Learning Clinical Skills during Bedside Teaching Encounters in General Practice: A Video-Observational Study with Insights from Activity Theory

ERIC Educational Resources Information Center

Ajjawi, Rola; Rees, Charlotte; Monrouxe, Lynn V.

2015-01-01

Purpose: This paper aims to explore how opportunities for learning clinical skills are negotiated within bedside teaching encounters (BTEs). Bedside teaching, within the medical workplace, is considered essential for helping students develop their clinical skills. Design/methodology/approach: An audio and/or video observational study examining…

To belong or not to belong: nursing students' interactions with clinical learning environments - an observational study.

PubMed

Liljedahl, Matilda; Björck, Erik; Kalén, Susanne; Ponzer, Sari; Bolander Laksov, Klara

2016-08-05

Belongingness has been argued to be a prerequisite for students' learning in the clinical setting but making students feel like they belong to the workplace is a challenge. From a sociocultural perspective, workplace participatory practices is a framework that views clinical learning environments to be created in interaction between students and the workplace and hence, are dependent on them both. The aim of this study was to explore the interdependence between affordances and engagement in clinical learning environments. The research question was: How are nursing students influenced in their interactions with clinical learning environments? An observational study with field observations and follow-up interviews was performed. The study setting comprised three academic teaching hospitals. Field observations included shadowing undergraduate nursing students during entire shifts. Fifty-five hours of field observations and ten follow-up interviews with students, supervisors and clinical managers formed the study data. A thematic approach to the analysis was taken and performed iteratively with the data collection. The results revealed that students strived to fill out the role they were offered in an aspirational way but that they became overwhelmed when given the responsibility of care. When students' basic values did not align with those enacted by the workplace, they were not willing to compromise their own values. Workplaces succeeded in inviting students into the community of nurses and the practice of care. Students demonstrated hesitance regarding their desire to belong to the workplace community. The results imply that the challenge for clinical education is not to increase the experience of belongingness but to maintain students' critical and reflective approach to health care practice. Additionally, results suggest students to be included as an important stakeholder in creating clinical learning environments rather than being viewed as consumer of clinical education.

Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

ERIC Educational Resources Information Center

Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

2011-01-01

We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

A pre-clinical safety study of PEGylated recombinant human endostatin (M2ES) in Sprague Dawley rats.

PubMed

Geng, Xingchao; Guo, Lifang; Liu, Li; Wang, Chao; Peng, Qian; Qi, Weihong; Sun, Li; Liu, Xiaomeng; Miao, Yufa; Lin, Zhi; Fu, Yan; Luo, Yongzhang; Li, Bo

2018-06-01

PEGylated recombinant human endostatin (M 2 ES) exhibited prolonged serum half-life and enhanced antitumor activity when compared with endostatin. A pre-clinical study was performed to evaluate the safety of M 2 ES in rats. After intravenous (IV) infusions of M 2 ES at a dose level of 3, 15 and 75 mg/kg in Sprague Dawley (SD) rats, M 2 ES was well tolerated in animals, with no observable changes in clinical observation, body weight, food consumption, urine analysis, hematology and serum biochemical analysis. The increase of kidney weights, and slight to severe vacuolation and necrosis of proximal tubule epithelial cells in kidney were observed in 15 and 75 mg/kg M 2 ES groups, but this adverse-effect was reversible. In summary, the major toxicity target organ of M 2 ES might be kidney, and the no observed adverse effect level (NOAEL) of M 2 ES in rats was 3 mg/kg in this study. These pre-clinical safety data contribute to the initiation of the ongoing clinical study. Copyright © 2018. Published by Elsevier Inc.

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.

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

PubMed

Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

2004-03-01

The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.

Demystifying the Enigma of Smoking – An Observational Comparative Study on Tobacco Smoking

PubMed Central

Nallakunta, Rajesh; Reddy, Sudhakara Reddy; Chennoju, Sai Kiran

2016-01-01

Introduction Smoking is a hazardous habit which causes definite changes in the oral cavity, consequently there exist changes in the mucosa when subjected to smoking. Palatal mucosa is first to be affected. The present study determines the palatal status in reverse smokers and conventional smokers. Aim To study and compare the clinical, cytological and histopathological changes in palatal mucosa among reverse and conventional smokers. Materials and Methods Study sample was categorized into two groups. Group 1 comprised of 20 subjects with the habit of reverse smoking and Group 2 comprised of 20 subjects with the habit of conventional smoking. Initially, clinical appearance of the palatal mucosa was recorded, followed by a cytological smear and biopsy of the involved area among all the subjects. The findings were studied clinically, the specimens were analysed cytologically and histopathologically, and compared among the two groups. Results The severity of clinical changes of the palatal mucosa among reverse smokers was statistically significant when compared to those of conventional smokers. There was no statistically significant difference observed in cytological staging between the groups with a p-value of 0.35. The histopathological changes in both the groups showed a significant difference with a p-value of 0.02. A significant positive correlation was observed between the clinical appearance, and cytological, histopathological changes. Conclusion Profound clinically aggressive changes were observed in group I compared to group II. Severity of dysplastic changes have been detected in few subjects through histopathological examination irrespective of no prominent clinical and cytological changes observed among the two groups. PMID:27190962

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.

Monitoring progression of clinical reasoning skills during health sciences education using the case method - a qualitative observational study.

PubMed

Orban, Kristina; Ekelin, Maria; Edgren, Gudrun; Sandgren, Olof; Hovbrandt, Pia; Persson, Eva K

2017-09-11

Outcome- or competency-based education is well established in medical and health sciences education. Curricula are based on courses where students develop their competences and assessment is also usually course-based. Clinical reasoning is an important competence, and the aim of this study was to monitor and describe students' progression in professional clinical reasoning skills during health sciences education using observations of group discussions following the case method. In this qualitative study students from three different health education programmes were observed while discussing clinical cases in a modified Harvard case method session. A rubric with four dimensions - problem-solving process, disciplinary knowledge, character of discussion and communication - was used as an observational tool to identify clinical reasoning. A deductive content analysis was performed. The results revealed the students' transition over time from reasoning based strictly on theoretical knowledge to reasoning ability characterized by clinical considerations and experiences. Students who were approaching the end of their education immediately identified the most important problem and then focused on this in their discussion. Practice knowledge increased over time, which was seen as progression in the use of professional language, concepts, terms and the use of prior clinical experience. The character of the discussion evolved from theoretical considerations early in the education to clinical reasoning in later years. Communication within the groups was supportive and conducted with a professional tone. Our observations revealed progression in several aspects of students' clinical reasoning skills on a group level in their discussions of clinical cases. We suggest that the case method can be a useful tool in assessing quality in health sciences education.

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

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.

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

A systematic review of clinical outcomes in surgical treatment of adult isthmic spondylolisthesis.

PubMed

Noorian, Shaya; Sorensen, Karen; Cho, Woojin

2018-05-07

A variety of surgical methods are available for the treatment of adult isthmic spondylolisthesis, but there is no consensus regarding their relative effects on clinical outcomes. To compare the effects of different surgical techniques on clinical outcomes in adult isthmic spondylolisthesis. Systematic Review PATIENT SAMPLE: A total of 1,538 patients from six randomized clinical trials and nine observational studies comparing different surgical treatments in adult isthmic spondylolisthesis. Primary outcome measures of interest included differences in pre- versus post-surgical assessments of pain, functional disability, and overall health as assessed by validated pain rating scales and questionnaires. Secondary outcome measures of interest included intraoperative blood loss, length of hospital stay, surgery duration, reoperation rates, and complication rates. A search of the literature was performed in September, 2017 for relevant comparative studies published in the prior 10-year period in the following databases: PubMed, Embase, Web of Science, and ClinicalTrials.Gov. PRISMA guidelines were followed and studies were included/excluded based on strict predetermined criteria. Quality appraisal was conducted using the Newcastle-Ottawa Scale (NOS) for observational studies and the Cochrane Collaboration's risk of bias assessment tool for randomized clinical trials. The authors received no funding support to conduct this review. A total of 15 studies (6 randomized clinical trials and 9 observational studies) were included for full text review, a majority of which only included cases of low-grade isthmic spondylolisthesis. 1 study examined the effects of adding pedicle screw fixation (PS) to posterolateral fusion (PLF) and 2 studies examined the effects of adding reduction to interbody fusion (IF) + PS on clinical outcomes. 5 studies compared PLF, 4 with and 1 without PS, to IF + PS. Additionally, 3 studies compared circumferential fusion (IF + PS + PLF) to IF + PS and 1 study compared circumferential fusion to PLF + PS. 3 studies compared clinical outcomes among different IF + PS techniques (ALIF + PS vs. PLIF + PS vs TLIF + PS) without PLF. As per the Cochrane Collaboration's risk of bias assessment tool, 4 randomized clinical trials had an overall low risk of bias, 1 randomized clinical trial had an unclear risk of bias, and 1 randomized clinical trial had a high risk of bias. As per the Newcastle-Ottawa scale, 3 observational studies were of overall good quality, 4 observational studies were of fair quality, and 2 observational studies were of poor quality. Available studies provide strong evidence that the addition of reduction to fusion does not result in better clinical outcomes of pain and function in low-grade isthmic spondylolisthesis. Evidence also suggests that there is no significant difference between interbody fusion (IF + PS) and posterior fusion (PLF +/- PS) in outcomes of pain, function, and complication rates at follow-up points up to approximately 3 years in cases of low-grade slips. However, studies with longer follow-up points suggest that interbody fusion (IF + PS) may perform better in these same measures at later follow-up points. Available evidence also suggests no difference between circumferential fusion (IF + PS + PLF) and interbody fusion (IF + PS) in outcomes of pain and function in low-grade slips, but circumferential fusion has been associated with greater intraoperative blood loss, longer surgery duration, and longer hospital stays. In terms of clinical outcomes, insufficient evidence is available to assess the utility of adding PS to PLF, the relative efficacy of different interbody fusion (IF + PS) techniques (ALIF + PS vs. TLIF + PS vs. PLIF + PS), and the relative efficacy of circumferential fusion and posterior fusion (PLF + PS). Copyright © 2018. Published by Elsevier Inc.

Exploring Patient Activation in the Clinic: Measurement from Three Perspectives

ERIC Educational Resources Information Center

Ledford, Christy J. W.; Ledford, Christopher C.; Childress, Marc A.

2013-01-01

Objective. To further conceptualize and operationalize patient activation (PA), using measures from patient, physician, and researcher perspectives. Data Source/Study Setting. Multimethod observation in 2010 within a family medicine clinic. Study Design. Part of an intervention with 130 patients with type 2 diabetes, this observational study…

Pre-admission criteria and pre-clinical achievement: Can they predict medical students performance in the clinical phase?

PubMed

Salem, Raneem O; Al-Mously, Najwa; AlFadil, Sara; Baalash, Amal

2016-01-01

Various factors affect medical students' performance during clinical phase. Identifying these factors would help in mentoring weak students and help in selection process for residency programmes. Our study objective is to evaluate the impact of pre-admission criteria, and pre-clinical grade point average (GPA) on undergraduate medical students' performance during clinical phase. This study has a cross-sectional design that includes fifth- and sixth-year female medical students (71). Data of clinical and pre-clinical GPA in medical school and pre-admission to medical school tests scores were collected. A significant correlation between clinical GPA with the pre-clinical GPA was observed (p < 0.05). Such significant correlation was not seen with other variables under study. A regression analysis was performed, and the only significant predictor of students clinical performance was the pre-clinical GPA (p < 0.001). However, no significant difference between students' clinical and pre-clinical GPA for both cohorts was observed (p > 0.05). Pre-clinical GPA is strongly correlated with and can predict medical students' performance during clinical years. Our study highlighted the importance of evaluating the academic performances of students in pre-clinical years before they move into clinical years in order to identify weak students to mentor them and monitor their progress.

Development and testing of the cancer multidisciplinary team meeting observational tool (MDT-MOT)

PubMed Central

Harris, Jenny; Taylor, Cath; Sevdalis, Nick; Jalil, Rozh; Green, James S.A.

2016-01-01

Abstract Objective To develop a tool for independent observational assessment of cancer multidisciplinary team meetings (MDMs), and test criterion validity, inter-rater reliability/agreement and describe performance. Design Clinicians and experts in teamwork used a mixed-methods approach to develop and refine the tool. Study 1 observers rated pre-determined optimal/sub-optimal MDM film excerpts and Study 2 observers independently rated video-recordings of 10 MDMs. Setting Study 2 included 10 cancer MDMs in England. Participants Testing was undertaken by 13 health service staff and a clinical and non-clinical observer. Intervention None. Main Outcome Measures Tool development, validity, reliability/agreement and variability in MDT performance. Results Study 1: Observers were able to discriminate between optimal and sub-optimal MDM performance (P ≤ 0.05). Study 2: Inter-rater reliability was good for 3/10 domains. Percentage of absolute agreement was high (≥80%) for 4/10 domains and percentage agreement within 1 point was high for 9/10 domains. Four MDTs performed well (scored 3+ in at least 8/10 domains), 5 MDTs performed well in 6–7 domains and 1 MDT performed well in only 4 domains. Leadership and chairing of the meeting, the organization and administration of the meeting, and clinical decision-making processes all varied significantly between MDMs (P ≤ 0.01). Conclusions MDT-MOT demonstrated good criterion validity. Agreement between clinical and non-clinical observers (within one point on the scale) was high but this was inconsistent with reliability coefficients and warrants further investigation. If further validated MDT-MOT might provide a useful mechanism for the routine assessment of MDMs by the local workforce to drive improvements in MDT performance. PMID:27084499

Development and testing of the cancer multidisciplinary team meeting observational tool (MDT-MOT).

PubMed

Harris, Jenny; Taylor, Cath; Sevdalis, Nick; Jalil, Rozh; Green, James S A

2016-06-01

To develop a tool for independent observational assessment of cancer multidisciplinary team meetings (MDMs), and test criterion validity, inter-rater reliability/agreement and describe performance. Clinicians and experts in teamwork used a mixed-methods approach to develop and refine the tool. Study 1 observers rated pre-determined optimal/sub-optimal MDM film excerpts and Study 2 observers independently rated video-recordings of 10 MDMs. Study 2 included 10 cancer MDMs in England. Testing was undertaken by 13 health service staff and a clinical and non-clinical observer. None. Tool development, validity, reliability/agreement and variability in MDT performance. Study 1: Observers were able to discriminate between optimal and sub-optimal MDM performance (P ≤ 0.05). Study 2: Inter-rater reliability was good for 3/10 domains. Percentage of absolute agreement was high (≥80%) for 4/10 domains and percentage agreement within 1 point was high for 9/10 domains. Four MDTs performed well (scored 3+ in at least 8/10 domains), 5 MDTs performed well in 6-7 domains and 1 MDT performed well in only 4 domains. Leadership and chairing of the meeting, the organization and administration of the meeting, and clinical decision-making processes all varied significantly between MDMs (P ≤ 0.01). MDT-MOT demonstrated good criterion validity. Agreement between clinical and non-clinical observers (within one point on the scale) was high but this was inconsistent with reliability coefficients and warrants further investigation. If further validated MDT-MOT might provide a useful mechanism for the routine assessment of MDMs by the local workforce to drive improvements in MDT performance. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

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.

Stroke prevention in atrial fibrillation: re-defining 'real-world data' within the broader data universe.

PubMed

Fanaroff, Alexander C; Steffel, Jan; Alexander, John H; Lip, Gregory Y H; Califf, Robert M; Lopes, Renato D

2018-04-23

Real-world data (RWD) has been defined as data generated outside of traditional randomized clinical trials (RCTs). Though RWD has received increasing attention from regulatory authorities and professional societies, dividing evidence into that derived from 'real-world' vs. 'non-real-world' sources provides only one element of a much larger framework for evidence evaluation. Evidence should be evaluated on the source of the data, the method of treatment allocation (whether any intervention being evaluated was assigned or simply observed as used in practice) and the context in which the evidence was generated (overall study design). Under this framework, RWD refers only to data source, and a study incorporates RWD when it primarily uses data collected for non-research purposes, such as insurance claims data or the electronic health record, regardless of study design. Separation of study design, data source, and context enables parallel evaluation of two critical elements: (i) whether a study can support claims of causal inference, which can be assured with a high degree of confidence only in studies where patients are assigned treatments by protocol; and (ii) whether the study population and clinical context mirror clinical practice, a strength of observational studies using data from clinical practice or administrative claims. In this review, we describe the strengths and weaknesses of observational and non-observational studies, and studies involving RWD and non-RWD, through the lens of anticoagulation for atrial fibrillation (AF). Observational studies employing RWD are useful for describing how oral anticoagulants are used in clinical practice, but generally cannot be used to make claims regarding comparative treatment effects. Questions regarding treatment effect generally are best answered through an RCT, and additional pragmatic RCTs are needed to compare different antithrombotic agents for the prevention of thrombotic events in AF.

Clinical profile, predisposing factors, and associated co-morbidities of children with cerebral palsy in South India

PubMed Central

Gowda, Vykuntaraju K.; Kumar, Anil; Shivappa, Sanjay K.; Srikanteswara, Praveen Kumar; Shivananda; Mahadeviah, M. S.; Govindraj, M.; Ramaswamy, Premalatha

2015-01-01

Introduction: Cerebral palsy (CP) is the most common physical disorder of children. Causes like jaundice and birth injury though are decreasing; complications resulting from the survival of low birth weight babies are replacing some of the older etiologies. Hence, this study was planned. Objectives: The objective was to study the clinical patterns, predisposing factors, and co-morbidities in children with CP. Materials and Methods: The present study is a hospital based prospective study conducted from January 2012 to January 2013 in children presenting to neurodevelopmental clinic at a tertiary care teaching hospital in India. Hundred cases with clinical features suggestive of CP were included in the study. Cases were evaluated by history, clinical examination, and necessary investigations. Results: Results of the study showed 81% of spastic, 12% of hypotonic, 5% of dystonic, and 2% of mixed CP cases. The mean age of presentation was 2 year, 2 month, and male to female ratio of 1:2. Pregnancy-induced hypertension (PIH) was the most common antenatal complication observed in 6%. Four percent had neonatal sepsis and 19% were born premature. Associated co-morbidities were mental retardation (55%), seizure disorder (46%), visual problems (26%), hearing problems (19%), and failure to thrive (47%). Discussion: Sex distribution observed in our study was male to female ratio of 1.2, which was comparable with a multicenter study in Europe. PIH was observed in 6% of cases, which was comparable with prior studies. Birth asphyxia was observed in 43% of cases. Eighty-one percent of the cases constituted a spastic variety of CP which was comparable to other studies. Conclusion: Perinatal asphyxia was the important etiological factor. We found preventable intranatal causes (60%) and antenatal causes (20%) forming a significant proportion. Co-morbidities were significantly observed in our study. PMID:26167210

An exploration of peer-assisted learning in undergraduate nursing students in paediatric clinical settings: An ethnographic study.

PubMed

Carey, Matthew C; Chick, Anna; Kent, Bridie; Latour, Jos M

2018-06-01

Peer-assisted leaning relates to the acquisition of knowledge and skills through shared learning of matched equals. The concept has been explored within the field of nurse education across a range of learning environments, but its impact in practice is still relatively unknown. This paper reports on findings when observing paediatric undergraduate nursing students who engage in PAL within the clinical practice setting. The aim of this paper is to report the findings of a study undertaken to explore peer-assisted learning in undergraduate nursing students, studying children's health, in the clinical practice setting. A qualitative ethnographic study using non-participant observations. A range of inpatient paediatric clinical settings across two teaching hospitals. First, second and third year paediatric student nurses enrolled on a Bachelor of Nursing Programme. Non-participant observations were used to observe a range of interactions between the participants when engaging in peer-assisted learning within the same clinical area. A total of 67 h of raw data collected across all observations was analysed using framework analysis to draw together key themes. Of the 20 identified students across two hospitals, 17 agreed to take part in the study. Findings were aggregated into three key themes; 1. Peers as facilitators to develop learning when engaging in peer-assisted learning, 2. Working together to develop clinical practice and deliver care, 3. Positive support and interaction from peers to enhance networking and develop working structure. Peer-assisted learning in undergraduate children's nursing students stimulates students in becoming engaged in their learning experiences in clinical practice and enhance collaborative support within the working environment. The benefits of peer-assisted learning in current clinical practice settings can be challenging. Therefore, education and practice need to be aware of the benefits and their contribution towards future strategies and models of learning. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

The role and potential contribution of clinical research nurses to clinical trials.

PubMed

Spilsbury, Karen; Petherick, Emily; Cullum, Nicky; Nelson, Andrea; Nixon, Jane; Mason, Su

2008-02-01

This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. Qualitative focus group study. A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Identifying Opportunities for Peer Learning: An Observational Study of Medical Students on Clinical Placements.

PubMed

Tai, Joanna H; Canny, Benedict J; Haines, Terry P; Molloy, Elizabeth K

2017-01-01

Phenomenon: Peer assisted learning (PAL) is frequently employed and researched in preclinical medical education. Fewer studies have examined PAL in the clinical context: These have focused mainly on the accuracy of peer assessment and potential benefits to learner communication and teamwork skills. Research has also examined the positive and negative effects of formal, structured PAL activities in the clinical setting. Given the prevalence of PAL activities during preclinical years, and the unstructured nature of clinical placements, it is likely that nonformal PAL activities are also undertaken. How PAL happens formally and informally and why students find PAL useful in this clinical setting remain poorly understood. This study aimed to describe PAL activities within the context of clinical placement learning and to explore students' perceptions of these activities. An ethnographic study was conducted to gather empirical data on engagement in clinical placement learning activities, including observations and interviews with students in their 1st clinical year, along with their supervising clinicians. Thematic analysis was used to interrogate the data. On average, students used PAL for 5.19 hours per week in a range of activities, of a total of 29.29 hours undertaking placements. PAL was recognized as a means of vicarious learning and had greater perceived value when an educator was present to guide or moderate the learning. Trust between students was seen as a requirement for PAL to be effective. Students found passive observation a barrier to PAL and were able to identify ways to adopt an active stance when observing peers interacting with patients. For example, learners reported that the expectation that they had to provide feedback to peers after task observation, resulted in them taking on a more critical gaze where they were encouraged to consider notions of good practice. Insights: Students use PAL in formal (i.e., tutorial) and nonformal (e.g., peer observation and feedback on the ward; discussion during lunch) situations in clinical education and find it useful. The educator is crucial in fostering PAL through providing opportunities for learners to practice together and in helping to moderate discussions about quality of performance. Student engagement in PAL may reduce passivity commonly reported in clinical rotations. Further directions for research into PAL in clinical education are identified along with potential strategies that may maximize the benefits of peer to peer learning.

Observational studies: a valuable source for data on the true value of RA therapies.

PubMed

van Vollenhoven, Ronald F; Severens, Johan L

2011-03-01

The validity of observational studies is sometimes questioned because of the limitations of non-randomly assigned controls, various biases such as channeling bias, confounding by indication, and other pitfalls. Yet, (post-marketing) observational data can provide important information regarding not only drug safety but also the effectiveness and appropriate use of agents in the real world, outside of clinical trials. Observational studies also provide data regarding the wider value of these agents in terms of, for example, reducing the need for surgical procedures, reducing absenteeism and increasing productivity. Importantly, data from some observational registry studies have subsequently been confirmed by clinical trials, supporting the overall validity of the registry-based approach. Observational studies also allow measures such as health assessment questionnaire scores, disease activity scores, and glucocorticoid use over time to be monitored for longer periods. Furthermore, observational data in real, less strictly selected patients without the constraints of formal study populations may produce findings not observed in clinical trials but that warrant further investigation in a controlled trial environment. For example, recent data from the Stockholm tumor necrosis factor follow-up registry in Sweden showed increases in the time people worked after initiation of biologics that, surprisingly, continued into the fourth and fifth years of treatment--a finding not observed with standardized outcomes. Observational studies are truly an underappreciated and valuable source of data on the real value of anti-rheumatic therapies, and these data are essential for making sound decisions regarding coverage and reimbursement.

Evaluation of a hand hygiene campaign in outpatient health care clinics.

PubMed

Kukanich, Kate Stenske; Kaur, Ramandeep; Freeman, Lisa C; Powell, Douglas A

2013-03-01

To improve hand hygiene in two outpatient health care clinics through the introduction of a gel sanitizer and an informational poster. In this interventional study, health care workers at two outpatient clinics were observed for frequency of hand hygiene (attempts versus opportunities). Gel sanitizer and informational posters were introduced together as an intervention. Direct observation of the frequency of hand hygiene was performed during baseline, intervention, and follow-up. A poststudy survey of health care workers was also distributed and collected. In both clinics, the frequency of hand hygiene was poor at baseline (11% and 21%) but improved significantly after intervention (36% and 54%) and was maintained through the follow-up period (32% and 51%). Throughout the study, postcontact hand hygiene was observed significantly more often than precontact hand hygiene. In both clinics, health care workers reported a preference for soap and water; yet observations showed that when the intervention made gel sanitizer available, sanitizer use predominated. Fifty percent of the surveyed health care workers considered the introduction of gel sanitizer to be an effective motivating tool for improving hand hygiene. Hand hygiene performance by health care workers in outpatient clinics may be improved through promoting the use of gel sanitizer and using informational posters. Compared with surveys, direct observation by trained observers may provide more accurate information about worker preferences for hand hygiene tools.

Heuristic errors in clinical reasoning.

PubMed

Rylander, Melanie; Guerrasio, Jeannette

2016-08-01

Errors in clinical reasoning contribute to patient morbidity and mortality. The purpose of this study was to determine the types of heuristic errors made by third-year medical students and first-year residents. This study surveyed approximately 150 clinical educators inquiring about the types of heuristic errors they observed in third-year medical students and first-year residents. Anchoring and premature closure were the two most common errors observed amongst third-year medical students and first-year residents. There was no difference in the types of errors observed in the two groups. Errors in clinical reasoning contribute to patient morbidity and mortality Clinical educators perceived that both third-year medical students and first-year residents committed similar heuristic errors, implying that additional medical knowledge and clinical experience do not affect the types of heuristic errors made. Further work is needed to help identify methods that can be used to reduce heuristic errors early in a clinician's education. © 2015 John Wiley & Sons Ltd.

Launching Effectiveness Research to Guide Practice in Neurosurgery: A National Institute Neurological Disorders and Stroke Workshop Report

PubMed Central

Walicke, Patricia; Abosch, Aviva; Asher, Anthony; Barker, Fred G.; Ghogawala, Zoher; Harbaugh, Robert; Jehi, Lara; Kestle, John; Koroshetz, Walter; Little, Roderick; Rubin, Donald; Valadka, Alex; Wisniewski, Stephen

2017-01-01

Abstract This workshop addressed challenges of clinical research in neurosurgery. Randomized controlled clinical trials (RCTs) have high internal validity, but often insufficiently generalize to real-world practice. Observational studies are inclusive but often lack sufficient rigor. The workshop considered possible solutions, such as (1) statistical methods for demonstrating causality using observational data; (2) characteristics required of a registry supporting effectiveness research; (3) trial designs combining advantages of observational studies and RCTs; and (4) equipoise, an identified challenge for RCTs. In the future, advances in information technology potentially could lead to creation of a massive database where clinical data from all neurosurgeons are integrated and analyzed, ending the separation of clinical research and practice and leading to a new “science of practice.” PMID:28362926

Relationship between Trypanosoma brucei rhodesiense genetic diversity and clinical spectrum among sleeping sickness patients in Uganda.

PubMed

Kato, Charles D; Mugasa, Claire M; Nanteza, Ann; Matovu, Enock; Alibu, Vincent P

2017-10-27

Human African trypanosomiasis (HAT) due to Trypanosoma brucei rhodesiense in East and southern Africa is reported to be clinically diverse. We tested the hypothesis that this clinical diversity is associated with a variation in trypanosome genotypes. Trypanosome DNA isolated from HAT patients was genotyped using 7 microsatellite markers directly from blood spotted FTA cards following a whole genome amplification. All markers were polymorphic and identified 17 multi-locus genotypes with 56% of the isolates having replicate genotypes. We did not observe any significant clustering between isolates and bootstrap values across major tree nodes were insignificant. When genotypes were compared among patients with varying clinical presentation or outcome, replicate genotypes were observed at both extremes showing no significant association between genetic diversity and clinical outcome. Our study shows that T. b. rhodesiense isolates are homogeneous within a focus and that observed clinical diversity may not be associated with parasite genetic diversity. Other factors like host genetics and environmental factors might be involved in determining clinical diversity. Our study may be important in designing appropriate control measures that target the parasite.

Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS).

PubMed

Napoli, Nicola; Langdahl, Bente L; Ljunggren, Östen; Lespessailles, Eric; Kapetanos, George; Kocjan, Tomaz; Nikolic, Tatjana; Eiken, Pia; Petto, Helmut; Moll, Thomas; Lindh, Erik; Marin, Fernando

2018-06-16

This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide. Of 1531 patients analysed (90.7% female, mean age: 70.3 years), 76 (5.0%) never took teriparatide. Median treatment duration was 23.6 months. The adjusted odds of clinical fracture decreased by 47% in the > 12- to 18-month treatment period (p = 0.013) compared with the first 6-month period, with no statistically significant reduction in the > 18- to 24-month interval. The clinical fracture rate remained stable during the 18 months' post-teriparatide, when approximately 98% of patients took osteoporosis medication (51% bisphosphonates). Clinical vertebral fractures were reduced at every time period compared with the first 6 months. Adjusted mean back pain scores decreased and EQ-5D scores increased significantly at each post-baseline observation. In a real-life clinical setting, the risk of clinical fractures declined during 24 months of teriparatide treatment. This reduction was maintained 18 months after stopping teriparatide. In parallel, patients reported significant improvements in back pain and HRQoL. The results should be interpreted in the context of the non-controlled design of this observational study.

[Assessment of competence in pediatric postgraduate education: implementation of a pediatric version of the Mini-Cex].

PubMed

Urman, Gabriela; Folgueral, Silvana; Gasparri, Mercedes; López, Diana; Urman, Jorge; Grosman, Arnoldo; Alves de Lima, Alberto

2011-12-01

Faced with the increased challenge of assessing competences in young doctors, the purpose of the study was to evaluate the implementation of a pediatric version of the Mini-Cex in pediatric trainees as well as the level of satisfaction of teachers and students with the new assessment tool. From July 2007 to August 2009, 54 pediatric trainees were periodically monitored in a variety of clinical settings by 50 teachers. The competences evaluated included medical interviewing, physical examination and counseling skills, humanistic qualities/ professionalism, clinical judgment, organization and overall clinical competence. The feasibility of this study was defined as an average 4 observations per participant, and observations in all clinical rotations. During the study, 388 observations were carried over 54 students (average of 7.18 observations per student); 57% took place in ambulatory settings, 60% were of low complexity and 85% involved healthy children programmed consultations. The ratings for specific competences had little variation; the focus related to the setting. Used in a variety of settings, with different patient problems, the method was well accepted by both students and teachers.

Delivery of Clinical Preventive Services in Family Medicine Offices

PubMed Central

Crabtree, Benjamin F.; Miller, William L.; Tallia, Alfred F.; Cohen, Deborah J.; DiCicco-Bloom, Barbara; McIlvain, Helen E.; Aita, Virginia A.; Scott, John G.; Gregory, Patrice B.; Stange, Kurt C.; McDaniel, Reuben R.

2005-01-01

BACKGROUND This study aimed to elucidate how clinical preventive services are delivered in family practices and how this information might inform improvement efforts. METHODS We used a comparative case study design to observe clinical preventive service delivery in 18 purposefully selected Midwestern family medicine offices from 1997 to 1999. Medical records, observation of outpatient encounters, and patient exit cards were used to calculate practice-level rates of delivery of clinical preventive services. Field notes from direct observation of clinical encounters and prolonged observation of the practice and transcripts from in-depth interviews of practice staff and physicians were systematically examined to identify approaches to delivering clinical preventive services recommended by the US Preventive Services Task Force. RESULTS Practices developed individualized approaches for delivering clinical preventive services, with no one approach being successful across practices. Clinicians acknowledged a 3-fold mission of providing acute care, managing chronic problems, and prevention, but only some made prevention a priority. The clinical encounter was a central focus for preventive service delivery in all practices. Preventive services delivery rates often appeared to be influenced by competing demands within the clinical encounter (including between different preventive services), having a physician champion who prioritized prevention, and economic concerns. CONCLUSIONS Practice quality improvement efforts that assume there is an optimal approach for delivering clinical preventive services fail to account for practices’ propensity to optimize care processes to meet local contexts. Interventions to enhance clinical preventive service delivery should be tailored to meet the local needs of practices and their patient populations. PMID:16189059

Accuracy of clinical observations of push-off during gait after stroke.

PubMed

McGinley, Jennifer L; Morris, Meg E; Greenwood, Ken M; Goldie, Patricia A; Olney, Sandra J

2006-06-01

To determine the accuracy (criterion-related validity) of real-time clinical observations of push-off in gait after stroke. Criterion-related validity study of gait observations. Rehabilitation hospital in Australia. Eleven participants with stroke and 8 treating physical therapists. Not applicable. Pearson product-moment correlation between physical therapists' observations of push-off during gait and criterion measures of peak ankle power generation from a 3-dimensional motion analysis system. A high correlation was obtained between the observational ratings and the measurements of peak ankle power generation (Pearson r =.98). The standard error of estimation of ankle power generation was .32W/kg. Physical therapists can make accurate real-time clinical observations of push-off during gait following stroke.

Balancing the Evidence: How to Reconcile the Results of Observational Studies vs. Randomized Clinical Trials in Dialysis.

PubMed

Shen, Jenny I; Lum, Erik L; Chang, Tara I

2016-09-01

Because large randomized clinical trials (RCTs) in dialysis have been relatively scarce, evidence-based dialysis care has depended heavily on the results of observational studies. However, when results from RCTs appear to contradict the findings of observational studies, nephrologists are left to wonder which type of study they should believe. In this editorial, we explore the key differences between observational studies and RCTs in the context of such seemingly conflicting studies in dialysis. Confounding is the major limitation of observational studies, whereas low statistical power and problems with external validity are more likely to limit the findings of RCTs. Differences in the specification of the population, exposure, and outcomes can also contribute to different results among RCTs and observational studies. Rigorous methods are required regardless of what type of study is conducted, and readers should not automatically assume that one type of study design is superior to the other. Ultimately, dialysis care requires both well-designed, well-conducted observational studies and RCTs to move the field forward. © 2016 Wiley Periodicals, Inc.

Balancing the Evidence: How to Reconcile the Results of Observational Studies vs. Randomized Clinical Trials in Dialysis

PubMed Central

Shen, Jenny I.; Lum, Erik L.; Chang, Tara I.

2016-01-01

Because large randomized clinical trials (RCTs) in dialysis have been relatively scarce, evidence-based dialysis care has depended heavily on the results of observational studies. However, when results from RCTs appear to contradict the findings of observational studies, nephrologists are left to wonder which type of study they should believe. In this editorial we explore the key differences between observational studies and RCTs in the context of such seemingly conflicting studies in dialysis. Confounding is the major limitation of observational studies, while low statistical power and problems with external validity are more likely to limit the findings of RCTs. Differences in the specification of the population, exposure, and outcomes can also contribute to different results among RCTs and observational studies. Rigorous methods are required regardless of what type of study is conducted, and readers should not automatically assume that one type of study design is superior to the other. Ultimately, dialysis care requires both well-designed, well-conducted observational studies and RCTs to move the field forward. PMID:27207819

[Registration of observational studies: it is time to comply with the Declaration of Helsinki requirement].

PubMed

Dal-Ré, Rafael; Delgado, Miguel; Bolumar, Francisco

2015-01-01

Publication bias is a serious deficiency in the current system of disseminating the results of human research studies. Clinical investigators know that, from an ethical standpoint, they should prospectively register clinical trials in a public registry before starting them. In addition, it is believed that this approach will help to reduce publication bias. However, most studies conducted in humans are observational rather than experimental. It is estimated that less than 2% out of 2 million concluded or ongoing observational studies have been registered. The 2013 revision of the Declaration of Helsinki requires registration of any type of research study involving humans or identifiable samples or data. It is proposed that funding agencies, such as the Fondo de Investigaciones Sanitarias, as well as private companies, require preregistration of observational studies before providing funding. It is also proposed that Research Ethics Committees which, following Spanish regulation, have been using the Declaration as the framework for assessing the ethics of clinical trials with medicines since 1990, should follow the same provisions for the assessment of health-related observational studies: therefore, they should require prospective registration of studies before granting their final approval. This would allow observational study investigators to be educated in complying with an ethical requirement recently introduced in the most important ethical code for research involving humans. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

Service and Education: The Association Between Workload, Patient Complexity, and Teaching on Internal Medicine Inpatient Services.

PubMed

Ratcliffe, Temple A; Crabtree, Meghan A; Palmer, Raymond F; Pugh, Jacqueline A; Lanham, Holly J; Leykum, Luci K

2018-04-01

Attending rounds remain the primary venue for formal teaching and learning at academic medical centers. Little is known about the effect of increasing clinical demands on teaching during attending rounds. To explore the relationships among teaching time, teaching topics, clinical workload, and patient complexity variables. Observational study of medicine teaching teams from September 2008 through August 2014. Teams at two large teaching hospitals associated with a single medical school were observed for periods of 2 to 4 weeks. Twelve medicine teaching teams consisting of one attending, one second- or third-year resident, two to three interns, and two to three medical students. The study examined relationships between patient complexity (comorbidities, complications) and clinical workload variables (census, turnover) with educational measures. Teams were clustered based on clinical workload and patient complexity. Educational measures of interest were time spent teaching and number of teaching topics. Data were analyzed both at the daily observation level and across a given patient's admission. We observed 12 teams, 1994 discussions (approximately 373 h of rounds) of 563 patients over 244 observation days. Teams clustered into three groups: low patient complexity/high clinical workload, average patient complexity/low clinical workload, and high patient complexity/high clinical workload. Modest associations for team, patient complexity, and clinical workload variables were noted with total time spent teaching (9.1% of the variance in time spent teaching during a patient's admission; F[8,549] = 6.90, p < 0.001) and number of teaching topics (16% of the variance in the total number of teaching topics during a patient's admission; F[8,548] = 14.18, p < 0.001). Clinical workload and patient complexity characteristics among teams were only modestly associated with total teaching time and teaching topics.

The rational clinical examination. Does this infant have pneumonia?

PubMed

Margolis, P; Gadomski, A

1998-01-28

Acute lower respiratory tract illness is common among children seen in primary care. We reviewed the accuracy and precision of the clinical examination in detecting pneumonia in children. Although most cases are viral, it is important to identify bacterial pneumonia to provide appropriate therapy. Studies were identified by searching MEDLINE from 1982 to 1995, reviewing reference lists, reviewing a published compendium of studies of the clinical examination, and consulting experts. Observer agreement is good for most signs on the clinical examination. Each study was reviewed by 2 observers and graded for methodologic quality. There is better agreement about signs that can be observed (eg, use of accessory muscles, color, attentiveness; kappa, 0.48-0.66) than signs that require auscultation of the chest (eg, adventitious sounds; kappa, 0.3). Measurements of the respiratory rate are enhanced by counting for 60 seconds. The best individual finding for ruling out pneumonia is the absence of tachypnea. Chest indrawing, and other signs of increased work of breathing, increases the likelihood of pneumonia. If all clinical signs (respiratory rate, auscultation, and work of breathing) are negative, the chest x-ray findings are unlikely to be positive. Studies are needed to assess the value of clinical findings when they are used together.

How Exemplary Inpatient Teaching Physicians Foster Clinical Reasoning.

PubMed

Houchens, Nathan; Harrod, Molly; Fowler, Karen E; Moody, Stephanie; Saint, Sanjay

2017-09-01

Clinical reasoning is a crucial component of training in health professions. These cognitive skills are necessary to provide quality care and avoid diagnostic error. Much previous literature has focused on teaching clinical reasoning in nonclinical environments and does not include learner reflections. The authors sought to explore, through multiple perspectives including learners, techniques used by exemplary inpatient clinician-educators for explicitly cultivating clinical reasoning. The authors conducted (2014-2015) a multisite, exploratory qualitative study examining how excellent clinician-educators foster clinical reasoning during general medicine rounds. This was accomplished through interviews of educators, focus group discussions with learners, and direct observations of clinical teaching. The authors reviewed field notes and transcripts using techniques of thematic analysis. Twelve clinician-educators, 57 current learners, and 26 former learners participated in observations and interviews. The techniques and behaviors of educators were categorized into 4 themes, including 1) emphasizing organization and prioritization, 2) accessing prior knowledge, 3) thinking aloud, and 4) analyzing the literature. The findings of this comprehensive study both confirm strategies found in previous literature and provide novel approaches. This is the first study to incorporate the perspectives of learners. Educators' techniques and behaviors, identified through direct observation and supported by reflections from the entire team, can inform best practices for the teaching of clinical reasoning. Copyright © 2017 Elsevier Inc. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.

PubMed

Rahbar, Mohammad H; Fox, Erin E; del Junco, Deborah J; Cotton, Bryan A; Podbielski, Jeanette M; Matijevic, Nena; Cohen, Mitchell J; Schreiber, Martin A; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah J; Reynolds, Robert J; Benjamin-Garner, Ruby; Holcomb, John B

2012-04-01

Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Media Coverage, Journal Press Releases and Editorials Associated with Randomized and Observational Studies in High-Impact Medical Journals: A Cohort Study.

PubMed

Wang, Michael T M; Bolland, Mark J; Gamble, Greg; Grey, Andrew

2015-01-01

Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage. We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported 'hard' outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting 'hard' outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported 'hard' outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14). The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage.

Effects of the Non-Nutritive Sweeteners on Glucose Metabolism and Appetite Regulating Hormones: Systematic Review of Observational Prospective Studies and Clinical Trials

PubMed Central

Romo-Romo, Alonso; Aguilar-Salinas, Carlos A.; Brito-Córdova, Griselda X.; Gómez Díaz, Rita A.; Vilchis Valentín, David

2016-01-01

Background The effects of non-nutritive sweeteners (NNS) on glucose metabolism and appetite regulating hormones are not clear. There is an ongoing debate concerning NNS use and deleterious changes in metabolism. Objectives The aim of this review is to analyze the scientific available evidence regarding the effects of NNS on glucose metabolism and appetite regulating hormones. Data Sources and Study Eligibility Criteria We identified human observational studies evaluating the relation between NNS consumption and obesity, diabetes, and metabolic syndrome, in addition to clinical trials evaluating the effects of NNS in glucose metabolism and appetite regulating hormones. Results Fourteen observational studies evaluating the association between NNS consumption and the development of metabolic diseases and twenty-eight clinical trials studying the effects of NNS on metabolism were included. Finally, two meta-analyses evaluating the association between the consumption of NNS-containing beverages and the development of type 2 diabetes were identified. Conclusions Some observational studies suggest an association between NNS consumption and development of metabolic diseases; however, adiposity is a confounder frequently found in observational studies. The effects of the NNS on glucose metabolism are not clear. The results of the identified clinical trials are contradictory and are not comparable because of the major existing differences between them. Studies evaluating specific NNS, with an adequate sample size, including a homogeneous study group, identifying significant comorbidities, with an appropriate control group, with an appropriate exposure time, and considering adjustment for confounder variables such as adiposity are needed. PMID:27537496

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

2011-01-01

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

Validation of Mismatch Negativity and P3a for Use in Multi-Site Studies of Schizophrenia: Characterization of Demographic, Clinical, Cognitive, and Functional Correlates in COGS-2

PubMed Central

Light, Gregory A.; Swerdlow, Neal R.; Thomas, Michael L.; Calkins, Monica E.; Green, Michael F.; Greenwood, Tiffany A.; Gur, Raquel E.; Gur, Ruben C.; Lazzeroni, Laura C.; Nuechterlein, Keith H.; Pela, Marlena; Radant, Allen D.; Seidman, Larry J.; Sharp, Richard F.; Siever, Larry J.; Silverman, Jeremy M.; Sprock, Joyce; Stone, William S.; Sugar, Catherine A.; Tsuang, Debby W.; Tsuang, Ming T.; Braff, David L.; Turetsky, Bruce I.

2014-01-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP data was obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. PMID:25449710

Validation of mismatch negativity and P3a for use in multi-site studies of schizophrenia: characterization of demographic, clinical, cognitive, and functional correlates in COGS-2.

PubMed

Light, Gregory A; Swerdlow, Neal R; Thomas, Michael L; Calkins, Monica E; Green, Michael F; Greenwood, Tiffany A; Gur, Raquel E; Gur, Ruben C; Lazzeroni, Laura C; Nuechterlein, Keith H; Pela, Marlena; Radant, Allen D; Seidman, Larry J; Sharp, Richard F; Siever, Larry J; Silverman, Jeremy M; Sprock, Joyce; Stone, William S; Sugar, Catherine A; Tsuang, Debby W; Tsuang, Ming T; Braff, David L; Turetsky, Bruce I

2015-04-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP recordings were obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. Published by Elsevier B.V.

Prevalence of Recommendations Made Within Dental Research Articles Using Uncontrolled Intervention or Observational Study Designs.

PubMed

Wilson, M K; Chestnutt, I G

2016-03-01

Evidence to inform clinical practice is reliant on research carried out using appropriate study design. The objectives of this work were to (i) identify the prevalence of articles reporting on human studies using uncontrolled intervention or observational research designs published in peer-reviewed dental journals and (ii) determine the nature of recommendations made by these articles. Six peer-reviewed dental journals were selected. Issues published in January to June 2013 were examined and the types of articles published categorized. Following pre-defined inclusion/exclusion criteria, human studies classified as using uncontrolled intervention or observational research designs were subject to detailed review by two independent investigators, to examine if they presented clinical, policy or research recommendations and if these recommendations were supported by the data presented. 52.9% (n = 156) of studies published during the time period met the inclusion criteria. Studies with uncontrolled intervention or observational research designs comprised a larger proportion of the primary research studies published in the journals with lower impact factors (73.3%; n = 107) compared to the high impact journals (38.9%; n = 49). Analysis showed that 60.9% (n = 95) of the included studies made recommendations for clinical practice/dental policy. In 28.2% (n = 44) of studies, the clinical/policy recommendations made were judged to not be fully supported by the data presented. Many studies published in the current dental literature, which are not considered to produce strong evidence, make recommendations for clinical practice or policy. There were some cases when the recommendations were not fully supported by the data presented. Copyright © 2016 Elsevier Inc. All rights reserved.

Registration practices for observational studies on ClinicalTrials.gov indicated low adherence.

PubMed

Boccia, Stefania; Rothman, Kenneth J; Panic, Nikola; Flacco, Maria Elena; Rosso, Annalisa; Pastorino, Roberta; Manzoli, Lamberto; La Vecchia, Carlo; Villari, Paolo; Boffetta, Paolo; Ricciardi, Walter; Ioannidis, John P A

2016-02-01

The study aims to assess the status of registration of observational studies. We identified studies on cancer research with prospective recruitment of participants that were registered from February 2000 to December 2011 in ClinicalTrials.gov. We recorded the dates of registration and start of recruitment, outcomes, and description of statistical method. We searched for publications corresponding to the registered studies through May 31, 2014. One thousand one hundred nine registered studies were eligible. Primary and secondary outcomes were reported in 809 (73.0%) and 464 (41.8%) of them. The date of registration preceded the month of the study start in 145 (13.8%) and coincided in 205 (19.5%). A total of 151 publications from 120 (10.8%) registered studies were identified. In 2 (33.3%) of the 6 publications where ClinicalTrials.gov reported that the study started recruitment after registration, and in 9 (50.0%) of 18 publications where ClinicalTrials.gov reported the same date for registration and start of recruitment, the articles showed that the study had actually started recruiting before registration. During the period reviewed, few observational studies have been registered. Registration usually occurred after the study started, and prespecification of outcomes and statistical analysis rarely occurred. Copyright © 2016 Elsevier Inc. All rights reserved.

Conducting clinical post-conference in clinical teaching: a qualitative study.

PubMed

Hsu, Li-Ling

2007-08-01

The aim of this study was to explore nurse educators' perceptions regarding clinical postconferences. Additional aims included the exploration of interaction characteristics between students and faculty in clinical postconferences. Nursing students are challenged to think and learn in ways that will prepare them for practice in a complex health care environment. Clinical postconferences give students the opportunity to share knowledge gained through transformative learning and provide a forum for discussion and critical thinking. Faculty members must guide students as the latter participate in discussions, develop problem-solving skills and express feedings and attitudes in clinical conferences. The study used qualitative research methods, including participant observation and an open-ended questionnaire. Participant observers watched interaction activities between teachers and students in clinical postconferences. A total of 20 clinical postconferences, two conferences per teacher, were observed. The Non-Numerical Unstructured Data Indexing Searching and Theory-building qualitative software program was used in data analysis. Research findings indicated that, of the six taxonomy questions, lower-level questions (knowledge and comprehensive questions) were mostly asked by faculty members' postclinical conferences. The most frequently used guideline was task orientation, which is related to practice goals and was found in discussions of assignments, reading reports, discussions of clinical experiences, role plays, psychomotor skill practice, quizzes and student evaluations. It is an essential responsibility of nurse educators to employ postconferences to assist students in applying their knowledge in practical situations, in developing professional values and in enhancing their problem solving abilities.

Standardized patient walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: common challenges to protocol implementation.

PubMed

Fussell, Holly E; Kunkel, Lynn E; McCarty, Dennis; Lewy, Colleen S

2011-09-01

Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation. Examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials. Actors portrayed clients and "walked through" study procedures with protocol research staff. The study completed 57 walkthroughs during implementation of 4 clinical trials. Observers and walkthrough participants identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns. Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.

WE-G-217BCD-04: Diagnostic Image Quality Evaluation of a Dedicated Extremity Cone- Beam CT Scanner: Pre-Clinical Studies and First Clinical Results.

PubMed

Muhit, A; Zbijewski, W; Stayman, J; Thawait, G; Yorkston, J; Foos, D; Packard, N; Yang, D; Senn, R; Carrino, J; Siewerdsen, J

2012-06-01

To assess the diagnostic performance of a prototype cone-beam CT (CBCT) scanner developed for musculoskeletal extremity imaging. Studies involved controlled observer studies conducted subsequent to rigorous technical assessment as well as patient images from the first clinical trial in imaging the hand and knee. Performance assessment included: 1.) rigorous technical assessment; 2.) controlled observer studies using CBCT images of cadaveric specimens; and 3.) first clinical images. Technical assessment included measurement of spatial resolution (MTF), constrast, and noise (SDNR) versus kVp and dose using standard CT phantoms. Diagnostic performance in comparison to multi- detector CT (MDCT) was assessed in controlled observer studies involving 12 cadaveric hands and knees scanned with and without abnormality (fracture). Observer studies involved five radiologists rating pertinent diagnostics tasks in 9-point preference and 10-point diagnostic satisfaction scales. Finally, the first clinical images from an ongoing pilot study were assessed in terms of diagnostic utility in disease assessment and overall workflow in patient setup. Quantitative assessment demonstrated sub-mm spatial resolution (MTF exceeding 10% out to 15-20 cm-1) and SDNR sufficient for relevant soft-tissue visualization tasks at dose <10 mGy. Observer studies confirmed optimal acquisition techniques and demonstrated superior utility of combined soft-tissue visualization and isotropic spatial resolution in diagnostic tasks. Images from the patient trial demonstrate exquisite contrast and detail and the ability to detect tissue impingement in weight-bearing exams. The prototype CBCT scanner provides isotropic spatial resolution superior to standard-protocol MDCT with soft-tissue visibility sufficient for a broad range of diagnostic tasks in musculoskeletal radiology. Dosimetry and workflow were advantageous in comparison to whole-body MDCT. Multi-mode and weight-bearing capabilities add valuable functionality. An ongoing clinical study further assesses diagnostic utility and defines the role of such technology in the diagnostic arsenal. - Research Grant, Carestream Health - Research Grant, National Institutes of Health 2R01-CA-112163. © 2012 American Association of Physicists in Medicine.

Observing how RNs use clinical time in a nursing home: a pilot study.

PubMed

Dellefield, Mary Ellen; Harrington, Charlene; Kelly, Ann

2012-01-01

Registered nurses (RNs) working in nursing homes (NHs) are a scarce professional resource. Their responsibilities include direct (e.g., assessment, physical care, and medication administration) and indirect care (e.g., documentation, supervision, and other activities performed away from the resident to manage their care environment). The purpose of the study was to describe the direct and indirect care distribution of RNs working day shift in an NH. All RN care was observed, although RN care associated with pressure ulcer prevention as a clinical outcome was highlighted. Work sampling was conducted using a personal data assistant-based RN Observation Measure. RNs spent 59% of their time on indirect care. Little direct care could be linked with specific clinical categories relevant to pressure ulcer prevention. RNs are challenged to use RN clinical time more strategically. Copyright © 2012 Mosby, Inc. All rights reserved.

Automated characterization of perceptual quality of clinical chest radiographs: Validation and calibration to observer preference

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

Samei, Ehsan, E-mail: samei@duke.edu; Lin, Yuan; Choudhury, Kingshuk R.

Purpose: The authors previously proposed an image-based technique [Y. Lin et al. Med. Phys. 39, 7019–7031 (2012)] to assess the perceptual quality of clinical chest radiographs. In this study, an observer study was designed and conducted to validate the output of the program against rankings by expert radiologists and to establish the ranges of the output values that reflect the acceptable image appearance so the program output can be used for image quality optimization and tracking. Methods: Using an IRB-approved protocol, 2500 clinical chest radiographs (PA/AP) were collected from our clinical operation. The images were processed through our perceptual qualitymore » assessment program to measure their appearance in terms of ten metrics of perceptual image quality: lung gray level, lung detail, lung noise, rib–lung contrast, rib sharpness, mediastinum detail, mediastinum noise, mediastinum alignment, subdiaphragm–lung contrast, and subdiaphragm area. From the results, for each targeted appearance attribute/metric, 18 images were selected such that the images presented a relatively constant appearance with respect to all metrics except the targeted one. The images were then incorporated into a graphical user interface, which displayed them into three panels of six in a random order. Using a DICOM calibrated diagnostic display workstation and under low ambient lighting conditions, each of five participating attending chest radiologists was tasked to spatially order the images based only on the targeted appearance attribute regardless of the other qualities. Once ordered, the observer also indicated the range of image appearances that he/she considered clinically acceptable. The observer data were analyzed in terms of the correlations between the observer and algorithmic rankings and interobserver variability. An observer-averaged acceptable image appearance was also statistically derived for each quality attribute based on the collected individual acceptable ranges. Results: The observer study indicated that, for each image quality attribute, the averaged observer ranking strongly correlated with the algorithmic ranking (linear correlation coefficient R > 0.92), with highest correlation (R = 1) for lung gray level and the lowest (R = 0.92) for mediastinum noise. There was a strong concordance between the observers in terms of their rankings (i.e., Kendall’s tau agreement > 0.84). The observers also generally indicated similar tolerance and preference levels in terms of acceptable ranges, as 85% of the values were close to the overall tolerance or preference levels and the differences were smaller than 0.15. Conclusions: The observer study indicates that the previously proposed technique provides a robust reflection of the perceptual image quality in clinical images. The results established the range of algorithmic outputs for each metric that can be used to quantitatively assess and qualify the appearance quality of clinical chest radiographs.« less

Can we use an ex vivo continuous hemofiltration model to describe the adsorption and elimination of meropenem and piperacillin?

PubMed

Jamal, Janattul-Ain; Udy, Andrew A; Wallis, Steven C; Ranganathan, Dwarakanathan; McWhinney, Brett C; Ungerer, Jacobus P J; Lipman, Jeffrey; Roberts, Jason A

2015-08-01

To determine the adsorption and elimination characteristics of meropenem and piperacillin during simulated continuous renal replacement therapy (CRRT), and to compare the observed data from this ex vivo study with previous data from clinical studies. This was an experimental study utilizing a modified CRRT circuit and polysulfone membrane (1.2 m2), circulated with a blood-crystalloid mixture. Adsorption onto the CRRT circuit was tested over a 4-h period, and clearance was assessed separately using variable continuous hemofiltration settings. A rapid 9% reduction in circulating meropenem and piperacillin concentrations was observed at approximately 0.5 and 1.0 h for each antibiotic, respectively. The post-dilution setting was associated with a significantly higher sieving coefficient (Sc) and filter clearance (CLfilter) (mean ± SD) (Sc 1.14 ± 0.10 versus 1.06 ± 0.04; CLfilter 19.05 ± 1.63 versus 17.59 ± 0.62 ml/min, P values < 0.05) for meropenem. No significant differences were observed for piperacillin pharmacokinetics. Clinically comparable Sc data were observed between data obtained from the ex vivo study and data from previous clinical studies, for both antibiotics. Meropenem and piperacillin appear to be rapidly adsorbed into the CRRT circuit, and the delivery site of fluid replacement significantly influences meropenem pharmacokinetics. However, these findings are likely to be clinically insignificant and not affect dosing requirements. This ex vivo method could be a surrogate for future clinical pharmacokinetic studies of CRRT. Further research is required to explore the applicability of the ex vivo method to further characterize antibiotic pharmacokinetics during CRRT.

Junk food seen at pediatric clinic visits: is it a problem?

PubMed

Frazier, Johnnie P; Land, Megan; Hsieh, Pei-Hsuan; Barratt, Michelle S

2014-04-01

To document the prevalence of junk foods seen at clinic visits. A cross-sectional 23-item survey of observed food items were completed by medical staff using a convenience sample of families from June 2, 2011 to March 2, 2012. The study was conducted in pediatric clinics affiliated with the University of Texas Medical School at Houston. A convenience sample consisting of 738 families with children from 4 months to 16 years old presenting for visits were included in the study. Children exclusively breast and formula fed was excluded. Junk food was observed 20.9% at the clinic visits. Junk food was often seen at clinic visits. There was a trend toward higher body mass index in patients whose families had junk food at the visit.

Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

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

Ryan, Patricia C., E-mail: ryanp@medimmune.com; Sleeman, Matthew A.; Rebelatto, Marlon

Mavrilimumab (CAM-3001) is an investigational human IgG4 monoclonal antibody (MAb) targeting GM-CSF receptor alpha which is currently being developed for the treatment of RA. GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. To support clinical development, the nonclinical safety of mavrilimumab was evaluated in several studies with cynomolgus monkeys as the pharmacologically relevant species. Comprehensive toxicity parameters were assessed in each study, and treatment duration ranged from 4 to 26 weeks. Mavrilimumab has an acceptable safety profile in monkeys with no changes in any parameters othermore » than microscopic findings in lung. In several studies, minimal accumulation of foamy alveolar macrophages was observed. This finding was only seen in studies of at least 11 weeks duration, was reversible following a dose-free recovery period and was considered non-adverse. At higher dose levels (≥ 30 mg/kg/week), in a 26-week repeat-IV dose study, the presence of lung foreign material, cholesterol clefts, and granulomatous inflammation was also observed in a few animals and was considered adverse. The dose- and time-related accumulation of foamy macrophages in lung following exposure to mavrilimumab observed in several NHP studies was expected based upon the known role of GM-CSFRα signaling in the function of alveolar macrophages. Overall, a clean no-observed-adverse-effect-level (NOAEL) without any effects in lung was established and provided adequate clinical safety margins. In clinical studies in RA patients, mavrilimumab has demonstrated good clinical activity with adequate safety to support further clinical development. A Phase 2b study of mavrilimumab in subjects with RA is in progress. - Highlights: • Mavrilimumab is a MAB targeting GM-CSFRα being developed for RA therapy. • Mavrilimumab has an acceptable safety profile in cynomolgus monkeys. • Lung changes observed reflect role of GM-CSF in alveolar macrophage function. • High safety margins support continued clinical development of mavrilimumab.« less

Platelet-rich plasma in orthopedic therapy: a comparative systematic review of clinical and experimental data in equine and human musculoskeletal lesions.

PubMed

Brossi, Patrícia M; Moreira, Juliana J; Machado, Thaís S L; Baccarin, Raquel Y A

2015-04-22

This systematic review aimed to present and critically appraise the available information on the efficacy of platelet rich plasma (PRP) in equine and human orthopedic therapeutics and to verify the influence of study design and methodology on the assumption of PRP's efficacy. We searched Medline, PubMed, Embase, Bireme and Google Scholar without restrictions until July 2013. Randomized trials, human cohort clinical studies or case series with a control group on the use of PRP in tendons, ligaments or articular lesions were included. Equine clinical studies on the same topics were included independently of their design. Experimental studies relevant to the clarification of PRP's effects and mechanisms of action in tissues of interest, conducted in any animal species, were selected. This review included 123 studies. PRP's beneficial effects were observed in 46.7% of the clinical studies, while the absence of positive effects was observed in 43.3%. Among experimental studies, 73% yielded positive results, and 7.9% yielded negative results. The most frequent flaws in the clinical trials' designs were the lack of a true placebo group, poor product characterization, insufficient blinding, small sampling, short follow-up periods, and adoption of poor outcome measures. The methods employed for PRP preparation and administration and the selected outcome measures varied greatly. Poor study design was a common feature of equine clinical trials. From studies in which PRP had beneficial effects, 67.8% had an overall high risk of bias. From the studies in which PRP failed to exhibit beneficial effects, 67.8% had an overall low risk of bias. Most experimental studies revealed positive effects of PRP. Although the majority of equine clinical studies yielded positive results, the human clinical trials' results failed to corroborate these findings. In both species, beneficial results were more frequently observed in studies with a high risk of bias. The use of PRP in musculoskeletal lesions, although safe and promising, has still not shown strong evidence in clinical scenarios.

Clinical Abacavir Hypersensitivity Reaction among Children in India.

PubMed

Chakravarty, Jaya; Sharma, Saurabh; Johri, Anuradha; Chourasia, Ankita; Sundar, Shyam

2016-08-01

Abacavir is currently recommended as a part of first line regimen by National AIDS Control Organization. The objective of this study was to observe the incidence of clinically diagnosed abacavir Hypersensitivity reaction (HSR) among children on abacavir based therapy in the National program. In this observational study, all children started on abacavir were included and HSR reaction was diagnosed clinically as per National guidelines. HLA- B*5701 testing was done in children diagnosed with clinical abacavir HSR. Among 101 children started on abacavir during the study period, 8 [7.9 % (95 % CI 3.5-15.0 %)] children developed clinically diagnosed abacavir HSR. All children with concomitant illness (4/8) were HLA-B*5701 negative. Only 2 (25 %, 2/8) carried HLA-B*5701 allele. Fever with abdominal symptoms as compared to respiratory symptoms were more common in HLA-B*5701 positive cases. Overdiagnosis of clinically diagnosed abacavir HSR is common and could be decreased by treating concomitant illness before starting abacavir.

The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies

PubMed Central

2014-01-01

Background Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. Methods Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). Results 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). Conclusions The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared ‘natural history’, enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design. PMID:24607083

Observing the work of the Clinical Nurse Specialist: a pilot study.

PubMed

Darmody, Julie V

2005-01-01

The Clinical Nurse Specialist (CNS) is an advanced practice nurse (APN) with graduate preparation as a clinical expert within a specialty area of nursing practice. There is a need for information about the work of the CNS in order to link CNS activities to outcomes and costs of care. To describe the work of the CNS in the acute care setting using the National Association of Clinical Nurse Specialists (NACNS) model as an organizing framework. Descriptive pilot study of the work of the CNS in acute care. A 500-bed academic medical center located in the Midwestern United States. Five masters-prepared APNs in a unit-based CNS role. Direct observation and time study were used to record activities and time for 4 hours with each CNS (n = 5) for a total of 20 hours of observation. CNS activity and time within each practice domain included patient/client (30%), nursing (44%), organization/system (10%), and other activities (16%). Specific activities observed were linked to possible outcomes in the NACNS framework. The NACNS model provided a useful framework for developing a data collection tool that can be used in a larger study that analyzes the work of the acute care CNS. Describing the work of the CNS is an important preliminary step to measuring outcomes and costs of care.

Media Coverage, Journal Press Releases and Editorials Associated with Randomized and Observational Studies in High-Impact Medical Journals: A Cohort Study

PubMed Central

Wang, Michael T. M.; Bolland, Mark J.; Gamble, Greg; Grey, Andrew

2015-01-01

Background Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage. Methods and Findings We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported ‘hard’ outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting ‘hard’ outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported ‘hard’ outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14). Conclusions The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage. PMID:26701758

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design.

PubMed

Moergel, Maximilian; Jahn-Eimermacher, Antje; Krummenauer, Frank; Reichert, Torsten E; Wagner, Wilfried; Wendt, Thomas G; Werner, Jochen A; Al-Nawas, Bilal

2009-12-23

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. ClinicalTrials.gov: NCT00964977.

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.

A comparison of propensity score-based approaches to health service evaluation: a case study of a preoperative physician-led clinic for high-risk surgical patients.

PubMed

Pham, Clarabelle T; Gibb, Catherine L; Mittinty, Murthy N; Fitridge, Robert A; Marshall, Villis R; Karnon, Jonathan D

2016-10-01

A physician-led clinic for the preoperative optimization and management of high-risk surgical patients was implemented in a South Australian public hospital in 2008. This study aimed to estimate the costs and effects of the clinic using a mixed retrospective and prospective observational study design. Alternative propensity score estimation methods were applied to retrospective routinely collected administrative and clinical data, using weighted and matched cohorts. Supplementary survey-based prospective data were collected to inform the analysis of the retrospective data and reduce potential unmeasured confounding. Using weighted cohorts, clinic patients had a significantly longer mean length of stay and higher mean cost. With the matched cohorts, reducing the calliper width resulted in a shorter mean length of stay in the clinic group, but the costs remained significantly higher. The prospective data indicated potential unmeasured confounding in all analyses other than in the most tightly matched cohorts. The application of alternative propensity-based approaches to a large sample of retrospective data, supplemented with a smaller sample of prospective data, informed a pragmatic approach to reducing potential observed and unmeasured confounding in an evaluation of a physician-led preoperative clinic. The need to generate tightly matched cohorts to reduce the potential for unmeasured confounding indicates that significant uncertainty remains around the effects of the clinic. This study illustrates the value of mixed retrospective and prospective observational study designs but also underlines the need to prospectively plan for the evaluation of costs and effects alongside the implementation of significant service innovations. © 2016 John Wiley & Sons, Ltd.

Describing and Modeling Workflow and Information Flow in Chronic Disease Care

PubMed Central

Unertl, Kim M.; Weinger, Matthew B.; Johnson, Kevin B.; Lorenzi, Nancy M.

2009-01-01

Objectives The goal of the study was to develop an in-depth understanding of work practices, workflow, and information flow in chronic disease care, to facilitate development of context-appropriate informatics tools. Design The study was conducted over a 10-month period in three ambulatory clinics providing chronic disease care. The authors iteratively collected data using direct observation and semi-structured interviews. Measurements The authors observed all aspects of care in three different chronic disease clinics for over 150 hours, including 157 patient-provider interactions. Observation focused on interactions among people, processes, and technology. Observation data were analyzed through an open coding approach. The authors then developed models of workflow and information flow using Hierarchical Task Analysis and Soft Systems Methodology. The authors also conducted nine semi-structured interviews to confirm and refine the models. Results The study had three primary outcomes: models of workflow for each clinic, models of information flow for each clinic, and an in-depth description of work practices and the role of health information technology (HIT) in the clinics. The authors identified gaps between the existing HIT functionality and the needs of chronic disease providers. Conclusions In response to the analysis of workflow and information flow, the authors developed ten guidelines for design of HIT to support chronic disease care, including recommendations to pursue modular approaches to design that would support disease-specific needs. The study demonstrates the importance of evaluating workflow and information flow in HIT design and implementation. PMID:19717802

Building a Common Pediatric Research Terminology for Accelerating Child Health Research

PubMed Central

Bailey, L. Charles; Forrest, Christopher B.; Padula, Michael A.; Hirschfeld, Steven

2014-01-01

Longitudinal observational clinical data on pediatric patients in electronic format is becoming widely available. A new era of multi-institutional data networks that study pediatric diseases and outcomes across disparate health delivery models and care settings are also enabling an innovative collaborative rapid improvement paradigm called the Learning Health System. However, the potential alignment of routine clinical care, observational clinical research, pragmatic clinical trials, and health systems improvement requires a data infrastructure capable of combining information from systems and workflows that historically have been isolated from each other. Removing barriers to integrating and reusing data collected in different settings will permit new opportunities to develop a more complete picture of a patient’s care and to leverage data from related research studies. One key barrier is the lack of a common terminology that provides uniform definitions and descriptions of clinical observations and data. A well-characterized terminology ensures a common meaning and supports data reuse and integration. A common terminology allows studies to build upon previous findings and to reuse data collection tools and data management processes. We present the current state of terminology harmonization and describe a governance structure and mechanism for coordinating the development of a common pediatric research terminology that links to clinical terminologies and can be used to align existing terminologies. By reducing the barriers between clinical care and clinical research, a Learning Health System can leverage and reuse not only its own data resources but also broader extant data resources. PMID:24534404

Clinical Characteristic of the HIV/AIDS Patients with Cryptosporidiosis Referring to Behavioral Diseases Consultation Center, Imam Khomeini Hospital, Tehran in 2013.

PubMed

Gholami, Rashid; Gholami, Shirzad; Emadi-Kouchak, Hamid; Abdollahi, Alireza; Shahriari, Mona

2016-01-01

Cryptosporidium is known as an opportunist disease-causing agent in man in recent decades. It causes diarrhea and intestinal disorders in the immune deficit and immune competent individuals. This study was aimed to investigate the clinical characteristics of HIV/AIDS patients with cryptosporidiosis infection. This cross-sectional descriptive study was performed on 53 HIV/AIDS patients referred to the Behavior Disease Consultation Center of Imam Khomeini Hospital in Tehran, Iran in 2013. First, the patients were studied clinically and the context data were recorded in a questionnaire for parasitological examination and referred to the laboratory for eosinophil count, and CD4 count per ml of blood. Cryptosporidiosis was observed in 4 (7.6%) of the total 53 HIV/AIDS patients. The highest prevalence of infection was observed in the age range of 30-39 yr. It was observed in different sexes as 5.7% of male and 1.9% of female, but statistically was insignificant (P=0.163).75% of patients had no intestinal symptom, 11.4% with acute diarrhea and 3.8% with chronic diarrhea. Cryptosporidiosis cases were observed in 5.7% of patients without intestinal symptom. Practitioners in the clinical examination for the detection of the opportunistic intestinal protozoan infection should use clinical and paraclinical characteristics of the HIV/AIDS patients for the diagnostic of Cryptosporidium and other opportunistic parasitic diseases.

Prospective clinical observational study evaluating gender-associated differences of preoperative pain intensity.

PubMed

Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning

2016-07-01

Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery.Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0-100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis.Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th-75th percentiles: 10-52) versus 21 (10-46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men.This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies.

Assessment of Female Participation in an Employee 20-Week Walking Incentive Program at Marshfield Clinic, a Large Multispecialty Group Practice

PubMed Central

Chyou, Po-Huang; Scheuer, David; Linneman, James G.

2006-01-01

Objective: We evaluated the short-term effect of a worksite-based walking incentive program to promote physical activity and well-being in employees of a private healthcare clinic. Design: A prospective, observational follow-up study. Setting: The study was conducted at Marshfield Clinic, a large private multispecialty group practice healthcare institution in Marshfield,Wisconsin, USA. Patients: Subjects for this study were Marshfield Clinic physicians and staff. Methods: From March 31, 2005 to August 20, 2005, physical activity level, body mass index (BMI) and other well-being characteristics were observed pre- and post-program among 191 female participants from the Marshfield Clinic. A brief Web site-accessible, self-reported survey assessed the effectiveness of the exercise program. Results: Our data show a statistically significant (p <0.0001) increase in participants’ physical activity level, while a significant (p = 0.021) decrease in mean BMI was observed. However, there was no evidence of our incentive program reducing participants’ blood pressure. Conclusion: Preliminary findings of our study suggest that the goal of worksite programs designed to support employees in their efforts to improve or maintain their level of wellness is potentially achievable. Continuing research is needed to further assess whether persistent health benefits can be induced by worksite wellness programs. PMID:17210975

Analysis of causality from observational studies and its application in clinical research in Intensive Care Medicine.

PubMed

Coscia Requena, C; Muriel, A; Peñuelas, O

2018-02-28

Random allocation of treatment or intervention is the key feature of clinical trials and divides patients into treatment groups that are approximately balanced for baseline, and therefore comparable covariates except for the variable treatment of the study. However, in observational studies, where treatment allocation is not random, patients in the treatment and control groups often differ in covariates that are related to intervention variables. These imbalances in covariates can lead to biased estimates of the treatment effect. However, randomized clinical trials are sometimes not feasible for ethical, logistical, economic or other reasons. To resolve these situations, interest in the field of clinical research has grown in designing studies that are most similar to randomized experiments using observational (i.e. non-random) data. Observational studies using propensity score analysis methods have been increasing in the scientific papers of Intensive Care. Propensity score analyses attempt to control for confounding in non-experimental studies by adjusting for the likelihood that a given patient is exposed. However, studies with propensity indexes may be confusing, and intensivists are not familiar with this methodology and may not fully understand the importance of this technique. The objectives of this review are: to describe the fundamentals of propensity index methods; to present the techniques to adequately evaluate propensity index models; to discuss the advantages and disadvantages of these techniques. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

PubMed

Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

2016-04-01

Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Prolonged infusion versus intermittent boluses of β-lactam antibiotics for treatment of acute infections: a meta-analysis.

PubMed

Teo, Jocelyn; Liew, Yixin; Lee, Winnie; Kwa, Andrea Lay-Hoon

2014-05-01

The clinical advantages of prolonged (extended/continuous) infusion remain controversial. Previous studies and reviews have failed to show consistent clinical benefits of extending the infusion time. This meta-analysis sought to determine whether prolonged β-lactam infusions were associated with a reduction in mortality and improvement in clinical success. A search of PubMed, EMBASE and The Cochrane Library for randomised controlled trials (RCTs) and observational studies comparing prolonged infusion with intermittent bolus administration of the same antibiotic in hospitalised adult patients was conducted. Primary outcomes evaluated were mortality and clinical success. A total of 29 studies with 2206 patients (18 RCTs and 11 observational studies) were included in the meta-analysis. Compared with intermittent boluses, use of prolonged infusion appeared to be associated with a significant reduction in mortality [pooled relative risk (RR) = 0.66, 95% confidence interval (CI) 0.53-0.83] and improvement in clinical success (RR = 1.12, 95% CI 1.03-1.21). Statistically significant benefit was supported by non-randomised studies (mortality, RR = 0.57, 95% CI 0.43-0.76; clinical success, RR = 1.34, 95% CI 1.02-1.76) but not by RCTs (mortality, RR = 0.83, 95% CI 0.57-1.21; clinical success, RR = 1.05, 95% CI 0.99-1.12). The positive results from observational studies, especially in the face of increasing antibiotic resistance, serve to justify the imperative need to conduct a large-scale, well-designed, multicentre RCT involving critically ill patients infected with high minimum inhibitory concentration pathogens to clearly substantiate this benefit. Copyright © 2014 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

Anterior Segment Optical Coherence Tomography Angiography for Identification of Iris Vasculature and Staging of Iris Neovascularization: A Pilot Study.

PubMed

Roberts, Philipp K; Goldstein, Debra A; Fawzi, Amani A

2017-08-01

Purpose/Aim of the study: To assess the ability of optical coherence tomographic angiography (OCTA) to visualize the normal iris vasculature as well as neovascularization of the iris (NVI). Study participants with healthy eyes, patients at risk of NVI development and patients with active or regressed NVI were consecutively included in this cross-sectional observational study. Imaging was performed using a commercially available OCTA system (RTVue- XR Avanti, Optovue Inc., Fremont, CA, USA). Abnormal iris vessels were graded on OCTA according to a modified clinical staging system and compared to slitlamp and gonioscopic findings. Fifty eyes of 26 study participants (16 healthy eyes, 19 eyes at risk, 15 eyes with different stages of NVI) were imaged using OCTA. In 11 out of 16 healthy eyes (69%) with light or moderately dark iris pigmentation, we observed physiological, radially aligned iris vasculature on OCTA imaging, which could not be visualized in five eyes (31%) with darkly pigmented irides. One eye in the "eyes at risk" group was diagnosed with NVI based on OCTA, which was not observed clinically. Fifteen eyes with clinically active or regressed NVI were imaged. Different stages of NVI could be differentiated by OCTA, corresponding well to an established clinical grading system. Four eyes showed regressed NVI by OCTA, not seen clinically, and were graded as a newly defined stage 4. This pilot clinical study showed that OCTA for imaging of the iris vasculature in health and disease is highly dependent on iris pigmentation. Fine, clinically invisible iris vessels can be visualized by OCTA in the very early stages as well as in the regressed stage of NVI.

Anterior Segment Optical Coherence Tomography Angiography for Identification of Iris Vasculature and Staging of Iris Neovascularization: A Pilot Study

PubMed Central

Roberts, Philipp K.; Goldstein, Debra A.; Fawzi, Amani A.

2017-01-01

Purpose/Aim of the study To assess the ability of optical coherence tomographic angiography (OCTA) to visualize the normal iris vasculature as well as neovascularization of the iris (NVI). Materials and Methods Study participants with healthy eyes, patients at risk of NVI development and patients with active or regressed NVI were consecutively included in this cross-sectional observational study. Imaging was performed using a commercially available OCTA system (RTVue- XR Avanti, Optovue Inc., Fremont, CA, USA). Abnormal iris vessels were graded on OCTA according to a modified clinical staging system and compared to slitlamp and gonioscopic findings. Results Fifty eyes of 26 study participants (16 healthy eyes, 19 eyes at risk, 15 eyes with different stages of NVI) were imaged using OCTA. In 11 out of 16 healthy eyes (69%) with light or moderately dark iris pigmentation, we observed physiological, radially aligned iris vasculature on OCTA imaging, which could not be visualized in five eyes (31%) with darkly pigmented irides. One eye in the “eyes at risk” group was diagnosed with NVI based on OCTA, which was not observed clinically. Fifteen eyes with clinically active or regressed NVI were imaged. Different stages of NVI could be differentiated by OCTA, corresponding well to an established clinical grading system. Four eyes showed regressed NVI by OCTA, not seen clinically, and were graded as a newly defined stage 4. Conclusions This pilot clinical study showed that OCTA for imaging of the iris vasculature in health and disease is highly dependent on iris pigmentation. Fine, clinically invisible iris vessels can be visualized by OCTA in the very early stages as well as in the regressed stage of NVI. PMID:28441067

Using task analysis in healthcare design to improve clinical efficiency.

PubMed

Lu, Jun; Hignett, Sue

2009-01-01

To review the functionality of the proposed soiled workroom design for efficient and safe clinical activities. As part of a hospital refurbishment program, the planning team of a United Kingdom National Health Service hospital requested a review of a proposed standardized room design. A 7-day observational study was conducted in five clinical departments at three hospitals. Link analysis was used to record and analyze the movements among components, i.e., nursing staff, equipment/devices, and furniture. Fifty-four observations were recorded for 18 clinical tasks. The most frequent tasks were the disposal of urine and used urine bottles, and returning used commode chairs. Minor recommendations were made to improve the proposed design, and major revisions were suggested to address functionality problems. It was found that the proposed design did not offer the optimal layout for efficient and safe clinical activities. Link analysis was found to be effective for plotting the movements of the staff and accounting for the complexity of tasks. This ergonomic method, in combination with observational field studies, provided a simple and effective way to determine functional space requirements for clinical activities and should be used in all healthcare building design projects.

A clinical study of patients with genetically confirmed Huntington's disease from India.

PubMed

Murgod, U A; Saleem, Q; Anand, A; Brahmachari, S K; Jain, S; Muthane, U B

2001-09-15

Clinical data across the globe especially in genetic diseases like Huntington's disease (HD) is most helpful when collected using standardized formats. This helps in proper comparison of clinical and genetic data. Herein, we report clinical data on 26 genetically confirmed HD patients from 19 Indian families predominantly from South India. Clinical data and evaluation was performed using standardized formats used by the Huntington Disease Study Group. Adult onset HD was commonest while Juvenile HD (onset <20 years) was observed in approximately 15% of patients. Chorea was the commonest presenting symptom (n=23, 88.5%) while remaining presented with psychiatric symptoms (n=3, 11.5%). Impairment of saccades was observed in approximately 75% of patients. Mean (SD) CAG repeats in the abnormal allele was 48.4 (8.7). Total motor score but not the total behavioral score worsens with duration of symptoms. The functional checklist score correlates with total motor score rather than with duration of symptoms. We detail clinical characteristics in genetically confirmed HD patients from a predominantly South Indian cohort. We observed a slightly higher occurrence of Juvenile HD. Functional disabilities in our patients correlate with worsening of motor rather than behavioral symptoms.

Operational Efficiency of an Immunization Clinic Attached to Rural Health Training Centre in Delhi, India: A Time and Motion Study

PubMed Central

Kumar, Varun; Mangal, Abha; Panesar, Sanjeet; Yadav, Geeta; Talwar, Richa; Raut, Deepak; Singh, Saudan

2014-01-01

Background. Obtaining baseline data about current patterns of work is important for assessing the effects of interventions designed to improve care delivery. Time and motion studies allow for the most accurate measurement of structured components. Therefore, the present study was conducted to study the operational efficiency of an immunization clinic in Delhi, India. Methods. An observational cross-sectional study was conducted at the immunization clinic of Rural Health Training Centre in Delhi, India, from January 2014 to March 2014. The study composed two stage evaluations, a passive observation and a time and motion study. Systemic random sampling method was used to select 863 mothers/caregivers attending the immunization clinic. Results. At the immunization clinic, the study participants spent 64.1% of their total time in waiting. For new cases, the mean time taken for initial registration and receiving postvaccination advice was found to be significantly longer than old cases. Delivering health care services took more time during Mondays and also during the first hour of the day. Conclusion. Results of this study will guide public health decision-makers at all government levels in planning and implementation of immunization programs in developing countries. PMID:25431679

Identifying Conditions That Support Causal Inference in Observational Studies in Education: Empirical Evidence from within Study Comparisons

ERIC Educational Resources Information Center

Hallberg, Kelly

2013-01-01

This dissertation is a collection of three papers that employ empirical within study comparisons (WSCs) to identify conditions that support causal inference in observational studies. WSC studies empirically estimate the extent to which a given observational study reproduces the result of a randomized clinical trial (RCT) when both share the same…

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

An analysis of clinical teacher behaviour in a nursing practicum in Taiwan.

PubMed

Hsu, Li-Ling

2006-05-01

The aim of this study was to identify and assess the teaching behaviours (knowledge, attitudes and skills) observed in nurse educators as they taught in the clinical setting. Many quantitative studies have defined and evaluated teaching effectiveness in the clinical area. Some of these studies established instruments to evaluate faculty effectiveness in the clinical setting; however, they tended to be so broad that they were of limited use in understanding clinical teaching behaviours in nursing education. This study explored clinical teaching behaviours in a nursing practicum. Ten nurse educators taught 10 students in the medical-surgical unit at a hospital in Taiwan for about four weeks. Each teacher was observed by the researcher and one other observer for two days during regularly scheduled clinical teaching time. Data collection and analysis were done by a qualitative approach. Content analysis is a process of identifying, coding and categorizing the themes in the data. The themes of clinical teaching that emerged from data analysis included teaching aims (task-oriented and learner-centred), teacher competence (teacher knowledge, instructional strategies, planning learning experience, teaching priorities, feedback and caring) and teaching commitment (professional identity and giving of self). These findings offer a holistic blueprint of clinical teaching for nursing faculty members, which will enhance the quality of nursing education. Complexity in nursing education has increased as it is challenged to meet the needs of diverse populations in rapidly evolving and highly technical health-care settings. Clinical teachers must be enabled and empowered to provide students with appropriate knowledge and skills to meet the needs of patients. To develop students' professional nursing identity now and in the future, nurse educators have to commit themselves to both nursing and teaching in clinical settings. More nurses need to be prepared for careers in education at the master's and doctoral levels.

THC:CBD spray and MS spasticity symptoms: data from latest studies.

PubMed

Rekand, Tiina

2014-01-01

New clinical experience with 9-delta-tetrahydocannabinol (THC) and cannabidiol (CBD) oromucosal spray (Sativex®) involving more than an additional 1,000 patients with MS spasticity (approximately 150 in clinical studies and 900 in post-marketing surveillance studies) have become available in 2013 and are reviewed. A randomized, placebo controlled long-term follow-up clinical trial with THC:CBD spray versus placebo demonstrated that it was not associated with cognitive decline, depression or significant mood changes after 12 months of treatment. Furthermore, in a prospective observational pilot study involving 33 patients (60% female) aged 33-68 years and a mean disease duration of 6.6 years, THC:CBD oromucosal spray did not adversely influence standard driving ability in patients with moderate to severe MS spasticity. Other new long term observational data about the use of THC:CBD oromucosal spray in clinical practice are available from patient registries in the UK, Germany and Spain. Findings to date reinforce the efficacy and safety observed in Phase III clinical trials. It is of interest that in practice average dosages used by patients tended to be lower than those reported in clinical studies (5-6.4 vs. >8 sprays/day), and effectiveness was maintained in the majority of patients. Importantly, no additional safety concerns were identified in the registry studies which included findings from patients who have been treated for prolonged periods (in the German/UK registry 45% of patients had >2 years exposure). Thus, these new data support a positive benefit-risk relationship for THC:CBD oromucosal spray during longer-term use. © 2014 S. Karger AG, Basel.

Inter- and intra-observer reliability of clinical movement-control tests for marines

PubMed Central

2012-01-01

Background Musculoskeletal disorders particularly in the back and lower extremities are common among marines. Here, movement-control tests are considered clinically useful for screening and follow-up evaluation. However, few studies have addressed the reliability of clinical tests, and no such published data exists for marines. The present aim was therefore to determine the inter- and intra-observer reliability of clinically convenient tests emphasizing movement control of the back and hip among marines. A secondary aim was to investigate the sensitivity and specificity of these clinical tests for discriminating musculoskeletal pain disorders in this group of military personnel. Methods This inter- and intra-observer reliability study used a test-retest approach with six standardized clinical tests focusing on movement control for back and hip. Thirty-three marines (age 28.7 yrs, SD 5.9) on active duty volunteered and were recruited. They followed an in-vivo observation test procedure that covered both low- and high-load (threshold) tasks relevant for marines on operational duty. Two independent observers simultaneously rated performance as “correct” or “incorrect” following a standardized assessment protocol. Re-testing followed 7–10 days thereafter. Reliability was analysed using kappa (κ) coefficients, while discriminative power of the best-fitting tests for back- and lower-extremity pain was assessed using a multiple-variable regression model. Results Inter-observer reliability for the six tests was moderate to almost perfect with κ-coefficients ranging between 0.56-0.95. Three tests reached almost perfect inter-observer reliability with mean κ-coefficients > 0.81. However, intra-observer reliability was fair-to-moderate with mean κ-coefficients between 0.22-0.58. Three tests achieved moderate intra-observer reliability with κ-coefficients > 0.41. Combinations of one low- and one high-threshold test best discriminated prior back pain, but results were inconsistent for lower-extremity pain. Conclusions Our results suggest that clinical tests of movement control of back and hip are reliable for use in screening protocols using several observers with marines. However, test-retest reproducibility was less accurate, which should be considered in follow-up evaluations. The results also indicate that combinations of low- and high-threshold tests have discriminative validity for prior back pain, but were inconclusive for lower-extremity pain. PMID:23273285

[Streptococcal tonsillopharyngitis: clinical vs. microbiological diagnosis].

PubMed

Boccazzi, A; Garotta, M; Pontari, S; Agostoni, C V

2011-06-01

This study aimed to evaluate the role of clinical diagnosis vs. rapid antigen detection tests (RADT) in identifying streptococcal vs. non-streptococcal cases of acute pharyngitis (AP) with respect to a scoring schedule. The Breese scoring system, modified by eliminating the count of peripheral WBC, was used in the study. At enrolment, cases of AP observed by office-based pediatricians were judged on a clinical basis as possibly of streptococcal or of non-streptococcal origin and a clinical score recorded. At the end of the visit and following completion of the clinical score to document the presence/absence of a group A beta haemolytic streptococcus (GABHS), a confirmatory RADT was performed. In RADT negative cases a standard throat swab and culture were performed. In all, 629 children presenting with AP were enrolled in the study. A correct clinical diagnosis was predicted on the basis of the clinical observation in 74.2% of cases (with a sensitivity of 81.1% and specificity of 70.5%). In cases judged as "streptococcal", a mean score of 27.6 was recorded both in those patients with a positive or negative RADT/throat swab for GABHS. By contrast, among cases considered of non-streptococcal aetiology, negative RADT/culture had a mean score of 24.3 compared to a mean score of 25 in those with a positive RADT/culture. Intragroup score differences were not significant, while intergroup differences were highly significant. Optimization of AP treatment requires careful identification of streptococcal cases, avoiding unnecessary antibiotic treatment which would contribute to enhancing antibiotic resistance and increase medical treatment costs. We document that clinical observation alone, although performed by skilled pediatricians, will misdiagnose a sizeable percentage of cases. As indicated by this study, scores may suffer from a subjective interpretative bias in grading the severity of signs and symptoms.

A systematic review on clinical benefits of continuous administration of beta-lactam antibiotics.

PubMed

Roberts, Jason A; Webb, Steven; Paterson, David; Ho, Kwok M; Lipman, Jeffrey

2009-06-01

The clinical benefits of extended infusion or continuous infusion of beta-lactam antibiotics remain controversial. We systematically reviewed the literature to determine whether any clinical benefits exist for administration of beta-lactam antibiotics by extended or continuous infusion. PubMed (January 1950 to November 2007), EMBASE (1966 to November 2007), and the Cochrane Controlled Trial Register were searched (updated November 2007). Randomized controlled trials (RCTs) were meta-analyzed, and observational studies were described by two unblinded reviewers. A total of 846 patients from eligible prospective randomized controlled studies were included in the meta-analysis. Two observational studies were deemed appropriate for description. A meta-analysis of prospective RCTs was undertaken using Review Manager. Among a total of 59 potentially relevant studies, 14 RCTs involving a total of 846 patients from nine countries were deemed appropriate for meta-analysis. The use of continuous infusion of a beta-lactam antibiotic was not associated with an improvement in clinical cure (n = 755 patients; odds ratio: 1.04, 95% confidence interval: 0.74-1.46, p = 0.83, I = 0%) or mortality (n = 541 patients; odds ratio: 1.00, 95% confidence interval: 0.48-2.06, p = 1.00, I = 14.8%). All RCTs except one used a higher antibiotic dose in the bolus administration group. Two observational studies, not pooled because they did not meet the a priori criteria for meta-analysis, showed that beta-lactam administration by extended or continuous infusion was associated with an improvement in clinical cure. The difference in the results between the meta-analysis results and the observational studies could be explained by the bias created by a higher dose of antibiotic in the bolus group in the RCTs and because many of the RCTs only recruited patients with a low acuity of illness. The limited data available suggest that continuous infusion of beta-lactam antibiotics leads to the same clinical results as higher dosed bolus administration in hospitalized patients.

Some strategies to address the challenges of collecting observational data in a busy clinical environment.

PubMed

Jackson, Debra; McDonald, Glenda; Luck, Lauretta; Waine, Melissa; Wilkes, Lesley

2016-01-01

Studies drawing on observational methods can provide vital data to enhance healthcare. However, collecting observational data in clinical settings is replete with challenges, particularly where multiple data-collecting observers are used. Observers collecting data require shared understanding and training to ensure data quality, and particularly, to confirm accurate and consistent identification, discrimination and recording of data. The aim of this paper is to describe strategies for preparing and supporting multiple researchers tasked with collecting observational data in a busy, and often unpredictable, hospital environment. We hope our insights might assist future researchers undertaking research in similar settings.

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.

Reliability Stress-Strength Models for Dependent Observations with Applications in Clinical Trials

NASA Technical Reports Server (NTRS)

Kushary, Debashis; Kulkarni, Pandurang M.

1995-01-01

We consider the applications of stress-strength models in studies involving clinical trials. When studying the effects and side effects of certain procedures (treatments), it is often the case that observations are correlated due to subject effect, repeated measurements and observing many characteristics simultaneously. We develop maximum likelihood estimator (MLE) and uniform minimum variance unbiased estimator (UMVUE) of the reliability which in clinical trial studies could be considered as the chances of increased side effects due to a particular procedure compared to another. The results developed apply to both univariate and multivariate situations. Also, for the univariate situations we develop simple to use lower confidence bounds for the reliability. Further, we consider the cases when both stress and strength constitute time dependent processes. We define the future reliability and obtain methods of constructing lower confidence bounds for this reliability. Finally, we conduct simulation studies to evaluate all the procedures developed and also to compare the MLE and the UMVUE.

Autologous Myoblast Transplantation for Oculopharyngeal Muscular Dystrophy: a Phase I/Iia Clinical Study

PubMed Central

Périé, Sophie; Trollet, Capucine; Mouly, Vincent; Vanneaux, Valérie; Mamchaoui, Kamel; Bouazza, Belaïd; Marolleau, Jean Pierre; Laforêt, Pascal; Chapon, Françoise; Eymard, Bruno; Butler-Browne, Gillian; Larghero, Jérome; St Guily, Jean Lacau

2014-01-01

Oculopharyngeal muscular dystrophy (OPMD) is a late-onset autosomal dominant genetic disease mainly characterized by ptosis and dysphagia. We conducted a phase I/IIa clinical study (ClinicalTrials.gov NCT00773227) using autologous myoblast transplantation following myotomy in adult OPMD patients. This study included 12 patients with clinical diagnosis of OPMD, indication for cricopharyngeal myotomy, and confirmed genetic diagnosis. The feasibility and safety end points of both autologous myoblast transplantation and the surgical procedure were assessed by videoendoscopy in addition to physical examinations. Potential therapeutic benefit was also assessed through videoendoscopy and videofluoroscopy of swallowing, quality of life score, dysphagia grade, and a drink test. Patients were injected with a median of 178 million myoblasts following myotomy. Short and long-term (2 years) safety and tolerability were observed in all the patients, with no adverse effects. There was an improvement in the quality of life score for all 12 patients, and no functional degradation in swallowing was observed for 10 patients. A cell dose-dependant improvement in swallowing was even observed in this study. This trial supports the hypothesis that a local injection of autologous myoblasts in the pharyngeal muscles is a safe and efficient procedure for OPMD patients. PMID:23831596

Through Clinical Observation: The History of Priapism After Spinal Cord Injuries.

PubMed

Turliuc, Mihaela Dana; Turliuc, Serban; Cucu, Andrei Ionut; Tamas, Camelia; Carauleanu, Alexandru; Buzduga, Catalin; Sava, Anca; Dumitrescu, Gabriela Florenta; Costea, Claudia Florida

2018-01-01

Since ancient times, physicians of antiquity noted the occurrence of priapism in some spinal cord injuries. Although priests saw it as a consequence of curses and witchcraft, after clinical observations of the Middle Ages and Renaissance, the first medical hypotheses emerged in the 17th-19th centuries completed and argued by neuroscience and neurology developed in the European laboratories and hospitals. This study aims to present a short overview of the history of clinical observations of posttraumatic male priapism after spinal cord injuries since antiquity until the beginning of the 20th century. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Self-perceived sensory responses to soap and synthetic detergent bars correlate with clinical signs of irritation.

PubMed

Simion, F A; Rhein, L D; Morrison, B M; Scala, D D; Salko, D M; Kligman, A M; Grove, G L

1995-02-01

Epidemiologic studies indicate that after using soaps and other personal care products, many consumers experience irritation. In 50% of the cases the feelings of skin dryness, itching, and stinging occur in the absence of visible signs of irritation. We sought to determine the relation between self-perceived sensory responses of panelists to cleansing products and clinical signs of irritation. A combination of exaggerated arm-washing methods was designed to induce clinical signs of irritation with psychometric techniques developed to quantify sensations. Two studies demonstrated that panelists could reproducibly differentiate between products on the basis of the sensations they felt and that there was a significant correlation (frequently r > 0.80) between these and the observable signs. In the case of skin dryness panelists differentiated products several washing cycles before observable differences were detected. Sensory evaluations of irritation yield additional information on soap and detergent irritancy beyond clinical observations and expand understanding of the irritation process.

Prevention and treatment of chemotherapy-induced neutropenia with the biosimilar filgrastim: a non-interventional observational study of clinical practice patterns.

PubMed

Tesch, Hans; Ulshöfer, Thomas; Vehling-Kaiser, Ursula; Ottillinger, Bertram; Bulenda, Dietmar; Turner, Matthew

2015-01-01

Biosimilars are similar but non-identical versions of existing biological drugs. The HEXAFIL study was an observational study that assessed the clinical usage, safety and efficacy of the biosimilar filgrastim in routine clinical practice in Germany. A total of 1,337 cancer patients received the biosimilar filgrastim for primary prophylaxis (PP), secondary prophylaxis (SP) or interventional treatment (TX) plus chemotherapy. Data including neutropenic complications and adverse events (AEs) were documented for up to 3 consecutive cycles. In cycle 1, 44.9% of the patients received the biosimilar filgrastim as PP, 31.0% as SP, and 23.6% as TX. Approximately 90% of the patients required no modifications to their chemotherapy regimen, with lower rates among the PP/SP versus the TX patients. Neutropenic complications occurred in 7.9%, 6.9%, and 3.9% of the patients (cycles 1, 2, and 3, respectively). Only 1.8% of the patients experienced febrile neutropenia during cycle 1. Earlier and longer filgrastim treatment reduced grade 3/4 leukopenia and neutropenic complications. The observed safety/tolerability profile was as expected; the most common AE (4.3%) was musculoskeletal back/bone pain. In this observational real-life study of clinical practice, the biosimilar filgrastim was effective and well tolerated, with results consistent with those reported in phase II and phase III trials. © 2015 S. Karger GmbH, Freiburg.

Portfolio: a prototype workstation for development and evaluation of tools for analysis and management of digital portal images.

PubMed

Boxwala, A A; Chaney, E L; Fritsch, D S; Friedman, C P; Rosenman, J G

1998-09-01

The purpose of this investigation was to design and implement a prototype physician workstation, called PortFolio, as a platform for developing and evaluating, by means of controlled observer studies, user interfaces and interactive tools for analyzing and managing digital portal images. The first observer study was designed to measure physician acceptance of workstation technology, as an alternative to a view box, for inspection and analysis of portal images for detection of treatment setup errors. The observer study was conducted in a controlled experimental setting to evaluate physician acceptance of the prototype workstation technology exemplified by PortFolio. PortFolio incorporates a windows user interface, a compact kit of carefully selected image analysis tools, and an object-oriented data base infrastructure. The kit evaluated in the observer study included tools for contrast enhancement, registration, and multimodal image visualization. Acceptance was measured in the context of performing portal image analysis in a structured protocol designed to simulate clinical practice. The acceptability and usage patterns were measured from semistructured questionnaires and logs of user interactions. Radiation oncologists, the subjects for this study, perceived the tools in PortFolio to be acceptable clinical aids. Concerns were expressed regarding user efficiency, particularly with respect to the image registration tools. The results of our observer study indicate that workstation technology is acceptable to radiation oncologists as an alternative to a view box for clinical detection of setup errors from digital portal images. Improvements in implementation, including more tools and a greater degree of automation in the image analysis tasks, are needed to make PortFolio more clinically practical.

Clinical and biological effects of demethylating agents on solid tumours - A systematic review.

PubMed

Linnekamp, J F; Butter, R; Spijker, R; Medema, J P; van Laarhoven, H W M

2017-03-01

It is assumed that DNA methylation plays a key role in both tumour development and therapy resistance. Demethylating agents have been shown to be effective in the treatment of haematological malignancies. Based on encouraging preclinical results, demethylating agents may also be effective in solid tumours. This systematic review summarizes the evidence of the effect of demethylating agents on clinical response, methylation and the immune system in solid tumours. We conducted a systematic literature search from 1949 to December 2016, according to the PRISMA guidelines. Studies which evaluated treatment with azacitidine, decitabine, guadecitabine, hydralazine, procaine, MG98 and/or zebularine in patients with solid tumours were included. Data on clinical response, effects on methylation and immune response were extracted. Fifty-eight studies were included: in 13 studies complete responses (CR) were observed, 35 studies showed partial responses (PR), 47 studies stable disease (SD) and all studies except two showed progressive disease (PD). Effects on global methylation were observed in 11/15 studies and demethylation/re-expression of tumour specific genes was seen in 15/17 studies. No clear correlation between (de)methylation and clinical response was observed. In 14 studies immune-related responses were reported, such as re-expression of cancer-testis antigens and upregulation of interferon genes. Demethylating agents are able to improve clinical outcome and alter methylation status in patients with solid tumours. Although beneficial effect has been shown in individual patients, overall response is limited. Further research on biomarker predicting therapy efficacy is indicated, particularly in earlier stage and highly methylated tumours. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

"Perpetual Problem-Solving": An Ethnographic Study of Clinical Reasoning in a Therapeutic Recreation Setting.

ERIC Educational Resources Information Center

Hutchinson, Susan L.; LeBlanc, Adrienne; Booth, Rhonda

2002-01-01

Reviews literature on the concept and practice of clinical reasoning, presenting evidence of clinical reasoning in a therapeutic recreation setting. Data from observations of and interviews with recreation therapists and clients in a Canadian rehabilitation hospital provided evidence of therapists' clinical reasoning practices which supported the…

Designing clinical trials for amblyopia

PubMed Central

Holmes, Jonathan M.

2015-01-01

Randomized clinical trial (RCT) study design leads to one of the highest levels of evidence, and is a preferred study design over cohort studies, because randomization reduces bias and maximizes the chance that even unknown confounding factors will be balanced between treatment groups. Recent randomized clinical trials and observational studies in amblyopia can be taken together to formulate an evidence-based approach to amblyopia treatment, which is presented in this review. When designing future clinical studies of amblyopia treatment, issues such as regression to the mean, sample size and trial duration must be considered, since each may impact study results and conclusions. PMID:25752747

Health effects of intermittent fasting: hormesis or harm? A systematic review.

PubMed

Horne, Benjamin D; Muhlestein, Joseph B; Anderson, Jeffrey L

2015-08-01

Intermittent fasting, alternate-day fasting, and other forms of periodic caloric desistance are gaining popularity in the lay press and among animal research scientists. Whether clinical evidence exists for or is strong enough to support the use of such dietary regimens as health interventions is unclear. This review sought to identify rigorous, clinically relevant research studies that provide high-quality evidence that therapeutic fasting regimens are clinically beneficial to humans. A systematic review of the published literature through January 2015 was performed by using sensitive search strategies to identify randomized controlled clinical trials that evaluated the effects of fasting on either clinically relevant surrogate outcomes (e.g., weight, cholesterol) or actual clinical event endpoints [e.g., diabetes, coronary artery disease (CAD)] and any other studies that evaluated the effects of fasting on clinical event outcomes. Three randomized controlled clinical trials of fasting in humans were identified, and the results were published in 5 articles, all of which evaluated the effects of fasting on surrogate outcomes. Improvements in weight and other risk-related outcomes were found in the 3 trials. Two observational clinical outcomes studies in humans were found in which fasting was associated with a lower prevalence of CAD or diabetes diagnosis. No randomized controlled trials of fasting for clinical outcomes were identified. Clinical research studies of fasting with robust designs and high levels of clinical evidence are sparse in the literature. Whereas the few randomized controlled trials and observational clinical outcomes studies support the existence of a health benefit from fasting, substantial further research in humans is needed before the use of fasting as a health intervention can be recommended. © 2015 American Society for Nutrition.

Evaluating the Impact of Database Heterogeneity on Observational Study Results

PubMed Central

Madigan, David; Ryan, Patrick B.; Schuemie, Martijn; Stang, Paul E.; Overhage, J. Marc; Hartzema, Abraham G.; Suchard, Marc A.; DuMouchel, William; Berlin, Jesse A.

2013-01-01

Clinical studies that use observational databases to evaluate the effects of medical products have become commonplace. Such studies begin by selecting a particular database, a decision that published papers invariably report but do not discuss. Studies of the same issue in different databases, however, can and do generate different results, sometimes with strikingly different clinical implications. In this paper, we systematically study heterogeneity among databases, holding other study methods constant, by exploring relative risk estimates for 53 drug-outcome pairs and 2 widely used study designs (cohort studies and self-controlled case series) across 10 observational databases. When holding the study design constant, our analysis shows that estimated relative risks range from a statistically significant decreased risk to a statistically significant increased risk in 11 of 53 (21%) of drug-outcome pairs that use a cohort design and 19 of 53 (36%) of drug-outcome pairs that use a self-controlled case series design. This exceeds the proportion of pairs that were consistent across databases in both direction and statistical significance, which was 9 of 53 (17%) for cohort studies and 5 of 53 (9%) for self-controlled case series. Our findings show that clinical studies that use observational databases can be sensitive to the choice of database. More attention is needed to consider how the choice of data source may be affecting results. PMID:23648805

Link between immunoexpression of hMLH1 and hMSH2 proteins and clinical-epidemiological aspects of actinic cheilitis*

PubMed Central

Sarmento, Dmitry José de Santana; Godoy, Gustavo Pina; Miguel, Márcia Cristina da Costa; da Silveira, Éricka Janine Dantas

2016-01-01

Background The studies found in the literature associate the immunoexpression of hMLH1 and hMSH2 proteins with histologic aspects, but do not correlate it with clinical and epidemiological data. Objective To evaluate the immunoexpression of hMLH1 and hMSH2 in actinic cheilitis, correlating it with clinical characteristics. Methods We analyzed 40 cases. Histological and immunohistochemical analyses were performed. The following clinical variables were evaluated: gender, age range, ethnicity, clinical aspect and occupational sunlight exposure. Statistical evaluation included the Student t-test, while the significance level was set at 5%. Results Greater immunoexpression of hMLH1 and hMSH2 was observed in females, individuals aged over 40, and mixed-race/black patients. Furthermore, the immunoexpression of these proteins was greater in actinic cheilitis with a white-colored appearance and in patients without occupational sunlight exposure. No statistical differences were observed for the variables studied. Conclusion This study uncovered variations of hMLH1 and hMSH2 protein expression upon evaluation of clinical aspects in actinic cheilitis. PMID:27579741

Link between immunoexpression of hMLH1 and hMSH2 proteins and clinical-epidemiological aspects of actinic cheilitis.

PubMed

Sarmento, Dmitry José de Santana; Godoy, Gustavo Pina; Miguel, Márcia Cristina da Costa; Silveira, Éricka Janine Dantas da

2016-01-01

The studies found in the literature associate the immunoexpression of hMLH1 and hMSH2 proteins with histologic aspects, but do not correlate it with clinical and epidemiological data. To evaluate the immunoexpression of hMLH1 and hMSH2 in actinic cheilitis, correlating it with clinical characteristics. We analyzed 40 cases. Histological and immunohistochemical analyses were performed. The following clinical variables were evaluated: gender, age range, ethnicity, clinical aspect and occupational sunlight exposure. Statistical evaluation included the Student t-test, while the significance level was set at 5%. Greater immunoexpression of hMLH1 and hMSH2 was observed in females, individuals aged over 40, and mixed-race/black patients. Furthermore, the immunoexpression of these proteins was greater in actinic cheilitis with a white-colored appearance and in patients without occupational sunlight exposure. No statistical differences were observed for the variables studied. This study uncovered variations of hMLH1 and hMSH2 protein expression upon evaluation of clinical aspects in actinic cheilitis.

An Observational Case Study of Near-peer Teaching in Medical and Pharmacy Experiential Training.

PubMed

Sharif-Chan, Bayan; Tankala, Dipti; Leong, Christine; Austin, Zubin; Battistella, Marisa

2016-09-25

Objective. To compare peer teaching in a medical and a pharmacy clinical teaching unit and to provide suggestions for future research in pharmacy near-peer teaching. Methods. This exploratory observational study used principles of ethnographic methodology for data collection and analysis. Observations were collected in a large downtown teaching hospital. An average of 4-6 hours per day were spent observing a team of medical trainees from the Faculty (School) of Medicine in the general internal medicine (unit for two weeks, followed by a team of pharmacy trainees in an ambulatory hemodialysis (HD) unit for two weeks. Data was collected through field notes and informal interviews that were audiotaped and subsequently transcribed. Data was interpreted by the observer and reviewed weekly by two impartial pharmacists. Results. Five major themes emerged: (1) influence of peer teaching hierarchy; (2) educational distance between peer learners and teachers; (3) effect of the clinical teaching unit size on peer learning; (4) trainees' perception of their teaching role in the clinical teaching unit; and (5) influence of daily schedule and workload on peer teaching. As opposed to pharmacy, a hierarchy and pyramidal structure of peer teaching was observed in medical experiential training. There appeared to be no effect of educational distance on near peer teaching; however, perception of teaching role and influence of daily schedule affected near-peer teaching. Conclusion. Through initial comparisons of medical and pharmacy clinical teaching units, this study provides a reflection of elements that may be necessary to successfully implement near-peer teaching in pharmacy experiential training. Future studies in this area should assess learning outcomes and participant satisfaction, preceptor workload, and impact on patient care.

An Observational Case Study of Near-peer Teaching in Medical and Pharmacy Experiential Training

PubMed Central

Sharif-Chan, Bayan; Tankala, Dipti; Leong, Christine; Austin, Zubin

2016-01-01

Objective. To compare peer teaching in a medical and a pharmacy clinical teaching unit and to provide suggestions for future research in pharmacy near-peer teaching. Methods. This exploratory observational study used principles of ethnographic methodology for data collection and analysis. Observations were collected in a large downtown teaching hospital. An average of 4-6 hours per day were spent observing a team of medical trainees from the Faculty (School) of Medicine in the general internal medicine (unit for two weeks, followed by a team of pharmacy trainees in an ambulatory hemodialysis (HD) unit for two weeks. Data was collected through field notes and informal interviews that were audiotaped and subsequently transcribed. Data was interpreted by the observer and reviewed weekly by two impartial pharmacists. Results. Five major themes emerged: (1) influence of peer teaching hierarchy; (2) educational distance between peer learners and teachers; (3) effect of the clinical teaching unit size on peer learning; (4) trainees’ perception of their teaching role in the clinical teaching unit; and (5) influence of daily schedule and workload on peer teaching. As opposed to pharmacy, a hierarchy and pyramidal structure of peer teaching was observed in medical experiential training. There appeared to be no effect of educational distance on near peer teaching; however, perception of teaching role and influence of daily schedule affected near-peer teaching. Conclusion. Through initial comparisons of medical and pharmacy clinical teaching units, this study provides a reflection of elements that may be necessary to successfully implement near-peer teaching in pharmacy experiential training. Future studies in this area should assess learning outcomes and participant satisfaction, preceptor workload, and impact on patient care. PMID:27756922

Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice.

PubMed

Janicak, Philip G; Dunner, David L; Aaronson, Scott T; Carpenter, Linda L; Boyadjis, Terrence A; Brock, David G; Cook, Ian A; Lanocha, Karl; Solvason, Hugh B; Bonneh-Barkay, Dafna; Demitrack, Mark A

2013-12-01

Transcranial magnetic stimulation (TMS) is an effective and safe therapy for major depressive disorder (MDD). This study assessed quality of life (QOL) and functional status outcomes for depressed patients after an acute course of TMS. Forty-two, U.S.-based, clinical TMS practice sites treated 307 outpatients with a primary diagnosis of MDD and persistent symptoms despite prior adequate antidepressant pharmacotherapy. Treatment parameters were based on individual clinical considerations and followed the labeled procedures for use of the approved TMS device. Patient self-reported QOL outcomes included change in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the EuroQol 5-Dimensions (EQ-5D) ratings from baseline to end of the acute treatment phase. Statistically significant improvement in functional status on a broad range of mental health and physical health domains was observed on the SF-36 following acute TMS treatment. Similarly, statistically significant improvement in patient-reported QOL was observed on all domains of the EQ-5D and on the General Health Perception and Health Index scores. Improvement on these measures was observed across the entire range of baseline depression symptom severity. These data confirm that TMS is effective in the acute treatment of MDD in routine clinical practice settings. This symptom benefit is accompanied by statistically and clinically meaningful improvements in patient-reported QOL and functional status outcomes.

Learning about systems-based practice in the informal curriculum: a case study in an academic pediatric continuity clinic.

PubMed

Balmer, Dorene; Ruzek, Sheryl; Ludwig, Stephen; Giardino, Angelo P

2007-01-01

Pediatric residents learn about systems-based practice (SBP) explicitly in the formal curriculum and implicitly in the informal curriculum as they engage in practice alongside physician faculty. Recent studies describe innovative ways to address SBP in the formal curriculum for SBP, but the informal curriculum has not been explored. We examined what, and how, third-year pediatric residents learn about SBP in the informal curriculum at one continuity clinic, and to consider how this learning aligns with the formal curriculum. A case study involving 10 third-year pediatric residents and 10 continuity preceptors was conducted at one continuity clinic, housed in a community-based, pediatric primary care center. Data were derived from 5 months (100 hours) of direct observation in the precepting room at the case clinic, semistructured interviews with residents (before and after observation) and with preceptors (after observation). Interview transcripts and notes from observation were inductively coded and analyzed for major themes. Two themes emerged in the informal curriculum. Residents perceived "our system," the academic health system in which they trained and practiced as separate and distinct from the "real system," the larger, societal context of health care. Residents also understood SBP as a commitment to helping individual patients and families navigate the complexities of "our system," dealing with issues that concerned them. Residents learn important lessons about SBP in the informal curriculum in continuity clinic. These lessons may reinforce some elements of the competency-based formal curriculum for SBP, but challenge others.

A waste walk through clinical pharmacy: how do the 'seven wastes' of Lean techniques apply to the practice of clinical pharmacists.

PubMed

Green, Christopher F; Crawford, Victoria; Bresnen, Gaynor; Rowe, Philip H

2015-02-01

This study used a 'Lean' technique, the 'waste walk' to evaluate the activities of clinical pharmacists with reference to the seven wastes described in 'Lean' including 'defects', 'unnecessary motion', 'overproduction', 'transport of products or material', 'unnecessary waiting', 'unnecessary inventory' and 'inappropriate processing'. The objectives of the study were to categorise the activities of ward-based clinical pharmacists into waste and non-waste, provide detail around what constitutes waste activity and quantify the proportion of time attributed to each category. This study was carried out in a district general hospital in the North West of England. Staff were observed using work-sampling techniques, to categorise activity into waste and non-waste, with waste activities being allocated to each of the seven wastes described earlier and subdivided into recurrent themes. Twenty different pharmacists were observed for 1 h on two separate occasions. Of 1440 observations, 342 (23.8%) were categorised as waste with 'defects' and 'unnecessary motion' accounting for the largest proportions of waste activity. Observation of clinical pharmacists' activities has identified that a significant proportion of their time could be categorised as 'waste'. There are practical steps that could be implemented in order to ensure their time is used as productively as possible. Given the challenges facing the UK National Health Service, the adoption of 'Lean' techniques provides an opportunity to improve quality and productivity while reducing costs. © 2014 Royal Pharmaceutical Society.

Observable phenomena that reveal medical students' clinical reasoning ability during expert assessment of their history taking: a qualitative study.

PubMed

Haring, Catharina M; Cools, Bernadette M; van Gurp, Petra J M; van der Meer, Jos W M; Postma, Cornelis T

2017-08-29

During their clerkships, medical students are meant to expand their clinical reasoning skills during their patient encounters. Observation of these encounters could reveal important information on the students' clinical reasoning abilities, especially during history taking. A grounded theory approach was used to analyze what expert physicians apply as indicators in their assessment of medical students' diagnostic reasoning abilities during history taking. Twelve randomly selected clinical encounter recordings of students at the end of the internal medicine clerkships were observed by six expert assessors, who were prompted to formulate their assessment criteria in a think-aloud procedure. These formulations were then analyzed to identify the common denominators and leading principles. The main indicators of clinical reasoning ability were abstracted from students' observable acts during history taking in the encounter. These were: taking control, recognizing and responding to relevant information, specifying symptoms, asking specific questions that point to pathophysiological thinking, placing questions in a logical order, checking agreement with patients, summarizing and body language. In addition, patients' acts and the course, result and efficiency of the conversation were identified as indicators of clinical reasoning, whereas context, using self as a reference, and emotion/feelings were identified by the clinicians as variables in their assessment of clinical reasoning. In observing and assessing clinical reasoning during history taking by medical students, general and specific phenomena to be used as indicators for this process could be identified. These phenomena can be traced back to theories on the development and the process of clinical reasoning.

A short-term clinical evaluation of IPS Empress 2 crowns.

PubMed

Toksavul, Suna; Toman, Muhittin

2007-01-01

The aim of this study was to evaluate the clinical performance of all-ceramic crowns made with the IPS Empress 2 system after an observation period of 12 to 60 months. Seventy-nine IPS Empress 2 crowns were placed in 21 patients. The all-ceramic crowns were evaluated clinically, radiographically, and using clinical photographs. The evaluations took place at baseline (2 days after cementation) and at 6-month intervals for 12 to 60 months. Survival rate of the crowns was determined using Kaplan-Meier statistical analysis. Based on the US Public Health Service criteria, 95.24% of the crowns were rated satisfactory after a mean follow-up period of 58 months. Fracture was registered in only 1 crown. One endodontically treated tooth failed as a result of fracture at the cervical margin area. In this in vivo study, IPS Empress 2 crowns exhibited a satisfactory clinical performance during an observation period ranging from 12 to 60 months.

Reliability of mercury-in-silastic strain gauge plethysmography curve reading: influence of clinical clues and observer variation.

PubMed

Høyer, Christian; Pavar, Susanne; Pedersen, Begitte H; Biurrun Manresa, José A; Petersen, Lars J

2013-08-01

Mercury-in-silastic strain gauge pletysmography (SGP) is a well-established technique for blood flow and blood pressure measurements. The aim of this study was to examine (i) the possible influence of clinical clues, e.g. the presence of wounds and color changes during blood pressure measurements, and (ii) intra- and inter-observer variation of curve interpretation for segmental blood pressure measurements. A total of 204 patients with known or suspected peripheral arterial disease (PAD) were included in a diagnostic accuracy trial. Toe and ankle pressures were measured in both limbs, and primary observers analyzed a total of 804 pressure curve sets. The SGP curves were later reanalyzed separately by two observers blinded to clinical clues. Intra- and inter-observer agreement was quantified using Cohen's kappa and reliability was quantified using intra-class correlation coefficients, coefficients of variance, and Bland-Altman analysis. There was an overall agreement regarding patient diagnostic classification (PAD/not PAD) in 202/204 (99.0%) for intra-observer (κ = 0.969, p < 0.001), and 201/204 (98.5%) for inter-observer readings (κ = 0.953, p < 0.001). Reliability analysis showed excellent correlation between blinded versus non-blinded and inter-observer readings for determination of absolute segmental pressures (all intraclass correlation coefficients ≥ 0.984). The coefficient of variance for determination of absolute segmental blood pressure ranged from 2.9-3.4% for blinded/non-blinded data and from 3.8-5.0% for inter-observer data. This study shows a low inter-observer variation among experienced laboratory technicians for reading strain gauge curves. The low variation between blinded/non-blinded readings indicates that SGP measurements are minimally biased by clinical clues.

Company observational post-marketing studies: drug risk assessment and drug research in special populations--a study-based analysis.

PubMed

Hasford, J; Lamprecht, T

1998-01-01

Company observational post-marketing studies (COPS) claim to provide essential data about drug risks and effectiveness in special populations not admitted to pre-approval clinical trials. Since COPS are often mainly regarded as a marketing activity, this study-based analysis tries to evaluate the scientific contributions of COPS. Thirty-five COPS were identified by hand-searching through medical journals, writing to pharmaceutical manufacturers and using MEDLINE. Fourteen COPS evaluated cardiovascular drugs, 9 evaluated NSAIDs and 12 evaluated various other indications. Thirty-five COPS listed effectiveness, 31 listed safety and 8 listed patient compliance as principal objectives. Not a single COPS included a control group. Seventeen of 21 evaluable COPS mentioned extensive exclusion criteria similar to those in clinical trials. Median observation time was 8 weeks, too short for chronic diseases and for adverse drug reactions with longer latency periods. One new adverse event was regarded. Global assessments of the outcomes by physicians dominated and were not based on objective clinical findings. None of the studies specified any details concerning the standardisation of observations or quality-control procedures. The current COPS scheme does not contribute significantly to our knowledge of drug safety and the effects in special populations. Despite serious criticism over the past 20 years, the poor quality of COPS compared with dramatic improvements of pre-approval trials - implies a need for detailed guidelines for non-experimental phase IV research, similar to the Good Clinical Practice-Guideline of the European Community.

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.

A Retrospective Study of Paresthesia of the Dental Alveolar Nerves

PubMed Central

Nickel, Alfred A.

1990-01-01

Paresthesia is a rare clinical finding subsequent to surgery accompanied by the administration of local anesthetics. A small patient population was identified whose clinical problem may be explained by neurotoxicity due to a local anesthetic metabolite. Reasonable questions arise from these clinical observations that would benefit from prospective studies to explain sensory loss on a biochemical basis. PMID:2077986

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

PubMed Central

2009-01-01

Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. Conclusion The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. Trial registration ClinicalTrials.gov: NCT00964977 PMID:20028566

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

[Observation of Attachment Disorder Symptoms in Middle Childhood].

PubMed

Iwanski, Alexandra; Zimmermann, Peter

2018-05-01

Observation of Attachment Disorder Symptoms in Middle Childhood Attachment in childhood is mainly assessed by observation. In contrast, assessment of attachment disorder symptoms (RAD) is mainly based on caregiver reports. The present study uses a newly developed observation tool (Coding of Attachment Disorder Behavior in Children; Iwanski u. Zimmermann, 2013) to assess attachment disorder symptoms in a group of school-aged children from a risk group for the development of attachment disorder symptoms and non-clinical controls. In addition, caregiver reports on RAD symptoms are also assessed (Relationship Problems Questionnaire; Minnis, Rabe-Hesketh, Wolkind, 2002; Disturbances of Attachment Interview; Smyke u. Zeanah, 1999). Moreover, associations with children's self-concept (Harter, 2012) were studied. Results reveal that children at risk showed more inhibited and disinhibited attachment disorder symptoms and a more negative self-concept compared to non-clinical controls. RAD symptoms are shown in interaction with both the caregiver and a stranger. The use of a reliable and valid observation tool for the diagnostic of attachment disorder symptoms besides ratings of caregivers is recommended for clinical practice and research.

Renal Damage Associated with Silicon Compounds in Dogs*

PubMed Central

Newberne, Paul M.; Wilson, Robert B.

1970-01-01

A number of oral preparations of various forms of silicon were fed to young adult Beagle dogs and young rats of both sexes for a period of four weeks. During the test period the animals were observed for clinical symptoms and urine and blood measurements were made. At the end of the experimental period all animals were sacrificed and subjected to a complete necropsy and histopathologic study. Polydipsia, polyuria, and soft stools in some animals fed sodium silicate and magnesium trisilicate were the only untoward clinical signs observed; all clinical tests on blood and urine were within normal limits. Gross and microscopic renal lesions were observed in dogs fed sodium silicate and magnesium trisilicate but no changes were seen in those animals fed silicon dioxide or aluminium silicate. Lesions were not observed in any of the rats. In view of the large number of commercial preparations which contain sodium silicate and magnesium trisilicate used in human medicine, these compounds deserve further study. Images PMID:5266156

The Use of Videotape Recordings to Teach Clinical Skills (Evaluation and Remediation) In the Fields of Communicative Disorders.

ERIC Educational Resources Information Center

Billeaud, Frances P.

A study was undertaken to evaluate the benefits derived by speech and language pathology students who used video tape recordings to learn diagnosis of communication disorders, to observe professional therapists and therapy programs, and to improve their own clinical techniques through self-observation. The use of video tapes to teach clinical…

Using a didactic model to improve patient observation skills in neonatal intensive care nurse trainees - a pilot study.

PubMed

Solberg, Marianne Trygg; Tandberg, Bente Silnes; Lerdal, Anners

2012-08-01

To implement a didactic model for students specialising in intensive care nursing (n=12) and nurses working in neonatal intensive care units (NICU) (n=17). To evaluate nurse self-assessments following observation of children with congenital heart disease (CHD), before and after participation in the programme, as well as the usefulness of the programme. A pilot study with a pre- and post-test design, using self-administered questionnaires. The didactic model increased the number of clinical observations and assessments of physiological factors made by both students and NICU nurses during evaluation of children with suspected CHD. The majority of nurses reported that both participation in the programme and the didactic model were useful and they demonstrated high-level knowledge, according to Bloom's taxonomy for cognitive learning. In particular, subjects found that the literature provided and structured bedside guidance in the clinical setting assisted learning. Intensive care students and NICU nurses performed clinical observations and physical factor assessments more frequently after completing the programme, compared with baseline. We speculate that this didactic model may also be useful in other clinical settings. Copyright © 2011 Elsevier Ltd. All rights reserved.

Key observations from the NHLBI Asthma Clinical Research Network.

PubMed

Szefler, Stanley J; Chinchilli, Vernon M; Israel, Elliot; Denlinger, Loren Clark; Lemanske, Robert F; Calhoun, William; Peters, Stephen P

2012-05-01

The National Heart, Lung and Blood Institute (NHLBI) Asthma Clinical Research Network (ACRN) recently completed its work after 20 years of collaboration as a multicentre clinical trial network. When formed, its stated mission was to perform multiple controlled clinical trials for treating patients with asthma by dispassionately examining new and existing therapies, and to rapidly communicate its findings to the medical community. The ACRN conducted 15 major clinical trials. In addition, clinical data, manual of operations, protocols and template informed consents from all ACRN trials are available via NHLBI BioLINCC (https://biolincc.nhlbi.nih.gov/studies/). This network contributed major insights into the use of inhaled corticosteroids, short-acting and long-acting ß-adrenergic agonists, leukotriene receptor antagonists, and novel agents (tiotropium, colchicine and macrolide antibiotics). They also pioneered studies of the variability in drug response, predictors of treatment response and pharmacogenetics. This review highlights the major research observations from the ACRN that have impacted the current management of asthma.

Establishing the feasibility of direct observation in the assessment of tics in children with chronic tic disorders.

PubMed

Himle, Michael B; Chang, Susanna; Woods, Douglas W; Pearlman, Amanda; Buzzella, Brian; Bunaciu, Liviu; Piacentini, John C

2006-01-01

Behavior analysis has been at the forefront in establishing effective treatments for children and adults with chronic tic disorders. As is customary in behavior analysis, the efficacy of these treatments has been established using direct-observation assessment methods. Although behavior-analytic treatments have enjoyed acceptance and integration into mainstream health care practices for tic disorders (e.g., psychiatry and neurology), the use of direct observation as a primary assessment tool has been neglected in favor of less objective methods. Hesitation to use direct observation appears to stem largely from concerns about the generalizability of clinic observations to other settings (e.g., home) and a lack of consensus regarding the most appropriate and feasible techniques for conducting and scoring direct observation. The purpose of the current study was to evaluate and establish a reliable, valid, and feasible direct-observation protocol capable of being transported to research and clinical settings. A total of 43 children with tic disorders, collected from two outpatient specialty clinics, were assessed using direct (videotape samples) and indirect (Yale Global Tic Severity Scale; YGTSS) methods. Videotaped observation samples were collected across 3 consecutive weeks and two different settings (clinic and home), were scored using both exact frequency counts and partial-interval coding, and were compared to data from a common indirect measure of tic severity (the YGTSS). In addition, various lengths of videotaped segments were scored to determine the optimal observation length. Results show that (a) clinic-based observations correspond well to home-based observations, (b) brief direct-observation segments scored with time-sampling methods reliably quantified tics, and (c) indirect methods did not consistently correspond with the direct methods.

Clinical manifestations of tension pneumothorax: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Although health care providers utilize classically described signs and symptoms to diagnose tension pneumothorax, available literature sources differ in their descriptions of its clinical manifestations. Moreover, while the clinical manifestations of tension pneumothorax have been suggested to differ among subjects of varying respiratory status, it remains unknown if these differences are supported by clinical evidence. Thus, the primary objective of this study is to systematically describe and contrast the clinical manifestations of tension pneumothorax among patients receiving positive pressure ventilation versus those who are breathing unassisted. Methods/Design We will search electronic bibliographic databases (MEDLINE, PubMed, EMBASE, and the Cochrane Database of Systematic Reviews) and clinical trial registries from their first available date as well as personal files, identified review articles, and included article bibliographies. Two investigators will independently screen identified article titles and abstracts and select observational (cohort, case–control, and cross-sectional) studies and case reports and series that report original data on clinical manifestations of tension pneumothorax. These investigators will also independently assess risk of bias and extract data. Identified data on the clinical manifestations of tension pneumothorax will be stratified according to whether adult or pediatric study patients were receiving positive pressure ventilation or were breathing unassisted, as well as whether the two investigators independently agreed that the clinical condition of the study patient(s) aligned with a previously published tension pneumothorax working definition. These data will then be summarized using a formal narrative synthesis alongside a meta-analysis of observational studies and then case reports and series where possible. Pooled or combined estimates of the occurrence rate of clinical manifestations will be calculated using random effects models (for observational studies) and generalized estimating equations adjusted for reported potential confounding factors (for case reports and series). Discussion This study will compile the world literature on tension pneumothorax and provide the first systematic description of the clinical manifestations of the disorder according to presenting patient respiratory status. It will also demonstrate a series of methods that may be used to address difficulties likely to be encountered during the conduct of a meta-analysis of data contained in published case reports and series. PROSPERO registration number: CRD42013005826. PMID:24387082

Assessment of cumulative exposure to UVA through the study of asymmetrical facial skin aging.

PubMed

Mac-Mary, Sophie; Sainthillier, Jean-Marie; Jeudy, Adeline; Sladen, Christelle; Williams, Cara; Bell, Mike; Humbert, Philippe

2010-09-23

Published studies assessing whether asymmetrical facial ultraviolet light exposure leads to underlying differences in skin physiology and morphology report only clinical observations. The aim of this study was to assess the visual impact on the skin of repeated ultraviolet-A (UVA) exposure through a window. Eight women and two men presenting with asymmetrical signs of photoaging due to overexposure of one side of their face to the sun through a window over a long period of time were enrolled in the study. Split-face biometrologic assessments were performed (clinical scoring, hydration with Corneometer, mechanical properties with Cutometer, transepidermal water loss with AquaFlux, skin relief with fringe projection, photography, stripping, and then lipid peroxidation analysis). Significant differences were observed in clinical scores for wrinkles, skin roughness assessed by fringe projection on the cheek, and skin heterogeneity assessed with spectrocolorimetry on the cheekbone. Other differences were observed for skin hydration, as well as skin laxity, which tended towards significance. This study suggests the potential benefit of daily UVA protection during nondeliberate exposure indoors as well as outside.

Association between painful physical symptoms and clinical outcomes in East Asian patients with major depressive disorder: a 3-month prospective observational study.

PubMed

Ang, Q Q; Wing, Y K; He, Y; Sulaiman, A H; Chiu, N-Y; Shen, Y-C; Wang, G; Zhang, C; Lee, K-H; Singh, P; Granger, R E; Raskin, J; Dossenbach, M

2009-07-01

Reports from non-Asian populations indicate that painful physical symptoms (PPS) are associated with poorer clinical and functional outcomes in major depressive disorder (MDD). The purpose of this study is to report comparative changes in disease severity, treatment patterns and quality of life observed in East Asian patients with MDD, with and without PPS, as assessed prospectively over a 3-month observation period. This observational study enrolled 909 patients with MDD in psychiatric care settings in China, Hong Kong, Korea, Malaysia, Singapore and Taiwan. Patients were classified as PPS positive (PPS+) or negative (PPS-) based on mean modified Somatic Symptom Inventory scores of >or= 2 or < 2 respectively. The Clinical Global Impression of Severity (CGI-S) and 17-item Hamilton Depression Rating Scale (HAMD(17)) determined depression severity; a visual analogue scale (VAS) determined pain severity; and the EuroQoL (EQ-5D) assessed well-being after 3 months observation. Of the 909 enrollees, 355/471 (75.4%) of PPS+ patients and 363/438 (82.9%) of PPS- patients completed the study (p = 0.006). PPS+ patients improved less than PPS- patients on depression, pain and quality of life measures during the study (HAMD(17) p < 0.001, CGI-S p < 0.001, VAS p = 0.008 and EQ-5D p = 0.004). Fewer PPS+ patients (46.5%) achieved remission compared with PPS- patients (69.4%, p < 0.001). As the presence of PPS is associated with poorer outcomes in East Asian MDD patients, clinical management should aim to address both the mental and PPS associated with MDD.

Clinical symptoms predict concurrent social and global functioning in an early psychosis sample.

PubMed

Cacciotti-Saija, Cristina; Langdon, Robyn; Ward, Philip B; Hickie, Ian B; Guastella, Adam J

2018-04-01

Although well established in chronic schizophrenia, the key determinants of functioning remain unknown during the early phase of a psychotic disorder. The aim of this study was to comprehensively examine the social cognitive, basic neurocognitive and clinical predictors of concurrent social functioning and global functioning in an early psychosis sample. This study examined the relationship between social cognition, basic neurocognition and clinical symptoms with concurrent functioning in 51 early psychosis individuals. Assessments included a range of self-report, observational and clinician-rated measures of cognitive, symptom severity and functioning domains. Results revealed a significant association between self-reported social function and lower levels of both social interaction anxiety and negative psychotic symptoms. A significant association was also observed between lower levels of negative psychotic symptoms and observed social functioning. Lastly, results demonstrated a significant association between reduced negative psychotic symptoms and clinician-rated global functioning. Clinical domains such as negative symptoms and social interaction anxiety significantly contribute to an optimal model predicting outcome during the early phase of a psychotic disorder. These clinical features may also provide useful markers of an individual's capacity for social participation. Clinical implications include the need for early targeted intervention to address social anxiety and negative psychotic symptoms to facilitate optimum patient outcome. © 2015 Wiley Publishing Asia Pty Ltd.

Home Videophones Improve Direct Observation in Tuberculosis Treatment: A Mixed Methods Evaluation

PubMed Central

Wade, Victoria A.; Karnon, Jonathan; Eliott, Jaklin A.; Hiller, Janet E.

2012-01-01

Background The use of direct observation to monitor tuberculosis treatment is controversial: cost, practical difficulties, and lack of patient acceptability limit effectiveness. Telehealth is a promising alternative delivery method for improving implementation. This study aimed to evaluate the clinical and cost-effectiveness of a telehealth service delivering direct observation, compared to an in-person drive-around service. Methodology/Principal Findings The study was conducted within a community nursing service in South Australia. Telehealth patients received daily video calls at home on a desktop videophone provided by the nursing call center. A retrospective cohort study assessed the effectiveness of the telehealth and traditional forms of observation, defined by the proportion of missed observations recorded in case notes. This data was inputted to a model, estimating the incremental cost-effectiveness ratio (ICER) of telehealth. Semi-structured interviews were conducted with current patients, community nursing and Chest Clinic staff, concerning service acceptability, usability and sustainability. The percentage of missed observations for the telehealth service was 12.1 (n = 58), compared to 31.1 for the in-person service (n = 70). Most of the difference of 18.9% (95% CI: 12.2 – 25.4) was due to fewer pre-arranged absences. The economic analysis calculated the ICER to be AUD$1.32 (95% CI: $0.51 – $2.26) per extra day of successful observation. The video service used less staff time, and became dominant if implemented on a larger scale and/or with decreased technology costs. Qualitative analysis found enabling factors of flexible timing, high patient acceptance, staff efficiency, and Chest Clinic support. Substantial technical problems were manageable, and improved liaison between the nursing service and Chest Clinic was an unexpected side-benefit. Conclusions/Significance Home video observation is a patient-centered, resource efficient way of delivering direct observation for TB, and is cost-effective when compared with a drive-around service. Future research is recommended to determine applicability and effectiveness in other settings. PMID:23226243

The Effect of Ginger (Zingiber officinale) on Platelet Aggregation: A Systematic Literature Review.

PubMed

Marx, Wolfgang; McKavanagh, Daniel; McCarthy, Alexandra L; Bird, Robert; Ried, Karin; Chan, Alexandre; Isenring, Liz

2015-01-01

The potential effect of ginger on platelet aggregation is a widely-cited concern both within the published literature and to clinicians; however, there has been no systematic appraisal of the evidence to date. Using the PRISMA guidelines, we systematically reviewed the results of clinical and observational trials regarding the effect of ginger on platelet aggregation in adults compared to either placebo or baseline data. Studies included in this review stipulated the independent variable was a ginger preparation or isolated ginger compound, and used measures of platelet aggregation as the primary outcome. Ten studies were included, comprising eight clinical trials and two observational studies. Of the eight clinical trials, four reported that ginger reduced platelet aggregation, while the remaining four reported no effect. The two observational studies also reported mixed findings. Many of the studies appraised for this review had moderate risks of bias. Methodology varied considerably between studies, notably the timeframe studied, dose of ginger used, and the characteristics of subjects recruited (e.g. healthy vs. patients with chronic diseases). The evidence that ginger affects platelet aggregation and coagulation is equivocal and further study is needed to definitively address this question.

The Effect of Ginger (Zingiber officinale) on Platelet Aggregation: A Systematic Literature Review

PubMed Central

Marx, Wolfgang; McKavanagh, Daniel; McCarthy, Alexandra L.; Bird, Robert; Ried, Karin; Chan, Alexandre; Isenring, Liz

2015-01-01

Background The potential effect of ginger on platelet aggregation is a widely-cited concern both within the published literature and to clinicians; however, there has been no systematic appraisal of the evidence to date. Methods Using the PRISMA guidelines, we systematically reviewed the results of clinical and observational trials regarding the effect of ginger on platelet aggregation in adults compared to either placebo or baseline data. Studies included in this review stipulated the independent variable was a ginger preparation or isolated ginger compound, and used measures of platelet aggregation as the primary outcome. Results Ten studies were included, comprising eight clinical trials and two observational studies. Of the eight clinical trials, four reported that ginger reduced platelet aggregation, while the remaining four reported no effect. The two observational studies also reported mixed findings. Discussion Many of the studies appraised for this review had moderate risks of bias. Methodology varied considerably between studies, notably the timeframe studied, dose of ginger used, and the characteristics of subjects recruited (e.g. healthy vs. patients with chronic diseases). Conclusion The evidence that ginger affects platelet aggregation and coagulation is equivocal and further study is needed to definitively address this question. PMID:26488162

Seeing beyond monitors-Critical care nurses' multiple skills in patient observation: Descriptive qualitative study.

PubMed

Alastalo, Mika; Salminen, Leena; Lakanmaa, Riitta-Liisa; Leino-Kilpi, Helena

2017-10-01

The aim of this study was to provide a comprehensive description of multiple skills in patient observation in critical care nursing. Data from semi-structured interviews were analysed using thematic analysis. Experienced critical care nurses (n=20) from three intensive care units in two university hospitals in Finland. Patient observation skills consist of: information gaining skills, information processing skills, decision-making skills and co-operation skills. The first three skills are integrated in the patient observation process, in which gaining information is a prerequisite for processing information that precedes making decisions. Co-operation has a special role as it occurs throughout the process. This study provided a comprehensive description of patient observation skills related to the three-phased patient observation process. The findings contribute to clarifying this part of the competence. The description of patient observation skills may be applied in both clinical practice and education as it may serve as a framework for orientation, ensuring clinical skills and designing learning environments. Based on this study, patient observation skills can be recommended to be included in critical care nursing education, orientation and as a part of critical care nurses' competence evaluation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Antiseptic with modern wound dressings in the treatment of venous leg ulcers: clinical and microbiological aspects.

PubMed

Sopata, M; Kucharzewski, M; Tomaszewska, E

2016-08-01

To assess the impact of a two-period treatment on the clinical condition, bacteriological changes and results of treatment of venous leg ulcers (VLU) using octenidine dihydrochloride. Patients with a VLU were recruited and treated with octenidine dihydrochloride for one month, after which they were randomised and treated with hydrocolloids or foam dressings. The wounds were clinically assessed for the amount of necrotic tissue, granulation tissue, epithelialisation, amount of exudate and pain level. During the first period, bacterial colonisation and antimicrobial efficacy of octenidine dihydrochloride were also evaluated. In the second period the efficacy of treatment, time of treatment and healing rate were investigated. In the group of 50 VLU patients, all wounds (100%) improved after the first treatment period. No clinical signs of infection were observed. Statistically significant changes were observed in all the clinical parameters studied in the treated groups of VLU patients, including reduction of necrotic tissue, the amount of exudate and of pain, as well as increased granulation and epithelialisation. In the second period including treatment with the two dressings, no differences were observed in treatment efficacy, time of treatment or healing rate. As used in this study, octenidine dihydrochloride proved to be effective and useful, changing the clinical condition of VLU, preparing the wound for future treatment with modern dressings. High microbicidal activity of octenidine was observed, both against Gram-negative and Gram-positive bacteria isolated from the ulcers. Octenidine dihydrochloride caused an eradication of multiresistant strains (88%) as well as of bacteria qualified as alert-pathogens (100%) in the treated wounds after four weeks. However, no differences in the effects, time or rate of healing of VLU with two dressings were found in the second period. No side effects or significant local intolerance reactions used for treatment were observed.

[Nursing students' satisfaction and perception of their first clinical placement: observational study].

PubMed

Comparcini, Dania; Simonetti, Valentina; Tomietto, Marco; Galli, Francesco; Fiorani, Catia; Di Labio, Luisa; Cicolini, Giancarlo

2014-01-01

Clinical learning environments are defined as an interactive network of forces within the clinical context that influence students' learning outcomes. Nursing students' satisfaction could be strictly related to their learning outcomes. Aim. To analyze the first year nursing students' clinical learning experience and to identify the main determinants of students' satisfaction. The observational study was carried out in five Italian nursing degree courses. 420 students filled out the validated Italian version of the "Clinical Learning Environment and Supervision plus Nurse Teacher (CLES+T) scale" after the conclusion of their first clinical placement. The mean values of the main sub-dimensions of CLES+T varied from 4.02 (pedagogical atmosphere) to 3.30 (supervisory relationship). Students were mainly satisfied with their clinical placement, however the findings showed statistical significantly differences among the five nursing courses. The main determinants of the overall students' satisfaction are the nurse manager's leadership style and the integration between theoretical knowledge and everyday practice of nursing through the relationship among students, clinical tutors and nurse teacher. Our results may contribute to better understand nursing students' perception of their first clinical placement. However, further research are needed to evaluate which organizational factors and clinical training models may enhance the clinical learning experience.

Educating for health service reform: clinical learning, governance and capability - a case study protocol.

PubMed

Gardner, Anne; Gardner, Glenn; Coyer, Fiona; Gosby, Helen

2016-01-01

The nurse practitioner is a growing clinical role in Australia and internationally, with an expanded scope of practice including prescribing, referring and diagnosing. However, key gaps exist in nurse practitioner education regarding governance of specialty clinical learning and teaching. Specifically, there is no internationally accepted framework against which to measure the quality of clinical learning and teaching for advanced specialty practice. A case study design will be used to investigate educational governance and capability theory in nurse practitioner education. Nurse practitioner students, their clinical mentors and university academic staff, from an Australian university that offers an accredited nurse practitioner Master's degree, will be invited to participate in the study. Semi-structured interviews will be conducted with students and their respective clinical mentors and university academic staff to investigate learning objectives related to educational governance and attributes of capability learning. Limited demographic data on age, gender, specialty, education level and nature of the clinical healthcare learning site will also be collected. Episodes of nurse practitioner student specialty clinical learning will be observed and documentation from the students' healthcare learning sites will be collected. Descriptive statistics will be used to report age groups, areas of specialty and types of facilities where clinical learning and teaching is observed. Qualitative data from interviews, observations and student documents will be coded, aggregated and explored to inform a framework of educational governance, to confirm the existing capability framework and describe any additional characteristics of capability and capability learning. This research has widespread significance and will contribute to ongoing development of the Australian health workforce. Stakeholders from industry and academic bodies will be involved in shaping the framework that guides the quality and governance of clinical learning and teaching in specialty nurse practitioner practice. Through developing standards for advanced clinical learning and teaching, and furthering understanding of capability theory for advanced healthcare practitioners, this research will contribute to evidence-based models of advanced specialty postgraduate education.

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.

Clinical decision making in dermatology: observation of consultations and the patients' perspectives.

PubMed

Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-01-01

Clinical decision making is a complex process and might be influenced by a wide range of clinical and non-clinical factors. Little is known about this process in dermatology. The aim of this study was to explore the different types of management decisions made in dermatology and to identify factors influencing those decisions from observation of consultations and interviews with the patients. 61 patient consultations were observed by a physician with experience in dermatology. The patients were interviewed immediately after each consultation. Consultations and interviews were audio recorded, transcribed and their content analysed using thematic content analysis. The most common management decisions made during the consultations included: follow-up, carrying out laboratory investigation, starting new topical treatment, renewal of systemic treatment, renewal of topical treatment, discharging patients and starting new systemic treatment. Common influences on those decisions included: clinical factors such as ineffectiveness of previous therapy, adherence to prescribing guidelines, side-effects of medications, previous experience with the treatment, deterioration or improvement in the skin condition, and chronicity of skin condition. Non-clinical factors included: patient's quality of life, patient's friends or relatives, patient's time commitment, travel or transportation difficulties, treatment-related costs, availability of consultant, and availability of treatment. The study has shown that patients are aware that management decisions in dermatology are influenced by a wide range of clinical and non-clinical factors. Education programmes should be developed to improve the quality of decision making. Copyright © 2010 S. Karger AG, Basel.

A phase I clinical study of immunotherapy for advanced colorectal cancers using carcinoembryonic antigen-pulsed dendritic cells mixed with tetanus toxoid and subsequent IL-2 treatment.

PubMed

Liu, Ko-Jiunn; Chao, Tsu-Yi; Chang, Jang-Yang; Cheng, Ann-Lii; Ch'ang, Hui-Ju; Kao, Woei-Yau; Wu, Yu-Chen; Yu, Wei-Lan; Chung, Tsai-Rong; Whang-Peng, Jacqueline

2016-08-24

To better evaluate and improve the efficacy of dendritic cell (DC)-based cancer immunotherapy, we conducted a clinical study of patients with advanced colorectal cancer using carcinoembryonic antigen (CEA)-pulsed DCs mixed with tetanus toxoid and subsequent interleukin-2 treatment. The tetanus toxoid in the vaccine preparation serves as an adjuvant and provides a non-tumor specific immune response to enhance vaccine efficacy. The aims of this study were to (1) evaluate the toxicity of this treatment, (2) observe the clinical responses of vaccinated patients, and (3) investigate the immune responses of patients against CEA before and after treatment. Twelve patients were recruited and treated in this phase I clinical study. These patients all had metastatic colorectal cancer and failed standard chemotherapy. We first subcutaneously immunized patients with metastatic colorectal cancer with 1 × 10(6) CEA-pulsed DCs mixed with tetanus toxoid as an adjuvant. Patients received 3 successive injections with 1 × 10(6) CEA-pulsed DCs alone. Low-dose interleukin-2 was administered subcutaneously following the final DC vaccination to boost the growth of T cells. Patients were evaluated for adverse event and clinical status. Blood samples collected before, during, and after treatment were analyzed for T cell proliferation responses against CEA. No severe treatment-related side effects or toxicity was observed in patients who received the regular 4 DC vaccine injections. Two patients had stable disease and 10 patients showed disease progression. A statistically significant increase in proliferation against CEA by T cells collected after vaccination was observed in 2 of 9 patients. The results of this study indicate that it is feasible and safe to treat colorectal cancer patients using this protocol. An increase in the anti-CEA immune response and a clinical benefit was observed in a small fraction of patients. This treatment protocol should be further evaluated in additional colorectal cancer patients with modifications to enhance T cell responses. ClinicalTrials.gov (identifier NCT00154713 ), September 8, 2005.

Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

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

Mishra, Mark V., E-mail: mmishra@umm.edu; Aggarwal, Sameer; Bentzen, Soren M.

Purpose: To review and assess ongoing proton beam therapy (PBT) clinical trials and to identify major gaps. Methods and Materials: Active PBT clinical trials were identified from (clinicaltrials.gov) and the World Health Organization International Clinical Trials Platform Registry. Data on clinical trial disease site, age group, projected patient enrollment, expected start and end dates, study type, and funding source were extracted. Results: A total of 122 active PBT clinical trials were identified, with target enrollment of >42,000 patients worldwide. Ninety-six trials (79%), with a median planned sample size of 68, were classified as interventional studies. Observational studies accounted for 21% ofmore » trials but 71% (n=29,852) of planned patient enrollment. The most common PBT clinical trials focus on gastrointestinal tract tumors (21%, n=26), tumors of the central nervous system (15%, n=18), and prostate cancer (12%, n=15). Five active studies (lung, esophagus, head and neck, prostate, breast) will randomize patients between protons and photons, and 3 will randomize patients between protons and carbon ion therapy. Conclusions: The PBT clinical trial portfolio is expanding rapidly. Although the majority of ongoing studies are interventional, the majority of patients will be accrued to observational studies. Future efforts should focus on strategies to encourage optimal patient enrollment and retention, with an emphasis on randomized, controlled trials, which will require support from third-party payers. Results of ongoing PBT studies should be evaluated in terms of comparative effectiveness, as well as incremental effectiveness and value offered by PBT in comparison with conventional radiation modalities.« less

Dental findings and oral health status in patients with mucopolysaccharidosis: a case series.

PubMed

Antunes, Lívia Azeredo Alves; Nogueira, Ana Paula Barreto; Castro, Glória Fernanda; Ribeiro, Márcia Gonçalves; de Souza, Ivete Pomarico Ribeiro

2013-01-01

To present a mucopolysaccharidosis (MPS) case series evaluating oral manifestations (clinical and radiographic), oral health status and discussing its implications. All patients with MPS attending the Genetics clinic/Brazil were evaluated by means of anamnesis, clinical and radiographic examinations. The final sample consisted of 12 subjects (nine males and three females), with ages ranging from 3-31 years old. Concerning oral health, it was observed high levels of caries and periodontal problems. About oral manifestations, this study clinically observed more cases of delayed tooth eruption, thickness of alveolar process and thick lips. Radiographically, it was observed alterations on condyle, mandibular ramus and joint fossa. The dental changes in MPS population are high and consequently it is important to know them for differential diagnoses, early treatment intervention, prevention and education of both patients and parents/caregivers about oral health.

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

PubMed Central

2012-01-01

Background Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory. Methods Adults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study. Discussion This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement. PMID:22264273

Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

PubMed

Kiguba, Ronald; Kutyabami, Paul; Kiwuwa, Stephen; Katabira, Elly; Sewankambo, Nelson K

2012-08-21

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

Recovery in patients with major depressive disorder (MDD): results of a 6-month, multinational, observational study.

PubMed

Novick, Diego; Montgomery, William; Vorstenbosch, Ellen; Moneta, Maria Victoria; Dueñas, Héctor; Haro, Josep Maria

2017-01-01

Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression.

Truth telling in medical practice: students' opinions versus their observations of attending physicians' clinical practice.

PubMed

Tang, Woung-Ru; Fang, Ji-Tseng; Fang, Chun-Kai; Fujimori, Maiko

2013-07-01

Truth telling or transmitting bad news is a problem that all doctors must frequently face. The purpose of this cross-sectional study was to investigate if medical students' opinions of truth telling differed from their observations of attending physicians' actual clinical practice. The subjects were 275 medical clerks/interns at a medical center in northern Taiwan. Data were collected on medical students' opinions of truth telling, their observations of physicians' clinical practice, students' level of satisfaction with truth telling practiced by attending physicians, and cancer patients' distress level when they were told the truth. Students' truth-telling awareness was significantly higher than the clinical truth-telling practice of attending physicians (p<0.001), and the means for these parameters had a moderate difference, especially in three aspects: method, emotional support, and providing additional information (p<0.001). Regardless of this difference, students were satisfied with the truth telling of attending physicians (mean ± SD=7.33 ± 1.74). However, our data also show that when cancer patients were informed of bad news, they all experienced medium to above average distress (5.93 ± 2.19). To develop the ability to tell the truth well, one must receive regular training in communication skills, including experienced attending physicians. This study found a significant difference between medical students' opinions on truth telling and attending physicians' actual clinical practice. More research is needed to objectively assess physicians' truth telling in clinical practice and to study the factors affecting the method of truth telling used by attending physicians in clinical practice. Copyright © 2012 John Wiley & Sons, Ltd.

Salicylic acid for the treatment of melasma: new acquisitions for monitoring the clinical improvement.

PubMed

Fabbrocini, Gabriella; De Vita, Valerio; Marasca, Claudio; Palmisano, Franco; Monfrecola, Giuseppe

2013-11-01

The Melasma Area and Severity Index (MASI) and the Melasma Severity Score (MSS) are calculated on the basis of only a subjective clinical assessment. This raises the need to have an objective score, uniform in the evaluation by different clinicians. The purpose of this study was to establish if the images by Canfield Reveal Imager can be correlated to MASI score to better evaluate the clinical efficacy of salicylic acid 33% peeling in the treatment of melasma respect to the clinical observation. The study was a voluntary observational study. Twenty female patients affected with melasma, aged between 30 and 60 years, were included in the study. Treatment with salicylic acid 33% was performed once a month, for a total of four times. The dermatologist (Doc A) examined each patient's melasma areas using MASI score, at the face-to-face observation and at Reveal images evaluation during the first (T0) and the end point time (T4). Digital photographs were also evaluated by another experienced dermatologist (Doc B), who has never seen clinically the patients before and who evaluated MASI score by Reveal images at time T0 and T4. Student's t-test and linear regression test were performed, showing statistically significant values comparing MASI score obtained by digital photo and MASI score obtained clinically. The monitoring of the improvement by Reveal images can optimize the treatment approach and the efficacy of same dermocosmetics procedures can be revised following standard criteria. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Skin problems of the stump in lower limb amputees: 1. A clinical study.

PubMed

Meulenbelt, Henk E J; Geertzen, Jan H B; Jonkman, Marcel F; Dijkstra, Pieter U

2011-03-01

Use of a prosthesis in lower limb amputees can lead to skin problems of the amputation stump. However, little is known about the epidemiology and type of problems experienced. We conducted a cross-sectional survey consisting of a questionnaire and a clinical assessment of the amputation stump. The aims of the study were to estimate the prevalence of skin problems of the amputation stump, to evaluate the impact of these skin problems and to evaluate differences between clinically observed skin problems and skin problems reported by the amputee. Participants (n = 124) were recruited from among lower limb amputees who visited an orthopaedic workshop. The prevalence of skin problems was 36%. Problems identified were: reduction in prosthesis use, and reduction in walking distance without a break. Significantly more skin problems were reported than observed (p = 0.011). Cold skin and excessive perspiration in particular were significantly more reported than observed.

The impact of extended longitudinal observation on the assessment of personality disorders.

PubMed

Pedersen, G; Karterud, S; Hummelen, B; Wilberg, T

2013-11-01

Multiple sources of information are necessary for a valid assessment of personality disorders (PDs). This study investigates the impact of longitudinal observation. The sample comprised 1217 patients from 15 different treatment units. PDs were assessed at admission to treatment using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) and additional clinical information (best estimate diagnosis). After approximately 18 weeks of treatment, the SCID-II protocols were re-examined at clinical conferences and the diagnostic status reassessed on the basis of longitudinal observations in multiple group situations (longitudinal, expert, all data principle). Using this procedure, 78% of the patients' diagnostic criteria sets were changed, and 32% of patients' diagnostic statuses were changed. Many (32%) patients who were evaluated initially as not having a PD received a PD diagnosis after re-examination. The information provided by customary clinical assessment has important limitations, and longitudinal observation provides additional information that may change the diagnostic status in approximately one-third of PD cases. Copyright © 2013 John Wiley & Sons, Ltd.

Convergence between observations and interviews in clinical diagnosis of reactive attachment disorder and disinhibited social engagement disorder.

PubMed

Giltaij, Hans Peter; Sterkenburg, Paula Sophia; Schuengel, Carlo

2017-10-01

A comprehensive approach is needed for diagnosing disordered attachment behavior due to the multifaceted nature of attachment. Differences between various indicators can pose a challenge for deciding on the proper diagnosis. This study assessed the convergence between clinical interview assessment and observation-based clinical diagnosis, and their linkages with inadequate care. Participating children ( N = 55) had intelligence quotients (IQs) between 50 and 85 and were referred for psychiatric consultation. Data were obtained by structured review of medical records, the Disturbances of Attachment Interview (DAI), and the Clinical Observation of Attachment (COA) procedure. Of the 18 children identified using the DAI with Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) diagnosis of reactive attachment disorder (RAD) and/or disinhibited social engagement disorder (DSED), only 7 received a clinical DSM-5 diagnosis of RAD and/or DSED. Observed maladaptive attachment behavior in the COA was strongly associated with DAI scores and with clinical diagnosis of DSM-5 RAD and/or DSED. There was a significantly higher prevalence of extremes of insufficient care in children who were classified with RAD by DAI or DSM-5 and/or with DSED by DSM-5 compared to those with no attachment disorder. Using structured observation and record assessment leads to more conservative identification of RAD or DSED than using the DAI.

Comparing the Hematopoetic Syndrome Time Course in the NHP Animal Model to Radiation Accident Cases From the Database Search.

PubMed

Graessle, Dieter H; Dörr, Harald; Bennett, Alexander; Shapiro, Alla; Farese, Ann M; MacVittie, Thomas J; Meineke, Viktor

2015-11-01

Since controlled clinical studies on drug administration for the acute radiation syndrome are lacking, clinical data of human radiation accident victims as well as experimental animal models are the main sources of information. This leads to the question of how to compare and link clinical observations collected after human radiation accidents with experimental observations in non-human primate (NHP) models. Using the example of granulocyte counts in the peripheral blood following radiation exposure, approaches for adaptation between NHP and patient databases on data comparison and transformation are introduced. As a substitute for studying the effects of administration of granulocyte-colony stimulating factor (G-CSF) in human clinical trials, the method of mathematical modeling is suggested using the example of G-CSF administration to NHP after total body irradiation.

Radiology image perception and observer performance: How does expertise and clinical information alter interpretation? Stroke detection explored through eye-tracking

NASA Astrophysics Data System (ADS)

Cooper, Lindsey; Gale, Alastair; Darker, Iain; Toms, Andoni; Saada, Janak

2009-02-01

Historically, radiology research has been dominated by chest and breast screening. Few studies have examined complex interpretative tasks such as the reading of multidimensional brain CT or MRI scans. Additionally, no studies at the time of writing have explored the interpretation of stroke images; from novices through to experienced practitioners using eye movement analysis. Finally, there appears a lack of evidence on the clinical effects of radiology reports and their influence on image appraisal and clinical diagnosis. A computer-based, eye-tracking study was designed to assess diagnostic accuracy and interpretation in stroke CT and MR imagery. Eight predetermined clinical cases, five images per case, were presented to participants (novices, trainee, and radiologists; n=8). The presence or absence of abnormalities was rated on a five-point Likert scale and their locations reported. Half cases of the cases were accompanied by clinical information; half were not, to assess the impact of information on observer performance. Results highlight differences in visual search patterns amongst novice, trainee and expert observers; the most marked differences occurred between novice readers and experts. Experts spent more time in challenging areas of interest (AOI) than novices and trainee, and were more confident unless a lesion was large and obvious. The time to first AOI fixation differed by size, shape and clarity of lesion. 'Time to lesion' dropped significantly when recognition appeared to occur between slices. The influence of clinical information was minimal.

Use of clinical and computed tomography findings to assess long-term unsatisfactory outcome after femoral head and neck ostectomy in four large breed dogs.

PubMed

Ober, Ciprian; Pestean, Cosmin; Bel, Lucia; Taulescu, Marian; Milgram, Joshua; Todor, Adrian; Ungur, Rodica; Leșu, Mirela; Oana, Liviu

2018-05-10

Femoral head and neck ostectomy (FHNO) is a salvage surgical procedure intended to eliminate hip joint laxity associated pain in the immature dog, or pain due to secondary osteoarthritis in the mature dog. The outcome of the procedure is associated with the size of the dog but the cause of a generally poorer outcome in larger breeds has not been determined. The objective of this study was to assess the long-term results of FHNO associated with unsatisfactory functional outcome by means of clinical examination and computed tomography (CT) scanning. Four large mixed breed dogs underwent FHNO in different veterinary clinics. Clinical and CT scanning evaluations were carried out long time after the procedures had been done. Hip pain, muscle atrophy, decreased range of motion and chronic lameness were observed at clinical examination. Extensive remodelling, unacceptable bone-on-bone contact with bony proliferation involving the femoral neck and acetabulum, but also excessive removal with bone lysis were observed by CT scanning. Revision osteotomy was performed in one dog. Deep gluteal muscle interposition was used, but no improvements were observed postoperatively. This is the first report on the evaluation of three-dimensional CT reconstructions of the late bone remodelling associated with poor clinical outcome in large dogs. The study shows that FHNO could lead to severe functional deficits in large breed dogs. An extensive follow-study is necessary to more accurately determine the frequency of such complications.

Clinical management issues vary by specialty in the Victorian Audit of Surgical Mortality: a retrospective observational study

PubMed Central

Vinluan, Jessele; Retegan, Claudia; Chen, Andrew; Beiles, Charles Barry

2014-01-01

Objective Clinical management issues are contributory factors to mortality. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM), an educational peer-review process for surgeons, to discover differences in the incidence of these issues between surgical specialties in order to focus attention to areas of care that might be improved. Design This study used retrospectively analysed observational data from VASM. Clinical management issues between eight specialties were assessed using χ2 analysis. Data sources VASM data were reported by participating public and private health services, the Coroner and self-reporting surgeons across Victoria. Results A total of 2946 specific clinical issues as deficiencies of care were reported. 15% of cases had significant issues of care. The most common clinical management issue was the delay in delivery of treatment. Other clinical issues included the quality of communication and documentation, preoperative and postoperative care, adverse events and protocol issues. There were significant differences in issues between specialties. Conclusions The clinical management issues presented across surgical specialties were similar; however, five issues of clinical care differed significantly in frequency across surgical specialties. The three main issues varying among specialties were complications after operation, communication and postoperative care. Addressing these clinical management issues via the peer-review process may impact positively on patient care. PMID:24980043

Physiotherapy Student Clinical Examinations: The Influence of Subjective Judgments on Observational Assessment.

ERIC Educational Resources Information Center

Alexander, Helen A.

1996-01-01

A study investigated the role of subjective assessment in the evaluation of physiotherapy students in clinical programs. Clinical teachers, visiting lecturers, and students recorded perceptions of daily events and interactions in journals. Analysis suggests that assessors make subjective judgments about students that influence grades, and…

PROFESSIONAL INTEGRATION AND CLINICAL RESEARCH.

ERIC Educational Resources Information Center

WARD, TED W.

THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…

Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

PubMed

Reichmann, H; Jost, W H

2010-09-01

The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

Clinical information transfer and data capture in the acute myocardial infarction pathway: an observational study.

PubMed

Kesavan, Sujatha; Kelay, Tanika; Collins, Ruth E; Cox, Benita; Bello, Fernando; Kneebone, Roger L; Sevdalis, Nick

2013-10-01

Acute myocardial infarctions (MIs) or heart attacks are the result of a complete or an incomplete occlusion of the lumen of the coronary artery with a thrombus. Prompt diagnosis and early coronary intervention results in maximum myocardial salvage, hence time to treat is of the essence. Adequate, accurate and complete information is vital during the early stages of admission of an MI patient and can impact significantly on the quality and safety of patient care. This study aimed to record how clinical information between different clinical teams during the journey of a patient in the MI care pathway is captured and to review the flow of information within this care pathway. A prospective, descriptive, structured observational study to assess (i) current clinical information systems (CIS) utilization and (ii) real-time information availability within an acute cardiac care setting was carried out. Completeness and availability of patient information capture across four key stages of the MI care pathway were assessed prospectively. Thirteen separate information systems were utilized during the four phases of the MI pathway. Observations revealed fragmented CIS utilization, with users accessing an average of six systems to gain a complete set of patient information. Data capture was found to vary between each pathway stage and in both patient cohort risk groupings. The highest level of information completeness (100%) was observed only in the discharge stage of the MI care pathway. The lowest level of information completeness (58%) was observed in the admission stage. The study highlights fragmentation, CIS duplication, and discrepancies in the current clinical information capture and data transfer across the MI care pathway in an acute cardiac care setting. The development of an integrated and user-friendly electronic data capture and transfer system would reduce duplication and would facilitate efficient and complete information provision at the point of care. © 2012 John Wiley & Sons Ltd.

Conceptual framework for outcomes research studies of hepatitis C: an analytical review

PubMed Central

Sbarigia, Urbano; Denee, Tom R; Turner, Norris G; Wan, George J; Morrison, Alan; Kaufman, Anna S; Rice, Gary; Dusheiko, Geoffrey M

2016-01-01

Hepatitis C virus infection is one of the main causes of chronic liver disease worldwide. Until recently, the standard antiviral regimen for hepatitis C was a combination of an interferon derivative and ribavirin, but a plethora of new antiviral drugs is becoming available. While these new drugs have shown great efficacy in clinical trials, observational studies are needed to determine their effectiveness in clinical practice. Previous observational studies have shown that multiple factors, besides the drug regimen, affect patient outcomes in clinical practice. Here, we provide an analytical review of published outcomes studies of the management of hepatitis C virus infection. A conceptual framework defines the relationships between four categories of variables: health care system structure, patient characteristics, process-of-care, and patient outcomes. This framework can provide a starting point for outcomes studies addressing the use and effectiveness of new antiviral drug treatments. PMID:27313473

Clinical implementation of a knowledge based planning tool for prostate VMAT.

PubMed

Powis, Richard; Bird, Andrew; Brennan, Matthew; Hinks, Susan; Newman, Hannah; Reed, Katie; Sage, John; Webster, Gareth

2017-05-08

A knowledge based planning tool has been developed and implemented for prostate VMAT radiotherapy plans providing a target average rectum dose value based on previously achievable values for similar rectum/PTV overlap. The purpose of this planning tool is to highlight sub-optimal clinical plans and to improve plan quality and consistency. A historical cohort of 97 VMAT prostate plans was interrogated using a RayStation script and used to develop a local model for predicting optimum average rectum dose based on individual anatomy. A preliminary validation study was performed whereby historical plans identified as "optimal" and "sub-optimal" by the local model were replanned in a blinded study by four experienced planners and compared to the original clinical plan to assess whether any improvement in rectum dose was observed. The predictive model was then incorporated into a RayStation script and used as part of the clinical planning process. Planners were asked to use the script during planning to provide a patient specific prediction for optimum average rectum dose and to optimise the plan accordingly. Plans identified as "sub-optimal" in the validation study observed a statistically significant improvement in average rectum dose compared to the clinical plan when replanned whereas plans that were identified as "optimal" observed no improvement when replanned. This provided confidence that the local model can identify plans that were suboptimal in terms of rectal sparing. Clinical implementation of the knowledge based planning tool reduced the population-averaged mean rectum dose by 5.6Gy. There was a small but statistically significant increase in total MU and femoral head dose and a reduction in conformity index. These did not affect the clinical acceptability of the plans and no significant changes to other plan quality metrics were observed. The knowledge-based planning tool has enabled substantial reductions in population-averaged mean rectum dose for prostate VMAT patients. This suggests plans are improved when planners receive quantitative feedback on plan quality against historical data.

Does design matter? Systematic evaluation of the impact of analytical choices on effect estimates in observational studies

PubMed Central

Ryan, Patrick B.; Schuemie, Martijn

2013-01-01

Background: Clinical studies that use observational databases, such as administrative claims and electronic health records, to evaluate the effects of medical products have become commonplace. These studies begin by selecting a particular study design, such as a case control, cohort, or self-controlled design, and different authors can and do choose different designs for the same clinical question. Furthermore, published papers invariably report the study design but do not discuss the rationale for the specific choice. Studies of the same clinical question with different designs, however, can generate different results, sometimes with strikingly different implications. Even within a specific study design, authors make many different analytic choices and these too can profoundly impact results. In this paper, we systematically study heterogeneity due to the type of study design and due to analytic choices within study design. Methods and findings: We conducted our analysis in 10 observational healthcare databases but mostly present our results in the context of the GE Centricity EMR database, an electronic health record database containing data for 11.2 million lives. We considered the impact of three different study design choices on estimates of associations between bisphosphonates and four particular health outcomes for which there is no evidence of an association. We show that applying alternative study designs can yield discrepant results, in terms of direction and significance of association. We also highlight that while traditional univariate sensitivity analysis may not show substantial variation, systematic assessment of all analytical choices within a study design can yield inconsistent results ranging from statistically significant decreased risk to statistically significant increased risk. Our findings show that clinical studies using observational databases can be sensitive both to study design choices and to specific analytic choices within study design. Conclusion: More attention is needed to consider how design choices may be impacting results and, when possible, investigators should examine a wide array of possible choices to confirm that significant findings are consistently identified. PMID:25083251

Implementation of Departmental Quality Strategies Is Positively Associated with Clinical Practice: Results of a Multicenter Study in 73 Hospitals in 7 European Countries

PubMed Central

2015-01-01

Background Given the amount of time and resources invested in implementing quality programs in hospitals, few studies have investigated their clinical impact and what strategies could be recommended to enhance its effectiveness. Objective To assess variations in clinical practice and explore associations with hospital- and department-level quality management systems. Design Multicenter, multilevel cross-sectional study. Setting and Participants Seventy-three acute care hospitals with 276 departments managing acute myocardial infarction, deliveries, hip fracture, and stroke in seven countries. Intervention None. Measures Predictor variables included 3 hospital- and 4 department-level quality measures. Six measures were collected through direct observation by an external surveyor and one was assessed through a questionnaire completed by hospital quality managers. Dependent variables included 24 clinical practice indicators based on case note reviews covering the 4 conditions (acute myocardial infarction, deliveries, hip fracture and stroke). A directed acyclic graph was used to encode relationships between predictors, outcomes, and covariates and to guide the choice of covariates to control for confounding. Results and Limitations Data were provided on 9021 clinical records by 276 departments in 73 hospitals. There were substantial variations in compliance with the 24 clinical practice indicators. Weak associations were observed between hospital quality systems and 4 of the 24 indicators, but on analyzing department-level quality systems, strong associations were observed for 8 of the 11 indicators for acute myocardial infarction and stroke. Clinical indicators supported by higher levels of evidence were more frequently associated with quality systems and activities. Conclusions There are significant gaps between recommended standards of care and clinical practice in a large sample of hospitals. Implementation of department-level quality strategies was significantly associated with good clinical practice. Further research should aim to develop clinically relevant quality standards for hospital departments, which appear to be more effective than generic hospital-wide quality systems. PMID:26588842

Implementation of Departmental Quality Strategies Is Positively Associated with Clinical Practice: Results of a Multicenter Study in 73 Hospitals in 7 European Countries.

PubMed

Sunol, Rosa; Wagner, Cordula; Arah, Onyebuchi A; Kristensen, Solvejg; Pfaff, Holger; Klazinga, Niek; Thompson, Caroline A; Wang, Aolin; DerSarkissian, Maral; Bartels, Paul; Michel, Philippe; Groene, Oliver

2015-01-01

Given the amount of time and resources invested in implementing quality programs in hospitals, few studies have investigated their clinical impact and what strategies could be recommended to enhance its effectiveness. To assess variations in clinical practice and explore associations with hospital- and department-level quality management systems. Multicenter, multilevel cross-sectional study. Seventy-three acute care hospitals with 276 departments managing acute myocardial infarction, deliveries, hip fracture, and stroke in seven countries. None. Predictor variables included 3 hospital- and 4 department-level quality measures. Six measures were collected through direct observation by an external surveyor and one was assessed through a questionnaire completed by hospital quality managers. Dependent variables included 24 clinical practice indicators based on case note reviews covering the 4 conditions (acute myocardial infarction, deliveries, hip fracture and stroke). A directed acyclic graph was used to encode relationships between predictors, outcomes, and covariates and to guide the choice of covariates to control for confounding. Data were provided on 9021 clinical records by 276 departments in 73 hospitals. There were substantial variations in compliance with the 24 clinical practice indicators. Weak associations were observed between hospital quality systems and 4 of the 24 indicators, but on analyzing department-level quality systems, strong associations were observed for 8 of the 11 indicators for acute myocardial infarction and stroke. Clinical indicators supported by higher levels of evidence were more frequently associated with quality systems and activities. There are significant gaps between recommended standards of care and clinical practice in a large sample of hospitals. Implementation of department-level quality strategies was significantly associated with good clinical practice. Further research should aim to develop clinically relevant quality standards for hospital departments, which appear to be more effective than generic hospital-wide quality systems.

Early vasopressor use following traumatic injury: a systematic review

PubMed Central

Hylands, Mathieu; Toma, Augustin; Beaudoin, Nicolas; Frenette, Anne Julie; D’Aragon, Frédérick; Belley-Côté, Émilie; Charbonney, Emmanuel; Møller, Morten Hylander; Laake, Jon Henrik; Vandvik, Per Olav; Siemieniuk, Reed Alexander; Rochwerg, Bram; Lauzier, François; Green, Robert S; Ball, Ian; Scales, Damon; Murthy, Srinivas; Kwong, Joey S W; Guyatt, Gordon; Rizoli, Sandro; Asfar, Pierre; Lamontagne, François

2017-01-01

Objectives Current guidelines suggest limiting the use of vasopressors following traumatic injury; however, wide variations in practice exist. Although excessive vasoconstriction may be harmful, these agents may help reduce administration of potentially harmful resuscitation fluids. This systematic review aims to compare early vasopressor use to standard resuscitation in adults with trauma-induced shock. Design Systematic review. Data sources We searched MEDLINE, EMBASE, ClinicalTrials.gov and the Central Register of Controlled Trials from inception until October 2016, as well as the proceedings of 10 relevant international conferences from 2005 to 2016. Eligibility criteria for selecting studies Randomised controlled trials and controlled observational studies that compared the early vasopressor use with standard resuscitation in adults with acute traumatic injury. Results Of 8001 citations, we retrieved 18 full-text articles and included 6 studies (1 randomised controlled trial and 5 observational studies), including 2 published exclusively in abstract form. Across observational studies, vasopressor use was associated with increased short-term mortality, with unadjusted risk ratios ranging from 2.31 to 7.39. However, the risk of bias was considered high in these observational studies because patients who received vasopressors were systematically sicker than patients treated without vasopressors. One clinical trial (n=78) was too imprecise to yield meaningful results. Two clinical trials are currently ongoing. No study measured long-term quality of life or cognitive function. Conclusions Existing data on the effects of vasopressors following traumatic injury are of very low quality according to the Grading of Recommendations, Assessment, Development and Evaluation methodology. With emerging evidence of harm associated with aggressive fluid resuscitation and, in selected subgroups of patients, with permissive hypotension, the alternatives to vasopressor therapy are limited. Observational data showing that vasopressors are part of usual care would provide a strong justification for high-quality clinical trials of early vasopressor use during trauma resuscitation. Trial registration number CRD42016033437. PMID:29151048

Assessment of Clinical Effect of Perioperative Comprehensive Nursing Intervention Pattern in 23G Minimally Invasive Vitreous Surgery.

PubMed

Shen, Jie; Li, Su-Yan; Wang, Jian-Yu; Chen, Jing; Wang, Wen

2016-01-01

We observed the clinical effects of comprehensive nursing intervention pattern in 23G minimally invasive vitreous surgery according to the comprehensive nursing intervention table developed by our hospital, which would supply a basis for its clinical application. In this prospective study, we followed 120 patients undergoing 23G minimally invasive vitreous surgery from Xuzhou First People's Hospital from February 2013 to February 2015 and divided them into control and observation groups by a random number table (60 patients in each group). A regular nursing pattern was adopted for the control group, and a comprehensive nursing intervention pattern was adopted for the observation group. After that, a comparative analysis was made to identify the differences between the clinical effects of the two groups. Scores of cognition ratio, patient compliance and comfort level of patients in the observation group were higher than those of the control group were, and there was significant difference between the groups (P< 0.05). Complication incidence of the observation group is significantly lower than that of the control group (P<0.05). The comprehensive nursing intervention pattern developed by our hospital can improve clinical effects notably, which is of application value .We recommend it to be applied in eye diseases.

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship-Observational Studies.

PubMed

Snyder, Graham M; Young, Heather; Varman, Meera; Milstone, Aaron M; Harris, Anthony D; Munoz-Price, Silvia

2016-10-01

Observational studies compare outcomes among subjects with and without an exposure of interest, without intervention from study investigators. Observational studies can be designed as a prospective or retrospective cohort study or as a case-control study. In healthcare epidemiology, these observational studies often take advantage of existing healthcare databases, making them more cost-effective than clinical trials and allowing analyses of rare outcomes. This paper addresses the importance of selecting a well-defined study population, highlights key considerations for study design, and offers potential solutions including biostatistical tools that are applicable to observational study designs. Infect Control Hosp Epidemiol 2016;1-6.

Experimental study on the clinical effects of Xiaoru Sanjie Jiaonang on mammary glands hyperplasia and ki-67

PubMed Central

Zheng, Zi-Hao; Liu, Lin; Zou, Shi-Fang; Xu, Yu-Ting; Chen, Cui-Cui; Liang, Wen-Long; Guo, Bao-Liang; Wang, Yu; Zhu, Kai-Yuan; Liu, Jie-Na; Xu, Dan-Dan; Wang, Ji-Yan; Lin, Jia-Yan; Liu, Li; Zhang, Jian Guo; Chen, Xi

2018-01-01

Objective: This study aims to observe the effect and mechanism of Xiaoru Sanjie Jiaonang (XRSJ) on the treatment of mammary gland hyperplasia, and provide a theoretical basis and clinical evidence for clinical expansion. Methods: Japanese white rabbits were randomly divided into three groups: high-, middle- and low-dose groups; Xiaoyao Pill group; model control group; normal control group. The observation points were as follows: before XRSJ administration, three months after XRSJ administration, and three months after XRSJ discontinuance. Changes in breast height, morphological changes of the mammary gland under a light and electron microscope, and the expression of ki-67 were observed. At the same time, patients diagnosed with mammary gland hyperplasia at an Outpatient Clinic were selected and divided into treatment groups. These patients received XRSJ and Xiaoyao Pills, respectively, for one month, while patients in the control group did not receive any drug treatment. Clinical efficacy was observed while rechecking at the Outpatient Clinic after three months. Treatment with a therapeutic dose of XRSJ could significantly reduce breast height, decrease the number of lobules and acini in hyperplastic mammary glands and the layer number of ductal glandular epithelial cells, substantially lower the content of serum estradiol (E2), significantly downregulate the expression of ki-67 protein in mammary tissues, and inhibit mammary gland hyperplasia. Conclusion: XRSJ treatment can relieve mammary tissue hyperplastic lesions, reduce E2 levels and downregulate the expression of ki-67. It has a significant therapeutic effect on mammary gland hyperplasia. PMID:29636873

Comparative audit of clinical research in pediatric neurology.

PubMed

Al-Futaisi, Amna; Shevell, Michael

2004-11-01

Clinical research involves direct observation or data collection on human subjects. This study was conducted to evaluate the profile of pediatric neurology clinical research over a decade. Trends in pediatric neurology clinical research were documented through a systematic comparative review of articles published in selected journals. Eleven journals (five pediatric neurology, three general neurology, three general pediatrics) were systematically reviewed for articles involving a majority of human subjects less than 18 years of age for the years 1990 and 2000. Three hundred thirty-five clinical research articles in pediatric neurology were identified in the 11 journals for 1990 and 398 for 2000, a 19% increase. A statistically significant increase in analytic design (21.8% vs 39.5%; P = .01), statistical support (6% vs 16.6%; P < .0001), and multidisciplinary team (69.9% vs 87%; P = .003) was observed. In terms of specific study design, a significant decline in case reports (34.3% vs 10.3%; P < .0001) and an increase in case-control studies (11.3% vs 22.9%; P = .02) were evident over the 10-year interval. This comparative audit revealed that there has been a discernible change in the methodology profile of clinical research in child neurology over a decade. Trends apparently suggest a more rigorous approach to study design and investigation in this field.

Examining the postural awareness and flexibility changes in physical therapy students who took clinical Pilates class.

PubMed

Atilgan, Esra; Tarakci, Devrim; Mutluay, Fatma

2017-01-01

This study aimed to evaluate postural awareness and changes in posture and flexibility of students who took Clinical Pilates class as an elective course at the undergraduate level. The study conducted from 2013-2016 included 98 students who took Clinical Pilates class at the Department of Physical Therapy and Rehabilitation, School of Health Sciences, Istanbul Medipol University, Turkey. The flexibility levels of the study participants were measured before and after the Clinical Pilates education using finger-to-floor test and modified Schober's test. Observational posture analysis and postural awareness were recorded using the scale prepared by the researchers. The post-education evaluations showed that postural distortions were fixed, and a significant increase in the postural awareness of the students was observed compared with the pre-education period. The results of both modified Schober's test and finger-to-floor test, which were used to measure the flexibility levels, showed a statistically significant increase in post-education scores compared with those of the pre-education period. This study showed that the Clinical Pilates course increased postural awareness and flexibility of physical therapy students and fixed postural distortions. Thus, the inclusion of Clinical Pilates class in the undergraduate education is considered to be important.

Examining the postural awareness and flexibility changes in physical therapy students who took clinical Pilates class

PubMed Central

Atilgan, Esra; Tarakci, Devrim; Mutluay, Fatma

2017-01-01

Objective: This study aimed to evaluate postural awareness and changes in posture and flexibility of students who took Clinical Pilates class as an elective course at the undergraduate level. Methods: The study conducted from 2013-2016 included 98 students who took Clinical Pilates class at the Department of Physical Therapy and Rehabilitation, School of Health Sciences, Istanbul Medipol University, Turkey. The flexibility levels of the study participants were measured before and after the Clinical Pilates education using finger-to-floor test and modified Schober’s test. Observational posture analysis and postural awareness were recorded using the scale prepared by the researchers. Results: The post-education evaluations showed that postural distortions were fixed, and a significant increase in the postural awareness of the students was observed compared with the pre-education period. The results of both modified Schober’s test and finger-to-floor test, which were used to measure the flexibility levels, showed a statistically significant increase in post-education scores compared with those of the pre-education period. Conclusion: This study showed that the Clinical Pilates course increased postural awareness and flexibility of physical therapy students and fixed postural distortions. Thus, the inclusion of Clinical Pilates class in the undergraduate education is considered to be important. PMID:28811786

Factors Influencing the Clinical Stratification of Suitability to Drive after Stroke: A Qualitative Study.

PubMed

Stapleton, Tadhg; Connolly, Deirdre; O'Neill, Desmond

2015-01-01

While a clinical pre-selection screening process for a stroke patient's suitability for driving has been acknowledged, little is known about the factors or processes influencing this screening typically conducted by clinicians practicing at a generalist level. This study explored this clinical stratification process through the use of semi-structured interviews with senior occupational therapists (n = 17) and stroke physicians (n = 7) using qualitative description methodology. The findings revealed a trichotomy stratification of stroke patients for driving in the clinical setting; those who are fit to drive, unfit to drive, and a "maybe" group who need more detailed assessment and observation. Factors that had a major influence on this clinical-based stratification of driving suitability were client's levels of awareness, insight, and impulsivity. A period of prolonged contact with the client was preferential to guide the stratification decision in order for clinicians to build a comprehensive picture of the person. A mix of assessment approaches including standardized assessment but with increased emphasis on naturalistic observation of functional performance underpinned the clinical stratification process. This study uncovers some of the factors and processes influencing the early clinical-based stratification of driving suitability after stroke, and highlights the contribution of the generalist practitioner in the assessment of fitness to drive continuum.

Sporotrichosis in Rio de Janeiro, Brazil: Sporothrix brasiliensis is associated with atypical clinical presentations.

PubMed

Almeida-Paes, Rodrigo; de Oliveira, Manoel Marques Evangelista; Freitas, Dayvison Francis Saraiva; do Valle, Antônio Carlos Francesconi; Zancopé-Oliveira, Rosely Maria; Gutierrez-Galhardo, Maria Clara

2014-09-01

There have been several recent changes in the taxonomy of Sporothrix schenckii as well as new observations regarding the clinical aspects of sporotrichosis. In this study, we determined the identification of the Sporothrix species associated with both classic and unusual clinical aspects of sporotrichosis observed in the endemic area of sporotrichosis in Rio de Janeiro, Brazil. To verify whether S. brasiliensis is associated with clinical manifestations of sporotrichosis, a cross-sectional study was performed in which Sporothrix isolates from 50 patients with different clinical manifestations were analyzed and their isolates were studied by phenotypic and genotypic methods. Data from these patients revealed a distinct clinical picture and therapeutic response in infections caused by Sporothrix brasiliensis (n = 45) compared to patients with S. schenckii sensu stricto (n = 5). S. brasiliensis was associated with disseminated cutaneous infection without underlying disease, hypersensitivity reactions, and mucosal infection, whereas patients with S. schenckii presented with less severe and more often localized disease, similar to the majority of previously described sporotrichosis cases. Interestingly, S. brasiliensis-infected patients overall required shorter durations of itraconazole (median 16 weeks) compared to the individuals with S. schenckii (median 24 weeks). These findings suggest that Sporothrix species are linked to different clinical manifestations of sporotrichosis and that S. brasiliensis is effectively treated with oral itraconazole.

Primary prevention of gestational diabetes mellitus through nutritional factors: a systematic review.

PubMed

Donazar-Ezcurra, Mikel; López-Del Burgo, Cristina; Bes-Rastrollo, Maira

2017-01-13

Gestational diabetes mellitus (GDM), defined as any degree of glucose intolerance with onset during pregnancy, is increasing worldwide, mostly because obesity among women of reproductive age is continuously escalating. GDM is associated with adverse maternal and fetal outcomes. The aim of this article was to systematically review literature on the effectiveness of nutritional factors before or during pregnancy to prevent GDM. We assessed the primary prevention of GDM through nutritional factors, as diet and supplements. We searched on PubMed, Cochrane Databases and ClinicalTrials.gov from inception to June 2016. Clinical trials and adjusted prospective cohort studies were included. Eight clinical trials and twenty observational studies assessing the association between dietary factors and primary prevention of GDM were included. Furthermore, six clinical trials and two observational studies related to supplements were also added. Only two nutritional interventions were found to significantly reduce the incidence of GDM, besides the supplements. However, the observational studies showed that a higher adherence to a healthier dietary pattern can prevent the incidence of GDM, especially in high risk population before getting pregnant. The results indicate that there may be some benefits of some nutritional factors to prevent GDM. However, better-designed studies are required to generate higher quality evidence. At the moment, no strong conclusions can be drawn with regard to the best intervention for the prevention of GDM.

Suspected Lonely Mouse Syndrome as a Cage Effect in a Drug Safety Study.

PubMed

Ye, Xiaobu; Itzoe, MariaLisa; Sarabia-Estrada, Rachel; DeTolla, Louis; Tyler, Betty M; Guarnieri, Michael

2018-01-01

Studies have demonstrated that buprenorphine, a front line drug for veterinary analgesia, may alleviate symptoms of chronic pain. A cage side observation protocol was used to record behavioral signs in a mouse clinical trial of extended release buprenorphine. A retrospective review of the observations for signs of pain and stress revealed that mice given a fivefold overdose of buprenorphine (16.25 mg/kg) showed lethargy and facial signs associated with stress. However, similar signs were observed in the drug-free control mice as early as Day 3 of single-cage housing. This appears to be the first report of cage effects in a clinical trial for a veterinary drug.

Suspected Lonely Mouse Syndrome as a Cage Effect in a Drug Safety Study

PubMed Central

Ye, Xiaobu; Itzoe, MariaLisa; Sarabia-Estrada, Rachel; DeTolla, Louis

2018-01-01

Studies have demonstrated that buprenorphine, a front line drug for veterinary analgesia, may alleviate symptoms of chronic pain. A cage side observation protocol was used to record behavioral signs in a mouse clinical trial of extended release buprenorphine. A retrospective review of the observations for signs of pain and stress revealed that mice given a fivefold overdose of buprenorphine (16.25 mg/kg) showed lethargy and facial signs associated with stress. However, similar signs were observed in the drug-free control mice as early as Day 3 of single-cage housing. This appears to be the first report of cage effects in a clinical trial for a veterinary drug. PMID:29854826

Long-term Clinical and Cost Outcomes of a Pharmacist-managed Risk Factor Management Clinic in Singapore: An Observational Study.

PubMed

Tan, She Hui; Kng, Kwee Keng; Lim, Sze Mian; Chan, Alexandre; Loh, Jason Kwok Kong; Lee, Joyce Yu-Chia

2017-12-01

Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care. This single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes. A total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17-12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001). The pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

[Clinical trials of flomoxef in complicated urinary tract infections].

PubMed

Ohta, N; Sudoko, H; Fukuta, K; Nakano, M; Ushiyama, T; Tajima, A; Aso, Y; Masuda, H; Suzuki, A; Suzuki, K

1987-10-01

Flomoxef (6315-S, FMOX), a new oxacephem antibiotic was studied clinically in 27 patients with complicated urinary tract infections. FMOX was intravenously administered at a dose of 1.0 g twice daily for 5 days. Clinical effect of FMOX on patients with complicated urinary tract infections were excellent in 11.5%, moderate in 57.7% and overall clinical efficacy rate was 69.2%. During the treatment with FMOX, urticaria was observed in 1 case. In laboratory tests, a decrease of RBC, Hb and Ht in 1 case, a decrease of WBC in 1 case and an elevation of GPT in another case were observed. But these abnormal values were slight and transient.

Are photographic records reliable for orthodontic screening?

PubMed

Mandall, N A

2002-06-01

The aim of the study was to evaluate the reliability of a panel of orthodontists for accepting new patient referrals based on clinical photographs. Eight orthodontists from Greater Manchester, Lancashire, Chester, and Derbyshire observed clinical photographs of 40 consecutive new patients attending the orthodontic department, Hope Hospital, Salford. They recorded whether or not they would accept the patient, as a new patient referral, in their department. Each consultant was asked to take into account factors, such as oral hygiene, dental development, and severity of the malocclusion. Kappa statistic for multiple-rater agreement and kappa statistic for intra-observer reliability were calculated. Inter-observer panel agreement for accepting new patient referrals based on photographic information was low (multiple rater kappa score 0.37). Intra-examiner agreement was better (kappa range 0.34-0.90). Clinician agreement for screening and accepting orthodontic referrals based on clinical photographs is comparable to that previously reported for other clinical decision making.

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.

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.

Assessing nursing clinical skills competence through objective structured clinical examination (OSCE) for open distance learning students in Open University Malaysia.

PubMed

Oranye, Nelson Ositadimma; Ahmad, Che'an; Ahmad, Nora; Bakar, Rosnida Abu

2012-06-01

The objective structured clinical skills examination (OSCE) has over the years emerged as a method of evaluating clinical skills in most medical and allied professions. Although its validity and objectivity has evoked so much debate in the literature, little has been written about its application in non-traditional education systems such as in distance learning. This study examined clinical skills competence among practising nursing students who were enrolled in a distance learning programme. The study examined the effect of work and years of nursing practice on nurses' clinical skills competence. This study used observational design whereby nursing students' clinical skills were observed and scored in five OSCE stations. Two instruments were used for the data collection - A self-administered questionnaire on the students' bio-demographic data, and a check list on the clinical skills which the examiners rated on a four point scale. The findings revealed that 14% of the nurses had level four competence, which indicated that they could perform the tasks correctly and complete. However, 12% failed the OSCE, even though they had more than 10 years experience in nursing and post basic qualifications. Inter-rater reliability was 0.92 for the five examiners. Factor analysis indicated that five participant factors accounted for 74.1% of the variations in clinical skills performance. An OSCE is a necessary assessment tool that should be continuously applied in nursing education, regardless of the mode of the education program, the student's years of experience or his/her clinical placement. This study validates the need for OSCE in both the design of tertiary nursing degree programs and the assessment of nurses' clinical competency level.

Ethical challenges in preclinical Alzheimer’s disease observational studies and trials: results of the Barcelona summit

PubMed Central

Molinuevo, José L.; Cami, Jordi; Carné, Xavier; Carrillo, Maria C.; Georges, Jean; Isaac, Maria B.; Khachaturian, Zaven; Kim, Scott Y. H.; Morris, John C.; Pasquier, Florence; Ritchie, Craig; Sperling, Reisa; Karlawish, Jason

2016-01-01

Alzheimer’s disease (AD) is among the most significant healthcare burdens. Disappointing results from clinical trials in late-stage AD persons combined with hopeful results from trials in persons with early-stage suggest that research in the preclinical stage of AD is necessary to define an optimal therapeutic success window. We review the justification for conducting trials in the preclinical stage and highlight novel ethical challenges that arise and are related to determining appropriate risk-benefit ratios and disclosing individuals’ biomarker status. We propose that to conduct clinical trials with these participants, we need to improve public understanding of AD using unified vocabulary, resolve the acceptable risk-benefit ratio in asymptomatic participants and disclose or not biomarker status with attention to study type (observational studies versus clinical trials). Overcoming these challenges will justify clinical trials in preclinical AD at the societal level and aid to the development of societal and legal support for trial participants. PMID:26988427

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/).

How Have Cancer Clinical Trial Eligibility Criteria Evolved Over Time?

PubMed Central

Yaman, Anil; Chakrabarti, Shreya; Sen, Anando; Weng, Chunhua

2016-01-01

Knowledge reuse of cancer trial designs may benefit from a temporal understanding of the evolution of the target populations of cancer studies over time. Therefore, we conducted a retrospective analysis of the trends of cancer trial eligibility criteria between 1999 and 2014. The yearly distributions of eligibility concepts for chemicals and drugs, procedures, observations, and medical conditions extracted from free-text eligibility criteria of 32,000 clinical trials for 89 cancer types were analyzed. We identified the concepts that trend upwards or downwards in all or selected cancer types, and the concepts that show anomalous trends for some cancers. Later, concept trends were studied in a disease-specific manner and illustrated for breast cancer. Criteria trends observed in this study are also validated and interpreted using evidence from the existing medical literature. This study contributes a method for concept trend analysis and original knowledge of the trends in cancer clinical trial eligibility criteria. PMID:27570681

A novel method for inferring RFID tag reader recordings into clinical events.

PubMed

Chang, Yung-Ting; Syed-Abdul, Shabbir; Tsai, Chung-You; Li, Yu-Chuan

2011-12-01

Nosocomial infections (NIs) are among the important indicators used for evaluating patients' safety and hospital performance during accreditation of hospitals. NI rate is higher in Intensive Care Units (ICUs) than in the general wards because patients require intense care involving both invasive and non-invasive clinical procedures. The emergence of Superbugs is motivating health providers to enhance infection control measures. Contact behavior between health caregivers and patients is one of the main causes of cross infections. In this technology driven era remote monitoring of patients and caregivers in the hospital setting can be performed reliably, and thus is in demand. Proximity sensing using radio frequency identification (RFID) technology can be helpful in capturing and keeping track on all contact history between health caregivers and patients for example. This study intended to extend the use of proximity sensing of radio frequency identification technology by proposing a model for inferring RFID tag reader recordings into clinical events. The aims of the study are twofold. The first aim is to set up a Contact History Inferential Model (CHIM) between health caregivers and patients. The second is to verify CHIM with real-time observation done at the ICU ward. A pre-study was conducted followed by two study phases. During the pre-study proximity sensing of RFID was tested, and deployment of the RFID in the Clinical Skill Center in one of the medical centers in Taiwan was done. We simulated clinical events and developed CHIM using variables such as duration of time, frequency, and identity (tag) numbers assigned to caregivers. All clinical proximity events are classified into close-in events, contact events and invasive events. During the first phase three observers were recruited to do real time recordings of all clinical events in the Clinical Skill Center with the deployed automated RFID interaction recording system. The observations were used to verify the CHIM recordings. In second phase the first author conducted 40 h of participatory observation in the ICU, and observed values that were used as golden standard to validate CHIM. There were a total of 193 events to validate the CHIM in the second phase. The sensitivity, specificity, and accuracy of close-in events were 73.8%, 83.8%, and 81.6%; contact events were 81.4%, 78.8%, and 80.7%; and invasive events were 90.9%, 98.0%, and 97.5% respectively. The results of the study indicated that proximity sensing of the RFID detects proximity events effectively, and the CHIM can infer proximity events accurately. RFID technology can be used for recording complete clinical contact history between caregivers and patients thus assisting in tracing cause of NIs. Since this model could infer the ICU activities accurately, we are convinced that the CHIM can also be applied in other wards and can be used for additional purposes. 2011 Elsevier Ireland Ltd. All rights reserved.

Confidentiality breaches in clinical practice: what happens in hospitals?

PubMed

Beltran-Aroca, Cristina M; Girela-Lopez, Eloy; Collazo-Chao, Eliseo; Montero-Pérez-Barquero, Manuel; Muñoz-Villanueva, Maria C

2016-09-02

Respect for confidentiality is important to safeguard the well-being of patients and ensure the confidence of society in the doctor-patient relationship. The aim of our study is to examine real situations in which there has been a breach of confidentiality, by means of direct observation in clinical practice. By means of direct observation, our study examines real situations in which there has been a breach of confidentiality in a tertiary hospital. To observe and collect data on these situations, we recruited students enrolled in the Medical Degree Program at the University of Cordoba. The observers recorded their entries on standardized templates during clinical internships in different departments: Internal Medicine; Gynecology and Obstetrics; Pediatrics; Emergency Medicine; General and Digestive Surgery; Maxillofacial Surgery; Plastic Surgery; Orthopedics and Traumatology; Digestive; Dermatology; Rheumatology; Mental Health; Nephrology; Pneumology; Neurology; and Ophthalmology. Following 7138 days and 33157 h of observation, we found an estimated Frequency Index of one breach per 62.5 h. As regards the typology of the observed breaches, the most frequent (54,6 %) were related to the consultation and/or disclosure of clinical and/or personal data to medical personnel not involved in the patient's clinical care, as well as people external to the hospital. As regards their severity, severe breaches were the most frequent, accounting for 46.7 % of all incidents. Most of the reported incidents were observed in public areas (37.9 %), such as corridors, elevators, the cafeteria, stairs, and locker rooms. In addition to aspects related to hospital organization or infrastructure, we have shown that all healthcare personnel are involved in confidentiality breaches, especially physicians. While most are committed unintentionally, a non-negligible number are severe, repeated breaches (9.5 %), thus suggesting a certain carelessness, perhaps through ignorance about certain behaviors that can jeopardize patient confidentiality.

New definitions of 6 clinical signs of perceptual disorder in children with cerebral palsy: an observational study through reliability measures.

PubMed

Ferrari, A; Sghedoni, A; Alboresi, S; Pedroni, E; Lombardi, F

2014-12-01

Recently authors have begun to emphasize the non-motor aspects of Cerebral Palsy and their influence on motor control and recovery prognosis. Much has been written about single clinical signs (i.e., startle reaction) but so far no definitions of the six perceptual signs presented in this study have appeared in literature. This study defines 6 signs (startle reaction, upper limbs in startle position, frequent eye blinking, posture freezing, averted eye gaze, grimacing) suggestive of perceptual disorders in children with cerebral palsy and measures agreement on sign recognition among independent observers and consistency of opinions over time. Observational study with both cross-sectional and prospective components. Fifty-six videos presented to observers in random order. Videos were taken from 19 children with a bilateral form of cerebral palsy referred to the Children Rehabilitation Unit in Reggio Emilia. Thirty-five rehabilitation professionals from all over Italy: 9 doctors and 26 physiotherapists. Measure of agreement among 35 independent observers was compiled from a sample of 56 videos. Interobserver reliability was determined using the K index of Fleiss and reliability intra-observer was calculated by the Spearman correlation index between ranks (rho - ρ). Percentage of agreement between observers and Gold Standard was used as criterion validity. Interobserver reliability was moderate for startle reaction, upper limb in startle position, adverted eye gaze and eye-blinking and fair for posture freezing and grimacing. Intraobserver reliability remained consistent over time. Criterion validity revealed very high agreement between independent observer evaluation and gold standard. Semiotics of perceptual disorders can be used as a specific and sensitive instrument in order to identify a new class of patients within existing heterogeneous clinical types of bilateral cerebral palsy forms and could help clinicians in identifying functional prognosis. To provide clinicians with a definition of 6 clinical signs found in children with cerebral palsy in routine rehabilitation settings. Future research should explore the link between these signs and motor prognosis (i.e., time to independent walking).

Clinical trials in dentistry in India: Analysis from trial registry.

PubMed

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy participants. From 2011, some of the postgraduate thesis trials had also been registered (2011-8; 2012-8; 2013-13; 2014-6). Inadequacy in reporting the method of randomization and allocation concealment was observed in 37/67 (55.2%) and 31/67 (46.2%) clinical trials respectively. A considerable number of postgraduate theses was also registered with CTRI in dentistry and majority of the clinical trials despite being completed are not yet published. The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.

Using EHR audit trail logs to analyze clinical workflow: A case study from community-based ambulatory clinics.

PubMed

Wu, Danny T Y; Smart, Nikolas; Ciemins, Elizabeth L; Lanham, Holly J; Lindberg, Curt; Zheng, Kai

2017-01-01

To develop a workflow-supported clinical documentation system, it is a critical first step to understand clinical workflow. While Time and Motion studies has been regarded as the gold standard of workflow analysis, this method can be resource consuming and its data may be biased due to the cognitive limitation of human observers. In this study, we aimed to evaluate the feasibility and validity of using EHR audit trail logs to analyze clinical workflow. Specifically, we compared three known workflow changes from our previous study with the corresponding EHR audit trail logs of the study participants. The results showed that EHR audit trail logs can be a valid source for clinical workflow analysis, and can provide an objective view of clinicians' behaviors, multi-dimensional comparisons, and a highly extensible analysis framework.

Clinical results from first use of prostate stent as fiducial for radiotherapy of prostate cancer.

PubMed

Carl, Jesper; Nielsen, Jane; Holmberg, Mats; Larsen, Erik Hoejkjaer; Fabrin, Knud; Fisker, Rune V

2011-05-01

A clinical feasibility study using a removable prostate stent as fiducial for image-guided radiotherapy (IGRT) of localized prostate cancer (PC). The study included patients with local or locally advanced PC. The clinical target volume (CTV) was outlined on magnetic resonance (MR) images co-registered to planning computer tomography (CT) images. Daily online IGRT was delivered using the stent as fiducial. Risk of migration was estimated using multiple MR. Acute urinary toxicity was scored using the international prostate symptom score (IPSS). Late gastro-intestinal (GI) and genito-urinary (GU) toxicity was scored using the Radio Therapy Oncology Group (RTOG) score, biochemical failure (BF) was defined as an elevation of prostate specific antigen (PSA) above nadir plus 2 ng/ml after radiotherapy. One hundred men were enrolled in the study. Ninety completed radiotherapy with the stent as fiducial. No migration of the stent was seen, but three cases of dislocation of the stent to the bladder were observed. Acute urinary toxicity based on IPSS was comparable to toxicity in patients who had gold markers (GM) as fiducials. Removal of the stent was associated with a high frequency of urinary retention. Late GI and GU toxicity and BF were comparable to those of other studies, but longer observation time is needed. This study reports the first clinical results of using a prostate stent as fiducial. No migration of the stent observed. Dislocation of the stent to the urinary bladder was observed in three cases, requiring removal of the stent and insertion of a new fiducial. Acute toxicity during radiotherapy evaluated from IPSS was comparable to toxicity in patients with GM. Removal of the stent was associated with a high frequency of post procedural urinary retention. Late toxicity and BF were comparable to those of other studies, though longer observation time is needed.

Early vasopressor use following traumatic injury: a systematic review.

PubMed

Hylands, Mathieu; Toma, Augustin; Beaudoin, Nicolas; Frenette, Anne Julie; D'Aragon, Frédérick; Belley-Côté, Émilie; Charbonney, Emmanuel; Møller, Morten Hylander; Laake, Jon Henrik; Vandvik, Per Olav; Siemieniuk, Reed Alexander; Rochwerg, Bram; Lauzier, François; Green, Robert S; Ball, Ian; Scales, Damon; Murthy, Srinivas; Kwong, Joey S W; Guyatt, Gordon; Rizoli, Sandro; Asfar, Pierre; Lamontagne, François

2017-11-17

Current guidelines suggest limiting the use of vasopressors following traumatic injury; however, wide variations in practice exist. Although excessive vasoconstriction may be harmful, these agents may help reduce administration of potentially harmful resuscitation fluids. This systematic review aims to compare early vasopressor use to standard resuscitation in adults with trauma-induced shock. Systematic review. We searched MEDLINE, EMBASE, ClinicalTrials.gov and the Central Register of Controlled Trials from inception until October 2016, as well as the proceedings of 10 relevant international conferences from 2005 to 2016. Randomised controlled trials and controlled observational studies that compared the early vasopressor use with standard resuscitation in adults with acute traumatic injury. Of 8001 citations, we retrieved 18 full-text articles and included 6 studies (1 randomised controlled trial and 5 observational studies), including 2 published exclusively in abstract form. Across observational studies, vasopressor use was associated with increased short-term mortality, with unadjusted risk ratios ranging from 2.31 to 7.39. However, the risk of bias was considered high in these observational studies because patients who received vasopressors were systematically sicker than patients treated without vasopressors. One clinical trial (n=78) was too imprecise to yield meaningful results. Two clinical trials are currently ongoing. No study measured long-term quality of life or cognitive function. Existing data on the effects of vasopressors following traumatic injury are of very low quality according to the Grading of Recommendations, Assessment, Development and Evaluation methodology. With emerging evidence of harm associated with aggressive fluid resuscitation and, in selected subgroups of patients, with permissive hypotension, the alternatives to vasopressor therapy are limited. Observational data showing that vasopressors are part of usual care would provide a strong justification for high-quality clinical trials of early vasopressor use during trauma resuscitation. CRD42016033437. © 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.

[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.

Worldwide Use of Antiretropulsive Techniques: Observations from the Clinical Research Office of the Endourological Society Ureteroscopy Global Study.

PubMed

Saussine, Christian; Andonian, Sero; Pacík, Dalibor; Popiolek, Marcin; Celia, Antonio; Buchholz, Noor; Sountoulides, Petros; Petrut, Bogdan; de la Rosette, Jean J M C H

2018-04-01

Retropulsion, defined as unintended migration of a stone under the influence of the fragmentation device in ureteroscopy (URS) procedures, occurs in 2% to 60% of the cases. Antiretropulsive devices (ARDs) have been studied in experimental and small clinical studies. The current study aims at describing the worldwide usage of ARD and the outcomes related to their usage. The Clinical Research Office of the Endourological Society URS Global Study enrolled 11,885 patients who underwent URS and stone fragmentation for ureteral and/or renal stones. Of the 11,885 treated patients, 9877 were treated for ureteral stones, and data were available on stone migration and ARD use. Of all procedures, 14.5% were performed with the use of an ARD. Less stone migration (-2.0%; p = 0.050), higher stone-free rates (SFRs) (2.8%; p < 0.001), and shorter length of stay (-4.7%; p = 0.001) were observed in the antiretropulsive group. When an ARD is used during URS, less migration, higher SFRs, and shorter length of hospital stay are observed. This effect is independent from baseline differences and corrected for other treatment characteristics.

326 Lung Age/Chronological Age Index as Indicator of Clinical Improvement or Severity in Asthma Patients

PubMed Central

Castrejon-Vázquez, Isabel; Vargas, Maria Eugenia; Sabido, Raúl Cicero; Tapía, Jorge Galicia

2012-01-01

Background Spirometry is a very useful clinical test to evaluate pulmonary function in asthma. However pulmonary function could be affected by the sex, time of clinical evolution, lung age (LA) and chronological age (CA). The aim of this study was to evaluate LA/CA as index of clinical improvement or severity in asthma patients. Methods The tenets of the Declaration of Helsinki were followed, and all patients gave their informed consent to participate in this study. Asthma severity was evaluated according with GINA classification. Spirometry was performed at the beginning of this study, at 46 days, 96 days, 192 days and after 8 months. Statistical analysis was performed using t test, 2-way ANOVA test, correlation and multiple regression models as well as ROC curves were also performed, a P < 0.05 was considered as significant. Results 70 asthma patients were included (22 male and 48 female), mean CA was 35-years old; mean LA was 48-years with a LA/CA index = 1.4, time of clinical evolution was 13 years. A LA/CA index = 1 (range 0.5 to 0.9) was observed in asymptomatic patients. LA/CA index over 1 were related with airway inflammation, and a LA/CA index more than 2 correlated with GINA step 3. Interestingly when we analyzed CA and LA, we observed that in female group more than 10 years of difference between CA and LA, (GINA Step2 and 3); while in male we observed (GINA Step1, Step2 and Step3). LA/CA index ≤ 1 was considered as normal. Conclusions LA/CA index is a good as clinical indicator of clinical improvement or severity in asthma patients in with excellent correlation of pulmonary function and age.

Do Clinical and Radiological Assessments Contribute to the Understanding of Biomaterials? Results From a Prospective Randomized Sinus Augmentation Split-Mouth Trial.

PubMed

Lorenz, Jonas; Korzinskas, Tadas; Chia, Poju; Maawi, Sarah Al; Eichler, Katrin; Sader, Robert A; Ghanaati, Shahram

2018-02-01

The present prospective randomized split-mouth trial reports on the 3-year clinical and radiological follow-up investigation of implants placed 7 months after sinus augmentation with 2 different bone substitute materials. The aim of the study was to complete the histologic observation of cellular reactions by analyses of the implants and the volumetric changes of the augmented bone substitute materials. A sinus augmentation split-mouth trial was performed in 14 patients with the synthetic bone substitute material Nanobone (NB) and the xenogeneic Bio-Oss (BO). Changes in volume and density of the augmented biomaterials were investigated by analysis of computed tomography scans, taken immediately after augmentation and after 7 months. Clinical implant parameters were assessed after 3 years of loading. Both bone substitute materials underwent nonsignificant volume reduction and significant increase in bone density over an integration period of 7 months. No significant differences concerning volume and bone density were observed between the groups. Three years after loading, 51 of 53 implants were in situ with no peri-implant infections, and only a few soft-tissue variations were present. The present prospective randomized study showed that no differences could be observed clinically and radiologically. Accordingly, it seems that both biomaterials, independent of their physicochemical composition, enable clinical success and long-time stability for dental implants. Interestingly, the histological results showed distinct differences in cellular reactions: While the xenogeneic BO induced a mild tissue reaction with only few multinucleated giant cells and comparably low vascularization, the synthetic NB induced a multinucleated giant cell-triggered tissue reaction with an increase of vascularization. Thus, the present study showed that a combination analysis-histological, clinical, and radiological-is necessary for a detailed assessment of a biomaterial's quality for clinical application.

Comparative toxicity study on classical and modified version of Jawarish Jalinoos (a traditional Unani formulation) in rats.

PubMed

Husain, Gulam Mohammed; Ahmed, Syed Shoeb; Azhar, Misbahuddin; Siddiqui, Javed Inam; Waheed, Mohammad Abdul; Kazmi, Munawwar Husain

2017-03-01

Jawarish Jalinoos (JJ) is a classical semisolid traditional Unani formulation clinically used for the treatment of weakness of vital organs, liver, and stomach. Although JJ has been widely used clinically for several decades, no scientific report is available for its safety. JJ and its sugar-free tablet version (SFJJ; formulated to target diabetic population) were assessed for safety in rats. Ninety-day repeated dose oral toxicity study was performed as per the Organisation for Economic Co-operation and Development Guideline 408. JJ was orally administered at the dose of 2000 mg/kg bw/d, whereas SFJJ was orally administered at the doses of 506 mg/kg body weight (bw)/d, 1012 mg/kg bw/d, and 2024 mg/kg bw/d for 90 days. The animals were periodically observed for clinical signs of toxicity, mortality, morbidity, body weight changes, and feed consumption. At the end of the study, hematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight, and histological examination were performed. Treatment with SFJJ and JJ showed no significant differences in body weight gain, feed consumption, hematology, clinical biochemistry, and serum electrolytes. No gross pathological findings and differences in relative organ weights were observed between control and drug treated rats. Histological examination revealed no toxicologically significant abnormalities related with SFJJ or JJ treatment. The 90-day repeated dose oral toxicity study demonstrates that the no observed adverse effect level of SFJJ and JJ is greater than 2024 mg/kg bw/d and 2000 mg/kg bw/d (p.o.) in rats, respectively. Both formulations were found to be safe up to the tested dose levels and experimental conditions, and therefore safe for clinical use as specified in the literature.

An observational clinical study of the efficacy and tolerability of donepezil in the treatment of Alzheimer's disease.

PubMed

Hager, Klaus; Calabrese, Pasquale; Frölich, Lutz; Göbel, Claus; Berger, Frank M

2003-01-01

An open-label, observational Post-Marketing Surveillance (PMS) study was undertaken in Germany to examine the efficacy and tolerability of donepezil in routine clinical practice. Alzheimer's disease (AD) patients were treated with donepezil (5 or 10 mg once daily) and observed for a period of approximately 3 months. Study assessments included the Mini-Mental State Examination (MMSE), the Nurses' Observation Scale for Geriatric Patients (NOSGER), and adverse events (AEs). A total of 2,092 patients (mean age 73.0 years; mean +/- SD MMSE score 17.8 +/- 5.8) were included in the efficacy assessments. MMSE and NOSGER scores showed statistically significant improvements in the total patient population and in the subpopulations with severe AD or AD with concomitant Parkinsonian symptoms (ADPS cohort). AEs were reported in a total of 12% of patients and were mostly due to peripheral cholinergic effects. In this observational PMS study, donepezil was shown to be an effective and well-tolerated therapy in the overall patient population, in patients with severe AD, and in the ADPS cohort. Copyright 2003 S. Karger AG, Basel

ICU nurses and physicians dialogue regarding patients clinical status and care options—a focus group study

PubMed Central

Kvande, Monica; Lykkeslet, Else; Storli, Sissel Lisa

2017-01-01

ABSTRACT Nurses and physicians work side-by-side in the intensive care unit (ICU). Effective exchanges of patient information are essential to safe patient care in the ICU. Nurses often rate nurse-physician communication lower than physicians and report that it is difficult to speak up, that disagreements are not resolved and that their input is not well received. Therefore, this study explored nurses’ dialogue with physicians regarding patients’ clinical status and the prerequisites for effective and accurate exchanges of information. We adopted a qualitative approach, conducting three focus group discussions with five to six nurses and physicians each (14 total). Two themes emerged. The first theme highlighted nurses’ contributions to dialogues with physicians; nurses’ ongoing observations of patients were essential to patient care discussions. The second theme addressed the prerequisites of accurate and effective dialogue regarding care options, comprising three subthemes: nurses’ ability to speak up and present clinical changes, establishment of shared goal and clinical understanding, and open dialogue and willingness to listen to each other. Nurses should understand their essential role in conducting ongoing observations of patients and their right to be included in care-related decision-making processes. Physicians should be willing to listen to and include nurses’ clinical observations and concerns. PMID:28452605

ICU nurses and physicians dialogue regarding patients clinical status and care options-a focus group study.

PubMed

Kvande, Monica; Lykkeslet, Else; Storli, Sissel Lisa

2017-12-01

Nurses and physicians work side-by-side in the intensive care unit (ICU). Effective exchanges of patient information are essential to safe patient care in the ICU. Nurses often rate nurse-physician communication lower than physicians and report that it is difficult to speak up, that disagreements are not resolved and that their input is not well received. Therefore, this study explored nurses' dialogue with physicians regarding patients' clinical status and the prerequisites for effective and accurate exchanges of information. We adopted a qualitative approach, conducting three focus group discussions with five to six nurses and physicians each (14 total). Two themes emerged. The first theme highlighted nurses' contributions to dialogues with physicians; nurses' ongoing observations of patients were essential to patient care discussions. The second theme addressed the prerequisites of accurate and effective dialogue regarding care options, comprising three subthemes: nurses' ability to speak up and present clinical changes, establishment of shared goal and clinical understanding, and open dialogue and willingness to listen to each other. Nurses should understand their essential role in conducting ongoing observations of patients and their right to be included in care-related decision-making processes. Physicians should be willing to listen to and include nurses' clinical observations and concerns.

A Complex Multiherbal Regimen Based on Ayurveda Medicine for the Management of Hepatic Cirrhosis Complicated by Ascites: Nonrandomized, Uncontrolled, Single Group, Open-Label Observational Clinical Study.

PubMed

Patel, Manish V; Patel, Kalapi B; Gupta, Shivenarain; Michalsen, Andreas; Stapelfeldt, Elmar; Kessler, Christian S

2015-01-01

Hepatic cirrhosis is one of the leading causes of death worldwide, especially if complicated by ascites. This chronic condition can be related to the classical disease entity jalodara in Traditional Indian Medicine (Ayurveda). The present paper aims to evaluate the general potential of Ayurvedic therapy for overall clinical outcomes in hepatic cirrhosis complicated by ascites (HCcA). In form of a nonrandomized, uncontrolled, single group, open-label observational clinical study, 56 patients fulfilling standardized diagnostic criteria for HCcA were observed during their treatment at the P. D. Patel Ayurveda Hospital, Nadiad, India. Based on Ayurvedic tradition, a standardized treatment protocol was developed and implemented, consisting of oral administration of single and compound herbal preparations combined with purificatory measures as well as dietary and lifestyle regimens. The outcomes were assessed by measuring liver functions through specific clinical features and laboratory parameters and by evaluating the Child-Pugh prognostic grade score. After 6 weeks of treatment and a follow-up period of 18 weeks, the outcomes showed statistically significant and clinically relevant improvements. Further larger and randomized trials on effectiveness, safety, and quality of the Ayurvedic approach in the treatment of HCcA are warranted to support these preliminary findings.

Effectiveness-implementation Hybrid Designs

PubMed Central

Curran, Geoffrey M.; Bauer, Mark; Mittman, Brian; Pyne, Jeffrey M.; Stetler, Cheryl

2013-01-01

Objectives This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a “hybrid effectiveness-implementation” typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. Results An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention’s impact on relevant outcomes. Conclusions The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice. PMID:22310560

Is the radiographic subsidence of stand-alone cages associated with adverse clinical outcomes after cervical spine fusion? An observational cohort study with 2-year follow-up outcome scoring.

PubMed

Zajonz, Dirk; Franke, Anne-Catherine; von der Höh, Nicolas; Voelker, Anna; Moche, Michael; Gulow, Jens; Heyde, Christoph-Eckhard

2014-01-01

The stand-alone treatment of degenerative cervical spine pathologies is a proven method in clinical practice. However, its impact on subsidence, the resulting changes to the profile of the cervical spine and the possible influence of clinical results compared to treatment with additive plate osteosynthesis remain under discussion until present. This study was designed as a retrospective observational cohort study to test the hypothesis that radiographic subsidence of cervical cages is not associated with adverse clinical outcomes. 33 cervical segments were treated surgically by ACDF with stand-alone cage in 17 patients (11 female, 6 male), mean age 56 years (33-82 years), and re-examined after eight and twenty-six months (mean) by means of radiology and score assessment (Medical Outcomes Study Short Form (MOS-SF 36), Oswestry Neck Disability Index (ONDI), painDETECT questionnaire and the visual analogue scale (VAS)). Subsidence was observed in 50.5% of segments (18/33) and 70.6% of patients (12/17). 36.3% of cases of subsidence (12/33) were observed after eight months during mean time of follow-up 1. After 26 months during mean time of follow-up 2, full radiographic fusion was seen in 100%. MOS-SF 36, ONDI and VAS did not show any significant difference between cases with and without subsidence in the two-sample t-test. Only in one type of scoring (painDETECT questionnaire) did a statistically significant difference in t-Test emerge between the two groups (p = 0.03; α = 0.05). However, preoperative painDETECT score differ significantly between patients with subsidence (13.3 falling to 12.6) and patients without subsidence (7.8 dropped to 6.3). The radiological findings indicated 100% healing after stand-alone treatment with ACDF. Subsidence occurred in 50% of the segments treated. No impact on the clinical results was detected in the medium-term study period.

Clinical height measurements are unreliable: a call for improvement.

PubMed

Mikula, A L; Hetzel, S J; Binkley, N; Anderson, P A

2016-10-01

Height measurements are currently used to guide imaging decisions that assist in osteoporosis care, but their clinical reliability is largely unknown. We found both clinical height measurements and electronic health record height data to be unreliable. Improvement in height measurement is needed to improve osteoporosis care. The aim of this study is to assess the accuracy and reliability of clinical height measurement in a university healthcare clinical setting. Electronic health record (EHR) review, direct measurement of clinical stadiometer accuracy, and observation of staff height measurement technique at outpatient facilities of the University of Wisconsin Hospital and Clinics. We examined 32 clinical stadiometers for reliability and observed 34 clinic staff perform height measurements at 12 outpatient primary care and specialty clinics. An EHR search identified 4711 men and women age 43 to 89 with no known metabolic bone disease who had more than one height measurement over 3 months. The short study period and exclusion were selected to evaluate change in recorded height not due to pathologic processes. Mean EHR recorded height change (first to last measurement) was -0.02 cm (SD 1.88 cm). Eighteen percent of patients had height measurement differences noted in the EHR of ≥2 cm over 3 months. The technical error of measurement (TEM) was 1.77 cm with a relative TEM of 1.04 %. None of the staff observed performing height measurements followed all recommended height measurement guidelines. Fifty percent of clinic staff reported they on occasion enter patient reported height into the EHR rather than performing a measurement. When performing direct measurements on stadiometers, the mean difference from a gold standard length was 0.24 cm (SD 0.80). Nine percent of stadiometers examined had an error of >1.5 cm. Clinical height measurements and EHR recorded height results are unreliable. Improvement in this measure is needed as an adjunct to improve osteoporosis care.

The role of observational investigations in comparative effectiveness research.

PubMed

Marko, Nicholas F; Weil, Robert J

2010-12-01

Comparative effectiveness research (CER) seeks to inform clinical decisions between alternate treatment strategies using data that reflects real patient populations and real-world clinical scenarios for the purpose of improving patient outcomes. There are multiple clinical situations where the unique characteristics of observational investigations can inform medical decision-making within the CER paradigm. Accordingly, it is critical for clinicians to appreciate the strengths and limitations of observational research, particularly as they apply to CER. This review focuses on the role of observational research in CER. We discuss the concept of evidence hierarchies as they relate to observational research and CER, review the scope and nature of observational research, present the rationale for its inclusion in CER investigations, discuss potential sources of bias in observational investigations as well as strategies used to compensate for these biases, and discuss a framework to implement observational research in CER. The CER paradigm recognizes the limitations of hierarchical models of evidence and favors application of a strength-of-evidence model. In this model, observational research fills gaps in randomized clinical trial data and is particularly valuable to investigate effectiveness, harms, prognosis, and infrequent outcomes as well as in circumstances where randomization is not possible and in studies of many surgical populations. Observational investigations must be designed with careful consideration of potential sources of bias and must incorporate strategies to control such bias prospectively, and their results must be reported in a uniform and transparent fashion. When these conditions can be achieved, observational research represents a valuable and critical component of modern CER. © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Physiotherapy students and clinical educators perceive several ways in which incorporating peer-assisted learning could improve clinical placements: a qualitative study.

PubMed

Sevenhuysen, Samantha; Farlie, Melanie K; Keating, Jennifer L; Haines, Terry P; Molloy, Elizabeth

2015-04-01

What are the experiences of students and clinical educators in a paired student placement model incorporating facilitated peer-assisted learning (PAL) activities, compared to a traditional paired teaching approach? Qualitative study utilising focus groups. Twenty-four physiotherapy students and 12 clinical educators. Participants in this study had experienced two models of physiotherapy clinical undergraduate education: a traditional paired model (usual clinical supervision and learning activities led by clinical educators supervising pairs of students) and a PAL model (a standardised series of learning activities undertaken by student pairs and clinical educators to facilitate peer interaction using guided strategies). Peer-assisted learning appears to reduce the students' anxiety, enhance their sense of safety in the learning environment, reduce educator burden, maximise the use of downtime, and build professional skills including collaboration and feedback. While PAL adds to the clinical learning experience, it is not considered to be a substitute for observation of the clinical educator, expert feedback and guidance, or hands-on immersive learning activities. Cohesion of the student-student relationship was seen as an enabler of successful PAL. Students and educators perceive that PAL can help to position students as active learners through reduced dependence on the clinical educator, heightened roles in observing practice, and making and communicating evaluative judgments about quality of practice. The role of the clinical educator is not diminished with PAL, but rather is central in designing flexible and meaningful peer-based experiences and in balancing PAL with independent learning opportunities. ACTRN12610000859088. [Sevenhuysen S, Farlie MK, Keating JL, Haines TP, Molloy E (2015) Physiotherapy students and clinical educators perceive several ways in which incorporating peer-assisted learning could improve clinical placements: a qualitative study.Journal of Physiotherapy61: 87-92]. Crown Copyright © 2015. Published by Elsevier B.V. All rights reserved.

Recovery in patients with major depressive disorder (MDD): results of a 6-month, multinational, observational study

PubMed Central

Novick, Diego; Montgomery, William; Vorstenbosch, Ellen; Moneta, Maria Victoria; Dueñas, Héctor; Haro, Josep Maria

2017-01-01

Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression. PMID:29184393

Neuroanatomical and Symptomatic Sex Differences in Individuals at Clinical High Risk for Psychosis.

PubMed

Guma, Elisa; Devenyi, Gabriel A; Malla, Ashok; Shah, Jai; Chakravarty, M Mallar; Pruessner, Marita

2017-01-01

Sex differences have been widely observed in clinical presentation, functional outcome and neuroanatomy in individuals with a first-episode of psychosis, and chronic patients suffering from schizophrenia. However, little is known about sex differences in the high-risk stages for psychosis. The present study investigated sex differences in cortical and subcortical neuroanatomy in individuals at clinical high risk (CHR) for psychosis and healthy controls (CTL), and the relationship between anatomy and clinical symptoms in males at CHR. Magnetic resonance images were collected in 26 individuals at CHR (13 men) and 29 CTLs (15 men) to determine total and regional brain volumes and morphology, cortical thickness, and surface area (SA). Clinical symptoms were assessed with the brief psychiatric rating scale. Significant sex-by-diagnosis interactions were observed with opposite directions of effect in male and female CHR subjects relative to their same-sex controls in multiple cortical and subcortical areas. The right postcentral, left superior parietal, inferior parietal supramarginal, and angular gyri [<5% false discovery rate (FDR)] were thicker in male and thinner in female CHR subjects compared with their same-sex CTLs. The same pattern was observed in the right superior parietal gyrus SA at the regional and vertex level. Using a recently developed surface-based morphology pipeline, we observed sex-specific shape differences in the left hippocampus (<5% FDR) and amygdala (<10% FDR). Negative symptom burden was significantly higher in male compared with female CHR subjects ( p  = 0.04) and was positively associated with areal expansion of the left amygdala in males (<5% FDR). Some limitations of the study include the sample size, and data acquisition at 1.5 T. This study demonstrates neuroanatomical sex differences in CHR subjects, which may be associated with variations in symptomatology in men and women with psychotic symptoms.

A Comparative Study of Efficacy and Safety of Eberconazole versus Terbinafine in Patients of Tinea Versicolor.

PubMed

Sharma, Jyoti; Kaushal, Jyoti; Aggarwal, Kamal

2018-01-01

Tinea versicolor (TV) is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%), respectively. However, early response (at the end of week 1) was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

Effect of Non-Surgical Periodontal Treatment on Clinical and Biochemical Risk Markers of Cardiovascular Disease: A Randomized Trial.

PubMed

Hada, Divya Singh; Garg, Subhash; Ramteke, Girish B; Ratre, Madhu Singh

2015-11-01

Various studies have shown periodontal disease is one of the risk factors for coronary heart disease (CHD), and periodontal treatment of patients with CHD has also been correlated with reduction in systemic markers of CHD. The aim of this study is to evaluate the effect of non-surgical periodontal treatment (NSPT) on the cardiovascular clinical and biochemical status of patients with CHD. Seventy known patients with CHD were allocated randomly to either a control group (C; no periodontal therapy) (n = 35) or an experimental group (E; NSPT in the form of scaling and root planing [SRP]) (n = 35). Cardiovascular status was assessed using clinical parameters such as pulse, respiratory rate, blood pressure (BP), and biochemical parameters, such as high-sensitivity C-reactive protein (hsCRP), lipid profile, and white blood cell (WBC) count, at baseline and 1, 3, and 6 months. Intergroup and intragroup comparisons were performed using Student t test, and P <0.05 was considered statistically significant. The complete data at the end of the study were provided by only 55 patients (group C, n = 25; group E, n = 30). Highly statistically significant reduction was observed in systolic BP (7.1 mm Hg) and very-low-density lipoproteins (VLDLs; 5.16 mg/dL) in group E. Changes were also observed in other cardiovascular biochemical and clinical parameters but were not statistically significant. NSPT (in the form of SRP) positively affects limited cardiovascular (clinical and biochemical) status of patients with CHD. Reduction in triglyceride, VLDL, total WBC, lymphocyte, and neutrophil counts and increase in hsCRP, total cholesterol, high-density lipoprotein, and low-density lipoprotein levels were observed. Highly significant reduction in VLDL cholesterol levels and systolic BP was observed among the various parameters measured.

[Infantile haemangioma: clinical and demographic characteristics, experiences in the treatment].

PubMed

Csoma, Zsanett Renáta; Dalmády, Szandra; Ábrahám, Rita; Rózsa, Tamás; Rácz, Katalin; Kemény, Lajos

2017-10-01

Infantile haemangiomas are the most common vascular tumours of infancy. The vast majority of the lesions do not require dermatological treatment due to their unique clinical course and the high rate of spontaneous regression. Approximately 10-15% of the tumours result in severe complications and sequale, requiring special management and close follow-up. The aim of the present study was to assess the data of the patients treated with infantile haemangiomas, and to summarize the results of the therapy during 4.5 years of study period, in the Paediatric Dermatology Outpatient Clinic of the Department of Dermatology and Allergology, at the University of Szeged. Demographic data of the infants (gender, gestational age and weight, perinatal history of the infant and medical history of mothers), exact date of the visits at Paediatric Dermatology Outpatient Clinic and tumour characteristics (number, subtype, anatomical localisation and complications) were analysed in details. Treatment modalities and therapy intervals, outcomes and the adverse events of the therapies were also discussed in the survey. During the study period, 96 infants with 163 infantile haemangiomas were observed. 54 patients required regular observations, while 42 infants required local or systemic beta-blocker therapy. All of the tumours treated with local or systemic therapy showed marked clinical regression; adverse effects were observed in only 6 cases. The gestational age and gestational weight of infants requiring beta-blocker therapy was significantly lower as compared to children needed only observation. Systemic propranolol is currently the first-line treatment modality for complicated infantile haemangiomas. Our results confirm the significant therapeutic efficacy of propranolol. Early introduction of the treatment is relevant; unfortunately a great proportion of patients are referred late to Paediatric Dermatology Centres. Orv Hetil. 2017; 158(39): 1535-1544.

Sex-related clinical aspects in insect venom anaphylaxis.

PubMed

Nittner-Marszalska, Marita; Liebhart, Jerzy; Dor-Wojnarowska, Anna

2015-06-01

Experimental studies, epidemiological data, and clinical observations suggest that the gender factor is involved in the development and manifestation of IgE-dependent allergic diseases. We intend to answer the question if sex-related factors may play a role in Hymenoptera venom allergy (HVA). In the majority of recent studies the frequency of HVA symptoms with respect to both LL and SYS reactions is similar for men and women, while proven sensitization to insect venom is less frequent in women. Studies assessing clinical reactivity in HVA indicate that male sex and vespid venom allergy are factors increasing the risk of severe allergic reactions. Regarding the risk of adverse events associated with gender in the course of venom immunotherapy (VIT), the results of two large EAACI multicenter studies are discordant. In the first study, women showed increased risk of VIT adverse events. In the latter, systemic allergic side effects were not associated with gender. Despite theoretical premises and certain clinical observations indicating an important role of estrogens in allergic diseases, their influence on stinging insects' venom hypersensitivity is not unequivocal and remains still open. Further studies on the safety of VIT in females seem to be advisable. © The Author(s) 2015.

Promoting mental health recovery and improving clinical assessment using video technology.

PubMed

Bradford, Daniel W; Cuddeback, Gary; Elbogen, Eric B

2017-12-01

Although individuals with medical problems (e.g., diabetes, hypertension) can monitor their symptoms using objective measures (e.g., blood glucose, blood pressure), objective measures are not typically used by individuals with psychotic disorders to monitor symptoms of mental illness. To examine the benefits and limitations of the use of video self-observation for treatment of individuals with psychotic disorders. The authors reviewed studies examining video self-observation among individuals with severe mental illnesses. Individuals with psychotic disorders who viewed videos of themselves while symptomatic reported some benefit to this approach, with 1 study showing sustained improvement in understanding of mental illness. Still, some individuals reported negative feelings about the process, and also attributed symptoms to stress or drug abuse rather than their psychotic disorder. The authors found no studies examining the potential for video self-observation as a strategy to improve clinical decision-making in the context of mental health care. Implications of this approach for mental health recovery and clinical practice are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

The synergy of honokiol and fluconazole against clinical isolates of azole-resistant Candida albicans.

PubMed

Jin, J; Guo, N; Zhang, J; Ding, Y; Tang, X; Liang, J; Li, L; Deng, X; Yu, L

2010-09-01

To evaluate the interaction of fluconazole (FLC) and honokiol (HNK) in vitro and vivo against azole-resistant (azole-R) clinical isolates of Candida albicans. A checkerboard microdilution method was used to study the in vitro interaction of FLC and HNK in 24 azole-R clinical isolates of C. albicans. In vivo antifungal activity was performed to further analyse the interaction between FLC and HNK. In the in vitro study, synergism was observed in all 24 FLC-resistant strains tested as determined by fractional inhibitory concentration index (FICI), and in 22 strains by Delta E models. No antagonistic activity was observed in any of the strains tested. These positive interactions were also confirmed by using the time-killing test for the selected strain C. albicans YL371, which shows strong susceptible to the combination of HNK and FLC. In the in vivo study, the mice with candidiasis were treated successfully by a combination therapy of HNK with FLC, the results showed a decrease of the colony forming unit in infected and treated animals compared to the controls, at the conditions of the treatment used in this study. Synergistic activity of HNK and FLC against clinical isolates of FLC-resistant C. albicans was observed in vitro and in vivo. This report might provide a potential therapeutic method to overcome the problem of drug-resistance in C. albicans.

Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study).

PubMed

Suh, Sunghwan; Song, Sun Ok; Kim, Jae Hyeon; Cho, Hyungjin; Lee, Woo Je; Lee, Byung-Wan

2017-01-01

The present observational study aimed to evaluate the clinical effectiveness of vildagliptin with metformin in Korean patients with type 2 diabetes mellitus (T2DM). Data were pooled from the vildagliptin postmarketing survey (PMS), the vildagliptin/metformin fixed drug combination (DC) PMS, and a retrospective observational study of vildagliptin/metformin (fixed DC or free DC). The effectiveness endpoint was the proportion of patients who achieved a glycemic target (HbA1c) of ≤7.0% at 24 weeks. In total, 4303 patients were included in the analysis; of these, 2087 patients were eligible. The mean patient age was 56.99 ± 11.25 years. Overall, 58.94% patients achieved an HbA1c target of ≤7.0% at 24 weeks. The glycemic target achievement rate was significantly greater in patients with baseline HbA1c < 7.5% versus ≥7.5% (84.64% versus 43.97%), receiving care at the hospital versus clinic (67.95% versus 52.33%), and receiving vildagliptin/metformin fixed DC versus free DC (70.69% versus 55.42%). Multivariate logistic regression analysis indicated that disease duration ( P < 0.0001), baseline HbA1c ( P < 0.0001), and DC type ( P = 0.0103) had significant effects on drug effectiveness. Vildagliptin plus metformin appeared as an effective treatment option for patients with T2DM in clinical practice settings in Korea.

Retrospective use of PBPK modelling to understand a clinical drug-drug interaction between dextromethorphan and GSK1034702.

PubMed

Hobbs, Michael J; Bloomer, Jackie; Dear, Gordon

2017-08-01

1. In a clinical trial, a strong drug-drug interaction (DDI) was observed between dextromethorphan (DM, the object or victim drug) and GSK1034702 (the precipitant or perpetrator drug), following single and repeat doses. This study determined the inhibition parameters of GSK1034702 in vitro and applied PBPK modelling approaches to simulate the clinical observations and provide mechanistic hypotheses to understand the DDI. 2. In vitro assays were conducted to determine the inhibition parameters of human CYP2D6 by GSK1034702. PBPK models were populated with the in vitro parameters and DDI simulations conducted and compared to the observed data from a clinical study with DM and GSK1034702. 3. GSK1034702 was a potent direct and metabolism-dependent inhibitor of human CYP2D6, with inhibition parameters of: IC 50  =   1.6 μM, K inact  = 3.7 h -1 and K I  = 0.8 μM. Incorporating these data into PBPK models predicted a DDI after repeat, but not single, 5 mg doses of GSK1034702. 4. The DDI observed with repeat administration of GSK1034702 (5 mg) can be attributed to metabolism-dependent inhibition of CYP2D6. Further, in vitro data were generated and several potential mechanisms proposed to explain the interaction observed following a single dose of GSK1034702.

[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.

A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children.

PubMed

Eichenfield, Lawrence F; Funk, Ann; Fallon-Friedlander, Sheila; Cunningham, Bari B

2002-06-01

A double-randomized, blinded crossover trial was performed to assess the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics (EMLA) for pain relief during pediatric venipuncture procedures. Safety was assessed by evaluation for topical or systemic effects and measurement of serum lidocaine concentrations. A total of 120 children who were scheduled for repeat venipuncture for non-study-related reasons at 2 sites participated in the study. Patients were doubly randomized to treatment regimen (study medication application time of either 30 or 60 minutes) and to the order of application of the topical anesthetics for each venipuncture. The primary outcome measures were the child's rating of pain immediately after the venipuncture procedures using a 100-mm visual analog scale (VAS) tool and the parent's and blinded research observer's Observed Behavioral Distress scores. Both ELA-Max and EMLA seemed to alleviate venipuncture pain. There was no clinically or statistically significant difference in the patient VAS scores within the 30-minute or 60-minute treatment groups, and there was no clinical or statistical difference in VAS scores between the 30-minute ELA-Max treatment without occlusion and the 60-minute EMLA treatment with occlusion. There were no clinically or statistically significant differences between treatment with ELA-Max and EMLA in parental or blinded researcher Observed Behavioral Distress scores, the most frequent response at any observation time being "no distress." This study demonstrates that a 30-minute application of ELA-Max without occlusion is as safe and as effective for ameliorating pain associated with venipuncture as a 60-minute application of the prescription product EMLA requiring occlusion.

Efficacy and Safety of Tacrolimus Therapy for Active Ulcerative Colitis; A Systematic Review and Meta-analysis

PubMed Central

Komaki, Yuga; Komaki, Fukiko; Ido, Akio

2016-01-01

Background: Approximately 25% of patients with ulcerative colitis [UC] experience a severe flare requiring steroid therapy to avoid colectomy. We performed a systematic review and meta-analysis to assess the efficacy of tacrolimus as a rescue therapy for active UC. Methods: Electronic databases were searched for relevant studies assessing the efficacy of tacrolimus for active UC. Outcomes included short- and long-term clinical response, colectomy free rates, and rate of adverse events in randomised controlled trials [RCTs] and observational studies. Results: Two RCTs comparing high trough concentration [10–15ng/ml] versus placebo [n = 103] and 23 observational studies [n = 831] were identified. Clinical response at 2 weeks was significantly higher with tacrolimus compared with placebo (risk ratio [RR] = 4.61, 95% confidence interval [CI] = 2.09–10.17, p = 0.15 x 10-3] among RCTs. Rates of clinical response at 1 and 3 months were 0.73 [95% CI = 0.64–0.81] and 0.76 [95% CI = 0.59–0.87], and colectomy-free rates remained high at 1, 3, 6, and 12 months [0.86, 0.84, 0.78, and 0.69, respectively] among observational studies. Among RCTs, adverse events were more frequent compared with placebo [RR = 2.01, 95% CI = 1.20–3.37, p = 0.83 x 10-2], but there was no difference in severe adverse events [RR = 3.15, 95% CI = 0.14–72.9, p = 0.47]. Severe adverse events were rare among observational studies [0.11, 95% CI = 0.06–0.20]. Conclusions: In the present meta-analysis, tacrolimus was associated with high clinical response and colectomy-free rates without increased risk of severe adverse events for active UC. PMID:26645641

Clinical photographic observation of plantar corns and callus associated with a nominal scale classification and inter- observer reliability study in a student population.

PubMed

Tollafield, David R

2017-01-01

The management of plantar corns and callus has a low cost-benefit with reduced prioritisation in healthcare. The distinction between types of keratin lesions that forms corns and callus has attracted limited interest. Observation is imperative to improving diagnostic predictions and a number of studies point to some confusion as to how best to achieve this. The use of photographic observation has been proposed to improve our understanding of intractable keratin lesions. Students from a podiatry school reviewed photographs where plantar keratin lesions were divided into four nominal groups; light callus (Grade 1), heavy defined callus (Grade 2), concentric keratin plugs (Grade 3) and callus with deeper density changes under the forefoot (Grade 4). A group of 'experts' assigned from qualified podiatrists validated the observer rated responses by the students. Cohen's weighted statistic (k) was used to measure inter-observer reliability. First year students (unskilled) performed less well when viewing photographs ( k  = 0.33) compared to third year students (semi-skilled, k  = 0.62). The experts performed better than students ( k  = 0.88) providing consistency with wound care models in other studies. Improved clinical annotation of clinical features, supported by classification of keratin- based lesions, combined with patient outcome tools, could improve the scientific rationale to prioritise patient care. Problems associated with photographic assessment involves trying to differentiate similar lesions without the benefit of direct palpation. Direct observation of callus with and without debridement requires further investigation alongside the model proposed in this paper.

Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers.

PubMed

Goldstein, Judith E; Jackson, Mary Lou; Fox, Sandra M; Deremeik, James T; Massof, Robert W

2015-07-01

To facilitate comparative clinical outcome research in low vision rehabilitation, we must use patient-centered measurements that reflect clinically meaningful changes in visual ability. To quantify the effects of currently provided low vision rehabilitation (LVR) on patients who present for outpatient LVR services in the United States. Prospective, observational study of new patients seeking outpatient LVR services. From April 2008 through May 2011, 779 patients from 28 clinical centers in the United States were enrolled in the Low Vision Rehabilitation Outcomes Study. The Activity Inventory, a visual function questionnaire, was administered to measure overall visual ability and visual ability in 4 functional domains (reading, mobility, visual motor function, and visual information processing) at baseline and 6 to 9 months after usual LVR care. The Geriatric Depression Scale, Telephone Interview for Cognitive Status, and Medical Outcomes Study 36-Item Short-Form Health Survey physical functioning questionnaires were also administered to measure patients' psychological, cognitive, and physical health states, respectively, and clinical findings of patients were provided by study centers. Mean changes in the study population and minimum clinically important differences in the individual in overall visual ability and in visual ability in 4 functional domains as measured by the Activity Inventory. Baseline and post-rehabilitation measures were obtained for 468 patients. Minimum clinically important differences (95% CIs) were observed in nearly half (47% [95% CI, 44%-50%]) of patients in overall visual ability. The prevalence rates of patients with minimum clinically important differences in visual ability in functional domains were reading (44% [95% CI, 42%-48%]), visual motor function (38% [95% CI, 36%-42%]), visual information processing (33% [95% CI, 31%-37%]), and mobility (27% [95% CI, 25%-31%]). The largest average effect size (Cohen d = 0.87) for the population was observed in overall visual ability. Age (P = .006) was an independent predictor of changes in overall visual ability, and logMAR visual acuity (P = .002) was predictive of changes in visual information processing. Forty-four to fifty percent of patients presenting for outpatient LVR show clinically meaningful differences in overall visual ability after LVR, and the average effect sizes in overall visual ability are large, close to 1 SD.

Development of a novel observational measure for anxiety in young children: The Anxiety Dimensional Observation Scale

PubMed Central

Mian, Nicholas D.; Carter, Alice S.; Pine, Daniel S.; Wakschlag, Lauren S.; Briggs-Gowan, Margaret J.

2015-01-01

Background Identifying anxiety disorders in preschool-age children represents an important clinical challenge. Observation is essential to clinical assessment and can help differentiate normative variation from clinically significant anxiety. Yet, most anxiety assessment methods for young children rely on parent-reports. The goal of this article is to present and preliminarily test the reliability and validity of a novel observational paradigm for assessing a range of fearful and anxious behaviors in young children, the Anxiety Dimensional Observation Schedule (Anx-DOS). Methods A diverse sample of 403 children, aged 3 to 6 years, and their mothers was studied. Reliability and validity in relation to parent reports (Preschool Age Psychiatric Assessment) and known risk factors, including indicators of behavioral inhibition (latency to touch novel objects) and attention bias to threat (in the dot-probe task) were investigated. Results The Anx-DOS demonstrated good inter-rater reliability and internal consistency. Evidence for convergent validity was demonstrated relative to mother-reported separation anxiety, social anxiety, phobic avoidance, trauma symptoms, and past service use. Finally, fearfulness was associated with observed latency and attention bias toward threat. Conclusions Findings support the Anx-DOS as a method for capturing early manifestations of fearfulness and anxiety in young children. Multimethod assessments incorporating standardized methods for assessing discrete, observable manifestations of anxiety may be beneficial for early identification and clinical intervention efforts. PMID:25773515

Current Educational Reforms in Nursing in the United Kingdom and Their Impact on the Role of Nursing Lecturers in Practice: A Case Study Approach.

ERIC Educational Resources Information Center

Camiah, Sada

1998-01-01

Observations of and interviews with 41 British nurse educators found that they are expected to spend more time doing clinical teaching, developing links with clinical staff, supporting the development of the clinical learning environment, and participating in educational audits. (SK)

A Study of Critical Reflection in Health Professional Education: "Learning Where Others Are Coming from"

ERIC Educational Resources Information Center

Delany, Clare; Watkin, Deborah

2009-01-01

A dominant focus of clinical education for health professional students is experiential learning through an apprentice model where students are exposed to a range of clinical scenarios and conditions through observation initially, and then through supervised clinical practice. However experiential learning may not be enough to meet the need for…

Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

PubMed

Curran, Geoffrey M; Bauer, Mark; Mittman, Brian; Pyne, Jeffrey M; Stetler, Cheryl

2012-03-01

This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.

Transparent Reporting of Data Quality in Distributed Data Networks

PubMed Central

Kahn, Michael G.; Brown, Jeffrey S.; Chun, Alein T.; Davidson, Bruce N.; Meeker, Daniella; Ryan, Patrick B.; Schilling, Lisa M.; Weiskopf, Nicole G.; Williams, Andrew E.; Zozus, Meredith Nahm

2015-01-01

Introduction: Poor data quality can be a serious threat to the validity and generalizability of clinical research findings. The growing availability of electronic administrative and clinical data is accompanied by a growing concern about the quality of these data for observational research and other analytic purposes. Currently, there are no widely accepted guidelines for reporting quality results that would enable investigators and consumers to independently determine if a data source is fit for use to support analytic inferences and reliable evidence generation. Model and Methods: We developed a conceptual model that captures the flow of data from data originator across successive data stewards and finally to the data consumer. This “data lifecycle” model illustrates how data quality issues can result in data being returned back to previous data custodians. We highlight the potential risks of poor data quality on clinical practice and research results. Because of the need to ensure transparent reporting of a data quality issues, we created a unifying data-quality reporting framework and a complementary set of 20 data-quality reporting recommendations for studies that use observational clinical and administrative data for secondary data analysis. We obtained stakeholder input on the perceived value of each recommendation by soliciting public comments via two face-to-face meetings of informatics and comparative-effectiveness investigators, through multiple public webinars targeted to the health services research community, and with an open access online wiki. Recommendations: Our recommendations propose reporting on both general and analysis-specific data quality features. The goals of these recommendations are to improve the reporting of data quality measures for studies that use observational clinical and administrative data, to ensure transparency and consistency in computing data quality measures, and to facilitate best practices and trust in the new clinical discoveries based on secondary use of observational data. PMID:25992385

Using dreams to assess clinical change during treatment.

PubMed

Glucksman, Myron L; Kramer, Milton

2004-01-01

This article describes several studies that examine the relationship between the manifest content of selected dreams reported by patients and their clinical progress during psychoanalytic and psychodynamically oriented treatment. There are a number of elements that dreaming and psychotherapy have in common: affect regulation; conflict resolution; problem-solving; self-awareness; mastery and adaptation. Four different studies examined the relationship between the manifest content of selected dreams and clinical progress during treatment. In each study, the ratings of manifest content and clinical progress by independent observers were rank-ordered and compared. In three of the four studies there was a significant correlation between the rankings of manifest content and the rankings of clinical progress. This finding suggests that the manifest content of dreams can be used as an independent variable to assess clinical progress during psychoanalytic and psychodynamically oriented treatment.

Determining the effect of different environmental conditions on Ebola virus viability in clinically relevant specimens.

PubMed

Palyi, Bernadett; Magyar, Nora; Henczko, Judit; Szalai, Balint; Farkas, Agnes; Strecker, Thomas; Takacs, Maria; Kis, Zoltan

2018-03-29

In 2013-2016, West Africa experienced the largest and longest Ebola virus disease outbreak ever documented. The wide geographic spread and magnitude of the outbreak often limited the timely and rapid testing of diagnostic samples from patients with suspected Ebola virus disease, raising questions regarding the optimal storage and shipping conditions of clinically relevant specimens, including EDTA-whole blood, plasma, capillary blood, urine and seminal fluid (associated with sexual transmission of the Ebola virus after recovery from the disease). Therefore, the aim of our study was to identify the extent to which storage temperature and clinical specimen type influence Ebola virus viability. Virus infectivity was determined using a fluorescent focus-forming assay. In our study, we show that Ebola virus was the most stable in EDTA-whole blood and plasma samples, whereas rapid decay of infectivity was observed in simulated capillary blood, urine and semen samples, especially when these samples were stored at higher temperatures. The analysis of variance results demonstrated that both temperature and clinical specimen type have significant effects on virus viability, whereas donor differences were not observed. Repeated freeze and thaw cycles of the samples also had a notable impact on virus viability in EDTA-whole blood and urine. Due to the rapid temperature- and specimen-dependent degradation of the virus observed here, our study highlights the importance of proper clinical sample storage at low temperatures during transportation and laboratory analysis.

Admission interview scores are associated with clinical performance in an undergraduate physiotherapy course: an observational study.

PubMed

Edgar, Susan; Mercer, Annette; Hamer, Peter

2014-12-01

The purpose of this study was to determine if there is an association between admission interview score and subsequent academic and clinical performance, in a four-year undergraduate physiotherapy course. Retrospective observational study. 141 physiotherapy students enrolled in two entry year groups. Individual student performance in all course units, practical examinations, clinical placements as well as year level and overall Grade Point Average. Predictor variables included admission interview scores, admission academic scores and demographic data (gender, age and entry level). Interview score demonstrated a significant association with performance in three of six clinical placements through the course. This association was stronger than for any other admission criterion although effect sizes were small to moderate. Further, it was the only admission score to have a significant association with overall Clinical Grade Point Average for the two year groups analysed (r=0.322). By contrast, academic scores on entry showed significant associations with all year level Grade Point Averages except Year 4, the clinical year. This is the first study to review the predictive validity of an admission interview for entry into a physiotherapy course in Australia. The results show that performance in this admission interview is associated with overall performance in clinical placements through the course, while academic admission scoring is not. These findings suggest that there is a role for both academic and non-academic selection processes for entry into physiotherapy. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Brief strategic therapy for obsessive–compulsive disorder: a clinical and research protocol of a one-group observational study

PubMed Central

Pietrabissa, Giada; Manzoni, Gian Mauro; Gibson, Padraic; Boardman, Donald; Gori, Alessio; Castelnuovo, Gianluca

2016-01-01

Introduction Obsessive–compulsive disorder (OCD) is a disabling psychopathology. The mainstay of treatment includes cognitive–behavioural therapy (CBT) and medication management. However, individual suffering, functional impairments as well as the direct and indirect costs associated with the disease remain substantial. New treatment programmes are necessary and the brief strategic therapy (BST) has recently shown encouraging results in clinical practice but no quantitative study has as yet been conducted. Methods and analysis The clinical effectiveness of the OCD-specific BST protocol will be evaluated in a one-group observational study. Participants will be sequentially recruited from a state community psychotherapy clinic in Dublin, Ireland. Outcome measures will be the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Beck Depression Inventory-II (BDI-II). Data will be collected at baseline, at treatment termination and at 3 month follow-up. The statistical significance of the post-treatment effect will be assessed by the paired-sample Student t test, while clinical significance will be evaluated by means of the equivalence testing method, which will be also used to assess the maintenance of effect at follow-up. Ethics/dissemination The present study is approved by the Hesed House Ethics Board in Dublin. Findings will enhance the evidence-based knowledge about the clinical effectiveness of BST in treating OCD symptoms, prior to assessing its efficacy in a randomised and controlled clinical trial, and will be disseminated through publication in peer-reviewed journals and conference presentations. PMID:27013594

Randomized controlled trials vs. observational studies: why not just live together?

PubMed

Faraoni, David; Schaefer, Simon Thomas

2016-10-21

Randomized controlled trials (RCTs) are considered the gold standard for clinical research, thus having a high impact on clinical guidelines and our daily patients' care. However, various treatment strategies which we consider "evidence based" have never been subject to a prospective RCT, as we would rate it unethical to withheld an established treatment to individuals in an placebo controlled trial.In a recent BMC Anesthesiology publication, Trentino et al. analyzed the usefulness of observational studies in assessing benefit and risk of different transfusion strategies. The authors nicely reviewed and summarized similarities and differences, advantages and limitations, between different study types frequently used in transfusion medicine. In this interesting article, the authors conclude, that 'when comparing the results of observational studies with RCTs assessing transfusion outcomes, it is important that one consider not only the study method, but also the key elements of the study design'. Thus, in this commentary we now discuss the pro's and con's of different study types, even irrespective of transfusion medicine.

Evidenced-based review of clinical studies on periodontics.

PubMed

2009-08-01

Periodontal diseases have several implications for the practice of endodontics. First, advanced periodontitis often has direct implications for the long-term prognosis of the case and requires careful evaluation and coordinated treatment of both the periodontic and endodontic diseases. Second, the potential for functional interactions between odontogenic pathoses and marginal periodontitis requires careful collection of clinical observations and monitoring the outcome of various treatments. In this section, we provide an analysis of recent clinical studies in this area.

Sequential changes from minimal pancreatic inflammation to advanced alcoholic pancreatitis.

PubMed

Noronha, M; Dreiling, D A; Bordalo, O

1983-11-01

A correlation of several clinical parameters and pancreatitis morphological alterations observed in chronic alcoholics with and without pancreatic is presented. Three groups of patients were studied: asymptomatic chronic alcoholics (24); non-alcoholic controls (10); and cases with advanced chronic pancreatitis (6). Clinical, biochemical and functional studies were performed. Morphological studies were made on surgical biopsy specimens in light and electron microscopy. The results of this study showed: 1) fat accumulates within pancreatic acinar cells in alcoholics drinking more than 80 g of ethanol per day; 2) ultrastructural changes found in acinar cells of the alcoholics are similar to those described for liver cells; 3) the alterations found in alcoholics without pancreatitis are also observed in those with advanced chronic pancreatitis. An attempt to correlate the sequential changes in the histopathology of alcoholic pancreatic disease with the clinical picture and secretory patterns was made. According to these observations, admitting the ultrastructural similarities between the liver and the pancreas and the recently demonstrated abnormalities of lipid metabolism in pancreatic cells in experimental animal research, the authors postulate a toxic-metabolic mechanism as a likely hypothesis for the pathogenesis of chronic alcoholic inflammation of the pancreas.

Tuberculosis patients hospitalized in the Albert Schweitzer Hospital, Lambaréné, Gabon-a retrospective observational study.

PubMed

Stolp, S M; Huson, M A M; Janssen, S; Beyeme, J O; Grobusch, M P

2013-11-01

Epidemiological data on tuberculosis in Central Africa are limited. We performed a retrospective observational study on clinical characteristics of 719 hospitalized tuberculosis patients in Lambaréné, Gabon. Human immunodeficiency virus (HIV) co-infection rate was high (34%) and in-hospital mortality was significantly higher in HIV-positive patients (10% versus 2%). Long-term information on patient outcome was limited; however, from 2008 to 2011, loss to follow up was noted in 28% of cases. Our data illustrate the high burden of TB in Gabon, where loss to follow up and emerging drug resistance are important problems for which comprehensive data are still lacking. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Sporotrichosis in Rio de Janeiro, Brazil: Sporothrix brasiliensis Is Associated with Atypical Clinical Presentations

PubMed Central

Almeida-Paes, Rodrigo; de Oliveira, Manoel Marques Evangelista; Freitas, Dayvison Francis Saraiva; do Valle, Antônio Carlos Francesconi; Zancopé-Oliveira, Rosely Maria; Gutierrez-Galhardo, Maria Clara

2014-01-01

Background There have been several recent changes in the taxonomy of Sporothrix schenckii as well as new observations regarding the clinical aspects of sporotrichosis. In this study, we determined the identification of the Sporothrix species associated with both classic and unusual clinical aspects of sporotrichosis observed in the endemic area of sporotrichosis in Rio de Janeiro, Brazil. Methodology/Principal Findings To verify whether S. brasiliensis is associated with clinical manifestations of sporotrichosis, a cross-sectional study was performed in which Sporothrix isolates from 50 patients with different clinical manifestations were analyzed and their isolates were studied by phenotypic and genotypic methods. Data from these patients revealed a distinct clinical picture and therapeutic response in infections caused by Sporothrix brasiliensis (n = 45) compared to patients with S. schenckii sensu stricto (n = 5). S. brasiliensis was associated with disseminated cutaneous infection without underlying disease, hypersensitivity reactions, and mucosal infection, whereas patients with S. schenckii presented with less severe and more often localized disease, similar to the majority of previously described sporotrichosis cases. Interestingly, S. brasiliensis-infected patients overall required shorter durations of itraconazole (median 16 weeks) compared to the individuals with S. schenckii (median 24 weeks). Conclusions/Significance These findings suggest that Sporothrix species are linked to different clinical manifestations of sporotrichosis and that S. brasiliensis is effectively treated with oral itraconazole. PMID:25233227

Clinical diagnostic dilemma of intracranial germinoma manifesting as wide skull base extension.

PubMed

Zhou, Zhi-hang; Zhang, Hai-bo; Rao, Jun; Bian, Xiu-wu

2014-09-01

The aims of this study were to present an uncommon intracranial germinoma manifesting as skull base extension and analyze its clinical characteristics to give valuable insight into such uncommon radiologic variant. This is a clinical study of a 15-year-old girl with intracranial germinoma manifesting as skull base extension. Clinical characteristics, magnetic resonance imaging scan observations, pathologic findings, and flow of the treatment procedure were presented and analyzed. She had a 5-month history of diuresis and diplopia. magnetic resonance imaging observation displayed a neoplasm located in the right-side central skull base and suprasellar area with wide extension into the cavernous sinus, intraorbital region, ethmoidal sinus, sphenoid sinus, and pituitary fossa. After administration of contrast medium, strong and heterogeneous enhancement of the mass was observed, with a dural tail sign along the right cerebellar tentorial. Right pterional approach was performed, and intraoperative histologic examination suspected the diagnosis of germinoma; partial resection was achieved, and postoperative radiotherapy was administered. Cranial nerve palsy improved greatly 6 months postoperatively. Although highly unusual, germinoma should be included in the differential diagnosis of all masses with extension along the midline region of skull base, especially when it happens in young female patients.

Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use

PubMed Central

Kinoshita, Yoshikazu; Ishimura, Norihisa; Ishihara, Shunji

2018-01-01

Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases including gastroesophageal reflux disease and secondary prevention of aspirin/NSAID-induced ulcers. Although clinically important adverse effects of PPIs can occur, just as with other drugs, those are not frequently observed during or after administration. Thus, PPIs are regarded as relatively safe and considered to be clinically beneficial. Recently, PPIs have become frequently administered to patients with functional gastrointestinal diseases or primary prevention of drug-related gastroduodenal damage, even though their beneficial effects for those conditions have not been fully confirmed. PPIs tend to be given for conditions in which the necessity of the drug has not been clarified, thus otherwise rare adverse effects are presented as clinically relevant. Although several PPI-related adverse effects have been reported, their clinical relevance is not yet clear, since the evidence reported in those studies is not at a high enough level, as the majority are based on retrospective observational studies and the reported hazard ratios are low. It is important to administer PPIs only for patients who will gain a substantial clinical benefit and to continue to investigate their adverse effects with high quality prospective studies. PMID:29605975

Intensive care unit patients with lower respiratory tract nosocomial infections: the ENIRRIs project.

PubMed

De Pascale, Gennaro; Ranzani, Otavio T; Nseir, Saad; Chastre, Jean; Welte, Tobias; Antonelli, Massimo; Navalesi, Paolo; Garofalo, Eugenio; Bruni, Andrea; Coelho, Luis Miguel; Skoczynski, Szymon; Longhini, Federico; Taccone, Fabio Silvio; Grimaldi, David; Salzer, Helmut J F; Lange, Christoph; Froes, Filipe; Artigas, Antoni; Díaz, Emili; Vallés, Jordi; Rodríguez, Alejandro; Panigada, Mauro; Comellini, Vittoria; Fasano, Luca; Soave, Paolo M; Spinazzola, Giorgia; Luyt, Charles-Edouard; Alvarez-Lerma, Francisco; Marin, Judith; Masclans, Joan Ramon; Chiumello, Davide; Pezzi, Angelo; Schultz, Marcus; Mohamed, Hafiz; Van Der Eerden, Menno; Hoek, Roger A S; Gommers, D A M P J; Pasquale, Marta Di; Civljak, Rok; Kutleša, Marko; Bassetti, Matteo; Dimopoulos, George; Nava, Stefano; Rios, Fernando; Zampieri, Fernando G; Povoa, Pedro; Bos, Lieuwe D; Aliberti, Stefano; Torres, Antoni; Martín-Loeches, Ignacio

2017-10-01

The clinical course of intensive care unit (ICU) patients may be complicated by a large spectrum of lower respiratory tract infections (LRTI), defined by specific epidemiological, clinical and microbiological aspects. A European network for ICU-related respiratory infections (ENIRRIs), supported by the European Respiratory Society, has been recently established, with the aim at studying all respiratory tract infective episodes except community-acquired ones. A multicentre, observational study is in progress, enrolling more than 1000 patients fulfilling the clinical, biochemical and radiological findings consistent with a LRTI. This article describes the methodology of this study. A specific interest is the clinical impact of non-ICU-acquired nosocomial pneumonia requiring ICU admission, non-ventilator-associated LRTIs occurring in the ICU, and ventilator-associated tracheobronchitis. The clinical meaning of microbiologically negative infectious episodes and specific details on antibiotic administration modalities, dosages and duration are also highlighted. Recently released guidelines address many unresolved questions which might be answered by such large-scale observational investigations. In light of the paucity of data regarding such topics, new interesting information is expected to be obtained from our network research activities, contributing to optimisation of care for critically ill patients in the ICU.

Rivaroxaban in patients with atrial fibrillation: from ROCKET AF to everyday practice.

PubMed

Barón-Esquivias, Gonzalo; Marín, Francisco; Sanmartín Fernandez, Marcelo

2017-05-01

Registries and non-interventional studies offer relevant and complementary information to clinical trials, since they have a high external validity. Areas covered: The information regarding the efficacy and safety of rivaroxaban compared with warfarin, or rivaroxaban alone in clinical practice was reviewed in this manuscript. For this purpose, a search on MEDLINE and EMBASE databases was performed. The MEDLINE and EMBASE search included both medical subject headings (MeSH) and keywords including: atrial fibrillation (AF) OR warfarin OR clinical practice OR ROCKET AF AND rivaroxaban. Case reports were not considered. Expert commentary: In ROCKET AF, rivaroxaban was at least as effective as warfarin for the prevention of stroke in patients with nonvalvular AF at high risk of stroke, but, importantly, with a lesser risk of intracranial, critical and fatal bleedings. A number of observational comparative and non-comparative studies, with more than 60,000 patients included treated with rivaroxaban, have analyzed the efficacy and safety of rivaroxaban in real-life patients with AF in different clinical settings. These studies have shown that in clinical practice, rates of stroke and major bleeding were consistently lower than those reported in ROCKET AF, likely due to the lower thromboembolic and bleeding risk observed in these patients.

Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use.

PubMed

Kinoshita, Yoshikazu; Ishimura, Norihisa; Ishihara, Shunji

2018-04-30

Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases including gastroesophageal reflux disease and secondary prevention of aspirin/NSAID-induced ulcers. Although clinically important adverse effects of PPIs can occur, just as with other drugs, those are not frequently observed during or after administration. Thus, PPIs are regarded as relatively safe and considered to be clinically beneficial. Recently, PPIs have become frequently administered to patients with functional gastrointestinal diseases or primary prevention of drug-related gastroduodenal damage, even though their beneficial effects for those conditions have not been fully confirmed. PPIs tend to be given for conditions in which the necessity of the drug has not been clarified, thus otherwise rare adverse effects are presented as clinically relevant. Although several PPI-related adverse effects have been reported, their clinical relevance is not yet clear, since the evidence reported in those studies is not at a high enough level, as the majority are based on retrospective observational studies and the reported hazard ratios are low. It is important to administer PPIs only for patients who will gain a substantial clinical benefit and to continue to investigate their adverse effects with high quality prospective studies.

Chamomile (Matricaria recutita) may provide antidepressant activity in anxious, depressed humans: an exploratory study.

PubMed

Amsterdam, Jay D; Shults, Justine; Soeller, Irene; Mao, Jun James; Rockwell, Kenneth; Newberg, Andrew B

2012-01-01

Anxiety and depression are the most commonly reported psychiatric conditions and frequently occur as comorbid disorders. While the advent of conventional drug therapies has simplified treatment, a large segment of the population goes untreated or declines conventional therapy for financial, cultural, or personal reasons. Therefore, the identification of inexpensive and effective alternative therapies for anxiety and depression is of relevance to public health. The current study explores data from a 2009 clinical chamomile trial in humans to determine if chamomile provides clinically meaningful antidepressant activity versus a placebo. In the 2009 randomized, double-blind, placebo-controlled study, the research team examined the antianxiety and antidepressant action of oral chamomile (Matricaria recutita) extract in participants with symptoms of comorbid anxiety and depression. In the 2009 study, all of participants' evaluations took place at the Depression Research Unit at the University of Pennsylvania. The study drew participants from patients at the Department of Family Medicine and Community Health's primary care clinic at the University of Pennsylvania, Philadelphia. Of the 57 participants in the 2009 trial, 19 had anxiety with comorbid depression; 16 had anxiety with a past history of depression; and 22 had anxiety with no current or past depression. The intervention and placebo groups in the 2009 trial received identically appearing 220-mg capsules containing either pharmaceutical-grade chamomile extract standardized to a content of 1.2% apigenin or a placebo (ie, lactose monohydrate NF), respectively. In the current study, the research team used generalized estimating equations analysis to identify clinically meaningful changes over time in scores from the Hamilton Depression Rating (HAM-D) questionnaire among treatment groups. In the current study, the research team observed a significantly greater reduction over time in total HAM-D scores for chamomile vs placebo in all participants (P < .05). The team also observed a clinically meaningful but nonsignificant trend for a greater reduction in total HAM-D scores for chamomile vs placebo in participants with current comorbid depression (P = .062). When the team examined the HAM-D core mood item scores, it observed a significantly greater reduction over time for chamomile vs placebo in all participants (P < .05) and a clinically meaningful but nonsignificant trend for a greater reduction over time for chamomile vs placebo in participants without current or past depression (P = .06). Chamomile may provide clinically meaningful antidepressant activity that occurs in addition to its previously observed anxiolytic activity.

Clinical assessment of effusion in knee osteoarthritis—A systematic review

PubMed Central

Maricar, Nasimah; Callaghan, Michael J.; Parkes, Matthew J.; Felson, David T.; O׳Neill, Terence W.

2016-01-01

Objective The aim of this systematic review was to determine the validity and inter- and intra-observer reliability of the assessment of knee joint effusion in osteoarthritis (OA) of the knee. Methods MEDLINE, Web of Knowledge, CINAHL, EMBASE, and AMED were searched from their inception to February 2015. Articles were included according to a priori defined criteria: samples containing participants with knee OA; prospective evaluation of clinical tests and assessments of knee effusion that included reliability, sensitivity, and specificity of these tests. Results A total of 10 publications were reviewed. Eight of these considered reliability and four on validity of clinical assessments against ultrasound effusion. It was not possible to undertake a meta-analysis of reliability or validity because of differences in study designs and the clinical tests. Intra-observer kappa agreement for visible swelling ranged from 0.37 (suprapatellar) to 1.0 (prepatellar); for bulge sign 0.47 and balloon sign 0.37. Inter-observer kappa agreement for visible swelling ranged from −0.02 (prepatellar) to 0.65 (infrapatellar), the balloon sign −0.11 to 0.82, patellar tap −0.02 to 0.75 and bulge sign kappa −0.04 to 0.14 or reliability coefficient 0.97. Reliability and diagnostic accuracy tended to be better in experienced observers. Very few data looked at performance of individual clinical tests with sensitivity ranging 18.2–85.7% and specificity 35.3–93.3%, both higher with larger effusions. Conclusion The majority of unstandardized clinical tests to assess joint effusion in knee OA had relatively low intra- and inter-observer reliability. There is some evidence experience improved reliability and diagnostic accuracy of tests. Currently there is insufficient evidence to recommend any particular test in clinical practice. PMID:26581486

Clinical assessment of effusion in knee osteoarthritis-A systematic review.

PubMed

Maricar, Nasimah; Callaghan, Michael J; Parkes, Matthew J; Felson, David T; O'Neill, Terence W

2016-04-01

The aim of this systematic review was to determine the validity and inter- and intra-observer reliability of the assessment of knee joint effusion in osteoarthritis (OA) of the knee. MEDLINE, Web of Knowledge, CINAHL, EMBASE, and AMED were searched from their inception to February 2015. Articles were included according to a priori defined criteria: samples containing participants with knee OA; prospective evaluation of clinical tests and assessments of knee effusion that included reliability, sensitivity, and specificity of these tests. A total of 10 publications were reviewed. Eight of these considered reliability and four on validity of clinical assessments against ultrasound effusion. It was not possible to undertake a meta-analysis of reliability or validity because of differences in study designs and the clinical tests. Intra-observer kappa agreement for visible swelling ranged from 0.37 (suprapatellar) to 1.0 (prepatellar); for bulge sign 0.47 and balloon sign 0.37. Inter-observer kappa agreement for visible swelling ranged from -0.02 (prepatellar) to 0.65 (infrapatellar), the balloon sign -0.11 to 0.82, patellar tap -0.02 to 0.75 and bulge sign kappa -0.04 to 0.14 or reliability coefficient 0.97. Reliability and diagnostic accuracy tended to be better in experienced observers. Very few data looked at performance of individual clinical tests with sensitivity ranging 18.2-85.7% and specificity 35.3-93.3%, both higher with larger effusions. The majority of unstandardized clinical tests to assess joint effusion in knee OA had relatively low intra- and inter-observer reliability. There is some evidence experience improved reliability and diagnostic accuracy of tests. Currently there is insufficient evidence to recommend any particular test in clinical practice. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers.

PubMed

Yoshita, Tomohiro; Uchida, Shinya; Namiki, Noriyuki

2013-01-01

Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; p<0.001). This study shows that all the tested products, which are clinically available in Japan, showed good disintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity.

Physiotherapists use a small number of behaviour change techniques when promoting physical activity: A systematic review comparing experimental and observational studies.

PubMed

Kunstler, Breanne E; Cook, Jill L; Freene, Nicole; Finch, Caroline F; Kemp, Joanne L; O'Halloran, Paul D; Gaida, James E

2018-06-01

Physiotherapists promote physical activity as part of their practice. This study reviewed the behaviour change techniques physiotherapists use when promoting physical activity in experimental and observational studies. Systematic review of experimental and observational studies. Twelve databases were searched using terms related to physiotherapy and physical activity. We included experimental studies evaluating the efficacy of physiotherapist-led physical activity interventions delivered to adults in clinic-based private practice and outpatient settings to individuals with, or at risk of, non-communicable diseases. Observational studies reporting the techniques physiotherapists use when promoting physical activity were also included. The behaviour change techniques used in all studies were identified using the Behaviour Change Technique Taxonomy. The behaviour change techniques appearing in efficacious and inefficacious experimental interventions were compared using a narrative approach. Twelve studies (nine experimental and three observational) were retained from the initial search yield of 4141. Risk of bias ranged from low to high. Physiotherapists used seven behaviour change techniques in the observational studies, compared to 30 behaviour change techniques in the experimental studies. Social support (unspecified) was the most frequently identified behaviour change technique across both settings. Efficacious experimental interventions used more behaviour change techniques (n=29) and functioned in more ways (n=6) than did inefficacious experimental interventions (behaviour change techniques=10 and functions=1). Physiotherapists use a small number of behaviour change techniques. Less behaviour change techniques were identified in observational studies compared to experimental studies, suggesting physiotherapists use less BCTs clinically than experimentally. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Physician decision-making in the management of work related upper extremity injuries.

PubMed

Szekeres, Mike; Macdermid, Joy C; Katchky, Adam; Grewal, Ruby

2018-05-22

Physicians working in a tertiary care injured worker clinic are faced with clinical decision-making that must balance the needs of patients and society in managing complex clinical problems that are complicated by the work-workplace context. The purpose of this study is to describe and characterize the decision-making process of upper extremity specialized surgeons when managing injured workers within a specialized worker's compensation clinic. Surgeons were interviewed in a semi-structured manner. Following each interview, the surgeon was also observed in a clinic visit during a new patient assessment, allowing observation of the interactional patterns between surgeon and patient, and comparison of the process described in the interview to what actually occurred during clinic visits. The primary central theme emerging from the surgeon interviews and the clinical observation was the focus on the importance of comprehensive assessment to make the first critical decision: an accurate diagnosis. Two subthemes were also found. The first of these involved the decision whether to proceed to management strategies or to continue with further investigation if the correct diagnosis is uncertain. Once the central theme of diagnosis was achieved, a second subtheme was highlighted; selecting appropriate management options, given the complexities of managing the injured worker, the workplace, and the compensation board. This study illustrates that upper extremity surgeons rely on their training and experience with upper extremity conditions to follow a sequential but iterative decision-making process to provide a more definitive diagnosis and treatment plan for workers with injuries that are often complex. The surgeons are challenged by the context which takes them out of their familiar zone of typical clinical practice to deal with the interactions between the injury, worker, work, workplace and insurer.

Angiogenic factors combined with clinical risk factors to predict preterm pre-eclampsia in nulliparous women: a predictive test accuracy study.

PubMed

Myers, J E; Kenny, L C; McCowan, L M E; Chan, E H Y; Dekker, G A; Poston, L; Simpson, N A B; North, R A

2013-09-01

To assess the performance of clinical risk factors, uterine artery Doppler and angiogenic markers to predict preterm pre-eclampsia in nulliparous women. Predictive test accuracy study. Prospective multicentre cohort study Screening for Pregnancy Endpoints (SCOPE). Low-risk nulliparous women with a singleton pregnancy were recruited. Clinical risk factor data were obtained and plasma placental growth factor (PlGF), soluble endoglin and soluble fms-like tyrosine kinase-1 (sFlt-1) were measured at 14-16 weeks of gestation. Prediction models were developed using multivariable stepwise logistic regression. Preterm pre-eclampsia (delivered before 37(+0)  weeks of gestation). Of the 3529 women recruited, 187 (5.3%) developed pre-eclampsia of whom 47 (1.3%) delivered preterm. Controls (n = 188) were randomly selected from women without preterm pre-eclampsia and included women who developed other pregnancy complications. An area under a receiver operating characteristic curve (AUC) of 0.76 (95% CI 0.67-0.84) was observed using previously reported clinical risk variables. The AUC improved following the addition of PlGF measured at 14-16 weeks (0.84; 95% CI 0.77-0.91), but no further improvement was observed with the addition of uterine artery Doppler or the other angiogenic markers. A sensitivity of 45% (95% CI 0.31-0.59) (5% false-positive rate) and post-test probability of 11% (95% CI 9-13) were observed using clinical risk variables and PlGF measurement. Addition of plasma PlGF at 14-16 weeks of gestation to clinical risk assessment improved the identification of nulliparous women at increased risk of developing preterm pre-eclampsia, but the performance is not sufficient to warrant introduction as a clinical screening test. These findings are marker dependent, not assay dependent; additional markers are needed to achieve clinical utility. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

Evaluation of Clinical Research Training Programs Using the Clinical Research Appraisal Inventory

PubMed Central

Lipira, Lauren; Jeffe, Donna B.; Krauss, Melissa; Garbutt, Jane; Piccirillo, Jay; Evanoff, Bradley; Fraser, Victoria

2010-01-01

Abstract The purpose of this study was to measure change in clinical research self‐efficacy after participating in KL2, postdoctoral and predoctoral clinical research training programs at Washington University School of Medicine. We surveyed program participants using a 76‐item version of the Clinical Research Appraisal Inventory (CRAI). Principal components analysis (PCA) examined the CRAI’s underlying factor structure; Cronbach alpha measured the internal consistency of items on each subscale and the overall CRAI. CRAI score changes from baseline to 1‐year follow‐up were assessed using repeated‐measures analysis of variance. All 29 KL2, 47 postdoctoral, and 31 TL1 scholars enrolled 2006–2009 (mean age 31.6 years, range 22–44; 59.6% female; 65.4% white) completed baseline surveys. Of these participants, 22 KL2, 17 postdoctoral, and 21 TL1 scholars completed the 1‐year follow‐up assessment. PCA resulted in a seven‐factor solution with 69 items (alphas > 0.849 for each subscale and 69‐item CRAI). Significant improvements at 1‐year follow‐up were observed across all programs for Study Design/Data Analysis (p= .016), Interpreting/Reporting/Presenting (p= .034), and overall CRAI (p= .050). Differences between programs were observed for all but one subscale (each p < .05). Clinical research self‐efficacy increased 1 year after clinical research training. Whether this short‐term outcome correlates with long‐term clinical research productivity, requires further study. Clin Trans Sci 2010; Volume 3: 243–248. PMID:21442017

Accuracy of clinical pallor in the diagnosis of anaemia in children: a meta-analysis.

PubMed

Chalco, Juan P; Huicho, Luis; Alamo, Carlos; Carreazo, Nilton Y; Bada, Carlos A

2005-12-08

Anaemia is highly prevalent in children of developing countries. It is associated with impaired physical growth and mental development. Palmar pallor is recommended at primary level for diagnosing it, on the basis of few studies. The objective of the study was to systematically assess the accuracy of clinical signs in the diagnosis of anaemia in children. A systematic review on the accuracy of clinical signs of anaemia in children. We performed an Internet search in various databases and an additional reference tracking. Studies had to be on performance of clinical signs in the diagnosis of anaemia, using haemoglobin as the gold standard. We calculated pooled diagnostic likelihood ratios (LR's) and odds ratios (DOR's) for each clinical sign at different haemoglobin thresholds. Eleven articles met the inclusion criteria. Most studies were performed in Africa, in children underfive. Chi-square test for proportions and Cochran Q for DOR's and for LR's showed heterogeneity. Type of observer and haemoglobin technique influenced the results. Pooling was done using the random effects model. Pooled DOR at haemoglobin <11 g/dL was 4.3 (95% CI 2.6-7.2) for palmar pallor, 3.7 (2.3-5.9) for conjunctival pallor, and 3.4 (1.8-6.3) for nailbed pallor. DOR's and LR's were slightly better for nailbed pallor at all other haemoglobin thresholds. The accuracy did not vary substantially after excluding outliers. This meta-analysis did not document a highly accurate clinical sign of anaemia. In view of poor performance of clinical signs, universal iron supplementation may be an adequate control strategy in high prevalence areas. Further well-designed studies are needed in settings other than Africa. They should assess inter-observer variation, performance of combined clinical signs, phenotypic differences, and different degrees of anaemia.

Donepezil treatment and Alzheimer disease: can the results of randomized clinical trials be applied to Alzheimer disease patients in clinical practice?

PubMed

Tinklenberg, Jared R; Kraemer, Helena C; Yaffe, Kristine; Ross, Leslie; Sheikh, Javaid; Ashford, John W; Yesavage, Jerome A; Taylor, Joy L

2007-11-01

To determine if results from randomized clinical trials of donepezil in Alzheimer disease (AD) patients can be applied to AD patients in clinical practice by comparing the findings from a Nordic one-year randomized AD donepezil trial with data from a one-year prospective, observational study of AD patients. AD patients from a consortium of California sites were systematically followed for at least one year. Their treatment regimens, including prescription of donepezil, were determined by their individual physician according to his or her usual criteria. The 148 California patients treated with donepezil had a one-year decline of 1.3 (3.5 SD) points on the Mini-Mental State Exam compared to a decline of 3.3 (4.4 SD) in the 158 AD patients who received no anti-Alzheimer drugs. The Mini-Mental State Exam decline in Nordic sample was approximately 0.25 points for the 91 patients receiving donepezil and approximately 2.2 for the 98 placebo patients. The overall effect sizes were estimated at about 0.49 in both studies. The California data were further analyzed using propensity methods; after taking into account differences that could bias prescribing decisions, benefits associated with taking donepezil remained. A comparison of a randomized clinical trial of donepezil in AD patients and this observational study indicates that if appropriate methodological and statistical precautions are undertaken, then results from randomized clinical trials can be predictive with AD patients in clinical practice. This California study supports the modest effectiveness of donepezil in AD patients having clinical characteristics similar to those of the Nordic study.

The Pain Course: Exploring the Feasibility of an Internet-delivered Pain Management Program When Offered by a Tertiary Pain Management Service.

PubMed

Dear, Blake F; Courtney, Catherine; Khor, Kok Eng; McDonald, Sarah; Ricciardi, Tahlia; Gandy, Milena; Fogliati, Vincent J; Titov, Nick

2018-06-01

This study examined the acceptability and preliminary outcomes of an internet-delivered pain management program, the Pain Course, when offered by a specialist pain management clinic in a large public hospital. A single-group feasibility open-trial design was used and 39 patients participated in the program, which ran for 8 weeks. Participants were supported through the program with weekly contact from a Clinical Psychologist at the clinic. All participants provided data at posttreatment and >90% of participants completed all 5 lessons of the course. High levels of satisfaction were observed and relatively little clinician time (M=71.99 min/participant; SD=32.82 min) was required to support patients through the program. Preliminary evidence of clinical improvements in depression symptoms (avg. improvement=38%; Cohen d=0.74), but not disability levels or anxiety symptoms, was observed in the overall sample. However, evidence of improvements was observed across all the primary outcomes among patients who had clinical levels of difficulties with disability (n=20; avg. improvement=11%; Cohen d=0.64), depression (n=17; avg. improvement=35%; Cohen d=1.24) and anxiety (n=8; avg. improvement=29%; Cohen d=0.57). These findings highlight the potential value of internet-delivered programs when provided by specialist pain management clinics as a part of their services and the value of larger scale studies in this area.

Workflow interruptions and mental workload in hospital pediatricians: an observational study.

PubMed

Weigl, Matthias; Müller, Andreas; Angerer, Peter; Hoffmann, Florian

2014-09-24

Pediatricians' workload is increasingly thought to affect pediatricians' quality of work life and patient safety. Workflow interruptions are a frequent stressor in clinical work, impeding clinicians' attention and contributing to clinical malpractice. We aimed to investigate prospective associations of workflow interruptions with multiple dimensions of mental workload in pediatricians during clinical day shifts. In an Academic Children's Hospital a prospective study of 28 full shift observations was conducted among pediatricians providing ward coverage. The prevalence of workflow interruptions was based on expert observation using a validated observation instrument. Concurrently, Pediatricians' workload ratings were assessed with three workload dimensions of the well-validated NASA-Task Load Index: mental demands, effort, and frustration. Observed pediatricians were, on average, disrupted 4.7 times per hour. Most frequent were interruptions by colleagues (30.2%), nursing staff (29.7%), and by telephone/beeper calls (16.3%). Interruption measures were correlated with two workload outcomes of interest: frequent workflow interruptions were related to less cognitive demands, but frequent interruptions were associated with increased frustration. With regard to single sources, interruptions by colleagues showed the strongest associations to workload. The findings provide insights into specific pathways between different types of interruptions and pediatricians' mental workload. These findings suggest further research and yield a number of work and organization re-design suggestions for pediatric care.

Using the Dreyfus Model of Skill Acquisition to Describe and Interpret Skill Acquisition and Clinical Judgment in Nursing Practice and Education

ERIC Educational Resources Information Center

Benner, Patricia

2004-01-01

Three studies using the Dreyfus model of skill acquisition were conducted over a period of 21 years. Nurses with a range of experience and reported skillfulness were interviewed. Each study used nurses' narrative accounts of actual clinical situations. A subsample of participants were observed and interviewed at work. These studies extend the…

The Therapy Process Observational Coding System for Child Psychotherapy Strategies Scale

ERIC Educational Resources Information Center

McLeod, Bryce D.; Weisz, John R.

2010-01-01

Most everyday child and adolescent psychotherapy does not follow manuals that document the procedures. Consequently, usual clinical care has remained poorly understood and rarely studied. The Therapy Process Observational Coding System for Child Psychotherapy-Strategies scale (TPOCS-S) is an observational measure of youth psychotherapy procedures…

Defining Research: The Effect of Linguistic Choices on the Intentions to Participate in Clinical Research.

PubMed

Strekalova, Yulia A

2017-06-01

Significant barriers to participant recruitment for clinical research (CR) are related to effective communication, and nurse coordinators are entrusted with being knowledge brokers between investigators and prospective participants. This prospective cohort study sought to identify linguistic choices that could inform and facilitate recruitment efforts. Healthy adults ( N = 204) were invited to join an online survey to assess the likelihood of participation in CR based on short and extended definitions of CR. Five short definitions included clinical trial, clinical study, health-related research study, community participatory study, and quality improvement study. The likelihood of participation in CR was the lowest for clinical trial and the highest for health-related research study. However, when only an extended definition was provided, those differences were not observed. A linguistic change from trial to study could lead to positive attitude toward CR and improvements in recruitment. However, ethical implications of linguistic choices should be considered.

Bovine thrombin safety reporting: an example of study design and publication bias.

PubMed

Crean, Sheila; Michels, Shannon L; Moschella, Kevin; Reynolds, Matthew W

2010-01-01

Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials. A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed. In 38 studies, about half were case reports and 31.5% were interventional trials. In case reports, 41% of authors reported severe coagulopathic adverse events. In contrast, whereas blood complications were common in large trials, no association of harm was established for bovine thrombin product exposure and/or immunization. In this review, later clinical trials failed to reproduce the common and severe coagulopathy predicted by earlier observational studies in bovine exposed patients. This example illustrates that perceptions of safety can change as a function of study design, even for a widely adopted, well established biologic such as thrombin. Caution must be exercised in interpreting evidence from observational studies alone.

Age dependence of clinical and pathological manifestations of autoimmune demyelination. Implications for multiple sclerosis.

PubMed

Smith, M E; Eller, N L; McFarland, H F; Racke, M K; Raine, C S

1999-10-01

A prominent feature of the clinical spectrum of multiple sclerosis (MS) is its high incidence of onset in the third decade of life and the relative rarity of clinical manifestations during childhood and adolescence, features suggestive of age-related restriction of clinical expression. Experimental allergic encephalomyelitis (EAE), a model of central nervous system (CNS) autoimmune demyelination with many similarities to MS, has a uniform rapid onset and a high incidence of clinical and pathological disease in adult (mature) animals. Like MS, EAE is most commonly seen and studied in female adults. In this study, age-related resistance to clinical EAE has been examined with the adoptive transfer model of EAE in SJL mice that received myelin basic protein-sensitized cells from animals 10 days (sucklings) to 12 weeks (young adults) of age. A variable delay before expression of clinical EAE was observed between the different age groups. The preclinical period was longest in the younger (<14 days of age) animals, and shortest in animals 6 to 8 weeks old at time of transfer. Young animals initially resistant to EAE eventually expressed well-developed clinical signs by 6 to 7 weeks of age. This was followed by a remitting, relapsing clinical course. For each age at time of sensitization, increased susceptibility of females compared to males was observed. Examination of the CNS of younger animal groups during the preclinical period showed lesions of acute EAE. Older age groups developed onset of signs coincident with acute CNS lesions. This age-related resistance to clinical EAE in developing mice is reminiscent of an age-related characteristic of MS previously difficult to study in vivo. The associated subclinical CNS pathology and age-related immune functions found in young animals may be relevant to the increasing clinical expression of MS with maturation, and may allow study of factors associated with the known occasional poor correlation of CNS inflammation and demyelination and clinical changes in this disease.

An observational study of socioeconomic and clinical gradients among diabetes patients hospitalized for avoidable causes: evidence of underlying health disparities in China?

PubMed

Chen, Brian; Eggleston, Karen; Li, Hong; Shah, Nilay; Wang, Jian

2014-01-30

Diabetes is an ambulatory care sensitive condition that can generally be managed in outpatient settings with little or no need for inpatient care. As a preliminary step to investigate whether health disparities can be detected in the inpatient setting in China, we study how diabetic patients hospitalized without prior primary care contact or with greater severity of illness differ from other diabetic inpatients along socioeconomic and clinical dimensions. We conduct an observational study using three years of clinical data for more than 1,800 adult patients with diabetes at two tertiary hospitals in East China. Univariate analysis and probit regression are used to characterize the differences in socioeconomic and clinical factors between patients hospitalized for diabetes with no prior primary care contact and those hospitalized with previous treatment experience. Secondarily, we use ordinary least squares regression to estimate the socioeconomic and clinical differences associated with poor serum glucose control at admission. We find that compared with patients hospitalized after prior treatment experience, inpatients with no previous primary care contact for diabetes have worse clinical laboratory values, are more likely to be young and male, to have lower education attainment, and to have poorer blood sugar control. Insurance, urban residence, and previous use of diabetic medication are in turn negatively correlated with HbA1c levels upon admission. Among hospitalized diabetic patients, socioeconomic factors such as lower education attainment, rural residence and lack of full insurance are associated with avoidable hospitalizations or worse indicators of health. Although we cannot definitively rule out selection bias, these findings are consistent with health disparities observable even at the inpatient level. Future studies should study the underlying mechanism by which traditionally vulnerable groups are more likely to be hospitalized for avoidable causes and with greater severity of illness.

The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome

PubMed Central

Dietrich, Johannes W; Stachon, Axel; Antic, Biljana; Klein, Harald H; Hering, Steffen

2008-01-01

Background Non-thyroidal illness syndrome (NTIS) is a characteristic functional constellation of thyrotropic feedback control that frequently occurs in critically ill patients. Although this condition is associated with significantly increased morbidity and mortality, there is still controversy on whether NTIS is caused by artefacts, is a form of beneficial adaptation, or is a disorder requiring treatment. Trials investigating substitution therapy of NTIS revealed contradictory results. The comparison of heterogeneous patient cohorts may be the cause for those inconsistencies. Objectives Primary objective of this study is the identification and differentiation of different functional states of thyrotropic feedback control in order to define relevant evaluation criteria for the prognosis of affected patients. Furthermore, we intend to assess the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent (so-called "sub-clinical") thyrotoxicosis. Secondary objective is observation of variables that quantify distinct components of NTIS in the context of independent predictors of evolution, survival or pathophysiological condition and influencing or disturbing factors like medication. Design The approach to a quantitative follow-up of non-thyroidal illness syndrome (AQUA FONTIS study) is designed as both a cross-sectional and prospective longitudinal observation trial in critically ill patients. Patients are observed in at least two evaluation points with consecutive assessments of thyroid status, physiological and clinical data in additional weekly observations up to discharge. A second part of the study investigates the neuropsychological impact of NTIS and medium-term outcomes. The study design incorporates a two-module structure that covers a reduced protocol in form of an observation trial before patients give informed consent. Additional investigations are performed if and after patients agree in participation. Trial Registration ClinicalTrials.gov NCT00591032 PMID:18851740

Mortality rate and clinical features of highly pathogenic avian influenza in naturally infected chickens in Bangladesh.

PubMed

Biswas, P K; Christensen, J P; Ahmed, S S U; Barua, H; Das, A; Rahman, M H; Giasuddin, M; Habib, M A; Hannan, A S M A; Debnath, N C

2011-12-01

A retrospective study was performed to assess the mortality rates and clinical signs in commercial and backyard chickens naturally infected with the highly pathogenic avian influenza (HPAI) H5N1 virus in Bangladesh. All of the 33 commercial and 25 backyard farms, recorded during the first wave of HPAI outbreaks (January to November 2007) in Bangladesh, were enrolled in this study. The farm profile data, stock information and major clinical signs recognised by the farmers and/or farm attendants, were collected through a prototype questionnaire. The investigating veterinarians' retrospective appraisals of the clinical signs were recorded by interview. After the clinical onset, the incidence rates of mortality in breeder, commercial broiler, commercial layer and backyard chickens were, respectively: 0.0215, 0.0341, 0.0179 and 0.0703 per chicken-day at risk. The four major clinical signs observed were cyanotic combs and wattles, oedema of the head and face, drowsiness and huddling and ecchymotic discoloration of the leg shanks. The first sign (cyanotic combs and wattles) was equally observed in chickens from commercial and backyard farms (p = 0.44) but the second (oedema of the head and face) was more common in backyard farms (p = 0.03).

Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial.

PubMed

Coric, Vladimir; Salloway, Stephen; van Dyck, Christopher H; Dubois, Bruno; Andreasen, Niels; Brody, Mark; Curtis, Craig; Soininen, Hilkka; Thein, Stephen; Shiovitz, Thomas; Pilcher, Gary; Ferris, Steven; Colby, Susan; Kerselaers, Wendy; Dockens, Randy; Soares, Holly; Kaplita, Stephen; Luo, Feng; Pachai, Chahin; Bracoud, Luc; Mintun, Mark; Grill, Joshua D; Marek, Ken; Seibyl, John; Cedarbaum, Jesse M; Albright, Charles; Feldman, Howard H; Berman, Robert M

2015-11-01

Early identification of Alzheimer disease (AD) is important for clinical management and affords the opportunity to assess potential disease-modifying agents in clinical trials. To our knowledge, this is the first report of a randomized trial to prospectively enrich a study population with prodromal AD (PDAD) defined by cerebrospinal fluid (CSF) biomarker criteria and mild cognitive impairment (MCI) symptoms. To assess the safety of the γ-secretase inhibitor avagacestat in PDAD and to determine whether CSF biomarkers can identify this patient population prior to clinical diagnosis of dementia. A randomized, placebo-controlled phase 2 clinical trial with a parallel, untreated, nonrandomized observational cohort of CSF biomarker-negative participants was conducted May 26, 2009, to July 9, 2013, in a multicenter global population. Of 1358 outpatients screened, 263 met MCI and CSF biomarker criteria for randomization into the treatment phase. One hundred two observational cohort participants who met MCI criteria but were CSF biomarker-negative were observed during the same study period to evaluate biomarker assay sensitivity. Oral avagacestat or placebo daily. Safety and tolerability of avagacestat. Of the 263 participants in the treatment phase, 132 were randomized to avagacestat and 131 to placebo; an additional 102 participants were observed in an untreated observational cohort. Avagacestat was relatively well tolerated with low discontinuation rates (19.6%) at a dose of 50 mg/d, whereas the dose of 125 mg/d had higher discontinuation rates (43%), primarily attributable to gastrointestinal tract adverse events. Increases in nonmelanoma skin cancer and nonprogressive, reversible renal tubule effects were observed with avagacestat. Serious adverse event rates were higher with avagacestat (49 participants [37.1%]) vs placebo (31 [23.7%]), attributable to the higher incidence of nonmelanoma skin cancer. At 2 years, progression to dementia was more frequent in the PDAD cohort (30.7%) vs the observational cohort (6.5%). Brain atrophy rate in PDAD participants was approximately double that of the observational cohort. Concordance between abnormal amyloid burden on positron emission tomography and pathologic CSF was approximately 87% (κ = 0.68; 95% CI, 0.48-0.87). No significant treatment differences were observed in the avagacestat vs placebo arm in key clinical outcome measures. Avagacestat did not demonstrate efficacy and was associated with adverse dose-limiting effects. This PDAD population receiving avagacestat or placebo had higher rates of clinical progression to dementia and greater brain atrophy compared with CSF biomarker-negative participants. The CSF biomarkers and amyloid positron emission tomography imaging were correlated, suggesting that either modality could be used to confirm the presence of cerebral amyloidopathy and identify PDAD. clinicaltrials.gov Identifier: NCT00890890.

Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

PubMed

Scrivani, Peter V; Erb, Hollis N

2013-01-01

High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project.

PubMed

Guetterman, Timothy C; Fetters, Michael D; Mawocha, Samkeliso; Legocki, Laurie J; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

2017-01-01

Clinical trials are complicated, expensive, time-consuming, and frequently do not lead to discoveries that improve the health of patients with disease. Adaptive clinical trials have emerged as a methodology to provide more flexibility in design elements to better answer scientific questions regarding whether new treatments are efficacious. Limited observational data exist that describe the complex process of designing adaptive clinical trials. To address these issues, the Adaptive Designs Accelerating Promising Treatments Into Trials project developed six, tailored, flexible, adaptive, phase-III clinical trials for neurological emergencies, and investigators prospectively monitored and observed the processes. The objective of this work is to describe the adaptive design development process, the final design, and the current status of the adaptive trial designs that were developed. To observe and reflect upon the trial development process, we employed a rich, mixed methods evaluation that combined quantitative data from visual analog scale to assess attitudes about adaptive trials, along with in-depth qualitative data about the development process gathered from observations. The Adaptive Designs Accelerating Promising Treatments Into Trials team developed six adaptive clinical trial designs. Across the six designs, 53 attitude surveys were completed at baseline and after the trial planning process completed. Compared to baseline, the participants believed significantly more strongly that the adaptive designs would be accepted by National Institutes of Health review panels and non-researcher clinicians. In addition, after the trial planning process, the participants more strongly believed that the adaptive design would meet the scientific and medical goals of the studies. Introducing the adaptive design at early conceptualization proved critical to successful adoption and implementation of that trial. Involving key stakeholders from several scientific domains early in the process appears to be associated with improved attitudes towards adaptive designs over the life cycle of clinical trial development.

Proposition of a Classification of Adult Patients with Hemiparesis in Chronic Phase.

PubMed

Chantraine, Frédéric; Filipetti, Paul; Schreiber, Céline; Remacle, Angélique; Kolanowski, Elisabeth; Moissenet, Florent

2016-01-01

Patients who have developed hemiparesis as a result of a central nervous system lesion, often experience reduced walking capacity and worse gait quality. Although clinically, similar gait patterns have been observed, presently, no clinically driven classification has been validated to group these patients' gait abnormalities at the level of the hip, knee and ankle joints. This study has thus intended to put forward a new gait classification for adult patients with hemiparesis in chronic phase, and to validate its discriminatory capacity. Twenty-six patients with hemiparesis were included in this observational study. Following a clinical examination, a clinical gait analysis, complemented by a video analysis, was performed whereby participants were requested to walk spontaneously on a 10m walkway. A patient's classification was established from clinical examination data and video analysis. This classification was made up of three groups, including two sub-groups, defined with key abnormalities observed whilst walking. Statistical analysis was achieved on the basis of 25 parameters resulting from the clinical gait analysis in order to assess the discriminatory characteristic of the classification as displayed by the walking speed and kinematic parameters. Results revealed that the parameters related to the discriminant criteria of the proposed classification were all significantly different between groups and subgroups. More generally, nearly two thirds of the 25 parameters showed significant differences (p<0.05) between the groups and sub-groups. However, prior to being fully validated, this classification must still be tested on a larger number of patients, and the repeatability of inter-operator measures must be assessed. This classification enables patients to be grouped on the basis of key abnormalities observed whilst walking and has the advantage of being able to be used in clinical routines without necessitating complex apparatus. In the midterm, this classification may allow a decision-tree of therapies to be developed on the basis of the group in which the patient has been categorised.

Proposition of a Classification of Adult Patients with Hemiparesis in Chronic Phase

PubMed Central

Filipetti, Paul; Remacle, Angélique; Kolanowski, Elisabeth

2016-01-01

Background Patients who have developed hemiparesis as a result of a central nervous system lesion, often experience reduced walking capacity and worse gait quality. Although clinically, similar gait patterns have been observed, presently, no clinically driven classification has been validated to group these patients’ gait abnormalities at the level of the hip, knee and ankle joints. This study has thus intended to put forward a new gait classification for adult patients with hemiparesis in chronic phase, and to validate its discriminatory capacity. Methods and Findings Twenty-six patients with hemiparesis were included in this observational study. Following a clinical examination, a clinical gait analysis, complemented by a video analysis, was performed whereby participants were requested to walk spontaneously on a 10m walkway. A patient’s classification was established from clinical examination data and video analysis. This classification was made up of three groups, including two sub-groups, defined with key abnormalities observed whilst walking. Statistical analysis was achieved on the basis of 25 parameters resulting from the clinical gait analysis in order to assess the discriminatory characteristic of the classification as displayed by the walking speed and kinematic parameters. Results revealed that the parameters related to the discriminant criteria of the proposed classification were all significantly different between groups and subgroups. More generally, nearly two thirds of the 25 parameters showed significant differences (p<0.05) between the groups and sub-groups. However, prior to being fully validated, this classification must still be tested on a larger number of patients, and the repeatability of inter-operator measures must be assessed. Conclusions This classification enables patients to be grouped on the basis of key abnormalities observed whilst walking and has the advantage of being able to be used in clinical routines without necessitating complex apparatus. In the midterm, this classification may allow a decision-tree of therapies to be developed on the basis of the group in which the patient has been categorised. PMID:27271533

Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database.

PubMed

Monticello, Thomas M; Jones, Thomas W; Dambach, Donna M; Potter, David M; Bolt, Michael W; Liu, Maggie; Keller, Douglas A; Hart, Timothy K; Kadambi, Vivek J

2017-11-01

The contribution of animal testing in drug development has been widely debated and challenged. An industry-wide nonclinical to clinical translational database was created to determine how safety assessments in animal models translate to First-In-Human clinical risk. The blinded database was composed of 182 molecules and contained animal toxicology data coupled with clinical observations from phase I human studies. Animal and clinical data were categorized by organ system and correlations determined. The 2×2 contingency table (true positive, false positive, true negative, false negative) was used for statistical analysis. Sensitivity was 48% with a 43% positive predictive value (PPV). The nonhuman primate had the strongest performance in predicting adverse effects, especially for gastrointestinal and nervous system categories. When the same target organ was identified in both the rodent and nonrodent, the PPV increased. Specificity was 84% with an 86% negative predictive value (NPV). The beagle dog had the strongest performance in predicting an absence of clinical adverse effects. If no target organ toxicity was observed in either test species, the NPV increased. While nonclinical studies can demonstrate great value in the PPV for certain species and organ categories, the NPV was the stronger predictive performance measure across test species and target organs indicating that an absence of toxicity in animal studies strongly predicts a similar outcome in the clinic. These results support the current regulatory paradigm of animal testing in supporting safe entry to clinical trials and provide context for emerging alternate models. Copyright © 2017 Elsevier Inc. All rights reserved.

Determination of the anaerobic threshold in the pre-operative assessment clinic: inter-observer measurement error.

PubMed

Sinclair, R C F; Danjoux, G R; Goodridge, V; Batterham, A M

2009-11-01

The variability between observers in the interpretation of cardiopulmonary exercise tests may impact upon clinical decision making and affect the risk stratification and peri-operative management of a patient. The purpose of this study was to quantify the inter-reader variability in the determination of the anaerobic threshold (V-slope method). A series of 21 cardiopulmonary exercise tests from patients attending a surgical pre-operative assessment clinic were read independently by nine experienced clinicians regularly involved in clinical decision making. The grand mean for the anaerobic threshold was 10.5 ml O(2).kg body mass(-1).min(-1). The technical error of measurement was 8.1% (circa 0.9 ml.kg(-1).min(-1); 90% confidence interval, 7.4-8.9%). The mean absolute difference between readers was 4.5% with a typical random error of 6.5% (6.0-7.2%). We conclude that the inter-observer variability for experienced clinicians determining the anaerobic threshold from cardiopulmonary exercise tests is acceptable.

Medication safety research by observational study design.

PubMed

Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

2016-06-01

Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

Evaluation of the clinical and antimicrobial effects of the Er:YAG laser or topical gaseous ozone as adjuncts to initial periodontal therapy.

PubMed

Yılmaz, Selçuk; Algan, Serdar; Gursoy, Hare; Noyan, Ulku; Kuru, Bahar Eren; Kadir, Tanju

2013-06-01

The aim of this study was to evaluate the clinical and microbiological results of treatment with the Er:YAG laser and topical gaseous ozone application as adjuncts to initial periodontal therapy in chronic periodontitis (CP) patients. Although many studies have evaluated the effectiveness of the Er:YAG laser as an adjunct to initial periodontal therapy, few studies have focused on the use of gaseous ozone as an adjunct. Thirty patients with CP were randomly divided into three parallel groups, each composed of 10 individuals with at least four teeth having at least one approximal site with a probing depth (PD) of ≥5 mm and a sulcus bleeding index (SBI) ≥2 in each quadrant. Groups of patients received: (1) Scaling and root planing (SRP)+Er:YAG laser; (2) SRP+topical gaseous ozone; or (3) SRP alone. The microbiological and clinical parameters were monitored at day 0 and day 90. At the end of the observation period, statistically significant improvements in clinical parameters were observed within each group. Parallel to the clinical changes, all treatments reduced the number of total bacteria and the proportion of obligately anaerobic microorganisms. Although intergroup comparisons of microbiological parameters showed no significant differences, clinical findings, including attachment gain and PD reduction, were found to be statistically significant in favor of the SRP+Er:YAG laser group. Although statistically nonsignificant, the fact that the obligate anaerobic change was mostly observed in the SRP+Er:YAG laser group, and a similar decrease was noted in the SRP+topical gaseous ozone group, shows that ozone has an antimicrobial effect equivalent to that of the Er:YAG laser.

The impact of cardiovascular disease prevalence on women's enrollment in landmark randomized cardiovascular trials: a systematic review.

PubMed

Tsang, Wendy; Alter, David A; Wijeysundera, Harindra C; Zhang, Tony; Ko, Dennis T

2012-01-01

Many studies have demonstrated that women are substantially underrepresented in cardiovascular trials, but few have considered that women develop cardiovascular disease at older ages than men. The extent to which observed gender enrollment inequalities persist after accounting for age-gender differences in disease prevalence is unknown. The purpose of the study was to compare observed rates of women participating in cardiovascular clinical trials with expected rates of female participation based on age- and gender-specific population disease prevalence. Publications between 1997 and 2009 in the three leading medical journals were included to calculate observed women's enrollment rates. Population-based data in Canada were used to determine the expected enrollment rates of women. Multicenter, randomized cardiovascular clinical trials that enrolled both men and women were analyzed. Two reviewers independently extracted data on women's enrollment and important clinical trial characteristics. The female enrollment rate was 30% in the included 325 trials, which ranged from 27% in trials of coronary artery disease, 27% in heart failure, 31% in arrhythmia, to 45% in primary prevention. Increased female enrollment correlated strongly with increasing age at recruitment in cardiovascular clinical trials (P < 0.001). After accounting for age- and gender-specific differences in disease prevalence, gaps in female enrollment were much lower than the expected enrollment rates estimated by 5% in coronary artery disease, 13% in heart failure, 9% in arrhythmia, and 3% in primary prevention. Only cardiovascular trials were evaluated in our study. Female underrepresentation in cardiovascular clinical trials is smaller than conventionally believed after accounting for age- and gender-specific population disease prevalence. Our findings suggest that greater representation of women in cardiovascular clinical trials can be achieved through the recruitment of older populations.

Use of lean sigma principles in a tertiary care otolaryngology clinic to improve efficiency.

PubMed

Lin, Sandra Y; Gavney, Dean; Ishman, Stacey L; Cady-Reh, Julie

2013-11-01

To apply Lean Sigma, a quality-improvement strategy supported by tactical tools to eliminate waste and reduce variation, to improve efficiency of patient flow in a large tertiary otolaryngology clinic. The project goals were to decrease overall lead time from patient arrival to start of interaction with care provider, improve on-time starts of patient visits, and decrease excess staff/patient motion. Prospective observational study. Patient flow was mapped through the clinic, including preregistration processes. A time-stamp observation study was performed on 188 patient visits over 5 days. Using Lean Sigma principles, time stamps were analyzed to identify patient flow constraints and areas for potential interventions. Interventions were evaluated and adjusted based on feedback from shareholders: removal of bottlenecks in clinic flow, elimination of non-value added registration staff tasks, and alignment of staff hours to accommodate times of high patient census. A postintervention time observation study of 141 patients was performed 5 months later. Patient lead time from clinic arrival to exam start time decreased by 12.2% on average (P = .042). On-time starts for patient exams improved by 34% (χ(2) = 16.091, P < .001). Excess patient motion was reduced by 74 feet per patient, which represents a 34% reduction in motion per visit. Use of Lean Sigma principles in a large tertiary otolaryngology clinic led to decreased patient wait time and significant improvements in on-time patient exam start time. Process mapping, engagement of leadership and staff, and elimination of non-value added steps or processes were key to improvement. Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Prepubertal and postpubertal vitiligo: a multivariate comparative study in 375 patients*

PubMed Central

Khurrum, Huma; AlGhamdi, Khalid M

2017-01-01

Background The onset of vitiligo during childhood is common. Limited data exist that compare the clinical associations of prepubertal and postpubertal vitiligo in Arabs. Objective To compare the clinical profile of pre and postpubertal onset vitiligo. Methods A cross-sectional observational study was conducted. The Vitiligo European Task Force questionnaire was completed for each patient. Results A total of 375 patients were included; 199 had postpubertal vitiligo (>12 years), and 176 had prepubertal onset vitiligo (<12years). There were more females in the prepubertal group (49%) than in the postpubertal group (29%), p-value <0.001. The prepubertal group has had more involvement than the postpubertal group (45% vs 30%, p=0.004). Only 8 cases of segmental vitiligo were observed; five were observed in the prepubertal group of patients. Female gender (OR=2.3; 95% CI:1.5, 3.5), presence of halo nevus (OR=2.2; 95% CI:1.1, 4.4) and face involvement (OR=1.9; 95% CI:1.2, 2.9) were positively associated with prepubertal vitiligo. Stress, as an onset factor, was positively associated (OR=0.51; 95% CI:0.3, 0.8) with postpubertal onset vitiligo. Study limitations A possible selection bias toward more severe vitiligo cases can be a limitation, because the study was conducted in a clinic specialized in vitiligo. Moreover, a likelihood of false recall bias cannot be excluded. Conclusions Our data present clinical evidence that vitiligo behaves mostly the same way in the prepubertal group as in the postpubertal group. However, female over-representation, more face involvement and more halo nevi were observed in prepubertal vitiligo, while stress was more prevalent as an aggravating factor in postpubertal vitiligo patients. PMID:29364437

Progression of leprosy neuropathy: a case series study

PubMed Central

Vital, Robson T; Illarramendi, Ximena; Nascimento, Osvaldo; Hacker, Mariana A; Sarno, Euzenir N; Jardim, Marcia R

2012-01-01

A need still exists to determine the clinical and neurophysiological characteristics of leprosy neuropathy at distinct times of the disease by different methods that measure the various nerve fiber functions. A prospective clinical study was performed with 10 paucibacillary (PB) and 12 multibacillary (MB) patients evaluated at diagnosis and one year after cessation of multidrug therapy (MDT). Peripheral nerve function was assessed clinically and by means of the sympathetic skin response, skin vasomotor reflex, and nerve conduction study (NCS). At diagnosis, 73% of the total 22 patients had nerve function impairment (NFI). Autonomic function (χ2= 5.5, P= 0.019) and NCS (χ2= 7.765, P= 0.01) were significantly more altered in MB than PB patients. At final evaluation, NFI of the MB patients had worsened, especially among the six who had leprosy reaction. As the NFI of PB patients showed improvement, a significant difference between the two groups (χ2= 12.320, P= 0.001) was observed. A high prevalence of neuropathy was observed in newly diagnosed patients. Associating different tests with a thorough clinical neurological evaluation increases detection rates. PMID:22741099

Fasting insulin levels and metabolic risk factors in type 2 diabetic patients at the first visit in Japan: a 10-year, nationwide, observational study (JDDM 28).

PubMed

Matsuba, Ikuro; Saito, Kazumi; Takai, Masahiko; Hirao, Koichi; Sone, Hirohito

2012-09-01

To investigate the relationship between fasting insulin levels and metabolic risk factors (MRFs) in type 2 diabetic patients at the first clinic/hospital visit in Japan over the years 2000 to 2009. In total, 4,798 drug-naive Japanese patients with type 2 diabetes were registered on their first clinic/hospital visits. Conventional clinical factors and fasting insulin levels were observed at baseline within the Japan Diabetes Clinical Data Management (JDDM) study between consecutive 2-year groups. Multiple linear regression analysis was performed using a model in which the dependent variable was fasting insulin values using various clinical explanatory variables. Fasting insulin levels were found to be decreasing from 2000 to 2009. Multiple linear regression analysis with the fasting insulin levels as the dependent variable showed that waist circumference (WC), BMI, mean blood pressure, triglycerides, and HDL cholesterol were significant, with WC and BMI as the main factors. ANCOVA after adjustment for age and fasting plasma glucose clearly shows the decreasing trend in fasting insulin levels and the increasing trend in BMI. During the 10-year observation period, the decreasing trend in fasting insulin was related to the slight increase in WC/BMI in type 2 diabetes. Low pancreatic β-cell reserve on top of a lifestyle background might be dependent on an increase in MRFs.

Clinical outcomes in relation to locations of bone marrow edema lesions in patients with a subchondral insufficiency fracture of the hip: a review of fifteen cases.

PubMed

Ikemura, Satoshi; Mawatari, Taro; Matsui, Gen; Iguchi, Takahiro; Mitsuyasu, Hiroaki

2016-10-01

The prognosis of patients with a subchondral insufficiency fracture remains unclear. The purpose of this study was to investigate the correlation between locations of bone marrow edema (BME) lesions and clinical outcome in patients with a subchondral insufficiency fracture of the hip. We retrospectively reviewed 15 consecutive hips in 14 patients who were diagnosed with subchondral insufficiency fracture of the hip at our institution between April 2013 and September 2014. This study included five males (six hips) and nine females (nine hips), ranging from 36 to 83 years of age (mean age: 66 years). The mean duration from the onset of hip pain to MRI examination was 1.8 months (range 0.5-5 months). Both clinical and imaging findings were investigated. Based on the findings of MR images, BME lesion in the femoral head alone was observed in six patients (six hips), BME lesion in the acetabulum alone was observed in one patient (two hips) and BME lesions in both the femoral head and acetabulum were observed in seven patients (seven hips). 3 of 15 hips resulted in rapidly destructive arthrosis and their BME lesions were observed in both the femoral head and acetabulum. 8 of 15 hips successfully healed by conservative treatment and BME lesions in 7 of these 8 hips were observed in only the femoral head or acetabulum. The results of this study indicate that the locations of BME lesions (femoral side alone, acetabular side alone or both) may be related to the clinical outcome in patients with a subchondral insufficiency fracture of the hip. Patients with subchondral insufficiency fracture of the hip in whom BME lesions were observed in both the femoral head and acetabulum may have a higher risk to need to undergo total hip arthroplasty.

Variability in adherence to clinical practice guidelines and recommendations in COPD outpatients: a multi-level, cross-sectional analysis of the EPOCONSUL study.

PubMed

Calle Rubio, Myriam; López-Campos, José Luis; Soler-Cataluña, Juan J; Alcázar Navarrete, Bernardino; Soriano, Joan B; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; Rodríguez Hermosa, Juan Luis

2017-12-02

Clinical audits have reported considerable variability in COPD medical care and frequent inconsistencies with recommendations. The objectives of this study were to identify factors associated with a better adherence to clinical practice guidelines and to explore determinants of this variability at the the hospital level. EPOCONSUL is a Spanish nationwide clinical audit that evaluates the outpatient management of COPD. Multilevel logistic regression with two levels was performed to assess the relationships between individual and disease-related factors, as well as hospital characteristics. A total of 4508 clinical records of COPD patients from 59 Spanish hospitals were evaluated. High variability was observed among hospitals in terms of medical care. Some of the patient's characteristics (airflow obstruction, degree of dyspnea, exacerbation risk, presence of comorbidities), the hospital factors (size and respiratory nurses available) and treatment at a specialized COPD outpatient clinic were identified as factors associated with a better adherence to recommendations, although this only explains a small proportion of the total variance. To be treated at a specialized COPD outpatient clinic and some intrinsic patient characteristics were factors associated with a better adherence to guideline recommendations, although these variables were only explaining part of the high variability observed among hospitals in terms of COPD medical care.

Incidence of mastitis and activity of milk neutrophils in Tharparkar cows reared under semi-arid conditions.

PubMed

Alhussien, Mohanned; Manjari, P; Mohammed, Seid; Sheikh, Aasif Ahmad; Reddi, Srinu; Dixit, Satpal; Dang, Ajay K

2016-08-01

Rearing of indigenous Tharparkar (TP) cows (native of arid Thar deserts) under high humid conditions (>75 % humidity) has increased the incidence of mammary infections in them. A study was undertaken to see the number, activity, and expression of milk neutrophils isolated from healthy and mastitic cows. There was a significant (P < 0.05) influx in milk somatic cell counts (SCC) and neutrophils in sub-clinical and clinical mastitis cows. No change was observed in the phagocytic activity (PA) of milk neutrophils between healthy and sub-clinical mastitis (SCM) cows, but these activities decreased significantly (P < 0.05) in clinical cases. Chemotactic activity showed a significant difference between all the groups. Lactose varied significantly (P < 0.05) between healthy, sub-clinical, and clinical mastitis (CM) cows. Expression of chemokine receptor (CXCR1) was more in mastitis cows and also higher as compared to CXCR2. No change was observed in cluster of differentiation molecule (CD62L) among all the three groups of TP cows. Expression of interleukin (IL-8) and CD11b was low in healthy cows, increased significantly (P < 0.05) in both sub-clinical and mastitis cows. This study indicates that low producing TP cows are also prone to mammary infections when reared under semi-arid conditions.

Synergism between Trichuris suis and the microbial flora of the large intestine causing dysentery in pigs.

PubMed

Rutter, J M; Beer, R J

1975-02-01

The role of the microbial flora of the large intestine in experimental Trichuris suis infection was studied by comparing the clinical syndrome in conventionally reared (CR) pigs, specific pathogen-free pigs, and gnotobiotic pigs. Thedisease in CR pigs was characterized by a severe mucohemorrhagic enteritis; in contrast, a mild catarrhal enteritis was observed in specific pathogen-free and gnotobiotic pigs. Spirochaetes and vibrio-like organisms were observed only in CR pigs and increased during the clinical phase of the disease. The clinical syndrome was not transmitted by oral administration of intestinal or fecal material from infected CR pigs to CR pigs free of T. suis. Smaller numbers of T. suis produced diarrhea in CR pigs and significantly reduced the growth rates of infected animals; clinical signs and the reduction in growth rate was prevented by incorporating an antibacterial substance (dimetridazole) in the food. Although clinical trichuriasis closely resembles swin dysentery, the two syndromes seem to be distinct. The present results suggest that a microbial component acts synergistically with T. suis to produce the severe clinical syndrome in CR pigs, but identification of the microbial component and the mechanism by which clinical signs are produced await further studies of the bacterial flora of the large intestine of pigs.

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

PubMed

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

2015-03-01

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

A Randomized Controlled Study of Art Observation Training to Improve Medical Student Ophthalmology Skills.

PubMed

Gurwin, Jaclyn; Revere, Karen E; Niepold, Suzannah; Bassett, Barbara; Mitchell, Rebecca; Davidson, Stephanie; DeLisser, Horace; Binenbaum, Gil

2018-01-01

Observation and description are critical to the practice of medicine, and to ophthalmology in particular. However, medical education does not provide explicit training in these areas, and medical students are often criticized for deficiencies in these skills. We sought to evaluate the effects of formal observation training in the visual arts on the general and ophthalmologic observational skills of medical students. Randomized, single-masked, controlled trial. Thirty-six first-year medical students, randomized 1:1 into art-training and control groups. Students in the art-training group were taught by professional art educators at the Philadelphia Museum of Art, during 6 custom-designed, 1.5-hour art observation sessions over a 3-month period. All subjects completed pre- and posttesting, in which they described works of art, retinal pathology images, and external photographs of eye diseases. Grading of written descriptions for observational and descriptive abilities by reviewers using an a priori rubric and masked to group assignment and pretesting/posttesting status. Observational skills, as measured by description testing, improved significantly in the training group (mean change +19.1 points) compared with the control group (mean change -13.5 points), P = 0.001. There were significant improvements in the training vs. control group for each of the test subscores. In a poststudy questionnaire, students reported applying the skills they learned in the museum in clinically meaningful ways at medical school. Art observation training for first-year medical students can improve clinical ophthalmology observational skills. Principles from the field of visual arts, which is reputed to excel in teaching observation and descriptive abilities, can be successfully applied to medical training. Further studies can examine the impact of such training on clinical care. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Intra- and inter-observer agreement in MRI assessment of rotator cuff healing using the Sugaya classification 10years after surgery.

PubMed

Niglis, L; Collin, P; Dosch, J-C; Meyer, N; Kempf, J-F

2017-10-01

The long-term outcomes of rotator cuff repair are unclear. Recurrent tears are common, although their reported frequency varies depending on the type and interpretation challenges of the imaging method used. The primary objective of this study was to assess the intra- and inter-observer reproducibility of the MRI assessment of rotator cuff repair using the Sugaya classification 10years after surgery. The secondary objective was to determine whether poor reproducibility, if found, could be improved by using a simplified yet clinically relevant classification. Our hypothesis was that reproducibility was limited but could be improved by simplifying the classification. In a retrospective study, we assessed intra- and inter-observer agreement in interpreting 49 magnetic resonance imaging (MRI) scans performed 10years after rotator cuff repair. These 49 scans were taken at random among 609 cases that underwent re-evaluation, with imaging, for the 2015 SoFCOT symposium on 10-year and 20-year clinical and anatomical outcomes of rotator cuff repair for full-thickness tears. Each of three observers read each of the 49 scans on two separate occasions. At each reading, they assessed the supra-spinatus tendon according to the Sugaya classification in five types. Intra-observer agreement for the Sugaya type was substantial (κ=0.64) but inter-observer agreement was only fair (κ=0.39). Agreement improved when the five Sugaya types were collapsed into two categories (1-2-3 and 4-5) (intra-observer κ=0.74 and inter-observer κ=0.68). Using the Sugaya classification to assess post-operative rotator cuff healing was associated with substantial intra-observer and fair inter-observer agreement. A simpler classification into two categories improved agreement while remaining clinically relevant. II, prospective randomised low-power study. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Seven deadly sins in trauma outcomes research: an epidemiologic post mortem for major causes of bias.

PubMed

del Junco, Deborah J; Fox, Erin E; Camp, Elizabeth A; Rahbar, Mohammad H; Holcomb, John B

2013-07-01

Because randomized clinical trials in trauma outcomes research are expensive and complex, they have rarely been the basis for the clinical care of trauma patients. Most published findings are derived from retrospective and occasionally prospective observational studies that may be particularly susceptible to bias. The sources of bias include some common to other clinical domains, such as heterogeneous patient populations with competing and interdependent short- and long-term outcomes. Other sources of bias are unique to trauma, such as rapidly changing multisystem responses to injury that necessitate highly dynamic treatment regimens such as blood product transfusion. The standard research design and analysis strategies applied in published observational studies are often inadequate to address these biases. Drawing on recent experience in the design, data collection, monitoring, and analysis of the 10-site observational PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, 7 common and sometimes overlapping biases are described through examples and resolution strategies. Sources of bias in trauma research include ignoring (1) variation in patients' indications for treatment (indication bias), (2) the dependency of intervention delivery on patient survival (survival bias), (3) time-varying treatment, (4) time-dependent confounding, (5) nonuniform intervention effects over time, (6) nonrandom missing data mechanisms, and (7) imperfectly defined variables. This list is not exhaustive. The mitigation strategies to overcome these threats to validity require epidemiologic and statistical vigilance. Minimizing the highlighted types of bias in trauma research will facilitate clinical translation of more accurate and reproducible findings and improve the evidence-base that clinicians apply in their care of injured patients.

Quality standards for real-world research. Focus on observational database studies of comparative effectiveness.

PubMed

Roche, Nicolas; Reddel, Helen; Martin, Richard; Brusselle, Guy; Papi, Alberto; Thomas, Mike; Postma, Dirjke; Thomas, Vicky; Rand, Cynthia; Chisholm, Alison; Price, David

2014-02-01

Real-world research can use observational or clinical trial designs, in both cases putting emphasis on high external validity, to complement the classical efficacy randomized controlled trials (RCTs) with high internal validity. Real-world research is made necessary by the variety of factors that can play an important a role in modulating effectiveness in real life but are often tightly controlled in RCTs, such as comorbidities and concomitant treatments, adherence, inhalation technique, access to care, strength of doctor-caregiver communication, and socio-economic and other organizational factors. Real-world studies belong to two main categories: pragmatic trials and observational studies, which can be prospective or retrospective. Focusing on comparative database observational studies, the process aimed at ensuring high-quality research can be divided into three parts: preparation of research, analyses and reporting, and discussion of results. Key points include a priori planning of data collection and analyses, identification of appropriate database(s), proper outcomes definition, study registration with commitment to publish, bias minimization through matching and adjustment processes accounting for potential confounders, and sensitivity analyses testing the robustness of results. When these conditions are met, observational database studies can reach a sufficient level of evidence to help create guidelines (i.e., clinical and regulatory decision-making).

How to write a surgical clinical research protocol: literature review and practical guide.

PubMed

Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

2014-02-01

The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

How can we improve clinical research in pneumonia?

PubMed

Ramirez, Julio A

2018-05-01

The primary challenges in the field of clinical research include a lack of support within existing infrastructure, insufficient number of clinical research training programs and a paucity of qualified mentors. Most medical centers offer infrastructure support for investigators working with industry sponsors or government-funded clinical trials, yet there are a significant amount of clinical studies performed in the field of pneumonia which are observational studies. For this type of research, which is frequently unfunded, support is usually lacking. In an attempt to optimize clinical research in pneumonia, at the University of Louisville, we developed a clinical research coordinating center (CRCC). The center manages clinical studies in the field of respiratory infections, with the primary focus being pneumonia. Other activities of the CRCC include the organization of an annual clinical research training course for physicians and other healthcare workers, and the facilitation of international research mentoring by a process of connecting new pneumonia investigators with established clinical investigators. To improve clinical research in pneumonia, institutions need to have the appropriate infrastructure in place to support investigators in all aspects of the clinical research process.

Relation between spiritual intelligence and clinical competency of nurses in Iran

PubMed Central

Karimi-Moonaghi, Hossein; Gazerani, Akram; Vaghee, Saeed; Gholami, Hassan; Salehmoghaddam, Amir Reza; Gharibnavaz, Raheleh

2015-01-01

Background: Clinical competency is one of the most important requirements in nursing profession, based on which nurses are assessed. To obtain an effective and improved form of clinical competency, several factors are observed and monitored by the health educational systems. Among these observed factors, spiritual intelligence is considered as one of the most significant factors in nurses’ success and efficacy. In this study, it is aimed to determine the spiritual intelligence status and its relationship with clinical competency. Materials and Methods: The descriptive–correlational research was carried out on 250 nurses in Mashhad educational hospitals, selected by multi-stage sampling. Demographic, clinical competency, and spiritual intelligence questionnaires were used for data collection and 212 questionnaires were analyzed. Results: About 53.3% of nurses obtained above average scores in spiritual intelligence. Clinical competency was evaluated by both self-evaluation and head nurse evaluation methods. Most nurses (53.8%) were having good level of clinical competency based on self-evaluation, 48.2% were at average level based on head nurse evaluation, and 53.3% were at average level based on overall score. A significant correlation was found between spiritual intelligence and clinical competency. Conclusions: In this study, the positive significant correlation between nurses’ spiritual intelligence and their clinical competency is investigated. Because of the positive effects of spiritual intelligence on nurses’ clinical competency and quality of care, it is recommended to develop nurses’ spiritual intelligence during their education and by way of continuous medical education. PMID:26793250

Differences in the Implementation of Diagnosis-Related Groups across Clinical Departments: A German Hospital Case Study

PubMed Central

Ridder, Hans-Gerd; Doege, Vanessa; Martini, Susanne

2007-01-01

Objective This article aims to examine the implementation process of diagnosis-related groups (DRGs) in the clinical departments of a German hospital group and to explain why some gain competitive advantage while others do not. Study Setting To investigate this research question, we conducted a qualitative study based on primary data obtained in six clinical departments in a German hospital group between 2003 and 2005. Study Design We chose the case study method in order to gain deep insights into the process dynamics of the implementation of DRGs in the six clinical departments. The dynamic capability approach is used as a theoretical foundation. Employing theory-driven categories we focused on idiosyncratic and common patterns of “successful coders” and “unsuccessful coders.” Data Collection To observe the implementation process of DRGs, we conducted 43 semistructured interviews with key persons, carried out direct observations of the monthly meetings of the DRG project group, and sampled written materials. Principal Findings “Successful coders” invest into change resources, demonstrate a high level of acceptance of innovations, and organize effective processes of coordination and learning. Conclusions All clinical departments only put an emphasis on the coding aspects of the DRGs. There is a lack of vision regarding the optimization of patient treatment processes and specialization. Physicians are the most important key actors, rather than the main barriers. PMID:17995556

Clinical impact of negative-pressure wound therapy: a 1,126-patient observational prospective study.

PubMed

Téot, Luc; Guillot-Masanovic, Margot; Miquel, Pierre; Truchetet, François; Meaume, Sylvie; Dompmartin, Anne; Charles Kerihuel, Jean; Trial, Chloé; Faure, Christine

2014-01-01

Negative-pressure wound therapy (NPWT) was developed in the early 1990s and reported in 1997 by Argenta and Morykwas. Ignored at first, this technique progressively came to be considered as an outstanding advancement in reconstructive surgery. Several randomized controlled studies produced evidence for the effect of NPWT on promotion of granulation tissue formation and prevention of tissue damage and amputation. However, no important longitudinal study has yet produced clinical and economic data on the consequences of integrating NPWT into practice in multiple institutions. This prospective, comparative longitudinal study of NPWT as a clinical-practice innovation was conducted in 1,126 patients between March 2006 and June 2009 in 30 university and nonuniversity public and private hospitals in France. NPWT was proposed in a nonrandomized fashion for various clinical indications, and the patients were divided into two groups, one using NPWT, the second using standard care. Efficacy criteria were spontaneous closure, closure after surgical coverage using skin grafts or flaps, or achievement of 40% wound area regression. The results, observed in a pragmatic but not randomized study, are suggestive of a favorable impact of NPWT in multiple clinical situations. The significance of differences between surgical patients who underwent NPWT and those who did not was unclear, as NPWT had already been adopted by most of the surgical wards. © 2014 by the Wound Healing Society.

Amateur boxing and risk of chronic traumatic brain injury: systematic review of observational studies

PubMed Central

Knowles, Charles H; Whyte, Greg P

2007-01-01

Objective To evaluate the risk of chronic traumatic brain injury from amateur boxing. Setting Secondary research performed by combination of sport physicians and clinical academics. Design, data sources, and methods Systematic review of observational studies in which chronic traumatic brain injury was defined as any abnormality on clinical neurological examination, psychometric testing, neuroimaging studies, and electroencephalography. Studies were identified through database (1950 to date) and bibliographic searches without language restrictions. Two reviewers extracted study characteristics, quality, and data, with adherence to a protocol developed from a widely recommended method for systematic review of observational studies (MOOSE). Results 36 papers had relevant extractable data (from a detailed evaluation of 93 studies of 943 identified from the initial search). Quality of evidence was generally poor. The best quality studies were those with a cohort design and those that used psychometric tests. These yielded the most negative results: only four of 17 (24%) better quality studies found any indication of chronic traumatic brain injury in a minority of boxers studied. Conclusion There is no strong evidence to associate chronic traumatic brain injury with amateur boxing. PMID:17916811

Amateur boxing and risk of chronic traumatic brain injury: systematic review of observational studies.

PubMed

Loosemore, Mike; Knowles, Charles H; Whyte, Greg P

2007-10-20

To evaluate the risk of chronic traumatic brain injury from amateur boxing. Secondary research performed by combination of sport physicians and clinical academics. DESIGN, DATA SOURCES, AND METHODS: Systematic review of observational studies in which chronic traumatic brain injury was defined as any abnormality on clinical neurological examination, psychometric testing, neuroimaging studies, and electroencephalography. Studies were identified through database (1950 to date) and bibliographic searches without language restrictions. Two reviewers extracted study characteristics, quality, and data, with adherence to a protocol developed from a widely recommended method for systematic review of observational studies (MOOSE). 36 papers had relevant extractable data (from a detailed evaluation of 93 studies of 943 identified from the initial search). Quality of evidence was generally poor. The best quality studies were those with a cohort design and those that used psychometric tests. These yielded the most negative results: only four of 17 (24%) better quality studies found any indication of chronic traumatic brain injury in a minority of boxers studied. There is no strong evidence to associate chronic traumatic brain injury with amateur boxing.

Cardiovascular consequences of hormone therapy in postmenopausal women: Messages to clinicians.

PubMed

Ylikorkala, O; Mikkola, T

2005-03-01

Results from the recent randomized clinical trials indicating that hormone therapy (HT) does not provide cardiovascular protection, but potentially harm are in profound disagreement with the sound evidence from numerous observational and experimental studies. While the observational studies have mainly assessed symptomatic recently menopausal women, the randomized trials have studied symptomless elderly postmenopausal women with established coronary heart disease or various risk factors for cardiovascular disease. Therefore, the recent trials have only revealed that HT does not provide secondary cardiovascular benefits. Since primary cardiovascular benefits of HT are rational but not yet proven in clinical trials, new studies are in demand. Until more data from recently menopausal symptomatic women are available, we need to base our decisions on existing evidence and good clinical practice. Although the potential of HT to provide cardiovascular benefits is decreased by advancing age and time since menopause, this should not preclude the use of individualized HT in younger postmenopausal women. (Reprod Med Biol 2005; 4 : 1- 6).

Database on veterinary clinical research in homeopathy.

PubMed

Clausen, Jürgen; Albrecht, Henning

2010-07-01

The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.

The Effect of Intestinal Parasitic Infection on the Clinical Outcome of Malaria in Coinfected Children in Cameroon

PubMed Central

Kwenti, Tebit E.; Nkume, Franklin A.; Tanjeko, Ajime T.; Kwenti, Tayong D. B.

2016-01-01

Background The interaction between intestinal parasites and malaria is still not clear. Data in published literature are conflicting. We studied the effect of intestinal parasitic infection (IPI) on the clinical outcome of malaria in coinfected children. Methods In a cross sectional study performed between October 2014 and September 2015, children infected with malaria, as demonstrated by the presence of asexual parasites in Giemsa stained blood films, were enrolled. Stool samples were obtained from participants and subjected to the formol-ether concentration technique for the detection of intestinal parasites. The Complete blood count was performed using an automated haematology analyser (Mindray, BC-2800). The risk ratio, Pearson’s chi-square and the student T test were all performed as part of the statistical analyses. Statistical significance was set at p < 0.05. Results In all, 405 children successfully took part in the study. The children were between 1 week and 120 months of age (mean ± SD = 41.5 ± 33.5). Coinfection with intestinal parasites was observed in 11.6%. The rate of severe malaria (SM) attack in this study was 10.9%. SM was not observed to be associated with age (p = 0.377) or gender (p = 0.387), meanwhile coinfection with intestinal parasites was associated with age (p = 0.003). Among SM cases, IPI prevalence was higher in children with mild (WHO group 3) severe malaria (p = 0.027). Overall, IPI was not observed to be associated with SM (p = 0.656) or malaria parasite density (p = 0.185) or haemoglobin concentration (p = 0.205). The main clinical features of SM observed were hyperpyrexia (68.2%), severe malarial anaemia (61.4%), and multiple convulsion (52.3%). Conclusion IPI was not observed to be associated with the severity of malaria, the malaria parasite density, and the haemoglobin concentration in coinfected children in Cameroon. The clinical outcome of malaria in children coinfected with intestinal parasites may depend on the geographical setting after all. PMID:27128975

The Effect of Intestinal Parasitic Infection on the Clinical Outcome of Malaria in Coinfected Children in Cameroon.

PubMed

Kwenti, Tebit E; Nkume, Franklin A; Tanjeko, Ajime T; Kwenti, Tayong D B

2016-04-01

The interaction between intestinal parasites and malaria is still not clear. Data in published literature are conflicting. We studied the effect of intestinal parasitic infection (IPI) on the clinical outcome of malaria in coinfected children. In a cross sectional study performed between October 2014 and September 2015, children infected with malaria, as demonstrated by the presence of asexual parasites in Giemsa stained blood films, were enrolled. Stool samples were obtained from participants and subjected to the formol-ether concentration technique for the detection of intestinal parasites. The Complete blood count was performed using an automated haematology analyser (Mindray, BC-2800). The risk ratio, Pearson's chi-square and the student T test were all performed as part of the statistical analyses. Statistical significance was set at p < 0.05. In all, 405 children successfully took part in the study. The children were between 1 week and 120 months of age (mean ± SD = 41.5 ± 33.5). Coinfection with intestinal parasites was observed in 11.6%. The rate of severe malaria (SM) attack in this study was 10.9%. SM was not observed to be associated with age (p = 0.377) or gender (p = 0.387), meanwhile coinfection with intestinal parasites was associated with age (p = 0.003). Among SM cases, IPI prevalence was higher in children with mild (WHO group 3) severe malaria (p = 0.027). Overall, IPI was not observed to be associated with SM (p = 0.656) or malaria parasite density (p = 0.185) or haemoglobin concentration (p = 0.205). The main clinical features of SM observed were hyperpyrexia (68.2%), severe malarial anaemia (61.4%), and multiple convulsion (52.3%). IPI was not observed to be associated with the severity of malaria, the malaria parasite density, and the haemoglobin concentration in coinfected children in Cameroon. The clinical outcome of malaria in children coinfected with intestinal parasites may depend on the geographical setting after all.

Instructional Development for Clinical Settings.

ERIC Educational Resources Information Center

Cranton, P. A.

Clinical teaching involves instruction in a natural health-related environment which allows students to observe and participate in the actual practice of the profession. The use of objectives, the sequence of instruction, the instructional methods and materials, and the evaluation of student performance constitute the components studied in…

Trichomycosis (Trichobacteriosis): Clinical and Microbiological Experience with 56 Cases

PubMed Central

Bonifaz, Alexandro; Váquez-González, Denisse; Fierro, Leonel; Araiza, Javier; Ponce, Rosa María

2013-01-01

Background: Trichomycosis is asymptomatic bacterial infection of the axillary hairs caused by Corynebacterium sp. Objective: to bring a series of cases of trichomycosis, its clinical and microbiological experience. Materials and Methods: This report consists in a linear and observational retrospective study of 15 years of cases of trichomycosis confirmed clinically and microbiologically. Results: Fifty six confirmed cases of trichomycosis were included in this report. The majority were men 53/56 (94.6%), mean age was 32.5 years. The most commonly affected area was the axilla (92%), trichomycosis flava was the principal variant 55/56 (98.2%) and signs and symptoms associated were hyperhidrosis (87.5%), hairs’ texture change (57.1%) and odor (35.7%). Bacterial concretions were observed in all cases, and the predominant causative agent in 89.3% of all cases was Corynebacterium sp. Thirty patients were included in therapeutic portion of the study, and 28 (93.3%) of them experienced a clinical and microbiological cure. Conclusion: Trichomycosis is asymptomatic, superficial infection, which primarily affects axillary hairs. PMID:23960390

National Rugby League athletes and tendon tap reflex assessment: a matched cohort clinical study.

PubMed

Maurini, James; Ohmsen, Paul; Condon, Greg; Pope, Rodney; Hing, Wayne

2016-11-04

Limited research suggests elite athletes may differ from non-athletes in clinical tendon tap reflex responses. In this matched cohort study, 25 elite rugby league athletes were compared with 29 non-athletes to examine differences in tendon reflex responses. Relationships between reflex responses and lengths of players' careers were also examined. Biceps, triceps, patellar and Achilles tendon reflexes were clinically assessed. Right and left reflexes were well correlated for each tendon (r S  = 0.7-0.9). The elite rugby league athletes exhibited significantly weaker reflex responses than non-athletes in all four tendons (p < 0.005). Biceps reflexes demonstrated the largest difference and Achilles reflexes the smallest difference. Moderate negative correlations (r S  = -0.3-0.6) were observed between reflex responses and lengths of players' careers. Future research is required to further elucidate mechanisms resulting in the observed differences in tendon reflexes and to ensure clinical tendon tap examinations and findings can be interpreted appropriately in this athletic population.

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.

PubMed

Burbach, J P M; Kurk, S A; Coebergh van den Braak, R R J; Dik, V K; May, A M; Meijer, G A; Punt, C J A; Vink, G R; Los, M; Hoogerbrugge, N; Huijgens, P C; Ijzermans, J N M; Kuipers, E J; de Noo, M E; Pennings, J P; van der Velden, A M T; Verhoef, C; Siersema, P D; van Oijen, M G H; Verkooijen, H M; Koopman, M

2016-11-01

Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients. This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

Recruitment and enrollment of African Americans into health promoting programs: the effects of health promoting programs on cardiovascular disease risk study.

PubMed

Okhomina, Victoria I; Seals, Samantha R; Marshall, Gailen D

2018-04-03

Randomized controlled trials (RCT) often employ multiple recruitment methods to attract participants, however, special care must be taken to be inclusive of under-represented populations. We examine how recruiting from an existing observational study affected the recruitment of African Americans into a RCT that included yoga-based interventions. In particular, we report the recruitment success of The Effects of Health Promoting Programs (HPP) on Cardiovascular Disease Risk (NCT02019953), the first yoga-based clinical trial to focus only on African Americans. To recruit participants, a multifaceted recruitment strategy was implemented exclusively in the Jackson Heart Study (JHS) cohort. The HPP recruited from the JHS cohort using direct mailings, signs and flyers placed around JHS study facilities, and through JHS annual follow-up interviews. Enrollment into HPP was open to all active JHS participants that were eligible to return for the third clinic exam (n = 4644). The target sample size was 375 JHS participants over a 24 month recruitment and enrollment period. From the active members of the JHS cohort, 503 were pre-screened for eligibility in HPP. More than 90% of those pre-screened were provisionally eligible for the study. The enrollment goal of 375 was completed after a 16-month enrollment period with over 25% (n = 97) of the required sample size enrolling during the second month of recruitment. The findings show that participants in observational studies can be successfully recruited into RCT. Observational studies provide researchers with a well-defined population that may be of interest when designing clinical trials. This is particularly useful in the recruitment of a high-risk, traditionally underrepresented populations for non-pharmacological clinical trials where traditional recruitment methods may prolong enrollment periods and extend study budgets.

Media coverage of medical journals: do the best articles make the news?

PubMed

Selvaraj, Senthil; Borkar, Durga S; Prasad, Vinay

2014-01-01

News coverage of medical research is followed closely by many Americans and affects the practice of medicine and influence of scientific research. Prior work has examined the quality of media coverage, but no investigation has characterized the choice of stories covered in a controlled manner. We examined whether the media systematically covers stories of weaker study design. We compared study characteristics of 75 clinically-oriented journal articles that received coverage in the top five newspapers by circulation against 75 clinically-oriented journal articles that appeared in the top five medical journals by impact factor over a similar timespan. Subgroup analysis was performed to determine whether differences between investigations from both sources varied by study type (randomized controlled trial [RCT] or observational study). Investigations receiving coverage from newspapers were less likely to be RCTs (17% vs. 35%, p = 0.016) and more likely to be observational studies (75% vs. 47%, p<0.001). No difference was observed in number of people studied (median: 1034 vs. 1901, p = 0.14) or length of follow-up (median: 1.80 vs. 1.00 years, p = 0.22). In subgroup analysis, observational studies from the media used smaller sample sizes (median: 1984 vs. 21136, p = 0.029) and were more likely to be cross-sectional (71% vs. 31%, p<0.001), while no differences were observed for RCTs. Newspapers were more likely to cover observational studies and less likely to cover RCTs than high impact journals. Additionally, when the media does cover observational studies, they select articles of inferior quality. Newspapers preferentially cover medical research with weaker methodology.

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.

Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study)

PubMed Central

Suh, Sunghwan; Song, Sun Ok; Kim, Jae Hyeon; Cho, Hyungjin

2017-01-01

The present observational study aimed to evaluate the clinical effectiveness of vildagliptin with metformin in Korean patients with type 2 diabetes mellitus (T2DM). Data were pooled from the vildagliptin postmarketing survey (PMS), the vildagliptin/metformin fixed drug combination (DC) PMS, and a retrospective observational study of vildagliptin/metformin (fixed DC or free DC). The effectiveness endpoint was the proportion of patients who achieved a glycemic target (HbA1c) of ≤7.0% at 24 weeks. In total, 4303 patients were included in the analysis; of these, 2087 patients were eligible. The mean patient age was 56.99 ± 11.25 years. Overall, 58.94% patients achieved an HbA1c target of ≤7.0% at 24 weeks. The glycemic target achievement rate was significantly greater in patients with baseline HbA1c < 7.5% versus ≥7.5% (84.64% versus 43.97%), receiving care at the hospital versus clinic (67.95% versus 52.33%), and receiving vildagliptin/metformin fixed DC versus free DC (70.69% versus 55.42%). Multivariate logistic regression analysis indicated that disease duration (P < 0.0001), baseline HbA1c (P < 0.0001), and DC type (P = 0.0103) had significant effects on drug effectiveness. Vildagliptin plus metformin appeared as an effective treatment option for patients with T2DM in clinical practice settings in Korea. PMID:29057274

Accuracy and reliability of observational gait analysis data: judgments of push-off in gait after stroke.

PubMed

McGinley, Jennifer L; Goldie, Patricia A; Greenwood, Kenneth M; Olney, Sandra J

2003-02-01

Physical therapists routinely observe gait in clinical practice. The purpose of this study was to determine the accuracy and reliability of observational assessments of push-off in gait after stroke. Eighteen physical therapists and 11 subjects with hemiplegia following a stroke participated in the study. Measurements of ankle power generation were obtained from subjects following stroke using a gait analysis system. Concurrent videotaped gait performances were observed by the physical therapists on 2 occasions. Ankle power generation at push-off was scored as either normal or abnormal using two 11-point rating scales. These observational ratings were correlated with the measurements of peak ankle power generation. A high correlation was obtained between the observational ratings and the measurements of ankle power generation (mean Pearson r=.84). Interobserver reliability was moderately high (mean intraclass correlation coefficient [ICC (2,1)]=.76). Intraobserver reliability also was high, with a mean ICC (2,1) of.89 obtained. Physical therapists were able to make accurate and reliable judgments of push-off in videotaped gait of subjects following stroke using observational assessment. Further research is indicated to explore the accuracy and reliability of data obtained with observational gait analysis as it occurs in clinical practice.

Using non-specialist observers in 4AFC human observer studies

NASA Astrophysics Data System (ADS)

Elangovan, Premkumar; Mackenzie, Alistair; Dance, David R.; Young, Kenneth C.; Wells, Kevin

2017-03-01

Virtual clinical trials (VCTs) are an emergent approach for rapid evaluation and comparison of various breast imaging technologies and techniques using computer-based modeling tools. Increasingly 4AFC (Four alternative forced choice) virtual clinical trials are used to compare detection performances of different breast imaging modalities. Most prior studies have used physicists and/or radiologists and physicists interchangeably. However, large scale use of statistically significant 4AFC observer studies is challenged by the individual time commitment and cost of such observers, often drawn from a limited local pool of specialists. This work aims to investigate whether non-specialist observers can be used to supplement such studies. A team of five specialist observers (medical physicists) and five non-specialists participated in a 4AFC study containing simulated 2D-mammography and DBT (digital breast tomosynthesis) images, produced using the OPTIMAM toolbox for VCTs. The images contained 4mm irregular solid masses and 4mm spherical targets at a range of contrast levels embedded in a realistic breast phantom background. There was no statistically significant difference between the detection performance of medical physicists and non-specialists (p>0.05). However, non-specialists took longer to complete the study than their physicist counterparts, which was statistically significant (p<0.05). Overall, the results from both observer groups indicate that DBT has a lower detectable threshold contrast than 2D-mammography for both masses and spheres, and both groups found spheres easier to detect than irregular solid masses.

Safety of fluralaner, a novel systemic antiparasitic drug, in MDR1(-/-) Collies after oral administration

PubMed Central

2014-01-01

Background Fluralaner is a novel systemic ectoparasiticide for dogs providing long-acting flea- and tick-control after a single oral dose. This study investigated the safety of oral administration of fluralaner at 3 times the highest expected clinical dose to Multi Drug Resistance Protein 1 (MDR1(-/-)) gene defect Collies. Methods Sixteen Collies homozygous for the MDR1 deletion mutation were included in the study. Eight Collies received fluralaner chewable tablets once at a dose of 168 mg/kg; eight sham dosed Collies served as controls. All Collies were clinically observed until 28 days following treatment. Results No adverse events were observed subsequent to fluralaner treatment of MDR1(-/-) Collies at three times the highest expected clinical dose. Conclusions Fluralaner chewable tablets are well tolerated in MDR1(-/-) Collies following oral administration. PMID:24602342

Thymomodulin: biological properties and clinical applications.

PubMed

Kouttab, N M; Prada, M; Cazzola, P

1989-01-01

Thymomodulin (Ellem Industria Farmaceutica s.p.a., Milan, Italy) is a calf thymus acid lysate derivative, composed of several peptides with a molecular weight range of 1-10 kD. Thymomodulin did not exhibit any mutagenic effect. Furthermore, thymomodulin used in animal studies showed no toxicity even when used at high concentrations. Of major significance are the observations in murine and human systems that thymomodulin remains active when administered orally. In vitro and in vivo administered thymomodulin was able to induce the maturation of T-lymphocytes. Additionally, studies in vitro showed that this thymic derivative can enhance the functions of mature T-lymphocytes with cascading effects on B-cell and macrophage functions. Extensive human clinical trials with thymomodulin showed that this agent can improve the clinical symptoms observed with various disease processes, including infections, allergies and malignancies, and can improve immunological functions during ageing.

The use of video clips in teleconsultation for preschool children with movement disorders.

PubMed

Gorter, Hetty; Lucas, Cees; Groothuis-Oudshoorn, Karin; Maathuis, Carel; van Wijlen-Hempel, Rietje; Elvers, Hans

2013-01-01

To investigate the reliability and validity of video clips in assessing movement disorders in preschool children. The study group included 27 children with neuromotor concerns. The explorative validity group included children with motor problems (n = 21) or with typical development (n = 9). Hempel screening was used for live observation of the child, full recording, and short video clips. The explorative study tested the validity of the clinical classifications "typical" or "suspect." Agreement between live observation and the full recording was almost perfect; Agreement for the clinical classification "typical" or "suspect" was substantial. Agreement between the full recording and short video clips was substantial to moderate. The explorative validity study, based on short video clips and the presence of a neuromotor developmental disorder, showed substantial agreement. Hempel screening enables reliable and valid observation of video clips, but further research is necessary to demonstrate the predictive value.

Effectiveness of a Training Program in Supervisors' Ability to Provide Feedback on Residents' Communication Skills

ERIC Educational Resources Information Center

Junod Perron, Noelle; Nendaz, Mathieu; Louis-Simonet, Martine; Sommer, Johanna; Gut, Anne; Baroffio, Anne; Dolmans, Diana; van der Vleuten, Cees

2013-01-01

Teaching communication skills (CS) to residents during clinical practice remains problematic. Direct observation followed by feedback is a powerful way to teach CS in clinical practice. However, little is known about the effect of training on feedback skills in this field. Controlled studies are scarce as well as studies that go beyond…

Mycobacterium genavense in the Netherlands: an opportunistic pathogen in HIV and non-HIV immunocompromised patients. An observational study in 14 cases.

PubMed

Hoefsloot, W; van Ingen, J; Peters, E J G; Magis-Escurra, C; Dekhuijzen, P N R; Boeree, M J; van Soolingen, D

2013-05-01

Mycobacterium genavense is an opportunistic non-tuberculous mycobacterium previously mostly associated with HIV-infected patients with CD4 counts below 100/μL. In this retrospective observational study of medical charts we studied all Dutch patients in whom M. genavense was detected between January 2002 and January 2010. Of the 14 patients identified, 13 (93%) showed clinically relevant M. genavense disease. All patients with M. genavense disease were severely immunocompromised, including HIV-infected patients, solid organ transplant recipients, those with chronic steroid use in combination with other immune modulating drugs, recipients of chemotherapy for non-Hodgkin lymphoma, and those with immunodeficiency syndromes. Two patients had non-disseminated pulmonary M. genavense disease. Of the 12 patients treated, eight (75%) showed a favourable outcome. Four patients died in this study, three despite treatment for M. genavense disease. We conclude that M. genavense is a clinically relevant pathogen in severely immunocompromised patients that causes predominantly disseminated disease with serious morbidity and mortality. M. genavense is increasingly seen among non-HIV immunocompromised patients. © 2012 The Authors. Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases.

Return of chloroquine-sensitive Plasmodium falciparum parasites and emergence of chloroquine-resistant Plasmodium vivax in Ethiopia

PubMed Central

2014-01-01

Background Increased resistance by Plasmodium falciparum parasites led to the withdrawal of the antimalarial drugs chloroquine and sulphadoxine-pyrimethamine in Ethiopia. Since 2004 artemether-lumefantrine has served to treat uncomplicated P. falciparum malaria. However, increasing reports on delayed parasite clearance to artemisinin opens up a new challenge in anti-malarial therapy. With the complete withdrawal of CQ for the treatment of Plasmodium falciparum malaria, this study assessed the evolution of CQ resistance by investigating the prevalence of mutant alleles in the pfmdr1 and pfcrt genes in P. falciparum and pvmdr1 gene in Plasmodium vivax in Southern and Eastern Ethiopia. Methods Of the 1,416 febrile patients attending primary health facilities in Southern Ethiopia, 329 febrile patients positive for P. falciparum or P. vivax were recruited. Similarly of the 1,304 febrile patients from Eastern Ethiopia, 81 febrile patients positive for P. falciparum or P. vivax were included in the study. Of the 410 finger prick blood samples collected from malaria patients, we used direct sequencing to investigate the prevalence of mutations in pfcrt and pfmdr1. This included determining the gene copy number in pfmdr1 in 195 P. falciparum clinical isolates, and mutations in the pvmdr1 locus in 215 P. vivax clinical isolates. Results The pfcrt K76 CQ-sensitive allele was observed in 84.1% of the investigated P.falciparum clinical isolates. The pfcrt double mutations (K76T and C72S) were observed less than 3%. The pfcrt SVMNT haplotype was also found to be present in clinical isolates from Ethiopia. The pfcrt CVMNK-sensitive haplotypes were frequently observed (95.9%). The pfmdr1 mutation N86Y was observed only in 14.9% compared to 85.1% of the clinical isolates that carried sensitive alleles. Also, the sensitive pfmdr1 Y184 allele was more common, in 94.9% of clinical isolates. None of the investigated P. falciparum clinical isolates carried S1034C, N1042D and D1246Y pfmdr1 polymorphisms. All investigated P. falciparum clinical isolates from Southern and Eastern Ethiopia carried only a single copy of the mutant pfmdr1 gene. Conclusion The study reports for the first time the return of chloroquine sensitive P. falciparum in Ethiopia. These findings support the rationale for the use of CQ-based combination drugs as a possible future alternative. PMID:24964730

Evaluation of the predictive value of a clinical worsening definition using 2-year outcomes in patients with pulmonary arterial hypertension: a REVEAL Registry analysis.

PubMed

Frost, Adaani E; Badesch, David B; Miller, Dave P; Benza, Raymond L; Meltzer, Leslie A; McGoon, Michael D

2013-11-01

Time to clinical worsening has been proposed as a primary end point in clinical trials of pulmonary arterial hypertension (PAH); however, neither standardized nor validated definitions of clinical worsening across PAH trials exist. This study aims to evaluate a proposed definition of clinical worsening within a large prospective, observational registry of patients with PAH with respect to its value as a predictor of proximate (within 1 year) risk for subsequent major events (ie, death, transplantation, or atrial septostomy). We assessed overall 2-year survival and survival free from major events to determine the relationship between clinical worsening and major events among adults with hemodynamically defined PAH (N = 3,001). Freedom from clinical worsening was defined as freedom from worsening functional class (FC), a ≥ 15% reduction in 6-min walk distance (6MWD), all-cause hospitalization, or the introduction of parenteral prostacyclin analog therapy. In the 2 years of follow-up, 583 patients died. Four hundred twenty-six died after a documented clinical worsening event, including FC worsening (n = 128), a ≥ 15% reduction in 6MWD (n = 118), all-cause hospitalization (n = 370), or introduction of a prostacyclin analog (n = 91). Patients who experienced clinical worsening had significantly poorer subsequent 1-year survival postworsening than patients who did not worsen (P < .001). Clinical worsening was highly predictive of subsequent proximate mortality in this analysis from an observational study. These results validate the use of clinical worsening as a meaningful prognostic tool in clinical practice and as a primary end point in clinical trial design. ClinicalTrials.gov; No.: NCT00370214; URL: www.clinicaltrials.gov.

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

Use of Atorvastatin in Lipid Disorders and Cardiovascular Disease in Chinese Patients

PubMed Central

Ye, Yi-Cong; Zhao, Xi-Liang; Zhang, Shu-Yang

2015-01-01

Objective: Statins are still underused for the prevention of cardiovascular disease (CVD) in China. Hence, we conducted a systemic review on the pharmacology, clinical efficacy, and adverse events of atorvastatin, as well as on patient adherence. Data Sources: We conducted a systemic search in PubMed with the following keywords: “atorvastatin” (Supplementary concept) or “atorvastatin” (All field) and (“China” [AD] or “China” [all field] or “Chinese” [All field]). Study Selection: Clinical or basic research articles on atorvastatin were included. Results: Atorvastatin is a reversible and competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A reductase, decreasing the de novo cholesterol synthesis. The pharmacokinetics of atorvastatin among Chinese is similar to those in Caucasians, and several gene polymorphisms have proved to be associated with the metabolism of atorvastatin in the Chinese population. Several international multiple-center randomized control trials have demonstrated the benefit of atorvastatin for primary and secondary prevention of CVD. None of them, however, included the Chinese, and current evidence in the population is still inadequate, due to the small sample size, low study quality, short study duration, and the use of surrogate endpoints instead of clinical endpoints. The overall incidence of adverse events observed with atorvastatin did not increase in the 10–80 mg dose range, and was similar to that observed with placebo and in patients treated with other statins, which makes atorvastatin well-tolerated in the Chinese population. Moreover, high patient adherence was observed in clinical studies. Conclusions: Based on the current available evidence, there is no significant difference between Chinese and non-Chinese population in term of pharmacology and clinical efficacy/safety. High-quality evidence is still needed to support the use of atorvastatin in high-risk Chinese population. PMID:25591572

A Review of the Evidence Supporting the Vitamin D-Cancer Prevention Hypothesis in 2017.

PubMed

Grant, William B

2018-02-01

The vitamin D-cancer prevention hypothesis has been evaluated through several types of studies, including geographical ecological studies related to indices of solar ultraviolet-B (UVB) dose (the primary source of vitamin D for most people), observational studies related to UVB exposure or serum 25-hydroxyvitamin D [25(OH)D] concentrations, laboratory studies of mechanisms, and clinical trials. Each approach has strengths and limitations. Ecological studies indirectly measure vitamin D production and incorporate the assumption that vitamin D mediates the effect of UVB exposure. Findings from observational studies with long follow-up times are affected by changing 25(OH)D concentrations over time. Most clinical trials have been poorly designed and conducted, based largely on guidelines for pharmaceutical drugs rather than on nutrients. However, three clinical trials do support the hypothesis. In general, the totality of the evidence, as evaluated using Hill's criteria for causality in a biological system, supports the vitamin D-cancer prevention hypothesis. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Clinical leadership: using observations of care to focus risk management and quality improvement activities in the clinical setting.

PubMed

Ferguson, Lorraine; Calvert, Judy; Davie, Marilyn; Fallon, Mark; Fred, Nada; Gersbach, Vicki; Sinclair, Lynn

2007-04-01

In an era when patient safety and quality of care are a daily concern for health care professionals, it is important for nurse managers and other clinical leaders to have a repertoire of skills and interventions that can be used to motivate and engage clinical teams in risk assessment and continuous quality improvement at the level of patient care delivery. This paper describes how a cohort of clinical leaders who were undertaking a leadership development program used a relatively simple, patient-focused intervention called the 'observation of care' to help focus the clinical team's attention on areas for improvement within the clinical setting. The main quality and safety themes arising out of the observations that were undertaken by the Clinical Leaders (CLs) were related to the environment, occupational health and safety, communication and team function, clinical practice and patient care. The observations of care also provided the CLs with many opportunities to acknowledge and celebrate exemplary practice as it was observed as a means of enhancing the development of a quality and safety culture within the clinical setting. The 'observation of care' intervention can be used by Clinical Leader's to engage and motivate clinical teams to focus on continuously improving the safety and quality of their own work environment and the care delivered to patients within that environment.

Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

PubMed

Gautier, Jean-Francois; Martinez, Luc; Penfornis, Alfred; Eschwège, Eveline; Charpentier, Guillaume; Huret, Benoît; Madani, Suliya; Gourdy, Pierre

2015-09-01

The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up. At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%. The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. Novo Nordisk A/S. ClinicalTrials.gov identifier, NCT01226966.

Inter-Observer and Intra-Observer Reliability of Clinical Assessments in Knee Osteoarthritis

PubMed Central

Maricar, Nasimah; Callaghan, Michael J; Parkes, Matthew J; Felson, David T; O’Neill, Terence W

2016-01-01

Background Clinical examination of the knee is subject to measurement error. The aim of this analysis was to determine inter- and intra-observer reliability of commonly used clinical tests in patients with knee osteoarthritis(OA). Methods We studied subjects with symptomatic knee OA who were participants in an open-label clinical trial of intra-articular steroid therapy. Following standardisation of the clinical test procedures, two clinicians assessed 25 subjects independently at the same visit, and the same clinician assessed 88 subjects over an interval period of 2–10 weeks; in both cases prior to the steroid intervention. Clinical examination included assessment of bony enlargement, crepitus, quadriceps wasting, knee effusion, joint-line and anserine tenderness and knee range of movement(ROM). Intra-class correlation coefficients(ICC), estimated kappa(κ), weighted kappa(κω) and Bland and Altman plots were used to determine inter- and intra-observer levels of agreement. Results Using Landis and Koch criteria, inter-observer kappa scores were moderate for patellofemoral joint(κ=0.53) and anserine tenderness(κ=0.48); good for bony enlargement(κ=0.66), quadriceps wasting(κ=0.78), crepitus(κ=0.78), medial tibiofemoral joint tenderness(κ=0.76), and effusion assessed by ballottement(κ=0.73) and bulge sign(κω =0.78); and excellent for lateral tibiofemoral joint tenderness(κ=1.00), flexion(ICC=0.97) and extension(ICC=0.87) ROM. Intra-observer kappa scores were moderate for lateral tibiofemoral joint tenderness(κ=0.60), good for crepitus(κ=0.78), effusion assessed by ballottement test(κ=0.77), patellofemoral joint(κ=0.66), medial tibiofemoral joint(κ=0.64) and anserine(κ=0.73) tenderness and excellent for effusion assessed by bulge sign(κω =0.83), bony enlargement(κ=0.98), quadriceps wasting(κ=0.83), flexion(ICC=0.99) and extension(ICC=0.96) ROM. Conclusion Among individuals with symptomatic knee OA, the reliability of clinical examination of the knee was at least good for the majority of clinical signs of knee OA. PMID:27909143

How physicians teach in the clinical setting: The embedded roles of teaching and clinical care.

PubMed

Steinert, Yvonne; Basi, Mandeep; Nugus, Peter

2017-12-01

Clinical teaching lies at the heart of medical education. However, few studies have explored the embedded nature of teaching and clinical care. The goal of this study was to examine the process of clinical teaching as it naturally, and spontaneously, unfolds in a broad range of authentic contexts with medical students and residents. This focused ethnographic study consisted of 160 hours of participant observation and field interviews with three internal medicine teams. Thematic analysis guided data organization and interpretation. Three overlapping themes emerged: the interconnectedness between clinical work and pedagogy; a multiplicity of teachers; and the influence of space and artifacts on teaching and learning. Clinical teaching, which was deeply embedded in clinical care, was influenced by the acuity of patient problems, learner needs, and the context in which teaching unfolded; it also occurred on a spectrum that included planned, opportunistic, formal, and informal teaching (and learning). Study findings suggest that clinical teaching, which is marked by an intersection between service and teaching, can be viewed as an example of work-based teaching. They also yield suggestions for the enhancement of clinical teaching in inpatient settings, faculty development, and educational policies that recognize clinical teaching and learning.

Clinical dental application of Er:YAG laser for Class V cavity preparation.

PubMed

Matsumoto, K; Nakamura, Y; Mazeki, K; Kimura, Y

1996-06-01

Following the development of the ruby laser by Maiman in 1960, the Nd:YAG laser, the CO2 laser, the semiconductor laser, the He-Ne laser, excimer lasers, the argon laser, and finally the Er:YAG laser capable of cutting hard tissue easily were developed and have come to be applied clinically. In the present study, the Er:YAG laser emitting at a wavelength of 2.94 microns developed by Luxar was used for the clinical preparation of class V cavities. Parameters of 8 Hz and approx. 250 mJ/pulse maximum output were used for irradiation. Sixty teeth of 40 patients were used in this clinical study. The Er:YAG laser used in this study was found to be a system suitable for clinical application. No adverse reaction was observed in any of the cases. Class V cavity preparation was performed without inducing any pain in 48/60 cases (80%). All of the 12 cases that complained of mild or severe intraoperative pain had previously complained of cervical dentin hypersensibility during the preoperative examination. Cavity preparation was completed with this laser system in 58/60 cases (91.7%). No treatment-related clinical problems were observed during the follow-up period of approx. 30 days after cavity preparation and resin filling. Cavity preparation took between approx. 10 sec and 3 min and was related more or less to cavity size and depth. Overall clinical evaluation showed no safety problem with very good rating in 49 cases (81.7%).

Feedback in clinical education, part I: Characteristics of feedback provided by approved clinical instructors.

PubMed

Nottingham, Sara; Henning, Jolene

2014-01-01

Providing students with feedback is an important component of athletic training clinical education; however, little information is known about the feedback that Approved Clinical Instructors (ACIs; now known as preceptors) currently provide to athletic training students (ATSs). To characterize the feedback provided by ACIs to ATSs during clinical education experiences. Qualitative study. One National Collegiate Athletic Association Division I athletic training facility and 1 outpatient rehabilitation clinic that were clinical sites for 1 entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. A total of 4 ACIs with various experience levels and 4 second-year ATSs. Extensive field observations were audio recorded, transcribed, and integrated with field notes for analysis. The constant comparative approach of open, axial, and selective coding was used to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. The ACIs gave 88 feedback statements in 45 hours and 10 minutes of observation. Characteristics of feedback categories included purpose, timing, specificity, content, form, and privacy. Feedback that ACIs provided included several components that made each feedback exchange unique. The ACIs in our study provided feedback that is supported by the literature, suggesting that ACIs are using current recommendations for providing feedback. Feedback needs to be investigated across multiple athletic training education programs to gain more understanding of certain areas of feedback, including frequency, privacy, and form.

Integrating antiretroviral therapy into antenatal care and maternal and child health settings: a systematic review and meta-analysis

PubMed Central

Hoos, David; Beqiri, Alba; Lorenz-Dehne, Karl; McClure, Craig; Duncombe, Chris

2013-01-01

Abstract Objective To determine whether integrating antiretroviral therapy (ART) into antenatal care (ANC) and maternal and child health (MCH) clinics could improve programmatic and patient outcomes. Methods The authors systematically searched PubMed, Embase, African Index Medicus and LiLACS for randomized controlled trials, prospective cohort studies, or retrospective cohort studies comparing outcomes in ANC or MCH clinics that had and had not integrated ART. The outcomes of interest were ART coverage, ART enrolment, ART retention, mortality and transmission of human immunodeficiency virus (HIV). Findings Four studies met the inclusion criteria. All were conducted in ANC clinics. Increased enrolment of pregnant women in ART was observed in ANC clinics that had integrated ART (relative risk, RR: 2.09; 95% confidence interval, CI; 1.78–2.46; I2: 15%). Increased ART coverage was also noted in such clinics (RR: 1.37; 95% CI: 1.05–1.79; I2: 83%). Sensitivity analyses revealed a trend for the national prevalence of HIV infection to explain the heterogeneity in the size of the effect of ART integration on ART coverage (P = 0.13). Retention in ART was similar in ANC clinics with and without ART integration. Conclusion Although few data were available, ART integration in ANC clinics appears to lead to higher rates of ART enrolment and ART coverage. Rates of retention in ART remain similar to those observed in referral-based models. PMID:23397350

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.

Correlation between Clinical Features and Magnetic Resonance Imaging Findings in Lumbar Disc Prolapse.

PubMed

Thapa, S S; Lakhey, R B; Sharma, P; Pokhrel, R K

2016-05-01

Magnetic resonance imaging is routinely done for diagnosis of lumbar disc prolapse. Many abnormalities of disc are observed even in asymptomatic patient.This study was conducted tocorrelate these abnormalities observed on Magnetic resonance imaging and clinical features of lumbar disc prolapse. A This prospective analytical study includes 57 cases of lumbar disc prolapse presenting to Department of Orthopedics, Tribhuvan University Teaching Hospital from March 2011 to August 2012. All patientshad Magnetic resonance imaging of lumbar spine and the findings regarding type, level and position of lumbar disc prolapse, any neural canal or foraminal compromise was recorded. These imaging findings were then correlated with clinical signs and symptoms. Chi-square test was used to find out p-value for correlation between clinical features and Magnetic resonance imaging findings using SPSS 17.0. This study included 57 patients, with mean age 36.8 years. Of them 41(71.9%) patients had radicular leg pain along specific dermatome. Magnetic resonance imaging showed 104 lumbar disc prolapselevel. Disc prolapse at L4-L5 and L5-S1 level constituted 85.5%.Magnetic resonance imaging findings of neural foramina compromise and nerve root compression were fairly correlated withclinical findings of radicular pain and neurological deficit. Clinical features and Magnetic resonance imaging findings of lumbar discprolasehad faircorrelation, but all imaging abnormalities do not have a clinical significance.

Pleuropulmonary Blastoma DICER1 Syndrome Study

Cancer.gov

Pleuropulmonary blastoma (PPB) is a rare tumor of the lung that affects young children. The PPB DICER1 Syndrome Study an observational clinical research study is enrolling children with PPB and their families.

Clinical progression of ocular injury following arsenical vesicant lewisite exposure.

PubMed

Tewari-Singh, Neera; Croutch, Claire R; Tuttle, Richard; Goswami, Dinesh G; Kant, Rama; Peters, Eric; Culley, Tara; Ammar, David A; Enzenauer, Robert W; Petrash, J Mark; Casillas, Robert P; Agarwal, Rajesh

2016-12-01

Ocular injury by lewisite (LEW), a potential chemical warfare and terrorist agent, results in edema of eyelids, inflammation, massive corneal necrosis and blindness. To enable screening of effective therapeutics to treat ocular injury from LEW, useful clinically-relevant endpoints are essential. Hence, we designed an efficient exposure system capable of exposing up to six New-Zealand white rabbits at one time, and assessed LEW vapor-induced progression of clinical ocular lesions mainly in the cornea. The right eye of each rabbit was exposed to LEW (0.2 mg/L) vapor for 2.5, 5.0, 7.5 and 10.0 min and clinical progression of injury was observed for 28 days post-exposure (dose-response study), or exposed to same LEW dose for 2.5 and 7.5 min and clinical progression of injury was observed for up to 56 days post-exposure (time-response study); left eye served as an unexposed control. Increasing LEW exposure caused corneal opacity within 6 h post-exposure, which increased up to 3 days, slightly reduced thereafter till 3 weeks, and again increased thereafter. LEW-induced corneal ulceration peaked at 1 day post-exposure and its increase thereafter was observed in phases. LEW exposure induced neovascularization starting at 7 days which peaked at 22-35 days post-exposure, and remained persistent thereafter. In addition, LEW exposure caused corneal thickness, iris redness, and redness and swelling of the conjunctiva. Together, these findings provide clinical sequelae of ocular injury following LEW exposure and for the first time establish clinically-relevant quantitative endpoints, to enable the further identification of histopathological and molecular events involved in LEW-induced ocular injury.

Rationale, Design, and Methodology of the APOLLON trial: A comPrehensive, ObservationaL registry of heart faiLure with midrange and preserved ejectiON fraction.

PubMed

Özlek, Bülent; Özlek, Eda; Çelik, Oğuzhan; Çil, Cem; Doğan, Volkan; Tekinalp, Mehmet; Zencirkıran Ağuş, Hicaz; Kahraman, Serkan; Ösken, Altuğ; Rencüzoğulları, İbrahim; Tanık, Veysel Ozan; Bekar, Lütfü; Çakır, Mustafa Ozan; Kaya, Bedri Caner; Tibilli, Hakan; Çelik, Yunus; Başaran, Özcan; Mert, Kadir Uğur; Sevinç, Samet; Demirci, Erkan; Dondurmacı, Engin; Biteker, Murat

2018-05-01

Although almost half of chronic heart failure (HF) patients have mid-range (HFmrEF) and preserved left-ventricular ejection fraction (HFpEF), no studies have been carried out with these patients in our country. This study aims to determine the demographic characteristics and current status of the clinical background of HFmrEF and HFpEF patients in a multicenter trial. A comPrehensive, ObservationaL registry of heart faiLure with mid range and preserved ejectiON fraction (APOLLON) trial will be an observational, multicenter, and noninterventional study conducted in Turkey. The study population will include 1065 patients from 12 sites in Turkey. All data will be collected at one point in time and the current clinical practice will be evaluated (ClinicalTrials.gov number NCT03026114). We will enroll all consecutive patients admitted to the cardiology clinics who were at least 18 years of age and had New York Heart Association class II, III, or IV HF, elevated brain natriuretic peptide levels within the last 30 days, and an left ventricular ejection fraction (LVEF) of at least 40%. Patients fulfilling the exclusion criteria will not be included in the study. Patients will be stratified into two categories according to LVEF: mid-range EF (HFmrEF, LVEF 40%-49%) and preserved EF (HFpEF, LVEF ≥50%). Regional quota sampling will be performed to ensure that the sample was representative of the Turkish population. Demographic, lifestyle, medical, and therapeutic data will be collected by this specific survey. The APOLLON trial will be the largest and most comprehensive study in Turkey evaluating HF patients with a LVEF ≥40% and will also be the first study to specifically analyze the recently designated HFmrEF category.

The utility of pre-test clinical scoring for clinical diagnosis of heparin-induced thrombocytopenia in cardiac surgery patients of a tertiary care centre in north India.

PubMed

Sachan, D; Gupta, N; Agarwal, P; Chaudhary, R

2011-08-01

Heparin-induced thrombocytopenia (HIT) should be diagnosed clinically as well as by laboratory assays for timely recognition, prevention and management of complications. To evaluate the clinical utility of pre-test clinical scoring system in combination with two immunoassays for the diagnosis of HIT in cardiac surgery patients. A total of 100 consecutive patients undergoing cardiac surgery were studied. Pre-test clinical scoring was carried out in patients with thrombocytopenia and further tested by two immunoassays, i.e., Heparin platelet factor 4 (H-PF4) enzyme-linked immunosorbent assay (ELISA) and particle gel immunoassay (PaGIA). Of the 100 patients studied, 42 patients developed thrombocytopenia post-operatively. On pre-test clinical scoring, low T-score was observed in 6 patients, intermediate in 28 and high score in 8 patients, whereas 19 patients (45.2%) were positive by H-PF4 ELISA and 10 (23.8%) by PaGIA for H-PF4 antibody. The difference in the incidence of clinically significant HIT antibodies in the three categories was statistically significant. A good correlation was also observed with ELISA optical density, T-scoring and PaGIA. Pre-test clinical scoring correlates well with the development of H-PF4 antibodies which are incriminated in the causation of thrombotic complications in patients with HIT. We also propose a protocol for diagnosing patients with clinical suspicion of HIT using pre-test clinical scoring and immunoassay. © 2011 The Authors. Transfusion Medicine © 2011 British Blood Transfusion Society.

The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field.

PubMed

Wolpaw, Benjamin J; Mathews, Catherine; Chopra, Mickey; Hardie, Diana; de Azevedo, Virginia; Jennings, Karen; Lurie, Mark N

2010-03-22

The rapid HIV antibody test is the diagnostic tool of choice in low and middle-income countries. Previous evidence suggests that rapid HIV diagnostic tests may underperform in the field, failing to detect a substantial number of infections. A research study inadvertently discovered that a clinic rapid HIV testing process was failing to detect cases of established (high antibody titer) infection, exhibiting an estimated 68.7% sensitivity (95% CI [41.3%-89.0%]) over the course of the first three weeks of observation. The setting is a public service clinic that provides STI diagnosis and treatment in an impoverished, peri-urban community outside of Cape Town, South Africa. The researchers and local health administrators collaborated to investigate the cause of the poor test performance and make necessary corrections. The clinic changed the brand of rapid test being used and later introduced quality improvement measures. Observations were made of the clinic staff as they administered rapid HIV tests to real patients. Estimated testing sensitivity was calculated as the number of rapid HIV test positive individuals detected by the clinic divided by this number plus the number of PCR positive, highly reactive 3rd generation ELISA patients identified among those who were rapid test negative at the clinic. In the period of five months after the clinic made the switch of rapid HIV tests, estimated sensitivity improved to 93.5% (95% CI [86.5%-97.6%]), during which time observations of counselors administering tests at the clinic found poor adherence to the recommended testing protocol. Quality improvement measures were implemented and estimated sensitivity rose to 95.1% (95% CI [83.5%-99.4%]) during the final two months of full observation. Poor testing procedure in the field can lead to exceedingly low levels of rapid HIV test sensitivity, making it imperative that stringent quality control measures are implemented where they do not already exist. Certain brands of rapid-testing kits may perform better than others when faced with sub-optimal use.

Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

PubMed

Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T

2018-02-01

The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Rationale, design and objectives of ARegPKD, a European ARPKD registry study.

PubMed

Ebner, Kathrin; Feldkoetter, Markus; Ariceta, Gema; Bergmann, Carsten; Buettner, Reinhard; Doyon, Anke; Duzova, Ali; Goebel, Heike; Haffner, Dieter; Hero, Barbara; Hoppe, Bernd; Illig, Thomas; Jankauskiene, Augustina; Klopp, Norman; König, Jens; Litwin, Mieczyslaw; Mekahli, Djalila; Ranchin, Bruno; Sander, Anja; Testa, Sara; Weber, Lutz Thorsten; Wicher, Dorota; Yuzbasioglu, Ayse; Zerres, Klaus; Dötsch, Jörg; Schaefer, Franz; Liebau, Max Christoph

2015-02-18

Autosomal recessive polycystic kidney disease (ARPKD) is a rare but frequently severe disorder that is typically characterized by cystic kidneys and congenital hepatic fibrosis but displays pronounced phenotypic heterogeneity. ARPKD is among the most important causes for pediatric end stage renal disease and a leading reason for liver-, kidney- or combined liver kidney transplantation in childhood. The underlying pathophysiology, the mechanisms resulting in the observed clinical heterogeneity and the long-term clinical evolution of patients remain poorly understood. Current treatment approaches continue to be largely symptomatic and opinion-based even in most-advanced medical centers. While large clinical trials for the frequent and mostly adult onset autosomal dominant polycystic kidney diseases have recently been conducted, therapeutic initiatives for ARPKD are facing the challenge of small and clinically variable cohorts for which reliable end points are hard to establish. ARegPKD is an international, mostly European, observational study to deeply phenotype ARPKD patients in a pro- and retrospective fashion. This registry study is conducted with the support of the German Society for Pediatric Nephrology (GPN) and the European Study Consortium for Chronic Kidney Disorders Affecting Pediatric Patients (ESCAPE Network). ARegPKD clinically characterizes long-term ARPKD courses by a web-based approach that uses detailed basic data questionnaires in combination with yearly follow-up visits. Clinical data collection is accompanied by associated biobanking and reference histology, thus setting roots for future translational research. The novel registry study ARegPKD aims to characterize miscellaneous subcohorts and to compare the applied treatment options in a large cohort of deeply characterized patients. ARegPKD will thus provide evidence base for clinical treatment decisions and contribute to the pathophysiological understanding of this severe inherited disorder.

Determination of spondylolisthesis in low back pain by clinical evaluation.

PubMed

Kalpakcioglu, Banu; Altinbilek, Turgay; Senel, Kazim

2009-01-01

Current guides recommend to evaluate the patients with low back pain complaints with initial clinical assessment and history, and to utilize radiological or other imaging technics, in case of possible diagnosis. The aim of this study was to compare the findings of radiological and clinical assessment, and validate the reliability of spondylolisthesis diagnosed with clinical assessment. This study is conducted on 100 patients with, and 30 patients without (control group) radiological diagnosis of spondylolisthesis, who had applied to Department of Physical Therapy and Rehabilitation, Haydarpasa Numune Hospital with low back pain complaints in one and a half year. Clinic assessment was consisted of 20 parameters including examinations of motor system such as, sign of slipping observed on palpation and inspection, extension of trunk and increase in lumbar lordosis. Antero-posterior, lateral, oblique and lateral flexion/extension radiographies were used for radiological assessment. Slipping degree and lumbar lordosis angle were measured. Women/men patients ratio was 91/9 in spondylolisthesis group and 22/8 in control group. Age of 69% of patients were 50 and over. In both groups, sciatalgia was observed in more than half of the patients, and no significant difference was detected in localization (p > 0.05). In clinical assessment, weak and drooping abdominal wall, paravertebral muscle hypertrophy, increase in lumbar lordosis, sign of slipping observed on palpation and inspection, hamstring muscle spasm, pain during lateral trunk flexion-extension tasks and during double leg raising task were found to be positively correlated with radiological assesment (p < 0.05). In our study, a systematic clinical assessment was proved to be useful in determination of possible spondylolisthesis cases. Radiological assessments are required in order to make the diagnosis clear and to determine the grade and prognosis of spondylolisthesis. Advanced imaging techniques like MRI and CT have to be used when neurological symptoms are present, and when surgical intervention is indicated.

Possible clinical effects of molecular hydrogen (H2) delivery during hemodialysis in chronic dialysis patients: Interim analysis in a 12 month observation

PubMed Central

Nakayama, Masaaki; Itami, Noritomo; Suzuki, Hodaka; Hamada, Hiromi; Osaka, Naoyuki; Yamamoto, Ryo; Tsunoda, Kazumasa; Nakano, Hirofumi; Watanabe, Kimio; Zhu, Wan-Jun; Maruyama, Yukio; Terawaki, Hiroyuki; Kabayama, Shigeru; Nakazawa, Ryoichi; Miyazaki, Mariko; Ito, Sadayoshi

2017-01-01

Background and aim It is supposed that enhanced oxidative stress and inflammation are involved with the poor clinical outcomes in patients on chronic dialysis treatment. Recent studies have shown that molecular hydrogen (H2) is biologically active as an anti-inflammatory agent. Thus, we developed a novel hemodialysis (E-HD) system which delivers H2 (30 to 80 ppb)-enriched dialysis solution, to conduct a prospective observational study (UMIN000004857) in order to compare the long-term outcomes between E-HD and conventional-HD (C-HD) in Japan. The present interim analysis aimed to look at potential clinical effects of E-HD during the first 12 months observation. Subjects and method 262 patients (140, E-HD; 122, C-HD) were subjected for analysis for comprehensive clinical profiles. They were all participating in the above mentioned study, and they had been under the respective HD treatment for 12 consecutive months without hospitalization. Collected data, such as, physical and laboratory examinations, medications, and self-assessment questionnaires on subjective symptoms (i.e., fatigue and pruritus) were compared between the two groups. Results In a 12-month period, no clinical relevant differences were found in dialysis-related parameters between the two groups. However, there were differences in the defined daily dose of anti-hypertensive agents, and subjective symptoms, such as severe fatigue, and pruritus, which were all less in the E-HD group. Multivariate analysis revealed E-HD was an independent significant factor for the reduced use of anti-hypertensive agents as well as the absence of severe fatigue and pruritus at 12 months after adjusting for confounding factors. Conclusion The data indicates E-HD could have substantial clinical benefits beyond conventional HD therapy, and support the rationale to conduct clinical trials of H2 application to HD treatment. PMID:28902900

Whole genome sequencing in support of wellness and health maintenance.

PubMed

Patel, Chirag J; Sivadas, Ambily; Tabassum, Rubina; Preeprem, Thanawadee; Zhao, Jing; Arafat, Dalia; Chen, Rong; Morgan, Alexander A; Martin, Gregory S; Brigham, Kenneth L; Butte, Atul J; Gibson, Greg

2013-01-01

Whole genome sequencing is poised to revolutionize personalized medicine, providing the capacity to classify individuals into risk categories for a wide range of diseases. Here we begin to explore how whole genome sequencing (WGS) might be incorporated alongside traditional clinical evaluation as a part of preventive medicine. The present study illustrates novel approaches for integrating genotypic and clinical information for assessment of generalized health risks and to assist individuals in the promotion of wellness and maintenance of good health. Whole genome sequences and longitudinal clinical profiles are described for eight middle-aged Caucasian participants (four men and four women) from the Center for Health Discovery and Well Being (CHDWB) at Emory University in Atlanta. We report multivariate genotypic risk assessments derived from common variants reported by genome-wide association studies (GWAS), as well as clinical measures in the domains of immune, metabolic, cardiovascular, musculoskeletal, respiratory, and mental health. Polygenic risk is assessed for each participant for over 100 diseases and reported relative to baseline population prevalence. Two approaches for combining clinical and genetic profiles for the purposes of health assessment are then presented. First we propose conditioning individual disease risk assessments on observed clinical status for type 2 diabetes, coronary artery disease, hypertriglyceridemia and hypertension, and obesity. An approximate 2:1 ratio of concordance between genetic prediction and observed sub-clinical disease is observed. Subsequently, we show how more holistic combination of genetic, clinical and family history data can be achieved by visualizing risk in eight sub-classes of disease. Having identified where their profiles are broadly concordant or discordant, an individual can focus on individual clinical results or genotypes as they develop personalized health action plans in consultation with a health partner or coach. The CHDWB will facilitate longitudinal evaluation of wellness-focused medical care based on comprehensive self-knowledge of medical risks.

Whole genome sequencing in support of wellness and health maintenance

PubMed Central

2013-01-01

Background Whole genome sequencing is poised to revolutionize personalized medicine, providing the capacity to classify individuals into risk categories for a wide range of diseases. Here we begin to explore how whole genome sequencing (WGS) might be incorporated alongside traditional clinical evaluation as a part of preventive medicine. The present study illustrates novel approaches for integrating genotypic and clinical information for assessment of generalized health risks and to assist individuals in the promotion of wellness and maintenance of good health. Methods Whole genome sequences and longitudinal clinical profiles are described for eight middle-aged Caucasian participants (four men and four women) from the Center for Health Discovery and Well Being (CHDWB) at Emory University in Atlanta. We report multivariate genotypic risk assessments derived from common variants reported by genome-wide association studies (GWAS), as well as clinical measures in the domains of immune, metabolic, cardiovascular, musculoskeletal, respiratory, and mental health. Results Polygenic risk is assessed for each participant for over 100 diseases and reported relative to baseline population prevalence. Two approaches for combining clinical and genetic profiles for the purposes of health assessment are then presented. First we propose conditioning individual disease risk assessments on observed clinical status for type 2 diabetes, coronary artery disease, hypertriglyceridemia and hypertension, and obesity. An approximate 2:1 ratio of concordance between genetic prediction and observed sub-clinical disease is observed. Subsequently, we show how more holistic combination of genetic, clinical and family history data can be achieved by visualizing risk in eight sub-classes of disease. Having identified where their profiles are broadly concordant or discordant, an individual can focus on individual clinical results or genotypes as they develop personalized health action plans in consultation with a health partner or coach. Conclusion The CHDWB will facilitate longitudinal evaluation of wellness-focused medical care based on comprehensive self-knowledge of medical risks. PMID:23806097

Combination of 595-nm pulsed dye laser, long-pulsed 755-nm alexandrite laser, and microdermabrasion treatment for keratosis pilaris: retrospective analysis of 26 Korean patients.

PubMed

Lee, Sang Ju; Choi, Min Ju; Zheng, Zhenlong; Chung, Won Soon; Kim, Young Koo; Cho, Sung Bin

2013-06-01

Keratosis pilaris (KP) has beenpresented as small keratotic follicular papules with or without surrounding erythema. Various treatments with laser or light therapy have been used for the management of KP with various clinical outcomes. In the present study, we investigated the efficacy and safety of a combination therapy for KP. A total of 29 anatomical sites with KP in 26 patients were treated using a 595-nm pulsed dye laser (PDL) with nonpurpuragenic fluences, a long-pulsed 755-nm alexandrite laser, and microdermabrasion. Clinical improvement was assessed by comparing preand posttreatment clinical photographs and patient satisfaction rates. Evaluation of the clinical results three months after the treatments showed that 12 of the 29 anatomical sites (41.4%) demonstrated Grade 3 clinical improvement, ten (34.5%) had Grade 2 clinical improvement, four (13.8%) showed Grade 1 improvement, and three (10.3%) showed Grade 4 improvement. We observed that KP lesions improved not only in erythema and skin texture, but also in brownish dyschromias. Potential adverse events were not observed, except prolonged posttherapy scaling. Our observations demonstrate that combination therapy using a 595-nm PDL, a long-pulsed 755-nm alexandrite laser, and microdermabrasion can have a positive therapeutic effect on KP.

Predicting out-of-office blood pressure level using repeated measurements in the clinic: an observational cohort study

PubMed Central

Sheppard, James P.; Holder, Roger; Nichols, Linda; Bray, Emma; Hobbs, F.D. Richard; Mant, Jonathan; Little, Paul; Williams, Bryan; Greenfield, Sheila; McManus, Richard J.

2014-01-01

Objectives: Identification of people with lower (white-coat effect) or higher (masked effect) blood pressure at home compared to the clinic usually requires ambulatory or home monitoring. This study assessed whether changes in SBP with repeated measurement at a single clinic predict subsequent differences between clinic and home measurements. Methods: This study used an observational cohort design and included 220 individuals aged 35–84 years, receiving treatment for hypertension, but whose SBP was not controlled. The characteristics of change in SBP over six clinic readings were defined as the SBP drop, the slope and the quadratic coefficient using polynomial regression modelling. The predictive abilities of these characteristics for lower or higher home SBP readings were investigated with logistic regression and repeated operating characteristic analysis. Results: The single clinic SBP drop was predictive of the white-coat effect with a sensitivity of 90%, specificity of 50%, positive predictive value of 56% and negative predictive value of 88%. Predictive values for the masked effect and those of the slope and quadratic coefficient were slightly lower, but when the slope and quadratic variables were combined, the sensitivity, specificity, positive and negative predictive values for the masked effect were improved to 91, 48, 24 and 97%, respectively. Conclusion: Characteristics obtainable from multiple SBP measurements in a single clinic in patients with treated hypertension appear to reasonably predict those unlikely to have a large white-coat or masked effect, potentially allowing better targeting of out-of-office monitoring in routine clinical practice. PMID:25144295

[Approaches, knowledge and capabilities of nurses and physicians regarding evidence-based clinical practice in the Imbadura province (Ecuador)].

PubMed

Molina Mula, Jesús; Muñoz Navarro, Paulina; Vaca Auz, Janeth; Cabascango Cabascango, Carmita; Cabascango Cabascango, Katty

2015-01-01

The research raises the need to increase understanding of organizational and personal factors that influence the attitude and aptitude of each professional, with respect to evidence-based clinical practice. The aim of this study is to describe the transfer of knowledge into clinical practice in hospital units in Imbabura (Ecuador) identifying the obstacles to implementing evidence-based clinical practice validated questionnaire EBPQ-19. A cross-sectional observational study was conducted in hospitals of the Ministry of Public Health of Imbabura of Ecuador took place, including a total of 281 nurses and physicians. Nurses and physicians showed positive attitudes toward evidence-based clinical practice (EBCP) and their use to support clinical decision-making. This research evidences perceptions of professionals on strategies for knowledge transfer and obstacles to carry it out. Significant differences between the perception of the use of EBCP strategies between nurses and physicians are observed. Physicians consider they use them frequently, while nurses acknowledge using them less (chi-square: 105.254, P=.018). In conclusion, we can say that these factors should be considered as necessary to improve the quality of care that is provided to users based on the best available evidence. It is necessary to start developing change interventions in this regard to remedy the current situation of clinical practice based not on evidence, but rather on experience only. Experimental studies demonstrating the effectiveness of strategies to eliminate barriers to scientific evidence-based clinical practice should be conducted. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: A randomized, observer-blind, parallel group study

PubMed Central

Chatterjee, Dattatreyo; Ghosh, Sudip Kumar; Sen, Sukanta; Sarkar, Saswati; Hazra, Avijit; De, Radharaman

2016-01-01

Objective: Epidermal dermatophyte infections most commonly manifest as tinea corporis or tinea cruris. Topical azole antifungals are commonly used in their treatment but literature suggests that most require twice-daily application and provide lower cure rates than the allylamine antifungal terbinafine. We conducted a head-to-head comparison of the effectiveness of the once-daily topical azole, sertaconazole, with terbinafine in these infections. Materials and Methods: We conducted a randomized, observer-blind, parallel group study (Clinical Trial Registry India [CTRI]/2014/09/005029) with adult patients of either sex presenting with localized lesions. The clinical diagnosis was confirmed by potassium hydroxide smear microscopy of skin scrapings. After baseline assessment of erythema, scaling, and pruritus, patients applied either of the two study drugs once daily for 2 weeks. If clinical cure was not seen at 2 weeks, but improvement was noted, application was continued for further 2 weeks. Patients deemed to be clinical failure at 2 weeks were switched to oral antifungals. Results: Overall 88 patients on sertaconazole and 91 on terbinafine were analyzed. At 2 weeks, the clinical cure rates were comparable at 77.27% (95% confidence interval [CI]: 68.52%–86.03%) for sertaconazole and 73.63% (95% CI 64.57%–82.68%) for terbinafine (P = 0.606). Fourteen patients in either group improved and on further treatment showed complete healing by another 2 weeks. The final cure rate at 4 weeks was also comparable at 93.18% (95% CI 88.75%–97.62%) and 89.01% (95% CI 82.59%–95.44%), respectively (P = 0.914). At 2 weeks, 6 (6.82%) sertaconazole and 10 (10.99%) terbinafine recipients were considered as “clinical failure.” Tolerability of both preparations was excellent. Conclusion: Despite the limitations of an observer-blind study without microbiological support, the results suggest that once-daily topical sertaconazole is as effective as terbinafine in localized tinea infections. PMID:28066103

Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: A randomized, observer-blind, parallel group study.

PubMed

Chatterjee, Dattatreyo; Ghosh, Sudip Kumar; Sen, Sukanta; Sarkar, Saswati; Hazra, Avijit; De, Radharaman

2016-01-01

Epidermal dermatophyte infections most commonly manifest as tinea corporis or tinea cruris. Topical azole antifungals are commonly used in their treatment but literature suggests that most require twice-daily application and provide lower cure rates than the allylamine antifungal terbinafine. We conducted a head-to-head comparison of the effectiveness of the once-daily topical azole, sertaconazole, with terbinafine in these infections. We conducted a randomized, observer-blind, parallel group study (Clinical Trial Registry India [CTRI]/2014/09/005029) with adult patients of either sex presenting with localized lesions. The clinical diagnosis was confirmed by potassium hydroxide smear microscopy of skin scrapings. After baseline assessment of erythema, scaling, and pruritus, patients applied either of the two study drugs once daily for 2 weeks. If clinical cure was not seen at 2 weeks, but improvement was noted, application was continued for further 2 weeks. Patients deemed to be clinical failure at 2 weeks were switched to oral antifungals. Overall 88 patients on sertaconazole and 91 on terbinafine were analyzed. At 2 weeks, the clinical cure rates were comparable at 77.27% (95% confidence interval [CI]: 68.52%-86.03%) for sertaconazole and 73.63% (95% CI 64.57%-82.68%) for terbinafine ( P = 0.606). Fourteen patients in either group improved and on further treatment showed complete healing by another 2 weeks. The final cure rate at 4 weeks was also comparable at 93.18% (95% CI 88.75%-97.62%) and 89.01% (95% CI 82.59%-95.44%), respectively ( P = 0.914). At 2 weeks, 6 (6.82%) sertaconazole and 10 (10.99%) terbinafine recipients were considered as "clinical failure." Tolerability of both preparations was excellent. Despite the limitations of an observer-blind study without microbiological support, the results suggest that once-daily topical sertaconazole is as effective as terbinafine in localized tinea infections.

Assessing Psychodynamic Conflict.

PubMed

Simmonds, Joshua; Constantinides, Prometheas; Perry, J Christopher; Drapeau, Martin; Sheptycki, Amanda R

2015-09-01

Psychodynamic psychotherapies suggest that symptomatic relief is provided, in part, with the resolution of psychic conflicts. Clinical researchers have used innovative methods to investigate such phenomenon. This article aims to review the literature on quantitative psychodynamic conflict rating scales. An electronic search of the literature was conducted to retrieve quantitative observer-rated scales used to assess conflict noting each measure's theoretical model, information source, and training and clinical experience required. Scales were also examined for levels of reliability and validity. Five quantitative observer-rated conflict scales were identified. Reliability varied from poor to excellent with each measure demonstrating good validity. However a small number of studies and limited links to current conflict theory suggest further clinical research is needed.

Skew-t partially linear mixed-effects models for AIDS clinical studies.

PubMed

Lu, Tao

2016-01-01

We propose partially linear mixed-effects models with asymmetry and missingness to investigate the relationship between two biomarkers in clinical studies. The proposed models take into account irregular time effects commonly observed in clinical studies under a semiparametric model framework. In addition, commonly assumed symmetric distributions for model errors are substituted by asymmetric distribution to account for skewness. Further, informative missing data mechanism is accounted for. A Bayesian approach is developed to perform parameter estimation simultaneously. The proposed model and method are applied to an AIDS dataset and comparisons with alternative models are performed.

Cartilage Repair With Autologous Bone Marrow Mesenchymal Stem Cell Transplantation: Review of Preclinical and Clinical Studies.

PubMed

Yamasaki, Shinya; Mera, Hisashi; Itokazu, Maki; Hashimoto, Yusuke; Wakitani, Shigeyuki

2014-10-01

Clinical trials of various procedures, including bone marrow stimulation, mosaicplasty, and autologous chondrocyte implantation, have been explored to treat articular cartilage defects. However, all of them have some demerits. We focused on autologous culture-expanded bone marrow mesenchymal stem cells (BMSC), which can proliferate without losing their capacity for differentiation. First, we transplanted BMSC into the defective articular cartilage of rabbit and succeeded in regenerating osteochondral tissue. We then applied this transplantation in humans. Our previous reports showed that treatment with BMSC relieves the clinical symptoms of chondral defects in the knee and elbow joint. We investigated the efficacy of BMSC for osteoarthritic knee treated with high tibial osteotomy, by comparing 12 BMSC-transplanted patients with 12 cell-free patients. At 16-month follow-up, although the difference in clinical improvement between both groups was not significant, the arthroscopic and histological grading score was better in the cell-transplanted group. At the over 10-year follow-up, Hospital for Special Surgery knee scores improved to 76 and 73 in the BMSC-transplanted and cell-free groups, respectively, which were better than preoperative scores. Additionally, neither tumors nor infections were observed in all patients, and in the clinical study, we have never observed hypertrophy of repaired tissue, thereby guaranteeing the clinical safety of this therapy. Although we have never observed calcification above the tidemark in rabbit model and human histologically, the repair cartilage was not completely hyaline cartilage. To elucidate the optimum conditions for cell therapy, other stem cells, culture conditions, growth factors, and gene transfection methods should be explored.

A comparative study of therapeutic response of patients with clinical chancroid to ciprofloxacin, erythromycin, and cotrimoxazole.

PubMed

D'Souza, P; Pandhi, R K; Khanna, N; Rattan, A; Misra, R S

1998-07-01

Cotrimoxazole has traditionally been used as first drug for treatment of chancroid in India. With reports of increasing resistance to the drug, this study was conducted to compare treatment response of clinical chancroid between ciprofloxacin, 500 mg twice daily for 3 days, erythromycin, 500 mg four times daily for 7 days, and double-strength cotrimoxazole (trimethoprim 160 mg + sulfamethoxazole 800 mg), twice daily for 7 days. Forty-six patients with a clinical diagnosis of chancroid were randomly divided into 3 groups. Sixteen patients received ciprofloxacin, whereas 15 each received erythromycin and cotrimoxazole. Patients were seen on day 7, 14, and if needed day 21. Clinical response was noted in terms of cure, improvement, or failure. Excellent response was observed to both ciprofloxacin and erythromycin therapy with cure rates of 93.7% and 93.3%, respectively. Improvement was observed in 6.7% cases in both groups. There were no failures with either ciprofloxacin or erythromycin. Poor response to cotrimoxazole therapy was observed with 53.3% cure rates and a high failure rate of 46.7%. Ciprofloxacin and erythromycin are equally effective in chancroid. Ciprofloxacin is better in terms of dosage schedule, duration of treatment, and low cost. Cotrimoxazole should be discontinued as drug of choice because of high failure rates.

Differences in the implementation of diagnosis-related groups across clinical departments: a German hospital case study.

PubMed

Ridder, Hans-Gerd; Doege, Vanessa; Martini, Susanne

2007-12-01

This article aims to examine the implementation process of diagnosis-related groups (DRGs) in the clinical departments of a German hospital group and to explain why some gain competitive advantage while others do not. To investigate this research question, we conducted a qualitative study based on primary data obtained in six clinical departments in a German hospital group between 2003 and 2005. We chose the case study method in order to gain deep insights into the process dynamics of the implementation of DRGs in the six clinical departments. The dynamic capability approach is used as a theoretical foundation. Employing theory-driven categories we focused on idiosyncratic and common patterns of "successful coders" and "unsuccessful coders." To observe the implementation process of DRGs, we conducted 43 semistructured interviews with key persons, carried out direct observations of the monthly meetings of the DRG project group, and sampled written materials. "Successful coders" invest into change resources, demonstrate a high level of acceptance of innovations, and organize effective processes of coordination and learning. All clinical departments only put an emphasis on the coding aspects of the DRGs. There is a lack of vision regarding the optimization of patient treatment processes and specialization. Physicians are the most important key actors, rather than the main barriers.

The clinical features of angular cheilitis occurring during orthodontic treatment: a multi-centre observational study.

PubMed

Cross, David; Eide, May L; Kotinas, Anastasios

2010-06-01

To report the prevalence and clinical features of angular cheilitis occurring in patients undergoing orthodontic treatment. Cross-sectional, observational study. Three centres were involved; Glasgow Dental Hospital and two specialist orthodontic practices, one in Scotland and one in Greece. Six hundred and sixty consecutive patients undergoing orthodontic treatment were examined over a 9 month period. The presence and absence of angular cheilitis was recorded. A six-point clinical scale was used to describe the clinical features of angular cheilitis when present. Chi-squared tests were used to investigate the association between the presence of angular cheilitis and oral hygiene level/appliance type. Eleven per cent of orthodontic patients in this Western European population, showed signs of angular cheilitis. No correlation was found between the presence of angular cheilitis and gender. Good oral hygiene was associated with a reduced prevalence (P<0.01). Angular cheilitis is a multifactorial condition that can occur in a small percentage of patients during orthodontic treatment. Good oral hygiene may be associated with a reduced risk. A new clinical grade of angular cheilitis is suggested that may help future research. Further studies are required to investigate the microbiological features associated with angular cheilitis occurring in orthodontic patients, as well as associations with medical conditions, such as asthma.

A novel approach to rater training and certification in multinational trials.

PubMed

Jeglic, Elizabeth; Kobak, Kenneth A; Engelhardt, Nina; Williams, Janet B W; Lipsitz, Joshua D; Salvucci, Donna; Bryson, Heather; Bellew, Kevin

2007-07-01

Clinical trials are becoming increasingly international in scope. Global studies pose unique challenges in training and calibrating raters owing to language and cultural differences. Recent findings that poorly conducted interviews reduce study power, makes attention to raters' clinical skills critical. In this study, 109 raters from 14 countries went through a two-step certification process on the Hamilton Depression and Anxiety Rating Scales: (i) an online didactic tutorial on scoring conventions, and (ii) applied clinical training, consisting of small language-specific groups in which raters took turns interviewing patients while observed by an expert trainer, and observation and evaluation of individual interviews. Translators were used when native-language trainers were unavailable. Those who were unable to attend the startup meeting received the training individually via telephone. Results found a significant improvement in raters' knowledge of scoring conventions, with the mean number of correct answers on the 20-item test improving from 14.59 to 17.83, P<0.0001. In addition, raters' clinical skills improved significantly, with the mean score on the Rater Applied Performance Scale improving from their first to their second testing from 10.25 to 11.31, P=0.003. These results support the efficacy of this applied training model in improving raters' applied clinical skills in multinational trials.

Interpretation of lung cancer study outcomes.

PubMed

Cortinovis, Diego; Abbate, Marida; Bidoli, Paolo; Pelizzoni, Davide; Canova, Stefania

2015-11-01

Lung cancer is the leading cause of cancer death in developed countries. However, in the last few years we observed an important acceleration in drug development due to oncogenic driver tumors discovery. Sharing and putting together preclinical data from benchmark and data from clinical research is the scientific paradigm that allows real breakthrough in clinical practice in this field, but only a few targeted agents are worthy and practice changing. The clinical research and proper use of statistical methodology are the pillars to continue to achieve important goals like improvement of overall survival. A good medical oncologist should be able to critically read a scientific paper and move from the observed outcomes into clinical perspective. Despite clinical improvements, sometimes the union of promising targeted agents and optimistic expectations misrepresent the reality and the value of clinical research. In this article, we try to analyze the meaning of statistical assumptions from clinical trials, especially in lung cancer, through a critical review of the concept of value-based medicine. We also attempt to give the reader some practical tools to weigh scientific value of literature reports.

What's new in atopic eczema? An analysis of systematic reviews published in 2007 and 2008. Part 2. Disease prevention and treatment.

PubMed

Williams, H C; Grindlay, D J C

2010-04-01

This review summarizes clinically important findings from systematic reviews indexed in bibliographical databases between August 2007 and August 2008 that dealt with disease prevention (six reviews) and treatment of atopic eczema (seven reviews). Regarding disease prevention, two independent systematic reviews found some clinical trial evidence that ingestion of probiotics by mothers during pregnancy might reduce the incidence of subsequent eczema. Another review failed to find any clear benefit of prebiotics in eczema prevention. Although furry pets are often cited as causing allergic disease, a systematic review of observational studies found no evidence that exposure to cats or dogs at birth increases eczema risk. One very large review of studies of breastfeeding found some evidence of a protective effect on eczema risk, although all the studies were limited by their observational nature. A German group has attempted an overview of eczema prevention studies with a view to informing national guidelines. In terms of eczema treatment, two systematic reviews have confirmed the efficacy of topical tacrolimus ointment. Another review of 31 trials confirms the efficacy of topical pimecrolimus, although many of those trials were vehicle controlled, which limits their clinical utility. A review of 23 studies of desensitization therapy for allergic diseases found some evidence of benefit for eczema, which needs to be explored further. Despite the popularity of antistaphylococcal therapies for eczema, a Cochrane Review of 21 trials failed to show any clear benefit for any of the therapies for infected or clinically noninfected eczema. Another Cochrane Review dealt with dietary exclusions for people with eczema and found little evidence to support any dietary exclusion, apart from avoidance of eggs in infants with suspected egg allergy supported by evidence of sensitization. A review of 13 studies of probiotics for treating established eczema did not show convincing evidence of a clinically worthwhile benefit, an observation that has been substantiated in a subsequent Cochrane Review.

Patterns Exploration on Patterns of Empirical Herbal Formula of Chinese Medicine by Association Rules

PubMed Central

Huang, Li; Yuan, Jiamin; Yang, Zhimin; Xu, Fuping; Huang, Chunhua

2015-01-01

Background. In this study, we use association rules to explore the latent rules and patterns of prescribing and adjusting the ingredients of herbal decoctions based on empirical herbal formula of Chinese Medicine (CM). Materials and Methods. The consideration and development of CM prescriptions based on the knowledge of CM doctors are analyzed. The study contained three stages. The first stage is to identify the chief symptoms to a specific empirical herbal formula, which can serve as the key indication for herb addition and cancellation. The second stage is to conduct a case study on the empirical CM herbal formula for insomnia. Doctors will add extra ingredients or cancel some of them by CM syndrome diagnosis. The last stage of the study is to divide the observed cases into the effective group and ineffective group based on the assessed clinical effect by doctors. The patterns during the diagnosis and treatment are selected by the applied algorithm and the relations between clinical symptoms or indications and herb choosing principles will be selected by the association rules algorithm. Results. Totally 40 patients were observed in this study: 28 patients were considered effective after treatment and the remaining 12 were ineffective. 206 patterns related to clinical indications of Chinese Medicine were checked and screened with each observed case. In the analysis of the effective group, we used the algorithm of association rules to select combinations between 28 herbal adjustment strategies of the empirical herbal formula and the 190 patterns of individual clinical manifestations. During this stage, 11 common patterns were eliminated and 5 major symptoms for insomnia remained. 12 association rules were identified which included 5 herbal adjustment strategies. Conclusion. The association rules method is an effective algorithm to explore the latent relations between clinical indications and herbal adjustment strategies for the study on empirical herbal formulas. PMID:26495415

In vivo clinical and radiological effects of platelet-rich plasma on interstitial supraspinatus lesion: Case series.

PubMed

Lädermann, A; Zumstein, M A; Kolo, F C; Grosclaude, M; Koglin, L; Schwitzguebel, A J P

2016-12-01

Rotator cuff tear (RCT) is a frequent condition of clinical relevance that can be managed with a symptomatic conservative treatment, but surgery is often needed. Biological components like leukocytes and platelet rich plasma (L-PRP) could represent an alternative curative method for interstitial RCT. It has been hypothesized that an ultrasound guided L-PRP injection in supraspinatus interstitial RCT could induce radiological healing. A prospective case series including 25 patients was performed in order to assess the effect of L-PRP infiltration into supraspinatus interstitial RCTs. Primary outcome was tear size change determined by magnetic resonance imaging arthrogram (MRA) before and 6 months after L-PRP infiltration. Secondary outcomes were Constant score, SANE score, and pain visual analog scale (VAS) after L-PRP infiltration. Tear volume diminution was statistically significant (P=.007), and a >50% tear volume diminution was observed in 15 patients. A statistically significant improvement of Constant score (P<.001), SANE score (P=.001), and VAS (P<.001) was observed. In 21 patients, Constant score improvement reached the minimal clinical important difference of 10.4 points. We observed a statistically significant and clinically relevant effect on RCT size and clinical parameters after L-PRP infiltration. Such an important improvement of supraspinatus interstitial RCT with conservative management is uncommon, therefore intratendinous L-PRP infiltrations could have been beneficial. This encouraging result could pave the way for future randomized studies in order to formally determinate whether L-PRP infiltrations are a possible alternative to surgical treatment of interstitial RCT. Prospective observational study; Level of evidence II. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Usability Evaluation of Electronic Health Record System around Clinical Notes Usage-An Ethnographic Study.

PubMed

Rizvi, Rubina F; Marquard, Jenna L; Hultman, Gretchen M; Adam, Terrence J; Harder, Kathleen A; Melton, Genevieve B

2017-10-01

Background A substantial gap exists between current Electronic Health Record (EHR) usability and potential optimal usability. One of the fundamental reasons for this discrepancy is poor incorporation of a User-Centered Design (UCD) approach during the Graphical User Interface (GUI) development process. Objective To evaluate usability strengths and weaknesses of two widely implemented EHR GUIs for critical clinical notes usage tasks. Methods Twelve Internal Medicine resident physicians interacting with one of the two EHR systems (System-1 at Location-A and System-2 at Location-B) were observed by two usability evaluators employing an ethnographic approach. User comments and observer findings were analyzed for two critical tasks: (1) clinical notes entry and (2) related information-seeking tasks. Data were analyzed from two standpoints: (1) usability references categorized by usability evaluators as positive, negative, or equivocal and (2) usability impact of each feature measured through a 7-point severity rating scale. Findings were also validated by user responses to a post observation questionnaire. Results For clinical notes entry, System-1 surpassed System-2 with more positive (26% vs. 12%) than negative (12% vs. 34%) usability references. Greatest impact features on EHR usability (severity score pertaining to each feature) for clinical notes entry were: autopopulation (6), screen options (5.5), communication (5), copy pasting (4.5), error prevention (4.5), edit ability (4), and dictation and transcription (3.5). Both systems performed equally well on information-seeking tasks and features with greatest impacts on EHR usability were navigation for notes (7) and others (e.g., looking for ancillary data; 5.5). Ethnographic observations were supported by follow-up questionnaire responses. Conclusion This study provides usability-specific insights to inform future, improved, EHR interface that is better aligned with UCD approach.

The clinical assessment study of the foot (CASF): study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population

PubMed Central

2011-01-01

Background Symptomatic osteoarthritis (OA) affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care. Methods All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only) and three years (clinic attenders and survey participants), and also by review of medical records. Discussion This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and clinical examination findings, and their presentation, diagnosis and management in primary care. PMID:21892960

Mass Spectrometry and Multiplex Antigen Assays to Assess Microbial Quality and Toxin Production of Staphylococcus aureus Strains Isolated from Clinical and Food Samples

PubMed Central

Attien, Paul; Sina, Haziz; Moussaoui, Wardi; Zimmermann-Meisse, Gaëlle; Dadié, Thomas; Keller, Daniel; Riegel, Philippe; Edoh, Vincent; Kotchoni, Simeon O.; Djè, Marcellin; Prévost, Gilles

2014-01-01

The aim of our study was to investigate the microbial quality of meat products and on some clinical samples in Abidjan focused on Staphylococcus genus and the toxin production profile of Staphylococcus aureus (S. aureus) isolated. Bacteria were collected from 240 samples of three meat products sold in Abidjan and 180 samples issued from clinical infections. The strains were identified by both microbiological and MALDI-TOF-MS methods. The susceptibility to antibiotics was determined by the disc diffusion method. The production of Panton-Valentine Leukocidin, LukE/D, and epidermolysins was screened using radial gel immunodiffusion. The production of staphylococcal enterotoxins and TSST-1 was screened by a Bio-Plex Assay. We observed that 96/240 of meat samples and 32/180 of clinical samples were contaminated by Staphylococcus. Eleven species were isolated from meats and 4 from clinical samples. Forty-two S. aureus strains were isolated from ours samples. Variability of resistance was observed for most of the tested antibiotics but none of the strains displays a resistance to imipenem and quinolones. We observed that 89% of clinical S. aureus were resistant to methicillin against 58% for those issued from meat products. All S. aureus isolates issued from meat products produce epidermolysins whereas none of the clinical strains produced these toxins. The enterotoxins were variably produced by both clinical and meat product samples. PMID:24987686

Does the MCAT predict medical school and PGY-1 performance?

PubMed

Saguil, Aaron; Dong, Ting; Gingerich, Robert J; Swygert, Kimberly; LaRochelle, Jeffrey S; Artino, Anthony R; Cruess, David F; Durning, Steven J

2015-04-01

The Medical College Admissions Test (MCAT) is a high-stakes test required for entry to most U. S. medical schools; admissions committees use this test to predict future accomplishment. Although there is evidence that the MCAT predicts success on multiple choice-based assessments, there is little information on whether the MCAT predicts clinical-based assessments of undergraduate and graduate medical education performance. This study looked at associations between the MCAT and medical school grade point average (GPA), Medical Licensing Examination (USMLE) scores, observed patient care encounters, and residency performance assessments. This study used data collected as part of the Long-Term Career Outcome Study to determine associations between MCAT scores, USMLE Step 1, Step 2 clinical knowledge and clinical skill, and Step 3 scores, Objective Structured Clinical Examination performance, medical school GPA, and PGY-1 program director (PD) assessment of physician performance for students graduating 2010 and 2011. MCAT data were available for all students, and the PGY PD evaluation response rate was 86.2% (N = 340). All permutations of MCAT scores (first, last, highest, average) were weakly associated with GPA, Step 2 clinical knowledge scores, and Step 3 scores. MCAT scores were weakly to moderately associated with Step 1 scores. MCAT scores were not significantly associated with Step 2 clinical skills Integrated Clinical Encounter and Communication and Interpersonal Skills subscores, Objective Structured Clinical Examination performance or PGY-1 PD evaluations. MCAT scores were weakly to moderately associated with assessments that rely on multiple choice testing. The association is somewhat stronger for assessments occurring earlier in medical school, such as USMLE Step 1. The MCAT was not able to predict assessments relying on direct clinical observation, nor was it able to predict PD assessment of PGY-1 performance. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

Feedback-giving behaviour in performance evaluations during clinical clerkships.

PubMed

Bok, Harold G J; Jaarsma, Debbie A D C; Spruijt, Annemarie; Van Beukelen, Peter; Van Der Vleuten, Cees P M; Teunissen, Pim W

2016-01-01

Narrative feedback documented in performance evaluations by the teacher, i.e. the clinical supervisor, is generally accepted to be essential for workplace learning. Many studies have examined factors of influence on the usage of mini-clinical evaluation exercise (mini-CEX) instruments and provision of feedback, but little is known about how these factors influence teachers' feedback-giving behaviour. In this study, we investigated teachers' use of mini-CEX in performance evaluations to provide narrative feedback in undergraduate clinical training. We designed an exploratory qualitative study using an interpretive approach. Focusing on the usage of mini-CEX instruments in clinical training, we conducted semi-structured interviews to explore teachers' perceptions. Between February and June 2013, we conducted interviews with 14 clinicians participated as teachers during undergraduate clinical clerkships. Informed by concepts from the literature, we coded interview transcripts and iteratively reduced and displayed data using template analysis. We identified three main themes of interrelated factors that influenced teachers' practice with regard to mini-CEX instruments: teacher-related factors; teacher-student interaction-related factors, and teacher-context interaction-related factors. Four issues (direct observation, relationship between teacher and student, verbal versus written feedback, formative versus summative purposes) that are pertinent to workplace-based performance evaluations were presented to clarify how different factors interact with each other and influence teachers' feedback-giving behaviour. Embedding performance observation in clinical practice and establishing trustworthy teacher-student relationships in more longitudinal clinical clerkships were considered important in creating a learning environment that supports and facilitates the feedback exchange. Teachers' feedback-giving behaviour within the clinical context results from the interaction between personal, interpersonal and contextual factors. Increasing insight into how teachers use mini-CEX instruments in daily practice may offer strategies for creating a professional learning culture in which feedback giving and seeking would be enhanced.

The utility of focused assessment with sonography for trauma as a triage tool in multiple-casualty incidents during the second Lebanon war.

PubMed

Beck-Razi, Nira; Fischer, Doron; Michaelson, Moshe; Engel, Ahuva; Gaitini, Diana

2007-09-01

The purpose of this study was to evaluate the role of focused assessment with sonography for trauma (FAST) as a triage tool in multiple-casualty incidents (MCIs) for a single international conflict. The charts of 849 casualties that arrived at our level 1 trauma referral center were reviewed. Casualties were initially triaged according to the Injury Severity Score at the emergency department gate. Two-hundred eighty-one physically injured patients, 215 soldiers (76.5%) and 66 civilians (23.5%), were admitted. Focused assessment with sonography for trauma was performed in 102 casualties suspected to have an abdominal injury. Sixty-eight underwent computed tomography (CT); 12 underwent laparotomy; and 28 were kept under clinical observation alone. We compared FAST results against CT, laparotomy, and clinical observation records. Focused assessment with sonography for trauma results were positive in 17 casualties and negative in 85. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of FAST were 75%, 97.6%, 88.2%, 94.1%, and 93.1%, respectively. A strong correlation between FAST and CT results, laparotomy, and clinical observation was obtained (P < .05). In a setting of a war conflict-related MCI, FAST enabled immediate triage of casualties to laparotomy, CT, or clinical observation. Because of its moderate sensitivity, a negative FAST result with strong clinical suspicion demands further evaluation, especially in an MCI.

Dermoscopic patterns of melanocytic nevi in children and adolescents: a cross-sectional study*

PubMed Central

Piazza, Christiane Donato; Yamada, Sergio; Marcassi, Aline P; Maciel, Marina G; Seize, Maria P; Cestari, Silmara C P

2017-01-01

Background Childhood is a dynamic period regarding nevogenesis. Dermoscopy is a noninvasive technique, recommended for the evaluation of pigmented cutaneous lesions. Objectives The purpose of this study was to describe the structures and dermoscopic patterns of melanocytic nevi observed in children and adolescents. Methods Dermoscopy with photographic documentation was used for nevi located on the face, trunk, and extremities of 38 patients aged from one to 16 years examined at the Pediatric Dermatology Outpatient Clinic of the Federal University of São Paulo. Results The study included 201 skin lesions that were diagnosed as nevi during clinic examination. Upon evaluation of the global dermoscopic pattern of the lesions, the most frequently observed nevi were reticular (39.0%), followed by homogeneous (23.9%) and globular nevi (16.4%). During evaluation of the dermoscopic structures, according to the body site, the pigment network was the most observed in the extremities. Study limitations A limitation to be considered is that the inclusion of small or new lesions may hinder the differentiation between dots and globules. Conclusions In our study, the most observed pattern was reticular. There was a difference in the predominance of structures dependent on the anatomical location. PMID:29186245

Development, Impact, and Measurement of Enhanced Physical Diagnosis Skills

ERIC Educational Resources Information Center

Smith, Miriam A.; Burton, William B.; Mackay, Meggan

2009-01-01

Evidence suggests that the quality and frequency of bedside clinical examination have declined. We undertook the study to (1) determine whether intensive instruction in physical examination enhances medical student skills and (2) develop a tool to evaluate those skills using a modified observed structured clinical examination (OSCE). This was a…

Are nurse-led chemotherapy clinics really nurse-led? An ethnographic study.

PubMed

Farrell, Carole; Walshe, Catherine; Molassiotis, Alex

2017-04-01

The number of patients requiring ambulatory chemotherapy is increasing year on year, creating problems with capacity in outpatient clinics and chemotherapy units. Although nurse-led chemotherapy clinics have been set up to address this, there is a lack of evaluation of their effectiveness. Despite a rapid expansion in the development of nursing roles and responsibilities in oncology, there is little understanding of the operational aspects of nurses' roles in nurse-led clinics. To explore nurses' roles within nurse-led chemotherapy clinics. A focused ethnographic study of nurses' roles in nurse-led chemotherapy clinics, including semi-structured interviews with nurses. Four chemotherapy units/cancer centres in the UK PARTICIPANTS: Purposive sampling was used to select four cancer centres/units in different geographical areas within the UK operating nurse-led chemotherapy clinics. Participants were 13 nurses working within nurse-led chemotherapy clinics at the chosen locations. Non-participant observation of nurse-led chemotherapy clinics, semi-structured interviews with nurse participants, review of clinic protocols and associated documentation. 61 nurse-patient consultations were observed with 13 nurses; of these 13, interviews were conducted with 11 nurses. Despite similarities in clinical skills training and prescribing, there were great disparities between clinics run by chemotherapy nurses and those run by advanced nurse practitioners. This included the number of patients seen within each clinic, operational aspects, nurses' autonomy, scope of practice and clinical decision-making abilities. The differences highlighted four different levels of nurse-led chemotherapy clinics, based on nurses' autonomy and scope of clinical practice. However, this was heavily influenced by medical consultants. Several nurses perceived they were undertaking holistic assessments, however they were using medical models/consultation styles, indicating medicalization of nurses' roles. Four different levels of nurse-led chemotherapy clinics were identified, illustrating disparities in nurses' roles. Although clinics are run by nurses they are often controlled by medical consultants, which can reduce nurses' autonomy and negatively impact on patient care. Copyright © 2017 Elsevier Ltd. All rights reserved.

Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval

DTIC Science & Technology

2017-10-01

publication delineating key methodological components of pain studies in prostate cancer. KEYWORDS Pain, metastatic castrate resistant prostate cancer...pain palliation and pain progression in prostate cancer clinical trials that are feasible, methodologically rigorous, and meet regulatory...requirements for drug approval and labeling. The primary aim of this award is to conduct an observational longitudinal study in men with castrate-resistant

Increasing the clinical efficacy of NK and antibody-mediated cancer immunotherapy: potential predictors of successful clinical outcome based on observations in high-risk neuroblastoma.

PubMed

Koehn, Tony A; Trimble, Lori L; Alderson, Kory L; Erbe, Amy K; McDowell, Kimberly A; Grzywacz, Bartosz; Hank, Jacquelyn A; Sondel, Paul M

2012-01-01

Disease recurrence is frequent in high-risk neuroblastoma (NBL) patients even after multi-modality aggressive treatment [a combination of chemotherapy, surgical resection, local radiation therapy, autologous stem cell transplantation, and cis-retinoic acid (CRA)]. Recent clinical studies have explored the use of monoclonal antibodies (mAbs) that bind to disialoganglioside (GD(2)), highly expressed in NBL, as a means to enable immune effector cells to destroy NBL cells via antibody-dependent cell-mediated cytotoxicity (ADCC). Preclinical data indicate that ADCC can be more effective when appropriate effector cells are activated by cytokines. Clinical studies have pursued this by administering anti-GD(2) mAb in combination with ADCC-enhancing cytokines (IL2 and GM-CSF), a regimen that has demonstrated improved cancer-free survival. More recently, early clinical studies have used a fusion protein that consists of the anti-GD(2) mAb directly linked to IL2, and anti-tumor responses were seen in the Phase II setting. Analyses of genes that code for receptors that influence ADCC activity and natural killer (NK) cell function [Fc receptor (FcR), killer immunoglublin-like receptor (KIR), and KIR-ligand (KIR-L)] suggest patients with anti-tumor activity are more likely to have certain genotype profiles. Further analyses will need to be conducted to determine whether these genotypes can be used as predictive markers for favorable therapeutic outcome. In this review, we discuss factors that affect response to mAb-based tumor therapies such as hu14.18-IL2. Many of our observations have been made in the context of NBL; however, we will also include some observations made with mAbs targeting other tumor types that are consistent with results in NBL. Therefore, we hypothesize that the NBL observations discussed here may also be relevant to mAb therapy for other cancers, in which ADCC is known to play a role.

In vitro synergy of natamycin and voriconazole against clinical isolates of Fusarium, Candida, Aspergillus and Curvularia spp.

PubMed

Sradhanjali, Swatishree; Yein, Bandana; Sharma, Savitri; Das, Sujata

2018-01-01

To determine the minimum inhibitory concentrations (MICs) of voriconazole and natamycin, alone and in combination, against the clinical isolates of Fungus and to evaluate the synergy between the drugs in an experimental in vitro study. In an experimental in vitro study, clinical isolates of Fusarium , Aspergillus , Candida and Curvularia spp were maintained on Sabouraud Dextrose Agar and used for the study. The MICs of natamycin and voriconazole, used alone and in combination, were evaluated by checkerboard microdilution technique based on the standard protocol proposed by the Clinical Laboratory Standards Institute. The interactions were assessed using the fractional inhibitory concentration (FIC) Index model. Tested with all the clinical isolates, the MICs ranged between 0.125 and 8 µg/mL both for natamycin and voriconazole. In descending order, maximum synergism (FIC ≤0.5) was observed in Candida spp (33.3%) followed by Curvularia spp and Fusarium spp (23.1%). Synergism was least for Aspergillus spp (22.2%). However, at 61.5% (8/13), maximum additive effect (>0.5-1) was observed in Aspergillus spp and minimum (33.3%, 2/6) in Candida spp. Indifference (FIC value >1 and≤4) was observed in 22.2% (2/9) of Aspergillus spp, 15.4% (2/13) of Fusarium spp, 33.3% (2/6) of Candida spp and 23.1% (3/13) of Curvularia spp. No cases of antagonism (FIC >4) were observed. Natamycin and voriconazole in combination demonstrated more effective antifungal activity than single-use in vitro treatment in all species tested, which implies that these combinations may be helpful in treating fungal keratitis. There was no antagonism between these two drugs. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Variability of carotid artery measurements on 3-Tesla MRI and its impact on sample size calculation for clinical research.

PubMed

Syed, Mushabbar A; Oshinski, John N; Kitchen, Charles; Ali, Arshad; Charnigo, Richard J; Quyyumi, Arshed A

2009-08-01

Carotid MRI measurements are increasingly being employed in research studies for atherosclerosis imaging. The majority of carotid imaging studies use 1.5 T MRI. Our objective was to investigate intra-observer and inter-observer variability in carotid measurements using high resolution 3 T MRI. We performed 3 T carotid MRI on 10 patients (age 56 +/- 8 years, 7 male) with atherosclerosis risk factors and ultrasound intima-media thickness > or =0.6 mm. A total of 20 transverse images of both right and left carotid arteries were acquired using T2 weighted black-blood sequence. The lumen and outer wall of the common carotid and internal carotid arteries were manually traced; vessel wall area, vessel wall volume, and average wall thickness measurements were then assessed for intra-observer and inter-observer variability. Pearson and intraclass correlations were used in these assessments, along with Bland-Altman plots. For inter-observer variability, Pearson correlations ranged from 0.936 to 0.996 and intraclass correlations from 0.927 to 0.991. For intra-observer variability, Pearson correlations ranged from 0.934 to 0.954 and intraclass correlations from 0.831 to 0.948. Calculations showed that inter-observer variability and other sources of error would inflate sample size requirements for a clinical trial by no more than 7.9%, indicating that 3 T MRI is nearly optimal in this respect. In patients with subclinical atherosclerosis, 3 T carotid MRI measurements are highly reproducible and have important implications for clinical trial design.

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

PubMed

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and/or trial subjects as specific risk-alleviating measures.

Investigating conditions for meaningful feedback in the context of an evidence-based feedback programme.

PubMed

Voyer, Stéphane; Cuncic, Cary; Butler, Deborah L; MacNeil, Kimberley; Watling, Christopher; Hatala, Rose

2016-09-01

We developed, implemented and evaluated an evidence-based programme of feedback designed to address limitations identified in the current literature. We sought to advance understanding about how and why feedback processes might be more effective in clinical education. Three faculty members and nine first-year internal medicine residents participated in the pilot programme. To counter challenges identified in the literature, feedback was based on direct observation, grounded in longitudinal faculty-resident relationships, and devoid of summative assessment. We used a qualitative case study design to address three research questions: (i) What benefits did the participants describe? (ii) What elements of the programme facilitated these benefits? (iii) What were the limitations and challenges of the programme? Collected data included audiotapes of interactions between faculty members and residents, field notes written during observations, and semi-structured interviews and focus groups with resident participants. Data analysis moved cyclically and iteratively through inductive and deductive analysis. Residents described benefits relating to their ways of working (clinical skills), ways of learning (accountability for learning) and ways of feeling (emotional well-being). According to participants, specific elements of the programme that achieved these benefits included the direct observation of authentic clinical work, the longitudinal relationship with a faculty member and the emergence of feedback as a conversation between the faculty member and learner. We conclude that the conditions established within our pilot feedback programme influenced the learning culture for first-year internal medicine residents by grounding direct observation in authentic clinical work and setting the observations in the context of a longitudinal, non-assessment-based relationship between a faculty member and resident. These conditions appeared to influence residents' participation in the feedback process, their ways of approaching their daily clinical work, their emotional well-being and their engagement in their own learning. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Peer review: a tool to enhance clinical teaching.

PubMed

Gusic, Maryellen; Hageman, Heather; Zenni, Elisa

2013-10-01

The system used by academic health centres to evaluate teaching must be valued by the large number of faculty staff that teach in clinical settings. Peer review can be used to evaluate and enhance clinical teaching. The objective of this study was to determine the perceptions of clinical faculty about the effects of participating in peer review. Faculty members were observed teaching in a clinical setting by trained peer observers. Feedback was provided using a checklist of behaviours and descriptive comments. Afterwards, semi-structured interviews were conducted to assess the faculty member's perception about the process. Notes from the interviews were analysed using a grounded theory approach. The study was approved by the institutional review boards of all the institutions involved. Three themes emerged from the interviews with faculty members: (1) they found the process to be valuable - they received information that affirmed "good" teaching behaviours, and were prompted to be more focused on their teaching; (2) they were motivated to enhance their teaching by being more deliberate, interactive and learner-centred; and (3) they were inspired to explore other opportunities to improve their teaching skills. Peer review is a process that promotes the open discussion and exchange of ideas. This conversation advances clinical teaching skills and allows high-quality teaching behaviours to be strengthened. © 2013 John Wiley & Sons Ltd.

Comparative effectiveness research in cancer with observational data.

PubMed

Giordano, Sharon H

2015-01-01

Observational studies are increasingly being used for comparative effectiveness research. These studies can have the greatest impact when randomized trials are not feasible or when randomized studies have not included the population or outcomes of interest. However, careful attention must be paid to study design to minimize the likelihood of selection biases. Analytic techniques, such as multivariable regression modeling, propensity score analysis, and instrumental variable analysis, also can also be used to help address confounding. Oncology has many existing large and clinically rich observational databases that can be used for comparative effectiveness research. With careful study design, observational studies can produce valid results to assess the benefits and harms of a treatment or intervention in representative real-world populations.

Histopathologic lesions in conventional pigs experimentally infected with Haemophilus parasuis serovar 5.

PubMed

Palzer, A; Austin-Busse, R-L; Ladinig, A; Balka, G; Zoels, S; Ritzmann, M

2015-01-01

In the present study various tissues of pigs were investigated for the presence of histopathologic lesions after an experimental infection with Haemophilus (H.) parasuis serovar 5. Conventional pigs (n = 36) were divided into a control group B (n = 9) and a challenge group A (n = 27), which was infected intratracheally. Pigs that did not die prior to study termination were euthanized on day 14 post inoculation. Postmortem samples of the lung, heart, liver, kidney, spleen, left tarsal joint capsule and brain were collected. All but one pig with detectable histopathologic lesions (n = 11) showed typical macroscopic changes. Histopathologic examination of all tissue samples identified pyelitis (n = 10), synovitis (n = 7) and meningitis (n = 7) and all those animals were euthanized prior to study termination. No histopathologic lesions were found in pigs of the control group. The correlations between pyelitis and meningitis, pyelitis and synovitis and synovitis and meningitis were significant (p < 0.001). No significant correlation could be observed between the histopathologic and the clinical examination of the joints. The investigation of samples from the joints by PCR was not significantly correlated with the observed synovitis. The clinical observation of neurologic signs was significantly correlated with meningitis (p = 0.03). A significant correlation (p < 0.001) could be detected between meningitis and the detection of H. parasuis by PCR in brain samples. H. parasuis constantly causes clinical signs and pathologic lesions as soon as it infects the brain while it can infect the joints without causing histopathologic lesions. Pigs with histopathologic lesions do not always show typical clinical signs. Only few studies described the finding of kidney lesions in pigs with Glässer's disease and this is the first study to describe a pyelitis in pigs experimentally infected with H. parasuis. The observed pyelitis mainly occurred in acute cases.

Efficacy and Safety of Tacrolimus Therapy for Active Ulcerative Colitis; A Systematic Review and Meta-analysis.

PubMed

Komaki, Yuga; Komaki, Fukiko; Ido, Akio; Sakuraba, Atsushi

2016-04-01

Approximately 25% of patients with ulcerative colitis [UC] experience a severe flare requiring steroid therapy to avoid colectomy. We performed a systematic review and meta-analysis to assess the efficacy of tacrolimus as a rescue therapy for active UC. Electronic databases were searched for relevant studies assessing the efficacy of tacrolimus for active UC. Outcomes included short- and long-term clinical response, colectomy free rates, and rate of adverse events in randomised controlled trials [RCTs] and observational studies. Two RCTs comparing high trough concentration [10-15ng/ml] versus placebo [n = 103] and 23 observational studies [n = 831] were identified. Clinical response at 2 weeks was significantly higher with tacrolimus compared with placebo (risk ratio [RR] = 4.61, 95% confidence interval [CI] = 2.09-10.17, p = 0.15 x 10(-3)] among RCTs. Rates of clinical response at 1 and 3 months were 0.73 [95% CI = 0.64-0.81] and 0.76 [95% CI = 0.59-0.87], and colectomy-free rates remained high at 1, 3, 6, and 12 months [0.86, 0.84, 0.78, and 0.69, respectively] among observational studies. Among RCTs, adverse events were more frequent compared with placebo [RR = 2.01, 95% CI = 1.20-3.37, p = 0.83 x 10(-2)], but there was no difference in severe adverse events [RR = 3.15, 95% CI = 0.14-72.9, p = 0.47]. Severe adverse events were rare among observational studies [0.11, 95% CI = 0.06-0.20]. In the present meta-analysis, tacrolimus was associated with high clinical response and colectomy-free rates without increased risk of severe adverse events for active UC. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Future enhanced clinical role of pharmacists in Emergency Departments in England: multi-site observational evaluation.

PubMed

Hughes, Elizabeth; Terry, David; Huynh, Chi; Petridis, Konstantinos; Aiello, Matthew; Mazard, Louis; Ubhi, Hirminder; Terry, Alex; Wilson, Keith; Sinclair, Anthony

2017-08-01

Background There are concerns about maintaining appropriate clinical staffing levels in Emergency Departments. Pharmacists may be one possible solution. Objective To determine if Emergency Department attendees could be clinically managed by pharmacists with or without advanced clinical practice training. Setting Prospective 49 site cross-sectional observational study of patients attending Emergency Departments in England. Method Pharmacist data collectors identified patient attendance at their Emergency Department, recorded anonymized details of 400 cases and categorized each into one of four possible options: cases which could be managed by a community pharmacist; could be managed by a hospital pharmacist independent prescriber; could be managed by a hospital pharmacist independent prescriber with additional clinical training; or medical team only (unsuitable for pharmacists to manage). Impact indices sensitive to both workload and proportion of pharmacist manageable cases were calculated for each clinical group. Main outcome measure Proportion of cases which could be managed by a pharmacist. Results 18,613 cases were observed from 49 sites. 726 (3.9%) of cases were judged suitable for clinical management by community pharmacists, 719 (3.9%) by pharmacist prescribers, 5202 (27.9%) by pharmacist prescribers with further training, and 11,966 (64.3%) for medical team only. Impact Indices of the most frequent clinical groupings were general medicine (13.18) and orthopaedics (9.69). Conclusion The proportion of Emergency Department cases that could potentially be managed by a pharmacist was 36%. Greatest potential for pharmacist management was in general medicine and orthopaedics (usually minor trauma). Findings support the case for extending the clinical role of pharmacists.

Prospective evaluation of the clinical utility of laryngeal electromyography.

PubMed

Ingle, John W; Young, VyVy N; Smith, Libby J; Munin, Micheal C; Rosen, Clark A

2014-12-01

To prospectively evaluate the clinical utility of laryngeal electromyography (LEMG) STUDY DESIGN: Prospective observational study. The study involved 50 consecutive patients referred for LEMG. Laryngologists initially indicated diagnoses and treatment plans under the assumption of no access to LEMG. Patients then underwent LEMG by blinded examiners. LEMG results were reviewed by each patient's laryngologist. Diagnoses and treatment plans were either maintained or altered based on the LEMG results. The diagnosis changed 10% (5/50) of the time and treatment plans were altered 36% (18/50) of the time based on information provided by LEMG. Observational periods were eliminated in 13/50 patients based on LEMG, moving them to permanent treatment. LEMG allowed the differentiation between joint fixation and bilateral paralysis in three patients. Previously unrecognized superior laryngeal neuropathies were identified in three patients. Laryngeal electromyography often provides clinically useful information that typically leads to a more accurate diagnosis and a more appropriate, expedited treatment plan. 2b. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Protocol evaluation for effective music therapy for persons with nonfluent aphasia.

PubMed

Kim, Mijin; Tomaino, Concetta M

2008-01-01

Although the notion of the language specificity of neural correlates has been widely accepted in the past (e.g., lefthemispheric dominance including Broca's and Wernike's area, N400 ERP component of semantic processing, and the P600 ERP component of syntactic processing, etc.), recent studies have shown that music and language share some important neurological aspects in their processing, both involving bilateral hemispheric activities. In line with this are the frequent behavioral clinical observations that persons with aphasia show improved articulation and prosody of speech in musically assisted phrases. Connecting recent neurological findings with clinical observations would not only inform clinical practice but would enhance understanding of the neurological mechanisms involved in the processing of speech/language and music. This article presents a music therapy treatment protocol study of 7 nonfluent patients with aphasia. The data and findings are discussed with regard to some of the recent focuses and issues addressed in the experimental studies using cognitive-behavioral, electrophysiological, and brain-imaging techniques.

Serotonergic Psychedelics: Experimental Approaches for Assessing Mechanisms of Action.

PubMed

Canal, Clinton E

2018-03-13

Recent, well-controlled - albeit small-scale - clinical trials show that serotonergic psychedelics, including psilocybin and lysergic acid diethylamide, possess great promise for treating psychiatric disorders, including treatment-resistant depression. Additionally, fresh results from a deluge of clinical neuroimaging studies are unveiling the dynamic effects of serotonergic psychedelics on functional activity within, and connectivity across, discrete neural systems. These observations have led to testable hypotheses regarding neural processing mechanisms that contribute to psychedelic effects and therapeutic benefits. Despite these advances and a plethora of preclinical and clinical observations supporting a central role for brain serotonin 5-HT 2A receptors in producing serotonergic psychedelic effects, lingering and new questions about mechanisms abound. These chiefly pertain to molecular neuropharmacology. This chapter is devoted to illuminating and discussing such questions in the context of preclinical experimental approaches for studying mechanisms of action of serotonergic psychedelics, classic and new.

The impact of clinical trial design on cost-effectiveness analyses: illustration from a published study of the one-touch ultrasmart blood glucose meter for insulin-using diabetes patients.

PubMed

Tunis, Sandra L; Minshall, Michael E

2008-06-01

One source of variation in cost-effectiveness analyses stems from the characteristics of the study upon which each is based. This report provides cost-effectiveness analyses using data from a recently published randomized clinical trial (RCT) comparing an integrated glucose meter/electronic logbook to a conventional glucose meter/paper logbook in helping to control hemoglobin A1c in type 1 or type 2 diabetes. RCT participants and health care professionals (HCPs) were "blinded" to results of meter downloads until week 16, when participants chose systems. They returned to "usual care" and could obtain meter results and share them with their HCPs. Those eligible returned 26-65 weeks later for an observational visit. The CORE Diabetes Model was used to estimate the 60-year cost-effectiveness of the electronic (vs. conventional) meter. With no price premium, the newer technology represented a dominant strategy (greater effectiveness/lower costs) based on the RCT alone or on the RCT + observational visit. With a $100.00/year premium, the incremental cost-effectiveness ratio was $28,053 based on the RCT, but the electronic monitor was dominant when simulations included observational visit results. One plausible reason for the greater benefits of the electronic monitor with the observational period included was the ability of patients and HCPs to make better clinical and lifestyle modifications based on fully available, formatted data. Because the advantages of the electronic meter are based on timely access to accurate feedback, the importance of naturalistic, unblinded studies for technology assessments can be appreciated. Addressing the methodological issues discussed here can help integrate clinical and economic outcomes for diabetes care innovations.

First application of dynamic infrared imaging in boron neutron capture therapy for cutaneous malignant melanoma

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

Santa Cruz, G. A.; Gonzalez, S. J.; Bertotti, J.

2009-10-15

Purpose: The purpose of this study is to assess the potential of dynamic infrared imaging (DIRI) as a functional, noninvasive technique for evaluating the skin acute toxicity and tumor control within the framework of the Argentine boron neutron capture therapy (BNCT) program for cutaneous malignant melanoma. Methods: Two patients enrolled in the Argentine phase I/II BNCT clinical trial for cutaneous malignant melanoma were studied with DIRI. An uncooled infrared camera, providing a video output signal, was employed to register the temperature evolution of the normal skin and tumor regions in patients subjected to a mild local cooling (cold stimulus). Inmore » order to study the spatial correlation between dose and acute skin reactions, three-dimensional representations of the superficial dose delivered to skin were constructed and cameralike projections of the dose distribution were coregistered with visible and infrared images. Results: The main erythematous reaction was observed clinically between the second and fifth week post-BNCT. Concurrently, with its clinical onset, a reactive increase above the basal skin temperature was observed with DIRI in the third week post-BNCT within regions that received therapeutic doses. Melanoma nodules appeared as highly localized hyperthermic regions. 2 min after stimulus, these regions reached a temperature plateau and increased in size. Temperature differences with respect to normal skin up to 10 deg. C were observed in the larger nodules. Conclusions: Preliminary results suggest that DIRI, enhanced by the application of cold stimuli, may provide useful functional information associated with the metabolism and vasculature of tumors and inflammatory processes related to radiation-induced changes in the skin as well. These capabilities are aimed at complementing the clinical observations and standard imaging techniques, such as CT and Doppler ultrasound.« less

Prepubertal and postpubertal vitiligo: a multivariate comparative study in 375 patients.

PubMed

Khurrum, Huma; AlGhamdi, Khalid M

2017-01-01

The onset of vitiligo during childhood is common. Limited data exist that compare the clinical associations of prepubertal and postpubertal vitiligo in Arabs. To compare the clinical profile of pre and postpubertal onset vitiligo. A cross-sectional observational study was conducted. The Vitiligo European Task Force questionnaire was completed for each patient. A total of 375 patients were included; 199 had postpubertal vitiligo (>12 years), and 176 had prepubertal onset vitiligo (<12years). There were more females in the prepubertal group (49%) than in the postpubertal group (29%), p-value <0.001. The prepubertal group has had more involvement than the postpubertal group (45% vs 30%, p=0.004). Only 8 cases of segmental vitiligo were observed; five were observed in the prepubertal group of patients. Female gender (OR=2.3; 95% CI:1.5, 3.5), presence of halo nevus (OR=2.2; 95% CI:1.1, 4.4) and face involvement (OR=1.9; 95% CI:1.2, 2.9) were positively associated with prepubertal vitiligo. Stress, as an onset factor, was positively associated (OR=0.51; 95% CI:0.3, 0.8) with postpubertal onset vitiligo. A possible selection bias toward more severe vitiligo cases can be a limitation, because the study was conducted in a clinic specialized in vitiligo. Moreover, a likelihood of false recall bias cannot be excluded. Our data present clinical evidence that vitiligo behaves mostly the same way in the prepubertal group as in the postpubertal group. However, female over-representation, more face involvement and more halo nevi were observed in prepubertal vitiligo, while stress was more prevalent as an aggravating factor in postpubertal vitiligo patients.

North vs south differences in acute peptic ulcer hemorrhage in Croatia: hospitalization incidence trends, clinical features, and 30-day case fatality

PubMed Central

Ljubičić, Neven; Pavić, Tajana; Budimir, Ivan; Puljiz, Željko; Bišćanin, Alen; Bratanić, Andre; Nikolić, Marko; Hrabar, Davor; Troskot, Branko

2014-01-01

Aim To assess the seven-year trends of hospitalization incidence due to acute peptic ulcer hemorrhage (APUH) and associated risk factors, and examine the differences in these trends between two regions in Croatia. Methods The study collected sociodemographic, clinical, and endoscopic data on 2204 patients with endoscopically confirmed APUH who were admitted to the Clinical Hospital Center “Sestre Milosrdnice,” Zagreb and Clinical Hospital Center Split between January 1, 2005 and December 31, 2011. We determined hospitalization incidence rates, 30-day case fatality rate, clinical outcomes, and incidence-associated factors. Results No differences were observed in APUH hospitalization incidence rates between the regions. Age-standardized one-year cumulative APUH hospitalization incidence rate calculated using the European Standard Population was significantly higher in Zagreb than in Split region (43.2/100 000 vs 29.2/100,000). A significantly higher APUH hospitalization incidence rates were observed in the above 65 years age group. Overall 30-day case fatality rate was 4.9%. Conclusion The hospitalization incidence of APUH in two populations did not change over the observational period and it was significantly higher in the Zagreb region. The incidence of acute duodenal ulcer hemorrhage also remained unchanged, whereas the incidence of acute gastric ulcer hemorrhage increased. The results of this study allow us to monitor epidemiological indicators of APUH and compare data with other countries. PMID:25559836

Inhalational botulism in rhesus macaques exposed to botulinum neurotoxin complex serotypes A1 and B1.

PubMed

Sanford, Daniel C; Barnewall, Roy E; Vassar, Michelle L; Niemuth, Nancy; Metcalfe, Karen; House, Robert V; Henderson, Ian; Shearer, Jeffry D

2010-09-01

A recombinant botulinum vaccine (rBV A/B) is being developed for protection against inhalational intoxication with botulinum neurotoxin (BoNT) complex serotype A, subtype A1 (BoNT/A1), and BoNT serotype B, subtype B1 (BoNT/B1). A critical component for evaluating rBV A/B efficacy will be the use of animal models in which the pathophysiology and dose-response relationships following aerosol exposure to well-characterized BoNT are thoroughly understood and documented. This study was designed to estimate inhaled 50% lethal doses (LD(50)) and to estimate 50% lethal exposure concentrations relative to time (LCt(50)) in rhesus macaques exposed to well-characterized BoNT/A1 and BoNT/B1. During the course of this study, clinical observations, body weights, clinical hematology results, clinical chemistry results, circulating neurotoxin levels, and telemetric parameters were documented to aid in the understanding of disease progression. The inhaled LD(50) and LCt(50) for BoNT/A1 and BoNT/B1 in rhesus macaques were determined using well-characterized challenge material. Clinical observations were consistent with the recognized pattern of botulism disease progression. A dose response was demonstrated with regard to the onset of these clinical signs for both BoNT/A1 and BoNT/B1. Dose-related changes in physiologic parameters measured by telemetry were also observed. In contrast, notable changes in body weight, hematology, and clinical chemistry parameters were not observed. Circulating levels of BoNT/B1 were detected in animals exposed to the highest levels of BoNT/B1; however, BoNT/A1 was not detected in the circulation at any aerosol exposure level. The rhesus macaque aerosol challenge model will be used for future evaluations of rBV A/B efficacy against inhalational BoNT/A1 and BoNT/B1 intoxication.

Inhalational Botulism in Rhesus Macaques Exposed to Botulinum Neurotoxin Complex Serotypes A1 and B1▿ †

PubMed Central

Sanford, Daniel C.; Barnewall, Roy E.; Vassar, Michelle L.; Niemuth, Nancy; Metcalfe, Karen; House, Robert V.; Henderson, Ian; Shearer, Jeffry D.

2010-01-01

A recombinant botulinum vaccine (rBV A/B) is being developed for protection against inhalational intoxication with botulinum neurotoxin (BoNT) complex serotype A, subtype A1 (BoNT/A1), and BoNT serotype B, subtype B1 (BoNT/B1). A critical component for evaluating rBV A/B efficacy will be the use of animal models in which the pathophysiology and dose-response relationships following aerosol exposure to well-characterized BoNT are thoroughly understood and documented. This study was designed to estimate inhaled 50% lethal doses (LD50) and to estimate 50% lethal exposure concentrations relative to time (LCt50) in rhesus macaques exposed to well-characterized BoNT/A1 and BoNT/B1. During the course of this study, clinical observations, body weights, clinical hematology results, clinical chemistry results, circulating neurotoxin levels, and telemetric parameters were documented to aid in the understanding of disease progression. The inhaled LD50 and LCt50 for BoNT/A1 and BoNT/B1 in rhesus macaques were determined using well-characterized challenge material. Clinical observations were consistent with the recognized pattern of botulism disease progression. A dose response was demonstrated with regard to the onset of these clinical signs for both BoNT/A1 and BoNT/B1. Dose-related changes in physiologic parameters measured by telemetry were also observed. In contrast, notable changes in body weight, hematology, and clinical chemistry parameters were not observed. Circulating levels of BoNT/B1 were detected in animals exposed to the highest levels of BoNT/B1; however, BoNT/A1 was not detected in the circulation at any aerosol exposure level. The rhesus macaque aerosol challenge model will be used for future evaluations of rBV A/B efficacy against inhalational BoNT/A1 and BoNT/B1 intoxication. PMID:20660138

Media Coverage of Medical Journals: Do the Best Articles Make the News?

PubMed Central

Selvaraj, Senthil; Borkar, Durga S.; Prasad, Vinay

2014-01-01

Background News coverage of medical research is followed closely by many Americans and affects the practice of medicine and influence of scientific research. Prior work has examined the quality of media coverage, but no investigation has characterized the choice of stories covered in a controlled manner. We examined whether the media systematically covers stories of weaker study design. Methods We compared study characteristics of 75 clinically-oriented journal articles that received coverage in the top five newspapers by circulation against 75 clinically-oriented journal articles that appeared in the top five medical journals by impact factor over a similar timespan. Subgroup analysis was performed to determine whether differences between investigations from both sources varied by study type (randomized controlled trial [RCT] or observational study). Results Investigations receiving coverage from newspapers were less likely to be RCTs (17% vs. 35%, p = 0.016) and more likely to be observational studies (75% vs. 47%, p<0.001). No difference was observed in number of people studied (median: 1034 vs. 1901, p = 0.14) or length of follow-up (median: 1.80 vs. 1.00 years, p = 0.22). In subgroup analysis, observational studies from the media used smaller sample sizes (median: 1984 vs. 21136, p = 0.029) and were more likely to be cross-sectional (71% vs. 31%, p<0.001), while no differences were observed for RCTs. Conclusions Newspapers were more likely to cover observational studies and less likely to cover RCTs than high impact journals. Additionally, when the media does cover observational studies, they select articles of inferior quality. Newspapers preferentially cover medical research with weaker methodology. PMID:24465543

Observational Study Designs for Comparative Effectiveness Research: An Alternative Approach to Close Evidence Gaps in Head-and-Neck Cancer

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

Goulart, Bernardo H.L., E-mail: bhg@uw.edu; University of Washington, Seattle, Washington; Ramsey, Scott D.

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H and N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H and N RCTs, which limits the validity of their results to the broader H and N cancer patient population seenmore » in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H and N cancer, including treatment comparisons for rare types of H and N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H and N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H and N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design.« less

Observational study designs for comparative effectiveness research: an alternative approach to close evidence gaps in head-and-neck cancer.

PubMed

Goulart, Bernardo H L; Ramsey, Scott D; Parvathaneni, Upendra

2014-01-01

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H&N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H&N RCTs, which limits the validity of their results to the broader H&N cancer patient population seen in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H&N cancer, including treatment comparisons for rare types of H&N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H&N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H&N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design. Copyright © 2014 Elsevier Inc. All rights reserved.

[Evaluation of initial results of treatment of lead poisoning with EDTA].

PubMed

Petkova, V; Adjarov, D; Pavlova, S; Naydenova, E; Kerimova, M; Kuneva, T

1994-01-01

The results of EDTA therapy were studied in 37 workers of a battery factory consisting of males with varying degrees of occupational lead poisoning (low exposure: 10 subjects, blood lead levels (PbB) lower than 400 micrograms/l with slight alterations in heme biosynthesis; beyond limit of effect: 5 subjects, PbB > 400 micrograms/l; slight intoxication: 19 subjects, with marked alterations in heme synthesis and preclinical signs of intoxication; average degree of intoxication: 3 subjects with clinical signs of intoxication. Clinical symptoms and the following parameters were investigated: blood lead (PbB), delta-aminolevulinic acid dehydratase in erythrocytes (ALA-D), zinc protoporphyrin (PP) in erythrocytes and delta-aminolevulinic acid (ALA) in 24-hour urine before and after EDTA chelating therapy. Simultaneous measurement of ALA-D and PP showed high diagnostic sensitivity in detecting lead poisoning in occupationally exposed subjects. In view of the high interindividual variability of the results, these indices did not, however, permit a useful differentiation to be made of the different degrees of intoxication at individual level, even though a good correlation was observed between PbB and porphyrin metabolism indices. From the alterations observed in ALA-D and PP values it was not possible to establish an association between degree of alteration and types of clinical symptoms in the different intoxication studies. At the end of EDTA treatment, a clinical improvement was observed in all cases studied but only in 5 cases was a reduction in PbB observed, to levels below 1.20 mol/l, which is accepted as a permissible limit for the general population; in 17 cases PbB remained at levels above the critical value for occupational lead poisoning (400 micrograms/l), although there was a decrease after treatment. The improvement observed in the indices of porphyrin metabolism at the end of treatment was only slight: significant variations were measured only for PbB. After treatment no association was observed between ALA-D and PP variations in erythrocytes and improvement in clinical symptoms; measurement of these indices therefore seems to be of little use in assessing the efficacy of the treatment. In spite of its limited diagnostic sensitivity during intoxication, measurement of ALA in urine could be useful to assess the efficacy of chelating therapy in subjects in whom the values are initially altered.

A randomized, double-blind, placebo-controlled trial of a Chinese herbal Sophora flower formula in patients with symptomatic haemorrhoids: a preliminary study.

PubMed

Man, Kee-Ming; Chen, Wen-Chi; Wang, Hwei-Ming; Chen, Huey-Yi; Shen, Jui-Lung; Chen, Lieh-Der; Tsai, Fuu-Jen; Chen, Yung-Hsiang; Yu, De-Xin; Chiang, Feng-Fan

2013-01-01

Dried flowers and buds of Sophora japonica (Huaihua) are used in China, Japan and Korea for treating haematemesis and bleeding haemorrhoids. This study compared the clinical safety and efficacy of a Sophora flower formula with a placebo for the conservative treatment of symptomatic haemorrhoids. The study was a prospective, double-blind, randomized placebo-controlled trial. The clinical effective rate, symptom score and the incidence of important clinical events were used as observation indices to evaluate the effect of the Sophora flower formula. The results showed that after 7 days of treatment, improvement was observed in 87.0% of the patients' major symptoms in the Sophora flower formula group compared with 81.8% of those in the placebo group. After 14 days, 78.2% patients in the Sophora flower formula group were asymptomatic, whereas 40.9% of those in the placebo group exhibited residual symptoms. However, the difference between both groups was not statistically significant. As the bowel habits of the patients improved and as the patients took sitz baths, their symptoms improved drastically, regardless of the use of the Sophora flower formula. These findings indicate that the traditional Chinese Sophora flower formula is clinically safe; however, its effects on haemorrhoids need to be studied in a larger sample size and with different dosages. The present study results may be a potential clinical reference for physicians prescribing medications for patients with symptomatic haemorrhoids.

The mid-term outcome of total ankle arthroplasty and ankle fusion in rheumatoid arthritis: a systematic review.

PubMed

van Heiningen, Jacqueline; Vliet Vlieland, Thea P M; van der Heide, Huub J L

2013-10-26

While arthrodesis is the standard treatment of a severely arthritic ankle joint, total ankle arthroplasty has become a popular alternative. This review provides clinical outcomes and complications of both interventions in patients with rheumatoid arthritis. Studies were obtained from Pubmed, Embase and Web of Science (January 1980-June 2011) and additional manual search. original clinical study, > 5 rheumatoid arthritis (population), internal fixation arthrodesis or three-component mobile bearing prosthesis (intervention), ankle scoring system (outcome). The clinical outcome score, complication- and failure rates were extracted and the methodological quality of the studies was analysed. 17 observational studies of 868 citations were included. The effect size concerning total ankle arthroplasty ranged between 1.9 and 6.0, for arthrodesis the effect sizes were 4.0 and 4.7. Reoperation due to implant failure or reoperation due to non-union, was 11% and 12% for respectively total ankle arthroplasty and arthrodesis. The methodological quality of the studies was low (mean 6.4 out of a maximum of 14 points) and was lower for arthrodesis (mean 4.8) as compared to arthroplasty (mean 7.8) (p = 0.04). 17 observational and no (randomized) controlled clinical trials are published on the effectiveness of arthroplasty or arthrodesis of the ankle in rheumatoid arthritis. Regardless of the methodological limitations it can be concluded that both interventions show clinical improvement and in line with current literature neither procedure is superior to the other.

Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study.

PubMed

Pranal, Thibaut; Pereira, Bruno; Berthelin, Pauline; Roszyk, Laurence; Godet, Thomas; Chabanne, Russell; Eisenmann, Nathanael; Lautrette, Alexandre; Belville, Corinne; Blondonnet, Raiko; Cayot, Sophie; Gillart, Thierry; Skrzypczak, Yvan; Souweine, Bertrand; Bouvier, Damien; Blanchon, Loic; Sapin, Vincent; Constantin, Jean-Michel; Jabaudon, Matthieu

2018-01-01

Although soluble forms of the receptor for advanced glycation end products (RAGE) have been recently proposed as biomarkers in multiple acute or chronic diseases, few studies evaluated the influence of usual clinical and biological parameters, or of patient characteristics and comorbidities, on circulating levels of soluble RAGE in the intensive care unit (ICU) setting. To determine, among clinical and biological parameters that are usually recorded upon ICU admission, which variables, if any, could be associated with plasma levels of soluble RAGE. Data for this ancillary study were prospectively obtained from adult patients with at least one ARDS risk factor upon ICU admission enrolled in a large multicenter observational study. At ICU admission, plasma levels of total soluble RAGE (sRAGE) and endogenous secretory (es)RAGE were measured by duplicate ELISA and baseline patient characteristics, comorbidities, and usual clinical and biological indices were recorded. After univariate analyses, significant variables were used in multivariate, multidimensional analyses. 294 patients were included in this ancillary study, among whom 62% were admitted for medical reasons, including septic shock (11%), coma (11%), and pneumonia (6%). Although some variables were associated with plasma levels of RAGE soluble forms in univariate analysis, multidimensional analyses showed no significant association between admission parameters and baseline plasma sRAGE or esRAGE. We found no obvious association between circulating levels of soluble RAGE and clinical and biological indices that are usually recorded upon ICU admission. This trial is registered with NCT02070536.

Study of the Socratic method during cognitive restructuring.

PubMed

Froján-Parga, María Xesús; Calero-Elvira, Ana; Montaño-Fidalgo, Montserrat

2011-01-01

Cognitive restructuring, in particular in the form of the Socratic method, is widely used by clinicians. However, little research has been published with respect to underlying processes, which has hindered well-accepted explanations of its effectiveness. The aim of this study is to present a new method of analysis of the Socratic method during cognitive restructuring based on the observation of the therapist's verbal behaviour. Using recordings from clinical sessions, 18 sequences were selected in which the Socratic method was applied by six cognitive-behavioural therapists working at a private clinical centre in Madrid. The recordings involved eight patients requiring therapy for various psychological problems. Observations were coded using a category system designed by the authors and that classifies the therapist's verbal behaviour into seven hypothesized functions based on basic behavioural operations. We used the Observer XT software to code the observed sequences. The results are summarized through a preliminary model which considers three different phases of the Socratic method and some functions of the therapist's verbal behaviour in each of these phases: discriminative and reinforcement functions in the starting phase, informative and motivational functions in the course of the debate, and instructional and reinforcement functions in the final phase. We discuss the long-term potential clinical benefits of the current proposal.  Copyright © 2010 John Wiley & Sons, Ltd.

Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

PubMed

Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

2015-01-01

Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. © 2014 Wiley Periodicals, Inc.

Occurrence, clinical features and outcome of canine pancreatitis (80 cases).

PubMed

Pápa, Kinga; Máthé, Akos; Abonyi-Tóth, Zsolt; Sterczer, Agnes; Psáder, Roland; Hetyey, Csaba; Vajdovich, Péter; Vörös, Károly

2011-03-01

Medical records of 80 dogs diagnosed with acute pancreatitis during a 4-year period were evaluated regarding history, breed predilection, clinical signs and additional examination findings. Cases were selected if compatible clinical symptoms, increased serum activity of amylase or lipase and morphologic evidence of pancreatitis by ultrasonography, laparotomy or necropsy were all present. Like in other studies, neutered dogs had an increased risk of developing acute pancreatitis. Although breed predilection was consistent with earlier reports, some notable differences were also observed. Apart from Dachshunds, Poodles, Cocker Spaniels and Fox Terriers, the sled dogs (Laikas, Alaskan Malamutes) also demonstrated a higher risk for pancreatitis according to our results. Concurrent diseases occurred in 56 dogs (70%), diabetes mellitus (n = 29, 36%) being the most common. Clinical signs of acute pancreatitis were similar to those observed in other studies. The study group represented a dog population with severe acute pancreatitis, having a relatively high mortality rate (40%) compared to data of the literature. Breed, age, gender, neutering and body condition had no significant association with the outcome. Hypothermia (p = 0.0413) and metabolic acidosis (p = 0.0063) correlated significantly with poor prognosis and may serve as valuable markers for severity assessment in canine acute pancreatitis.

Mixed messages in learning communication skills? Students comparing role model behaviour in clerkships with formal training.

PubMed

Essers, Geurt; Van Weel-Baumgarten, Evelyn; Bolhuis, Sanneke

2012-01-01

Medical students learn professional communication through formal training and in clinical practice. Physicians working in clinical practice have a powerful influence on student learning. However, they may demonstrate communication behaviours not aligning with recommendations in training programs. This study aims to identify more precisely what differences students perceive between role model communication behaviour during clerkships and formal training. In a cross-sectional study, data were collected about physicians' communication performance as perceived by students. Students filled out a questionnaire in four different clerkships in their fourth and fifth year. Just over half of the students reported communication similar to formal training. This was especially true for students in the later clerkships (paediatrics and primary care). Good examples were seen in providing information corresponding to patients' needs and in shared decision making, although students often noted that in fact the doctor made the decision. Bad examples were observed in exploring cognitions and emotions, and in providing information meeting patient's pace. Further study is needed on actual physician behaviour in clinical practice. From our results, we conclude that students need help in reflecting on and learning from the gap in communication patterns they observe in training versus clinical practice.

Development and validation of self-reported line drawings of the modified Beighton score for the assessment of generalised joint hypermobility.

PubMed

Cooper, Dale J; Scammell, Brigitte E; Batt, Mark E; Palmer, Debbie

2018-01-17

The impracticalities and comparative expense of carrying out a clinical assessment is an obstacle in many large epidemiological studies. The purpose of this study was to develop and validate a series of electronic self-reported line drawing instruments based on the modified Beighton scoring system for the assessment of self-reported generalised joint hypermobility. Five sets of line drawings were created to depict the 9-point Beighton score criteria. Each instrument consisted of an explanatory question whereby participants were asked to select the line drawing which best represented their joints. Fifty participants completed the self-report online instrument on two occasions, before attending a clinical assessment. A blinded expert clinical observer then assessed participants' on two occasions, using a standardised goniometry measurement protocol. Validity of the instrument was assessed by participant-observer agreement and reliability by participant repeatability and observer repeatability using unweighted Cohen's kappa (k). Validity and reliability were assessed for each item in the self-reported instrument separately, and for the sum of the total scores. An aggregate score for generalised joint hypermobility was determined based on a Beighton score of 4 or more out of 9. Observer-repeatability between the two clinical assessments demonstrated perfect agreement (k 1.00; 95% CI 1.00, 1.00). Self-reported participant-repeatability was lower but it was still excellent (k 0.91; 95% CI 0.74, 1.00). The participant-observer agreement was excellent (k 0.96; 95% CI 0.87, 1.00). Validity was excellent for the self-report instrument, with a good sensitivity of 0.87 (95% CI 0.81, 0.91) and excellent specificity of 0.99 (95% CI 0.98, 1.00). The self-reported instrument provides a valid and reliable assessment of the presence of generalised joint hypermobility and may have practical use in epidemiological studies.

Assessment of low-contrast detectability for compressed digital chest images

NASA Astrophysics Data System (ADS)

Cook, Larry T.; Insana, Michael F.; McFadden, Michael A.; Hall, Timothy J.; Cox, Glendon G.

1994-04-01

The ability of human observers to detect low-contrast targets in screen-film (SF) images, computed radiographic (CR) images, and compressed CR images was measured using contrast detail (CD) analysis. The results of these studies were used to design a two- alternative forced-choice (2AFC) experiment to investigate the detectability of nodules in adult chest radiographs. CD curves for a common screen-film system were compared with CR images compressed up to 125:1. Data from clinical chest exams were used to define a CD region of clinical interest that sufficiently challenged the observer. From that data, simulated lesions were introduced into 100 normal CR chest films, and forced-choice observer performance studies were performed. CR images were compressed using a full-frame discrete cosine transform (FDCT) technique, where the 2D Fourier space was divided into four areas of different quantization depending on the cumulative power spectrum (energy) of each image. The characteristic curve of the CR images was adjusted so that optical densities matched those of the SF system. The CD curves for SF and uncompressed CR systems were statistically equivalent. The slope of the CD curve for each was - 1.0 as predicted by the Rose model. There was a significant degradation in detection found for CR images compressed to 125:1. Furthermore, contrast-detail analysis demonstrated that many pulmonary nodules encountered in clinical practice are significantly above the average observer threshold for detection. We designed a 2AFC observer study using simulated 1-cm lesions introduced into normal CR chest radiographs. Detectability was reduced for all compressed CR radiographs.

The role of peer-assisted learning in building evaluative judgement: opportunities in clinical medical education.

PubMed

Tai, Joanna Hong-Meng; Canny, Benedict J; Haines, Terry P; Molloy, Elizabeth K

2016-08-01

This study explored the contribution of peer-assisted learning (PAL) in the development of evaluative judgement capacity; the ability to understand work quality and apply those standards to appraising performance. The study employed a mixed methods approach, collecting self-reported survey data, observations of, and reflective interviews with, the medical students observed. Participants were in their first year of clinical placements. Data were thematically analysed. Students indicated that PAL contributed to both the comprehension of notions of quality, and the practice of making comparisons between a given performance and the standards. Emergent themes included peer story-telling, direct observation of performance, and peer-based feedback, all of which helped students to define 'work quality'. By participating in PAL, students were required to make comparisons, therefore using the standards of practice and gaining a deeper understanding of them. The data revealed tensions in that peers were seen as less threatening than supervisors with the advantage of increasing learners' appetites for thoughtful 'intellectual risk taking'. Despite this reported advantage of peer engagement, learners still expressed a preference for feedback from senior teachers as more trusted sources of clinical knowledge. While this study suggests that PAL already contributes to the development of evaluative judgement, further steps could be taken to formalise PAL in clinical placements to improve learners' capacity to make accurate judgements on the performance of self and others. Further experimental studies are necessary to confirm the best methods of using PAL to develop evaluative judgement. This may include both students and educators as instigators of PAL in the workplace.

Associations between the incidence of antiphosphatidylserine and antiphosphatidylethanolamine antibodies and clinical manifestations of systemic lupus erythematosus.

PubMed

Butkiewicz, Filip; Kaszuba, Michał; Brzeziński, Michał; Iżbicki, Jan; Kubiś, Marek; Lopiński, Hubert; Borowiak, Michał; Szelepajło, Michał; Fischer, Katarzyna; Fliciński, Jacek

2014-01-01

Antiphosphatidylethanolamine antibodies (aPE) and antiphosphatidylserine antibodies (aPS) belong to a group of antiphospholipid antibodies (aPL) that occur in patients with antiphospholipid syndrome (APS) and systemic lupus erythematosus (SLE). The aim of this study was to examine associations between the elevated serum concentration of aPE/aPS, the clinical manifestations of SLE, and the presence of other autoantibodies. The study group included 71 patients with SLE. The control group comprised 36 healthy volunteers. In both groups, serum aPS and aPE concentrations were measured with enzyme‑linked immunosorbent assays. Clinical data, including clinical manifestations and the laboratory markers of SLE, were obtained from medical records. The study revealed a higher prevalence of aPE in patients with SLE than in controls (54.93% vs. 5.56%). aPS were observed in the study group less frequently compared with aPE (12.68% vs. 54.93%) and were absent in controls. Anticardiolipin antibodies and APS were found to be associated with the presence of aPS. Thrombocytopenia, Raynaud phenomenon, and myocardial infarction were observed more frequently among aPS‑positive patients. The presence of aPE was also associated with the occurrence of mucosal ulcers in the mouth cavity. A positive correlation between aPS and erythrocyte sedimentation rate (ESR) was also observed. The serum concentration of aPE inversely correlated with red blood cell count and positively with ESR. The presence of aPS in patients with SLE is associated with thrombocytopenia, Raynaud phenomenon, and cardiac complications.

Development of a Model of Interprofessional Shared Clinical Decision Making in the ICU: A Mixed-Methods Study.

PubMed

DeKeyser Ganz, Freda; Engelberg, Ruth; Torres, Nicole; Curtis, Jared Randall

2016-04-01

To develop a model to describe ICU interprofessional shared clinical decision making and the factors associated with its implementation. Ethnographic (observations and interviews) and survey designs. Three ICUs (two in Israel and one in the United States). A convenience sample of nurses and physicians. None. Observations and interviews were analyzed using ethnographic and grounded theory methodologies. Questionnaires included a demographic information sheet and the Jefferson Scale of Attitudes toward Physician-Nurse Collaboration. From observations and interviews, we developed a conceptual model of the process of shared clinical decision making that involves four stepped levels, proceeding from the lowest to the highest levels of collaboration: individual decision, information exchange, deliberation, and shared decision. This process is influenced by individual, dyadic, and system factors. Most decisions were made at the lower two levels. Levels of perceived collaboration were moderate with no statistically significant differences between physicians and nurses or between units. Both qualitative and quantitative data corroborated that physicians and nurses from all units were similarly and moderately satisfied with their level of collaboration and shared decision making. However, most ICU clinical decision making continues to take place independently, where there is some sharing of information but rarely are decisions made collectively. System factors, such as interdisciplinary rounds and unit culture, seem to have a strong impact on this process. This study provides a model for further study and improvement of interprofessional shared decision making.

Clinical performance of bonded ceramic inlays/onlays: A 5- to 18-year retrospective longitudinal study.

PubMed

Borgia Botto, Ernesto; Baró, Rosario; Borgia Botto, José Luis

2016-08-01

This retrospective longitudinal study evaluated the clinical performance of bonded ceramic inlays/onlays, placed by the first author in his private practice, in a 5 to 18-year period. The patients evaluated had been treated in the office for at least 7 years and were still in the practice up to year 2013. 130 randomly selected patients agreed to participate in the study. 93 bonded ceramic inlays/onlays (BCRs), were placed on posterior teeth in 47 subjects. Gender, age, tooth preparation, number, type, extent, location, quality and survival of the restorations, ceramic materials, luting resins cements, parafunctional habits, secondary caries and maintenance therapy were the variables evaluated. Cohen 's Kappa coefficient, on the quality analysis of the restorations, ranged from 0.78 to 1. Fisher 's exact test, Chi Square test, Kruskal-Wallis test and Mann-Whitney non-parametric test were indicated to analyze significant differences. At the initial examination, 87 (93.5%) restorations were in function and six failed (6.5%). 81 (93%) were rated as clinical successes. The observed mean survival time of those that remained functional was 11 years. The standard deviation was 4 years, with a 95% CI for the overall observed mean survival time (10 years-11 years, 9 months). 87 of 93 BCRs had a functional success of 93.5%, with an observed mean survival of 11 years. The clinical performance of bonded ceramic onlays was very acceptable. Bonded ceramic onlays showed a predictable, esthetic, and functional treatment, with acceptable longevity.

Brief strategic therapy for obsessive-compulsive disorder: a clinical and research protocol of a one-group observational study.

PubMed

Pietrabissa, Giada; Manzoni, Gian Mauro; Gibson, Padraic; Boardman, Donald; Gori, Alessio; Castelnuovo, Gianluca

2016-03-24

Obsessive-compulsive disorder (OCD) is a disabling psychopathology. The mainstay of treatment includes cognitive-behavioural therapy (CBT) and medication management. However, individual suffering, functional impairments as well as the direct and indirect costs associated with the disease remain substantial. New treatment programmes are necessary and the brief strategic therapy (BST) has recently shown encouraging results in clinical practice but no quantitative study has as yet been conducted. The clinical effectiveness of the OCD-specific BST protocol will be evaluated in a one-group observational study. Participants will be sequentially recruited from a state community psychotherapy clinic in Dublin, Ireland. Outcome measures will be the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Beck Depression Inventory-II (BDI-II). Data will be collected at baseline, at treatment termination and at 3 month follow-up. The statistical significance of the post-treatment effect will be assessed by the paired-sample Student t test, while clinical significance will be evaluated by means of the equivalence testing method, which will be also used to assess the maintenance of effect at follow-up. The present study is approved by the Hesed House Ethics Board in Dublin. Findings will enhance the evidence-based knowledge about the clinical effectiveness of BST in treating OCD symptoms, prior to assessing its efficacy in a randomised and controlled clinical trial, and will be disseminated through publication in peer-reviewed journals and conference presentations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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.

Evaluation of inter-observer agreement when using a clinical respiratory scoring system in pre-weaned dairy calves.

PubMed

Buczinski, S; Faure, C; Jolivet, S; Abdallah, A

2016-07-01

To determine inter-observer agreement for a clinical scoring system for the detection of bovine respiratory disease complex in calves, and the impact of classification of calves as sick or healthy based on different cut-off values. Two third-year veterinary students (Observer 1 and 2) and one post-graduate student (Observer 3) received 4 hours of training on scoring dairy calves for signs of respiratory disease, including rectal temperature, cough, eye and nasal discharge, and ear position. Observers 1 and 2 scored 40 pre-weaning dairy calves 24 hours apart (80 observations) over three visits to a calf-rearing facility, and Observers 1, 2 and 3 scored 20 calves on one visit. Inter-observer agreement was assessed using percentage of agreement (PA) and Kappa statistics for individual clinical signs, comparing Observers 1 and 2. Agreement between the three observers for total clinical score was assessed using cut-off values of ≥4, ≥5 and ≥6 to indicate unhealthy calves. Inter-observer PA for rectal temperature was 0.68, for cough 0.78, for nasal discharge 0.62, for eye discharge 0.63, and for ear position 0.85. Kappa values for all clinical signs indicated slight to fair agreement (<0.4), except temperature that had moderate agreement (0.6). The Fleiss' Kappa for total score, using cut-offs of ≥4, ≥5 and ≥6 to indicate unhealthy calves, was 0.35, 0.06 and 0.13, respectively, indicating slight to fair agreement. There was important inter-observer discrepancies in scoring clinical signs of respiratory disease, using relatively inexperienced observers. These disagreements may ultimately mean increased false negative or false positive diagnoses and incorrect treatment of cases. Visual assessment of clinical signs associated with bovine respiratory disease needs to be thoroughly validated when disease monitoring is based on the use of a clinical scoring system.

The association between Staphylococcus aureus nasal colonization and symptomatic infection in children in Korea where ST72 is the major genotype: A prospective observational study.

PubMed

Kang, Sunghan; Lee, Jina; Kim, Mina

2017-08-01

This study was performed to investigate the concordance in terms of molecular characteristics and antimicrobial susceptibility between colonizing and clinical Staphylococcus aureus isolates obtained from children in Korea, where ST72 is the major genotype.This was a prospective observational descriptive study of culture-confirmed S aureus infections obtained from children ≤18 years old admitted to Asan Medical Center Children's Hospital in Seoul, Korea, from March 2014 to April 2015. Molecular studies including multilocus sequence typing (MLST), SCCmec typing, polymerase chain reaction amplification of the Panton-Valentine leukocidin (PVL) genes, and antibiotic susceptibility tests were performed on S aureus isolates obtained from nares and clinical specimens.During the study period, 126 clinically significant S aureus infections were identified. Nasal swab cultures were made from 113 of the 126 children, and 46.0% (52/113) showed S aureus colonization. The overall concordance between colonizing and clinical isolates by methicillin susceptibility was 94.2% (49/52); all 3 discordant cases were HA-MSSA cases with nasal MRSA. Among the 37 pairs of colonizing and clinical S aureus isolates included in the genotyping analysis, ST72-SCCmec type IV was the most prevalent clone and the PVL genes were positive in 2 patients. Among the 31 pairs of healthcare-associated cases, concordance rates by methicillin susceptibility and sequence type (ST) were 90.3% (28/31) and 84% (26/31), respectively. For the 6 pairs of community-associated (CA) S aureus including 3 CA-MRSA cases, 100% concordance was observed by methicillin susceptibility and ST.The concordance between isolates obtained from children who required medical services was relatively high in Korean children where ST72-SCCmec type IV is the predominant clone as the colonizer and the pathogen. It is suggested that decolonization and continuous care to prevent transmission could be effective in managing and preventing both HA- and CA-SA infections in our setting.

The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia.

PubMed

Joshi, Kruti; Mao, Lian; Biondi, David M; Millet, Robert

2018-01-29

Outpatient facilities, such as community behavioral health organizations (CBHOs), play a critical role in the care of patients with serious mental illness, but there is a paucity of "real-world" patient outcomes data from this health care setting. Therefore, we conducted The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) trial, a real-world, prospective, noninterventional observational study of patients with mental illness treated at CBHOs across the United States. We describe demographic and clinical characteristics, antipsychotic therapy (APT) treatment patterns, and health care resource utilization in patients with schizophrenia undergoing medical care as usual. This study enrolled adults with schizophrenia or bipolar I disorder who initiated APT treatment at various time points: 1) within 8 weeks of initiating risperidone long-acting injectables (RLAIs) or other APTs except paliperidone palmitate (PP), 2) after more than 24 weeks of continuous RLAI treatment, or 3) at any time after initiating PP LAI treatment (schizophrenia only). Study assessments were performed via participant interview, medical chart abstraction, and clinical survey at enrollment and at month 12. A total of 1065 patients from 46 CBHOs were enrolled. Of these, 944 (88.6%) had a diagnosis of schizophrenia and 121 (11.4%) had bipolar I disorder. At enrollment, 599 (63.5%) of patients with schizophrenia were receiving RLAIs or PP LAI, 281 (29.8%) were receiving oral APTs, and 64 (6.8%) were receiving other injectable APTs. A number of differences in patient characteristics and outcomes were observed between patients in the LAI APT cohort and the oral APT cohort. Descriptive analyses from this observational study suggest differences in the patient characteristics, treatment patterns, and clinical and economic outcomes among those with schizophrenia treated at CBHOs with LAI APT or oral APTs. Additional analyses will be conducted to delineate the impact of LAI APT versus oral APTs on patient outcomes. Clinical Trial Registry: NCT01181960 . Registered 12 August 2010.

Accuracy of clinical pallor in the diagnosis of anaemia in children: a meta-analysis

PubMed Central

Chalco, Juan P; Huicho, Luis; Alamo, Carlos; Carreazo, Nilton Y; Bada, Carlos A

2005-01-01

Background Anaemia is highly prevalent in children of developing countries. It is associated with impaired physical growth and mental development. Palmar pallor is recommended at primary level for diagnosing it, on the basis of few studies. The objective of the study was to systematically assess the accuracy of clinical signs in the diagnosis of anaemia in children. Methods A systematic review on the accuracy of clinical signs of anaemia in children. We performed an Internet search in various databases and an additional reference tracking. Studies had to be on performance of clinical signs in the diagnosis of anaemia, using haemoglobin as the gold standard. We calculated pooled diagnostic likelihood ratios (LR's) and odds ratios (DOR's) for each clinical sign at different haemoglobin thresholds. Results Eleven articles met the inclusion criteria. Most studies were performed in Africa, in children underfive. Chi-square test for proportions and Cochran Q for DOR's and for LR's showed heterogeneity. Type of observer and haemoglobin technique influenced the results. Pooling was done using the random effects model. Pooled DOR at haemoglobin <11 g/dL was 4.3 (95% CI 2.6–7.2) for palmar pallor, 3.7 (2.3–5.9) for conjunctival pallor, and 3.4 (1.8–6.3) for nailbed pallor. DOR's and LR's were slightly better for nailbed pallor at all other haemoglobin thresholds. The accuracy did not vary substantially after excluding outliers. Conclusion This meta-analysis did not document a highly accurate clinical sign of anaemia. In view of poor performance of clinical signs, universal iron supplementation may be an adequate control strategy in high prevalence areas. Further well-designed studies are needed in settings other than Africa. They should assess inter-observer variation, performance of combined clinical signs, phenotypic differences, and different degrees of anaemia. PMID:16336667

An integrative model for in-silico clinical-genomics discovery science.

PubMed

Lussier, Yves A; Sarkar, Indra Nell; Cantor, Michael

2002-01-01

Human Genome discovery research has set the pace for Post-Genomic Discovery Research. While post-genomic fields focused at the molecular level are intensively pursued, little effort is being deployed in the later stages of molecular medicine discovery research, such as clinical-genomics. The objective of this study is to demonstrate the relevance and significance of integrating mainstream clinical informatics decision support systems to current bioinformatics genomic discovery science. This paper is a feasibility study of an original model enabling novel "in-silico" clinical-genomic discovery science and that demonstrates its feasibility. This model is designed to mediate queries among clinical and genomic knowledge bases with relevant bioinformatic analytic tools (e.g. gene clustering). Briefly, trait-disease-gene relationships were successfully illustrated using QMR, OMIM, SNOMED-RT, GeneCluster and TreeView. The analyses were visualized as two-dimensional dendrograms of clinical observations clustered around genes. To our knowledge, this is the first study using knowledge bases of clinical decision support systems for genomic discovery. Although this study is a proof of principle, it provides a framework for the development of clinical decision-support-system driven, high-throughput clinical-genomic technologies which could potentially unveil significant high-level functions of genes.

A Phase 1, Single-center, Double-blind, Placebo-controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Clinical Effects, and Pharmacokinetics-Pharmacodynamics of Intravenous Cyclopropyl-methoxycarbonylmetomidate (ABP-700) after a Single Ascending Bolus Dose.

PubMed

Struys, Michel M R F; Valk, Beatrijs I; Eleveld, Douglas J; Absalom, Anthony R; Meyer, Peter; Meier, Sascha; den Daas, Izaak; Chou, Thomas; van Amsterdam, Kai; Campagna, Jason A; Sweeney, Steven P

2017-07-01

Cyclopropyl-methoxycarbonylmetomidate (ABP-700) is a new "soft" etomidate analog. The primary objectives of this first-in-human study were to describe the safety and efficacy of ABP-700 and to determine its maximum tolerated dose. Secondary objectives were to characterize the pharmacokinetics of ABP-700 and its primary metabolite (cyclopropyl-methoxycarbonyl acid), to assess the clinical effects of ABP-700, and to investigate the dose-response and pharmacokinetic/pharmacodynamic relationships. Sixty subjects were divided into 10 cohorts and received an increasing, single bolus of either ABP-700 or placebo. Safety was assessed by clinical laboratory evaluations, infusion-site reactions, continuous monitoring of vital signs, physical examination, adverse event monitoring, and adrenocorticotropic hormone stimulation testing. Clinical effects were assessed with modified observer's assessment of alertness/sedation and Bispectral Index monitoring. Pharmacokinetic parameters were calculated. Stopping criteria were met at 1.00 mg/kg dose. No serious adverse events were reported. Adverse events were dose-dependent and comprised involuntary muscle movement, tachycardia, and ventilatory effects. Adrenocorticotropic hormone stimulation evoked a physiologic cortisol response in all subjects, no different from placebo. Pharmacokinetics were dose-proportional. A three-compartment pharmacokinetic model described the data well. A rapid onset of anesthesia/sedation after bolus administration and also a rapid recovery were observed. A quantitative concentration-effect relationship was described for the modified observer's assessment of alertness/sedation and Bispectral Index. This first-in-human study of ABP-700 shows that ABP-700 was safe and well tolerated after single-bolus injections up to 1.00 mg/kg. Bolus doses of 0.25 and 0.35 mg/kg were found to provide the most beneficial clinical effect versus side-effect profile.

Patients' approaches to students' learning at a clinical education ward--an ethnographic study.

PubMed

Manninen, Katri; Henriksson, Elisabet Welin; Scheja, Max; Silén, Charlotte

2014-07-02

It is well known that patients' involvement in health care students' learning is essential and gives students opportunities to experience clinical reasoning and practice clinical skills when interacting with patients. Students encounter patients in different contexts throughout their education. However, looking across the research providing evidence about learning related to patient-student encounters reveals a lack of knowledge about the actual learning process that occurs in encounters between patients and students. The aim of this study was to explore patient-student encounters in relation to students' learning in a patient-centered health-care setting. An ethnographic approach was used to study the encounters between patients and students. The setting was a clinical education ward for nursing students at a university hospital with eight beds. The study included 10 observations with 11 students and 10 patients. The observer followed one or two students taking care of one patient. During the fieldwork observational and reflective notes were taken. After each observation follow-up interviews were conducted with each patient and student separately. Data were analyzed using an ethnographic approach. The most striking results showed that patients took different approaches in the encounters with students. When the students managed to create a good atmosphere and a mutual relationship, the patients were active participants in the students' learning. If the students did not manage to create a good atmosphere, the relationship became one-way and the patients were passive participants, letting the students practice on their bodies but without engaging in a dialogue with the students. Patient-student encounters, at a clinical education ward with a patient-centred pedagogical framework, can develop into either a learning relationship or an attending relationship. A learning relationship is based on a mutual relationship between patients and students resulting in patients actively participating in students' learning and they both experience it as a joint action. An attending relationship is based on a one-way relationship between patients and students resulting in patients passively participating by letting students to practice on their bodies but without engaging in a learning dialogue with the students.

[Clinical studies on flomoxef in neonates].

PubMed

Tabuki, K; Nishimura, T

1993-07-01

Clinical studies on flomoxef (FMOX) were performed in neonates and the results obtained are summarized as follows. Treatment with FMOX was made in 4 cases of neonatal bacterial infections; 2 cases of sepsis (suspected) and 1 case each of infection of umbilicus and staphylococcal scalded skin syndrome. Results obtained were excellent in 1 case, good in 3 cases. No significant side effects due to the drug were observed in any cases.

Feedback in Clinical Education, Part I: Characteristics of Feedback Provided by Approved Clinical Instructors

PubMed Central

Nottingham, Sara; Henning, Jolene

2014-01-01

Context Providing students with feedback is an important component of athletic training clinical education; however, little information is known about the feedback that Approved Clinical Instructors (ACIs; now known as preceptors) currently provide to athletic training students (ATSs). Objective To characterize the feedback provided by ACIs to ATSs during clinical education experiences. Design Qualitative study. Setting One National Collegiate Athletic Association Division I athletic training facility and 1 outpatient rehabilitation clinic that were clinical sites for 1 entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. Patients or Other Participants A total of 4 ACIs with various experience levels and 4 second-year ATSs. Data Collection and Analysis Extensive field observations were audio recorded, transcribed, and integrated with field notes for analysis. The constant comparative approach of open, axial, and selective coding was used to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. Results The ACIs gave 88 feedback statements in 45 hours and 10 minutes of observation. Characteristics of feedback categories included purpose, timing, specificity, content, form, and privacy. Conclusions Feedback that ACIs provided included several components that made each feedback exchange unique. The ACIs in our study provided feedback that is supported by the literature, suggesting that ACIs are using current recommendations for providing feedback. Feedback needs to be investigated across multiple athletic training education programs to gain more understanding of certain areas of feedback, including frequency, privacy, and form. PMID:24143902

Development of a tool to support holistic generic assessment of clinical procedure skills.

PubMed

McKinley, Robert K; Strand, Janice; Gray, Tracey; Schuwirth, Lambert; Alun-Jones, Tom; Miller, Helen

2008-06-01

The challenges of maintaining comprehensive banks of valid checklists make context-specific checklists for assessment of clinical procedural skills problematic. This paper reports the development of a tool which supports generic holistic assessment of clinical procedural skills. We carried out a literature review, focus groups and non-participant observation of assessments with interview of participants, participant evaluation of a pilot objective structured clinical examination (OSCE), a national modified Delphi study with prior definitions of consensus and an OSCE. Participants were volunteers from a large acute teaching trust, a teaching primary care trust and a national sample of National Health Service staff. Results In total, 86 students, trainees and staff took part in the focus groups, observation of assessments and pilot OSCE, 252 in the Delphi study and 46 candidates and 50 assessors in the final OSCE. We developed a prototype tool with 5 broad categories amongst which were distributed 38 component competencies. There was > 70% agreement (our prior definition of consensus) at the first round of the Delphi study for inclusion of all categories and themes and no consensus for inclusion of additional categories or themes. Generalisability was 0.76. An OSCE based on the instrument has a predicted reliability of 0.79 with 12 stations and 1 assessor per station or 10 stations and 2 assessors per station. This clinical procedural skills assessment tool enables reliable assessment and has content and face validity for the assessment of clinical procedural skills. We have designated it the Leicester Clinical Procedure Assessment Tool (LCAT).

PPB | About

Cancer.gov

The Pleuropulmonary Blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study is enrolling children with PPB and their families. The goal of the study is to improve the care of children with PPB and other tumors associated with DICER1.

An Observational Study of the Lecture Delivery Style Characteristics of High and Low Rated Lectures.

ERIC Educational Resources Information Center

Albanese, Mark A.; And Others

This study identifies distinguishing differences in lecture delivery styles of lecturers rated by students in a large multi-instructor course: the Introduction to Clinical Medicine Course (ICM). The 20 lowest- and highest-rated lecturers of the 1982 and 1983 ICM courses served as the target group. Non-student raters observing the 1984 lectures…

Therapeutic Observation of an Infant in Foster Care

ERIC Educational Resources Information Center

Wakelyn, Jenifer

2011-01-01

The paper describes a clinical research study of therapeutic observation of an infant in foster care. Infants and children under five represent more than half of all children entering care in the UK. The emotional needs of this population tend to be overlooked. This study aimed to find out about the experience of an infant or young child in care,…

Higher magnesium intake is associated with lower fasting glucose and insulin, with no evidence of interaction with select genetic loci, in a meta-analysis of 15 charge consortium studies

USDA-ARS?s Scientific Manuscript database

Favorable associations between magnesium intake and glycemic traits, such as fasting glucose and insulin, are observed in observational and clinical studies, but whether genetic variation affects these associations is largely unknown. We hypothesized that single nucleotide polymorphisms (SNPs) assoc...

A Qualitative Study to Explore Ways to Observe Results of Engaging Activities in Clients with Dementia.

PubMed

Ogawa, Masahiro; Nishida, Seiji; Shirai, Haruna

2017-01-01

Many occupational therapists face the challenge of helping clients with dementia to select and perform meaningful occupations, which may be difficult due to cognitive impairment. Understanding tacit knowledge of well-experienced occupational therapists could positively affect occupational therapy practice for clients with dementia. To explore the observations of experienced occupational therapists when evaluating the effects of activities in clients with dementia. Ten occupational therapists with over 10 years of clinical experience participated in this qualitative study. In-depth interviews were conducted to ask the question, "What do you observe in clients with dementia when you assess the effectiveness of activities among these clients?" Findings . From 47 cases, we found five major themes and 18 subthemes. Main themes were "engaging activity," "emotional expression during activity," "verbal expression during activity," "social interaction through activity," and "something obtained as outcome of activity." Relevance to Clinical Practice . The 18 subthemes could be used as viewpoints to observe engagements of activity in clients with dementia. Future studies could examine which viewpoints were utilized for each type of activity and/or severity of dementia as this was not investigated in the current study.

The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit.

PubMed

Chan, Yu-Feng Yvonne; Wang, Pei; Rogers, Linda; Tignor, Nicole; Zweig, Micol; Hershman, Steven G; Genes, Nicholas; Scott, Erick R; Krock, Eric; Badgeley, Marcus; Edgar, Ron; Violante, Samantha; Wright, Rosalind; Powell, Charles A; Dudley, Joel T; Schadt, Eric E

2017-04-01

The feasibility of using mobile health applications to conduct observational clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment, consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys, devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires. Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

PubMed

Jermendy, György

2018-04-01

Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

'I wish someone watched me interview:' medical student insight into observation and feedback as a method for teaching communication skills during the clinical years.

PubMed

Schopper, Heather; Rosenbaum, Marcy; Axelson, Rick

2016-11-09

Experts suggest observation and feedback is a useful tool for teaching and evaluating medical student communication skills during the clinical years. Failing to do this effectively risks contributing to deterioration of students' communication skills during the very educational period in which they are most important. While educators have been queried about their thoughts on this issue, little is known about what this process is like for learners and if they feel they get educational value from being observed. This study explored student perspectives regarding their experiences with clinical observation and feedback on communication skills. A total of 125 senior medical students at a U.S. medical school were interviewed about their experiences with observation and feedback. Thematic analysis of interview data identified common themes among student responses. The majority of students reported rarely being observed interviewing, and they reported receiving feedback even less frequently. Students valued having communication skills observed and became more comfortable with observation the more it occurred. Student-identified challenges included supervisor time constraints and grading based on observation. Most feedback focused on information gathering and was commonly delayed until well after the observed encounter. Eliciting students' perspectives on the effect of observation and feedback on the development of their communication skills is a unique way to look at this topic, and brings to light many student-identified obstacles and opportunities to maximize the educational value of observation and feedback for teaching communication, including increasing the number of observations, disassociating observation from numerically scored evaluation, training faculty to give meaningful feedback, and timing the observation/feedback earlier in clerkships.

New opportunities of real-world data from clinical routine settings in life-cycle management of drugs: example of an integrative approach in multiple sclerosis.

PubMed

Rothenbacher, Dietrich; Capkun, Gorana; Uenal, Hatice; Tumani, Hayrettin; Geissbühler, Yvonne; Tilson, Hugh

2015-05-01

The assessment and demonstration of a positive benefit-risk balance of a drug is a life-long process and includes specific data from preclinical, clinical development and post-launch experience. However, new integrative approaches are needed to enrich evidence from clinical trials and sponsor-initiated observational studies with information from multiple additional sources, including registry information and other existing observational data and, more recently, health-related administrative claims and medical records databases. To illustrate the value of this approach, this paper exemplifies such a cross-package approach to the area of multiple sclerosis, exploring also possible analytic strategies when using these multiple sources of information.

Who uses multivitamins? A cross-sectional study in the Physicians' Health Study.

PubMed

Rautiainen, Susanne; Wang, Lu; Gaziano, J Michael; Sesso, Howard D

2014-06-01

The aim of this study was to examine the prevalence of self-reported multivitamin use in the Physicians' Health Study (PHS) cohort and its association with various lifestyle, clinical, and dietary factors to improve our understanding of who tends to use multivitamins. Among 18,040 middle-aged and older men, information on lifestyle and clinical factors was collected from a baseline enrollment questionnaire, and supplement use and dietary factors were assessed through a food-frequency questionnaire. Four categories of multivitamin use were considered: (1) no supplement use, (2) use of multivitamins only, (3) use of multivitamins with other individual vitamin/mineral supplements, and (4) use of other supplements only. We used logistic regression to calculate multivariate odds ratios and 95% confidence intervals of taking multivitamin supplements for various lifestyle, clinical and dietary factors. Overall, 36% of men reported current multivitamin use. Men who were older, current smokers, and currently using aspirin were 143, 43, and 74% more likely to use multivitamins only. Men having a history of hypercholesterolemia were 16% more likely to use multivitamins only. A 14, 24, and 26% greater likelihood of using multivitamins was also observed among men consuming more fruits and vegetables, whole grains, and tea, respectively. Similar associations were observed for the likelihood of using multivitamins with other supplements; however, men with higher physical activity, history of cancer, hypertension, higher consumption of nuts, and lower consumption of red meat and coffee were also more likely to use multivitamins with other supplements (all P < 0.05). Self-reported multivitamin use associated with lifestyle, clinical and dietary factors may be an indicator of healthy behaviors. These results provide important information for the interpretation of the recent findings from the PHS II trial and consideration of results from observational studies of multivitamin use and chronic disease.

SOSPES: SPIRIVA® observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe

PubMed Central

Fležar, Matjaž; Jahnz-Różyk, Karina; Enache, Gloria; Martynenko, Tatiana; Kristufek, Peter; Škrinjarić-Cincar, Sanda; Kadlecová, Pavla; Martinovic, Goran

2013-01-01

Purpose The long-acting inhaled anticholinergic agent, tiotropium, is recommended as first-line maintenance therapy for moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) to improve symptoms, exercise tolerance, health status, and to reduce exacerbations. Few studies have evaluated the therapeutic efficacy of tiotropium in patients in routine clinical conditions. The current study was designed to investigate the therapeutic efficacy of tiotropium delivered via the HandiHaler® device on the health status of patients with COPD with Global initiative for chronic Obstructive Lung Disease (GOLD) disease classification 2–4 in six central and eastern European countries in a real-life clinical setting. Methods The study was an open-label, prospective, uncontrolled, and single-arm surveillance study with three clinic visits during a 6-month observation period (baseline, and months 3 and 6). Health status was measured using the disease-specific St George’s Respiratory Questionnaire (SGRQ). The primary efficacy endpoint was the mean change from baseline in SGRQ total score at the end of the 6-month observational period. Results Patients treated with tiotropium 18 μg once daily showed statistically significant and clinically meaningful reduction (improvement) of 21.7 units in the SGRQ total score, regardless of smoking status or cardiac comorbidities at enrollment (P < 0.0001). The analysis also showed that age, treatment compliance, and GOLD disease classification were significant factors that impact the health status of patients with COPD differently. Conclusion These results provide further support for the use of the tiotropium HandiHaler® as first-line maintenance treatment of patients with COPD with a clinician-assessed disease. PMID:24159258

The Psychometric Properties of the Kentucky Inventory of Mindfulness Skills in Clinical Populations

ERIC Educational Resources Information Center

Baum, Corinna; Kuyken, Willem; Bohus, Martin; Heidenreich, Thomas; Michalak, Johannes; Steil, Regina

2010-01-01

The Kentucky Inventory of Mindfulness Skills (KIMS) is a well-validated multidimensional questionnaire measuring dimensions of mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Even though the KIMS has been used in several clinical studies no information is available about the psychometric…

A Qualitative Study of Resident Learning in Ambulatory Clinic

ERIC Educational Resources Information Center

Smith, C. Scott; Morris, Magdalena; Francovich, Chris; Hill, William; Gieselman, Janet

2004-01-01

Qualitative analysis of a large ethnographic database from observations of a resident teaching clinic revealed three important findings. The first finding was that breakdown, a situation where an "actor" (such as a person or the group) is not achieving expected effectiveness, was the most important category because of its frequency and explanatory…

Clinical Efficacy of Psychoeducational Interventions with Family Caregivers

ERIC Educational Resources Information Center

Limiñana-Gras, Rosa M.; Colodro-Conde, Lucía; Cuéllar-Flores, Isabel; Sánchez-López, M. Pilar

2016-01-01

The goal of this study is to investigate the efficacy of psychoeducational interventions geared to reducing psychological distress for caregivers in a sample of 90 family caregivers of elderly dependent (78 women and 12 men). We conducted an analysis of the statistical and clinical significance of the changes observed in psychological health…

Succinate-based preparation alleviates manifestations of the climacteric syndrome in women.

PubMed

Peskov, A B; Maevskii, E I; Uchitel', M L; Sakharova, N Yu; Vize-Khripunova, M A

2005-09-01

Clinical placebo-controlled study of Enerlit-Clima (bioactive succinate-based food additive) a showed positive effect of the preparation on general clinical and psychoemotional manifestations of the climacteric syndrome. A trend to an increase in estradiol level in early pathological climacteric and normalization of the endometrial status were observed.

Clinical Efficacy of Low Molecular Heparin on Unexplained Recurrent Spontaneous Abortion.

PubMed

Xu, Guang-Li; Hu, Xiao-Fang; Han, Yong-Mei; Wei, Ai-Wu

2018-06-01

To study the clinical effect of low molecular heparin on unexplained recurrent spontaneous abortion (URSA). A total of 120 URSA patients were collected in our hospital from October 2015 to September 2017. They were divided into two groups: control group (n = 60) and observation group (n = 60). The patients in the control group were administered with progesterone and human chorionic gonadotropin, and the observation group with low molecular heparin. Pregnancy outcomes, incidence of complications in pregnancy and adverse drug reactions were compared in the two groups. The pregnancy success rate of patients in the observation group (90.00%) is higher than that in the control group (68.33%) (p < 0.05). The incidence of complications in pregnancy in the observation group (90.00%) is lower than those in the control group (68.33%) (p < 0.05). The incidence of adverse drug reactions between the patients in the observation group (20.00%) and those in the control group (23.33%) showed no significant difference (p > 0.05). Low molecular heparin treatment can improve pregnancy success rate and reduce the incidence of complications in the URSA patients. Low molecular heparin is characterized by safety and reliability and has potential for application in clinic.

[Vedolizumab (Entyvio®) for the treatment of inflammatory bowel diseases].

PubMed

Van Kemseke, C; Louis, E; Reenaers, C

2015-11-01

Anti-TNF agents are highly effective in treating inflammatory bowel diseases, but loss of response and side-effects leading to drug interruption are often reported. New molecules are needed to treat these patients. Vedolizumab is a fully humanized anti-body inhibiting the migration of circulating lymphocytes to the gut by binding the integrin α4β7. In ulcerative colitis, clinical response, remission and mucosal healing were observed at 6 weeks in 47%, 17% and 40% of the patients, respectively. The maintenance study demonstrated 42% and 52% of clinical remission and response at week 52. In Crohn's disease, clinical response and remission were respectively observed in 15% and 31% of the patients at 6 weeks. Clinical remission at week 52 was 39%. The time to clinical response was longer in patients who had failed anti-TNF. The safety profile is excellent with the same proportion of side-effects in the placebo and in the treated groups. The most frequently reported adverse events were pharyngitis and headaches.

[Pharmacokinetical and clinical study of cefpirome in children].

PubMed

Kida, K; Morimoto, T; Matsuda, H; Murase, M

1991-02-01

This study describes the pharmacokinetic characteristics and clinical usefulness of cefpirome (CPR) in children. Mean half-lives of 20 mg/kg and 40 mg/kg of CPR injected intravenously in one shot were 1.18 and 1.34 hours, respectively, and their mean recovery rates into urine were 69.8 and 72.2%, respectively. Minimum inhibitory concentrations of CPR against Staphylococcus aureus, Streptococcus pneumoniae, Klebsiella pneumoniae, Escherichia coli and Haemophilus influenzae were the same as or lower than those of ceftazidime. CPR was clinically effective in 14/15 of patients with bacterial infections; 8/9 of pneumonia, 2/2 of bronchitis, 1/1 of pharyngitis, 1/1 of tonsillitis, 1/1 of osteomyelitis, 1/1 of urinary tract infection. No clinically overt side effects of CPR were found, while an increase of eosinophils in blood was observed in 2 cases, and an increase of platelet in blood in 1 case and an elevation of serum GPT activity in 1 case were also observed. These findings indicate that CPR is useful for the treatment of bacterial infections in children.

Supervisors' pedagogical role at a clinical education ward - an ethnographic study.

PubMed

Manninen, Katri; Henriksson, Elisabet Welin; Scheja, Max; Silén, Charlotte

2015-01-01

Clinical practice is essential for health care students. The supervisor's role and how supervision should be organized are challenging issues for educators and clinicians. Clinical education wards have been established to meet these challenges and they are units with a pedagogical framework facilitating students' training in real clinical settings. Supervisors support students to link together theoretical and practical knowledge and skills. From students' perspectives, clinical education wards have shown potential to enhance students' learning. Thus there is a need for deeper understanding of supervisors' pedagogical role in this context. We explored supervisors' approaches to students' learning at a clinical education ward where students are encouraged to independently take care of patients. An ethnographic approach was used to study encounters between patients, students and supervisors. The setting was a clinical education ward for nursing students at a university hospital. Ten observations with ten patients, 11 students and five supervisors were included in the study. After each observation, individual follow-up interviews with all participants and a group interview with supervisors were conducted. Data were analysed using an ethnographic approach. Supervisors' pedagogical role has to do with balancing patient care and student learning. The students were given independence, which created pedagogical challenges for the supervisors. They handled these challenges by collaborating as a supervisory team and taking different acts of supervision such as allowing students their independence, being there for students and by applying patient-centredness. The supervisors' pedagogical role was perceived as to facilitate students' learning as a team. Supervisors were both patient- and student-centred by making a nursing care plan for the patients and a learning plan for the students. The plans were guided by clinical and pedagogical guidelines, individually adjusted and followed up.

The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project

PubMed Central

Guetterman, Timothy C; Fetters, Michael D; Mawocha, Samkeliso; Legocki, Laurie J; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

2017-01-01

Objectives: Clinical trials are complicated, expensive, time-consuming, and frequently do not lead to discoveries that improve the health of patients with disease. Adaptive clinical trials have emerged as a methodology to provide more flexibility in design elements to better answer scientific questions regarding whether new treatments are efficacious. Limited observational data exist that describe the complex process of designing adaptive clinical trials. To address these issues, the Adaptive Designs Accelerating Promising Treatments Into Trials project developed six, tailored, flexible, adaptive, phase-III clinical trials for neurological emergencies, and investigators prospectively monitored and observed the processes. The objective of this work is to describe the adaptive design development process, the final design, and the current status of the adaptive trial designs that were developed. Methods: To observe and reflect upon the trial development process, we employed a rich, mixed methods evaluation that combined quantitative data from visual analog scale to assess attitudes about adaptive trials, along with in-depth qualitative data about the development process gathered from observations. Results: The Adaptive Designs Accelerating Promising Treatments Into Trials team developed six adaptive clinical trial designs. Across the six designs, 53 attitude surveys were completed at baseline and after the trial planning process completed. Compared to baseline, the participants believed significantly more strongly that the adaptive designs would be accepted by National Institutes of Health review panels and non-researcher clinicians. In addition, after the trial planning process, the participants more strongly believed that the adaptive design would meet the scientific and medical goals of the studies. Conclusion: Introducing the adaptive design at early conceptualization proved critical to successful adoption and implementation of that trial. Involving key stakeholders from several scientific domains early in the process appears to be associated with improved attitudes towards adaptive designs over the life cycle of clinical trial development. PMID:29085638

Multidisciplinary acute care research organization (MACRO): if you build it, they will come.

PubMed

Early, Barbara J; Huang, David T; Callaway, Clifton W; Zenati, Mazen; Angus, Derek C; Gunn, Scott R; Yealy, Donald M; Unikel, Daniel; Billiar, Timothy R; Peitzman, Andrew B; Sperry, Jason L

2013-07-01

Clinical research will increasingly play a core role in the evolution and growth of acute care surgery program development across the country. What constitutes an efficient and effective clinical research infrastructure in the current fiscal and academic environment remains obscure. We sought to characterize the effects of implementation of a multidisciplinary acute care research organization (MACRO) at a busy tertiary referral university setting. In 2008, to minimize redundancy and cost as well as to maximize existing resources promoting acute care research, MACRO was created, unifying clinical research infrastructure among the Departments of Critical Care Medicine, Emergency Medicine, and Surgery. During the periods 2008 to 2012, we performed a retrospective analysis and determined volume of clinical studies, patient enrollment for both observational and interventional trials, and staff growth since MACRO's origination and characterized changes over time. From 2008 to 2011, the volume of patients enrolled in clinical studies, which MACRO facilitates has significantly increased more than 300%. The percentage of interventional/observational trials has remained stable during the same period (50-60%). Staff has increased from 6 coordinators to 10, with an additional 15 research associates allowing 24/7 service. With this significant growth, MACRO has become financially self-sufficient, and additional outside departments now seek MACRO's services. Appropriate organization of acute care clinical research infrastructure minimizes redundancy and can promote sustainable, efficient growth in the current academic environment. Further studies are required to determine if similar models can be successful at other acute care surgery programs.

[Tuberculous otitis].

PubMed

Aimoni, C; Scanelli, G; Blotta, P

1999-05-01

Recent works show an increase of the incidence of extrapulmonary tuberculosis with a peculiar localization to the middle ear, until now considered a rare clinical manifestation. At the Ear, Noise, Throat Clinic of the University of Ferrara a total of 5 cases of tuberculous otitis media were observed during the last 25 years. Aim of the present study is to describe their clinical manifestations, their symptomatic aspects and the way to reach a careful diagnosis and more rapid therapeutic choice.

A two-stage clinical decision support system for early recognition and stratification of patients with sepsis: an observational cohort study.

PubMed

Amland, Robert C; Lyons, Jason J; Greene, Tracy L; Haley, James M

2015-10-01

To examine the diagnostic accuracy of a two-stage clinical decision support system for early recognition and stratification of patients with sepsis. Observational cohort study employing a two-stage sepsis clinical decision support to recognise and stratify patients with sepsis. The stage one component was comprised of a cloud-based clinical decision support with 24/7 surveillance to detect patients at risk of sepsis. The cloud-based clinical decision support delivered notifications to the patients' designated nurse, who then electronically contacted a provider. The second stage component comprised a sepsis screening and stratification form integrated into the patient electronic health record, essentially an evidence-based decision aid, used by providers to assess patients at bedside. Urban, 284 acute bed community hospital in the USA; 16,000 hospitalisations annually. Data on 2620 adult patients were collected retrospectively in 2014 after the clinical decision support was implemented. 'Suspected infection' was the established gold standard to assess clinical decision support clinimetric performance. A sepsis alert activated on 417 (16%) of 2620 adult patients hospitalised. Applying 'suspected infection' as standard, the patient population characteristics showed 72% sensitivity and 73% positive predictive value. A postalert screening conducted by providers at bedside of 417 patients achieved 81% sensitivity and 94% positive predictive value. Providers documented against 89% patients with an alert activated by clinical decision support and completed 75% of bedside screening and stratification of patients with sepsis within one hour from notification. A clinical decision support binary alarm system with cross-checking functionality improves early recognition and facilitates stratification of patients with sepsis.

The Clinical Research Center for Depression Study: Baseline Characteristics of a Korean Long-Term Hospital-Based Observational Collaborative Prospective Cohort Study

PubMed Central

Kim, Tae-Suk; Jeong, Seung Hee; Kim, Jung-Bum; Lee, Min-Soo; Kim, Jae-Min; Yim, Hyeon-Woo

2011-01-01

Objective The Clinical Research Center for Depression (CRESCEND) study is a 9-year observational collaborative prospective cohort study for the clinical outcomes in participants with depressive disorders in Korea. In this study, we examined the baseline characteristics of the depressive participants as the hospital-based cohort. Methods Participants were assessed using various instruments including the Clinical Global Impression scale, 17-item Hamilton Depression Rating Scale (HDRS-17), Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, Social and Occupational Functioning Assessment Scale, Beck Depression Inventory-Second Edition, Scale for Suicide Ideation, and World Health Organization Quality of Life assessment instruments-abbreviated version. Also, personal histories of medical and psychiatric illnesses and the range of socio-epidemiologic and clinical data were collected from each participant. Results One thousand one hundred eighty three participants were recruited from 18 hospitals. The mean age of the participants was 47.9±15.9 year-old, 74.4% were female, 82.9% had been diagnosed of major depressive disorder, 40.9% were experiencing their first depressive episode, and 21.4% had a past history of suicide attempts. The majority (85.3%) of the participants were moderately to severely ill. The average HDRS-17 was 19.8±6.1. Significant gender differences at baseline were shown in age, education, marriage, employment, religion, and first depressive episode. Conclusion The baseline findings in the CRESCEND study showed some different characteristics of depression in Korea, suggesting a possibility of ethnic and cultural factors in depression. PMID:21519530

Trueperella pyogenes multispecies infections in domestic animals: a retrospective study of 144 cases (2002 to 2012).

PubMed

Ribeiro, M G; Risseti, R M; Bolaños, C A D; Caffaro, K A; de Morais, A C B; Lara, G H B; Zamprogna, T O; Paes, A C; Listoni, F J P; Franco, M M J

2015-06-01

Formerly, Arcanobacterium pyogenes was recently renamed Trueperella pyogenes. This opportunistic bacterium is related to miscellaneous pyogenic infections in animals. Most studies involving T. pyogenes are case reports, whereas few surveys have focused the major aspects of T. pyogenes infections involving a case series study design. The aim of this study was to retrospectively evaluate selected epidemiological and clinical aspects, as well as the in vitro antimicrobial susceptibility pattern of 144 cases of T. pyogenes infections among domestic animals from 2002 to 2012. T. pyogenes was isolated from different clinical specimens from cattle, goats, sheep, pigs, horses, dogs, and buffaloes. Correlations were assessed by the Chi-square or Fisher's exact tests. Mastitis (45.1%), abscesses (18.0%), pneumonia (11.1%), and lymphadenitis (9.0%) were the most common clinical manifestations. In addition, the organism was also isolated from other miscellaneous clinical specimens from cases of septicemia, encephalitis, pyometra, prostatitis, orchitis, seminal vesiculitis, pericarditis, and omphalitis. No statistical association was observed between T. pyogenes infections and age, gender, or season across the study. The most effective drugs against the pathogen were florfenicol (99.1%), cefoperazone (96.0%), cephalexin (95.0%), and ceftiofur (94.8%). High resistance rates were observed against trimethoprim-sulfamethoxazole (49.3%), followed by norfloxacin (10.9%) and tetracycline (9.2%). This study highlights the diversity of clinical manifestations and the opportunistic behavior of T. pyogenes infections in domestic animals, with predominance of mastitis, abscesses, pneumonia, and lymphadenitis. It also reinforces the importance of knowing the susceptibility profile before initiating therapy, to improve antimicrobial therapy approaches.

Everyday ethics issues in the outpatient clinical practice of pediatric residents.

PubMed

Moon, Margaret; Taylor, Holly A; McDonald, Erin L; Hughes, Mark T; Carrese, Joseph A

2009-09-01

To describe the ethics issues that pediatric residents encounter during routine care in an outpatient teaching clinic. Qualitative study including in-depth interviews with pediatric residents and direct observation of interactions between preceptors and residents in a pediatric teaching clinic. The Johns Hopkins Harriet Lane Pediatric Primary Care Clinic, March 20 through April 11, 2006. A convenience sample including all pediatric faculty preceptors supervising at the clinic during the 19 half-day sessions that occurred during the observation period (N = 15) and the pediatric residents seeing patients during these clinic sessions (N = 50). Main Outcome Measure Field notes of preceptor-resident discussions about patient care were made and transcribed for qualitative analysis. Qualitative analysis of the ethics content of cases presented by residents in this pediatric teaching clinic identified 5 themes for categorizing ethics challenges: (1) promoting the child's best interests in complex and resource-poor home and social settings; (2) managing the therapeutic alliance with parents and caregivers; (3) protecting patient privacy and confidentiality; (4) balancing the dual roles of learner and health care provider; and (5) using professional authority appropriately. Qualitative analysis of the ethics content of directly observed preceptor-resident case discussions yielded a set of themes describing the ethics challenges facing pediatric residents. The themes are somewhat different from the lists of residents' ethics experiences developed using recall or survey methods and may be very different from the ideas usually included in hospital-based ethics discussions. This may have implications for improving ethics education during residency training.

Multimodal endocavitary ultrasound versus MRI and clinical findings in pre- and post-treatment advanced cervical cancer. Preliminary report.

PubMed

Csutak, Csaba; Badea, Radu; Bolboaca, Sorana D; Ordeanu, Claudia; Nagy, Viorica M; Fekete, Zsolt; Chiorean, Liliana; Dudea, Sorin M

2016-03-01

The aim of this study was to evaluate the use of pre and post-therapy transrectal and transvaginal ultrasonography (TRUS, TVUS) with contrast enhancement and strain elastography compared with clinical examination and magnetic resonance imaging (MRI) in the assessment of advanced stage cervical cancer. This was a prospective study, carried out over a period of nine months on subjects with advanced-stage cervical cancer (stage >/= IIB). All included patients were examined clinically and underwent abdomino-pelvic contrast enhanced MRI and multimodal US examinations (TRUS with strain elastography and contrast enhanced TVUS) at the time of diagnosis and after radiochemotherapy. Tumor size and staging at TRUS and TVUS was compared with the same data obtained by clinical examination and MRI. Pathology was the golden standard. Eight patients accomplished the inclusion criteria. In five cases the tumor stage was identical on clinical and MRI examinations. In all cases parametrial infiltration was diagnosed by all pre-treatment examinations. No significant differences were observed in tumor size between clinical, US and MRI exams either at baseline or post-therapy, in native or post-contrast examinations. The size of the tumor evaluated pre-treatment proved to be significantly smaller post-contrast in both US and MRI examinations compared with the native images. Post-therapy, no significant differences were observed on US measured tumor dimensions when comparing native with post-contrast images. Oppositely, significant smaller dimensions were observed on post-contrast MRI compared with native scans. TRUS is accurate in the estimation of pre-therapy cervical cancer dimension. The post therapy tumor evaluation is better performed with MRI. The use of intravenous contrast agents on both examinations did not improved the accuracy of tumor evaluation pre or post-therapy.

The anticoagulant effects of warfarin and the bleeding risk associated with its use in patients with chronic thromboembolic pulmonary hypertension at a specialist center in Japan: a retrospective cohort study

PubMed Central

Jujo-Sanada, Takayuki; Tanabe, Nobuhiro; Sakao, Seiichiro; Sugiura, Toshihiko; Sekine, Ayumi; Nishimura, Rintaro; Suda, Rika; Naito, Akira; Miwa, Hideki; Yamamoto, Keiko; Sasaki, Akane; Matsumura, Akane; Ema, Ryogo; Kasai, Hajime; Kato, Fumiaki; Tatsumi, Koichiro

2017-01-01

Patients with chronic thromboembolic pulmonary hypertension (CTEPH) require lifelong anticoagulation therapy. However, the bleeding risk and recurrence of venous thromboembolism (VTE) in CTEPH patients who are administered warfarin have not been adequately evaluated. The purpose of this study was to evaluate the risk of clinically relevant bleeding, recurrent VTE, and clinical worsening in patients with CTEPH who were administered warfarin. The clinical records of 72 patients with CTEPH who regularly visited our institution and were administered warfarin were retrospectively reviewed between 1 January 2011 and 31 December 2015. We investigated the incidence of clinically relevant bleeding events, recurrent VTE, and hospitalization for the deterioration of pulmonary hypertension or right heart failure (RHF) during the observation period. The mean observation period for the 72 patients was 3.60 ± 1.60 person-years. Clinically relevant bleeding, RHF, and recurrent VTE occurred in 21 (29.2%), eight (11.1%), and three (4.2%) of 72 patients, respectively, and the incidence rates for these events were 8.1%/person-year, 3.1%/person-year, and 1.2%/person-year, respectively. The incidence rates for the major and non-major bleeding events were 5.0%/person-year and 3.9%/person-year, respectively. The incidence of clinically relevant bleeding events was 20.8%/person-year during medical treatment with a soluble guanylate cyclase stimulator. One of 35 patients (2.9%) during the post-pulmonary endarterectomy period experienced hemoptysis during observation period (> 6 months after pulmonary endarterectomy). No bleeding events occurred during the post-balloon pulmonary angioplasty period. In conclusion, warfarin effectively prevents VTE recurrence in CTEPH patients, but its effects may be associated with a considerable bleeding risk. PMID:28604280

A multi-centre study of interactional style in nurse specialist- and physician-led Rheumatology clinics in the UK.

PubMed

Vinall-Collier, Karen; Madill, Anna; Firth, Jill

2016-07-01

Nurse-led care is well established in Rheumatology in the UK and provides follow-up care to people with inflammatory arthritis including treatment, monitoring, patient education and psychosocial support. The aim of this study is to compare and contrast interactional style with patients in physician-led and nurse-led Rheumatology clinics. A multi-centre mixed methods approach was adopted. Nine UK Rheumatology out-patient clinics were observed and audio-recorded May 2009-April 2010. Eighteen practitioners agreed to participate in clinic audio-recordings, researcher observations, and note-taking. Of 9 nurse specialists, 8 were female and 5 of 9 physicians were female. Eight practitioners in each group took part in audio-recorded post-clinic interviews. All patients on the clinic list for those practitioners were invited to participate and 107 were consented and observed. In the nurse specialist cohort 46% were female; 71% had a diagnosis of Rheumatoid Arthritis (RA). The physician cohort comprised 31% female; 40% with RA and 16% unconfirmed diagnosis. Nineteen (18%) of the patients observed were approached for an audio-recorded telephone interview and 15 participated (4 male, 11 female). Forty-four nurse specialist and 63 physician consultations with patients were recorded. Roter's Interactional Analysis System (RIAS) was used to code this data. Thirty-one semi-structured interviews were conducted (16 practitioner, 15 patients) within 24h of observed consultations and were analyzed using thematic analysis. RIAS results illuminated differences between practitioners that can be classified as 'socio-emotional' versus 'task-focussed'. Specifically, nurse specialists and their patients engaged significantly more in the socio-emotional activity of 'building a relationship'. Across practitioners, the greatest proportion of 'patient initiations' were in 'giving medical information' and reflected what patients wanted the practitioner to know rather than giving insight into what patients wanted to know from practitioners. Interviews revealed that continuity of practitioner was highly valued by patients as offering the benefits of an established relationship and of emotional support beyond that of the clinical encounter. This fostered familiarity not only with their particular medical history, but also their individual personal circumstances, and this encouraged patient participation. In contrast, practitioners (mis)perceived waiting times to have a greater impact on patient satisfaction. However, practitioner interviews also revealed that clinic structure is often outside of the practitioner control and can undermine the possibility of maintaining patient-practitioner continuity. This research enhances understanding of nurse specialist consultation styles in Rheumatology, specifically the value of their socio-emotional communication skills to enhance patient participation. Copyright © 2016 Elsevier Ltd. All rights reserved.

Case Report: Myiasis due to Cochliomyia hominivorax and Dermatobia hominis: Clinical and Pathological Differences between Two Species in Northern Peru.

PubMed

Failoc-Rojas, Virgilio E; Molina-Ayasta, Carolina; Salazar-Zuloeta, Jaime; Samamé, Abel; Silva-Díaz, Heber

2018-01-01

Infestations caused by fly larvae (Myiasis) have been observed in patients with risk factors and in tropical zones. The aim of our study was to describe the clinical and epidemiological aspects and the risk factors associated with the occurrence of obligatory myiasis, as well as the therapeutic approach to patients. We identified the cases of myiasis diagnosed in two referral hospitals in northern Peru from January 2012 to December 2015 and included patients in whom larval development and a compatible clinical profile were observed. Epidemiological, clinical, analytical, diagnostic, therapeutic, and follow-up data were collected from clinical files. Nine clinical cases were compatible with a diagnosis of myiasis; of these, two were pediatric patients, one was a middle-aged adult, and six were elderly patients. Four of the nine patients were male. The identified species were Dermatobia hominis and Cochliomyia hominivorax. The therapeutic approach included antiparasitic therapy with ivermectin, antibacterial, and in some cases, anti-inflammatory drugs. Dermatobia hominis and C. hominivorax are the predominant species causing myiasis in northern Peru.

Characteristics of Stuttering in Dutch-Speaking Individuals

ERIC Educational Resources Information Center

Boey, Ronny A.; Wuyts, Floris L.; van de Heyning, Paul H.; Heylen, Louis; de Bodt, Marc S.

2009-01-01

Clinical diagnostic procedures to distinguish stuttering from non-stuttering individuals partially rely on the observation of characteristics of stuttered words or syllables. The purpose of this study was to examine the sensitivity and specificity of such a procedure, and to describe the observed characteristics of stuttered words. Methods…

The effects of intrathecal administration of betamethasone over the dogs' spinal cord and meninges.

PubMed

Barros, Guilherme Antonio Moreira de; Marques, Mariângela Esther Alencar; Ganem, Eliana Marisa

2007-01-01

To determinate the potential clinical and histological changes due the injection of betamethasone, when administered into the canine intrathecal space. Twenty one animals were included in a random and blind manner in the study. After general anesthesia, intrathecal puncture was performed and 1 ml of the random solution was injected. The G1 dogs received 0.9% saline solution, the G2 dogs received 1.75 mg betamethasone and the G3 dogs received 3.5 mg of betamethasone. The animals were clinically evaluated for 21 days and then sacrificed. The lumbar and sacral portions of the spinal cord were removed for light microscopy histological analyses. No clinical changes were observed in any of the animals included in this study. No histological changes were observed in G1 animals. Inflammatory infiltration was observed in two dogs, one in G2, another in G3. Hemorrhage and necrosis were also seen in the G2 dog which inflammatory infiltration was detected. In other two dogs, one from G2 and another from G3, there was discreet fibrosis and thickness of the arachnoid layer which was focal in one and diffuse in the other. Intrathecal administration of betamethasone caused histological changes in the spinal cord and meninges in some of the dogs involved in this study.

Extracutaneous atypical syphilis in HIV-infected patients.

PubMed

Prieto, Paula; Imaz, Arkaitz; Calatayud, Laura; García, Olga; Saumoy, María; Podzamczer, Daniel

2017-12-07

We describe a series of cases of syphilis with atypical extracutaneous clinical presentation diagnosed in HIV-infected patients. Retrospective observational study. All cases of syphilis diagnosed in HIV-infected patients during the period between June 2013 and June 2016 in a tertiary hospital of the Barcelona metropolitan area were analysed. A total of 71 cases of syphilis were diagnosed, 32 of them presenting with clinical signs or symptoms. Seven of these cases (9.8% of the total and 21.8% of the symptomatic cases) had atypical presentations with extracutaneous involvement: ocular (4), gastric (1), multiple hepatic abscesses (1) and generalised adenopathies (1). Patients were treated with intramuscular or intravenous penicillin and the clinical and serological evolution was good in all of them. Extracutaneous atypical clinical presentations were observed in 21.8% of symptomatic cases of syphilis in HIV+ patients with ocular involvement being the most freqent. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

High fidelity simulation effectiveness in nursing students' transfer of learning.

PubMed

Kirkman, Tera R

2013-07-13

Members of nursing faculty are utilizing interactive teaching tools to improve nursing student's clinical judgment; one method that has been found to be potentially effective is high fidelity simulation (HFS). The purpose of this time series design study was to determine whether undergraduate nursing students were able to transfer knowledge and skills learned from classroom lecture and a HFS clinical to the traditional clinical setting. Students (n=42) were observed and rated on their ability to perform a respiratory assessment. The observations and ratings took place at the bedside, prior to a respiratory lecture, following the respiratory lecture, and following simulation clinical. The findings indicated that there was a significant difference (p=0.000) in transfer of learning demonstrated over time. Transfer of learning was demonstrated and the use of HFS was found to be an effective learning and teaching method. Implications of results are discussed.

Acute and 28-Day Subacute Toxicity Studies of Hexane Extracts of the Roots of Lithospermum erythrorhizon in Sprague-Dawley Rats

PubMed Central

Han, Chung-Tack; Kim, Myoung-Jun; Moon, Seol-Hee; Jeon, Yu-Rim; Hwang, Jae-Sik; Nam, Chunja; Park, Chong-Woo; Lee, Sun-Ho; Na, Jae-Bum; Park, Chan-Sung; Park, Hee-Won; Lee, Jung-Min; Jang, Ho-Song; Park, Sun-Hee; Han, Kyoung-Goo; Choi, Young Whan

2015-01-01

Lithospermum erythrorhizon has long been used as a traditional oriental medicine. In this study, the acute and 28-day subacute oral dose toxicity studies of hexane extracts of the roots of L. erythrorhizon (LEH) were performed in Sprague-Dawley rats. In the acute toxicity study, LEH was administered once orally to 5 male and 5 female rats at dose levels of 500, 1,000, and 2,000 mg/kg. Mortality, clinical signs, and body weight changes were monitored for 14 days. Salivation, soft stool, soiled perineal region, compound-colored stool, chromaturia and a decrease in body weight were observed in the extract-treated groups, and no deaths occurred during the study. Therefore, the approximate lethal dose (ALD) of LEH in male and female rats was higher than 2,000 mg/kg. In the subacute toxicity study, LEH was administered orally to male and female rats for 28 days at dose levels of 25, 100, and 400 mg/kg/day. There was no LEH-related toxic effect in the body weight, food consumption, ophthalmology, hematology, clinical chemistry and organ weights. Compound-colored (black) stool, chromaturia and increased protein, ketone bodies, bilirubin and occult blood in urine were observed in the male and female rats treated with the test substance. In addition, the necropsy revealed dark red discoloration of the kidneys, and the histopathological examination showed presence of red brown pigment or increased hyaline droplets in the renal tubules of the renal cortex. However, there were no test substance-related toxic effects in the hematology and clinical chemistry, and no morphological changes were observed in the histopathological examination of the kidneys. Therefore, it was determined that there was no significant toxicity because the changes observed were caused by the intrinsic color of the test substance. These results suggest that the no-observed-adverse-effect Level (NOAEL) of LEH is greater than 400 mg/kg/day in both sexes. PMID:26877842

Acute and 28-Day Subacute Toxicity Studies of Hexane Extracts of the Roots of Lithospermum erythrorhizon in Sprague-Dawley Rats.

PubMed

Han, Chung-Tack; Kim, Myoung-Jun; Moon, Seol-Hee; Jeon, Yu-Rim; Hwang, Jae-Sik; Nam, Chunja; Park, Chong-Woo; Lee, Sun-Ho; Na, Jae-Bum; Park, Chan-Sung; Park, Hee-Won; Lee, Jung-Min; Jang, Ho-Song; Park, Sun-Hee; Han, Kyoung-Goo; Choi, Young Whan; Lee, Hye-Yeong; Kang, Jong-Koo

2015-12-01

Lithospermum erythrorhizon has long been used as a traditional oriental medicine. In this study, the acute and 28-day subacute oral dose toxicity studies of hexane extracts of the roots of L. erythrorhizon (LEH) were performed in Sprague-Dawley rats. In the acute toxicity study, LEH was administered once orally to 5 male and 5 female rats at dose levels of 500, 1,000, and 2,000 mg/kg. Mortality, clinical signs, and body weight changes were monitored for 14 days. Salivation, soft stool, soiled perineal region, compound-colored stool, chromaturia and a decrease in body weight were observed in the extract-treated groups, and no deaths occurred during the study. Therefore, the approximate lethal dose (ALD) of LEH in male and female rats was higher than 2,000 mg/kg. In the subacute toxicity study, LEH was administered orally to male and female rats for 28 days at dose levels of 25, 100, and 400 mg/kg/day. There was no LEH-related toxic effect in the body weight, food consumption, ophthalmology, hematology, clinical chemistry and organ weights. Compound-colored (black) stool, chromaturia and increased protein, ketone bodies, bilirubin and occult blood in urine were observed in the male and female rats treated with the test substance. In addition, the necropsy revealed dark red discoloration of the kidneys, and the histopathological examination showed presence of red brown pigment or increased hyaline droplets in the renal tubules of the renal cortex. However, there were no test substance-related toxic effects in the hematology and clinical chemistry, and no morphological changes were observed in the histopathological examination of the kidneys. Therefore, it was determined that there was no significant toxicity because the changes observed were caused by the intrinsic color of the test substance. These results suggest that the no-observed-adverse-effect Level (NOAEL) of LEH is greater than 400 mg/kg/day in both sexes.

Early impact of treatment with tiotropium, long-acting anticholinergic preparation, in patients with COPD – real-life experience from an observational study

PubMed Central

Jahnz-Różyk, Karina; Szepiel, Paweł

2015-01-01

Background Long-acting inhaled bronchodilators, including anticholinergic tiotropium, are recommended for the maintenance therapy of chronic obstructive pulmonary disease (COPD). It has been shown in a number of studies that treatment with tiotropium alleviates symptoms, improves exercise tolerance, health status, and reduces exacerbations in patients with moderate to very severe stage COPD. Aim The aim of this noninterventional study was to observe the early effects of the maintenance treatment with tiotropium in patients with COPD of different severities, who had been previously treated on a regular basis, or as required, with at least one short-acting bronchodilator, in a real-life setting in Poland. The effect of the treatment was assessed through the collection of COPD Assessment Test (CAT) data. Patients and methods The MATHS clinical study was an observational, noninterventional, open-label, prospective, uncontrolled, single-arm, postmarketing, surveillance, real-life study conducted with the involvement of 236 pulmonology clinics based in Poland. The tiotropium observational period was 3 months. The health and COPD status was measured with the CAT questionnaire. The primary efficacy endpoint was the mean change from the baseline in the total CAT score at the end of the 3-month observational period. Results Patients treated with 18 μg of tiotropium once daily for 3 months showed a statistically significant result, with a clinically meaningful mean reduction (improvement) of 7.0 points in the total CAT score. The improvement was slightly greater in patients with more severe COPD; the mean change in the total CAT score was 7.6 in the subgroup of patients with more severe COPD and 6.7 points in the subgroup of patients with moderate COPD. Conclusion Results of this real-life study provide further support for the use of tiotropium as a first-line maintenance treatment for patients with COPD of different severities in Poland. PMID:25834420

Communication of mechanically ventilated patients in intensive care units

PubMed Central

Martinho, Carina Isabel Ferreira; Rodrigues, Inês Tello Rato Milheiras

2016-01-01

Objective The aim of this study was to translate and culturally and linguistically adapt the Ease of Communication Scale and to assess the level of communication difficulties for patients undergoing mechanical ventilation with orotracheal intubation, relating these difficulties to clinical and sociodemographic variables. Methods This study had three stages: (1) cultural and linguistic adaptation of the Ease of Communication Scale; (2) preliminary assessment of its psychometric properties; and (3) observational, descriptive-correlational and cross-sectional study, conducted from March to August 2015, based on the Ease of Communication Scale - after extubation answers and clinical and sociodemographic variables of 31 adult patients who were extubated, clinically stable and admitted to five Portuguese intensive care units. Results Expert analysis showed high agreement on content (100%) and relevance (75%). The pretest scores showed a high acceptability regarding the completion of the instrument and its usefulness. The Ease of Communication Scale showed excellent internal consistency (0.951 Cronbach's alpha). The factor analysis explained approximately 81% of the total variance with two scale components. On average, the patients considered the communication experiences during intubation to be "quite hard" (2.99). No significant correlation was observed between the communication difficulties reported and the studied sociodemographic and clinical variables, except for the clinical variable "number of hours after extubation" (p < 0.05). Conclusion This study translated and adapted the first assessment instrument of communication difficulties for mechanically ventilated patients in intensive care units into European Portuguese. The preliminary scale validation suggested high reliability. Patients undergoing mechanical ventilation reported that communication during intubation was "quite hard", and these communication difficulties apparently existed regardless of the presence of other clinical and/or sociodemographic variables. PMID:27410408

Acupuncture (PDQ)

MedlinePlus

... patients who were waiting to receive treatment later. Observational studies have also reported both real acupuncture and ... NCCIH) are sponsoring a number of clinical trials (research studies) at ... and alternative methods. Few CAM therapies have been tested using demanding ...

Trends in published meta-analyses in cancer research, 2008-2013.

PubMed

Qadir, Ximena V; Clyne, Mindy; Lam, Tram Kim; Khoury, Muin J; Schully, Sheri D

2017-01-01

In order to capture trends in the contribution of epidemiology to cancer research, we describe an online meta-analysis database resource for cancer clinical and population research and illustrate trends and descriptive detail of cancer meta-analyses from 2008 through 2013. A total of 4,686 cancer meta-analyses met our inclusion criteria. During this 6-year period, a fivefold increase was observed in the yearly number of meta-analyses. Fifty-six percent of meta-analyses concerned observational studies, mostly of cancer risk, more than half of which were genetic studies. The major cancer sites were breast, colorectal, and digestive. This online database for Cancer Genomics and Epidemiology Navigator will be continuously updated to allow investigators to quickly navigate the meta-analyses emerging from cancer epidemiology studies and cancer clinical trials.

The reporting of clinical signs in laboratory animals: FELASA Working Group Report.

PubMed

Fentener van Vlissingen, J M; Borrens, M; Girod, A; Lelovas, P; Morrison, F; Torres, Y Saavedra

2015-10-01

Observing and reporting clinical signs in laboratory animals is necessary for many reasons: the assessment of animal welfare, compliance with the principle of refinement (e.g. humane endpoints), regulatory compliance (e.g. reporting severity) and, importantly, as a scientific outcome, e.g. in animal models of disease or safety studies. Developments in the reporting of clinical signs will enhance the scientific value gained from animal experiments and further address the ethical cost. This paper discusses systematic approaches to the observation and reporting of clinical signs in animals (to be) used for research. Glossaries from public and corporate institutions have been consulted and a reference glossary has been set up, providing terminology to be tailored for institutional or project-specific use. The clinical examination of animals must be carried out by competent and specifically trained staff in a systematic way and repeated at adequate intervals and clinical observations must be registered effectively to allow this information to be used. The development of institutional or project-specific glossaries and the use of handwritten records or automated databases are discussed in detail. Among the users are animal care staff, veterinarians and researchers who will need to agree on a given set of clinical signs to be monitored routinely or as a scientific read-out and to train for the proper application. The paper introduces a long list of clinical signs with scientific terminology, descriptions and explanations as a reference glossary to be published and maintained online as a living document supported by the authors as an editorial committee. © The Author(s) 2015.

Symptomatic Dengue Disease in Five Southeast Asian Countries: Epidemiological Evidence from a Dengue Vaccine Trial.

PubMed

Nealon, Joshua; Taurel, Anne-Frieda; Capeding, Maria Rosario; Tran, Ngoc Huu; Hadinegoro, Sri Rezeki; Chotpitayasunondh, Tawee; Chong, Chee Kheong; Wartel, T Anh; Beucher, Sophie; Frago, Carina; Moureau, Annick; Simmerman, Mark; Laot, Thelma; L'Azou, Maïna; Bouckenooghe, Alain

2016-08-01

Dengue incidence has increased globally, but empirical burden estimates are scarce. Prospective methods are best-able to capture all severities of disease. CYD14 was an observer-blinded dengue vaccine study conducted in children 2-14 years of age in Indonesia, Malaysia, Thailand, the Philippines, and Vietnam. The control group received no vaccine and resembled a prospective, observational study. We calculated the rates of dengue according to different laboratory or clinical criteria to make inferences about dengue burden, and compared with rates reported in the passive surveillance systems to calculate expansion factors which describe under-reporting. Over 6,933 person-years of observation in the control group there were 319 virologically confirmed dengue cases, a crude attack rate of 4.6%/year. Of these, 92 cases (28.8%) were clinically diagnosed as dengue fever or dengue hemorrhagic fever by investigators and 227 were not, indicating that most symptomatic disease fails to satisfy existing case definitions. When examining different case definitions, there was an inverse relationship between clinical severity and observed incidence rates. CYD14's active surveillance system captured a greater proportion of symptomatic dengue than national passive surveillance systems, giving rise to expansion factors ranging from 0.5 to 31.7. This analysis showed substantial, unpredictable and variable under-reporting of symptomatic dengue, even within a controlled clinical trial environment, and emphasizes that burden estimates are highly sensitive to case definitions. These data will assist in generating disease burden estimates and have important policy implications when considering the introduction and health economics of dengue prevention and control interventions.

Symptomatic Dengue Disease in Five Southeast Asian Countries: Epidemiological Evidence from a Dengue Vaccine Trial

PubMed Central

Taurel, Anne-Frieda; Capeding, Maria Rosario; Tran, Ngoc Huu; Hadinegoro, Sri Rezeki; Chotpitayasunondh, Tawee; Chong, Chee Kheong; Wartel, T. Anh; Beucher, Sophie; Frago, Carina; Moureau, Annick; Simmerman, Mark; Laot, Thelma; L’Azou, Maïna; Bouckenooghe, Alain

2016-01-01

Dengue incidence has increased globally, but empirical burden estimates are scarce. Prospective methods are best-able to capture all severities of disease. CYD14 was an observer-blinded dengue vaccine study conducted in children 2–14 years of age in Indonesia, Malaysia, Thailand, the Philippines, and Vietnam. The control group received no vaccine and resembled a prospective, observational study. We calculated the rates of dengue according to different laboratory or clinical criteria to make inferences about dengue burden, and compared with rates reported in the passive surveillance systems to calculate expansion factors which describe under-reporting. Over 6,933 person-years of observation in the control group there were 319 virologically confirmed dengue cases, a crude attack rate of 4.6%/year. Of these, 92 cases (28.8%) were clinically diagnosed as dengue fever or dengue hemorrhagic fever by investigators and 227 were not, indicating that most symptomatic disease fails to satisfy existing case definitions. When examining different case definitions, there was an inverse relationship between clinical severity and observed incidence rates. CYD14’s active surveillance system captured a greater proportion of symptomatic dengue than national passive surveillance systems, giving rise to expansion factors ranging from 0.5 to 31.7. This analysis showed substantial, unpredictable and variable under-reporting of symptomatic dengue, even within a controlled clinical trial environment, and emphasizes that burden estimates are highly sensitive to case definitions. These data will assist in generating disease burden estimates and have important policy implications when considering the introduction and health economics of dengue prevention and control interventions. PMID:27532617

Pharmacoepigenomic responses of antipsychotic drugs on pharmacogenes are likely to be modulated by miRNAs.

PubMed

Swathy, Babu; Saradalekshmi, Koramannil R; Nair, Indu V; Nair, Chandrasekharan; Banerjee, Moinak

2017-06-01

It is imperative to differentiate the role of host epigenetics from pharmacoepigenetics in resolving therapeutic response. Therefore, the objective was to identify how antipsychotic drugs influence epigenetic response on pharmacogenes. The study design was based on in vitro evaluation of pharmacoepigenetic response of haloperidol, clozapine and olanzapine. Post antipsychotic treatment, the alterations in expression of ABCB1, CYP1A2 and CYP3A4 were monitored, and followed up by promoter methylation and their target miRNA expression studies. Critical observations were followed up in a restrictive clinical setting. Under in vitro conditions increased expression of ABCB1, CYP1A2 and CYP3A4 was observed which seems to be regulated by miR-27a and miR-128a and not by methylation. A similar pattern was observed in clinical setting with ABCB1, which was reflective of good therapeutic response. The study demonstrates that antipsychotic drugs can influence miRNA-mediated epigenetic response in pharmacogenes resulting in modulating therapeutic response.

Opioid-Sparing Effect of Cannabinoids: A Systematic Review and Meta-Analysis.

PubMed

Nielsen, Suzanne; Sabioni, Pamela; Trigo, Jose M; Ware, Mark A; Betz-Stablein, Brigid D; Murnion, Bridin; Lintzeris, Nicholas; Khor, Kok Eng; Farrell, Michael; Smith, Andrew; Le Foll, Bernard

2017-08-01

Cannabinoids, when co-administered with opioids, may enable reduced opioid doses without loss of analgesic efficacy (ie, an opioid-sparing effect). The aim of this study was to conduct a systematic review to determine the opioid-sparing potential of cannabinoids. Eligible studies included pre-clinical and clinical studies for which the outcome was either analgesia or opioid dose requirements. Clinical studies included controlled studies and case series. We searched Scopus, Cochrane Database of Systematic Reviews, Medline, and Embase. Nineteen pre-clinical and nine clinical studies met the search criteria. Seventeen of the 19 pre-clinical studies provided evidence of synergistic effects from opioid and cannabinoid co-administration. Our meta-analysis of pre-clinical studies indicated that the median effective dose (ED 50 ) of morphine administered in combination with delta-9-tetrahydrocannabinol (delta-9-THC) is 3.6 times lower (95% confidence interval (CI) 1.95, 6.76; n=6) than the ED 50 of morphine alone. In addition, the ED 50 for codeine administered in combination with delta-9-THC was 9.5 times lower (95% CI 1.6, 57.5, n=2) than the ED 50 of codeine alone. One case series (n=3) provided very-low-quality evidence of a reduction in opioid requirements with cannabinoid co-administration. Larger controlled clinical studies showed some clinical benefits of cannabinoids; however, opioid dose changes were rarely reported and mixed findings were observed for analgesia. In summary, pre-clinical studies provide robust evidence of the opioid-sparing effect of cannabinoids, whereas one of the nine clinical studies identified provided very-low-quality evidence of such an effect. Prospective high-quality-controlled clinical trials are required to determine the opioid-sparing effect of cannabinoids.

A real-world, multi-site, observational study of infusion time and treatment satisfaction with rheumatoid arthritis patients treated with intravenous golimumab or infliximab.

PubMed

Daniel, Shoshana R; McDermott, John D; Le, Cathy; Pierce, Christine A; Ziskind, Michael A; Ellis, Lorie A

2018-05-25

To assess real-world infusion times for golimumab (GLM-IV) and infliximab (IFX) for rheumatoid arthritis (RA) patients and factors associated with treatment satisfaction. An observational study assessed infusion time including: clinic visit duration, RA medication preparation and infusion time, and infusion process time. Satisfaction was assessed by a modified Treatment Satisfaction Questionnaire for Medication (patient) and study-specific questionnaires (patient and clinic personnel). Comparative statistical testing for patient data utilized analysis of variance for continuous measures, and Fisher's exact or Chi-square test for categorical measures. Multivariate analysis was performed for the primary time endpoints and patient satisfaction. One hundred and fifty patients were enrolled from six US sites (72 GLM-IV, 78 IFX). The majority of patients were female (80.0%) and Caucasian (88.7%). GLM-IV required fewer vials per infusion (3.7) compared to IFX (4.9; p = .0001). Clinic visit duration (minutes) was shorter for GLM-IV (65.1) compared to IFX (153.1; p < .0001), as was total infusion time for RA medication (32.8 GLM-IV, 119.5 IFX; p < .0001) and infusion process times (45.8 GLM-IV, 134.1 IFX; p < .0001). Patients treated with GLM-IV reported higher satisfaction ratings with infusion time (p < .0001) and total visit time (p = .0003). Clinic personnel reported higher satisfaction with GLM-IV than IFX specific to medication preparation time, ease of mixing RA medication, frequency of patients requiring pre-medication, and infusion time. Findings may not be representative of care delivery for all RA infusion practices or RA patients. Shorter overall clinic visit duration, infusion process, and RA medication infusion times were observed for GLM-IV compared to IFX. A shorter duration in infusion time was associated with higher patient and clinic personnel satisfaction ratings.

A software tool to analyze clinical workflows from direct observations.

PubMed

Schweitzer, Marco; Lasierra, Nelia; Hoerbst, Alexander

2015-01-01

Observational data of clinical processes need to be managed in a convenient way, so that process information is reliable, valid and viable for further analysis. However, existing tools for allocating observations fail in systematic data collection of specific workflow recordings. We present a software tool which was developed to facilitate the analysis of clinical process observations. The tool was successfully used in the project OntoHealth, to build, store and analyze observations of diabetes routine consultations.

The Demographic and Clinical Characteristics of Ulcerative Colitis in a Northeast Brazilian Population

PubMed Central

da Silva, Bruno César; Lyra, Andre Castro; Mendes, Carlos Maurício Cardeal; Ribeiro, Camila Paula Oliveira; Lisboa, Sonyara Rauedys Oliveira; de Souza, Mariana Tinoco Lordello; Portela, Renata Cavalcanti; Santana, Genoile Oliveira

2015-01-01

Introduction. The purpose of this study was to describe the clinical and demographic characteristics of UC in Bahia, a Brazilian state, and to identify the variables associated with extensive colitis, steroid therapy, immunosuppression, and colectomy. Methods. In this cross-sectional study UC patients were interviewed, and additional information was collected from the medical records. Descriptive statistics and multivariate Poisson regression analysis were used. Results. This study included 267 individuals, the mean age of whom was 39.4 years at diagnosis. There was a predominance of females and left-side colitis. Extensive colitis was positively associated with male gender, diarrhea, weight loss, and a younger age at diagnosis. In contrast, active smoking and a family history of IBD were negatively associated with extensive colitis. Positive associations were observed between steroid therapy and diarrhea, weight loss, urban patients, extraintestinal manifestations (EIMs), and hospitalization. Younger age and weight loss at diagnosis, a family history of IBD, extensive colitis, EIMs, hospitalization, and steroid therapy were all positively associated with immunosuppression. In contrast, Caucasian individuals, smokers, patients with rectal bleeding, and rural patients areas were all observed to have a decreased likelihood of immunosuppression. Conclusions. Our results corroborate the association between higher prevalence of extensive colitis and younger age at diagnosis. An association between steroid therapy and clinical presentation at diagnosis was observed. The observation that white individuals and rural patients use less immunosuppressive drugs highlights the need to study the influence of environmental and genetic factors on the behavior of UC in this population. PMID:26509150

A double blind placebo controlled randomized trial of the effect of acute uric acid changes on inflammatory markers in humans: A pilot study

PubMed Central

Milaneschi, Yuri; Zhang, Yongqing; Becker, Kevin G.; Zukley, Linda; Ferrucci, Luigi

2017-01-01

Uric acid has been linked with increased risk of chronic disease such as cardiovascular disease and this association has been attributed to a pro-inflammatory effect. Indeed, observational studies have shown that high uric acid is associated with high level of pro-inflammatory cytokines in the blood. However, whether high uric acid directly affects inflammation or rather represents a parallel defensive antioxidant mechanism in response to pathology that causes inflammation is unknown. To determine whether acute increase or decrease uric acid levels affects inflammation in healthy individuals, a randomized, placebo-controlled, double blind clinical study of uric acid or rasburicase with 20 healthy volunteers in each treatment-placebo group was conducted at the National Institute on Aging (NIA) Clinical Research Unit (CRU) at Harbor Hospital in Baltimore, MD. Change in inflammatory response was assessed by administering an oral lipid tolerance before and after the treatment of uric acid, rasburicase and placebo. Following uric acid administration, there was an accentuated increase in IL-6 during the oral lipid tolerance test (P<0.001). No significant differences were observed after lowering of uric acid with rasburicase. No side effects were reported throughout the trial. In health individuals, acute increase in uric acid results in an increased IL-6 response when challenged with lipid load. Such effect of amplification of inflammatory response may explain the higher risk of chronic diseases observed in subclinical hyperuricemia in observational studies. Trial Registration: ClinicalTrials.gov NCT01323335 PMID:28786993

Cellular transplants in amyotrophic lateral sclerosis patients: an observational study.

PubMed

Gamez, Josep; Carmona, Francesc; Raguer, Nuria; Ferrer-Sancho, Jaume; Martín-Henao, Gregorio A; Martí-Beltrán, Sergi; Badia, Merce; Gratacós, Margarita; Rodriguez-Gónzalez, Esther; Seoane, Jose Luis; Pallero-Castillo, Mercedes; Burgos, Rosa; Puiggros, Carolina; Pasarin, Alejandro; Bori-Fortuny, Inmaculada

2010-09-01

Cytotherapy is a promising option for neurodegenerative disease treatment. Because of the fatal prognosis and imperative need for effective treatment, amyotrophic lateral sclerosis (ALS) patients request this therapy before its effectiveness has been verified. The increase in clinics offering cytotherapies but providing little scientific information has prompted considerable medical tourism. We present an observational study of Spanish ALS patients receiving cytotherapy, analyzing the experiences arising from the treatment (TX) and considering two progression markers, FVC and ALSFRS-R. Twelve ALS patients with a mean age of 48.6 years (SD 12.8) received cytotherapy 26.9 months (SD 15.8) after clinical onset. ALSFRS-R and FVC at TX were 32.3 (SD 6.8) and 63.4% (SD 15.3), respectively. TX involved transplants of olfactory ensheathing cells in three patients, and autologous mesenchymal stromal cells in the remainder. One patient died 33 months post-TX after surviving for 49 months. Five required mechanical non-invasive home ventilation 7.4 months post-TX. Two required invasive ventilation 13 months post-TX. Five patients needed gastrostomy feeding 23.3 months post-TX. Survival between clinical onset and the study end date was 50 months (SD 17.2). No significant adverse events or changes in the decline of FVC and ALSFRS-R compared with the disease's natural history were observed. Our observations suggest that these therapies do not halt the course of the disease. Cytotherapy cannot yet be considered a curative treatment for ALS.

Clinical and Laboratory Characteristics of a Tinea Capitis Outbreak Among Novice Buddhist Monks.

PubMed

Bunyaratavej, Sumanas; Leeyaphan, Charussri; Rujitharanawong, Chuda; Muanprasat, Chanai; Matthapan, Lalita

2017-05-01

Sixty novice Buddhist monks with tinea capitis confirmed according to clinical presentation and mycological laboratory finding were included in this study. Mixed-type clinical presentation was observed in approximately half of all cases, together with scarring alopecia (95%) and superficial fungal skin infection at locations other than the scalp (43.3%). The major isolated organism was Trichophyton violaceum, and mixed-organism infection was found in 27 cases (45%). Slow-onset presentation and an extensive area of infection were significantly associated with mixed-type clinical presentation. © 2017 Wiley Periodicals, Inc.

Factors affecting receipt of chemotherapy in women with breast cancer

PubMed Central

Morimoto, Libby; Coalson, Jenna; Mowat, Fionna; O’Malley, Cynthia

2010-01-01

Aims: To review literature describing factors associated with receipt of chemotherapy for breast cancer, to better understand what factors are most relevant to women’s health and whether health disparities are apparent, and to assess how these factors might affect observational studies and outcomes research. Patterns of care for metastatic breast cancer, for which no standard-of-care exists, were of particular interest. Methods: Relevant studies written in English, Italian, French, or Spanish, published in 2000 or later, were identified through MEDLINE and reviewed. Review articles and clinical trials were excluded; all observational studies and surveys were considered. Articles were reviewed for any discussion of patient characteristics, hospital/physician/insurance characteristics, psychosocial characteristics, and clinical characteristics affecting receipt of chemotherapy by breast cancer patients. Results: In general, factors associated with increased likelihood of receiving chemotherapy included younger age, being Caucasian, having good general health and few co-morbidities, having more severe clinical disease, having responded well to previous treatment, and having breast cancer that is estrogen- or progesterone-receptor-negative. Many of the clinical factors found to increase the likelihood of receiving chemotherapy were consistent with current oncology guidelines. Of the relevant 19 studies identified, only six (32%) reported data specific to metastatic cancer; most studies aggregated women with stage I–IV for purposes of analysis. Conclusion: Studies of patterns of care in breast cancer treatment can help identify challenges in health care provided to particular subgroups of women and can aid researchers in designing studies that account for such factors in clinical and outcomes research. Although scarce, studies evaluating only women with metastatic breast cancer indicate that factors affecting decisions related to receipt of chemotherapy are similar across stage for this disease. PMID:21072304

A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries (protocol): the Australasian Paediatric Head Injury Rules Study (APHIRST).

PubMed

Babl, Franz E; Lyttle, Mark D; Bressan, Silvia; Borland, Meredith; Phillips, Natalie; Kochar, Amit; Dalziel, Stuart R; Dalton, Sarah; Cheek, John A; Furyk, Jeremy; Gilhotra, Yuri; Neutze, Jocelyn; Ward, Brenton; Donath, Susan; Jachno, Kim; Crowe, Louise; Williams, Amanda; Oakley, Ed

2014-06-13

Head injuries in children are responsible for a large number of emergency department visits. Failure to identify a clinically significant intracranial injury in a timely fashion may result in long term neurodisability and death. Whilst cranial computed tomography (CT) provides rapid and definitive identification of intracranial injuries, it is resource intensive and associated with radiation induced cancer. Evidence based head injury clinical decision rules have been derived to aid physicians in identifying patients at risk of having a clinically significant intracranial injury. Three rules have been identified as being of high quality and accuracy: the Canadian Assessment of Tomography for Childhood Head Injury (CATCH) from Canada, the Children's Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) from the UK, and the prediction rule for the identification of children at very low risk of clinically important traumatic brain injury developed by the Pediatric Emergency Care Applied Research Network (PECARN) from the USA. This study aims to prospectively validate and compare the performance accuracy of these three clinical decision rules when applied outside the derivation setting. This study is a prospective observational study of children aged 0 to less than 18 years presenting to 10 emergency departments within the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network in Australia and New Zealand after head injuries of any severity. Predictor variables identified in CATCH, CHALICE and PECARN clinical decision rules will be collected. Patients will be managed as per the treating clinicians at the participating hospitals. All patients not undergoing cranial CT will receive a follow up call 14 to 90 days after the injury. Outcome data collected will include results of cranial CTs (if performed) and details of admission, intubation, neurosurgery and death. The performance accuracy of each of the rules will be assessed using rule specific outcomes and inclusion and exclusion criteria. This study will allow the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting. The study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR)- ACTRN12614000463673 (registered 2 May 2014).

Workflow in clinical trial sites & its association with near miss events for data quality: ethnographic, workflow & systems simulation.

PubMed

de Carvalho, Elias Cesar Araujo; Batilana, Adelia Portero; Claudino, Wederson; Reis, Luiz Fernando Lima; Schmerling, Rafael A; Shah, Jatin; Pietrobon, Ricardo

2012-01-01

With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil. Two sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem. Patterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage professionals to reduce near miss events and save time/cost. Clinical trial sponsors should improve relevant support systems.

Workflow in Clinical Trial Sites & Its Association with Near Miss Events for Data Quality: Ethnographic, Workflow & Systems Simulation

PubMed Central

Araujo de Carvalho, Elias Cesar; Batilana, Adelia Portero; Claudino, Wederson; Lima Reis, Luiz Fernando; Schmerling, Rafael A.; Shah, Jatin; Pietrobon, Ricardo

2012-01-01

Background With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil. Methodology/Principal Findings Two sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem. Conclusions/Significance Patterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage professionals to reduce near miss events and save time/cost. Clinical trial sponsors should improve relevant support systems. PMID:22768105

Improvement of the clinical outcome in Ankylosing spondylitis by balneotherapy.

PubMed

Yurtkuran, Merih; Ay, Alev; Karakoç, Yüksel

2005-07-01

This study is designed to show the efficacy of balneotherapy and balneotherapy (BT) + nonsteroid antiinflammatory drug (NSAID) use in Ankylosing spondylitis (AS) patients. In this prospective study, BT, BT+ NSAID and NSAID therapy in 61 patients with AS were evaluated by ASAS core set. BT group (21 patients) was treated only with BT for 20 min, once a day, 5 days a week, over a period of 3 weeks. BT+NSAID group (20 patients) was treated with 1000 mg naproxen as well as BT. NSAID group (20 patients) was treated with 1000 mg naproxen. All of the participants did respiratory and postural exercises for 20 min a day and for the whole study period. Each patient was evaluated on admission (before treatment), at the end of the therapy and 6 months after the treatment. At the end of the study, statistically significant improvement was observed in all the clinical parameters of the patients in BT (G1), BT+NSAID (G2) and NSAID (G3) groups. This significant symptomatic and clinical improvement was maintained even 6 months after the treatment. The changes from baseline to follow up were similar in G1 and G2 except duration of morning stiffness (DMS) and chest expansion (CE). Improvements in CE and DMS were better in G1 and G2, respectively. Improvements observed in G1 and G2 were superior to the improvements observed in G3 for the variables of morning pain, nocturnal pain, DMS, global well being of the patient, occiput-wall distance, CE, finger to floor distance and functional index. In Schober test, improvement observed in G1 was statistically superior to G3. We concluded that BT can be suggested as an effective symptomatic treatment modality in patients with AS. Furthermore, sufficient improvement in clinical parameters can be obtained by BT alone.

Evaluation of a Standardized Extract from Morus alba against α-Glucosidase Inhibitory Effect and Postprandial Antihyperglycemic in Patients with Impaired Glucose Tolerance: A Randomized Double-Blind Clinical Trial

PubMed Central

Hwang, Seung Hwan; Li, Hong Mei; Wang, Zhiqiang

2016-01-01

To evaluate the antihyperglycemic effect of a standardized extract of the leaves of Morus alba (SEMA), the present study was designed to investigate the α-glucosidase inhibitory effect and acute single oral toxicity as well as evaluate blood glucose reduction in animals and in patients with impaired glucose tolerance in a randomized double-blind clinical trial. SEMA was found to inhibit α-glucosidase at a fourfold higher level than the positive control (acarbose), in a concentration-dependent manner. Moreover, blood glucose concentration was suppressed by SEMA in vivo. Clinical signs and weight changes were observed when conducting an evaluation of the acute toxicity of SEMA through a single-time administration, with clinical observation conducted more than once each day. After administration of the SEMA, observation was for 14 days; all of the animals did not die and did not show any abnormal symptoms. In addition, the inhibitory effects of rice coated with SEMA were evaluated in a group of impaired glucose tolerance patients on postprandial glucose and a group of normal persons, and results showed that SEMA had a clear inhibitory effect on postprandial hyperglycemia in both groups. Overall, SEMA showed excellent potential in the present study as a material for improving postprandial hyperglycemia. PMID:27974904

Implementation research to improve quality of maternal and newborn health care, Malawi.

PubMed

Brenner, Stephan; Wilhelm, Danielle; Lohmann, Julia; Kambala, Christabel; Chinkhumba, Jobiba; Muula, Adamson S; De Allegri, Manuela

2017-07-01

To evaluate the impact of a performance-based financing scheme on maternal and neonatal health service quality in Malawi. We conducted a non-randomized controlled before and after study to evaluate the effects of district- and facility-level performance incentives for health workers and management teams. We assessed changes in the facilities' essential drug stocks, equipment maintenance and clinical obstetric care processes. Difference-in-difference regression models were used to analyse effects of the scheme on adherence to obstetric care treatment protocols and provision of essential drugs, supplies and equipment. We observed 33 health facilities, 23 intervention facilities and 10 control facilities and 401 pregnant women across four districts. The scheme improved the availability of both functional equipment and essential drug stocks in the intervention facilities. We observed positive effects in respect to drug procurement and clinical care activities at non-intervention facilities, likely in response to improved district management performance. Birth assistants' adherence to clinical protocols improved across all studied facilities as district health managers supervised and coached clinical staff more actively. Despite nation-wide stock-outs and extreme health worker shortages, facilities in the study districts managed to improve maternal and neonatal health service quality by overcoming bottlenecks related to supply procurement, equipment maintenance and clinical performance. To strengthen and reform health management structures, performance-based financing may be a promising approach to sustainable improvements in quality of health care.

Clinical response and mortality in tigecycline complicated intra-abdominal infection and complicated skin and soft-tissue infection trials.

PubMed

Bassetti, Matteo; McGovern, Paul C; Wenisch, Christoph; Meyer, R Daniel; Yan, Jean Li; Wible, Michele; Rottinghaus, Scott T; Quintana, Alvaro

2015-09-01

An imbalance in all-cause mortality was noted in tigecycline phase 3 and 4 comparative clinical trials across all studied indications. We investigated clinical failure and mortality in phase 3 and 4 complicated skin and soft-tissue infection (cSSTI) and complicated intra-abdominal infection (cIAI) tigecycline trials using descriptive analyses of a blinded adjudication of mortality and multivariate regression analyses. Attributable mortality analyses of cSSTI revealed death due to infection in 0.1% of each treatment group (P=1.000). In cIAI, there were no significant differences between tigecycline (1.2%) and comparator (0.7%) subjects who died due to infection (P=0.243). For cIAI clinical failure, treatment interaction with organ dysfunction was observed with no difference observed between clinical cure for tigecycline (85.4%) and comparator (76.7%) treatment groups (odds ratio=0.58, 95% confidence interval 0.28-1.19). Tigecycline-treated subjects had more adverse events of secondary pneumonias (2.1% vs. 1.2%) and more adverse events of secondary pneumonias with an outcome of death (0.5% vs. 0.1%). These analyses do not suggest that tigecycline is a factor either for failure (cSSTI and cIAI studies) or for death (cIAI studies). Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

Ablation effects of noninvasive radiofrequency field-induced hyperthermia on liver cancer cells.

PubMed

Chen, Kaiyun; Zhu, Shuguang; Xiang, Guoan; Duan, Xiaopeng; He, Jiwen; Chen, Guihua

2016-05-01

To have in-depth analysis of clinical ablation effect of noninvasive radiofrequency field-induced hyperthermia on liver cancer cells, this paper collected liver cancer patients' treatment information from 10 hospitals during January 2010 and December 2011, from which 1050 cases of patients were randomly selected as study object of observation group who underwent noninvasive radiofrequency field-induced hyperthermia treatment; in addition, 500 cases of liver cancer patients were randomly selected as study object of control group who underwent clinical surgical treatment. After treatment was completed, three years of return visit were done, survival rates of the two groups of patients after 1 year, 2 years, and 3 years were compared, and clinical effects of radiofrequency ablation of liver cancer were evaluated. Zoom results show that the two groups are similar in terms of survival rate, and the difference is without statistical significance. 125 patients in observation group had varying degrees of adverse reactions, while 253 patients in control group had adverse reactions. There was difference between groups P < 0.05, with significant statistical significance. It can be concluded that radiofrequency ablation of liver cancer is more secure. Therefore, the results of this study fully demonstrate that liver cancer treatment with noninvasive radiofrequency field-induced hyperthermia is with safety effect and satisfactory survival rate, thus with relatively high clinical value in clinical practice.

Bisoprolol for the treatment of chronic heart failure: a meta-analysis on individual data of two placebo-controlled studies--CIBIS and CIBIS II. Cardiac Insufficiency Bisoprolol Study.

PubMed

Leizorovicz, Alain; Lechat, Philippe; Cucherat, Michel; Bugnard, Françoise

2002-02-01

Despite the available evidence from randomized clinical trials, beta-blockers are often not used optimally in patients with congestive heart failure (CHF). This meta-analysis aims at providing a precise and quantitative estimate of the benefit and risks of long-term bisoprolol on major clinical events in patients with CHF, both overall and in selected subgroups. This may help clinicians in their decisions as to whether to prescribe bisoprolol for their individual patients. Meta-analysis was performed of results from the 2 randomized, controlled clinical studies in which bisoprolol was compared with placebo (Cardiac Insufficiency Bisoprolol Study [CIBIS and CIBIS II]), which included 3288 patients with proven CHF. The main outcomes were total death, cardiovascular death, sudden death, hospitalization for heart failure, and myocardial infarction. A highly significant 29.3% relative reduction of death (17%, 40%; P =.00003) was observed, as well as significant risk reduction in cardiovascular death and sudden death in favor of bisoprolol. Also, a highly significant relative reduction of 18.4% (25%, 11%; P =.00001) in hospital admission or death was observed. A similar relative reduction of death was consistently observed in selected subgroups of patients. Bisoprolol prevents major cardiovascular events in patients with CHF with a high benefit-to-risk ratio and can be recommended for these patients.

Cannabis (medical marijuana) treatment for motor and non-motor symptoms of Parkinson disease: an open-label observational study.

PubMed

Lotan, Itay; Treves, Therese A; Roditi, Yaniv; Djaldetti, Ruth

2014-01-01

The use of cannabis as a therapeutic agent for various medical conditions has been well documented. However, clinical trials in patients with Parkinson disease (PD) have yielded conflicting results. The aim of the present open-label observational study was to assess the clinical effect of cannabis on motor and non-motor symptoms of PD. Twenty-two patients with PD attending the motor disorder clinic of a tertiary medical center in 2011 to 2012 were evaluated at baseline and 30 minutes after smoking cannabis using the following battery: Unified Parkinson Disease Rating Scale, visual analog scale, present pain intensity scale, Short-Form McGill Pain Questionnaire, as well as Medical Cannabis Survey National Drug and Alcohol Research Center Questionnaire. Mean (SD) total score on the motor Unified Parkinson Disease Rating Scale score improved significantly from 33.1 (13.8) at baseline to 23.2 (10.5) after cannabis consumption (t = 5.9; P < 0.001). Analysis of specific motor symptoms revealed significant improvement after treatment in tremor (P < 0.001), rigidity (P = 0.004), and bradykinesia (P < 0.001). There was also significant improvement of sleep and pain scores. No significant adverse effects of the drug were observed. The study suggests that cannabis might have a place in the therapeutic armamentarium of PD. Larger, controlled studies are needed to verify the results.

A study to derive a clinical decision rule for triage of emergency department patients with chest pain: design and methodology

PubMed Central

Hess, Erik P; Wells, George A; Jaffe, Allan; Stiell, Ian G

2008-01-01

Background Chest pain is the second most common chief complaint in North American emergency departments. Data from the U.S. suggest that 2.1% of patients with acute myocardial infarction and 2.3% of patients with unstable angina are misdiagnosed, with slightly higher rates reported in a recent Canadian study (4.6% and 6.4%, respectively). Information obtained from the history, 12-lead ECG, and a single set of cardiac enzymes is unable to identify patients who are safe for early discharge with sufficient sensitivity. The 2007 ACC/AHA guidelines for UA/NSTEMI do not identify patients at low risk for adverse cardiac events who can be safely discharged without provocative testing. As a result large numbers of low risk patients are triaged to chest pain observation units and undergo provocative testing, at significant cost to the healthcare system. Clinical decision rules use clinical findings (history, physical exam, test results) to suggest a diagnostic or therapeutic course of action. Currently no methodologically robust clinical decision rule identifies patients safe for early discharge. Methods/design The goal of this study is to derive a clinical decision rule which will allow emergency physicians to accurately identify patients with chest pain who are safe for early discharge. The study will utilize a prospective cohort design. Standardized clinical variables will be collected on all patients at least 25 years of age complaining of chest pain prior to provocative testing. Variables strongly associated with the composite outcome acute myocardial infarction, revascularization, or death will be further analyzed with multivariable analysis to derive the clinical rule. Specific aims are to: i) apply standardized clinical assessments to patients with chest pain, incorporating results of early cardiac testing; ii) determine the inter-observer reliability of the clinical information; iii) determine the statistical association between the clinical findings and the composite outcome; and iv) use multivariable analysis to derive a highly sensitive clinical decision rule to guide triage decisions. Discussion The study will derive a highly sensitive clinical decision rule to identify low risk patients safe for early discharge. This will improve patient care, lower healthcare costs, and enhance flow in our busy and overcrowded emergency departments. PMID:18254973

Effectiveness of Internet-based cognitive-behavior therapy for social anxiety disorder in clinical psychiatry.

PubMed

El Alaoui, Samir; Hedman, Erik; Kaldo, Viktor; Hesser, Hugo; Kraepelien, Martin; Andersson, Evelyn; Rück, Christian; Andersson, Gerhard; Ljótsson, Brjánn; Lindefors, Nils

2015-10-01

Internet-based cognitive-behavioral therapy (ICBT) has received increased attention as an innovative approach to improve access to evidence-based psychological treatments. Although the efficacy of ICBT for social anxiety disorder has been established in several studies, there is limited knowledge of its effectiveness and application in clinical psychiatric care. The purpose of this study was to evaluate the effectiveness of ICBT in the treatment of social anxiety disorder and to determine the significance of patient adherence and the clinic's years of experience in delivering ICBT. A longitudinal cohort study was conducted using latent growth curve modeling of patients (N = 654) treated with ICBT at an outpatient psychiatric clinic between 2009 and 2013. The primary outcome measure was the Liebowitz Social Anxiety Scale-Self-Rated. Significant reductions in symptoms of social anxiety were observed after treatment (effect size d = 0.86, 99% CI [0.74, 0.98]). Improvements were sustained at 6-month follow-up (d = 1.15, 99% CI [0.99, 1.32]). Patient adherence had a positive effect on the rate of improvement. A positive association between the clinic's years of experience with ICBT and treatment outcome was also observed. This study suggests that ICBT for social anxiety disorder is effective when delivered within the context of a unit specialized in Internet-based psychiatric care and may be considered as a treatment alternative for implementation within the mental health care system. (c) 2015 APA, all rights reserved).

Improving access to interventions among mothers screened positive for post-partum depression (PPD) at National Programme on Immunization (NPI) clinics in south-western and south-eastern Nigeria - A service development report.

PubMed

Bakare, Muideen O; Bello-Mojeed, Mashudat A; Munir, Kerim M; Duduyemi, Olaniyi O; Orovwigho, Andrew O; Odetunde, Odutola I; Taiwo, Olufemi G; Olofinlade, Jushua A; Omotoso, Olakunle N; Famurewa, Olayinka H; Omolabi, Oladipupo O; Jejeloye, Adebayo O

2017-01-01

We investigate the possibility of improving access to interventions among mothers screened positive for post-partum depression (PPD) at National Programme on Immunization (NPI) clinics randomly selected from Lagos and Enugu States in south-western and south-eastern Nigeria respectively. The principle of human centred design was employed by engaging the mothers screened positive for PPD to be part of the decision making regarding their further assessment and intervention services. The study brought intervention services to primary healthcare centre at the NPI clinics. Improvement in willingness to seek interventions was observed among the mothers screened positive for PPD in this study when compared to our observation in a previous report, where mothers diagnosed with PPD were referred and requested to visit a mental health facility closer to their NPI clinics for further assessment and interventions (95.2% versus 33.7%). Interventional services for the mothers diagnosed with PPD also impact positively on the growth parameters of their infants on follow-up. Principle of human centred design improved access to intervention services among the mothers and infants studied. NPI clinics at primary healthcare level would provide appropriate forum for early screening of mothers for PPD and interventions in low-resource setting like Nigeria. There would be improvement in maternal and child health coverage if the Nigerian Government can adapt human centred design principles employed in this study nationwide.

Tafenoquine is not neurotoxic following supertherapeutic dosing in rats.

PubMed

Dow, Geoffrey S; Brown, Tracey; Reid, Mark; Smith, Bryan; Toovey, Stephen

Tafenoquine is a new drug for malaria prevention. The goal of the present work was to conduct a specific neurobehavioral study in rats with histopathological assessment of the brain. The clinical, hematological, behavioral, motor activity, and neurohistopathologic changes induced by different dose levels of tafenoquine were evaluated following single super-therapeutic dose administration. Toxicokinetic data were generated to allow extrapolation to clinical exposures. At the highest dose (500 mg/kg), two animals (of 12) died. Surviving animals showed clinical signs of toxicity and had reduced body weight 7-8 days after dosing. Decreases in motor activity were observed on more than one occasion at doses > 9-fold higher than the clinical exposure. No statistically significant changes were observed for other behavioral endpoints. No neurohistopathological changes were noted. Changes in hematological and clinical pathology endpoints were observed at the lowest dose level (125 mg/kg). For context, the human dosing regimen is a 10 mg/kg load followed by 3.3 mg/kg weekly (in a 60 kg person). As in humans, adverse events other than neurotoxicity were dose-limiting for tafenoquine in rats. This raises the prospect that a new weekly prophylactic, without neurologic liability, may become available in the near future. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Exploring the clinical decision-making used by experienced cardiorespiratory physiotherapists: A mixed method qualitative design of simulation, video recording and think aloud techniques.

PubMed

Thackray, Debbie; Roberts, Lisa

2017-02-01

The ability of physiotherapists to make clinical decisions is a vital component of being an autonomous practitioner, yet this complex phenomenon has been under-researched in cardiorespiratory physiotherapy. The purpose of this study was to explore clinical decision-making (CDM) by experienced physiotherapists in a scenario of a simulated patient experiencing acute deterioration of their respiratory function. The main objective of this observational study was to identify the actions, thoughts, and behaviours used by experienced cardiorespiratory physiotherapists in their clinical decision-making processes. A mixed-methods (qualitative) design employing observation and think-aloud, was adopted using a computerised manikin in a simulated environment. The participants clinically assessed the manikin programmed with the same clinical signs, under standardised conditions in the clinical skills practice suite, which was set up as a ward environment. Experienced cardiorespiratory physiotherapists, recruited from clinical practice within a 50-mile radius of the University(*). Participants were video-recorded throughout the assessment and treatment and asked to verbalise their thought processes using the 'think-aloud' method. The recordings were transcribed verbatim and managed using a Framework approach. Eight cardiorespiratory physiotherapists participated (mean 7years clinical experience, range 3.5-16years. CDM was similar to the collaborative hypothetico-deductive model, five-rights nursing model, reasoning strategies, inductive reasoning and pattern recognition. However, the CDM demonstrated by the physiotherapists was complex, interactive and iterative. Information processing occurred continuously throughout the whole interaction with the patient, and the specific cognitive skills of recognition, matching, discriminating, relating, inferring, synthesising and prediction were identified as being used sequentially. The findings from this study were used to develop a new conceptual model of clinical decision-making for cardiorespiratory physiotherapy. This conceptual model can be used to inform future educational strategies to prepare physiotherapists and nurses for working in acute respiratory care. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Idiopathic inflammatory myositis.

PubMed

Tieu, Joanna; Lundberg, Ingrid E; Limaye, Vidya

2016-02-01

Knowledge on idiopathic inflammatory myopathy (IIM) has evolved with the identification of myositis-associated and myositis-specific antibodies, development of histopathological classification and the recognition of how these correlate with clinical phenotype and response to therapy. In this paper, we outline key advances in diagnosis and histopathology, including the more recent identification of antibodies associated with immune-mediated necrotising myopathy (IMNM) and inclusion body myositis (IBM). Ongoing longitudinal observational cohorts allow further classification of these patients with IIM, their predicted clinical course and response to specific therapies. Registries have been developed worldwide for this purpose. A challenging aspect in IIM, a multisystem disease with multiple clinical subtypes, has been defining disease status and clinically relevant improvement. Tools for assessing activity and damage are now recognised to be important in determining disease activity and guiding therapeutic decision-making. The International Myositis Assessment and Clinical Studies (IMACS) group has developed such tools for use in research and clinical settings. There is limited evidence for specific treatment strategies in IIM. With significant development in the understanding of IIM and improved classification, longitudinal observational cohorts and trials using validated outcome measures are necessary, to provide important information for evidence-based care in the clinical setting. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Using case study within a sequential explanatory design to evaluate the impact of specialist and advanced practice roles on clinical outcomes: the SCAPE study.

PubMed

Lalor, Joan G; Casey, Dympna; Elliott, Naomi; Coyne, Imelda; Comiskey, Catherine; Higgins, Agnes; Murphy, Kathy; Devane, Declan; Begley, Cecily

2013-04-08

The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed 'different', and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Multiple approaches to data collection are needed to evaluate the impact of complex roles and interventions in health care outcomes and service delivery. Case study design is an appropriate methodology to use when study outcomes relate to clinical practice.

Understanding Study Participants Views on Co-Creation of Data and Use of EHR in Clinical Studies.

PubMed

Scott Duncan, Therese; Hägglund, Maria

2018-01-01

In order to increase clinical trial participation, the reasons for participating need to be observed. Since there is rather inadequate information concerning how individuals such as patients, decides to participate in clinical trials semi-structured interviews have been done. Examining the use of EHR in clinical trials and co-creation of data, the result showed that it is important for the researches to have access to the patients' EHR and for the patients to contribute with their own ideas of research. Important aspects of further participation in clinical trials were that it should be fun and informative. The patients agreed on that the effort of participating could decrease with the use of electronically collection and self-reporting of data, e.g. through a patient portal.

Ragweed sublingual tablet immunotherapy: part I - evidence-based clinical efficacy and safety.

PubMed

Creticos, Peter Socrates; Pfaar, Oliver

2018-06-01

Sublingual tablet immunotherapy provides an attractive alternative approach to allergen immunotherapy, as the allergen is administered as a rapidly dissolving sublingual tablet. Part I of this two-part series on the ragweed sublingual tablet describes the dose-ranging clinical work, the safety studies and the clinical outcomes from the pivotal trials which provide clear evidence for statistically significant and clinically meaningful benefit in the treatment of patients suffering from ragweed-induced seasonal allergic rhinitis-conjunctivitis with or without milder asthma. The robust results observed in the clinical trials performed with the ragweed sublingual tablet are defined by the quality of their study design, their use of a standardized allergen extract, their consistent reproducibility in demonstrating therapeutic efficacy and their properly quantified and graded safety data.

Chronic myelocytic leukaemia with unusual (27 years) complete remission terminating in acute undifferentiated leukaemia: a clinical and karyotypic study.

PubMed

Najean, Y; Miclea, M; Tanzer, J; Lessard, M; Sigaux, F

1991-07-01

A case of clinically typical CML (300 x 10(6)/l leukocytes, 400 x 10(6)/l platelets, splenomegaly) is presented. After complete remission induced by busulphan, no clinical or haematological abnormalities were observed for 27 years until the development of acute leukaemia (type M1), which was rapidly fatal after a brief chemotherapy-induced remission. The cytogenetic findings were also original: no chromosome Ph1 (during remission 3 years after the onset of the disease), no translocation (banding study 5 years later), and no bcr/abl rearrangement (during the terminal phase).

Nursing students' early exposure to clinical practice: an innovation in curriculum development.

PubMed

Hoyles, A; Pollard, C; Lees, S; Glossop, D

2000-08-01

This paper describes a pilot study addressing issues surrounding the balance and status given to both theory and practice in the foundation part of a pre-registration programme. Contemporary thinking seems to suggest that there is a need to reverse recent trends which have placed an emphasis on theory. To facilitate this a framework for clinical learning was adapted to guide students' early exposure to clinical practice. The focus was to develop the students' observational and reflective skills whilst also providing the students with a frame of reference within which they could explore their theoretical studies. The information and experiences gained as a result of this study have led to the integration of an Orientation Framework to support students' early clinical experiences in a pre-registration programme.

Observed use of standard precautions in Chilean community clinics.

PubMed

Ferrer, Lilian Marcela; Cianelli, Rosina; Norr, Kathleen F; Cabieses, Baltica; Araya, Alejandra; Irarrázabal, Lisette; Bernales, Margarita

2009-01-01

In Chile, little information about the use of standard precautions (SP) among health care workers (HCWs) exists. As part of a larger study to tailor and test an HIV prevention intervention for community HCWs, this study describes the observed frequency with which appropriate SP were used by HCWs in low-income community clinics of Santiago. Also, the availability of supplies is described. A total of 52 structured observations with potential contamination with body fluids were done. HCWs used SP inconsistently, especially neglecting hand washing, surface cleaning, and cleaning of shared materials. Lack of materials contributed in some instances of failure to use SPs, especially wiping surfaces and safe disposal of sharp instruments, as shown by a positive correlation between use of SP and availability of materials. Essential materials were usually available. Although more education should relate to a better understanding of the importance of SP, no difference was found between professionals and paraprofessionals in the use of SP. It is clear that the initial training, continuing education, and ongoing support for practicing SP are not adequate. Training should be offered to HCWs involved in caring for clients at community clinics to stop the spread of HIV or other infectious diseases in health care settings.

Clinical study of Manjishthadi Ghrita in vrana ropana

PubMed Central

Baria, Jyoti; Gupta, S. K.; Bhuyan, C.

2011-01-01

Healing of vrana (wound) is either primary or secondary by nature. Secondary healing requires more attention than primary healing. Basically, two things, shodhana (making free from undesirable healing factors) and ropana (closure of wound), are desirable for proper healing. Many drugs have been described in classics for healing, but none of them is capable of healing the wound individually. Hence, to fulfill the aim, manjishthadi ghrita was prepared with the help of 7 drugs having vrana ropana effects and was evaluated clinically for its healing properties in this study. It was used topically in postoperative wounds, mostly of ano-rectal cases, twice a day, for 21 days. The follow-up period was 1 month to observe the healing as well as vaikritapaham (reduced deformity) properties and any untoward effects of the drug. A randomized control clinical trial was done. Out of 45 patients, 24 patients in group A were treated with “Manjishthadi Ghrita” (treated group), while 21 patients in group B (standard group) treated with povidine iodine ointment. Better result was observed in the treated group in comparison to the standard group. No adverse effect was observed in any patient. Manjishthadi ghrita can be prescribed as a local healing agent for common wound. PMID:22131765

A subchronic dietary toxicity study of rice hull fiber in rats.

PubMed

Gao, Yonglin; Shen, Jingyu; Yin, Jungang; Li, Chunmei; Fu, Chengyu; Cho, Susan

2013-01-01

We conducted a 90-day feeding study to investigate subchronic toxicity of rice hull fiber. Sprague Dawley rats were randomly divided into four groups; each received a diet containing 0%, 2.5%, 3.75% and 5.0% (w/w) rice hull fiber for 90days. Clinical observations were carried out daily, with weekly measurements of body weight and food consumption. We performed ophthalmic and histological examinations at termination. Blood and urine samples were collected to measure hematology and clinical chemistry parameters. No mortality, ophthalmic abnormalities, or adverse treatment-related effects were seen during clinical observations, hematological tests, or analyses of urine. Macroscopic or microscopic examinations of organs revealed no treatment related abnormalities. The only treatment related significant changes were reduced concentrations of fasting blood glucose (up to 17.6%) and cholesterol (up to 22.0%), typical benefits of dietary fiber, in males treated with 3.75 and 5% rice hull fiber. The no-observed-adverse-effect-level (NOAEL) for rice hull fiber was 5.0% for both genders (females, 3.80g/kg body weight/day; males, 4.11g/kg body weight/day). Copyright © 2012 Elsevier Ltd. All rights reserved.

Computer-assisted bar-coding system significantly reduces clinical laboratory specimen identification errors in a pediatric oncology hospital.

PubMed

Hayden, Randall T; Patterson, Donna J; Jay, Dennis W; Cross, Carl; Dotson, Pamela; Possel, Robert E; Srivastava, Deo Kumar; Mirro, Joseph; Shenep, Jerry L

2008-02-01

To assess the ability of a bar code-based electronic positive patient and specimen identification (EPPID) system to reduce identification errors in a pediatric hospital's clinical laboratory. An EPPID system was implemented at a pediatric oncology hospital to reduce errors in patient and laboratory specimen identification. The EPPID system included bar-code identifiers and handheld personal digital assistants supporting real-time order verification. System efficacy was measured in 3 consecutive 12-month time frames, corresponding to periods before, during, and immediately after full EPPID implementation. A significant reduction in the median percentage of mislabeled specimens was observed in the 3-year study period. A decline from 0.03% to 0.005% (P < .001) was observed in the 12 months after full system implementation. On the basis of the pre-intervention detected error rate, it was estimated that EPPID prevented at least 62 mislabeling events during its first year of operation. EPPID decreased the rate of misidentification of clinical laboratory samples. The diminution of errors observed in this study provides support for the development of national guidelines for the use of bar coding for laboratory specimens, paralleling recent recommendations for medication administration.

Comprehensive oral-health assessment of individuals with acquired brain-injury in neuro-rehabilitation setting.

PubMed

Kothari, Mohit; Spin-Neto, Rubens; Nielsen, Jørgen Feldbæk

2016-01-01

To perform a detailed clinical oral health assessment and oral-health-related social and behavioural aspect assessment in individuals with acquired brain injury (ABI). Prospective observational study. Thirteen individuals with ABI were recruited. Individual's social and behavioural history, bed-side oral examination score (BOE), tooth condition and periodontal status (bleeding, plaque and clinical attachment loss) were thoroughly examined. The entire examination took up to 60 minutes, using proper dental armamentarium. All evaluated individuals were diagnosed with chronic generalized periodontitis. A relationship between active periodontal disease and severe BOE score was observed (p = 0.01). Significant interaction between severe BOE scores (≥ 15 or ≥ 14) and periodontal disease severity of ≥ 2 mm (p = 0.01) was observed. The same interaction was seen between severe BOE scores and the combination of 75% extent and 2 mm severity (p = 0.01). Severity and activity of periodontitis showed dependence on individual brushing frequency (p = 0.03 and p = 0.05, respectively). Individuals with ABI had a poor status across a range of oral-, dental- and periodontal-related parameters. Further structured studies are required to define evidence-based assessment approaches for such clinical reality.

Caregiver person-centeredness and behavioral symptoms during mealtime interactions: development and feasibility of a coding scheme.

PubMed

Gilmore-Bykovskyi, Andrea L

2015-01-01

Mealtime behavioral symptoms are distressing and frequently interrupt eating for the individual experiencing them and others in the environment. A computer-assisted coding scheme was developed to measure caregiver person-centeredness and behavioral symptoms for nursing home residents with dementia during mealtime interactions. The purpose of this pilot study was to determine the feasibility, ease of use, and inter-observer reliability of the coding scheme, and to explore the clinical utility of the coding scheme. Trained observers coded 22 observations. Data collection procedures were acceptable to participants. Overall, the coding scheme proved to be feasible, easy to execute and yielded good to very good inter-observer agreement following observer re-training. The coding scheme captured clinically relevant, modifiable antecedents to mealtime behavioral symptoms, but would be enhanced by the inclusion of measures for resident engagement and consolidation of items for measuring caregiver person-centeredness that co-occurred and were difficult for observers to distinguish. Published by Elsevier Inc.

A bias-adjusted evidence synthesis of RCT and observational data: the case of total hip replacement.

PubMed

Schnell-Inderst, Petra; Iglesias, Cynthia P; Arvandi, Marjan; Ciani, Oriana; Matteucci Gothe, Raffaella; Peters, Jaime; Blom, Ashley W; Taylor, Rod S; Siebert, Uwe

2017-02-01

Evaluation of clinical effectiveness of medical devices differs in some aspects from the evaluation of pharmaceuticals. One of the main challenges identified is lack of robust evidence and a will to make use of experimental and observational studies (OSs) in quantitative evidence synthesis accounting for internal and external biases. Using a case study of total hip replacement to compare the risk of revision of cemented and uncemented implant fixation modalities, we pooled treatment effect estimates from OS and RCTs, and simplified existing methods for bias-adjusted evidence synthesis to enhance practical application. We performed an elicitation exercise using methodological and clinical experts to determine the strength of beliefs about the magnitude of internal and external bias affecting estimates of treatment effect. We incorporated the bias-adjusted treatment effects into a generalized evidence synthesis, calculating both frequentist and Bayesian statistical models. We estimated relative risks as summary effect estimates with 95% confidence/credibility intervals to capture uncertainty. When we compared alternative approaches to synthesizing evidence, we found that the pooled effect size strongly depended on the inclusion of observational data as well as on the use bias-adjusted estimates. We demonstrated the feasibility of using observational studies in meta-analyses to complement RCTs and incorporate evidence from a wider spectrum of clinically relevant studies and healthcare settings. To ensure internal validity, OS data require sufficient correction for confounding and selection bias, either through study design and primary analysis, or by applying post-hoc bias adjustments to the results. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

Role of interleukin-6 as an early marker of fat embolism syndrome: a clinical study.

PubMed

Prakash, Shiva; Sen, Ramesh Kumar; Tripathy, Sujit Kumar; Sen, Indu Mohini; Sharma, R R; Sharma, Sadhna

2013-07-01

A few animal studies have shown that IL-6 can serve as an early marker of fat embolism syndrome. The degree to which this is true in human trauma victims is unknown. In this clinical study, we sought to determine (1) whether elevated serum IL-6 levels at 6, 12, and 24 hours in patients with skeletal trauma were associated with the development of fat embolism syndrome (FES) within 72 hours after injury, and (2) at what time after trauma peak IL-6 levels are observed. Forty-eight patients between 16 and 40 years old who presented to our tertiary trauma center within 6 hours of injury with long bone and/or pelvic fractures were included in this study. Serum IL-6 levels were measured at 6, 12, and 24 hours after injury. The patients were observed clinically and monitored for 72 hours for development of FES symptoms. Gurd's criteria were used to diagnose FES. Elevated serum IL-6 levels 12 hours after trauma correlated with an increased likelihood of having FES develop; no significant relationship was observed between IL-6 levels at 6 or 24 hours and the development of FES. Patients with FES had a mean IL-6 level of 131 pg/mL, whereas those without FES had a mean IL-6 level of 72 pg/mL. Peak IL-6 levels were observed at 12 hours. An elevated serum IL-6 level may be useful as an early marker of FES in patients with isolated skeletal trauma. Level II, diagnostic study. See Guidelines for Authors for a complete description of levels of evidence.