard to panic/phobia disorders have been limited to open-label studies and a single report from a placebo-controlled study. In depression, both open-label and double-blind studies (vs tricyclic antidepressants) have been published. PMID:2859879

Effects of Team-Based Learning on the Core Competencies of Nursing Students: A Quasi-Experimental Study.

PubMed

Lee, Kyung Eun

2018-04-01

An important goal of nursing education is helping students achieve core competencies efficiently. One proposed way of improving nursing education is team-based learning (TBL). The aim of this study was to assess the comparative effectiveness of TBL and lecture-style classes in terms of teaching core competencies in nursing education, which include clinical competence skills, problem-solving ability, communication competencies, critical thinking ability, and self-leadership. This quasi-experimental study enrolled 183 students as participants, with 95 and 88 in the experimental and control groups, respectively. These two groups attended 6 hours (2 hours weekly for 3 weeks) of TBL and lecture-style classes, respectively. Differences in core competencies between the two groups were compared before and after the intervention. The experimental group achieved significantly higher scores for clinical competence skills, communication competence, critical thinking ability, and self-leadership at posttest than at pretest, whereas the control group achieved significantly higher scores for clinical competence skills and critical thinking ability at posttest than at pretest. After the intervention, the experimental group had significantly better clinical competence skills, communication competence, and self-leadership than the control group. TBL is an effective approach method to teaching core competencies in nursing education.

A study of intrauterine infusion of human chorionic gonadotropin (hCG) before frozen-thawed embryo transfer after two or more implantation failures.

PubMed

Huang, Pinxiu; Wei, Lihong; Li, Xinlin

2017-01-01

To investigate the effect of intrauterine infusion of human chorionic gonadotropin (hCG) before frozen-thawed embryo transfer (FET) after two or more implantation failures (TIFs). The study was a prospective randomized single-blind study of 161 cycles in patients undergoing FET who had TIFs. The intervention group received an intrauterine injection of 1000 IU of hCG before embryo transfer (ET) (n = 62). A placebo group (n = 49) received an intrauterine injection of physiological saline before ET. A control group (n = 50) did not receive an intrauterine injection. Clinical pregnancy rates, abortion rates, and ongoing pregnancy rates were compared between the three groups. The clinical pregnancy rates were 59.68%, 53.06%, and 32.00% in the hCG group, placebo group, and control group, respectively. The clinical pregnancy rates were significantly higher in the hCG and placebo groups than in the control group. There were no significant differences in the abortion rates among the three groups. An intrauterine administration of hCG before FET significantly improved the pregnancy rates after TIFs. But local injury caused by the operation of intrauterine perfusion may play an important role in improving clinical pregnancy rates.

Honey - A Novel Antidiabetic Agent

PubMed Central

Erejuwa, Omotayo O.; Sulaiman, Siti A.; Wahab, Mohd S. Ab

2012-01-01

Diabetes mellitus remains a burden worldwide in spite of the availability of numerous antidiabetic drugs. Honey is a natural substance produced by bees from nectar. Several evidence-based health benefits have been ascribed to honey in the recent years. In this review article, we highlight findings which demonstrate the beneficial or potential effects of honey in the gastrointestinal tract (GIT), on the gut microbiota, in the liver, in the pancreas and how these effects could improve glycemic control and metabolic derangements. In healthy subjects or patients with impaired glucose tolerance or diabetes mellitus, various studies revealed that honey reduced blood glucose or was more tolerable than most common sugars or sweeteners. Pre-clinical studies provided more convincing evidence in support of honey as a potential antidiabetic agent than clinical studies did. The not-too-impressive clinical data could mainly be attributed to poor study designs or due to the fact that the clinical studies were preliminary. Based on the key constituents of honey, the possible mechanisms of action of antidiabetic effect of honey are proposed. The paper also highlights the potential impacts and future perspectives on the use of honey as an antidiabetic agent. It makes recommendations for further clinical studies on the potential antidiabetic effect of honey. This review provides insight on the potential use of honey, especially as a complementary agent, in the management of diabetes mellitus. Hence, it is very important to have well-designed, randomized controlled clinical trials that investigate the reproducibility (or otherwise) of these experimental data in diabetic human subjects. PMID:22811614

Chinese proprietary herbal medicine listed in 'China national essential drug list' for common cold: a systematic literature review.

PubMed

Chen, Wei; Lewith, George; Wang, Li-qiong; Ren, Jun; Xiong, Wen-jing; Lu, Fang; Liu, Jian-ping

2014-01-01

Chinese proprietary herbal medicines (CPHMs) have long history in China for the treatment of common cold, and lots of them have been listed in the 'China national essential drug list' by the Chinese Ministry of Health. The aim of this review is to provide a well-round clinical evidence assessment on the potential benefits and harms of CPHMs for common cold based on a systematic literature search to justify their clinical use and recommendation. We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites from their inception to 31 March 2013 for clinical studies of CPHMs listed in the 'China national essential drug list' for common cold. There was no restriction on study design. A total of 33 CPHMs were listed in 'China national essential drug list 2012' for the treatment of common cold but only 7 had supportive clinical evidences. A total of 6 randomised controlled trials (RCTs) and 7 case series (CSs) were included; no other study design was identified. All studies were conducted in China and published in Chinese between 1995 and 2012. All included studies had poor study design and methodological quality, and were graded as very low quality. The use of CPHMs for common cold is not supported by robust evidence. Further rigorous well designed placebo-controlled, randomized trials are needed to substantiate the clinical claims made for CPHMs.

Walk-in clinics versus physician offices and emergency rooms for urgent care and chronic disease management.

PubMed

Chen, Connie E; Chen, Christopher T; Hu, Jia; Mehrotra, Ateev

2017-02-17

Walk-in clinics are growing in popularity around the world as a substitute for traditional medical care delivered in physician offices and emergency rooms, but their clinical efficacy is unclear. To assess the quality of care and patient satisfaction of walk-in clinics compared to that of traditional physician offices and emergency rooms for people who present with basic medical complaints for either acute or chronic issues. We searched CENTRAL, MEDLINE, Embase, six other databases, and two trials registers on 22 March 2016 together with reference checking, citation searching, and contact with study authors to identify additional studies. We applied no restrictions on language, publication type, or publication year. Study design: randomized trials, non-randomized trials, and controlled before-after studies. standalone physical clinics not requiring advance appointments or registration, that provided basic medical care without expectation of follow-up. Comparisons: traditional primary care practices or emergency rooms. We used standard methodological procedures expected by Cochrane and the Cochrane Effective Practice and Organisation of Care (EPOC) Group. The literature search identified 6587 citations, of which we considered 65 to be potentially relevant. We reviewed the abstracts of all 65 potentially relevant studies and retrieved the full texts of 12 articles thought to fit our study criteria. However, following independent author assessment of the full texts, we excluded all 12 articles. Controlled trial evidence about the mortality, morbidity, quality of care, and patient satisfaction of walk-in clinics is currently not available.

Impact of guided reciprocal peer questioning on nursing students' self-esteem and learning.

PubMed

Lakdizaji, Sima; Abdollahzadeh, Farahnaz; Hassankhanih, Hadi; Kalantari, Manizhe

2013-07-01

Self-esteem is essential for clinical judgments. Nursing students in clinical environments should make a bridge between theoretical education and clinical function. This study was aimed to survey the effect of guided questioning in peer groups on nursing students' self-esteem and clinical learning. In this quasi-experimental study, all nursing students in semester 4 (60) were selected. The autumn semester students (n = 28) were chosen as the control group, and the spring semester students (n = 32) as the experimental group. The experimental group underwent the course of cardiac medical surgical training by the Guided Reciprocal Peer Questioning. The control group was trained by lecture. After confirmation of the validity and reliability of tools including Rosenberg Self-esteem Scale and the researcher-made questionnaire, data were collected and analyzed by SPSS version 17.0. There was no significant difference concerning demographic and educational characteristics between the two groups. Mean score differences of self-esteem and learning were not significant before teaching, while they were significantly promoted after teaching in the experimental (P < 0.001) and control (P < 0.05) groups. Promotion in the experimental group was more considerable than in the control group. As revealed by the results, inquiry method, due to its more positive impact on self-esteem and students' learning, can be applied alone or in combination with the other methods. Conducting this study for other students and for theoretical courses is suggested.

Assessing the accuracy of blood RNA profiles to identify patients with post-concussion syndrome: A pilot study in a military patient population.

PubMed

Hardy, Jimmaline J; Mooney, Scott R; Pearson, Andrea N; McGuire, Dawn; Correa, Daniel J; Simon, Roger P; Meller, Robert

2017-01-01

Mild traumatic brain injury (mTBI) is a complex, neurophysiological condition that can have detrimental outcomes. Yet, to date, no objective method of diagnosis exists. Physical damage to the blood-brain-barrier and normal waste clearance via the lymphatic system may enable the detection of biomarkers of mTBI in peripheral circulation. Here we evaluate the accuracy of whole transcriptome analysis of blood to predict the clinical diagnosis of post-concussion syndrome (PCS) in a military cohort. Sixty patients with clinically diagnosed chronic concussion and controls (no history of concussion) were recruited (retrospective study design). Male patients (46) were split into a training set comprised of 20 long-term concussed (> 6 months and symptomatic) and 12 controls (no documented history of concussion). Models were validated in a testing set (control = 9, concussed = 5). RNA_Seq libraries were prepared from whole blood samples for sequencing using a SOLiD5500XL sequencer and aligned to hg19 reference genome. Patterns of differential exon expression were used for diagnostic modeling using support vector machine classification, and then validated in a second patient cohort. The accuracy of RNA profiles to predict the clinical diagnosis of post-concussion syndrome patients from controls was 86% (sensitivity 80%; specificity 89%). In addition, RNA profiles reveal duration of concussion. This pilot study shows the potential utility of whole transcriptome analysis to establish the clinical diagnosis of chronic concussion syndrome.

Development of a Clinical Tool to Predict Home Death of a Discharged Cancer Patient in Japan: a Case-Control Study.

PubMed

Fukui, Sakiko; Morita, Tatsuya; Yoshiuchi, Kazuhiro

2017-08-01

The aim of this study was to investigate the predictive value of a clinical tool to predict whether discharged cancer patients die at home, comparing groups of case who died at home and control who died in hospitals or other facilities. We conducted a nationwide case-control study to identify the determinants of home death for a discharged cancer patient. We randomly selected nurses in charge of 2000 home-visit nursing agencies from all 5813 agencies in Japan by referring to the nationwide databases in January 2013. The nurses were asked to report variables of their patients' place of death, patients' and caregivers' clinical statuses, and their preferences for home death. We used logistic regression analysis and developed a clinical tool to accurately predict it and investigated their predictive values. We identified 466 case and 478 control patients. Five predictive variables of home death were obtained: patients' and caregivers' preferences for home death [OR (95% CI) 2.66 (1.99-3.55)], availability of visiting physicians [2.13 (1.67-2.70)], 24-h contact between physicians and nurses [1.68 (1.30-2.18)], caregivers' experiences of deathwatch at home [1.41 (1.13-1.75)], and patients' insights as to their own prognosis [1.23 (1.02-1.50)]. We calculated the scores predicting home death for each variable (range 6-28). When using a cutoff point of 16, home death was predicted with a sensitivity of 0.72 and a specificity of 0.81 with the Harrell's c-statistic of 0.84. This simple clinical tool for healthcare professionals can help predict whether a discharged patient is likely to die at home.

Risk factors for spinal cord lesions in dystonic cerebral palsy and generalised dystonia.

PubMed

Guettard, Emilie; Ricard, Damien; Roze, Emmanuel; Elbaz, Alexis; Anheim, Mathieu; Thobois, Stéphane; Lepeintre, Jean-Francois; Galanaud, Damien; Mazel, Christian; Vidailhet, Marie

2012-02-01

Cervical myelopathy (CM) in patients with cerebral palsy (CP) is underdiagnosed as symptoms of spinal cord lesions, being similar to those due to dystonia, may be overlooked or identified late. The aim of this study is to identify the risk factors and clinical characteristics of CM in patients with generalised dystonia, including dystonic CP. The authors conducted a case-control study to identify early clinical signs of CM in consecutive patients with generalised dystonia. The authors compared the clinical characteristics and symptoms of those who developed CM (cases) and those who did not (controls). The same clinical information on possible neurological manifestations of CM was collected for cases and controls at the date of the last visit. Out of 54 patients, 17 (31%) developed symptomatic CM during the study period. In all cases, CM occurred after the age of 36 years. 81% of cases and 35% of controls had a Burke-Fahn-Marsden movement subscore for the neck >4. Age (OR per 10 years=2.3, 95% CI 1.4 to 4.2, p=0.006) and severity of neck dystonia (OR=7.7, 95% CI 1.7 to 49.6, p=0.005) were the main risk factors of CM. Gait disorders and falls, wasting of hand muscles and bladder disorders were the best clinical clues of CM. As severity of cervical dystonia and age are the major risk factors for spinal cord lesions, dystonic patients, including patients with dystonic CP, should be screened for CM from the third decade of life onwards. Early recognition of CM is crucial for functional prognosis and impact on autonomy.

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

PubMed

Pérula-de-Torres, Luis Á; Martínez-Adell, Miguel Á; González-Blanco, Virginia; Baena-Díez, José M; Martín-Rioboó, Enrique; Parras-Rejano, Juan M; González-Lama, Jesús; Martín-Alvarez, Remedios; Ruiz-Moral, Roger; Fernández-García, José Á; Pérez-Díaz, Modesto; Ruiz-de-Castroviejo, Joaquin; Pérula-de-Torres, Carlos; Valero-Martín, Antonio; Roldán-Villalobos, Ana; Criado-Larumbe, Margarita; Burdoy-Joaquín, Emili; Coma-Solé, Montserrat; Cervera-León, Mercè; Cuixart-Costa, Lluís

2012-10-30

Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. The study is registered as NCT01291953 (ClinicalTrials.gob).

Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

PubMed

Visscher, Arjan P; Lam, Tze J; Meurs-Szojda, Maria M; Felt-Bersma, Richelle J F

2017-08-01

Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. This was a randomized sham-controlled clinical trial from 2008 to 2015. This study was conducted in an outpatient clinic. Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-of-life score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-of-life score at t = 6 months was not statistically different. Anorectal function did not show any alteration. Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known. See Video Abstract at http://links.lww.com/DCR/A373.

Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study.

PubMed

Guarda-Nardini, Luca; Manfredini, Daniele; Salamone, Milena; Salmaso, Luigi; Tonello, Stefano; Ferronato, Giuseppe

2008-04-01

The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.

Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

PubMed

Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

2011-11-01

This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

Identification of psychological comorbidity in TMD-patients.

PubMed

Ismail, F; Eisenburger, M; Lange, K; Schneller, T; Schwabe, L; Strempel, J; Stiesch, M

2016-05-01

The aim of the current study was to access the prevalence of depression among patients with Temporomandibular Joint Disorder (TMD) compared to patients with no current TMD. Patients (92) and controls (90) answered questionnaires on subjective pain, severity of chronic pain, jaw disability, emotional well-being and depression, and a clinical examination was performed. Temporomandibular Joint Disorder patients reported higher disability of jaw function, compared to controls (p<0.001). The myoarthopathy subgroup (67.4%) had slightly more jaw disability than the myopathy subgroup (p>0.05). While 51% of TMD patients reported poor emotional well-being, only 7.8% of controls were affected (p<0.001). Clinical symptoms of depression were reported by 16% of TMD patients and not in the controls (p<0.001). Among TMD patients, a higher prevalence of depression was observed in the myopathy subgroup. A regular screening for psychological problems, using standardized questionnaires, should be integrated in clinical examination of TMD patients.

Self-reported post-exertional fatigue in Gulf War veterans: roles of autonomic testing

PubMed Central

Li, Mian; Xu, Changqing; Yao, Wenguo; Mahan, Clare M.; Kang, Han K.; Sandbrink, Friedhelm; Zhai, Ping; Karasik, Pamela A.

2014-01-01

To determine if objective evidence of autonomic dysfunction exists from a group of Gulf War veterans with self-reported post-exertional fatigue, we evaluated 16 Gulf War ill veterans and 12 Gulf War controls. Participants of the ill group had self- reported, unexplained chronic post-exertional fatigue and the illness symptoms had persisted for years until the current clinical study. The controls had no self-reported post-exertional fatigue either at the time of initial survey nor at the time of the current study. We intended to identify clinical autonomic disorders using autonomic and neurophysiologic testing in the clinical context. We compared the autonomic measures between the 2 groups on cardiovascular function at both baseline and head-up tilt, and sudomotor function. We identified 1 participant with orthostatic hypotension, 1 posture orthostatic tachycardia syndrome, 2 distal small fiber neuropathy, and 1 length dependent distal neuropathy affecting both large and small fiber in the ill group; whereas none of above definable diagnoses was noted in the controls. The ill group had a significantly higher baseline heart rate compared to controls. Compound autonomic scoring scale showed a significant higher score (95% CI of mean: 1.72–2.67) among ill group compared to controls (0.58–1.59). We conclude that objective autonomic testing is necessary for the evaluation of self-reported, unexplained post-exertional fatigue among some Gulf War veterans with multi-symptom illnesses. Our observation that ill veterans with self-reported post-exertional fatigue had objective autonomic measures that were worse than controls warrants validation in a larger clinical series. PMID:24431987

Longitudinal Multicenter Analysis of Outcomes After Cessation of Control Measures for Vancomycin-Resistant Enterococci.

PubMed

Lemieux, Camille; Gardam, Michael; Evans, Gerald; John, Michael; Suh, Kathryn N; vanWalraven, Carl; Vicencio, Elisa; Coulby, Cameron; Roth, Virginia; Hota, Susy

2017-01-01

OBJECTIVE To assess clinically relevant outcomes after complete cessation of control measures for vancomycin-resistant enterococci (VRE). DESIGN Quasi-experimental ecological study over 3.5 years. METHODS All VRE screening and isolation practices at 4 large academic hospitals in Ontario, Canada, were stopped on July 1, 2012. In total, 618 anonymized abstracted charts of patients with VRE-positive clinical isolates identified between July 1, 2010, and December 31, 2013, were reviewed to determine whether the case was a true VRE infection, a VRE colonization or contaminant, or a true VRE bacteremia. All deaths within 30 days of the last VRE infection were also reviewed to determine whether the death was fully or partially attributable to VRE. All-cause mortality was evaluated over the study period. Generalized estimating equation methods were used to cluster outcome rates within hospitals, and negative binomial models were created for each outcome. RESULTS The incidence rate ratio (IRR) for VRE infections was 0.59 and the associated P value was .34. For VRE bacteremias, the IRR was 0.54 and P=.38; for all-cause mortality the IRR was 0.70 and P=.66; and for VRE attributable death, the IRR was 0.35 and P=.49. VRE control measures were not significantly associated with any of the outcomes. Rates of all outcomes appeared to increase during the 18-month period after cessation of VRE control measures, but none reached statistical significance. CONCLUSION Clinically significant VRE outcomes remain rare. Cessation of all control measures for VRE had no significant attributable adverse clinical impact. Infect Control Hosp Epidemiol 2016;1-7.

Use of historical control data for assessing treatment effects in clinical trials.

PubMed

Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

2014-01-01

Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study's control arm. There is obvious appeal in using (i.e., 'borrowing') this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of 'dynamic' (versus 'static') borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. Copyright © 2013 John Wiley & Sons, Ltd.

Impact of innate immunity in a subset of children with autism spectrum disorders: a case control study

PubMed Central

Jyonouchi, Harumi; Geng, Lee; Cushing-Ruby, Agnes; Quraishi, Huma

2008-01-01

Background Among patients with autism spectrum disorders (ASD) evaluated in our clinic, there appears to be a subset that can be clinically distinguished from other ASD children because of frequent infections (usually viral) accompanied by worsening behavioural symptoms and/or loss/decrease in acquired skills. This study assessed whether these clinical features of this ASD subset are associated with atopy, asthma, food allergy (FA), primary immunodeficiency (PID), or innate immune responses important in viral infections. Methods This study included the ASD children described above (ASD test, N = 26) and the following controls: ASD controls (N = 107), non-ASD controls with FA (N = 24), non-ASD controls with chronic rhinosinusitis/recurrent otitis media (CRS/ROM; N = 38), and normal controls (N = 43). We assessed prevalence of atopy, asthma, FA, CRS/ROM, and PID. Innate immune responses were assessed by measuring production of proinflammatory and counter-regulatory cytokines by peripheral blood mononuclear cells (PBMCs) in response to agonists of Toll-like receptors (TLRs), with or without pre-treatment of lipopolysaccharide (LPS), a TLR4 agonist. Results Non-IgE mediated FA was equally prevalent in both ASD test and ASD control groups, occurring at higher frequency than in the non-ASD controls. Allergic rhinitis, atopic/non-atopic asthma, and atopic dermatitis were equally prevalent among the study groups except for the CRS/ROM group in which non-atopic asthma was more prevalent (52.6%). CRS/ROM and specific polysaccharide antibody deficiency (SPAD) were more prevalent in the ASD test group than in the ASD control, FA, and normal control groups: 23.1% vs. < 5% for CRS/ROS and 19.2% vs. < 1% for SPAD. However, CRS/ROM patients had the highest prevalence of SPAD (34.2%). When compared to ASD and normal case controls, PBMCs from 19 non-SPAD, ASD test group children produced: 1) less IL-1β with a TLR7/8 agonist, less IL-10 with a TLR2/6 agonist, and more IL-23 with a TLR4 agonist without LPS pre-treatment, and 2) less IL-1β with TLR4/7/8 agonists with LPS pre-treatment. These are cytokines associated with the neuro-immune network. Conclusion Clinical features of the ASD test group were not associated with atopy, asthma, FA, or PID in our study but may be associated with altered TLR responses mediating neuro-immune interactions. PMID:19025588

Telephone reminders reduced the non-attendance rate in a gastroenterology outpatient clinic.

PubMed

Jeppesen, Maja Haunstrup; Ainsworth, Mark Andrew

2015-06-01

Non-attendance is a global health-care problem. The aim of the present study was 1) to investigate if a telephone reminder could reduce the non-attendance rate, 2) to study reasons for non-attendance and 3) to evaluate if a permanent implementation would be economically advantageous in a gastroenterology outpatient clinic like ours. This was a comparative intervention study with a historical control group in a gastroenterology outpatient clinic. The study lasted six months. Patients with a scheduled appointment in the first three-month period received no reminder (control group, n = 2,705). Patients in the following three-month period were reminded by telephone one weekday in advance of their appointment, when possible (intervention group, n = 2,479). Non-attending patients in the intervention group received a questionnaire. Based on the results, a financial cost-benefit analysis was made. In the intervention group, 1,577 (64%) patients answered the reminder telephone call. The non-attendance rate was significantly lower in the intervention group (6.1%) than in the control group (10.5%) (p < 0.00001). Only 1.3% of the patients who answered the reminder turned out to be non-attendees. The most common explanation for non-attendance in the intervention group was forgetfulness (39%). The reminder telephone call was cost-effective. In this outpatient clinic, telephone reminders were cost-effective and significantly reduced the non-attendance rate by 43%.

Group Patient Education: Effectiveness of a Brief Intervention in People with Type 2 Diabetes Mellitus in Primary Health Care in Greece: A Clinically Controlled Trial

ERIC Educational Resources Information Center

Merakou, K.; Knithaki, A.; Karageorgos, G.; Theodoridis, D.; Barbouni, A.

2015-01-01

This study aims to assess the impact of a brief patient group education intervention in people with type 2 diabetes mellitus. The sample, 193 people with type 2 diabetes mellitus who were patients at the diabetic clinic of a primary health care setting in Attica, was assigned to two groups, intervention (138 individuals) and control group (55…