Clinical Knowledge from Observational Studies: Everything You Wanted to Know but Were Afraid to Ask.

PubMed

Gershon, Andrea S; Jafarzadeh, S Reza; Wilson, Kevin C; Walkey, Allan J

2018-05-07

Well-done randomized trials provide accurate estimates of treatment effect by producing groups that are similar on all measures except for the intervention of interest. However, inferences of efficacy in tightly-controlled experimental settings may not translate into similar effectiveness in real-world settings. Observational studies generally enable inferences over a wider range of patient characteristics and evaluation of a broader range of outcomes over a longer period than randomized trials. However, clinicians are often reluctant to incorporate the findings of observational studies into clinical practice. Reason for uncertainty regarding observational studies include a lack of familiarity with observational research methods, occasional disagreements between results of observational studies and randomized trials, the perceived risk of spurious results from systematic bias, and prior teaching that randomized trials are the most reliable source of medical evidence. We propose that a better understanding of observational research will enhance clinicians' ability to distinguish reliable observational studies from those that are subjected to biases and, therefore, provide more confidence to apply observational research results into clinical practice when appropriate. Herein, we explain why observational studies may be perceived as less conclusive than randomized trials, address situations in which observational research and randomized trials produced different findings, and provide information on observational study design so that quality can be evaluated. We conclude that observational research is a valuable source of medical evidence and that clinical action is strongest when supported by both high quality observational studies and randomized trials.

Diagnosing dehydration? Blend evidence with clinical observations.

PubMed

Armstrong, Lawrence E; Kavouras, Stavros A; Walsh, Neil P; Roberts, William O

2016-11-01

The purpose of the review is to provide recommendations to improve clinical decision-making based on the strengths and weaknesses of commonly used hydration biomarkers and clinical assessment methods. There is widespread consensus regarding treatment, but not the diagnosis of dehydration. Even though it is generally accepted that a proper clinical diagnosis of dehydration can only be made biochemically rather than relying upon clinical signs and symptoms, no gold standard biochemical hydration index exists. Other than clinical biomarkers in blood (i.e., osmolality and blood urea nitrogen/creatinine) and in urine (i.e., osmolality and specific gravity), blood pressure assessment and clinical symptoms in the eye (i.e., tear production and palpitating pressure) and the mouth (i.e., thirst and mucous wetness) can provide important information for diagnosing dehydration. We conclude that clinical observations based on a combination of history, physical examination, laboratory values, and clinician experience remain the best approach to the diagnosis of dehydration.

[Clinical observation on fuzhong (supporting the middle-jiao) manipulation of tuina for infantile anorexia].

PubMed

Wang, Yuan-Yuan; Liu, Xiao-Ying

2014-01-01

To observe clinical therapeutic effect of fuzhong (supporting the middle-jiao) manipulation of tuina for infantile anorexia. Eighty-one children with anorexia were treated with fuzhong manipulation, including abdominal kneading, acupressure at Zhongwan (CV 12), Lanmen (Extra), Tianshu (ST 25), Zusanli (ST 36), Sanyinjiao (SP 6), spine pinching, warm moxibustion and warm scraping with supporting-yang cupping, three times a week, six times as a session. Onset time, therapeutic effect and TCM symptom scores before and after treatment were observed after two sessions and differences of therapeutic effect among different patterns were compared. Seventy-two children had the effect in one session while 41 children had the effect within half of a session. 38 cases were clinically cured, 15 cases were markedly effective, 23 cases were effective and 5 cases were failed. The total effective rate was 93.8%. Compared with before treatment, TCM symptom scores, including appetite, food intake, complexion and defecation, were all obviously improved after treatment (all P < 0.001). The clinical cured rate was 45.2% (19/42) in the pattern of dysfunction of spleen in transportation, 45.8% (11/24) in the pattern of qi deficiency of spleen and stomach, 50.0% (4/8) in the pattern of yin deficiency of spleen and stomach, 57.1% (4/7) in the pattern of liver sufficiency and spleen insufficiency, which had no obvious differences among different patterns (all P > 0.05). The fuzhong manipulation of tuina has quick onset time and satisfied clinical therapeutic effect, which could obviously improve symptoms and is fit for different patterns of infantile anorexia.

Reflective Observation in the Clinical Education Setting: A Way to Promote Learning

ERIC Educational Resources Information Center

Mazerolle, Stephanie M.; Bowman, Thomas G.; Benes, Sarah S.

2015-01-01

Context: Clinical experiences help athletic training students gain real-time learning experiences by engaging in patient care. Observational learning has been identified as important to athletic training student development, yet little is known about its effectiveness. Objective: To explore the athletic training students' perspectives on their…

How clinical observation enhances recruitment and selection.

PubMed

Sutherland, Clare

2012-11-01

A survey of nurse managers in Derby Hospitals NHS Foundation Trust in 2010 found 51 practitioners working at an advanced clinical level, but there were variations in titles, pay bands, clinical skills and academic qualifications. This prompted the introduction of a local framework to support the development of the advanced nurse practitioner (ANP) role and a review of the interview process to enable managers to assess applicants' skills, competencies and knowledge. The process is now used in practice, with candidates' clinical skills now observed as part of the ANP selection process. This article describes how the new process works.

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

Gas formation and biological effects of biodegradable magnesium in a preclinical and clinical observation

PubMed Central

Lee, Kwang-Bok; Bode, Ken; Kwon, Tae-Young; Jeon, Moo Heon

2018-01-01

Abstract Magnesium alloys are biodegradable metals receiving increasing attention, but the clinical applications of these materials are delayed by concerns over the rapid corrosion rate and gas formation. Unlike corrosion, which weakens mechanical properties, the gas formation issue has received little attention. Therefore, we evaluated the gas formation and biological effects for Mg implants through preclinical (immersed in Earle’s balanced salt solution and in vivo) and clinical studies. The immersion test examined the gas volume and composition. The in vivo study also examined gas volume and histological analysis. The clinical study examined the gas volume and safety after Mg screw metatarsal fixation. Gas was mainly composed of H2, CO and CO2. Maximum volumes of gas formed after 5 days for in vivo and 7 days in clinical study. Within the clinical examination, two superficial wound complications healed with local wound care. Osteolytic lesions in the surrounding metaphysis of the Mg screw insertion developed in all cases and union occurred at 3 months. Mg implants released gas with variable volumes and composition (H2, CO, and CO2), with no long-term toxic effects on the surrounding tissue. The implants enabled bone healing, although complications of wound breakdown and osteolytic lesions developed. PMID:29707071

Observation of clinical teaching: interest in a faculty development program for surgeons.

PubMed

Peyre, Sarah E; Frankl, Susan E; Thorndike, Mary; Breen, Elizabeth M

2011-01-01

Observation of clinical teaching is a powerful tool to develop faculty teaching skills. However, the process of being observed can be intimidating for any educator. Our aim is to assess interest in an Observation of Teaching Program within an academic surgical department. An electronic survey asking faculty to indicate interest in participation in a faculty development program that consists of a peer, expert, and/or cross-disciplinary physician observation of teaching was used. Faculty members were also asked whether they would like to observe other faculty as part of a peer-review track. The results were compiled for descriptive statistical analysis. Electronic survey. In all, 46 faculty, all of whom have assigned medical student and resident teaching responsibilities, were introduced to the Observation of Teaching Program and surveyed on their interest in participating. A total of 87% (40/46) of faculty responded after 2 e-mails and 75% (30/40) indicated interest in the Observation of Teaching Program. All faculty who responded positively indicated interest in expert review (30/30), 90% (27/30) in peer review, 87% (26/30) in surgeon review, and 83% (25/30) in cross-disciplinary physician review. A total of 48% (19/40) indicated interest in observing others. Of those who were not interested in the Observation of Teaching Program, restrictions on time (4/10), not enough clinical care responsibilities (2/10), not wanting to be watched (2/10), and program did not seem effective (1/10) were cited as reasons for not participating. Surgical faculty are interested in being observed and receiving feedback about their clinical teaching by experts, peers, colleagues, and cross-disciplinary physicians. Professional development programs for surgeons should consider observation as a teaching methodology. Copyright © 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

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 impacts of observing flawed and flawless demonstrations on clinical skill learning.

PubMed

Domuracki, Kurt; Wong, Arthur; Olivieri, Lori; Grierson, Lawrence E M

2015-02-01

Clinical skills expertise can be advanced through accessible and cost-effective video-based observational practice activities. Previous findings suggest that the observation of performances of skills that include flaws can be beneficial to trainees. Observing the scope of variability within a skilled movement allows learners to develop strategies to manage the potential for and consequences associated with errors. This study tests this observational learning approach on the development of the skills of central line insertion (CLI). Medical trainees with no CLI experience (n = 39) were randomised to three observational practice groups: a group which viewed and assessed videos of an expert performing a CLI without any errors (F); a group which viewed and assessed videos that contained a mix of flawless and errorful performances (E), and a group which viewed the same videos as the E group but were also given information concerning the correctness of their assessments (FA). All participants interacted with their observational videos each day for 4 days. Following this period, participants returned to the laboratory and performed a simulation-based insertion, which was assessed using a standard checklist and a global rating scale for the skill. These ratings served as the dependent measures for analysis. The checklist analysis revealed no differences between observational learning groups (grand mean ± standard error: [20.3 ± 0.7]/25). However, the global rating analysis revealed a main effect of group (d.f.2,36 = 4.51, p = 0.018), which describes better CLI performance in the FA group, compared with the F and E groups. Observational practice that includes errors improves the global performance aspects of clinical skill learning as long as learners are given confirmation that what they are observing is errorful. These findings provide a refined perspective on the optimal organisation of skill education programmes that combine physical and observational practice

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.

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.

Pedagogical strategies used in clinical medical education: an observational study

PubMed Central

2010-01-01

Background Clinical teaching is a complex learning situation influenced by the learning content, the setting and the participants' actions and interactions. Few empirical studies have been conducted in order to explore how clinical supervision is carried out in authentic situations. In this study we explore how clinical teaching is carried out in a clinical environment with medical students. Methods Following an ethnographic approach looking for meaning patterns, similarities and differences in how clinical teachers manage clinical teaching; non-participant observations and informal interviews were conducted during a four month period 2004-2005. The setting was at a teaching hospital in Sweden. The participants were clinical teachers and their 4th year medical students taking a course in surgery. The observations were guided by the aim of the study. Observational notes and notes from informal interviews were transcribed after each observation and all data material was analysed qualitatively. Results Seven pedagogical strategies were found to be applied, namely: 1) Questions and answers, 2) Lecturing, 3) Piloting, 4) Prompting, 5) Supplementing, 6) Demonstrating, and 7) Intervening. Conclusions This study contributes to previous research in describing a repertoire of pedagogical strategies used in clinical education. The findings showed that three superordinate qualitatively different ways of teaching could be identified that fit Ramsden's model. Each of these pedagogical strategies encompass different focus in teaching; either a focus on the teacher's knowledge and behaviour or the student's behaviour and understanding. We suggest that an increased awareness of the strategies in use will increase clinical teachers' teaching skills and the consequences they will have on the students' ability to learn. The pedagogical strategies need to be considered and scrutinized in further research in order to verify their impact on students' learning. PMID:20105340

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.

Structural effects of clinically observed mutations in JAK2 exons 13-15: comparison with V617F and exon 12 mutations

PubMed Central

Lee, Tai-Sung; Ma, Wanlong; Zhang, Xi; Kantarjian, Hagop; Albitar, Maher

2009-01-01

Background The functional relevance of many of the recently detected JAK2 mutations, except V617F and exon 12 mutants, in patients with chronic myeloproliferative neoplasia (MPN) has been significantly overlooked. To explore atomic-level explanations of the possible mutational effects from those overlooked mutants, we performed a set of molecular dynamics simulations on clinically observed mutants, including newly discovered mutations (K539L, R564L, L579F, H587N, S591L, H606Q, V617I, V617F, C618R, L624P, whole exon 14-deletion) and control mutants (V617C, V617Y, K603Q/N667K). Results Simulation results are consistent with all currently available clinical/experimental evidence. The simulation-derived putative interface, not possibly obtained from static models, between the kinase (JH1) and pseudokinase (JH2) domains of JAK2 provides a platform able to explain the mutational effect for all mutants, including presumably benign control mutants, at the atomic level. Conclusion The results and analysis provide structural bases for mutational mechanisms of JAK2, may advance the understanding of JAK2 auto-regulation, and have the potential to lead to therapeutic approaches. Together with recent mutation profiling results demonstrating the breadth of clinically observed JAK2 mutations, our findings suggest that molecular testing/diagnostics of JAK2 should extend beyond V617F and exon 12 mutations, and perhaps should encompass most of the pseudo-kinase domain-coding region. PMID:19744331

Effect of clinical information and previous exam execution on observer agreement and reliability in the analysis of hysteroscopic video-recordings.

PubMed

Martinho, Margarida Suzel Lopes; da Costa Santos, Cristina Maria Nogueira; Silva Carvalho, João Luís Mendonça; Bernardes, João Francisco Montenegro Andrade Lima

2018-02-01

Inter-observer agreement and reliability in hysteroscopic image assessment remain uncertain and the type of factors that may influence it has only been studied in relation to the experience of hysteroscopists. We aim to assess the effect of clinical information and previous exam execution on observer agreement and reliability in the analysis of hysteroscopic video-recordings. Ninety hysteroscopies were video-recorded and randomized into a group without (Group 1) and with clinical information (Group 2). The videos were independently analyzed by three hysteroscopists, regarding lesion location, dimension, and type, as well as decision to perform a biopsy. One of the hysteroscopists had executed all the exams before. Proportions of agreement (PA) and kappa statistics (κ) with 95% confidence intervals (95% CI) were used. In Group 2, there was a higher proportion of a normal diagnosis (p < 0.001) and a lower proportion of biopsies recommended (p = 0.027). Observer agreement and reliability were better in Group 2, with the PA and κ ranging, respectively, from 0.73 (95% CI 0.62, 0.83) and 0.44 (95% CI 0.26, 0.63), for image quality, to 0.94 (95% CI 0.88, 0.99) and 0.85 (95% CI 0.65, 0.95), for the decision to perform a biopsy. Execution of the exams before the analysis of the video-recordings did not significantly affect the results. With clinical information, agreement and reliability in the overall analysis of hysteroscopic video-recordings may reach almost perfect results and this was not significantly affected by the execution of the exams before the analysis. However, there is still uncertainty in the analysis of specific endometrial cavity abnormalities.

How to become a better clinical teacher: a collaborative peer observation process.

PubMed

Finn, Kathleen; Chiappa, Victor; Puig, Alberto; Hunt, Daniel P

2011-01-01

Peer observation of teaching (PoT) is most commonly done as a way of evaluating educators in lecture or small group teaching. Teaching in the clinical environment is a complex and hectic endeavor that requires nimble and innovative teaching on a daily basis. Most junior faculty start their careers with little formal training in education and with limited opportunity to be observed or to observe more experienced faculty. Formal PoT would potentially ameliorate these challenges. This article describes a collaborative peer observation process that a group of 11 clinician educators is using as a longitudinal faculty development program. The process described in this article provides detailed and specific teaching feedback for the observed teaching attending while prompting the observing faculty to reflect on their own teaching style and to borrow effective teaching techniques from the observation. This article provides detailed examples from written feedback obtained during collaborative peer observation to emphasize the richness of this combined experience.

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.

Clinical observation on 96 cases of primary osteoporosis treated with kidney-tonifying and bone-strengthening mixture.

PubMed

Mingyue, Wang; Ling, Gong; Bei, Xia; Junqing, Cao; Peiqing, Zhou; Jie, Hu

2005-06-01

To objectively evaluate the therapeutic effect and safety of Mixture for Nourishing Kidney and Strengthening Bone. Among 160 cases of osteoporosis under clinical observation, 96 patients in the treatment group were treated with Mixture for Nourishing Kidney and Strengthening Bone, 32 patients in the control group were given Shen Gu Capsule and 32 patients in the blank group were given no drug in half a year. Observation and determination were conducted on bone mineral density (BMD), clinical symptoms, bone gla protein (BGP), pyridinoline (PYD), estradiol (E2), testosterone (T), blood urea nitrogen (BUN), transaminase and routine test on blood and urine. The comprehensive effect in the treatment group was remarkably superior to that in the control group. The safe and reliable Chinese drug can enhance BMD, promote osteogenesis and inhibit bone absorption, hence treating osteoporosis with marked effect.

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.

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.

[Observation on the clinical application effects of skin distractor on the treatment of scars].

PubMed

Gui, W L; Yang, E; Zhang, H S

2017-03-20

Objective: To explore clinical application effects of skin distractor on the treatment of scars and to observe effects of skin distractor with different pull speeds on different parts scars of human body. Methods: One hundred and four patients with scars, conforming to the study criteria, were hospitalized in our unit from January 2014 to June 2015. Patients were divided into 2 mm/d group and 4 mm/d group according to the random number table, with 52 patients in each group. After admission, skin distractors were pasted on scars in face and neck, trunk, and extremities of patients in 2 groups, with inner edges of pasteboards close to outside edges of longer sides of scars. Skin distractors in 2 mm/d group and 4 mm/d group were pulled to scars axis direction as speeds of 2 mm/d and 4 mm/d, respectively. Pull time equals values of pull speeds divided by width of scars. Scars were resected after finishing pulling. Immediately after scars resection, skin distractors were pasted again with inner edges of pasteboards close to outside edges of longer sides of incision and removed when stitches were taken out. Scars of patients were scored by Vancouver Scar Scale (VSS), and Patient and Observer Scar Assessment Scale (POSAS) was used to record scores of patient scar assessment scale (PSAS), observer scar assessment scale (OSAS) and overall scores of patients and observers of scars of patients before and one year after scars resection. Data were processed with χ (2) test, independent samples t test, paired samples t test, independent samples non-parametric rank-sum test and paired samples non-parametric rank-sum test. Results: (1) Scores of all scars of patients in 2 groups before scars resection were close (with t values from -1.384 to 0.622, P values above 0.05), obviously higher than those of one year post scars resection (with t values from 11.085 to 24.835, P values below 0.01). Scores of scars in face and neck, trunk and extremities in 2 groups before scars resection

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.

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

Observation of Couple Conflicts: Clinical Assessment Applications, Stubborn Truths, and Shaky Foundations

PubMed Central

Heyman, Richard E.

2006-01-01

The purpose of this review is to provide a balanced examination of the published research involving the observation of couples, with special attention toward the use of observation for clinical assessment. All published articles that (a) used an observational coding system and (b) relate to the validity of the coding system are summarized in a table. The psychometric properties of observational systems and the use of observation in clinical practice are discussed. Although advances have been made in understanding couple conflict through the use of observation, the review concludes with an appeal to the field to develop constructs in a psychometrically and theoretically sound manner. PMID:11281039

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

Untapped Potential of Observational Research to Inform Clinical Decision Making: American Society of Clinical Oncology Research Statement.

PubMed

Visvanathan, Kala; Levit, Laura A; Raghavan, Derek; Hudis, Clifford A; Wong, Sandra; Dueck, Amylou; Lyman, Gary H

2017-06-01

ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.

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.

Observation of Effectiveness of Clinical Sterilization by CASP-80A Low-Temperature Plasma Sterilizer

NASA Astrophysics Data System (ADS)

Li, Si; Zhang, Yangde; Liu, Weidong

2006-09-01

The influence on the effectiveness of sterilization by low-temperature plasma sterilizer CASP-80A was investigated so as to provide a theoretical basis for reducing medical costs and achieving ideal sterilization effectiveness. To conduct the on-site simulation test, a clinical material sterilization test and a test of the influence of organic substance were conducted, the former by using the representative of Bacillus Stearothermophilus, preparing the bacteria-contaminated carrier through polytetrafluoroethylene (PTFE) simulated hose endoscopes, and the latter by using calf serum as the influence factor of the organic substance. The results show that the CASP-80A low-temperature plasma sterilizer could achieve effective sterilization by either the short-cycle or the long-cycle sterilization method depending on different materials, apparatus, and extent of contamination. The organic substances could influence the effectiveness of sterilization by the low-temperature plasma (H2O2) sterilizer.

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

Regression-based statistical mediation and moderation analysis in clinical research: Observations, recommendations, and implementation.

PubMed

Hayes, Andrew F; Rockwood, Nicholas J

2017-11-01

There have been numerous treatments in the clinical research literature about various design, analysis, and interpretation considerations when testing hypotheses about mechanisms and contingencies of effects, popularly known as mediation and moderation analysis. In this paper we address the practice of mediation and moderation analysis using linear regression in the pages of Behaviour Research and Therapy and offer some observations and recommendations, debunk some popular myths, describe some new advances, and provide an example of mediation, moderation, and their integration as conditional process analysis using the PROCESS macro for SPSS and SAS. Our goal is to nudge clinical researchers away from historically significant but increasingly old school approaches toward modifications, revisions, and extensions that characterize more modern thinking about the analysis of the mechanisms and contingencies of effects. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

Clinical Impact Research - how to choose experimental or observational intervention study?

PubMed

Malmivaara, Antti

2016-11-01

Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

[Clinical observation on acupuncture by stages combined with exercise therapy for treatment of Bell palsy at acute stage].

PubMed

Qu, Yong

2005-08-01

To find out a method for increasing clinical therapeutic effect on Bell palsy at acute stage. Ninety cases of Bell palsy were randomly divided into an observation group, a control group I and a control group II, 30 cases in each group. They were treated respectively with acupuncture plus exercise therapy, simple acupuncture therapy, and simple exercise therapy, and their therapeutic effects were observed. The cured rate was 66.7% in the observation group, 53.3% in the control group I and 46.70% in the control group II, the observation group being better than the two control groups (P<0.05). Acupuncture by stage combined with exercise therapy can increase the therapeutic effect on Bell palsy at acute stage, and it is a better therapy for Bell palsy.

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.

Conveying Clinical Reasoning Based on Visual Observation via Eye-Movement Modelling Examples

ERIC Educational Resources Information Center

Jarodzka, Halszka; Balslev, Thomas; Holmqvist, Kenneth; Nystrom, Marcus; Scheiter, Katharina; Gerjets, Peter; Eika, Berit

2012-01-01

Complex perceptual tasks, like clinical reasoning based on visual observations of patients, require not only conceptual knowledge about diagnostic classes but also the skills to visually search for symptoms and interpret these observations. However, medical education so far has focused very little on how visual observation skills can be…

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

Characteristics of Effective Clinical Teachers in Simulated Clinical Experiences Compared to Traditional Clinical Experiences

ERIC Educational Resources Information Center

Sieh-Bliss, Selina

2014-01-01

While there is evidence in the literature measuring effective clinical teacher characteristics in traditional experiences, little is known of effective characteristics expected from clinical teachers during simulated clinical experiences. This study examined which clinical teaching behaviors and characteristics are perceived by nursing students'…

[Clinical observation of modified Da Chaihu decoction in treating essential hypertension with anxiety].

PubMed

Zhang, Xiang-Dong; Cheng, Wang-Qiang; Wang, Yong-Gang; Zhang, Zheng

2017-06-01

To observe the clinical efficacy of modified Da Chaihu decoction in treating essential hypertension with anxiety, the randomized, controlled, clinical trial was performed in this study. One hundred and twenty-six hypertensive patients with anxiety meeting the inclusive criteria were randomized into the treatment group and the control group. All of the included patients in the above 2 groups were treated by amlodipine besylate tablets. Patients in the treatment group were given Chinese herbal medicine modified Da Chaihu decoction every day. And patients in the control group were given flupentixol and melitracen tablets. The treatment course was 4 weeks. Blood pressure, the score of traditional Chinese medicine syndrome, blood lipids, C reactive protein, the Hamilton anxiety scale score and adverse effects were observed. It has been identified that, both systolic and diastolic blood pressure were significantly reduced (P<0.05). However, no significant difference between the treatment group and the control group was identified. For traditional Chinese medicine syndrome, it was significantly improved in the treatment group (P<0.05). For blood lipids, TC, TG, HDL-C, and LDL-C were significantly improved in the treatment group (P<0.05). After treatment, only TC was significantly reduced in the treatment group when compared to the control group (P<0.05). For C reactive protein, it was significantly reduced in the treatment group after treatment (P<0.05). For anxiety, no significant difference between the treatment group and the control group on the Hamilton anxiety scale score was identified. For adverse effect, no severe adverse effect was identified in this study. The modified Da Chaihu decoction maybe effective in the treatment of essential hypertension with anxiety. In addition to a certain role in lowering blood pressure, the modified Da Chaihu decoction was also effective in improving traditional Chinese medicine syndrome and blood lipids, reducing the level of C

Analysis of clinical observation on acute psychiatric wards.

PubMed

Najim, Hellme; Saleem, Khalid; Al Shirbiny, Basil; Ezeasor, Nebo

2013-09-01

Clinical observation is very important to manage risk of people who are acutely ill on psychiatric wards. It is always an area of dispute between different specialities and disciplines in serious untoward incidents (SUI). Three levels of observations have been applied on acute psychiatric words. Assessing practice is important to help to identify any area needs improving. A questionnaire was developed by HN to collect demographics. Medical notes on Westley and Grangewater wards were reviewed. Excel Microsoft Office World Computer Programme was used to analyse the results. 57% were men. 62% were above 41 years of age. Majority were suffering from schizophrenia and schizoaffective disorders 61%. 64.28% were admitted as formal patients. 31.42% were on level I observation.62.53 were informal. 54.76% were risk to themselves, 28.57% risk to others. 82.3% were on level II observation, 31.42% formal and 68.50% informal. 21.32% were on level III observation. 66.66% were formal and 66.66% had an incident before this level. This study have shown that patients are assessed properly before they go on any level of care. Some patients need to go on level III as they pose a risk mainly to other people. Regular reviews of patients, especially on high level of observation should be done more promptly, as being on observation is not a comfortable experience to go through and applying the least restrictive practice should always be sought and adopted.

[How to Increase the Effectiveness of Antihypertensive Therapy in Clinical Practice: Results of the Russian Observational Program FORSAZH].

PubMed

Glezer, M G; Deev On Behalf Of The Participants Of The Program, A D

2016-01-01

im of the study - to evaluate the possibility of increasing the effectiveness of antihypertensive therapy by simplifying regimens, improving knowledge and practical skills of the doctors on the use of modern tactical approaches to treatment as well as patients education methods of measuring blood pressure (BP), the principles of a healthy lifestyle and explain the need to follow the prescribing physician. Post-marketing observational discovery program FORSAZH held in 29 cities of the Russian Federation. Participation in the program received 442 physician (internists and general practitioners), which included 1969 patients with prior failure of combination antihypertensive therapy. Patients in 86% of cases took the free combination, 14% - fixed combinations of drugs. The change of the treatment on reception of a preparation containing a fixed combination of perindopril/indapamide (10 mg/2.5 mg) after 3 months led to decrease in systolic blood pressure by an average of 39.5 mm Hg, diastolic - 18.7 per mm Hg. The frequency of achieving the target BP <140 mm Hg and 90 it was 76%. Marked reduction in BP and frequency to achieve the target BP is not dependent on additional training of physicians and patients, the use of prior therapy in free or fixed combination, but depended on the initial degree of increase in BP and duration of therapy. Predictors of failure to achieve target BP were age, male gender, low initial adherence, good health, a higher baseline BP, elevated cholesterol levels, body weight, heart rate and decreased glomerular filtration rate. Adherence to therapy patients (on a scale of Morisky-Green) and health assessment on a visual analog scale significantly increased. This tactic has been a change of therapy is not only effective but also safe. Adverse events were reported in 28 patients (1.4% of the total number of observed cases) and only 1 case required dose reduction due to development of clinically manifested hypotension. In enhancing the

Comparing Parent-Child Interactions in the Clinic and at Home: An Exploration of the Validity of Clinical Behavior Observations Using Sequential Analysis

ERIC Educational Resources Information Center

Shriver, Mark D.; Frerichs, Lynae J.; Williams, Melissa; Lancaster, Blake M.

2013-01-01

Direct observation is often considered the "gold standard" for assessing the function, frequency, and intensity of problem behavior. Currently, the literature investigating the construct validity of direct observation conducted in the clinic setting reveals conflicting results. Previous studies on the construct validity of clinic-based…

Cardiovascular Protective Effects and Clinical Applications of Resveratrol.

PubMed

Cho, Sanghyun; Namkoong, Kyung; Shin, Minji; Park, Jueun; Yang, Eunyeong; Ihm, Jinsoo; Thu, Vu Thi; Kim, Hyoung Kyu; Han, Jin

2017-04-01

Resveratrol is a naturally occurring phenol that is generated by plant species following injury or attack by bacterial and fungal pathogens. This compound was first described as the French Paradox in 1992. Later in 2003, resveratrol was reported to activate sirtuins in yeast cells. Recent experimental studies have found that resveratrol offers a variety of benefits that include both anticarcinogenic and anti-inflammatory effects in addition to the ability to reverse obesity, attenuate hyperglycemia and hyperinsulinemia, protect heart and endothelial function, and increase the life span. Multiple molecular targets are associated with the cardioprotective capabilities of resveratrol, and therefore, resveratrol has potential for a wide range of new therapeutic strategies for atherosclerosis, ischemia/reperfusion, metabolic syndrome, cardiac failure, and inflammatory alterations during aging. Expectations for application in human patients, however, suffer from a lack of sufficient clinical evidence in support of these beneficial effects. This article reviews recently reported basic research results that describe the beneficial effects of resveratrol in an attempt to condense the evidence observed in clinical trials and provide support for the future development of novel clinical therapeutics in patients with cardiovascular diseases.

Clinical Impact Research – how to choose experimental or observational intervention study?

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study

[Clinical efficacy of special effect san xiao decoction on type 2 diabetes mellitus].

PubMed

Li, Zhi-Qiang; Chang, Hong-Juan; Sang, Wen-Feng

2013-01-01

To investigate the clinical efficacies of the special effect San Xiao decoction on type 2 diabetes mellitus and its impact on inflammatory factors. 116 patients with type 2 diabetes mellitus were randomly divided into control group and observation group from Aug. 2010 to Aug. 2012, and each group had 58 cases. Both of the two groups were given the conventional basic treatment and 0.5 g/time, oral, 2 times/d of metformin. The observation group was received 1 dose/d of special effect San Xiao decoction on the basis of the basic treatment, and the treatment course was 12 weeks. The fasting blood glucose (FBG), 2h postprandial blood glucose (PBG), glycosylated hemoglobin (HbA1c), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 ( IL-6) and c-reactive protein (CRP) were observed after the treatment. The FBG, PBG, HbA1c and insulin sensitive index (ISI) of the observation group were better than those of the control group (P < 0.05 or P < 0.01); BMI and body weight of the observation group were lower than those of the control group (P < 0.05); The blood sugar control effect of the observation group was better than that of the control group (P < 0.05); The hypoglycemia incidence of the observation group was lower than that of the control group (P < 0.01); TNF-alpha, IL-6 and CRP of the observation group were lower than those of the control group (P < 0.01). The clinical efficacy of the special effect San Xiao decoction on type 2 diabetes mellitus is significant, it has the role of alleviating inflammatory response for diabetes and it also has less adverse reactions, which is worth to be applied in clinical.

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.

[Clinical observation on therapeutic effect of cupping combined with acupuncture stimulation at trigger points for lumbar myofascial pain syndrome].

PubMed

Zhao, Hong

2014-08-01

To observe the clinical effect of cupping combined with acupuncture stimulation of trigger points on lumbar myofascial pain syndrome (MPS). Sixty MPS patients were randomly divided into acupuncture + TDP group (n = 30), and cupping + acupuncture group (n = 30). Patients in the acupuncture + TDP group were treated by acupuncture stimulation of trigger points and local TDP irradiation, and patients of the cupping + acupuncture group treated by intensive cupping applied to the myofascial band and acupuncture stimulation of the locus according to the position of muscular tension band. The therapeutic effects were assessed according to the score of the McGill pain questionnaire composing of pain rating index (PRI), visual analogue scale (VAS) and present pain intensity (PPI) before, immediately and 1 month after the treatment. After the treatment, the total effective rates of the acupuncture+ TDP and cupping + acupuncture groups were 83.3% (25/30) and 96.6% (29/30), respectively, without significant difference between the two groups (P > 0.05). One month's follow-up showed that the total effective rates of the acupuncture + TDP and cupping + acupuncture groups were 40.0% and 90.0% respectively, and the latter group was significantly better than the acupuncture + TDP group in the therapeutic effect (P < 0.05). The scores of PRI, VAS, PPI after the treatment were markedly decreased in both groups (P < 0.05). One month later, the scores of PRI, VAS and PPI in the cupping + acupuncture group were obviously lower than those of the acupuncture group (P < 0.05). Both acupuncture stimulation of trigger points plus TDP and cupping plus acupuncture can effectively relieve pain in MPS patients, while the therapeutic effect of cupping plus acupuncture treatment lasts longer analgesic effect.

Clinical observation on effect of scalp electroacupuncture for mild cognitive impairment.

PubMed

Zhang, Hong; Zhao, Ling; Yang, Sha; Chen, Zhigang; Li, Yingkun; Peng, Xiaohong; Yang, Yulong; Zhu, Manjia

2013-02-01

To evaluate the therapeutic effect of scalp electroacupuncture for mild cognitive impairment (MCI) in the early stage. Two hundred and thirty three MCI patients were randomly divided into three groups: the drug group, the scalp electroacupuncture group, and the syndrome differentiation group. For the scalp electroacupuncture group, the points of Baihui (DU 20), Sishecong (EX-HN1), Fengchi (GB 20), and Shenting (DU 24) were selected. For the syndrome differentiation group, specific acupoints were added on the basis of syndrome differentiation and according to the scale for the differentiation of syndromes in vascular dementia (SDSVD) beside the acupoints used in the scalp electroacupuncture group. For the drug group, nimodipine was orally administered. Each patient was treated for two courses, eight weeks. The score differences in mini-mental state examination (MMSE), picture recognition, and clock drawing test were observed before and after the treatment. After treatment, the score differences in MMSE and clock drawing test were of obvious statistical significance among three groups (P < 0.01, P < 0.05). The score differences in picture recognition were of extremely statistical significance between the scalp electroacupuncture group and the syndrome differentiation group (P < 0.01), while the difference was not found in the drug group (P > 0.05). There were statistical significant differences in therapeutic effects between the scalp electroacupuncture group and the drug group, and between the syndrome differentiation group and the drug group (P < 0.05), while no statistical difference was found between scalp electroacupuncture group and the syndrome differentiation group (P > 0.05). All the three therapies may improve the cognitive function of MCI patients. The therapeutic effects in the scalp electroacupuncture and syndrome differentiation groups were basically the same, but superior to nimodipine.

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

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.

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.

Clinical observations from nutrition services in college athletics.

PubMed

Quatromoni, Paula A

2008-04-01

College athletes are vulnerable to nutritional risks because of the rigorous demands of their sport, and because of the realities of college lifestyles. Athletes often adopt rigid training diets that predispose them to undernutrition, fatigue, and injury. Disordered eating, a common concern for college-aged women, affects a substantial number of female collegiate athletes, and is a growing concern for their male counterparts. Few resources exist to promote nutritional well-being among college athletes, particularly for individuals who suffer from eating pathology that is subclinical and often perceived as benign. This article presents evidence of the need for nutrition services for college athletes and describes nutritional risks that affect individuals across a variety of athletic teams. A multidisciplinary treatment model is depicted, featuring a nutrition practice at the core of a sports medicine wellness program in Division I college athletics. Observations from this practice document a substantial burden of subclinical eating disorders and elucidate characteristics of high-risk individuals. The Female Athlete Screening Tool is advocated as a useful tool for identifying eating pathology and triggering timely interventions. These insights from clinical practice identify opportunities and behavioral targets for intervention, and promote an effective model for health promotion in college athletics.

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.

[Clinical observation on effect of shaogen decoction for the prevention and treatment of acute radiation esophagitis].

PubMed

Zhang, Jie; Zhang, Li; Wang, Jun

2010-12-01

To observe the effect of Shaogen Decoction (SGD) for the prevention and treatment of acute radiation esophagitis (ARE). Sixty patients with breast tumor receiving chemo/radiotherapy were assigned to two groups, the SGD group and the control group. The patients in the SGD group were administered with SGD, a Chinese preparation consisted of Radix Sophorae tonkinensis 10 g, Radix Paeoniae Alba 30 g, Radix Scrophulariae 15 g, Rhizoma Bletillae 15 g, Radix Notoginseng 3 g, etc., starting from the initial day of radiotherapy, 10 mL, thrice a day, while in case of 2nd or over 2nd grade ARE occurred, it was changed to 10 mL, every 2 h, medicated by keeping in mouth and slowly swallowed followed with 5-min forbiddance of food and water. The patients in the control group were treated, in case of 2nd or over 2nd grade ARE occurred, with antibiotic drugs (such as cefuroxime 4.5 g) and hormone (dexamethasone 5 mg) by intravenous infusion for 7 days. The incidence, happening time, and retaining time of ARE, therapeutic effect on it, as well as the proportion of patients for whom antibiotics and hormone were used in the two groups were observed. The incidence of 2nd or over 2nd grade ARE in the SGD group and the control group was 33.33% and 63.33%, respectively, that in the former was significantly lower (chi2 = 5.406, P<0.05). Different degrees of acute esophageal toxic response occurred in both groups, initially presenting at 19.8 +/- 7.4 days in the SGD group and at 20.2 +/- 9.6 days in the control group after radiotherapy, that was delayed in the former (t=2.130, P<0.05). Clinical symptom of ARE retained for 56.4 +/- 19.5 days and 58.2 +/- 15.0 days in the two groups, respectively, it was shorter in the SGD groups (t=2.441, P<0.05). Moreover, the proportion of patients for whom antibiotics and hormone were used in the SGD group was less. SGD acted, in coordinating with chemo-radiotherapy, to reduce the incidence, retard the happening and shorten the retaining time of 2nd or

Utilizing visual art to enhance the clinical observation skills of medical students.

PubMed

Jasani, Sona K; Saks, Norma S

2013-07-01

Clinical observation is fundamental in practicing medicine, but these skills are rarely taught. Currently no evidence-based exercises/courses exist for medical student training in observation skills. The goal was to develop and teach a visual arts-based exercise for medical students, and to evaluate its usefulness in enhancing observation skills in clinical diagnosis. A pre- and posttest and evaluation survey were developed for a three-hour exercise presented to medical students just before starting clerkships. Students were provided with questions to guide discussion of both representational and non-representational works of art. Quantitative analysis revealed that the mean number of observations between pre- and posttests was not significantly different (n=70: 8.63 vs. 9.13, p=0.22). Qualitative analysis of written responses identified four themes: (1) use of subjective terminology, (2) scope of interpretations, (3) speculative thinking, and (4) use of visual analogies. Evaluative comments indicated that students felt the exercise enhanced both mindfulness and skills. Using visual art images with guided questions can train medical students in observation skills. This exercise can be replicated without specially trained personnel or art museum partnerships.

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 efficacy of adalimumab in Crohn's disease: a real practice observational study in Japan.

PubMed

Takeshima, Fuminao; Yoshikawa, Daisuke; Higashi, Syuntaro; Morisaki, Tomohito; Oda, Hidetoshi; Ikeda, Maho; Machida, Haruhisa; Matsushima, Kayoko; Minami, Hitomi; Akazawa, Yuko; Yamaguchi, Naoyuki; Ohnita, Ken; Isomoto, Hajime; Ueno, Masato; Nakao, Kazuhiko

2016-07-29

There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study. We evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated. In 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months. ADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting.

Quantum Observables and Effect Algebras

NASA Astrophysics Data System (ADS)

Dvurečenskij, Anatolij

2018-03-01

We study observables on monotone σ-complete effect algebras. We find conditions when a spectral resolution implies existence of the corresponding observable. We characterize sharp observables of a monotone σ-complete homogeneous effect algebra using its orthoalgebraic skeleton. In addition, we study compatibility in orthoalgebras and we show that every orthoalgebra satisfying RIP is an orthomodular poset.

The effect of piracetam on ataxia: clinical observations in a group of autosomal dominant cerebellar ataxia patients.

PubMed

Ince Gunal, D; Agan, K; Afsar, N; Borucu, D; Us, O

2008-04-01

Autosomal dominant cerebellar ataxias are clinically and genetically heterogeneous neurodegenerative disorders. There is no known treatment to prevent neuronal cell death in these disorders. Current treatment is purely symptomatic; ataxia is one of the most disabling symptoms and represents the main therapeutic challenge. A previous case report suggesting benefit from administration of high dose piracetam inspired the present study of the efficacy of this agent in patients with cerebellar ataxia. Piracetam is a low molecular weight derivative of gamma-aminobutyric acid. Although little is known of its mode of action, its efficacy has been documented in a wide range of clinical indications, such as cognitive disorders, dementia, vertigo and dyslexia, as well as cortical myoclonus. The present report investigated the role of high dose piracetam in patients with cerebellar ataxia. Eight patients with autosomal dominant cerebellar ataxia were given intravenous piracetam 60 g/day by a structured protocol for 14 days. The baseline and end-of-the study evaluations were based on the International Cooperative Ataxia Rating Scale. Statistical analysis demonstrated a significant improvement in the patients' total score (P = 0.018) and a subscale analysis showed statistical significance for only the posture and gait disturbances item (P = 0.018). This study is providing good clinical observation in favour of high dose piracetam infusion to reduce the disability of the patients by improving their gait ataxia.

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.

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.

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.

Clinical observations with AN-1792 using TAPIR analyses.

PubMed

Hock, Christoph; Nitsch, Roger M

2005-01-01

Clinical observations with AN-1792 using tissue amyloid plaque immunoreactivity (TAPIR) analyses established for the first time evidence in humans that antibodies against beta-amyloid-related epitopes are capable of slowing progression in Alzheimer's disease. Antibodies derived upon TAPIR assay selection may specifically target the pathologic neoepitopes of aggregated A beta species present in amyloid plaques and some of their aggregated, protofibrillar and low molecular weight oligomeric precursors. We briefly summarize here how the proof of concept was established and why it provides the basis for a potential cure for Alzheimer's disease. Copyright 2005 S. Karger AG, Basel.

A controlled evaluation of case clinical effect coding by poison center specialists for detection of WMD scenarios.

PubMed

Beuhler, Michael C; Wittler, Mary A; Ford, Marsha; Dulaney, Anna R

2011-08-01

Many public health entities employ computer-based syndromic surveillance to monitor for aberrations including possible exposures to weapons of mass destruction (WMD). Often, this is done by screening signs and symptoms reported for cases against syndromic definitions. Poison centers (PCs) may offer significant contributions to public health surveillance because of their detailed clinical effect data field coding and real-time data entry. Because improper clinical effect coding may impede syndromic surveillance, it is important to assess this accuracy for PCs. An AAPCC-certified regional PC assessed the accuracy of clinical effect coding by specialists in poison information (SPIs) listening to audio recordings of standard cases. Eighteen different standardized cases were used, consisting of six cyanide, six botulism, and six control cases. Cases were scripted to simulate clinically relevant telephone conversations and converted to audio recordings. Ten SPIs were randomly selected from the center's staff to listen to and code case information from the recorded cases. Kappa scores and the percentage of correctly coding a present clinical effect were calculated for individual clinical effects summed over all test cases along with corresponding 95% confidence intervals. The rate of the case coding by the SPIs triggering the PC's automated botulism and cyanide alerts was also determined. The kappa scores and the percentage of correctly coding a present clinical effect varied depending on the specific clinical effect, with greater accuracy observed for the clinical effects of vomiting and agitation/irritability, and poor accuracy observed for the clinical effects of visual defect and anion gap increase. Lack of correct coding resulted in only 60 and 86% of the cases that met the botulism and cyanide surveillance definitions, respectively, triggering the corresponding alert. There was no difference observed in the percentage of coding a present clinical effect between

Development of the Huddle Observation Tool for structured case management discussions to improve situation awareness on inpatient clinical wards.

PubMed

Edbrooke-Childs, Julian; Hayes, Jacqueline; Sharples, Evelyn; Gondek, Dawid; Stapley, Emily; Sevdalis, Nick; Lachman, Peter; Deighton, Jessica

2018-05-01

'Situation Awareness For Everyone' (SAFE) was a 3-year project which aimed to improve situation awareness in clinical teams in order to detect potential deterioration and other potential risks to children on hospital wards. The key intervention was the 'huddle', a structured case management discussion which is central to facilitating situation awareness. This study aimed to develop an observational assessment tool to assess the team processes occurring during huddles, including the effectiveness of the huddle. A cross-sectional observational design was used to psychometrically develop the 'Huddle Observation Tool' (HOT) over three phases using standardised psychometric methodology. Huddles were observed across four NHS paediatric wards participating in SAFE by five researchers; two wards within specialist children hospitals and two within district general hospitals, with location, number of beds and length of stay considered to make the sample as heterogeneous as possible. Inter-rater reliability was calculated using the weighted kappa and intraclass correlation coefficient. Inter - rater reliability was acceptable for the collaborative culture (weighted kappa=0.32, 95% CI 0.17 to 0.42), environment items (weighted kappa=0.78, 95% CI 0.52 to 1) and total score (intraclass correlation coefficient=0.87, 95% CI 0.68 to 0.95). It was lower for the structure and risk management items, suggesting that these were more variable in how observers rated them. However, agreement on the global score for huddles was acceptable. We developed an observational assessment tool to assess the team processes occurring during huddles, including the effectiveness of the huddle. Future research should examine whether observational evaluations of huddles are associated with other indicators of safety on clinical wards (eg, safety climate and incidents of patient harm), and whether scores on the HOT are associated with improved situation awareness and reductions in deterioration and adverse

Development of the Huddle Observation Tool for structured case management discussions to improve situation awareness on inpatient clinical wards

PubMed Central

Edbrooke-Childs, Julian; Hayes, Jacqueline; Sharples, Evelyn; Gondek, Dawid; Stapley, Emily; Lachman, Peter; Deighton, Jessica

2018-01-01

Background ‘Situation Awareness For Everyone’ (SAFE) was a 3-year project which aimed to improve situation awareness in clinical teams in order to detect potential deterioration and other potential risks to children on hospital wards. The key intervention was the ‘huddle’, a structured case management discussion which is central to facilitating situation awareness. This study aimed to develop an observational assessment tool to assess the team processes occurring during huddles, including the effectiveness of the huddle. Methods A cross-sectional observational design was used to psychometrically develop the ‘Huddle Observation Tool’ (HOT) over three phases using standardised psychometric methodology. Huddles were observed across four NHS paediatric wards participating in SAFE by five researchers; two wards within specialist children hospitals and two within district general hospitals, with location, number of beds and length of stay considered to make the sample as heterogeneous as possible. Inter-rater reliability was calculated using the weighted kappa and intraclass correlation coefficient. Results Inter-rater reliability was acceptable for the collaborative culture (weighted kappa=0.32, 95% CI 0.17 to 0.42), environment items (weighted kappa=0.78, 95% CI 0.52 to 1) and total score (intraclass correlation coefficient=0.87, 95% CI 0.68 to 0.95). It was lower for the structure and risk management items, suggesting that these were more variable in how observers rated them. However, agreement on the global score for huddles was acceptable. Conclusion We developed an observational assessment tool to assess the team processes occurring during huddles, including the effectiveness of the huddle. Future research should examine whether observational evaluations of huddles are associated with other indicators of safety on clinical wards (eg, safety climate and incidents of patient harm), and whether scores on the HOT are associated with improved situation

A mediator effect size in randomized clinical trials.

PubMed

Kraemer, Helena Chmura

2014-12-01

To understand the process by which a treatment (T) achieves an effect on outcome (O) and thus to improve the effect of T on O, it is vital to detect mediators, to compare the impact of different mediators, and to develop hypotheses about the causal factors (all mediators) linking T and O. An index is needed to facilitate interpretation of the potential clinical importance of a mediator (M) of choice of T on treatment O in randomized clinical trials (RCTs). Ideally such a mediator effect size should (1) be invariant under any rescaling of M and O consistent with the model used, and (2) reflect the difference between the overall observed effect of T on O and what the maximal effect of T on O could be were the association between T and M broken. A mediator effect size is derived first for the traditional linear model, and then more generally for any categorical (ordered or non-ordered) potential mediator. Issues such as the problem of multiple treatments, outcomes and mediators, and of causal inferences, and the correspondence between this approach and earlier ones, are discussed. Illustrations are given of the application of the approach. Copyright © 2014 John Wiley & Sons, Ltd.

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.

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.

Quantifying peer interactions for research and clinical use: the Manchester Inventory for Playground Observation.

PubMed

Gibson, Jenny; Hussain, Jamilla; Holsgrove, Samina; Adams, Catherine; Green, Jonathan

2011-01-01

Direct observation of peer relating is potentially a sensitive and ecologically valid measure of child social functioning, but there has been a lack of standardised methods. The Manchester Inventory for Playground Observation (MIPO) was developed as a practical yet rigorous assessment of this kind for 5-11 year olds. We report on the initial reliability and validity of the MIPO and its ability to distinguish social impairments within different psychopathologies. We observed 144 clinically referred children aged 5;00-11;11 (mean 8.8) years with Externalising (n = 44), Internalising (n = 19), Autism Spectrum Disorders (n = 39) or Specific Language Impairment (n = 42), and 44 class-controls, in naturalistic playground interaction. Observers, blind to clinical diagnosis, completed the MIPO and the teacher checklist from the Social Skills Rating System (SSRS). MIPO items showed high internal consistency (alpha = .924; all 'alpha if item deleted' values>.91), inter-observer reliability (mean κ(w) = .77) and test-retest stability (over 2 weeks; mean κ(w) = .58). MIPO totals showed convergence with SSRS (n = 68, r(s) = .78, p<.01) and excellent discrimination between case and control (sensitivity = 0.75 and specificity = 0.88, AUC = .897). Externalising, Autistic Spectrum and Language Impaired groups showed distinct profiles of MIPO impairment consistent with theory:Internalising disorders less so. 65.3% of clinical cases were classified accurately for primary diagnosis. The MIPO shows reliability and validity as a measure of children's social functioning relevant in developmental research and as a clinical tool to aid differential diagnosis and intervention planning. Copyright © 2011 Elsevier Ltd. All rights reserved.

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/

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…

[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.

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

Interprofessional communication supporting clinical handover in emergency departments: An observation study.

PubMed

Redley, Bernice; Botti, Mari; Wood, Beverley; Bucknall, Tracey

2017-08-01

Poor interprofessional communication poses a risk to patient safety at change-of-shift in emergency departments (EDs). The purpose of this study was to identify and describe patterns and processes of interprofessional communication impacting quality of ED change-of-shift handovers. Observation of 66 change-of-shift handovers at two acute hospital EDs in Victoria, Australia. Focus groups with 34 nurse participants complemented the observations. Qualitative data analysis involved content and thematic methods. Four structural components of ED handover processes emerged represented by (ABCD): (1) Antecedents; (2) Behaviours and interactions; (3) Content; and (4) Delegation of ongoing care. Infrequent and ad hoc interprofessional communication and discipline-specific handover content and processes emerged as specific risks to patient safety at change-of-shift handovers. Three themes related to risky and effective practices to support interprofessional communications across the four stages of ED handovers emerged: 1) standard processes and practices, 2) teamwork and interactions and 3) communication activities and practices. Unreliable interprofessional communication can impact the quality of change-of-shift handovers in EDs and poses risk to patient safety. Structured reflective analysis of existing practices can identify opportunities for standardisation, enhanced team practices and effective communication across four stages of the handover process to support clinicians to enhance local handover practices. Future research should test and refine models to support analysis of practice, and identify and test strategies to enhance ED interprofessional communication to support clinical handovers. Copyright © 2017 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.

[Clinical efficacy observation of acupuncture at suliao (GV 25) on improving regain of consciousness from coma in severe craniocerebral injury].

PubMed

Xu, Kai-Sheng; Song, Jian-Hua; Huang, Tiao-Hua; Huang, Zhi-Hua; Yu, Lu-Chang; Zheng, Wei-Ping; Chen, Xiao-Shan; Liu, Chuan

2014-06-01

To compare the clinical therapeutic effects differences between acupuncture at Suliao (GV 25) and Shuigou (GV 26) on promoting regain of consciousness from coma in severe craniocerebral injury. Based on regular emergency treatments of neurosurgery, eighty-two cases of craniocerebral injury who were under stable condition were randomly divided into an observation group (42 cases) and a control group (40 cases). Suliao (GV 25) was selected as main aupoint, while Laogong (PC 8) and Yongquan (KI 1), etc. were selected as adjuvant acupoints and Neiguan (PC 6), Sanyinjiao (SP 6), Yifeng (TE 17) and Wangu (GB 12), etc. were selected as matching acupoints in the observation group where a strong needle manipulation was applied to improve the regain of consciousness. The main acupoint of Shuigou (GV 26) along with identical adjuvant acupoints and matching acupoints in the observation group were selected in the control group with identical strong needle manipulation. The treatment was given once a day in both groups, five times per week and ten times were considered as one session. The immediate clinical symptoms after acupuncture at Suliao (GV 25) and Shuigou (GV 26) were observed as well as Glasgow coma scale (GCS) before the treatment, after 45 days and 90 days of treatment to assess the resuscitation time and rate. Also the clinical efficacy was compared between both groups. The occurrence rate of sneezing reflex was 85.7% (36/42) in the observation group, which was higher than 25.0% (10/40) in the control group (P < 0.01). The average resuscitation time was (64.6 +/- 19.4) days in the observation group, which was obviously shorter than (73.8 +/- 14. 6) days in the control group (P < 0.05). The resuscitation rate was 88.1% (37/42) in the observation group, which was similar to 75.0% (30/40) in the control group (P > 0.05). Compared before the treatment, GCS were both improved after the treatment in two groups (both P < 0.01). The 90-day GCS was 9.52 +/- 2.32 in the

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.

[Clinical effect on migraine treated with acupoint implantation].

PubMed

Feng, Yanting

2016-04-01

To observe the clinical efficacy on migraine treated with acupoint implantation. Sixty cases of migraine were randomized into a implantation group and an electroacupuncture (EA) group, 30 cases in each one. In the implantation group, implantation was used at Fengchi (GB 20), Taiyang (EX-HN 5), Waiguan (TE 5), Yanglingquan (GB 34), etc., once every 2 weeks, for 4 weeks totally. In the EA group, the acupoints were the same as the implantation group, and EA was applied to Fengchi (GB 20) and Taiyang (EX-HN 5), Yanglingquan (GB 34) and Zusanli (ST 36), once every two days, for 4 weeks totally. The visual analogue scale (VAS) was adopted before and after treatment and the clinical efficacy was compared between the two groups. After treatment, VAS score was reduced in the implantation group and the EA group as compared with that before treatment (both P < 0.01). After treatment, VAS score in the implantation group was lower than that in the EA group (P < 0.01). The difference in VAS score before and after treatment in the implantation group was improved apparently as compared with that in the EA group (P < 0.01). The total effective rate in the implantation group was higher than that in the EA group (P < 0.05). The acupoint implantation reduces VAS score in the patients of migraine and its clinical efficacy is better than that in the EA group. The therapy presents the long-term clinical effect and deserves to be promoted in clinical practice.

Effect of hyperglycaemia on inflammatory and stress responses and clinical outcome of pneumonia in non-critical-care inpatients: results from an observational cohort study.

PubMed

Schuetz, Philipp; Friedli, Natalie; Grolimund, Eva; Kutz, Alexander; Haubitz, Sebastian; Christ-Crain, Mirjam; Thomann, Robert; Zimmerli, Werner; Hoess, Claus; Henzen, Christoph; Mueller, Beat

2014-02-01

Despite the condition's high prevalence, the influence of hyperglycaemia on clinical outcomes in non-critical-care inpatients with infections remains ill defined. In this study, we analysed associations of glucose levels at admission and during initial inpatient treatment with the inflammatory response and clinical outcome in community-acquired pneumonia (CAP) patients. This secondary observational analysis included 880 confirmed CAP patients. We used severity-adjusted multivariate regression models to investigate associations of initial and 96 h mean glucose levels with serially measured biomarker levels over 7 days (C-reactive protein [CRP], procalcitonin, white blood cell count [WBC], pro-adrenomedullin [ProADM]) and adverse clinical course (death and intensive-care unit admission). In the 724 non-diabetic patients (82.3% of the study population), moderate or severe hyperglycaemia (glucose 6-11 mmol/l and >11 mmol/l, respectively) was associated with increased risk for adverse clinical course (adjusted OR [95% CI] 1.4 [0.8, 2.4] and 3.0 [1.1, 8.0], respectively) and with higher CRP, WBC and ProADM levels over 7 days (p < 0.05, ANOVA, all days). In diabetic patients (n = 156), no similar associations were found for initial hyperglycaemia, although mean 96 h glucose levels  ≥ 9 mmol/l were associated with adverse clinical course (adjusted OR 5.4 [1.1, 25.8]; p = 0.03). No effect modification by insulin treatment was detected (interaction terms p > 0.2 for all analyses). Initial hyperglycaemia in non-diabetic CAP patients, and prolonged hyperglycaemia in diabetic or non-diabetic CAP patients, are associated with a more pronounced inflammatory response and CAP-related adverse clinical outcome. Optimal glucose targets for insulin treatment of hyperglycaemia in non-critical-care settings should be defined.

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

Clinical studies of the effectiveness and safety of antivenoms.

PubMed

Williams, David J; Habib, Abdulrazaq G; Warrell, David A

2018-05-07

In the 1890s, hyperimmune sera proved effective in animals against challenge by the snake venom against which they had been raised. They were first used, apparently successfully, in a human patient in about 1895. Since then, antivenoms have become accepted as the only reliable specific treatment for snake-bite envenoming. Despite decades of accumulated clinical experience and a number of published randomized comparative and observational studies, the clinical effectiveness and safety of some antivenoms remain open to question, due to a lack of robust randomized controlled trial data. Antivenoms in some poorly regulated markets may have high rates of potentially fatal adverse effects and their use must be balanced by demonstrable effectiveness. Even those manufactured to strict regulatory requirements may pose a rare risk of severe adverse reactions. Most antivenoms currently marketed around the world were registered without first being studied clinically. There is increasing pressure to subject antivenoms, even those that are long-established, to the same protocols of rigorous pre-clinical and clinical assessment that are standard regulatory requirements for other drugs. Conventional clinical testing progresses through Phases I, II, III to IV. Most authorities consider antivenoms too dangerous to be used in Phase I studies in healthy volunteers. An alternative method for preliminary estimation of safety, dose-finding and effectiveness, is proposed - the "3 + 3" dose escalation or de-escalation design, in volunteer patients, as used in oncology to test cytotoxic drugs. Antivenoms are so widely used and well trusted, that there are few ethical justifications for placebo controls. However, placebo might be ethically justified if there were no proven effective treatment and or if withholding or delaying treatment posed acceptably negligible risks to the participants. Antivenom trials are most urgently needed in low-to middle-income countries where there are many

Shared Mycobacterium avium Genotypes Observed among Unlinked Clinical and Environmental Isolates

PubMed Central

Weigel, Kris M.; Yakrus, Mitchell A.; Becker, Annie L.; Chen, Hui-Ling; Fridley, Gina; Sikora, Arthur; Speake, Cate; Hilborn, Elizabeth D.; Pfaller, Stacy

2013-01-01

Our understanding of the sources of Mycobacterium avium infection is partially based on genotypic matching of pathogen isolates from cases and environmental sources. These approaches assume that genotypic identity is rare in isolates from unlinked cases or sources. To test this assumption, a high-resolution PCR-based genotyping approach, large-sequence polymorphism (LSP)-mycobacterial interspersed repetitive unit–variable-number tandem repeat (MIRU-VNTR), was selected and used to analyze clinical and environmental isolates of M. avium from geographically diverse sources. Among 127 clinical isolates from seven locations in North America, South America, and Europe, 42 genotypes were observed. Among 12 of these genotypes, matches were seen in isolates from apparently unlinked patients in two or more geographic locations. Six of the 12 were also observed in environmental isolates. A subset of these isolates was further analyzed by alternative strain genotyping methods, pulsed-field gel electrophoresis and MIRU-VNTR, which confirmed the existence of geographically dispersed strain genotypes. These results suggest that caution should be exercised in interpreting high-resolution genotypic matches as evidence for an acquisition event. PMID:23851084

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

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

Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease - a prospective multicenter observational study.

PubMed

Stallmach, A; Langbein, C; Atreya, R; Bruns, T; Dignass, A; Ende, K; Hampe, J; Hartmann, F; Neurath, M F; Maul, J; Preiss, J C; Schmelz, R; Siegmund, B; Schulze, H; Teich, N; von Arnim, U; Baumgart, D C; Schmidt, C

2016-12-01

Vedolizumab, a monoclonal antibody targeting the α4β7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials. To determine the long-term effectiveness of vedolizumab in a real-world clinical setting. This observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60). Primary endpoint was clinical remission (HBI ≤ 4/pMayo ≤ 1) at week 54. Secondary endpoints included clinical response rates (HBI/pMayo score drop ≥3) and steroid-free clinical remission at weeks 30 and 54. Vedolizumab was stopped in 69/127 (56%) patients after a median time of 18 weeks (range 2-49) predominantly owing to lack or loss of response. Using nonresponder imputation analysis, clinical remission and steroid-free remission rates were 21% and 15% in Crohn's disease and 25% and 22% in ulcerative colitis, respectively. Lack of clinical remission was associated with prior treatment with anti-TNF or with steroids for more than 3 months in the last 6 months in ulcerative colitis. At week 14, the absence of remission in Crohn's disease or nonresponse in ulcerative colitis indicated a low likelihood of clinical remission at week 54 [2/31 (7%) in Crohn's disease, 4/41 (10%) in ulcerative colitis]. Accordingly, declining C-reactive protein in inflammatory bowel disease and/or lower faecal calprotectin in ulcerative colitis at week 14 predicted remission at week 54. Among patients who started vedolizumab for active inflammatory bowel disease, clinical remission rates are 21-25% after 54 weeks. © 2016 John Wiley & Sons Ltd.

The factors facilitating and inhibiting effective clinical decision-making in nursing: a qualitative study

PubMed Central

Hagbaghery, Mohsen Adib; Salsali, Mahvash; Ahmadi, Fazlolah

2004-01-01

Background Nurses' practice takes place in a context of ongoing advances in research and technology. The dynamic and uncertain nature of health care environment requires nurses to be competent decision-makers in order to respond to clients' needs. Recently, the public and the government have criticized Iranian nurses because of poor quality of patient care. However nurses' views and experiences on factors that affect their clinical function and clinical decision-making have rarely been studied. Methods Grounded theory methodology was used to analyze the participants' lived experiences and their viewpoints regarding the factors affecting their clinical function and clinical decision-making. Semi-structured interviews and participant observation methods were used to gather the data. Thirty-eight participants were interviewed and twelve sessions of observation were carried out. Constant comparative analysis method was used to analyze the data. Results Five main themes emerged from the data. From the participants' points of view, "feeling competent", "being self-confident", "organizational structure", "nursing education", and "being supported" were considered as important factors in effective clinical decision-making. Conclusion As participants in this research implied, being competent and self-confident are the most important personal factors influencing nurses clinical decision-making. Also external factors such as organizational structure, access to supportive resources and nursing education have strengthening or inhibiting effects on the nurses' decisions. Individual nurses, professional associations, schools of nursing, nurse educators, organizations that employ nurses and government all have responsibility for developing and finding strategies that facilitate nurses' effective clinical decision-making. They are responsible for identifying barriers and enhancing factors within the organizational structure that facilitate nurses' clinical decision-making. PMID

Effect of observation on lower limb prosthesis gait biomechanics: Preliminary results.

PubMed

Malchow, Connor; Fiedler, Goeran

2016-12-01

The Hawthorne effect, a subcategory of reactivity, causes human behavior to change when under observation. Such an effect may apply to gait variation of persons with prosthetics or orthotics devices. This study investigated whether the presence of observers directly affects the gait pattern of users of lower limb prostheses. Within-subject intervention study. Primary outcome measures were gait parameters of initial double support time and upper body lateral tilt angle, which were collected with a mobile sensor attached to the subjects' back. To make subjects feel unwatched, a certain amount of deception was necessary, and two different conditions were created and statistically compared against each other: one in which the subjects were initially unaware of the attention of observers and another one in which the same subjects were aware of a group of observers. Data from two subjects using trans-femoral prosthesis are reported. Findings included a change in step initial double support percentage by up to 14.2% (p = 0.019). Considerable changes were also noted in secondary outcome measures including speed, stride length, and stride symmetry. A reactivity effect of observation exists in prosthetics gait analysis. More comprehensive studies may be motivated by these preliminary findings. Results of this study suggest that users of lower limb prostheses walk differently when their gait is being assessed (e.g. in the prosthetist's office) than in situations without observers. This may in part explain the clinical experience that modifications of prosthetic fit or alignment provide only short-term betterment. © The International Society for Prosthetics and Orthotics 2015.

Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP.

PubMed

Lazar, Ann A; Bonetti, Marco; Cole, Bernard F; Yip, Wai-Ki; Gelber, Richard D

2016-04-01

Investigators conducting randomized clinical trials often explore treatment effect heterogeneity to assess whether treatment efficacy varies according to patient characteristics. Identifying heterogeneity is central to making informed personalized healthcare decisions. Treatment effect heterogeneity can be investigated using subpopulation treatment effect pattern plot (STEPP), a non-parametric graphical approach that constructs overlapping patient subpopulations with varying values of a characteristic. Procedures for statistical testing using subpopulation treatment effect pattern plot when the endpoint of interest is survival remain an area of active investigation. A STEPP analysis was used to explore patterns of absolute and relative treatment effects for varying levels of a breast cancer biomarker, Ki-67, in the phase III Breast International Group 1-98 randomized clinical trial, comparing letrozole to tamoxifen as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer. Absolute treatment effects were measured by differences in 4-year cumulative incidence of breast cancer recurrence, while relative effects were measured by the subdistribution hazard ratio in the presence of competing risks using O-E (observed-minus-expected) methodology, an intuitive non-parametric method. While estimation of hazard ratio values based on O-E methodology has been shown, a similar development for the subdistribution hazard ratio has not. Furthermore, we observed that the subpopulation treatment effect pattern plot analysis may not produce results, even with 100 patients within each subpopulation. After further investigation through simulation studies, we observed inflation of the type I error rate of the traditional test statistic and sometimes singular variance-covariance matrix estimates that may lead to results not being produced. This is due to the lack of sufficient number of events within the subpopulations, which we refer to as instability of

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).

[Clinical observation of preoperative administration of enteral nutrition support in gastric cancer patients at risk of malnutrition].

PubMed

Chen, Bo; Zhou, Yong; Yang, Ping; Qin, Xian-peng; Li, Ning-ning; He, Dan; Feng, Jin-yan; Yan, Chuan-jing; Wu, Xiao-ting

2013-11-01

To evaluate safety and efficacy of preoperative administration of enteral nutrition support in gastric cancer patients at risk of malnutrition. A single center randomized controlled clinical trial was performed in 60 gastric cancer patients in West China Hospital from May to October 2012. Thirty patients were given enteral nutrition support(Ensure(R)) manufactured by Abbott Laboratories for ten consecutive days before surgical operation in the treatment group, and 30 patients were given an isocaloric and isonitrogenous homogenized diet in the control group for 10 days as well. The laboratory parameters of nutritional status and hepatorenal function were observed and compared between the two groups on admission, preoperative day 1 and postoperative day 3, respectively. Clinical observations, such as nausea and vomiting, were carried out until patients were discharged. Before the intervention, there were no significant differences in the baseline characteristics between the two groups. The levels of serum albumin [(33.9±5.6) g/L vs. (31.0±5.3) g/L, P<0.05], and hemoglobin[(103.4±7.7) g/L vs.(96.6±10.5) g/L, P<0.01] were significantly improved in the treatment group on postoperative day 3. However, the levels of body mass index, lymphocyte count, liver and renal function, serum glucose, sodium, and potassium were not significantly different between the two groups(all P>0.05). Moreover, two patients with nausea and one with vomiting in each group were found. In clinical observation period, no severe treatment-related adverse event were observed. The enteral supplement with Ensure(R) in gastric cancer patients at risk of malnutrition during preoperative period is effective and safe, which is superior to homogenized diet and an appropriate choice for gastric cancer patients with nutritional risk.

Development and Initial Testing of a Structured Clinical Observation Tool to Assess Pharmacotherapy Competence

ERIC Educational Resources Information Center

Young, John Q.; Lieu, Sandra; O'Sullivan, Patricia; Tong, Lowell

2011-01-01

Objective: The authors developed and tested the feasibility and utility of a new direct-observation instrument to assess trainee performance of a medication management session. Methods: The Psychopharmacotherapy-Structured Clinical Observation (P-SCO) instrument was developed based on multiple sources of expertise and then implemented in 4…

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.

Managing side effects of JAK inhibitors for myelofibrosis in clinical practice.

PubMed

Saeed, Iram; McLornan, Donal; Harrison, Claire N

2017-07-01

Myelofibrosis (MF) is characterized by bone marrow fibrosis, abnormalities in peripheral counts, extramedullary hematopoiesis, splenomegaly and an increased risk of transformation to acute myeloid leukaemia. The disease course is often heterogeneous and management can range from observation alone through to allogeneic stem cell transplantation. As of 2017, the only approved medication for MF remains the JAK Inhibitor (JAKi), ruxolitinib (Novartis Pharmaceuticals, Basel, Switzerland; Incyte, Wilmington, Detroit, USA) although several others have reached advanced stages of clinical trials. Areas covered: In this review, we focus on the management of both common and uncommon side effects arising from the use of currently approved and clinical trial JAKi. Most of the discussion concerns ruxolitinib although we also cover both pacritinib (CTI BioPharma) and momelotinib (Gilead Sciences, Foster City, California) which have been in recent large, multinational phase III trials. The various approaches to management of JAKi-related side effects are discussed - with particular emphasis to anaemia, thrombocytopaenia and infection risk. Expert commentary: JAK inhibitors are effective in many individuals with MF and have revolutionized the current treatment paradigm. The side effect profile, in the most, is predictable and manageable with high degrees of clinical surveillance and dose modifications.

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.

[Clinical observation on idiopathic tinnitus treated with acupuncture, buzhong yiqi tang and cizhu wan].

PubMed

Chen, Surong; Tan, Xuming; Fei, Lanbo; Xiang, Xiande

2018-04-12

To observe the differences in the clinical therapeutic effects on idiopathic tinnitus between the combined therapy with acupuncture and the modified formula of buzhong yiqi tang and cizhu wan and the simple administration of the modified formula of buzhong yiqi tang and cizhu wan . A total of 60 patients were randomized into a combined treatment group and an herbal medicine group, 30 cases in each one and 2 cases dropped out in the herbal medicine group. In the combined treatment group, acupuncture was given at the local acupoints for tinnitus, such as Yifeng (TE 17), penetrating needling technique from Ermen (TE 21) to Tinggong (SI 19) and Tinghui (GB 2) combined with the scalp acupuncture [the vertigo-auditory area, Baihui (GV 20)] and the oral administration of the modified formula of buzhong yiqi tang and cizhu wan . In the herbal medicine group, the oral administration of the modified formula of buzhong yiqi tang and cizhu wan was only applied. The treatment was given once a day in each group, 5 times a week for acupuncture and 7 times a week for the oral administration of herbal medicine. Totally, the treatment for 6 weeks was required in the two groups. Before and after treatment, the tinnitus severity score (TSS) and the score of tinnitus handicap inventory (THI) were observed and the clinical therapeutic effects were compared between the two groups. After treatment, the TSS and THI scores reduced as compared with those before treatment in the two groups (all P <0.05). The scores in the combined treatment group were lower than those in the herbal medicine group (both P <0.05). The total effective rate in the combined treatment group was 93.3% (28/30), better than 67.9% (19/28) in the herbal medicine group ( P <0.05). The combined treatment with scalp acupuncture, acupuncture around the ear and the modified formula of buzhong yiqi tang and cizhu wan achieve the superior therapeutic effects on idiopathic tinnitus as compared with the simple oral

Systematic review of the clinical and cost effectiveness of cholecystectomy versus observation/conservative management for uncomplicated symptomatic gallstones or cholecystitis.

PubMed

Brazzelli, Miriam; Cruickshank, Moira; Kilonzo, Mary; Ahmed, Irfan; Stewart, Fiona; McNamee, Paul; Elders, Andy; Fraser, Cynthia; Avenell, Alison; Ramsay, Craig

2015-03-01

Gallstone disease is a common gastrointestinal disorder in industrialised countries. Although symptoms can be severe, some people can be symptom free for many years after the original attack. Surgery is the current treatment of choice, but evidence suggests that observation is also feasible and safe. We reviewed the evidence on cholecystectomy versus observation for uncomplicated symptomatic gallstones and conducted a cost-effectiveness analysis. We searched six electronic databases (last search April 2014). We included randomised controlled trials (RCTs) or non-randomised comparative studies where adults received either cholecystectomy or observation/conservative management for the first episode of symptomatic gallstone disease (biliary pain or cholecystitis) being considered for surgery in secondary care. Meta-analysis was used to combine results. A de novo Markov model was developed to assess the cost effectiveness of the interventions. Two RCTs (201 participants) were included. Eighty-eight percent of people randomised to surgery and 45 % of people randomised to observation underwent cholecystectomy during the 14-year follow-up period. Participants randomised to observation were significantly more likely to experience gallstone-related complications (RR = 6.69, 95 % CI = 1.57-28.51, p = 0.01), in particular acute cholecystitis (RR = 9.55, 95 % CI = 1.25-73.27, p = 0.03), and less likely to undergo surgery (RR = 0.50, 95 % CI = 0.34-0.73, p = 0.0004) or experience surgery-related complications (RR = 0.36, 95 % CI = 0.16-0.81, p = 0.01) than those randomised to surgery. Fifty-five percent of people randomised to observation did not require surgery, and 12 % of people randomised to cholecystectomy did not undergo surgery. On average, surgery costs £1,236 more per patient than conservative management, but was more effective. Cholecystectomy is the preferred treatment for symptomatic gallstones. However, approximately half the observation group did not require

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.

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.

Comparative effectiveness analysis of anticoagulant strategies in a large observational database of percutaneous coronary interventions.

PubMed

Wise, Gregory R; Schwartz, Brian P; Dittoe, Nathaniel; Safar, Ammar; Sherman, Steven; Bowdy, Bruce; Hahn, Harvey S

2012-06-01

Percutaneous coronary intervention (PCI) is the most commonly used procedure for coronary revascularization. There are multiple adjuvant anticoagulation strategies available. In this era of cost containment, we performed a comparative effectiveness analysis of clinical outcomes and cost of the major anticoagulant strategies across all types of PCI procedures in a large observational database. A retrospective, comparative effectiveness analysis of the Premier observational database was conducted to determine the impact of anticoagulant treatment on outcomes. Multiple linear regression and logistic regression models were used to assess the association of initial antithrombotic treatment with outcomes while controlling for other factors. A total of 458,448 inpatient PCI procedures with known antithrombotic regimen from 299 hospitals between January 1, 2004 and March 31, 2008 were identified. Compared to patients treated with heparin plus glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin was associated with a 41% relative risk reduction (RRR) for inpatient mortality, a 44% RRR for clinically apparent bleeding, and a 37% RRR for any transfusion. Furthermore, treatment with bivalirudin alone resulted in a cost savings of $976 per case. Similar results were seen between bivalirudin and heparin in all end-points. Combined use of both bivalirudin and GPI substantially attenuated the cost benefits demonstrated with bivalirudin alone. Bivalirudin use was associated with both improved clinical outcomes and decreased hospital costs in this large "real-world" database. To our knowledge, this study is the first to demonstrate the ideal comparative effectiveness end-point of both improved clinical outcomes with decreased costs in PCI. ©2012, Wiley Periodicals, Inc.

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

PubMed

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

2001-01-01

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

Incremental cost effectiveness evaluation in clinical research.

PubMed

Krummenauer, Frank; Landwehr, I

2005-01-28

The health economic evaluation of therapeutic and diagnostic strategies is of increasing importance in clinical research. Therefore also clinical trialists have to involve health economic aspects more frequently. However, whereas they are quite familiar with classical effect measures in clinical trials, the corresponding parameters in health economic evaluation of therapeutic and diagnostic procedures are still not this common. The concepts of incremental cost effectiveness ratios (ICERs) and incremental net health benefit (INHB) will be illustrated and contrasted along the cost effectiveness evaluation of cataract surgery with monofocal and multifocal intraocular lenses. ICERs relate the costs of a treatment to its clinical benefit in terms of a ratio expression (indexed as Euro per clinical benefit unit). Therefore ICERs can be directly compared to a pre-specified willingness to pay (WTP) benchmark, which represents the maximum costs, health insurers would invest to achieve one clinical benefit unit. INHBs estimate a treatment's net clinical benefit after accounting for its cost increase versus an established therapeutic standard. Resource allocation rules can be formulated by means of both effect measures. Both the ICER and the INHB approach enable the definition of directional resource allocation rules. The allocation decisions arising from these rules are identical, as long as the willingness to pay benchmark is fixed in advance. Therefore both strategies crucially call for a priori determination of both the underlying clinical benefit endpoint (such as gain in vision lines after cataract surgery or gain in quality-adjusted life years) and the corresponding willingness to pay benchmark. The use of incremental cost effectiveness and net health benefit estimates provides a rationale for health economic allocation discussions and founding decisions. It implies the same requirements on trial protocols as yet established for clinical trials, that is the a priori

A deep learning model observer for use in alterative forced choice virtual clinical trials

NASA Astrophysics Data System (ADS)

Alnowami, M.; Mills, G.; Awis, M.; Elangovanr, P.; Patel, M.; Halling-Brown, M.; Young, K. C.; Dance, D. R.; Wells, K.

2018-03-01

Virtual clinical trials (VCTs) represent an alternative assessment paradigm that overcomes issues of dose, high cost and delay encountered in conventional clinical trials for breast cancer screening. However, to fully utilize the potential benefits of VCTs requires a machine-based observer that can rapidly and realistically process large numbers of experimental conditions. To address this, a Deep Learning Model Observer (DLMO) was developed and trained to identify lesion targets from normal tissue in small (200 x 200 pixel) image segments, as used in Alternative Forced Choice (AFC) studies. The proposed network consists of 5 convolutional layers with 2x2 kernels and ReLU (Rectified Linear Unit) activations, followed by max pooling with size equal to the size of the final feature maps and three dense layers. The class outputs weights from the final fully connected dense layer are used to consider sets of n images in an n-AFC paradigm to determine the image most likely to contain a target. To examine the DLMO performance on clinical data, a training set of 2814 normal and 2814 biopsy-confirmed malignant mass targets were used. This produced a sensitivity of 0.90 and a specificity of 0.92 when presented with a test data set of 800 previously unseen clinical images. To examine the DLMOs minimum detectable contrast, a second dataset of 630 simulated backgrounds and 630 images with simulated lesion and spherical targets (4mm and 6mm diameter), produced contrast thresholds equivalent to/better than human observer performance for spherical targets, and comparable (12 % difference) for lesion targets.

'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.

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.

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.

Direct Observation of Clinical Skills Feedback Scale: Development and Validity Evidence.

PubMed

Halman, Samantha; Dudek, Nancy; Wood, Timothy; Pugh, Debra; Touchie, Claire; McAleer, Sean; Humphrey-Murto, Susan

2016-01-01

Construct: This article describes the development and validity evidence behind a new rating scale to assess feedback quality in the clinical workplace. Competency-based medical education has mandated a shift to learner-centeredness, authentic observation, and frequent formative assessments with a focus on the delivery of effective feedback. Because feedback has been shown to be of variable quality and effectiveness, an assessment of feedback quality in the workplace is important to ensure we are providing trainees with optimal learning opportunities. The purposes of this project were to develop a rating scale for the quality of verbal feedback in the workplace (the Direct Observation of Clinical Skills Feedback Scale [DOCS-FBS]) and to gather validity evidence for its use. Two panels of experts (local and national) took part in a nominal group technique to identify features of high-quality feedback. Through multiple iterations and review, 9 features were developed into the DOCS-FBS. Four rater types (residents n = 21, medical students n = 8, faculty n = 12, and educators n = 12) used the DOCS-FBS to rate videotaped feedback encounters of variable quality. The psychometric properties of the scale were determined using a generalizability analysis. Participants also completed a survey to gather data on a 5-point Likert scale to inform the ease of use, clarity, knowledge acquisition, and acceptability of the scale. Mean video ratings ranged from 1.38 to 2.96 out of 3 and followed the intended pattern suggesting that the tool allowed raters to distinguish between examples of higher and lower quality feedback. There were no significant differences between rater type (range = 2.36-2.49), suggesting that all groups of raters used the tool in the same way. The generalizability coefficients for the scale ranged from 0.97 to 0.99. Item-total correlations were all above 0.80, suggesting some redundancy in items. Participants found the scale easy to use (M = 4.31/5) and clear

Highly effective cystic fibrosis clinical research teams: critical success factors.

PubMed

Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W

2014-08-01

Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.

Nanoindentation of orthodontic archwires: The effect of decontamination and clinical use on hardness, elastic modulus and surface roughness.

PubMed

Alcock, Joseph P; Barbour, Michele E; Sandy, Jonathan R; Ireland, Anthony J

2009-08-01

The purpose of this research was to investigate the effects of decontamination and clinical exposure on the elastic moduli, hardness and surface roughness of two frequently used orthodontic archwires, namely 0.020in.x0.020in. heat activated (martensitic active) nickel titanium archwires and 0.019in.x0.025in. austenitic stainless steel archwires. This study was a prospective clinical trial in which 20 consecutive patients requiring an archwire change as part of their course of orthodontic fixed appliance therapy, had either a nickel titanium or stainless steel archwire fitted as deemed clinically necessary. The effect of clinical use was determined by comparing distal end cuts of the "as received" archwires before and after decontamination, with the same retrieved archwires following clinical use and decontamination. Hardness, elastic modulus and surface roughness were determined using an atomic force microscope (AFM) coupled with a nanoindenter. The results showed that the decontamination regimen and clinical use had no statistically significant effect on the nickel titanium archwires, but did have a statistically significant effect on the steel archwires. Decontamination of the steel wires significantly increased the observed surface hardness (p=0.01) and reduced the surface roughness (p=0.02). Clinical use demonstrated a statistically significant increase in the observed elastic modulus (p<0.001) and a decrease in surface roughness (p=0.001). At present it is difficult to predict the clinical significance of these statistically significant changes in archwire properties on orthodontic tooth movement.

The use of clinical trials in comparative effectiveness research on mental health.

PubMed

Blanco, Carlos; Rafful, Claudia; Olfson, Mark

2013-08-01

A large body of comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health. Examination of three ongoing randomized clinical trials in psychiatry addressing issues that would pose difficulties for nonexperimental CER methods. Existing statistical approaches to nonexperimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout. Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult-to-reach populations, or when examining sequential treatments or stepped-care algorithms. Progress in CER on mental health will require careful consideration of appropriate selection between clinical trials and nonexperimental designs and on allocation of research resources to optimally inform key treatment decisions for each patient. Copyright © 2013 Elsevier Inc. All rights reserved.

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.

Student's perceptions of effective clinical teaching revisited.

PubMed

Kelly, Claudette

2007-11-01

Despite a wealth of research on clinical teaching, the criteria for determining what constitutes effective clinical teaching remain poorly defined [Cholowski, K., 2002. Nursing students' and clinical educators' perceptions of characteristics of effective clinical educators in an Australian university school of nursing. Journal of Advanced Nursing 39 (5), 412-420]. This paper reports on two studies exploring second and third year nursing student's perceptions of effective clinical teaching over 14 years (1989-2003). The aim of the inquiry was to compare student's perceptions in diploma and baccalaureate programs within existing clinical contexts. This research used a generative approach to elicit learner's views of what teacher characteristics and contextual influences impact them in clinical settings. A convenience sample of 30 students at the end of second and third years volunteered to be interviewed in-depth for each study. The first study was conducted in a diploma program, whereas in the second study all but a few students were elected to complete a four year baccalaureate nursing degree. Findings from both studies are remarkably consistent. Students in both studies rated teacher knowledge as most important followed by feedback and communication skills. Teacher knowledge appeared critical in four areas: as it pertains to the clinical setting, the curriculum, the learner and teaching/learning theory. How well students perceived that they were accepted by staff, student-teacher ratios and peer support also appeared to impact student's views of effective clinical teaching. This research has implications for employment and evaluation practices for teachers in applied fields such as nursing. The study raises questions about the recent trend toward temporary employment of clinical teachers and in the separation of academic and clinical roles of nurse educators.

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.

Effective utilization of clinical laboratories.

PubMed

Murphy, J; Henry, J B

1978-11-01

Effective utilization of clinical laboratories requires that underutilization, overutilization, and malutilization be appreciated and eliminated or reduced. Optimal patient care service, although subjective to a major extent, is reflected in terms of outcome and cost. Increased per diem charges, reduced hospital stay, and increased laboratory workload over the past decade all require each laboratory to examine its internal operations to achieve economy and efficiency as well as maximal effectiveness. Increased research and development, an active managerial role on the part of pathologists, internal self-assessment, and an aggressive response to sophisticated scientific and clinical laboratory data base requirements are not only desirable but essential. The importance of undergraduate and graduate medical education in laboratory medicine to insure understanding as well as effective utilization is stressed. The costs and limitations as well as the accuracy, precision, sensitivity, specificity, and pitfalls of measurements and examinations must also be fully appreciated. Medical malpractice and defensive medicine and the use of critical values, emergency and routine services, and an active clinical role by the pathologist are of the utmost value in assuring effective utilization of the laboratory. A model for the optimal use of the laboratory including economy and efficiency has been achieved in the blood bank in regard to optimal hemotherapy for elective surgery, assuring superior patient care in a cost effective and safe manner.

Clinical observation, pharmacotherapy and referral on discharge of patients with anxiety disorder in a psychiatric emergency service.

PubMed

Pailhez, Guillem; Majó, Albert; Córcoles, David; Ginés, José M; Arcega, José M; Castaño, Juan; Merino, Ana; Bulbena, Antonio; Pérez, Víctor

2015-01-01

To analyze factors associated with clinical observation, pharmacotherapy and referral on discharge of patients with anxiety disorder (AD) seeking care at a psychiatric emergency unit. A total of 5003 consecutive visits were reviewed over a three-year period at a psychiatric emergency service in a tertiary university hospital. Data collected included sociodemographic and clinical information as well as the Global Assessment of Functioning (GAF) and the Severity Psychiatric Illness (SPI) scale scores. Of all the visits, 992 (19.8%) were diagnosed of AD. Of these, 19.6% required clinical observation and 72.2% were referred to a psychiatrist at discharge. Regression analysis showed that referral to psychiatry was associated with being male, native, psychiatric background, greater severity, lower global functioning, and behavioral disorders. Clinical observation (in a box) was associated with being female, greater severity, and psychotic or behavioral symptoms. Prescription of benzodiazepines was associated with anxiety, no history of addiction, and lower global functioning. Antidepressants were associated with being a native, anxiety with no history of addiction, and lower functioning. Antipsychotics were associated with being native, psychiatric background (not addiction), anxiety, and lower functioning. Behavior, psychiatric background and illness severity were determinants of referral to a specialist. Besides these, psychotic symptoms and non-specific clinical symptoms were determinants of observation. Drug prescription in AD is less frequent if the main complaint is not anxiety and depends more on the level of functioning than on that of severity.

Validation of Clinical Observations of Mastication in Persons with ALS.

PubMed

Simione, Meg; Wilson, Erin M; Yunusova, Yana; Green, Jordan R

2016-06-01

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that can result in difficulties with mastication leading to malnutrition, choking or aspiration, and reduced quality of life. When evaluating mastication, clinicians primarily observe spatial and temporal aspects of jaw motion. The reliability and validity of clinical observations for detecting jaw movement abnormalities is unknown. The purpose of this study is to determine the reliability and validity of clinician-based ratings of chewing performance in neuro-typical controls and persons with varying degrees of chewing impairments due to ALS. Adults chewed a solid food consistency while full-face video were recorded along with jaw kinematic data using a 3D optical motion capture system. Five experienced speech-language pathologists watched the videos and rated the spatial and temporal aspects of chewing performance. The jaw kinematic data served as the gold-standard for validating the clinicians' ratings. Results showed that the clinician-based rating of temporal aspects of chewing performance had strong inter-rater reliability and correlated well with comparable kinematic measures. In contrast, the reliability of rating the spatial and spatiotemporal aspects of chewing (i.e., range of motion of the jaw, consistency of the chewing pattern) was mixed. Specifically, ratings of range of motion were at best only moderately reliable. Ratings of chewing movement consistency were reliable but only weakly correlated with comparable measures of jaw kinematics. These findings suggest that clinician ratings of temporal aspects of chewing are appropriate for clinical use, whereas ratings of the spatial and spatiotemporal aspects of chewing may not be reliable or valid.

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.

[Clinical observation on nanometer acupoint mounting method for alleviation of myospasm complicated by spinal injury].

PubMed

Zhang, Su-Jie; Si, Tong; Li, Zhi

2008-11-01

To observe clinical effect of nanometer acupoint mounting method for alleviation of myospasm complicated by spinal injury. Sixty cases were randomly divided into an observation group and a control group, 30 cases in each group. The observation group were treated by nanometer mounting at 4 Jiaji (EX-B 2) points each on both sides of the affected spine and Shenshu (BL 23), Shangliao (BL 31), Ciliao (BL 32), Yang-lingquan (GB 34), Xuanzhong (GB 39); and the control group by mounting zinc oxide sticking tablets at the above acupoints. The mounting was replaced once each two days, 7 times constituting one course. One week and one month after the end of 3 courses, their results were recorded, respectively. Before treatment, there was no significant difference between the two groups in grades of the myospasm degree (P > 0.05). One week after the end of treatment, 15 cases were grade I of myospasm, 9 cases were grade II, 5 cases were grade III and 1 case was grade IV in the observation group, and 1 cases grade I, 7 cases grade II, 14 cases grade III, 8 cases grade IV in the control group. Ridit analysis on the data indicated that there were significant differences before and after treatment in the myospasm degree (P < 0.01) and between the two groups after treatment (P < 0.01). One month after the end of treatment, the results were similar to those one week after the end of treatment. Nanometer acupoint mounting method is a new one for alleviation of myospasm complicated by spinal injury, with convenience, safety and no side effect.

Clinical effectiveness of garlic (Allium sativum).

PubMed

Pittler, Max H; Ernst, Edzard

2007-11-01

The objective of this review is to update and assess the clinical evidence based on rigorous trials of the effectiveness of garlic (A. sativum). Systematic searches were carried out in Medline, Embase, Amed, the Cochrane Database of Systematic Reviews, Natural Standard, and the Natural Medicines Comprehensive Database (search date December 2006). Our own files, the bibliographies of relevant papers and the contents pages of all issues of the review journal FACT were searched for further studies. No language restrictions were imposed. To be included, trials were required to state that they were randomized and double blind. Systematic reviews and meta-analyses of garlic were included if based on the results of randomized, double-blind trials. The literature searches identified six relevant systematic reviews and meta-analysis and double-blind randomized trials (RCT) that were published subsequently. These relate to cancer, common cold, hypercholesterolemia, hypertension, peripheral arterial disease and pre-eclampsia. The evidence based on rigorous clinical trials of garlic is not convincing. For hypercholesterolemia, the reported effects are small and may therefore not be of clinical relevance. For reducing blood pressure, few studies are available and the reported effects are too small to be clinically meaningful. For all other conditions not enough data are available for clinical recommendations.

Comparative effectiveness research and its utility in In-clinic practice

PubMed Central

Dang, Amit; Kaur, Kirandeep

2016-01-01

One of the important components of patient-centered healthcare is comparative effectiveness research (CER), which aims at generating evidence from the real-life setting. The primary purpose of CER is to provide comparative information to the healthcare providers, patients, and policy makers about the standard of care available. This involves research on clinical questions unanswered by the explanatory trials during the regulatory approval process. Main methods of CER involve randomized controlled trials and observational methods. The limitations of these two methods have been overcome with the help of new statistical methods. After the evidence generation, it is equally important to communicate the results to all the interested organizations. CER is beginning to have its impact in the clinical practice as its results become part of the clinical practice guidelines. CER will have far-reaching scientific and financial impact. CER will make both the treating physician and the patient equally responsible for the treatment offered. PMID:26955571

Effects of Prophylactic Antiepileptic Drugs on Clinical Outcomes in Patients with a Good Clinical Grade Suffering from Aneurysmal Subarachnoid Hemorrhage

PubMed Central

Yoon, Seon Jin; Joo, Jin-Yang; Kim, Yong Bae; Hong, Chang-Ki

2015-01-01

Objective Routine use of prophylactic antiepileptic drugs (AED) has been debated. We retrospectively evaluated the effects of prophylactic AED on clinical outcomes in patients with a good clinical grade suffering from aneurysmal subarachnoid hemorrhage (aSAH). Materials and Methods Between September 2012 and December 2014, 84 patients who met the following criteria were included: (1) presence of a ruptured aneurysm; (2) Hunt-Hess grade 1, 2, or 3; and (3) without seizure presentation. Patients were divided into two groups; the AED group (n = 44) and the no AED group (n = 40). Clinical data and outcomes were compared between the two groups. Results Prophylactic AEDs were used more frequently in patients who underwent microsurgery (84.1%) compared to those who underwent endovascular surgery (15.9%, p < 0.001). Regardless of prophylactic AED use, seizure episodes were not observed during the six-month follow-up period. No statistical difference in clinical outcomes at discharge (p = 0.607) and after six months of follow-up (p = 0.178) were between the two groups. After six months, however, favorable outcomes in the no AED group tended to increase and poor outcomes tended to decrease. Conclusion No difference in the clinical outcomes and systemic complications at discharge and after six months of follow-up was observed between the two groups. However, favorable outcomes in the no AED group showed a slight increase after six months. These findings suggest that discontinuation of the current practice of using prophylactic AED might be recommended in patients with a good clinical grade. PMID:26526008

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

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.

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

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.

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.

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).

The use of clinical trials in comparative effectiveness research on mental health

PubMed Central

Blanco, Carlos; Rafful, Claudia; Olfson, Mark

2013-01-01

Objectives A large body of research on comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health. Study Design and Setting Examination of three ongoing randomized clinical trials in psychiatry that address issues which would pose difficulties for non-experimental CER methods. Results Existing statistical approaches to non-experimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout. Conclusions Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult to reach populations or when examining sequential treatments or stepped-care algorithms. Progress in CER in mental health will require careful consideration of appropriate selection between clinical trials and non-experimental designs and on allocation of research resources to optimally inform key treatment decisions for each individual patient. PMID:23849150

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.

Final year MBBS students' perception for observed structured clinical examination.

PubMed

Siddiqui, Faisal Ghani

2013-01-01

To determine perceptions of final year students about observed structured clinical examination (OSCE) and to determine its acceptance among these students. Sequential mixed method design using survey questionnair and in-depth interviews. The study constituted a one-time survey and in-depth interviews conducted over a period of three consecutive days during final year MBBS annual examination at OSCE centre, from April 04, 2010 to April 06, 2010. Three hundred and fifty final year MBBS students, selected through non-probability convenience sampling, were asked to fill the 12-item questionnaire. Three hundred and thirty one students returned the forms. In-depth, structured interviews with 22 students, selected by non-probability purposive sampling, were conducted. The interviews were tape recorded for subsequent transcription. The statistical analysis was done using SPSS 17. The qualitative data was analyzed through content analysis techniques. Three hundred and thirty one final year MBBS students (50.6% females) filled the questionnaire (response rate 94.6%). Fifty three percent respondents agreed that the OSCE tasks were taught during clinical rotations. The experience was stressful for 67.9% respondents. Inadequate prior guidelines, inadequate time for stations, newness of the assessment format and vague instructions were the main causes for stress. Over 70% of the students felt that OSCE helped them identify areas of weakness in their practical and clinical skills; 56.5% felt that the stations dealt with practical skills. Seventy nine percent students were happy with the attitude of the examiners while 19% students felt that the facilitators were uncooperative; failure of the examiners to observe the students during performance of the tasks was the major cause for dissatisfaction. Nearly thirty percent (29.9%) respondent felt that the stations were difficult to understand. Over forty nine percent (49.7%) complained that adequate guidelines were not given prior to

[Clinical observation of teacher tablets in treatment of pharyngitis].

PubMed

Qin, Dong-yun; Wu, Tie

2008-07-01

To evaluate the efficacy of teacher tablets in the treatment of pharyngitis. One hundred and thirty six patients with acute pharyngitis or chronic pharyngitis in attack were randamly divided into two groups: treated group (n=68), the patients were given teacher tablets for 7 days, control group (n=68), the patients were given Qinlian capsule for 7 days. Before and after the experimental medicine-taking test, general condition, clinical symptoms and features of examinations on laryngo-pharynx, throat swab bacterial culture were measured. After 7 day medicine-taking experiment, teacher tablets can improve clinical symptoms (at an efficacy rate of more than 60%) and features (at an efficacy rate of more than 80%) of laryngopharynx, in treated group, the inhibition ratios of alpha streptococcus, neisseria and staphylococcus aureus are more than 50%. There are no significant difference between treated group and control groups in those detected index. Teacher tablets is effective for pharyagitis.

The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials.

PubMed

Stanmore, Emma; Stubbs, Brendon; Vancampfort, Davy; de Bruin, Eling D; Firth, Joseph

2017-07-01

Physically-active video games ('exergames') have recently gained popularity for leisure and entertainment purposes. Using exergames to combine physical activity and cognitively-demanding tasks may offer a novel strategy to improve cognitive functioning. Therefore, this systematic review and meta-analysis was performed to establish effects of exergames on overall cognition and specific cognitive domains in clinical and non-clinical populations. We identified 17 eligible RCTs with cognitive outcome data for 926 participants. Random-effects meta-analyses found exergames significantly improved global cognition (g=0.436, 95% CI=0.18-0.69, p=0.001). Significant effects still existed when excluding waitlist-only controlled studies, and when comparing to physical activity interventions. Furthermore, benefits of exergames where observed for both healthy older adults and clinical populations with conditions associated with neurocognitive impairments (all p<0.05). Domain-specific analyses found exergames improved executive functions, attentional processing and visuospatial skills. The findings present the first meta-analytic evidence for effects of exergames on cognition. Future research must establish which patient/treatment factors influence efficacy of exergames, and explore neurobiological mechanisms of action. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Methylmercury poisoning in Iraqi children: clinical observations over two years.

PubMed Central

Amin-zaki, L; Majeed, M A; Clarkson, T W; Greenwood, M R

1978-01-01

The clinical features of 49 children who had eaten bread contaminated with methylmercury in rural Iraq were reviewed. Symptoms and signs relating to the nervous system--varying degrees of ataxia, weakness, and visual and sensory changes--dominated the clinical picture. The severity of poisoning was related to the blood mercury concentration, as was the degree of recovery. Follow-up over two years showed that children who had had mild or moderate poisoning slowly but steadily improved, some of them recovering normal function, though all had a residual generalized hyperreflexia. In some patients ataxia and motor weakness disappeared. Visual changes also improved, though less completely, and of 17 blind children, only five had recovered partial sight by the end of two years. Seven of the 18 children who suffered very severe poisoning were left physically and mentally incapacitated. The degree of clinical progress shown by these children was better than that shown by some other groups of patients, possibly because the poisoning was relatively acute and mercury consumption was stopped immediately after its effects had become obvious. PMID:630256

[Clinical and pathologic observation of uveal metastatic carcinoma].

PubMed

Cong, C X; Lin, J Y; Wang, L H

2016-10-11

Objective: To observe the clinical and pathological features of uveal metastatic carcinoma. Methods: It was a retrospective case series study. The clinical manifestation, growth pattern, tumor types and relative pathological features of 13 patients visiting from January 1980 to December 2014 with uveal metastatic carcinoma in Tianjin Eye Hospital were analyzed retrospectively. Results: There were 13 cases, 6 cases of male and 7 of female. Age was from 37.0 to 66.0 years old. The mean age was 52.1 years old. all cases were monocular. There were 5 cases with right eye and 8 cases with left eye. Among 13 cases, 10 tumors were in posterior choroid, one tumor was in anterior choroid and ciliary body, 2 tumors were in the iris. There were 5 patients with lung cancer, 4 patients with breast cancer, 1 patient with prostate cancer, 1 patient with thyroid cancer and 1 patient with esophageal cancer. The primary tumor wasn't found in 1 patient. The rapid decrease of visual acuity showed in 10 patients with posterior choroidal metastatic carcinoma, 8 of them accompanied with extensive retinal detachment and 6 of them had secondary glaucoma. The multiple gray-white nodule or pink cauliflower mass on the papillary margin of iris were showed respectively in 2 patients with iris metastatic carcinoma. The pathological examination found that posterior choroidal metastatic carcinoma mainly located in temporal or nasal side choroids in 10 cases, among them, local or diffuse flat choroidal masses showed in 6cases, extensive mass involving choroid and ciliary body showed in 1 case, large nodular or globular choroidal mass showed in 2 cases, choroidal mass surrounded the optic disc in 1 case, optic nerve invasion showed in 3 cases and extraocular or orbital invasion showed in 3 cases. The scleral and subconjunctival invasion showed in 1 case of anterior choroid and ciliary body metastatic carcinoma. Conclusions: Uveal metastatic carcinoma manifested various growth pattern, the rapid

[Clinical observation on the therapeutic effect of electroacupuncture combined with cupping on post-stroke fatigue].

PubMed

Zhou, Yuan; Zhou, Guo-Ying; Li, Shao-Kun; Jin, Jian-Hong

2010-10-01

To observe the therapeutic effect of electroacupuncture (EA) combined with cupping at the lumbo-back on post-stroke fatigue. A total of 128 cases of post-stroke fatigue patients were randomly divided into EA + cupping group and medication group, with 64 cases in each group. EA (20 Hz, 2 mA) was applied to Baihui (GV 20), Yintang (EX-HN 3), Shuigou (GV 26), Hegu (LI 4), Zusanli (ST 36), Sanyinjiao (SP 6), and Taichong (LR 3) for 30 min, once daily for 30 times, and cupping was applied at the patient's lumbo-back region once every two days, and continuously for 5 weeks. Patients of medication group were ordered to take compound aminobutyric acid vitamin E capsule (20 mg, t. i.d, po), magnesium gluconate solution (10 mL, t. i. d, po), sertraline hydrochloridetablet (50 mg, qd, po) for 5 weeks. The Stroke Specific Quality of Life Scale (SS-QOL) was used to evaluate the patients' energy state. After the treatment, the energy scores of SS-QOL of both EA + cupping and medication groups were increased significantly in comparison with the pre-treatment in each group (P < 0.05), and that of the EA+ cupping group was significantly higher than the score of the medication group (P < 0.05). Of the two 64 cases in EA + cupping group and medication group, 42 and 23 were recovered basically, 13 and 13 experienced marked improvement, 7 and 18 were effective, 2 and 10 failed in the treatment, with the effective rates being 96.87% and 84.37% respectively. The effective rate of EA + cupping group was obviously higher than that of medication group (P < 0.01). EA+ cupping at the lumbo-back can effectively relieve fatigue of post-stroke patients, and its therapeutic effect is superior to medication.

Use of Vitex agnus-castus in migrainous women with premenstrual syndrome: an open-label clinical observation.

PubMed

Ambrosini, Anna; Di Lorenzo, Cherubino; Coppola, Gianluca; Pierelli, Francesco

2013-03-01

Premenstrual syndrome (PMS) affects most women during their reproductive life. Headache is regarded as a typical symptom of PMS and, close to menses, migrainous women could experience their worst migraine attacks. Vitex agnus-castus (VAC) is a phytopharmaceutical compound, considered worldwide to be a valid tool to treat PMS. Aim of this study is to explore if headache is ameliorate in migrainous women treated with VAC for PMS by an open-label clinical observation. Migrainous women with PMS were enrolled in the study and advised to assume a treatment with VAC (40 mg/day) for PMS for a 3-month period. Effects both on PMS and headache were assessed. Out of 107 women, 100 completed the 3-month treatment for PMS. Out of them, 66 women reported a dramatic reduction of PMS symptoms, 26 a mild reduction, and 8 no effect. Concerning migraine, 42 % of patients experienced a reduction higher than 50 % in frequency of monthly attacks, and 57 % of patients experienced a reduction higher than 50 % in monthly days with headache. No patients reported remarkable side effects. Pending a placebo-controlled trial to confirm our results, we observed that the use of VAC in migrainous women affected by PMS resulted to be safe and well tolerated, and may positively influence the frequency and duration of migraine attacks.

Digit-sucking: a review of the literature, clinical observations and treatment recommendations.

PubMed

Van Norman, R A

1997-01-01

Prolonged digit-sucking habits can have a negative impact on dental, speech, physical and emotional development. Children can be helped to eliminate their sucking habits quickly, without coercion, and in a positive way. Admittedly, most of my data is based purely on clinical observation. However, clinical observation is the basis for classical scientific investigation. I welcome this investigation; it is long overdue. Much of the literature available to parents appears to take a rather cavalier attitude with regard to the dental consequences of sucking habits. Parents are frequently left with the impression that no harm is done to the teeth. This perspective is based on the assumption that most children stop the sucking behavior before permanent teeth erupt into the mouth. Therefore, any dental malocclusion in the primary teeth will often be transitional or will spontaneously self-correct. However, as demonstrated by Kelly, et al (1973), millions of children do not discontinue their sucking habits before permanent teeth erupt. In addition, stress levels in today's world are probably significantly greater than when this study was done. Because stress is a powerful stimulus for the sucking activity, it is highly probable that if a similar study were done today, it would produce a substantially greater number of individuals with prolonged sucking habits. The active pursuit of insurance benefits for the Certified Orofacial Myologist providing therapy for the elimination of these habits will be germane to prevention. Research is needed to accomplish this goal including: investigation of the incidence of prolonged digit-sucking habits; the impact of these habits on the entire stomatognathic system, speech development and emotional health; efficacy of treatment (including psychological response) both through the utilization of habit appliances and motivational therapy. The Certified Orofacial Myologist provides many valuable therapeutic programs to enhance dental and

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.

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

A case of basilar artery aneurysm rupture from 1836: lessons in clinical observation and the natural history of the disease.

PubMed

Demetriades, Andreas K; Horiguchi, Takashi; Goodrich, James T; Kawase, Takeshi

2014-11-01

Although credit is given to Sir William Gull for highlighting the clinical picture of subarachnoid hemorrhage in 1859, we discuss a case presented by Mr. Egerton A. Jennings, Fellow of the Linnaean Society, published 23 years earlier in the 1836 edition of the Transactions of the Provincial Medical and Surgical Association. This case, probably the first reported in the English language of a basilar aneurysm rupture, is of medico-historical interest. Jennings provided a remarkably accurate and detailed description of the patient, who experienced coma as a result of the severity of subarachnoid hemorrhage. The detailed clinical observations on initial assessment and the description of the patient's deterioration to the time of death are a succinct representation of the natural history of this disease. The author's discussion provides evidence of a philosophy committed to medical education and progress at the time based on principles of rational observation, meticulous clinical acumen, insight into experimental physiology, and the awareness of ethical boundaries. In provincial 1836 England, similar to most of Europe, cerebral localization was elementary. Nonetheless, this case report highlights the attempt at linking structure to function by means of observation on the effects of lesioning. It provides evidence of an established thought process already in progress in England in the 19th century. It is characteristic that this thought process came from a surgical practitioner. The cultivation of practical observation in British surgical culture would allow the late 19th century surgeon scientists to match the contributions of British neurologists with landmark steps in the development and establishment of neurosurgery. Copyright © 2014 Elsevier Inc. 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.

[Clinical research XVII. χ(2) test, from the expected to the observed].

PubMed

Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez, Marcela; Talavera, Juan O

2013-01-01

When you want to show if there is a statistical association or differences between categorical variables, it is recommended to use the χ(2) test. This nonparametric test is one of the most used in clinical research; it contrasts nominal or ordinal qualitative variables that are observed in clinical practice. This test calculates the p value that determines whether differences between groups are real or due to chance. The χ(2) test is the basis of other tests to analyze qualitative ordinal variables as χ(2) for linear trend, which compares three groups with two outcomes or McNemar test, which contrasts two related samples (a before and afterward comparison) or Mantel-Haenszel χ(2), which controls for potential confounding variables. When using small samples, where the expected results are less than 5, Fisher's exact test should be used. These tests are the most widely used in the medical literature; however, they do not give us the magnitude or the direction of the event and a proper interpretation that requires clinical judgment is needed.

Developing performance indicators for clinical governance in dimensions of risk management and clinical effectiveness.

PubMed

Azami-Aghdash, Saber; Tabrizi, Jafar Sadegh; Sadeghi-Bazargani, Homayoun; Hajebrahimi, Sakineh; Naghavi-Behzad, Mohammad

2015-04-01

This study has been designed and conducted to develop domestic indicators for evaluating the performance of clinical governance in dimensions of risk management and clinical effectiveness. This study implemented a 5-stage process including conducting a comprehensive literature review, expert panel (∼ 1000 h per person per session, 11 experts), semi-structured interviews, a 2-round Delphi study (33 experts were in attendance) and a final expert panel (8 experts were in attendance). East Azerbaijan-Iran Province. Fifty-six specialists and experts in different fields of medical sciences. Importance and applicability of indicators. Using a thorough literature review, 361 indicators (129 risk management indicators in 4 dimensions and 232 clinical effectiveness indicators in 18 dimensions) were found. After conducting expert panels and interviews, the number of indicators decreased to 168 cases (65 risk management indicators in 4 dimensions and 103 clinical effectiveness indicators in 12 dimensions). Two rounds of Delphi identified four indicators that were omitted. The members of the final expert panel agreed on 113 indicators (43 risk management indicators in 4 dimensions and 70 clinical effectiveness indicators in 11 dimensions). In this study, indicators for assessing clinical governance in domains of risk management and clinical effectiveness were designed that can be used by policy-makers and other authorities for improving the quality of services and evaluating the performance of clinical governance. Those indicators can be used with slight modifications in other countries having healthcare systems similar to that of Iran. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

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.

Using direct clinical observation to assess the quality of cesarean delivery in Afghanistan: an exploratory study

PubMed Central

2014-01-01

Background As part of a National Emergency Obstetric and Newborn Care (EmONC) Needs Assessment, a special study was undertaken in July 2010 to examine the quality of cesarean deliveries in Afghanistan and examine the utility of direct clinical observation as an assessment method in low-resource settings. Methods This cross-sectional assessment of the quality of cesareans at 14 facilities in Afghanistan included a survey of surgeons regarding their routine cesarean practices, direct observation of 29 cesarean deliveries and comparison of observations with facility records for 34 additional cesareans conducted during the 3 days prior to the observation period at each facility. For both observed cases and record reviews, we assessed time intervals between specified points of care-arrival to the ward, first evaluation, detection of a complication, decision for cesarean, incision, and birth. Results All time intervals with the exception of “decision to skin incision” were longer in the record reviews than in observed cases. Prior cesarean was the most common primary indication for all cases. All mothers in both groups observed survived through one hour postpartum. Among newborns there were two stillbirths (7%) in observed births and seven (21%) record reviews. Although our sample is too small to show statistical significance, the difference is noteworthy. In six of the reviewed cesareans resulting in stillbirth, a fetal heart rate was recorded in the operating theater, although four were recorded as macerated. For the two fresh stillbirths, the cesarean surgeries were recorded as scheduled and not urgent. Conclusions Direct observation of cesarean deliveries enabled us to assess a number of preoperative, postoperative, and intraoperative procedures that are often not described in medical records in low resource settings. Comparison of observations with findings from provider interviews and facility records allowed us to infer whether observed practices were typical

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

Rotigotine transdermal patch in combination therapy for Parkinson's disease--observations in routine clinical practice.

PubMed

Ceballos-Baumann, Andres; Häck, Hermann-Josef

2011-10-01

The dopamine agonist rotigotine has shown efficacy and safety for the treatment of early and advanced Parkinson's disease (PD) in controlled clinical trials. This observational study evaluated rotigotine administration in combination with other antiparkinsonian medication in routine clinical practice. Data were collected by 688 German practice-based neurologists, initiating rotigotine treatment in patients with idiopathic Parkinson's disease. Assessments included rotigotine maintenance dose, changes in concomitant PD medication, changes in sleep quality, and rotigotine tolerability over an observation period of 12-16 weeks. The median rotigotine maintenance dose was 6 mg/24 h (n = 969, full analysis set). The proportion of all other prescribed PD medications declined over the observation period; combination therapy decreased by 18.7%. Daily levodopa intake was markedly reduced by 87 mg (18.9%) in 47.6% of the patients with levodopa documentation; 7% no longer required levodopa after 12-16 weeks. Mean overall sleep quality (PD Sleep Scale item 1) improved by 21.4 points, the occurrence of nocturias (PDSS item 8) by 13.4 points, and 'turning in bed' (Unified Parkinson's Disease Rating Scale part II) by 0.6 points. Drug-related adverse events were reported for 7.9% of all patients (n = 1152, safety population). Application site reactions were the most common adverse events (2.2%) resulting in early discontinuation in 1.4% of patients. In routine clinical practice, treatment initiation with rotigotine transdermal patch was associated with a reduction of other prescribed PD medications and with an improvement of self-reported sleep quality.

Cost-Effectiveness Analysis of Family Planning Services Offered by Mobile Clinics versus Static Clinics in Assiut, Egypt.

PubMed

Al-Attar, Ghada S T; Bishai, David; El-Gibaly, Omaima

2017-03-01

Cost effectiveness studies of family planning (FP) services are very valuable in providing evidence-based data for decision makers in Egypt. Cost data came from record reviews for all 15 mobile clinics and a matched set of 15 static clinics and interviews with staff members of the selected clinics at Assiut Governorate. Effectiveness measures included couple years of protection (CYPs) and FP visits. Incremental cost-effectiveness ratios (ICER) and sensitivity analyses were calculated. Mobile clinics cost more per facility, produced more CYPs but had fewer FP visits. Sensitivity analysis was done using: total costs, CYP and FP visits of mobile and static clinics and showed that variations in CYP of mobile and static clinics altered the ICER for CYP from $2 -$6. Mobile clinics with their high emphasis on IUDs offer a reasonable cost effectiveness of $4.46 per additional CYP compared to static clinics. The ability of mobile clinics to reach more vulnerable women and to offer more long acting methods might affect a policy decision between these options. Static clinics should consider whether emphasizing IUDs may make their services more cost-effective.

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.

Effect Size in Clinical Phonology

ERIC Educational Resources Information Center

Gierut, Judith A.; Morrisette, Michele L.

2011-01-01

The purpose of this article is to motivate the use of effect size (ES) for single-subject research in clinical phonology, with an eye towards meta-analyses of treatment effects for children with phonological disorders. Standard mean difference (SMD) is introduced and illustrated as one ES well suited to the multiple baseline (MBL) design and…

On heterogeneity of treatment effects and clinical freedom.

PubMed

Sacristán, J A; Avendaño-Solá, C

2015-01-01

Three decades ago, John R Hampton announced the death of clinical freedom. Since then, evidence-based medicine has been the predominant paradigm in clinical research. By applying a population-based approach, the randomised controlled trial has become the cornerstone for demonstrating the overall effect of a treatment and for developing guidelines. The new patient-centred medicine movement is rediscovering the important implications of heterogeneity of treatment effects for clinical practice and that a better understanding of such variability can contribute to improve health outcomes for individual patients through practicing a science-based clinical freedom. © 2015 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Dementia Prevention: optimizing the use of observational data for personal, clinical, and public health decision-making.

PubMed

Dacks, Penny A; Andrieu, Sandrine; Blacker, Deborah; Carman, Aaron J; Green, Allan M; Grodstein, Francine; Henderson, Victor W; James, Bryan D; Lane, Rachel F; Lau, Joseph; Lin, Pei-Jung; Reeves, Barnaby C; Shah, Raj C; Vellas, Bruno; Yaffe, Kristine; Yurko-Mauro, Karin; Shineman, Diana W; Bennett, David A; Fillit, Howard M

2014-02-01

Worldwide, over 35 million people suffer from Alzheimer's disease and related dementias. This number is expected to triple over the next 40 years. How can we improve the evidence supporting strategies to reduce the rate of dementia in future generations? The risk of dementia is likely influenced by modifiable factors such as exercise, cognitive activity, and the clinical management of diabetes and hypertension. However, the quality of evidence is limited and it remains unclear whether specific interventions to reduce these modifiable risk factors can, in turn, reduce the risk of dementia. Although randomized controlled trials are the gold-standard for causality, the majority of evidence for long-term dementia prevention derives from, and will likely continue to derive from, observational studies. Although observational research has some unavoidable limitations, its utility for dementia prevention might be improved by, for example, better distinction between confirmatory and exploratory research, higher reporting standards, investment in effectiveness research enabled by increased data-pooling, and standardized exposure and outcome measures. Informed decision-making by the general public on low-risk health choices that could have broad potential benefits could be enabled by internet-based tools and decision-aids to communicate the evidence, its quality, and the estimated magnitude of effect.

Clinical effectiveness of a cognitive behavioral group treatment program for anxiety disorders: a benchmarking study.

PubMed

Oei, Tian P S; Boschen, Mark J

2009-10-01

Previous research has established efficacy of cognitive behavioral therapy (CBT) for anxiety disorders, yet it has not been widely assessed in routine community clinic practices. Efficacy research sacrifices external validity to achieve maximum internal validity. Recently, effectiveness research has been advocated as more ecologically valid for assessing routine clinical work in community clinics. Furthermore, there is a lack of effectiveness research in group CBT. This study aims to extend existing research on the effectiveness of CBT from individual therapy into group therapy delivery. It aimed also to examine outcome using not only symptom measures, but also measures of related symptoms, cognitions, and life quality and satisfaction. Results from a cohort of patients with various anxiety disorders demonstrated that treatment was effective in reducing anxiety symptoms to an extent comparable with other effectiveness studies. Despite this, only 43% of individuals showed reliable change, and 17% were 'recovered' from their anxiety symptoms, and the post-treatment measures were still significantly different from the level of anxiety symptoms observed in the general population.

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.

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.

The clinical and cost effectiveness of a virtual fracture clinic service

PubMed Central

Imbuldeniya, A. M.

2017-01-01

Objectives To assess the clinical and cost-effectiveness of a virtual fracture clinic (VFC) model, and supplement the literature regarding this service as recommended by The National Institute for Health and Care Excellence (NICE) and the British Orthopaedic Association (BOA). Methods This was a retrospective study including all patients (17 116) referred to fracture clinics in a London District General Hospital from May 2013 to April 2016, using hospital-level data. We used interrupted time series analysis with segmented regression, and direct before-and-after comparison, to study the impact of VFCs introduced in December 2014 on six clinical parameters and on local Clinical Commissioning Group (CCG) spend. Student’s t-tests were used for direct comparison, whilst segmented regression was employed for projection analysis. Results There were statistically significant reductions in numbers of new patients seen face-to-face (140.4, sd 39.6 versus 461.6, sd 61.63, p < 0.0001), days to first orthopaedic review (5.2, sd 0.66 versus 10.9, sd 1.5, p < 0.0001), discharges (33.5, sd 3.66 versus 129.2, sd 7.36, p < 0.0001) and non-attendees (14.82, sd 1.48 versus 60.47, sd 2.68, p < 0.0001), in addition to a statistically significant increase in number of patients seen within 72-hours (46.4% 3873 of 8345 versus 5.1% 447 of 8771, p < 0.0001). There was a non-significant increase in consultation time of 1 minute 9 seconds (14 minutes 53 seconds sd 106 seconds versus 13 minutes 44 seconds sd 128 seconds, p = 0.0878). VFC saved the local CCG £67 385.67 in the first year and is set to save £129 885.67 annually thereafter. Conclusions We have shown VFCs are clinically and cost-effective, with improvement across several clinical performance parameters and substantial financial savings for CCGs. To our knowledge this is the largest study addressing clinical practice implications of VFCs in England, using robust methodology to adjust for pre-existing trends. Further studies are

Dengue Fever in American Military Personnel in the Philippines: Clinical Observations on Hospitalized Patients during a 1984 Epidemic

DTIC Science & Technology

1989-03-01

the mean maximum temperature was Hypotenson 15 (62.5) 102.0 + 1.3 F. A "saddle back" or dip- Rash (Non- Petechial ) 13 (54.2) hasic fever pattern was not...DENGUE FEVER IN AMERICAN MILITARY PERSONNEL IN THE PHILIPPINES: CLINICAL OBSERVATIONS ON HOSPITALIZED PATIENS DURING A 1984 EPIDEMIC C.G. Hayes, T.F...Accession Tr~I Jti ti DENGUE FEVER IN AMERICAN MILITARY PERSONNEL IN THE PHILIPPINES: CLINICAL OBSERVATIONS ON HOSPITALIZED PATIENTS DURING A 1984

Hypoalbuminemia and acute kidney injury: a meta-analysis of observational clinical studies.

PubMed

Wiedermann, Christian J; Wiedermann, Wolfgang; Joannidis, Michael

2010-10-01

To test the hypothesis that hypoalbuminemia is independently associated with increased risk of acute kidney injury (AKI). A meta-analysis was performed of observational clinical studies evaluating the relationship between serum albumin level and the occurrence of AKI by multivariate methods. Additionally, the impact was assessed of lower serum albumin on mortality in patients who developed AKI. Eligible studies were sought by multiple methods, and adjusted odds ratios (OR) were quantitatively combined using a random effects model. Seventeen clinical studies with 3,917 total patients were included: 11 studies (6 in surgical or intensive care unit patients and 5 in other hospital settings) evaluating the influence of serum albumin on AKI incidence and 6 studies describing the relationship between serum albumin and mortality among patients who had developed AKI. Lower serum albumin was an independent predictor both of AKI and of death after AKI development. With each 10 g L(-1) serum albumin decrement, the odds of AKI increased by 134%. The pooled OR for AKI was 2.34 with a 95% confidence interval (CI) of 1.74-3.14. Among patients who had developed AKI, the odds of death rose 147% (pooled OR 2.47, 95% CI 1.51-4.05) with each 10 g L(-1) serum albumin decrement. This meta-analysis provides evidence that hypoalbuminemia is a significant independent predictor both of AKI and of death following AKI development. Serum albumin determinations may be of utility in identifying patients at increased risk for AKI or for death after AKI. Controlled studies are warranted to assess interventions aimed at correcting hypoalbuminemia.

Subcutaneous administration of fentanyl in childbirth: an observational study on the clinical effectiveness of fentanyl for mother and neonate.

PubMed

Fleet, Julie; Jones, Meril; Belan, Ingrid

2014-01-01

to explore the maternal and neonatal effects of fentanyl administered subcutaneously to women during labour. two methods were used: (1) A retrospective audit of the birth register and maternal and neonatal records for the period from January 2000 to December 2007. (2) A pilot study was also conducted on a convenience sample of women between July 2008 and October 2008. this study was conducted within a maternity unit at a rural South Australian hospital where approximately 350 babies are birthed each year. audit participants included women who had uncomplicated pregnancies and birthed at term (37-42 weeks gestation). Women in the experimental group consisted of those who had utilised only subcutaneous fentanyl for pain relief (n=75), or nitrous oxide and oxygen prior to being administered subcutaneous fentanyl (n=196). Stratified random selection based on parity and age was used to determine the control group, which consisted of women who used no pharmacological pain relief (n=196). The pilot study involved a convenience sample of women (n=10) assessed to have an uncomplicated pregnancy and labour occurring at term (≥37 weeks gestation). audit variables examined included the women's age, parity, labour duration, mode of birth (spontaneous or assisted), analgesia used, total dosage, time administered prior to birth, time of birth, neonatal Apgar scores, time to establish breathing, naloxone use, days spent in hospital post-birth and breast-feeding outcomes upon discharge. The pilot study explored maternal effects assessed pre- and 30 minutes post-administration of subcutaneously administered fentanyl by observing pain scores, vital signs, sedation levels, nausea/vomiting scores and anti-emetic use. To assess possible adverse effects in the neonate Apgar scores, time to establish respiration, naloxone use, transfer to neonatal nursery and breast-feeding outcomes upon discharge were recorded. women in the experimental groups were more likely to be induced

Clinical efficacy of polyspecific intravenous immunoglobulin therapy in patients with streptococcal toxic shock syndrome: a comparative observational study.

PubMed

Linnér, Anna; Darenberg, Jessica; Sjölin, Jan; Henriques-Normark, Birgitta; Norrby-Teglund, Anna

2014-09-15

Streptococcal toxic shock syndrome (STSS) and necrotizing fasciitis are the 2 most severe invasive manifestations caused by group A Streptococcus (GAS). Intravenous immunoglobulin (IVIG) therapy has been suggested as adjunctive treatment with a beneficial effect on mortality. However the clinical evidence is limited. Here we aim to further document the clinical efficacy of administered IVIG therapy in a comparative observational study of well-defined patients with STSS. The effect of IVIG was evaluated in patients with STSS prospectively identified in a nationwide Swedish surveillance study conducted between April 2002 and December 2004. Detailed data on symptoms, severity of disease, treatment, and outcome were obtained from 67 patients. Crude and adjusted analyses with logistic regression were performed. Twenty-three patients received IVIG therapy compared with 44 who did not. No significant difference in comorbidities, severity of disease, organ failures, or sex was seen, but the IVIG group was slightly younger and had a higher degree of necrotizing fasciitis (56% vs 14%). The primary endpoint was 28-day survival. Adjusted analysis revealed that factors influencing survival in STSS were Simplified Acute Physiology Score II (odds ratio [OR], 1.1; P = .007), clindamycin (OR, 8.6; P = .007), and IVIG (OR, 5.6; P = .030). This comparative observational study of prospectively identified STSS patients demonstrates that both IVIG and clindamycin therapy contribute to a significantly improved survival in STSS. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

A Comparison of Assessment Tools: Is Direct Observation an Improvement Over Objective Structured Clinical Examinations for Communications Skills Evaluation?

PubMed

Goch, Abraham M; Karia, Raj; Taormina, David; Kalet, Adina; Zuckerman, Joseph; Egol, Kenneth A; Phillips, Donna

2018-04-01

Evaluation of resident physicians' communications skills is a challenging task and is increasingly accomplished with standardized examinations. There exists a need to identify the effective, efficient methods for assessment of communications skills. We compared objective structured clinical examination (OSCE) and direct observation as approaches for assessing resident communications skills. We conducted a retrospective cohort analysis of orthopaedic surgery resident physicians at a single tertiary care academic institution, using the Institute for Healthcare Communication "4 Es" model for effective communication. Data were collected between 2011 and 2015. A total of 28 residents, each with OSCE and complete direct observation assessment checklists, were included in the analysis. Residents were included if they had 1 OSCE assessment and 2 or more complete direct observation assessments. There were 28 of a possible 59 residents (47%) included. A total of 89% (25 of 28) of residents passed the communications skills OSCE; only 54% (15 of 28) of residents passed the direct observation communications assessment. There was a positive, moderate correlation between OSCE and direct observation scores overall ( r  = 0.415, P  = .028). There was no agreement between OSCE and direct observation in categorizing residents into passing and failing scores (κ = 0.205, P  = .16), after adjusting for chance agreement. Our results suggest that OSCE and direct observation tools provide different insights into resident communications skills (simulation of rare and challenging situations versus real-life daily encounters), and may provide useful perspectives on resident communications skills in different contexts.

Early experiences in evolving an enterprise-wide information model for laboratory and clinical observations.

PubMed

Chen, Elizabeth S; Zhou, Li; Kashyap, Vipul; Schaeffer, Molly; Dykes, Patricia C; Goldberg, Howard S

2008-11-06

As Electronic Healthcare Records become more prevalent, there is an increasing need to ensure unambiguous data capture, interpretation, and exchange within and across heterogeneous applications. To address this need, a common, uniform, and comprehensive approach for representing clinical information is essential. At Partners HealthCare System, we are investigating the development and implementation of enterprise-wide information models to specify the representation of clinical information to support semantic interoperability. This paper summarizes our early experiences in: (1) defining a process for information model development, (2) reviewing and comparing existing healthcare information models, (3) identifying requirements for representation of laboratory and clinical observations, and (4) exploring linkages to existing terminology and data standards. These initial findings provide insight to the various challenges ahead and guidance on next steps for adoption of information models at our organization.

Assessing treatment effects in older breast cancer patients: systematic review of observational research methods.

PubMed

de Glas, N A; Kiderlen, M; de Craen, A J M; Hamaker, M E; Portielje, J E A; van de Velde, C J H; Liefers, G J; Bastiaannet, E

2015-03-01

Solid evidence of treatment effects in older women with breast cancer is lacking, as they are generally underrepresented in randomized clinical trials on which guideline recommendations are based. An alternative way to study treatment effects in older patients could be to use data from observational studies. However, using appropriate methods in analyzing observational data is a key condition in order to draw valid conclusions, as directly comparing treatments generally results in biased estimates due to confounding by indication. The aim of this systematic review was to investigate the methods that have been used in observational studies that assessed the effects of breast cancer treatment on survival, breast cancer survival and recurrence in older patients (aged 65 years and older). Studies were identified through systematic review of the literature published between January 1st 2009 and December 13th 2013 in the PubMed database and EMBASe. Finally, 31 studies fulfilled the inclusion criteria. Of these, 22 studies directly compared two treatments. Fifteen out of these 22 studies addressed the problem of confounding by indication, while seven studies did not. Nine studies used some form of instrumental variable analysis. In conclusion, the vast majority of observational studies that investigate treatment effects in older breast cancer patients compared treatments directly. These studies are therefore likely to be biased. Observational research will be essential to improve treatment and outcome of older breast cancer patients, but the use of accurate methods is essential to draw valid conclusions from this type of data. Copyright © 2015 Elsevier Ltd. All rights reserved.

Importance of placebo effect in cough clinical trials.

PubMed

Eccles, Ron

2010-01-01

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

Toxoplasmosis: A history of clinical observations.

PubMed

Weiss, Louis M; Dubey, Jitender P

2009-07-01

It has been 100 years since Toxoplasma gondii was initially described in Tunis by Nicolle and Manceaux (1908) in the tissues of the gundi (Ctenodoactylus gundi) and in Brazil by Splendore (1908) in the tissues of a rabbit. Toxoplasma gondii is a ubiquitous, Apicomplexan parasite of warm-blooded animals that can cause several clinical syndromes including encephalitis, chorioretinitis, congenital infection and neonatal mortality. Fifteen years after the description of T. gondii by Nicolle and Manceaux a fatal case of toxoplasmosis in a child was reported by Janků. In 1939 Wolf, Cowen and Paige were the first to conclusively identify T. gondii as a cause of human disease. This review examines the clinical manifestations of infection with T. gondii and the history of the discovery of these manifestations.

Toxoplasmosis: a history of clinical observations

PubMed Central

Weiss, Louis M.; Dubey, Jitender. P.

2009-01-01

It has been 100 years since Toxoplasma gondii was initially described in Tunis by Nicolle and Manceaux (1908) in the tissues of the gundi (Ctenodoactylus gundi) and in Brazil by Splendore (1908) in the tissues of a rabbit. Toxoplasma gondii is a ubiquitous, Apicomplexan parasite of warm-blooded animals that can cause several clinical syndromes including encephalitis, chorioretinitis, congenital infection and neonatal mortality. Fifteen years after the description of T. gondii by Nicolle and Manceaux a fatal case of toxoplasmosis in a child was reported by Janků. In 1939 Wolf, Cowen and Paige were the first to conclusively identify T. gondii as a cause of human disease. This review examines the clinical manifestations of infection with T. gondii and the history of the discovery of these manifestations. PMID:19217908

Synergistic Fungistatic Effects of Lactoferrin in Combination with Antifungal Drugs against Clinical Candida Isolates

PubMed Central

Kuipers, M. E.; de Vries, H. G.; Eikelboom, M. C.; Meijer, D. K. F.; Swart, P. J.

1999-01-01

Because of the rising incidence of failures in the treatment of oropharyngeal candidosis in the case of severely immunosuppressed patients (mostly human immunodeficiency virus [HIV]-infected patients), there is need for the development of new, more effective agents and/or compounds that support the activity of the common antifungal agents. Since lactoferrin is one of the nonspecific host defense factors present in saliva that exhibit antifungal activity, we studied the antifungal effects of human, bovine, and iron-depleted lactoferrin in combination with fluconazole, amphotericin B, and 5-fluorocytosine in vitro against clinical isolates of Candida species. Distinct antifungal activities of lactoferrin were observed against clinical isolates of Candida. The MICs generally were determined to be in the range of 0.5 to 100 mg · ml−1. Interestingly, in the combination experiments we observed pronounced cooperative activity against the growth of Candida by using lactoferrin and the three antifungals tested. Only in a limited concentration range was minor antagonism detected. The use of lactoferrin and fluconazole appeared to be the most successful combination. Significant reductions in the minimal effective concentrations of fluconazole were found when it was combined with a relatively low lactoferrin concentration (1 mg/ml). Such combinations still resulted in complete growth inhibition, while synergy of up to 50% against several Candida species was observed. It is concluded that the combined use of lactoferrin and antifungals against severe infections with Candida is an attractive therapeutic option. Since fluconazole-resistant Candida species have frequently been reported, especially in HIV-infected patients, the addition of lactoferrin to the existing fluconazole therapy could postpone the occurrence of species resistance against fluconazole. Clinical studies to further elucidate the potential utility of this combination therapy have been initiated. PMID:10543740

Synergistic fungistatic effects of lactoferrin in combination with antifungal drugs against clinical Candida isolates.

PubMed

Kuipers, M E; de Vries, H G; Eikelboom, M C; Meijer, D K; Swart, P J

1999-11-01

Because of the rising incidence of failures in the treatment of oropharyngeal candidosis in the case of severely immunosuppressed patients (mostly human immunodeficiency virus [HIV]-infected patients), there is need for the development of new, more effective agents and/or compounds that support the activity of the common antifungal agents. Since lactoferrin is one of the nonspecific host defense factors present in saliva that exhibit antifungal activity, we studied the antifungal effects of human, bovine, and iron-depleted lactoferrin in combination with fluconazole, amphotericin B, and 5-fluorocytosine in vitro against clinical isolates of Candida species. Distinct antifungal activities of lactoferrin were observed against clinical isolates of Candida. The MICs generally were determined to be in the range of 0.5 to 100 mg. ml(-1). Interestingly, in the combination experiments we observed pronounced cooperative activity against the growth of Candida by using lactoferrin and the three antifungals tested. Only in a limited concentration range was minor antagonism detected. The use of lactoferrin and fluconazole appeared to be the most successful combination. Significant reductions in the minimal effective concentrations of fluconazole were found when it was combined with a relatively low lactoferrin concentration (1 mg/ml). Such combinations still resulted in complete growth inhibition, while synergy of up to 50% against several Candida species was observed. It is concluded that the combined use of lactoferrin and antifungals against severe infections with Candida is an attractive therapeutic option. Since fluconazole-resistant Candida species have frequently been reported, especially in HIV-infected patients, the addition of lactoferrin to the existing fluconazole therapy could postpone the occurrence of species resistance against fluconazole. Clinical studies to further elucidate the potential utility of this combination therapy have been initiated.

Observational Research Opportunities and Limitations

PubMed Central

Boyko, Edward J.

2013-01-01

Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principle engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision. PMID:24055326

Observational research--opportunities and limitations.

PubMed

Boyko, Edward J

2013-01-01

Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principal engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision. © 2013.

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.

Therapeutic effectiveness of Ageratina pichinchensis on the treatment of chronic interdigital tinea pedis: a randomized, double-blind clinical trial.

PubMed

Romero-Cerecero, Ofelia; Zamilpa, Alejandro; Jiménez-Ferrer, Enrique; Tortoriello, Jaime

2012-06-01

Interdigital tinea pedis is the most frequent presentation, as well as the most severe clinical form of tinea pedis, constituting a therapeutic challenge. The aim of the study was to evaluate the effectiveness and tolerability of two concentrations of Ageratina pichinchensis extract (encecalin content, 0.76 and 1.52%, respectively) on patients with clinical and mycological diagnosis of chronic interdigital tinea pedis. By means of a randomized, double-blind clinical trial, three groups of patients were treated topically for 4 weeks with a cream containing the following: Group I-the lower concentration of A. pichinchensis extract, group II-the higher concentration, group III-2% ketoconazole. One hundred and sixty (160) ambulatory patients of either sex between the ages of 18 and 65 years were enrolled. The primary outcome variables were: clinical effectiveness, mycological effectiveness, therapeutic cure, tolerability, and treatment compliance. The secondary outcome variable was therapeutic success. At the end of treatment, therapeutic cure was achieved by 34.1, 41.8, and 39.53% of Groups I, II, and III, respectively. No statistical difference between the groups was observed. Both treatments were effective for the treatment of interdigital-type tinea pedis, while better results were observed on patients that received the higher concentration of the extract.

Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

PubMed

Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

2014-01-01

This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

Effects of basic clinical skills training on objective structured clinical examination performance.

PubMed

Jünger, Jana; Schäfer, Sybille; Roth, Christiane; Schellberg, Dieter; Friedman Ben-David, Miriam; Nikendei, Christoph

2005-10-01

The aim of curriculum reform in medical education is to improve students' clinical and communication skills. However, there are contradicting results regarding the effectiveness of such reforms. A study of internal medicine students was carried out using a static group design. The experimental group consisted of 77 students participating in 7 sessions of communication training, 7 sessions of skills-laboratory training and 7 sessions of bedside-teaching, each lasting 1.5 hours. The control group of 66 students from the traditional curriculum participated in equally as many sessions but was offered only bedside teaching. Students' cognitive and practical skills performance was assessed using Multiple Choice Question (MCQ) testing and an objective structured clinical examination (OSCE), delivered by examiners blind to group membership. The experimental group performed significantly better on the OSCE than did the control group (P < 0.01), whereas the groups did not differ on the MCQ test (P < 0.15). This indicates that specific training in communication and basic clinical skills enabled students to perform better in an OSCE, whereas its effects on knowledge did not differ from those of the traditional curriculum. Curriculum reform promoting communication and basic clinical skills are effective and lead to an improved performance in history taking and physical examination skills.

EFFECTIVENESS OF DIALECTICAL BEHAVIOR THERAPY VERSUS COLLABORATIVE ASSESSMENT AND MANAGEMENT OF SUICIDALITY TREATMENT FOR REDUCTION OF SELF-HARM IN ADULTS WITH BORDERLINE PERSONALITY TRAITS AND DISORDER-A RANDOMIZED OBSERVER-BLINDED CLINICAL TRIAL.

PubMed

Andreasson, Kate; Krogh, Jesper; Wenneberg, Christina; Jessen, Helle K L; Krakauer, Kristine; Gluud, Christian; Thomsen, Rasmus R; Randers, Lasse; Nordentoft, Merete

2016-06-01

Many psychological treatments have shown effect on reducing self-harm in adults with borderline personality disorder. There is a need of brief psychotherapeutical treatment alternative for suicide prevention in specialized outpatient clinics. The DiaS trial was designed as a pragmatic single-center, two-armed, parallel-group observer-blinded, randomized clinical superiority trial. The participants had at least two criteria from the borderline personality disorder diagnosis and a recent suicide attempt (within a month). The participants were offered 16 weeks of dialectical behavior therapy (DBT) versus up to 16 weeks of collaborative assessment and management of suicidality (CAMS) treatment. The primary composite outcome was the number of participants with a new self-harm (nonsuicidal self-injury [NSSI] or suicide attempt) at week 28 from baseline. Other exploratory outcomes were: severity of borderline symptoms, depressive symptoms, hopelessness, suicide ideation, and self-esteem. At 28 weeks, the number of participants with new self-harm in the DBT group was 21 of 57 (36.8%) versus 12 of 51 (23.5%) in the CAMS treatment (OR: 1.90; 95% CI: 0.80-4.40; P = .14). When assessing the effect of DBT versus CAMS treatment on the individual components of the primary outcome, we observed no significant differences in the number of NSSI (OR: 1.60; 95% CI: 0.70-3.90; P = .31) or number of attempted suicides (OR: 2.24; 95% CI: 0.80-7.50; P = .12). In adults with borderline personality traits and disorder and a recent suicide attempt, DBT does not seem superior compared with CAMS for reduction of number of self-harm or suicide attempts. However, further randomized clinical trials may be needed. © 2016 Wiley Periodicals, Inc.

The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study

PubMed Central

Damas, Fátima; Páramo, Maria Dolores; Ruiz-Peña, Juan Luis; Navarro, Guillermo

2017-01-01

Fingolimod approval was based mainly on two clinical trials, FREEDOMS and TRANSFORMS, which demonstrated the efficacy and safety of fingolimod in patients with multiple sclerosis (MS). We present an observational study that validates these trials findings in a real-world setting, whereby the effectiveness and safety of fingolimod was assessed in Seville’s’ (Spain) clinical practice. This retrospective study in MS patients assessed effectiveness (relapses, EDSS, gadolinium-enhancing T1 and new/enlarged T2-weighted lesions): total cohort (n = 249) and stratified according to prior treatment (glatiramer acetate/interferon beta-1 [immunomodulator], natalizumab, naïve), gender, basal EDSS score, basal Gd+ lesions, ARR prior to treatment, age at treatment initiation and number of prior treatments. A multivariante model was used to assess the ARR with baseline characteristics. The safety profile (adverse events [AEs]) was also described. Fingolimod reduced the annualized relapse rate (ARR) by 75%, 67% and 85% in the total cohort, patients previously treated with immunomodulatory and naïve patients (p<0.0001 all cases). However, patients previously treated with natalizumab kept a constant ARR. The ARR results and the consequent increase in the proportion of relapse-free patients were independent of the age at treatment initiation, number of prior treatments, gender and basal Gd+ lesions. Although fingolimod was effective regardless the basal EDSS score and ARR prior to fingolimod treatment, better outcomes were observed in patients with basal EDSS score <3 (0.2 vs. 0.4; p = 0.0244) and ARR ≥ 2 prior to fingolimod treatment (p = 0.0338). Only the basal EDSS score was association with ARR in the first 24 months of fingolimod treatment in the multivariante model (p = 0.0439). The cumulative probability of disability progression was 20% (month-24) in the total cohort, and was independent from prior treatment, age at treatment initiation, number of prior treatments

On Orders of Observables on Effect Algebras

NASA Astrophysics Data System (ADS)

Dvurečenskij, Anatolij

2017-12-01

On the set of bounded observables on an effect algebra, the Olson order defined by spectral resolutions and the standard order defined by a system of σ-additive states are introduced. We show that sharp bounded observables form a Dedekind σ-complete sublattice of a Dedekind complete lattice under the Olson order. In addition, we compare both orders, and we illustrate them on different effect algebras.

[Pharmacokinetics and clinical effects of aspoxicillin in pediatric patients].

PubMed

Fujii, R; Meguro, H; Kim, B; Yonezawa, H; Kawaoi, T; Tajima, T; Mashiko, J; Nakazawa, S; Niino, K; Sato, H

1987-09-01

Since the efficacy and the safety of aspoxicillin (ASPC, TA-058) have been established on adult patients and the need of ASPC use on pediatric patients was anticipated, we performed a 16 center study on the clinical utility of ASPC in pediatric patients. 1. Pharmacokinetics ASPC was intravenously administered to 45 patients at a dose of 10, 20 or 40 mg/kg by one shot. Serum concentrations of ASPC were dependent of dose levels, and maximum levels of 58.4-230.8 micrograms/ml and half-lives (beta) of 1.08-1.16 hours were observed. Urinary recovery rates were 62.7-67.2% in 6 hours. Results obtained upon drip infusions (0.5-1 hour) were similar to one shot injections. 2. Clinical results (1) Clinical effectiveness Of 318 evaluable patients including 175 boys and 143 girls, 18.2% were nurslings and 61% were young children under 4 years of age. One hundred eighty six patients from whom causative organisms were isolated were classified as A group. Among them were 5 patients suffered with sepsis, but the ASPC treatment eradicated all the bacteria but Salmonella java in 1 case. All of 4 patients with meningitis were cured and all causative organisms (3 cases with Haemophilus influenzae and 1 case with Gram-positive coccus) were eradicated. Cure rates were 90% for 130 patients with respiratory tract infection, 88.6% for 35 with urinary tract infection, 85.7% for 7 with skin soft tissue infection and 89.8% for all the A group patients. Meanwhile, no causative organisms were isolated from 132 patients (B group patients) but cure rate of 91.7% was obtained for this group. No statistical difference was observed between A and B groups. For all the patients (318), the cure rate was 90.6%. (2) Bacteriological effects Of 63 Gram-positive bacteria isolated as pathogens, 58 strains were eradicated. Of 117 Gram-negative bacterial, 101 were eradicated. The eradication rate on all 180 strains was 88.3%. Overall, ASPC showed excellent effects against Streptococcus. Among strains of

Clinical observations on the use of honcrivine in the chemical debridement of wounds.

PubMed

Efem, S E E

2009-12-01

Chronic and non healing wounds, necrotic wounds and contused and devitalized wounds require debridement to rid the wounds of all these impediments that encourage bacterial growth and multiplications with consequent impairment of wound healing. Whereas there are several methods of wound debridement with their peculiar indications, merits and demerits, the ideal method of debridement is yet to be discovered. The aim of this study is to investigate clinically the ability of honcrivine (honey plus acriflavine 0.1%) to chemically debride various wounds in routine clinical practice. One hundred and eighty nine consecutive patients managed by the author between June 1995 and June 2005 were included in this study. They were 125 males and 64 females and their ages ranged between 6 and 78 years. Initially swab was taken for bacterial culture from each wound before being cleaned with normal saline, then dressed daily with gauze soaked in honcrivine. Bacterial culture was repeated fortnightly. Antibiotics were administered as dictated by culture and sensitivity report. Wound debridement progressed rapidly and impressively with necrotic and devitalized tissues as well as tenacious pus and fibrin deposits being replaced with healthy granulation tissue. Patients age, sex and bacterial burden did not influence the rate of debridement, rather wound age and necrotic burden were inversely proportional to the debridement rate. Honcrivine did not provoke any inflammatory response nor was any allergic reaction observed. It is one of the oldest remedies known to mankind and is still useful and versatile today as it was 2000 years ago. It is a very effective chemical wound debridant.

Clinical and Histologic Effects of Fractional Microneedling Radiofrequency Treatment on Rosacea.

PubMed

Park, Seon Yong; Kwon, Hyuck Hoon; Yoon, Ji Young; Min, Seonguk; Suh, Dae Hun

2016-12-01

Fractional microneedling radiofrequency (FMR) is an emerging treatment modality, but its effect on rosacea has not been studied yet. To investigate the potential impact of FMR treatment on clinical improvement and histologic changes in rosacea patients. A 12-week, prospective, randomized, split-face clinical trial was conducted. Two sessions of FMR were performed on one side of the cheeks with 4-week interval and the other side remained untreated. Erythema index from DermaSpectrometer and a* value from Spectrophotometer CM-2002 were measured at each visit for the objective measurement of erythema. Histologic analysis of skin samples was also carried out. Clinical evaluation and photometric measurement revealed the reduction of redness in the treated side compared with untreated side and baseline. Erythema index decreased 13.6% and a* value decreased 6.8% at Week 12 compared with baseline. Reduced expression of markers related to inflammation, innate immunity, and angiogenesis was observed in immunohistochemical staining of tissue obtained after FMR treatment. Fractional microneedling radiofrequency treatment showed modest clinical and histologic improvement of rosacea, and it might be used as an alternative or in combination with other treatment methods.

Dextromethorphan/Quinidine in Migraine Prophylaxis: An Open-label Observational Clinical Study.

PubMed

Berkovich, Regina R; Sokolov, Alexey Y; Togasaki, Daniel M; Yakupova, Aida A; Cesar, Paul-Henry; Sahai-Srivastava, Soma

This study aimed to assess potential efficacy and safety of dextromethorphan/quinidine (DMQ) in prophylactic treatment of migraine in patients with multiple sclerosis (MS) with superimposed pseudobulbar affect (PBA). Multiple sclerosis patients with superimposed PBA and comorbid migraine were enrolled into this open-label observational study at the University of Southern California Comprehensive MS Center. The baseline characteristics included, among other data, frequency and severity of acute migraine attacks and use of migraine relievers. The DMQ was used exclusively per its primary indication - PBA symptoms control - 20/10 mg orally, twice a day for the mean of 4.5 months (the shortest exposure registered was 3 months and the longest, 6 months). To determine whether treatment caused an effect on migraine frequency and severity, the baseline and posttreatment values were compared using nonparametric sign test. Thirty-three MS subjects with PBA, who also suffered from migraines, were identified. Twenty-nine subjects had improvement in headache frequency, 4 had no change, and none had worsening (P < 0.001 as compared with the baseline). Twenty-eight subjects had improvement in headache severity, 5 had no change, and none had worsening (P < 0.001). Our pilot study results provide evidence that DMQ shows promise as a candidate for larger clinical studies evaluating its efficacy for the prevention of migraine headaches.

Effect of investigator observation on gait parameters in individuals with and without chronic low back pain.

PubMed

Vickers, Joshua; Reed, Austin; Decker, Robert; Conrad, Bryan P; Olegario-Nebel, Marissa; Vincent, Heather K

2017-03-01

Despite the ubiquity of gait assessment in clinic and research, it is unclear how observation impacts gait, particularly in persons with chronic pain and psychological stress. We compared temporal spatial gait patterns in people with and without chronic low back pain (CLBP) when they were aware and unaware of being observed. This was a repeated-measures, deception study in 55 healthy persons (32.0±12.4 yr, 24.2±2.7kg/m 2 ) and persons with CLBP (51.9±17.9 yr, 27.8±4.4kg/m 2 ). Participants performed one condition in which they were unaware of observation (UNW), and three conditions under investigator observation: (1) aware of observation (AWA), (2) investigators watching cadence, (3) investigators watching step length. Participants walked across an 8.4m gait mat, while temporal spatial parameters of gait were collected. The Medical Outcomes Short Form (SF-12), Beck Depression Inventory (BDI), State Trait Anxiety Inventory (STAI), and Oswestry Disability Index (ODI) were completed. Significant condition by group interactions were found for velocity and step length (p<0.05). Main effects of study condition existed for all gait variables except for step width. Main effects of group (healthy, LBP) were significant for all variables except for step width (p<0.05). Regression analyses revealed that after accounting for age, sex, and SF-12 mental component score, BDI scores predict velocity changes during walking from the UNW to AWA conditions. These findings show that people change their gait patterns when being observed. Gait analyses may require additional trials before data can reliably be interpreted and used for clinical decision-making. Copyright © 2017 Elsevier B.V. All rights reserved.

[Clinical effect of hemoperfusion combined with hemodialysis in treatment of severe organophosphate pesticide poisoning].

PubMed

Guo, Lei; Ye, Hua; Pan, Liwei; Sun, Laifang; Ying, Binyu

2014-12-01

To investigate the clinical effect of hemoperfusion combined with hemodialysis in the treatment of severe organophosphate pesticide poisoning. Ninety-eight patients with severe organophosphate pesticide poisoning who were admitted to the emergency department of our hospital from March 2005 to September 2013 were equally divided into control group and observation group according to treatment methods. The control group was given conventional emergency treatment, while the observation group was given hemoperfusion combined with hemodialysis and the conventional emergency treatment. The clinical outcomes and complications of two groups were compared. In the control group, 35 patients were cured and 14 patients died, so the cure rate was 71.4%. In the treatment group, 46 patients were cured and 3 patients died, so the cure rate was 93.9%. The treatment group had a significantly higher cure rate than the control group (χ² = 8.611, P < 0.05). And the treatment group had significantly shorter duration of coma (P < 0.01), mean length of hospital stay (P < 0.01), and time to recovery of cholinesterase activity (P < 0.01) and a significantly reduced dose of atropine than the control group (P < 0.01). The control group had significantly more cases of urinary retention than the treatment group (18 vs. 6, χ² = 4.991, P < 0.05). And the control group had more cases of intermediate syndrome, respiratory failure, delayed neurological damage, and rebound than the treatment group. Hemoperfusion combined hemodialysis has a good clinical effect and causes fewer complications in treating severe organophosphate pesticide poisoning, so it is worthy of clinical promotion.

21 CFR 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Approval based on a surrogate endpoint or on an... Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or... uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical...

21 CFR 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Approval based on a surrogate endpoint or on an... Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or... uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical...

21 CFR 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Approval based on a surrogate endpoint or on an... Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or... uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical...

21 CFR 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Approval based on a surrogate endpoint or on an... Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or... uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical...

21 CFR 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Approval based on a surrogate endpoint or on an... Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or... uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical...

Validation of an image-based technique to assess the perceptual quality of clinical chest radiographs with an observer study

NASA Astrophysics Data System (ADS)

Lin, Yuan; Choudhury, Kingshuk R.; McAdams, H. Page; Foos, David H.; Samei, Ehsan

2014-03-01

We previously proposed a novel image-based quality assessment technique1 to assess the perceptual quality of clinical chest radiographs. In this paper, an observer study was designed and conducted to systematically validate this technique. Ten metrics were involved in the observer study, i.e., lung grey level, lung detail, lung noise, riblung contrast, rib sharpness, mediastinum detail, mediastinum noise, mediastinum alignment, subdiaphragm-lung contrast, and subdiaphragm area. For each metric, three tasks were successively presented to the observers. In each task, six ROI images were randomly presented in a row and observers were asked to rank the images only based on a designated quality and disregard the other qualities. A range slider on the top of the images was used for observers to indicate the acceptable range based on the corresponding perceptual attribute. Five boardcertificated radiologists from Duke participated in this observer study on a DICOM calibrated diagnostic display workstation and under low ambient lighting conditions. The observer data were analyzed in terms of the correlations between the observer ranking orders and the algorithmic ranking orders. Based on the collected acceptable ranges, quality consistency ranges were statistically derived. The observer study showed that, for each metric, the averaged ranking orders of the participated observers were strongly correlated with the algorithmic orders. For the lung grey level, the observer ranking orders completely accorded with the algorithmic ranking orders. The quality consistency ranges derived from this observer study were close to these derived from our previous study. The observer study indicates that the proposed image-based quality assessment technique provides a robust reflection of the perceptual image quality of the clinical chest radiographs. The derived quality consistency ranges can be used to automatically predict the acceptability of a clinical chest radiograph.

Ethnic bias and clinical decision-making among New Zealand medical students: an observational study.

PubMed

Harris, Ricci; Cormack, Donna; Stanley, James; Curtis, Elana; Jones, Rhys; Lacey, Cameron

2018-01-23

Health professional racial/ethnic bias may impact on clinical decision-making and contribute to subsequent ethnic health inequities. However, limited research has been undertaken among medical students. This paper presents findings from the Bias and Decision-Making in Medicine (BDMM) study, which sought to examine ethnic bias (Māori (indigenous peoples) compared with New Zealand European) among medical students and associations with clinical decision-making. All final year New Zealand (NZ) medical students in 2014 and 2015 (n = 888) were invited to participate in a cross-sectional online study. Key components included: two chronic disease vignettes (cardiovascular disease (CVD) and depression) with randomized patient ethnicity (Māori or NZ European) and questions on patient management; implicit bias measures (an ethnicity preference Implicit Association Test (IAT) and an ethnicity and compliant patient IAT); and, explicit ethnic bias questions. Associations between ethnic bias and clinical decision-making responses to vignettes were tested using linear regression. Three hundred and two students participated (34% response rate). Implicit and explicit ethnic bias favoring NZ Europeans was apparent among medical students. In the CVD vignette, no significant differences in clinical decision-making by patient ethnicity were observed. There were also no differential associations by patient ethnicity between any measures of ethnic bias (implicit or explicit) and patient management responses in the CVD vignette. In the depression vignette, some differences in the ranking of recommended treatment options were observed by patient ethnicity and explicit preference for NZ Europeans was associated with increased reporting that NZ European patients would benefit from treatment but not Māori (slope difference 0.34, 95% CI 0.08, 0.60; p = 0.011), although this was the only significant finding in these analyses. NZ medical students demonstrated ethnic bias, although

[Development of Autogenic Training Clinical Effectiveness Scale (ATCES)].

PubMed

Ikezuki, Makoto; Miyauchi, Yuko; Yamaguchi, Hajime; Koshikawa, Fusako

2002-02-01

The purpose of the present study was to develop a scale measuring clinical effectiveness of autogenic training. In Study 1, 167 undergraduates completed a survey of items concerning physical and mental states, which were thought to vary in the course of autogenic training. With item and factor analyses, 20 items were selected, and the resulting scale (ATCES) had high discrimination and clear factor structure. In Study 2, reliability and concurrent and clinical validity of the scale were examined with three groups of respondents: 85 mentally healthy, 31 control, 13 clinical persons. The scale showed a high test-retest correlation (r = .83) and alpha coefficient (alpha = .86). ATCES had a Pearson correlation coefficient of r = .56 with General Health Questionnaire (GHQ-12), and r = .73 with trait anxiety (STAI-T). And ATCES successfully discriminated the mentally healthy and clinical groups in terms of clinical effectiveness. These results demonstrated high reliability and sufficient concurrent and clinical validity of the new scale.

Mucoceles of minor salivary glands in children. Own clinical observations.

PubMed

Lewandowski, Bogumił; Brodowski, Robert; Pakla, Paweł; Makara, Aleksander; Stopyra, Wojciech; Startek, Bartek

Mucoceles are benign lesions associated with the pathology of the oral mucosa of minor salivary glands. Two types of cysts are distinguished depending on their pathogenesis. Most often they occur as a result of mechanical trauma and mucus extravasation into tissues or obstruction of the gland ducts. The aim of the study was to present our own experiences regarding mucoceles of minor salivary glands in the oral cavity taking into account how frequently the individual types of cysts occur in children. The research was carried out based on medical files from the years 2005-2015. These were: medical case records, operating books and the medical registry of patients treated at the Clinic of Maxillofacial Surgery, Frederic Chopin Clinical Regional Hospital in Rzeszow. In that period 64 children and teenagers, 28 girls and 36 boys were treated. What was considered was the age and gender of the patients, the reason for their appointment with a doctor, the location, size and histopathological type of the cysts, as well as the course and results of the diagnostic and therapeutic process. In the group analyzed, the reasons for referral to the Clinic were: in 25 patients accidental ascertainment of a non-symptomatic tumor in the oral cavity during examination by a dentist, pediatrician or laryngologist which had not caused any discomfort to the children; in 13 patients concern had been raised by a gradually increasing tumor; in 18 cases there was an increased tissue tension surrounding the tumor, while in 3 children red oedema was observed in the oral cavity (suspicion of abscess). The most frequent mucocele location was the lower lip (34 children). The most frequent size was 2.1-3 cm (28 children). The most frequent histological type was MEP. All the patients were treated at the Clinic in the one-day surgery mode, with good outcome. Mucocele ascertainment in children's oral cavity could be made accidentally in routine pediatric examination, therefore it is necessary to extend

Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report.

PubMed

Berger, Marc L; Dreyer, Nancy; Anderson, Fred; Towse, Adrian; Sedrakyan, Art; Normand, Sharon-Lise

2012-01-01

In both the United States and Europe there has been an increased interest in using comparative effectiveness research of interventions to inform health policy decisions. Prospective observational studies will undoubtedly be conducted with increased frequency to assess the comparative effectiveness of different treatments, including as a tool for "coverage with evidence development," "risk-sharing contracting," or key element in a "learning health-care system." The principle alternatives for comparative effectiveness research include retrospective observational studies, prospective observational studies, randomized clinical trials, and naturalistic ("pragmatic") randomized clinical trials. This report details the recommendations of a Good Research Practice Task Force on Prospective Observational Studies for comparative effectiveness research. Key issues discussed include how to decide when to do a prospective observational study in light of its advantages and disadvantages with respect to alternatives, and the report summarizes the challenges and approaches to the appropriate design, analysis, and execution of prospective observational studies to make them most valuable and relevant to health-care decision makers. The task force emphasizes the need for precision and clarity in specifying the key policy questions to be addressed and that studies should be designed with a goal of drawing causal inferences whenever possible. If a study is being performed to support a policy decision, then it should be designed as hypothesis testing-this requires drafting a protocol as if subjects were to be randomized and that investigators clearly state the purpose or main hypotheses, define the treatment groups and outcomes, identify all measured and unmeasured confounders, and specify the primary analyses and required sample size. Separate from analytic and statistical approaches, study design choices may strengthen the ability to address potential biases and confounding in

The Unruh effect for eccentric uniformly rotating observers

NASA Astrophysics Data System (ADS)

Ramezani-Aval, H.

It is common to use Galilean rotational transformation (GRT) to investigate the Unruh effect for uniformly rotating observers. However, the rotating observer in this subject is an eccentric observer while GRT is only valid for centrally rotating observers. Thus, the reliability of the results of applying GRT to the study of the Unruh effect might be considered as questionable. In this work, the rotational analog of the Unruh effect is investigated by employing two relativistic rotational transformations corresponding to the eccentric rotating observer, and it is shown that in both cases, the detector response function is nonzero. It is also shown that although consecutive Lorentz transformations cannot give a frame within which the canonical construction can be carried out, the expectation value of particle number operator in canonical approach will be zero if we use modified Franklin transformation. These conclusions reinforce the claim that correspondence between vacuum states defined via canonical field theory and a detector is broken for rotating observers. Some previous conclusions are commented on and some controversies are also discussed.

Clinical risk factors for weight gain during psychopharmacologic treatment of depression: results from 2 large German observational studies.

PubMed

Kloiber, Stefan; Domschke, Katharina; Ising, Marcus; Arolt, Volker; Baune, Bernhard T; Holsboer, Florian; Lucae, Susanne

2015-06-01

Weight gain during psychopharmacologic treatment has considerable impact on the clinical management of depression, treatment continuation, and risk for metabolic disorders. As no profound clinical risk factors have been identified so far, the aim of our analyses was to determine clinical risk factors associated with short-term weight development in 2 large observational psychopharmacologic treatment studies for major depression. Clinical variables at baseline (age, gender, depression psychopathology, anthropometry, disease history, and disease entity) were analyzed for association with percent change in body mass index (BMI; normal range, 18.5 to 25 kg/m(2)) during 5 weeks of naturalistic psychopharmacologic treatment in patients who had a depressive episode as single depressive episode, in the course of recurrent unipolar depression or bipolar disorder according to DSM-IV criteria. 703 patients participated in the Munich Antidepressant Response Signature (MARS) project, an ongoing study since 2002, and 214 patients participated in a study conducted at the University of Muenster from 2004 to 2006 in Germany. Lower BMI, weight-increasing side effects of medication, severity of depression, and psychotic symptoms could be identified as clinical risk factors associated with elevated weight gain during the initial treatment phase of 5 weeks in both studies. Based on these results, a composite risk score for weight gain consisting of BMI ≤ 25 kg/m(2), Hamilton Depression Rating Scale (17-item) score > 20, presence of psychotic symptoms, and administration of psychopharmacologic medication with potential weight-gaining side effects was highly discriminative for mean weight gain (F4,909 = 26.77, P = 5.14E-21) during short-term psychopharmacologic treatment. On the basis of our results, depressed patients with low to normal BMI, severe depression, or psychotic symptoms should be considered at higher risk for weight gain during acute antidepressant treatment. We introduce

Clinical observations of a Cantonese cognitive-behavioral treatment program for Chinese immigrants.

PubMed

Shen, Edward K; Alden, Lynn E; Söchting, Ingrid; Tsang, Pheobe

2006-01-01

In this article, the authors describe our clinical observations about the process of delivering a Cantonese-language cognitive- behavioral therapy program to treat depression in Hong Kong immigrants to Vancouver, Canada. Our experiences indicated that standard referral and assessment procedures were not optimal for this population. Other factors that required consideration were how to convert Cantonese terms for dysphoric affect into English equivalents and how to implement cognitive modification strategies when dealing with culture-syntonic beliefs about social relationships. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

Effects of FDA approved medications for Alzheimer’s disease on clinical progression

PubMed Central

Mielke, Michelle M.; Leoutsakos, Jeannie-Marie; Corcoran, Chris D.; Green, Robert C.; Norton, Maria C.; Welsh-Bohmer, Kathleen A.; Tschanz, JoAnn T.; Lyketsos, Constantine G.

2011-01-01

Background Observational studies suggest cholinesterase inhibitors and/or memantine may delay clinical progression of Alzheimer’s disease (AD) in 40% of individuals taking the medications. Given this response and existence of side effects, we sought to quantify medication use and benefits in a population-based study of incident AD cases. Methods The Cache County Dementia Progression study (DPS) enrolled and followed a cohort of 327 incident AD cases up to 9 years. Drug exposure was expressed using a persistency index (PI), calculated as total years of drug use divided by total years of observation. Linear mixed effects models examined PI, and interactions with sex and APOE ε4, as predictors of clinical progression on the Mini-Mental State Exam (MMSE) and Clinical Dementia Rating-Sum of Boxes (CDR-Sum). Results Sixty-nine participants (21.1%) ever used cholinesterase inhibitors or memantine. There was a strong three-way interaction between PI, sex, and time. Among women, a higher PI (i.e. greater duration of use) of cholinesterase inhibitors was associated with slower progression on the MMSE and CDR-Sum, particularly among those with an APOE ε4 allele. In contrast, higher PI was associated with faster progression in males. Conclusion A low percentage of individuals with AD in the community are taking cholinesterase inhibitors or memantine. This study suggests that women, particularly those with an APOE ε4 allele, may receive the most benefit from these medications. With the newly approved increased dose of donepezil, it will be imperative to determine whether a higher dose is needed in men or whether other factors warrant consideration. PMID:22301194

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

PubMed

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

Observations from the Mayo Clinic National Conference on Medicine and the Media.

PubMed

Lantz, Jane C; Lanier, William L

2002-12-01

In September 2002, the Mayo Clinic National Conference on Medicine and the Media convened to consider the accurate, timely, and responsible reporting of medical news to the public. The more than 500 participants included medical and health journalists, scientific journal editors, physicians and other health care professionals, industry representatives, government officials, institutional public information officers, public relations professionals, patients, and representatives of patient advocacy groups. The goal of the conference was to bring together all facets of the medical news dissemination process with the hope of identifying ways to serve the public more effectively. Several key observations emerged: Medical news reports may be confusing because the underlying scientific issues are unresolved and open to multiple interpretations. People who are ill have different information needs than the rest of the public. Journalists' primary concern is accurate, clear reporting, with secondary concern for a story's consequences. Journalists consider themselves primarily reporters rather than educators, but the public expects reporting to contain an educational element. Financial and other more subtle interests may influence the quality and content of scientific news releases, presentations in scientific journals, and stories covered by print and broadcast news media. Full disclosure of commercial support and affiliations, peer review of study reports, and formal guidelines for conduct may limit inappropriate financial influence.

Skeletal and Clinical Effects of Exoskeleton-Assisted Gait

DTIC Science & Technology

2015-10-01

AWARD NUMBER: W81XWH-14-1-0611 TITLE: Skeletal and Clinical Effects of Exoskeleton -Assisted Gait PRINCIPAL INVESTIGATOR: Paolo Bonato, PhD...AND SUBTITLE 5a. CONTRACT NUMBER Skeletal and Clinical Effects of Exoskeleton -Assisted Gait 5b. GRANT NUMBER W81XWH-14-1-0611 5c. PROGRAM ELEMENT...purpose of this project is to study the effects on bone health of exoskeleton -assisted gait in individuals with a complete spinal cord injury. Advanced

The clinical effect and tolerability of ezetimibe in high-risk patients managed in a specialty cardiovascular risk reduction clinic

PubMed Central

Pearson, Glen J; Francis, Gordon A; Romney, Jacques S; Gilchrist, Dawna M; Opgenorth, Andrea; Gyenes, Gabor T

2006-01-01

INTRODUCTION Ezetimibe (EZ) is a selective cholesterol absorption inhibitor approved for use in Canada. The effect and tolerability of EZ among patients was evaluated in the clinical setting of a specialty cardiovascular risk reduction clinic at the University of Alberta Hospital, Edmonton, Alberta. PATIENTS AND METHODS All patients 18 years of age or older who were prescribed EZ were included, unless they failed to take EZ for a minimum of two weeks, did not have baseline and on-EZ low-density lipoprotein cholesterol (LDL-C) levels, or had concomitant lipid-lowering drugs or dosages changed within one month of starting EZ. RESULTS Eighty-four patients (mean age 57.9 years) were included. By Framingham risk calculation, 71.4% were found to be high-risk patients, 13.1% moderate-risk patients and 15.5% low-risk patients; 66.7% of patients had prior cardiovascular events. On EZ, the mean reductions were: total cholesterol level 1.11 mmol/L (16.5%); LDL-C level 1.01 mmol/L (22.3%); high-density lipoprotein cholesterol level 0.06 mmol/L (4.6%); and ratio of total cholesterol level to high-density lipoprotein cholesterol level 0.68 mmol/L (12.8%); all were statistically significant (P<0.001). Results were similar when stratified by primary (n=28) versus secondary (n=56) prevention. Patients on EZ monotherapy (n=34) had mean LDL-C reductions of 1.03 mmol/L (20.5%) compared with 1.19 mmol/L (30.1%) or 0.95 mmol/L (22.5%), where EZ was added to low-dose or high-dose statins (P<0.01 for all). On EZ, 30 patients (35.7%) achieved previously unattainable target LDL-C levels. Four patients discontinued the drug due to side effects. CONCLUSIONS EZ is safe and effective in high-risk patients treated in the clinical setting of a cardiovascular risk reduction clinic. A mean LDL-C reduction of 1 mmol/L (20% to 30%) in all patient subgroups is consistent with previous clinical trial results. The significant reduction in LDL-C (mean 22.5%) observed in the EZ plus high-dose statin

Costs and cost-effectiveness of different DOT strategies for the treatment of tuberculosis in Pakistan. Directly Observed Treatment.

PubMed

Khan, M A; Walley, J D; Witter, S N; Imran, A; Safdar, N

2002-06-01

An economic study was conducted alongside a clinical trial at three sites in Pakistan to establish the costs and effectiveness of different strategies for implementing directly observed treatment (DOT) for tuberculosis. Patients were randomly allocated to one of three arms: DOTS with direct observation by health workers (at health centres or by community health workers); DOTS with direct observation by family members; and DOTS without direct observation. The clinical trial found no statistically significant difference in cure rate for the different arms. The economic study collected data on the full range of health service costs and patient costs of the different treatment arms. Data were also disaggregated by gender, rural and urban patients, by treatment site and by economic categories, to investigate the costs of the different strategies, their cost-effectiveness and the impact that they might have on patient compliance with treatment. The study found that direct observation by health centre-based health workers was the least cost-effective of the strategies tested (US dollars 310 per case cured). This is an interesting result, as this is the model recommended by the World Health Organization and International Union against Tuberculosis and Lung Disease. Attending health centres daily during the first 2 months generated high patient costs (direct and in terms of time lost), yet cure rates for this group fell below those of the non-observed group (58%, compared with 62%). One factor suggested by this study is that the high costs of attending may be deterring patients, and in particular, economically active patients who have most to lose from the time taken by direct observation. Without stronger evidence of benefits, it is hard to justify the costs to health services and patients that this type of direct observation imposes. The self-administered group came out as most cost-effective (164 dollars per case cured). The community health worker sub-group achieved the

Development of a Cost-Effective Modular Pixelated NaI(Tl) Detector for Clinical SPECT Applications

PubMed Central

Rozler, Mike; Liang, Haoning; Chang, Wei

2013-01-01

A new pixelated detector for high-resolution clinical SPECT applications was designed and tested. The modular detector is based on a scintillator block comprised of 2.75×2.75×10 mm3 NaI(Tl) pixels and decoded by an array of 51 mm diameter single-anode PMTs. Several configurations, utilizing two types of PMTs, were evaluated using a collimated beam source to measure positioning accuracy directly. Good pixel separation was observed, with correct pixel identification ranging from 60 to 72% averaged over the entire area of the modules, depending on the PMT type and configuration. This translates to a significant improvement in positioning accuracy compared to continuous slab detectors of the same thickness, along with effective reduction of “dead” space at the edges. The observed 10% average energy resolution compares well to continuous slab detectors. The combined performance demonstrates the suitability of pixelated detectors decoded with a relatively small number of medium-sized PMTs as a cost-effective approach for high resolution clinical SPECT applications, in particular those involving curved detector geometries. PMID:24146436

[Dynamic observation of clinical course in patients with subacute 1, 2-dichloroethane poisoning].

PubMed

Liu, Weiwei; Chen, Yuquan; Pan, Jing; Yang, Zhiqian; Liu, Yimin

2015-03-01

To observe the clinical characteristics and regular patterns of subacute 1, 2-dichloroethane poisoning patients for providing evidences to it's diagnosis, treatment and prognosis. 51 cases of subacute 1, 2-dichloroethane poisoning analyzed. They were divided into 3 groups according to their main clinical manifestation: group A mainly with intracranial hypertension (n = 25), group B with limbs tremor (n = 18), group C with mental and behavior disorder (n = 8). All cases' clinical symptoms, cranial computer tomography, cerebrospinal pressure (Group A) were observed, the durations of the onset, deterioration, improvement, recovery and whole course of the disease were compared between groups and in each group. In all of 51 cases, only the differences between the deterioration duration of cranial CT and symptom was significantly (t = 2.555, P<0.05), which indicate the deterioration of symptom was earlier than radiological change. The symptom deterioration of group C was the fastest than group A and group B (P<0.00). As to the change of symptom duration, group B's improvement, recovery and whole course was the longest comparing with group A and group C (P<0.05). As to the change of cranial CT duration, group B's recovery duration was the shortest and group A's recovery duration was the longest (P<0.01); group B's whole course was also the shortest and group A's whole course was the longest (P<0.05). The clinical course of symptoms, cranial computer tomography, cerebrospinal pressure (Group A) was compared in each group, in group A, the duration of improvement and whole course of the cranial CT and cerebrospinal pressure change was longer than that of the symptom change (P<0.01), this indicated that group A has longer asymptomatic intracranial hypertension and their cranial radiography recover slowly. In group B, their symptoms (3.94 ± 4.31 days) deteriorated is earlier than cranial CT changes (P<0.05), the recovery (92.39 ± 55.04 days) and whole course of symptom was

Clinical effects of iridectomy performed by laser YAG Nd+3 Q switch

NASA Astrophysics Data System (ADS)

Kecik, Tadeusz; Zydecki, Miroslaw

1995-03-01

Clinical effects of iridectomy performed by the use of laser Yag Nd+3-Q-switch on 38 patients treated for intra-ocular pressure increase were analyzed. In 32 cases primary glaucoma was diagnosed. In 11 cases secondary glaucoma was caused by pupil blocking. Pressure normalization was obtained in 27 cases (71%). In the remaining 11 patients pressure decreasing was acquired but at the same time administration of antiglaucoma medicines was indispensable. Time of observation took from 4 weeks to 3 years.

Global developmental delay in guanidionacetate methyltransferase deficiency: differences in formal testing and clinical observation.

PubMed

Verbruggen, Krijn T; Knijff, Wilma A; Soorani-Lunsing, Roelineke J; Sijens, Paul E; Verhoeven, Nanda M; Salomons, Gajja S; Goorhuis-Brouwer, Siena M; van Spronsen, Francjan J

2007-09-01

Guanidinoacetate N-methyltransferase (GAMT) deficiency is a defect in the biosynthesis of creatine (Cr). So far, reports have not focused on the description of developmental abilities in this disorder. Here, we present the result of formal testing of developmental abilities in a GAMT-deficient patient. Our patient, a 3-year-old boy with GAMT deficiency, presented clinically with a severe language production delay and nearly normal nonverbal development. Treatment with oral Cr supplementation led to partial restoration of the cerebral Cr concentration and a clinically remarkable acceleration of language production development. In contrast to clinical observation, formal testing showed a rather harmonic developmental delay before therapy and a general improvement, but no specific acceleration of language development after therapy. From our case, we conclude that in GAMT deficiency language delay is not always more prominent than delays in other developmental areas. The discrepancy between the clinical impression and formal testing underscores the importance of applying standardized tests in children with developmental delays. Screening for Cr deficiency by metabolite analysis of body fluids or proton magnetic resonance spectroscopy of the brain deficiency should be considered in any child with global developmental delay/mental retardation lacking clues for an alternative etiology.

Using Electronic Medical Records to Assess the Effectiveness of Pharmacotherapy in Pain: A Review of Recent Observational Studies.

PubMed

Biltaji, Eman; Tak, Casey; Ma, Junjie; Ruiz-Negron, Natalia; Bellows, Brandon K

2016-09-01

Pain disorders affect a large number of individuals throughout the world and are costly. Although randomized clinical trials assess the efficacy (i.e., how well treatments work in controlled settings) of pain pharmacotherapy, clinical trials do not assess effectiveness (i.e., how well treatments work in real-world settings). The number of observational studies that use real-world data to assess the effectiveness of medications is increasing rapidly in many disease areas. It is important for clinicians to understand how real-world data may be used to assess the effectiveness of medications. This paper aims to review the current body of literature assessing the effectiveness of pain pharmacotherapy using medical records. To do this, a literature search was conducted to identify papers published between January 2013 and September 2015 that examined the effectiveness of pain pharmacotherapy using electronic medical records. The search found only three papers meeting these criteria, which were described, reviewed, and critiqued in this paper. Electronic medical records are an underutilized source of data to assess pain outcomes in real-world settings. Although there are many methodological challenges in using these data, there is also great opportunity to impact clinical practice and explore the real-world effectiveness of pharmacotherapy used in pain management.

The Art of Observation: A Pedagogical Framework.

PubMed

Wellbery, Caroline; McAteer, Rebecca A

2015-12-01

Observational skills, honed through experience with the literary and visual arts, bring together in a timely manner many of the goals of the medical humanities, providing thematic cohesion through the act of seeing while aiming to advance clinical skills through a unified practice. In an arts observation pedagogy, nature writing serves as an apt model for precise, clinically relevant linguistic noticing because meticulous attention to the natural world involves scientific precision; additionally, a number of visual metaphors employed in medicine are derived from close observation of the natural world. Close reading reinforces observational skills as part of integrative, multidisciplinary clinical practice. Literary precision provides an educational bridge to recognizing the importance of detail in the clinical realm. In weighing multiple perspectives, observation applied to practice helps learners understand the nuances of the role of witness, activating reflection consonant with the viewer's professional identity. The realization that seeing is highly filtered through the observer's values allows the act of observation to come under scrutiny, opening the observer's gaze to disturbance and challenging the values and precepts of the prevailing medical culture. Application of observational skills can, for example, help observers recognize and address noxious effects of the built environment. As learners describe what they see, they also develop the communication skills needed to articulate both problems and possible improvements within their expanding sphere of influence. The ability to craft this speech as public narrative can lead to interventions with positive impacts on physicians, their colleagues, and patients.

Patient Expectancy as a Mediator of Placebo Effects in Antidepressant Clinical Trials.

PubMed

Rutherford, Bret R; Wall, Melanie M; Brown, Patrick J; Choo, Tse-Hwei; Wager, Tor D; Peterson, Bradley S; Chung, Sarah; Kirsch, Irving; Roose, Steven P

2017-02-01

Causes of placebo effects in antidepressant trials have been inferred from observational studies and meta-analyses, but their mechanisms have not been directly established. The goal of this study was to examine in a prospective, randomized controlled trial whether patient expectancy mediates placebo effects in antidepressant studies. Adult outpatients with major depressive disorder were randomly assigned to open or placebo-controlled citalopram treatment. Following measurement of pre- and postrandomization expectancy, participants were treated with citalopram or placebo for 8 weeks. Independent samples t tests determined whether patient expectancy differed between the open and placebo-controlled groups, and mixed-effects models assessed group effects on Hamilton Depression Rating Scale (HAM-D) scores over time while controlling for treatment assignment. Finally, mediation analyses tested whether between-group differences in patient expectancy mediated the group effect on HAM-D scores. Postrandomization expectancy scores were significantly higher in the open group (mean=12.1 [SD=2.1]) compared with the placebo-controlled group (mean=11.0 [SD=2.0]). Mixed-effects modeling revealed a significant week-by-group interaction, indicating that HAM-D scores for citalopram-treated participants declined at a faster rate in the open group compared with the placebo-controlled group. Patient expectations postrandomization partially mediated group effects on week 8 HAM-D. Patient expectancy is a significant mediator of placebo effects in antidepressant trials. Expectancy-related interventions should be investigated as a means of controlling placebo responses in antidepressant clinical trials and improving patient outcome in clinical treatment.

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.

[The effects of Omega-3 fatty acids in clinical medicine].

PubMed

Reiner, Martin F; Stivala, Simona; Camici, Giovanni G; Beer, Jürg H

2014-03-12

Effects of Omega-3 fatty acids (n-3 FA) in particular on the development of cardiovascular disease (CVD) are of major interest. Many experimental studies reported their anti-inflammatory, anti-thrombotic and anti-atherosclerotic properties and suggested favourable effects on the prevention of CVD. While the majority of former studies showed a benefit of n-3 FA acid intake, recent clinical trials using n-3 supplements on top of established medication and prudent nutrition did not confirm these findings. The conflicting data may be due to several factors such as the selection of study population with different sizes or characteristics as well as choosing different doses or types of n-3 FA. The most recent meta-analyses observed clear benefits of fish consumption, but not of n-3 capsules intake. Furthermore, a nutrition rich in plant-derived n-3 FA alpha-linolenic acid has been found to have beneficial effects on the development of cardio- and cerebrovascular diseases.

An observational study of Venlafaxine and CYP2D6 in clinical practice.

PubMed

Rolla, R; Gramaglia, Carla; Dalò, Valentina; Ressico, Francesca; Prosperini, Pierluigi; Vidali, Matteo; Meola, Silvia; Pollarolo, Paola; Bellomo, Giorgio; Torre, Eugenio; Zeppegno, Patrizia

2014-01-01

Venlafaxine (V) is a serotonin-norepinephrine selective reuptake inhibitor, mainly metabolized by cytochrome P4502D6 (CYP2D6). CYP2D6 polymorphisms result in a variety of phenotypes: poor (PMs), intermediate (IMs), extensive (EMs), and ultrarapid metabolizers (UMs). PMs usually show poor tolerance to drugs metabolized by CYP2D6, while UMs need greater doses. The aim of this study was to evaluate the impact of CYP2D6 genotype on V dosage, therapeutic response, and side effects in a clinical outpatient setting. 47 patients with Major Depressive Disorder, treated with V 75 - 300 mg/day, underwent CYP2D6 genotyping using the INFINITI-CYP2D6 assay. Duration of treatment and clinical outcome (Clinical Global Impression [CGI] effectiveness index) were assessed. CGI assessment was performed after 6 weeks, 6 months, and 1 year of treatment with a V median dose of 150 mg/day. CYP2D6 genotyping resulted in 1 PM, 3 IMs, 42 EMs, and 1 UM. The UM took the greatest V dose (375 mg) without side effects; IMs/PMs took moderate/high doses of V (150 - 300 mg) without adverse effects; EMs displayed high response variability. PM/IM patients responded to V differently than expected according to genotype. However, the UM patient responded to a dosage higher than the usual therapeutic range and without developing side effects, suggesting an association between CYP2D6 gene duplication and the therapeutic efficacy of venlafaxine. The CYP2D6 genotyping may thus provide clinicians with a potential explanation for those patients requiring greater doses of CYP2D6 substrates in order to obtain the same therapeutic efficacy.

Early clinical observations on the use of imatinib mesylate in FOP: A report of seven cases.

PubMed

Kaplan, Frederick S; Andolina, Jeffrey R; Adamson, Peter C; Teachey, David T; Finklestein, Jerry Z; Ebb, David H; Whitehead, Benjamin; Jacobs, Benjamin; Siegel, David M; Keen, Richard; Hsiao, Edward; Pignolo, Robert J

2018-04-01

Fibrodysplasia ossificans progressiva (FOP) is an ultrarare genetic disorder of progressive, disabling heterotopic ossification (HO) for which there is presently no definitive treatment. Research studies have identified multiple potential targets for therapy in FOP, and novel drug candidates are being developed for testing in clinical trials. A complementary approach seeks to identify approved drugs that could be re-purposed for off-label use against defined targets in FOP. One such drug is imatinib mesylate, a tyrosine kinase inhibitor originally developed for use in patients with chronic myeloid leukemia (CML). Imatinib has the desirable effect of attacking multiple targets involved in the early hypoxic and inflammatory stages of FOP flare-ups, including HIF1-α, PDGFRα, c-KIT, and multiple MAP kinases. Based on compelling biologic rationale, strong preclinical data, and a favorable safety profile, imatinib has been prescribed on an off-label basis in a non-trial setting in seven children with continuous FOP flare-ups, predominantly in the axial regions, and which were not responsive to standard-of-care regimens. Anecdotal reports in these seven isolated cases document that the medication was well-tolerated with a ubiquitous reported decrease in the intensity of flare-ups in the six children who took the medication. These early clinical observations support the implementation of clinical trials in children with uncontrolled FOP flare-ups to determine if imatinib may ameliorate symptoms or alter the natural history of this debilitating and life-threatening disease. Copyright © 2017 Elsevier Inc. All rights reserved.

Effectiveness of cold therapy in reducing pain, trismus, and oedema after impacted mandibular third molar surgery: a randomized, self-controlled, observer-blind, split-mouth clinical trial.

PubMed

Zandi, M; Amini, P; Keshavarz, A

2016-01-01

Cold therapy is a conventional and widely used modality for reducing pain, trismus, and oedema after dentoalveolar surgeries. However, information reported in the literature on its effectiveness is insufficient and controversial. This study was performed to evaluate the effect of local cold application in reducing pain, trismus, and swelling after impacted mandibular third molar surgery. Thirty patients (seven males and 23 females) with bilateral symmetrical mandibular impacted third molars were enrolled in this randomized, self-controlled, observer-blind clinical trial. The patients were aged between 18 and 30 years. After surgical removal of the tooth on one side (intervention), ice pack therapy was given for 24h after surgery; for the other side (control), no cold therapy was given. The time interval between the two surgeries was at least 4 weeks. The amount of pain, trismus, and facial swelling was measured on days 2 and 7 postoperative, and patient satisfaction with the cold therapy vs. no cold therapy was assessed. The amount of pain, trismus, and facial swelling, and the extent of patient satisfaction were not significantly different between the intervention and control sides. Cold therapy had no beneficial effects on postoperative sequelae after impacted mandibular third molar surgery. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

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…

Chronic histiocytic intervillositis - Clinical, biochemical and radiological findings: An observational study.

PubMed

Koby, Lawrence; Keating, Sarah; Malinowski, Ann Kinga; D'Souza, Rohan

2018-04-01

Chronic histiocytic intervillositis (CHI) of the placenta although rare, has a high recurrence rate, is associated with serious adverse pregnancy outcomes and has no available treatment. This study aims to determine clinical, biochemical and radiological factors associated with CHI, to guide management of subsequent pregnancies. This retrospective observational study included consecutive cases with a histopathologic diagnosis of CHI after 18 weeks of gestation, between 2001 and 2014, and no controls. Clinical (maternal, fetal and delivery outcomes), biochemical (first- and second-trimester biomarkers for fetal aneuploidy and serum alkaline phosphatase) and radiological (second- and third-trimester fetal, placental and Doppler ultrasound) factors associated with a histopathological diagnosis of CHI were identified and results presented as percentages. Outcomes of subsequent pregnancies were described. Of 231 identified cases of 'intervillositis', 33 were confirmed to have CHI, of which only 4/33 (12.1%) had prior uncomplicated term deliveries. During pregnancy, 10/18 (55.5%) had abnormal first-trimester screening, 4/16 (25%) had abnormal second-trimester screening, 6/19 (31.6%) had at least one elevated alkaline phosphatase level, and 15/20 (75%) had at least one abnormal feature on mid-trimester placental ultrasound. In subsequent pregnancies that were closely followed with a combination of biochemical and radiologic tests, there were no cases of fetal loss, and lower incidence of fetal growth restriction and preterm birth. No clinical, biochemical or radiological finding is consistently associated with CHI and adverse outcomes thereof. Whether the incorporation of these tests in individualized care-plans could improve outcomes in subsequent pregnancies needs to be studied further. Copyright © 2018 Elsevier Ltd. All rights reserved.

Sexual orientations of women with polycystic ovary syndrome: clinical observation in Taiwan.

PubMed

Chen, Ching-Hui; Wang, Peng-Hui; Hsieh, Meng-Ti; Tzeng, Chii-Ruey; Wu, Yi-Hsuan; Lee, Chin-San; Chu, Yuan-Hsiang; Chang, Heng-Yu

2014-12-01

-related clinical or biochemical characteristics. This observation requires further confirmation. Copyright © 2014. Published by Elsevier B.V.

The no-observed-adverse-effect-level in drug safety evaluations: use, issues, and definition(s).

PubMed

Dorato, Michael A; Engelhardt, Jeffery A

2005-08-01

The no-observed-adverse-effect-level (NOAEL) is an important part of the non-clinical risk assessment. It is a professional opinion based on the design of the study, indication of the drug, expected pharmacology, and spectrum of off-target effects. There is no consistent standard definition of NOAEL. This is based, in part, on the varied definitions of what constitutes an adverse effect. Toxicologists, either investigating or reviewing, have not been consistent in defining an effect as either adverse or acceptable. The common definition of NOAEL, "the highest experimental point that is without adverse effect," serves us well in general discussions. It does not, however, address the interpretation of risk based on toxicologically relevant effects, nor does it consider the progression of effect with respect to duration and/or dose. This paper will discuss the issues and application of a functional definition of the NOAEL in toxicology evaluations.

Improving observational study estimates of treatment effects using joint modeling of selection effects and outcomes: the case of AAA repair.

PubMed

O'Malley, A James; Cotterill, Philip; Schermerhorn, Marc L; Landon, Bruce E

2011-12-01

When 2 treatment approaches are available, there are likely to be unmeasured confounders that influence choice of procedure, which complicates estimation of the causal effect of treatment on outcomes using observational data. To estimate the effect of endovascular (endo) versus open surgical (open) repair, including possible modification by institutional volume, on survival after treatment for abdominal aortic aneurysm, accounting for observed and unobserved confounding variables. Observational study of data from the Medicare program using a joint model of treatment selection and survival given treatment to estimate the effects of type of surgery and institutional volume on survival. We studied 61,414 eligible repairs of intact abdominal aortic aneurysms during 2001 to 2004. The outcome, perioperative death, is defined as in-hospital death or death within 30 days of operation. The key predictors are use of endo, transformed endo and open volume, and endo-volume interactions. There is strong evidence of nonrandom selection of treatment with potential confounding variables including institutional volume and procedure date, variables not typically adjusted for in clinical trials. The best fitting model included heterogeneous transformations of endo volume for endo cases and open volume for open cases as predictors. Consistent with our hypothesis, accounting for unmeasured selection reduced the mortality benefit of endo. The effect of endo versus open surgery varies nonlinearly with endo and open volume. Accounting for institutional experience and unmeasured selection enables better decision-making by physicians making treatment referrals, investigators evaluating treatments, and policy makers.

The clinical and cost effectiveness of bee honey dressing in the treatment of diabetic foot ulcers.

PubMed

Moghazy, A M; Shams, M E; Adly, O A; Abbas, A H; El-Badawy, M A; Elsakka, D M; Hassan, S A; Abdelmohsen, W S; Ali, O S; Mohamed, B A

2010-09-01

Honey is known, since antiquity, as an effective wound dressing. Emergence of resistant strains and the financial burden of modern dressings, have revived honey as cost-effective dressing particularly in developing countries. Its suitability for all stages of wound healing suggests its clinical effectiveness in diabetic foot wound infections. Thirty infected diabetic foot wounds were randomly selected from patients presenting to Surgery Department, Suez Canal University Hospital, Ismailia, Egypt. Honey dressing was applied to wounds for 3 months till healing, grafting or failure of treatment. Changes in grade and stage of wounds, using University of Texas Diabetic Wound Classification, as well as surface area were recorded weekly. Bacterial load was determined before and after honey dressing. Complete healing was significantly achieved in 43.3% of ulcers. Decrease in size and healthy granulation was significantly observed in another 43.3% of patients. Bacterial load of all ulcers was significantly reduced after the first week of honey dressing. Failure of treatment was observed in 6.7% of ulcers. This study proves that commercial clover honey is a clinical and cost-effective dressing for diabetic wound in developing countries. It is omnipresence and concordance with cultural beliefs makes it a typical environmentally based method for treating these conditions. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

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.

[Clinical application of moving cupping therapy based on skin reaction observation and syndrome differentiation].

PubMed

Deng, Xiao-Lan; Chen, Bo; Chen, Ze-Lin

2014-12-01

The diagnostic evidence on clinical diseases and theoretic basis of moving cupping therapy were ex- plored in the paper. By the observation of the local reaction, such as skin appearance and color, the affected location, duration of sickness and nature of disease were judged. Different moving cupping methods were selected for different disorders. It was discovered that the property of syndromes should be recognized by the palpation on skin and muscle in the moving cupping therapy so that the pathogenesis and treating principle could be carefully determined. The moving cupping therapy is the important component of body surface therapy. Skin reaction observation and syndrome differentiation is the essential guidance of the moving cupping therapy.

Observation Versus Initial Treatment for Men With Localized, Low-Risk Prostate Cancer A Cost-Effectiveness Analysis

PubMed Central

Hayes, Julia H.; Ollendorf, Daniel A.; Pearson, Steven D.; Barry, Michael J.; Kantoff, Philip W.; Lee, Pablo A.; McMahon, Pamela M.

2015-01-01

Background Observation is underused among men with localized, low-risk prostate cancer. Objective To assess the costs and benefits of observation versus initial treatment. Design Decision analysis simulating treatment or observation. Data Sources Medicare schedules, published literature. Target Population Men ages 65 and 75 years with newly diagnosed low-risk prostate cancer (prostate-specific antigen level <10 μg/L, stage ≤T2a, Gleason score ≤3+3). Time Horizon Lifetime. Perspective Societal. Intervention Treatment (brachytherapy, intensity-modulated radiation therapy, or radical prostatectomy) or observation (active surveillance [AS] or watchful waiting [WW]). Outcome Measures Quality-adjusted life expectancy, costs. Results of Base-Case Analysis Observation was more effective and less costly than initial treatment. Compared with AS, WW provided 2 additional months of quality-adjusted life expectancy (9.02 vs. 8.85 years) at a savings of $15 374 ($24 520 vs. $39 894) in men aged 65 years and 2 additional months (6.14 vs. 5.98 years) at a savings of $11 746 ($18 302 vs. $30 048) in men aged 75 years. Brachytherapy was the most effective and least expensive initial treatment. Results of Sensitivity Analysis Treatment became more effective than observation when it led to more dramatic reductions in prostate cancer death (hazard ratio, 0.47 vs. WW and 0.64 vs. AS). Active surveillance became as effective as WW in men aged 65 years when the probability of progressing to treatment on AS decreased below 63% or when the quality of life with AS versus WW was 4% higher in men aged 65 years or 1% higher in men aged 75 years. Watchful waiting remained least expensive in all analyses. Limitation Results depend on outcomes reported in the published literature, which is limited. Conclusion Among these men, observation is more effective and costs less than initial treatment, and WW is most effective and least expensive under a wide range of clinical scenarios. Primary

Development of the Clinical Teaching Effectiveness Questionnaire in the United States.

PubMed

Wormley, Michelle E; Romney, Wendy; Greer, Anna E

2017-01-01

The purpose of this study was to develop a valid measure for assessing clinical teaching effectiveness within the field of physical therapy. The Clinical Teaching Effectiveness Questionnaire (CTEQ) was developed via a 4-stage process, including (1) initial content development, (2) content analysis with 8 clinical instructors with over 5 years of clinical teaching experience, (3) pilot testing with 205 clinical instructors from 2 universities in the Northeast of the United States, and (4) psychometric evaluation, including principal component analysis. The scale development process resulted in a 30-item questionnaire with 4 sections that relate to clinical teaching: learning experiences, learning environment, communication, and evaluation. The CTEQ provides a preliminary valid measure for assessing clinical teaching effectiveness in physical therapy practice.

Observational methods in comparative effectiveness research.

PubMed

Concato, John; Lawler, Elizabeth V; Lew, Robert A; Gaziano, J Michael; Aslan, Mihaela; Huang, Grant D

2010-12-01

Comparative effectiveness research (CER) may be defined informally as an assessment of available options for treating specific medical conditions in selected groups of patients. In this context, the most prominent features of CER are the various patient populations, medical ailments, and treatment options involved in any particular project. Yet, each research investigation also has a corresponding study design or "architecture," and in patient-oriented research a common distinction used to describe such designs are randomized controlled trials (RCTs) versus observational studies. The purposes of this overview, with regard to CER, are to (1) understand how observational studies can provide accurate results, comparable to RCTs; (2) recognize strategies used in selected newer methods for conducting observational studies; (3) review selected observational studies from the Veterans Health Administration; and (4) appreciate the importance of fundamental methodological principles when conducting or evaluating individual studies. Published by Elsevier Inc.

Bias in Observational Studies of Prevalent Users: Lessons for Comparative Effectiveness Research From a Meta-Analysis of Statins

PubMed Central

Danaei, Goodarz; Tavakkoli, Mohammad; Hernán, Miguel A.

2012-01-01

Randomized clinical trials (RCTs) are usually the preferred strategy with which to generate evidence of comparative effectiveness, but conducting an RCT is not always feasible. Though observational studies and RCTs often provide comparable estimates, the questioning of observational analyses has recently intensified because of randomized-observational discrepancies regarding the effect of postmenopausal hormone replacement therapy on coronary heart disease. Reanalyses of observational data that excluded prevalent users of hormone replacement therapy led to attenuated discrepancies, which begs the question of whether exclusion of prevalent users should be generally recommended. In the current study, the authors evaluated the effect of excluding prevalent users of statins in a meta-analysis of observational studies of persons with cardiovascular disease. The pooled, multivariate-adjusted mortality hazard ratio for statin use was 0.77 (95% confidence interval (CI): 0.65, 0.91) in 4 studies that compared incident users with nonusers, 0.70 (95% CI: 0.64, 0.78) in 13 studies that compared a combination of prevalent and incident users with nonusers, and 0.54 (95% CI: 0.45, 0.66) in 13 studies that compared prevalent users with nonusers. The corresponding hazard ratio from 18 RCTs was 0.84 (95% CI: 0.77, 0.91). It appears that the greater the proportion of prevalent statin users in observational studies, the larger the discrepancy between observational and randomized estimates. PMID:22223710

In vitro effect of bergamot (Citrus bergamia) juice against cagA-positive and-negative clinical isolates of Helicobacter pylori.

PubMed

Filocamo, Angela; Bisignano, Carlo; Ferlazzo, Nadia; Cirmi, Santa; Mandalari, Giuseppina; Navarra, Michele

2015-07-30

Helicobacter pylori infection has been associated with chronic gastritis, peptic ulcer and gastric carcinoma as over half of the world's population is colonized with this gram-negative bacterium. Due to the increasing antibiotic resistance, its eradication rates fails in a great portion of patients. A number of studies showed that molecules largely distributed in commonly consumed fruits and vegetables may have antimicrobial activity. The aim of the present study was to investigate the effect of bergamot juice (BJ) against Helicobacter pylori in vitro. The potential therapeutic combination between BJ and the antibiotics amoxicillin (AMX), clarithromycin (CLA) and metronidazole (MTZ) has also been evaluated. The minimum inhibitory concentration (MIC) of BJ, AMX, CLA and MTZ against 2 ATCC and 32 clinical isolates of H. pylori was assayed according to CLSI. The checkerboard method was used to determine the efficacy of the association BJ with the three reference antibiotics. Killing curves were performed on the two cagA-positive ATCC strains of H. pylori (ATCC 43504 and ATCC 49503), on the clinical isolate cagA-positive HP6 strain of H. pylori and on the clinical isolate cagA-negative HP61 strain of H. pylori. BJ (2.5%, v/v) inhibited the growth of 50% of the H. pylori clinical isolates, whereas 5% (v/v) inhibited 90%. AMX was the most effective antibiotic against the reference strains and the clinical isolates, followed by CLA and MTZ. In the combination assays, synergism was observed between BJ and AMX and between BJ and MTZ against both the reference strains and the clinical isolates. Indifference was observed between BJ and CLA. BJ was effective in vitro against H. pylori and the genotype status of the clinical strains may have an impact on its susceptibility. The synergistic combination of BJ and antibiotics could be used to prevent or treat resistance.

Effects of Saponins against Clinical E. coli Strains and Eukaryotic Cell Line

PubMed Central

Arabski, Michał; Węgierek-Ciuk, Aneta; Czerwonka, Grzegorz; Lankoff, Anna; Kaca, Wiesław

2012-01-01

Saponins are detergent-like substances showing antibacterial as well as anticancer potential. In this study, the effects of saponins from Quillaja saponaria were analyzed against prokaryotic and eukaryotic cells. Multidrug-resistant clinical E. coli strains were isolated from human urine. As eukaryotic cells, the CHO-K1 cell lines were applied. Antibacterial effect of ampicillin, streptomycin, and ciprofloxacin in the presence of saponins was measured by cultivation methods. Properties of saponins against CHO-K1 cells were measured by the MTT test, hemolysis assay and flow cytometry. Saponin from Quillaja saponaria has a cytotoxic effect at concentrations higher than 25 μg/mL and in the range of 12–50 μg/mL significantly increases the level of early apoptotic cells. Saponin at dose of 12 μg/mL enhances the six E. coli strains growth. We postulate that saponins increase the influx of nutrients from the medium into E. coli cells. Saponins do not have synergetic effects on antibacterial action of tested antibiotics. In contrary, in the presence of saponins and antibiotics, more CFU/mL E. coli cells were observed. This effect was similar to saponins action alone towards E. coli cells. In conclusion, saponins was cytotoxic against CHO-K1 cells, whereas against E. coli cells this effect was not observed. PMID:22500084

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.

Clinical Relevance of Nontuberculous Mycobacteria Isolated from Sputum in a Gold Mining Workforce in South Africa: An Observational, Clinical Study.

PubMed

van Halsema, Clare L; Chihota, Violet N; Gey van Pittius, Nicolaas C; Fielding, Katherine L; Lewis, James J; van Helden, Paul D; Churchyard, Gavin J; Grant, Alison D

2015-01-01

The clinical relevance of nontuberculous mycobacteria (NTM), detected by liquid more than solid culture in sputum specimens from a South African mining workforce, is uncertain. We aimed to describe the current spectrum and relevance of NTM in this population. An observational study including individuals with sputum NTM isolates, recruited at workforce tuberculosis screening and routine clinics. Symptom questionnaires were administered at the time of sputum collection and clinical records and chest radiographs reviewed retrospectively. Of 232 individuals included (228 (98%) male, median age 44 years), M. gordonae (60 individuals), M. kansasii (50), and M. avium complex (MAC: 38) were the commonest species. Of 38 MAC isolates, only 2 (5.3%) were from smear-positive sputum specimens and 30/38 grew in liquid but not solid culture. MAC was especially prevalent among symptomatic, HIV-positive individuals. HIV prevalence was high: 57/74 (77%) among those tested. No differences were found in probability of death or medical separation by NTM species. M. gordonae, M. kansasii, and MAC were the commonest NTM among miners with suspected tuberculosis, with most MAC from smear-negative specimens in liquid culture only. HIV testing and identification of key pathogenic NTM in this setting are essential to ensure optimal treatment.

Clinical Relevance of Nontuberculous Mycobacteria Isolated from Sputum in a Gold Mining Workforce in South Africa: An Observational, Clinical Study

PubMed Central

van Halsema, Clare L.; Chihota, Violet N.; Gey van Pittius, Nicolaas C.; Fielding, Katherine L.; Lewis, James J.; van Helden, Paul D.; Churchyard, Gavin J.; Grant, Alison D.

2015-01-01

Background. The clinical relevance of nontuberculous mycobacteria (NTM), detected by liquid more than solid culture in sputum specimens from a South African mining workforce, is uncertain. We aimed to describe the current spectrum and relevance of NTM in this population. Methods. An observational study including individuals with sputum NTM isolates, recruited at workforce tuberculosis screening and routine clinics. Symptom questionnaires were administered at the time of sputum collection and clinical records and chest radiographs reviewed retrospectively. Results. Of 232 individuals included (228 (98%) male, median age 44 years), M. gordonae (60 individuals), M. kansasii (50), and M. avium complex (MAC: 38) were the commonest species. Of 38 MAC isolates, only 2 (5.3%) were from smear-positive sputum specimens and 30/38 grew in liquid but not solid culture. MAC was especially prevalent among symptomatic, HIV-positive individuals. HIV prevalence was high: 57/74 (77%) among those tested. No differences were found in probability of death or medical separation by NTM species. Conclusions. M. gordonae, M. kansasii, and MAC were the commonest NTM among miners with suspected tuberculosis, with most MAC from smear-negative specimens in liquid culture only. HIV testing and identification of key pathogenic NTM in this setting are essential to ensure optimal treatment. PMID:26180817

The clinical spectrum of Erdheim-Chester disease: an observational cohort study

PubMed Central

O’Brien, Kevin J.; Xi, Liqiang; Malayeri, Ashkan A.; Gardner, Pamela J.; Alvarado Enriquez, Jhonell R.; Shah, Nikeith; Gochuico, Bernadette R.; Raffeld, Mark; Gahl, William A.

2017-01-01

Erdheim-Chester disease (ECD) is a rare, potentially fatal multiorgan myeloid neoplasm occurring mainly in adults. The diagnosis is established by clinical, radiologic, and histologic findings; ECD tumors contain foamy macrophages that are CD68+, CD163+, CD1a−, and frequently S100−. The purpose of this report is to describe the clinical and molecular variability of ECD. Between 2011 and 2015, 60 consecutive ECD patients (45 males, 15 females) were prospectively evaluated at the National Institutes of Health Clinical Center. Comprehensive imaging and laboratory studies were performed, and tissues were examined for BRAF V600E and MAPK pathway mutations. Mean age at first manifestations of ECD was 46 years; a diagnosis was established, on average, 4.2 years after initial presentation. Bone was the most common tissue affected, with osteosclerosis in 95% of patients. Other manifestations observed in one-third to two-thirds of patients included cardiac mass and periaortic involvement, diabetes insipidus, retro-orbital infiltration, retroperitoneal, lung, central nervous system, skin, and xanthelasma, affecting patients in variable ways. Methods of detection included imaging studies of various modalities. Mutation in BRAF V600E was detected in 51% of 57 biopsy specimens. One patient had an ARAF D228V mutation, and 1 patient had an activating ALK fusion. Treatments included interferon α, imatinib, anakinra, cladribine, vemurafenib, and dabrafenib with trametinib; 11 patients received no therapy. The diagnosis of ECD is elusive because of the rarity and varied presentations of the disorder. Identification of BRAF and other MAPK pathway mutations in biopsy specimens improves ECD diagnosis, allows for development of targeted treatments, and demonstrates that ECD is a neoplastic disorder. This study was registered at www.clinicaltrials.gov as #NCT01417520. PMID:28553668

Overview of Experimental and Clinical Findings regarding the Neuroprotective Effects of Cerebral Ischemic Postconditioning.

PubMed

Ma, Di; Feng, Liangshu; Deng, Fang; Feng, Jia-Chun

2017-01-01

Research on attenuating the structural and functional deficits observed following ischemia-reperfusion has become increasingly focused on the therapeutic potential of ischemic postconditioning. In recent years, various methods and animal models of ischemic postconditioning have been utilized. The results of these numerous studies have indicated that the mechanisms underlying the neuroprotective effects of ischemic postconditioning may involve reductions in the generation of free radicals and inhibition of calcium overload, as well as the release of endogenous active substances, alterations in membrane channel function, and activation of protein kinases. Here we review the novel discovery, mechanism, key factors, and clinical application of ischemic postconditioning and discuss its implications for future research and problem of clinical practice.

Comparative effectiveness research in clinical practice.

PubMed

Lawrence, William F; Chang, Stephanie; Kane, Robert L; Wilt, Timothy J

2014-08-01

The Agency for Healthcare Research and Quality (AHRQ) has funded systematic reviews of comparative effectiveness research in 17 areas over the last 10 years as part of a federal mandate. These reviews provide a reliable and unbiased source of comprehensive information about the effectiveness and risks of treatment alternatives for patients and clinicians. This article describes comparative effectiveness research, provides an overview of how physicians can use it in clinical practice, and references important contributions made by the Minnesota Evidence-based Practice Center.

[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.

Effectiveness and clinical inertia in patients with antidiabetic therapy.

PubMed

Machado-Duque, Manuel Enrique; Ramírez-Riveros, Adriana Carolina; Machado-Alba, Jorge Enrique

2017-06-01

To establish the effectiveness of antidiabetic therapy and the frequency of clinical inertia in the management of type 2 diabetes mellitus in Colombia. A cross-sectional study with follow-up of patients who had been treated for at least 1 year and were receiving medical consultation for antidiabetic treatment. Effectiveness was established when haemoglobin-A1c levels were <7% and when clinical inertia was reached, which was defined as no therapeutic modifications despite not achieving management controls. Sociodemographic, clinical and pharmacological variables were evaluated, and multivariate analyses were performed. In total, 363 patients with type 2 diabetes mellitus were evaluated, with a mean age of 62.0±12.2 years. A total of 1,016 consultations were evaluated, and the therapy was effective at the end of the follow-up in 57.9% of cases. Clinical inertia was found in 56.8% of patients who did not have metabolic control. The most frequently prescribed medications were metformin (84.0%), glibenclamide (23.4%) and insulin glargine (20.7%). Moreover, 57.6% of the patients were treated with two or more antidiabetic medications. Having metabolic control in the first consult of the follow-up was a protective factor against clinical inertia in the subsequent consultations (OR: 0.08; 95%CI: 0.04-0.15; P<.001). The effectiveness of treatment for patients with type 2 diabetes mellitus has increased in Colombia, and for the first time, clinical inertia was identifiable and quantifiable and found in similar proportions to other countries. Clinical inertia is a relevant condition given that it interferes with the possibility of controlling this pathology. © 2017 John Wiley & Sons Ltd.

Implementation of a cystic fibrosis lung transplant referral patient decision aid in routine clinical practice: an observational study.

PubMed

Stacey, Dawn; Vandemheen, Katherine L; Hennessey, Rosamund; Gooyers, Tracy; Gaudet, Ena; Mallick, Ranjeeta; Salgado, Josette; Freitag, Andreas; Berthiaume, Yves; Brown, Neil; Aaron, Shawn D

2015-02-07

The decision to have lung transplantation as treatment for end-stage lung disease from cystic fibrosis (CF) has benefits and serious risks. Although patient decision aids are effective interventions for helping patients reach a quality decision, little is known about implementing them in clinical practice. Our study evaluated a sustainable approach for implementing a patient decision aid for adults with CF considering referral for lung transplantation. A prospective pragmatic observational study was guided by the Knowledge-to-Action Framework. Healthcare professionals in all 23 Canadian CF clinics were eligible. We surveyed participants regarding perceived barriers and facilitators to patient decision aid use. Interventions tailored to address modifiable identified barriers included training, access to decision aids, and conference calls. The primary outcome was >80% use of the decision aid in year 2. Of 23 adult CF clinics, 18 participated (78.2%) and 13 had healthcare professionals attend training. Baseline barriers were healthcare professionals' inadequate knowledge for supporting patients making decisions (55%), clarifying patients' values for outcomes of options (58%), and helping patients handle conflicting views of others (71%). Other barriers were lack of time (52%) and needing to change how transplantation is discussed (42%). Baseline facilitators were healthcare professionals feeling comfortable discussing bad transplantation outcomes (74%), agreeing the decision aid would be easy to experiment with (71%) and use in the CF clinic (87%), and agreeing that using the decision aid would not require reorganization of the CF clinic (90%). After implementing the decision aid with interventions tailored to the barriers, decision aid use increased from 29% at baseline to 85% during year 1 and 92% in year 2 (p < 0.001). Compared to baseline, more healthcare professionals at the end of the study were confident in supporting decision-making (p = 0.03) but

Effect of Olanzapine on Clinical and Polysomnography Profiles in Patients with Schizophrenia

PubMed Central

Sarkar, Sukanto; Nizamie, S. Haque

2018-01-01

Acute and short-term administration of olanzapine has a favorable effect on sleep in schizophrenia patients. This study aimed to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients during the acute phase of illness after controlling for previous drug exposure. Twenty-five drug-naïve or drug-free schizophrenia patients were assessed at baseline and after six weeks of olanzapine treatment on Brief Psychiatric Rating Scale (BPRS), Positive and Negative Syndrome Scale (PANSS), and Udvalg for Kliniske Undersogelser (UKU) side-effect rating scale and a whole-night polysomnography; fifteen patients completed the study. There was a significant reduction in all psychopathological variables with maximum reduction in PANSS total, BPRS total, and PANSS positive scores. A significant increase in total sleep time (TST), sleep efficiency (SE), nonrapid eye movement (NREM) stage 1 duration, stage 3 duration, stage 4 duration, and stage 4 percentage of TST, number of rapid eye movement (REM) periods, REM duration, and REM percentage of TST was observed. REM latency at baseline inversely predicted the reduction in BPRS total and PANSS total and positive scores. In summary, short-term treatment with olanzapine produced significant improvement in clinical and polysomnography profiles of patients with schizophrenia with shorter REM latency predicting a good clinical response. PMID:29675276

Psychological variables potentially implicated in opioid-related mortality as observed in clinical practice.

PubMed

Passik, Steven D; Lowery, Amy

2011-06-01

Opioid-related deaths in the United States have become a public health problem, with accidental and unintended overdoses being especially troubling. Screening for psychological risk factors is an important first step in safeguarding against nonadherence practices and identifying patients who may be vulnerable to the risks associated with opioid therapy. Validated screening instruments can aid in this attempt as a complementary tool to clinicians' assessments. A structured screening is imperative as part of an assessment, as clinician judgment is not the most reliable method of identifying nonadherence. As a complement to formal screening, we present for discussion and possible future study certain psychological variables observed during years of clinical practice that may be linked to medication nonadherence and accidental overdose. These variables include catastrophizing, fear, impulsivity, attention deficit disorders, existential distress, and certain personality disorders. In our experience, chronic pain patients with dual diagnoses may become "chemical copers" as a way of coping with their negative emotion. For these patients, times of stress could lead to accidental overdose. Behavioral, cognitive-behavioral (acceptance and commitment, dialectical behavior), existential (meaning-centered, dignity), and psychotropic therapies have been effective in treating these high-risk comorbidities, while managing expectations of pain relief appears key to preventing accidental overdose. Wiley Periodicals, Inc.

Psychological Variables Potentially Implicated in Opioid-Related Mortality as Observed in Clinical Practice

PubMed Central

Passik, Steven D.; Lowery, Amy

2014-01-01

Opioid-related deaths in the United States have become a public health problem, with accidental and unintended overdoses being especially troubling. Screening for psychological risk factors is an important first step in safeguarding against nonadherence practices and identifying patients who may be vulnerable to the risks associated with opioid therapy. Validated screening instruments can aid in this attempt as a complementary tool to clinicians’ assessments. A structured screening is imperative as part of an assessment, as clinician judgment is not the most reliable method of identifying nonadherence. As a complement to formal screening, we present for discussion and possible future study certain psychological variables observed during years of clinical practice that may be linked to medication nonadherence and accidental overdose. These variables include catastrophizing, fear, impulsivity, attention deficit disorders, existential distress, and certain personality disorders. In our experience, chronic pain patients with dual diagnoses may become “chemical copers” as a way of coping with their negative emotion. For these patients, times of stress could lead to accidental overdose. Behavioral, cognitive-behavioral (acceptance and commitment, dialectical behavior), existential (meaning-centered, dignity), and psychotropic therapies have been effective in treating these high-risk comorbidities, while managing expectations of pain relief appears key to preventing accidental overdose. PMID:21668755

Clinical observation of lymphocyte active immunotherapy in 380 patients with unexplained recurrent spontaneous abortion.

PubMed

Chen, Jian-Ling; Yang, Jian-Ming; Huang, Ya-Zhe; Li, Ying

2016-11-01

This study aims to investigate the clinical curative effect of lymphocyte active immunotherapy (LAI) on unexplained recurrent spontaneous abortion (RSA). A total of 749 RSA patients who received medical service in our hospital from October 2009 to June 2013 were enrolled into this study. These patients were randomly divided into two groups: LAI group (treatment group) and routine progesterone for maintenance tocolysis group (control group). A comparative analysis on the pregnancy outcomes in these two groups was conducted. Abortion rate was significantly lower in the LAI group than in the control group (P<0.05). Furthermore, pregnancy success rates were 89.7% and 32.2% in patients who received LAI and routine progesterone for maintenance tocolysis, respectively, and the difference was statistically significant (P<0.05). Our analysis suggested that LAI can treat RSA effectively and has an excellent clinical effect. Furthermore, the detection of blocking antibodies showed a positive prediction on pregnancy outcome. Copyright © 2016 Elsevier B.V. All rights reserved.

[Clinical observation of post-herpetic neuralgia treated with TCM herbal cupping therapy].

PubMed

Wu, Xi; Hu, Hui; Guo, Liang; Wang, Hui

2013-02-01

To compare the difference in the efficacy on post-herpetic neuralgia among TCM herbal cupping therapy, Chinese medicine thermal compressing therapy and mecobalamine. Fifty-seven cases were randomized into a TCM herbal cupping group, a thermal compressing group and a western medicine group, 19 cases in each one. The oral administration of ibuprofen was applied in every group. In the herbal cupping group, the bamboo cups soaked in the boiled Chinese herbal decoction were sucked on the most significant painful area. In the thermal compressing group, the towel soaked in the boiled Chinese herbal decoction was compressed on the most significant painful area. In the medication group, the muscular injection of mecobalamine was adopted. The treatment was given once a day, for 2 weeks totally in each group. SF-MPQ score and clinical efficacy before and after treatment were observed in each group. The remarkable effective rates were 78.9% (15/19), 36.8% (7/19) and 5.3% (1/19) in the TCM herbal cupping group, thermal compressing group and western medicine group separately. The efficacy in the TCM herbal cupping group was significantly superior to the thermal compressing group and western medicine group (all P < 0.05), and that in the thermal compressing group was superior to the western medicine group (P < 0.05). After treatment, SF-MPQ score was reduced significantly in each group (P < 0.001, P < 0.01). The score in the herbal cupping group was reduced more significantly as compared with the thermal compressing group and western medicine group (all P < 0.01). The improvement in pain in the thermal compressing group was superior to the western medicine group (P < 0.01). TCM herbal cupping therapy achieves the superior efficacy for post-herpetic neuralgia and relieves pain effectively of the patients, which is more advantageous than CM herbal thermal compressing therapy and Mecobalamine.

Observation of a superfluid Hall effect

PubMed Central

Jiménez-García, Karina; Williams, Ross A.; Beeler, Matthew C.; Perry, Abigail R.; Phillips, William D.; Spielman, Ian B.

2012-01-01

Measurement techniques based upon the Hall effect are invaluable tools in condensed-matter physics. When an electric current flows perpendicular to a magnetic field, a Hall voltage develops in the direction transverse to both the current and the field. In semiconductors, this behavior is routinely used to measure the density and charge of the current carriers (electrons in conduction bands or holes in valence bands)—internal properties of the system that are not accessible from measurements of the conventional resistance. For strongly interacting electron systems, whose behavior can be very different from the free electron gas, the Hall effect’s sensitivity to internal properties makes it a powerful tool; indeed, the quantum Hall effects are named after the tool by which they are most distinctly measured instead of the physics from which the phenomena originate. Here we report the first observation of a Hall effect in an ultracold gas of neutral atoms, revealed by measuring a Bose–Einstein condensate’s transport properties perpendicular to a synthetic magnetic field. Our observations in this vortex-free superfluid are in good agreement with hydrodynamic predictions, demonstrating that the system’s global irrotationality influences this superfluid Hall signal. PMID:22699494

Can medical therapy mimic the clinical efficacy or physiological effects of bariatric surgery?

PubMed Central

Miras, A D; le Roux, C W

2014-01-01

The number of bariatric surgical procedures performed has increased dramatically. This review discusses the clinical and physiological changes, and in particular, the mechanisms behind weight loss and glycaemic improvements, observed following the gastric bypass, sleeve gastrectomy and gastric banding bariatric procedures. The review then examines how close we are to mimicking the clinical or physiological effects of surgery through less invasive and safer modern interventions that are currently available for clinical use. These include dietary interventions, orlistat, lorcaserin, phentermine/topiramate, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, pramlintide, dapagliflozin, the duodenal–jejunal bypass liner, gastric pacemakers and gastric balloons. We conclude that, based on the most recent trials, we cannot fully mimic the clinical or physiological effects of surgery; however, we are getting closer. A ‘medical bypass' may not be as far in the future as we previously thought, as the physician's armamentarium against obesity and type 2 diabetes has recently got stronger through the use of specific dietary modifications, novel medical devices and pharmacotherapy. Novel therapeutic targets include not only appetite but also taste/food preferences, energy expenditure, gut microbiota, bile acid signalling, inflammation, preservation of β-cell function and hepatic glucose output, among others. Although there are no magic bullets, an integrated multimodal approach may yield success. Non-surgical interventions that mimic the metabolic benefits of bariatric surgery, with a reduced morbidity and mortality burden, remain tenable alternatives for patients and health-care professionals. PMID:24213310

The Hawthorne effect in direct observation research with physicians and patients.

PubMed

Goodwin, Meredith A; Stange, Kurt C; Zyzanski, Stephen J; Crabtree, Benjamin F; Borawski, Elaine A; Flocke, Susan A

2017-12-01

This study examines the degree to which a "Hawthorne effect" alters outpatient-visit content. Trained research nurses directly observed 4454 visits to 138 family physicians. Multiple data sources were used to examine the Hawthorne effect including differences in medical record documentation for observed visits and the prior visit by the same patient, time use during visits on the first versus the second observation day of each physician, and report by the patient, physician, and observer of the effect of observation. Visits on the first versus the second observation day were longer by an average of 1 minute (P < .001); there were time-use differences for 4 of 20 behaviour categories evaluated. No effect of the observer on the interaction was reported by 74% of patients and 55% of physicians. Most of those that reported an affect indicated it was slight. Patients with non-White race, lower-educational level, and poorer health were more likely to report being affected by the observer. In a study that was designed to minimize the Hawthorne effect, the presence of an observer had little effect on most patient-physician visits but appeared to at least slightly effect a subgroup of vulnerable patients. © 2017 John Wiley & Sons, Ltd.

Iranian Effective Clinical Nurse Instructor evaluation tool: Development and psychometric testing

PubMed Central

Shahsavari, Hooman; Yekta, Zohreh Parsa; Zare, Zahra; Sigaroodi, Abdolhossain Emami

2014-01-01

Background: Clinical education is the heart of the nursing education program. Effective nursing clinical instructors are needed for graduating the future qualified nurses. There is a well-developed body of knowledge about the effectiveness of clinical teaching and the instructors. However, translating this knowledge into a context-based evaluation tool for measuring the effectiveness of Iranian clinical nursing instructors remains a deficiency. The purpose of this study is to describe the development and psychometric testing process of an instrument to evaluate the characteristics of Iranian effective clinical nurse instructor. Materials and Methods: Following a precise review of Iranian literatures and expert consultation, 83 statements about the characteristics that make clinical nurse instructors effective were extracted. In the next phase, the psychometric properties of the instrument were established by looking at the content validity, face validity, and internal consistency. Content validity of the instrument was assessed based on the comments of an expert panel including 10 nursing faculty members. During this phase, 30 items of the instrument were omitted or merged. Face validity of the instrument was assured based on the advices of 10 nursing students and 10 nursing faculty members. Finally, in the pilot test, the data of 168 filled questionnaires were gathered and analyzed by an exploratory factor analysis to reduce the items and identify the factor structure of the instrument. Results: Through subsequent analyses, of the 83 items, 31 items were merged or omitted. At last, 52 retained items were divided into four subscales including student-centric behaviors, clinical performances, planning ability, and personality traits. The Cronbach's alpha level of the inventory was 0.96, with the value for each domain ranging from 0.87 to 0.94. Conclusions: Iranian Effective Clinical Nurse Instructor evaluation tool has acceptable psychometric properties and can be

Systematic effects in LOD from SLR observations

NASA Astrophysics Data System (ADS)

Bloßfeld, Mathis; Gerstl, Michael; Hugentobler, Urs; Angermann, Detlef; Müller, Horst

2014-09-01

Beside the estimation of station coordinates and the Earth’s gravity field, laser ranging observations to near-Earth satellites can be used to determine the rotation of the Earth. One parameter of this rotation is ΔLOD (excess Length Of Day) which describes the excess revolution time of the Earth w.r.t. 86,400 s. Due to correlations among the different parameter groups, it is difficult to obtain reliable estimates for all parameters. In the official ΔLOD products of the International Earth Rotation and Reference Systems Service (IERS), the ΔLOD information determined from laser ranging observations is excluded from the processing. In this paper, we study the existing correlations between ΔLOD, the orbital node Ω, the even zonal gravity field coefficients, cross-track empirical accelerations and relativistic accelerations caused by the Lense-Thirring and deSitter effect in detail using first order Gaussian perturbation equations. We found discrepancies due to different a priories by using different gravity field models of up to 1.0 ms for polar orbits at an altitude of 500 km and up to 40.0 ms, if the gravity field coefficients are estimated using only observations to LAGEOS 1. If observations to LAGEOS 2 are included, reliable ΔLOD estimates can be achieved. Nevertheless, an impact of the a priori gravity field even on the multi-satellite ΔLOD estimates can be clearly identified. Furthermore, we investigate the effect of empirical cross-track accelerations and the effect of relativistic accelerations of near-Earth satellites on ΔLOD. A total effect of 0.0088 ms is caused by not modeled Lense-Thirring and deSitter terms. The partial derivatives of these accelerations w.r.t. the position and velocity of the satellite cause very small variations (0.1 μs) on ΔLOD.

Daily pilates exercise or inactivity for patients with low back pain: a clinical prospective observational study.

PubMed

Notarnicola, A; Fischetti, F; Maccagnano, G; Comes, R; Tafuri, S; Moretti, B

2014-02-01

Studies have shown the effectiveness of a few weekly pilates sessions as helping to reduce lower back pain (LBP). However many patients fear that physical activity can actually make the pain and disability worse. We carried out this observational prospective clinical study to look at the effects that taking part in daily pilates has one on side and on the other the effects of LBP management without physical exercise. The volunteers who participated in this study were recruited from among some local cultural associations. Patients affected by LBP were evaluated. The subjects were 60 volunteers (27 males and 33 females) with a mean age of 51.2 years who had chronic low back pain (CLBP). They were allocated to pilates group (N.=30) or inactivity control group (N.=30). The pilates group performed one-hour lesson of pilates exercise, 5 lessons per week during the following 6 months. The inactivity group continued with their normal daily activities. The Roland-Morris Disability, the Oswestry, the SF-36 and the Spinal Functional Sort Questionaries of all subjects were measured at the baseline (T1) and at 6 months (T2). At T2 improvements were observed in the pilates group with increases in physical and social functioning, general health and vitality (P<0.05) and decreases in disability and pain (P<0.05). The inactivity group showed worsening in the same measures at T2. We found an important improvement of pain, disability and physical and psychological perception of health in individuals who did the daily sessions of pilates. Some authors underlined the possible risk of a lack of adherence to an exercise program at home. This study suggests that a daily pilates program is effective for the management of CLBP. On the other hand, the inactivity contributes to further worsening, inducing a vicious cycle in which pain and physical activity intolerance follow each other.

The Effect of Trim5 Polymorphisms on the Clinical Course of HIV-1 Infection

PubMed Central

van Manen, Daniëlle; Rits, Maarten A. N; Beugeling, Corrine; van Dort, Karel; Schuitemaker, Hanneke; Kootstra, Neeltje A

2008-01-01

The antiviral factor tripartite interaction motif 5α (Trim5α) restricts a broad range of retroviruses in a species-specific manner. Although human Trim5α is unable to block HIV-1 infection in human cells, a modest inhibition of HIV-1 replication has been reported. Recently two polymorphisms in the Trim5 gene (H43Y and R136Q) were shown to affect the antiviral activity of Trim5α in vitro. In this study, participants of the Amsterdam Cohort studies were screened for polymorphisms at amino acid residue 43 and 136 of the Trim5 gene, and the potential effects of these polymorphisms on the clinical course of HIV-1 infection were analyzed. In agreement with the reported decreased antiviral activity of Trim5α that contains a Y at amino acid residue 43 in vitro, an accelerated disease progression was observed for individuals who were homozygous for the 43Y genotype as compared to individuals who were heterozygous or homozygous for the 43H genotype. A protective effect of the 136Q genotype was observed but only after the emergence of CXCR4-using (X4) HIV-1 variants and when a viral load of 104.5 copies per ml plasma was used as an endpoint in survival analysis. Interestingly, naive CD4 T cells, which are selectively targeted by X4 HIV-1, revealed a significantly higher expression of Trim5α than memory CD4 T cells. In addition, we observed that the 136Q allele in combination with the −2GG genotype in the 5′UTR was associated with an accelerated disease progression. Thus, polymorphisms in the Trim5 gene may influence the clinical course of HIV-1 infection also underscoring the antiviral effect of Trim5α on HIV-1 in vivo. PMID:18248091

Effect of experience on clinical decision making by cardiorespiratory physiotherapists in acute care settings.

PubMed

Smith, Megan; Higgs, Joy; Ellis, Elizabeth

2010-02-01

This article investigates clinical decision making in acute care hospitals by cardiorespiratory physiotherapists with differing degrees of clinical experience. Participants were observed as they engaged in their everyday practice and were interviewed about their decision making. Texts of the data were interpreted by using a hermeneutic approach that involved repeated reading and analysis of fieldnotes and interview transcripts to develop an understanding of the effect of experience on clinical decision making. Participants were classified into categories of cardiorespiratory physiotherapy experience: less experienced (<2 years), intermediate experience (2.5-4 years), and more experienced (>7 years). Four dimensions characteristic of increasing experience in cardiorespiratory physiotherapy clinical decision making were identified: 1) an individual practice model, 2) refined approaches to clinical decision making, 3) working in context, and 4) social and emotional capability. Underpinning these dimensions was evidence of reflection on practice, motivation to achieve best practice, critique of new knowledge, increasing confidence, and relationships with knowledgeable colleagues. These findings reflect characteristics of physiotherapy expertise that have been described in the literature. This study adds knowledge about the field of cardiorespiratory physiotherapy to the existing body of research on clinical decision making and broadens the existing understanding of characteristics of physiotherapy expertise.

[Glioblastoma metastases: a literature review and a description of six clinical observations].

PubMed

Goryaynov, S A; Potapov, A A; Ignatenko, M A; Zhukov, V Yu; Protskiy, S V; Zakharova, N A; Okhlopkov, V A; Shishkina, L V

2015-01-01

since the 1990s, the literature has described cases of glioblastoma metastases with the development of foci located at a distance from the primary tumor. However, the pathogenesis of this process remains unclear until the end. This focus is believed to result, on the one hand, from tumor metastasis from the primary site and, on the other hand, from multifocal growth. This article presents a literature review and a description of clinical observations of patients with glioblastoma metastases. The study included 6 patients (1 female and 5 males) with brain glioblastomas who received treatment at the Burdenko Neurosurgical Institute (5 patients) and the Department of Neurosurgery of the Research Center of Neurology (1 patient) in the period from 2010 to 2014. Neurophysiological control was used if the tumor was localized near the eloquent cortical areas and pathways; 4 of 6 patients were operated on using the methods of intraoperative fluorescence diagnosis (5-ALA agent--Alasens). Four patients had metastases within one hemisphere, two had metastases in the contralateral hemisphere in the period of 5 to 18 months after the first operation. The primary tumor site was located near the ventricular system in two patients. In one patient, the lateral ventricle was opened during the first operation. In another patient, the prepontine cistern was opened during the first operation. In two patients, the primary tumor site was located at a distance from the lateral ventricles, however, the tumor was located near them during recurrence. Based on metabolic navigation, fluorescence of the tumor was observed in the four patients during both the first and repeated operations. The close relationship between primary glioblastomas and metastases and the cerebrospinal fluid circulation pathways may confirm the fact of dissemination of tumor cells with cerebrospinal fluid flow. In our opinion, there should be an increased suspicion of the possibility for metastases of glioblastomas that

Management of toxoplasmic retinochoroiditis during pregnancy, postpartum period and lactation: clinical observations.

PubMed

Brydak-Godowska, Joanna; Moneta-Wielgoś, Joanna; Kęcik, Dariusz; Borkowski, Piotr Karol

2015-02-25

During pregnancy and labor, the immune response is physiologically impaired and women are more susceptible to infections. Since many drugs may have potentially adverse effects on the fetus and newborn, less aggressive treatment regimens should be considered in pregnant and lactating patients. The aim of our study was to present the management of toxoplasmic retinochoroiditis during pregnancy, postpartum period, and lactation. A retrospective study was undertaken of the clinical records of 24 women during pregnancy, postpartum period, and lactation who were referred in the years 1994-2014 to the Department of Zoonoses and Tropical Diseases or the Department of Ophthalmology, Medical University of Warsaw for toxoplasmic retinochoroiditis. The diagnosis was based on the typical ophthalmoscopic picture, confirmed by serological testing using an ELISA method. A total of 28 attacks of toxoplasmic retinochoroiditis were observed in 24 patients during pregnancy, postpartum period, and lactation. The choice of treatment was guided by the character and location of the inflammatory lesion and the gestational age. Topical (steroidal/nonsteroidal eye drops) and systemic treatments with spiramycin or azithromycin, Fansidar (pyrimethamine 25 mg/sulfadoxine 500 mg), and prednisone were used. Management of toxoplasmic retinochoroiditis during pregnancy, postpartum period, or lactation must be individualized and guided by the gestational age and location of the active lesion. Women of childbearing age with toxoplasma ocular lesions should be informed by their doctors about possible active recurrences during pregnancy and followed carefully by an ophthalmologist when pregnant.

The effect of periodontal treatment on C-reactive protein: A clinical study.

PubMed

Kumar, Santosh; Shah, Samir; Budhiraja, Shilpa; Desai, Khushboo; Shah, Chirag; Mehta, Dhaval

2013-07-01

Chronic periodontitis in amultifactorial inflammatory disease which is caused by various microorganisms. Many studies have found close association between chronic periodontitis and C-reactive protein (CRP). CRPis an inflammatory marker which increases in all inflammatory condition. The present clinical study was designed to show the effect of periodontal treatment on the CRP levels of gingival crevicular fluid and to determine the effect of nonsurgical therapy in minimizing the CRP levels in chronic generalized periodontitis. Gingival crevicular fluid was collected using a micro capillary pipette that was hand calibrated at every 1 mm till 10 mm, from selected sites in the subjects on the 1st, 14th and 45th days. Decreased CRP levels of gingival crevicular fluid were observed at the end of the study. There was a 37% reduction in probing pocket depth and 45% gain in clinical attachment level and a reduction of about 57% after 14 days and 90% reduction of CRP levels in gingival crevicular fluid after 45 days. Thus, the results show that the presence of CRP level is more significant in gingival crevicular fluid and confirms the underlying inflammatory component of the disease activity in chronic periodontitis.

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

Clinical effectiveness of low-power laser radiation and functioning of hemosalivatory barrier in patients with rheumatic diseases

NASA Astrophysics Data System (ADS)

Gladkova, Natalia D.; Karachistov, Alexander B.; Komarova, Lia G.; Alekseeva, Olga P.; Grunina, Elena A.

1996-11-01

We have estimated the clinical effectiveness of several regimes and ways of low power laser therapy (LT) on the basis of a double 'blind', placebo-controlling randomizing comparative test in 454 patients with rheumatic diseases (RD). LT for RD has a well-expressed placebo effect. The level of clinical effect of LT for RD is not so high. We couldn't achieve 'a considerable improvement' in any cases, 'an improvement' was secured in only 18 percent. LT should be viewed as a symptomatic means, with a primary anesthetic and feebly expressed anti-inflammatory effect, which can not influence the course of the rheumatoid process. Only in 15 percent of patients with RD, a sufficient functioning of hemo-salivary barrier was observed, the latter providing a reserve for adaption mechanism, which leads under the influence of stressor agents of medium strength not only to anesthetic, but also to moderately expressed anti- inflammatory effect.

[ZHENG's gold hook fishing acupuncture for lumbar disc herniation: a clinical observation].

PubMed

Zhu, Bowen; Zhang, Xinghua; Sun, Runjie; Qin, Xiaoguang

2016-04-01

To compare the clinical efficacy differences between Zheng's gold hook, fishing acupuncture and electroacupuncture (EA) for lumbar disc herniation (LDH). Sixty patients of LDH were randomly allocated to a gold hook fishing acupuncture group and an EA group, 30 cases in each one. Lumbar Jiaji (EX-1 B 2), Yaoyangguan (GV 3), Shenshu (BL 23), Dachangshu (BL 25), Guanyuanshu (BL 26) and ashi points were selected in the gold hook fishing acupuncture group; after the needles were inserted, the manipulation of gold hook fishing acupuncture was applied at tendon junction points and ashi points. The identical acupoints were selected in the EA group and patients were treated with EA. The treatment was both given once a day; ten days of treatment were taken as one session, and totally 3 sessions were given. The clinical effective rate, visual analogue scale (VAS), low back pain score and Oswestry disability index (ODI) were used for efficacy evaluation. The effective rate was 93.3% (28/30) in the gold hook fishing acupuncture group, which was superior to 86.7% (26/30) in the EA group (P < 0.05). The VAS, low back pain score and ODI were both significantly improved after treatment (all P < 0.05), which were more significant in the gold hook fishing acupuncture group (all P < 0.05). ZHENG's gold hook fishing acupuncture could effectively improve the symptoms and sings of LDH, reduce the disability index and improve the quality of life, which is superior to EA.

Family-based therapy for dementia caregivers: clinical observations

PubMed Central

MITRANI, V. B.; CZAJA, S. J.

2008-01-01

Family caregiving for dementia patients is a major social and clinical problem. Family caregivers face major stressful emotional, social and economic burdens, and the negative consequences associated with caregiving are well documented. Given the projected increase in the number of people with dementia, there is a need to identify approaches that will help families manage the challenges of caregiving. Social support from friends and family members has consistently been found to mediate caregiver outcomes, yet many caregivers face problems with isolation and estrangement from family members. In this regard, family-based therapy is a promising intervention for increasing social support for caregivers, and enhancing their quality of life and ability to provide care.This paper will discuss how family-based therapy can be applied as an intervention for family caregivers of dementia patients.The clinical implications of specific interactional patterns will be presented via case examples from an ongoing clinical trial with white American and Cuban American caregivers of dementia patients.The intent is to demonstrate how identification of interactional patterns is a valuable tool for implementing family-based interventions. PMID:18548132

Clinical Outcomes of Fixed Versus As-Needed Use of Artificial Tears in Dry Eye Disease: A 6-Week, Observer-Masked Phase 4 Clinical Trial.

PubMed

Asbell, Penny; Vingrys, Algis J; Tan, Jacqueline; Ogundele, Abayomi; Downie, Laura E; Jerkins, Gary; Shettle, Lee

2018-05-01

To evaluate the clinical effects of using fixed (four times daily [QID]) versus as-needed (PRN) dosing of an artificial tear product (polyethylene glycol/propylene glycol [PEG/PG]; Systane Ultra) in individuals with dry eye disease. In this prospective, multicenter, observer-masked, active-control, parallel-group trial, participants were randomized (1:2 allocation) to receive 1 drop of PEG/PG QID (n = 34) or PRN (n = 63) for 28 days. The primary endpoint was change from baseline in the total ocular surface staining (TOSS) score (according to the Oxford scale) at day 28. At day 28, the change from baseline in least squares mean (LSM) TOSS scores for QID and PRN groups were -1.19 and -0.94, respectively (treatment difference [TD]: -0.26; 95% confidence interval [CI]: -∞ to 0.21; P = 0.184); superiority of QID versus PRN dosing was not established, as the upper limit of one-sided 95% CI for TD was not <0 (prespecified limit). At day 28, for QID and PRN groups, the LSM change from baseline in Impact of Dry Eye on Everyday Life (IDEEL) scores was symptom-bother, -7.0 and -2.94 (TD: -4.06, P = 0.037); treatment effectiveness, 2.43 and 0.16 (TD: 2.28, P = 0.278); and treatment-related inconvenience, -11.56 and -2.77 (TD: -8.8, P = 0.996), respectively. Incidence of adverse events was low (≤3.2%) in both the groups; no serious adverse events were reported. QID dosing of PEG/PG was not superior to PRN dosing in terms of ocular staining. The IDEEL symptom-bother score favored QID dosing, suggesting that regular use of artificial tears may provide better symptomatic relief than PRN use. (ClinicalTrials.gov number, NCT02446015.).

Evaluation of chest tomosynthesis for the detection of pulmonary nodules: effect of clinical experience and comparison with chest radiography

NASA Astrophysics Data System (ADS)

Zachrisson, Sara; Vikgren, Jenny; Svalkvist, Angelica; Johnsson, Åse A.; Boijsen, Marianne; Flinck, Agneta; Månsson, Lars Gunnar; Kheddache, Susanne; Båth, Magnus

2009-02-01

Chest tomosynthesis refers to the technique of collecting low-dose projections of the chest at different angles and using these projections to reconstruct section images of the chest. In this study, a comparison of chest tomosynthesis and chest radiography in the detection of pulmonary nodules was performed and the effect of clinical experience of chest tomosynthesis was evaluated. Three senior thoracic radiologists, with more than ten years of experience of chest radiology and 6 months of clinical experience of chest tomosynthesis, acted as observers in a jackknife free-response receiver operating characteristics (JAFROC-1) study, performed on 42 patients with and 47 patients without pulmonary nodules examined with both chest tomosynthesis and chest radiography. MDCT was used as reference and the total number of nodules found using MDCT was 131. To investigate the effect of additional clinical experience of chest tomosynthesis, a second reading session of the tomosynthesis images was performed one year after the initial one. The JAFROC-1 figure of merit (FOM) was used as the principal measure of detectability. In comparison with chest radiography, chest tomosynthesis performed significantly better with regard to detectability. The observer-averaged JAFROC-1 FOM was 0.61 for tomosynthesis and 0.40 for radiography, giving a statistically significant difference between the techniques of 0.21 (p<0.0001). The observer-averaged JAFROC-1 FOM of the second reading of the tomosynthesis cases was not significantly higher than that of the first reading, indicating no improvement in detectability due to additional clinical experience of tomosynthesis.

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

[Clinical evaluation of the effect of gold alloy and Ni-Cr alloy porcelain fused metal crown restorations].

PubMed

Sun, Wei-ge; Liu, Xiang-hui; Zhang, Ling; Zhang, Chun; Xie, Ming-yi; Zhou, Wen-juan

2009-02-01

To observe the clinical effect of gold alloy porcelain fused metal (PFM) crown restoration and Ni-Cr alloy PFM crown restoration. A total of 168 teeth from 48 patients were restored with gold alloy PFM crown. The other 48 patients, with a total of 179 teeth were restored with Ni-Cr alloy PFM crown. They were examined in integrality, retention, shade, cervical margin, and gingival health immediately, 6 months, one year, two years ,and three years after restoration. The date was analyzed by rank sum test using SPSS12.0 software package. The clinical effect of Ni-Cr alloy PFM crown was as good as gold alloy PFM crown when checked up after cementation at once. However, when they were examined 6 months, one year, two years ,and three years after restoration, the clinical effect of gold alloy PFM crown group was significantly better than that of Ni-Cr alloy PFM crown, P<0.05. The gold alloy PFM crown has better properties than Ni-Cr alloy PFM crown as a kind of long-term restoration, especially on the aspect of shade.

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

Clinical and neural effects of six-week administration of oxytocin on core symptoms of autism.

PubMed

Watanabe, Takamitsu; Kuroda, Miho; Kuwabara, Hitoshi; Aoki, Yuta; Iwashiro, Norichika; Tatsunobu, Natsubori; Takao, Hidemasa; Nippashi, Yasumasa; Kawakubo, Yuki; Kunimatsu, Akira; Kasai, Kiyoto; Yamasue, Hidenori

2015-11-01

Autism spectrum disorder is a prevalent neurodevelopmental disorder with no established pharmacological treatment for its core symptoms. Although previous literature has shown that single-dose administration of oxytocin temporally mitigates autistic social behaviours in experimental settings, it remains in dispute whether such potentially beneficial responses in laboratories can result in clinically positive effects in daily life situations, which are measurable only in long-term observations of individuals with the developmental disorder undergoing continual oxytocin administration. Here, to address this issue, we performed an exploratory, randomized, double-blind, placebo-controlled, crossover trial including 20 high-functional adult males with autism spectrum disorder. Data obtained from 18 participants who completed the trial showed that 6-week intranasal administration of oxytocin significantly reduced autism core symptoms specific to social reciprocity, which was clinically evaluated by Autism Diagnostic Observation Scale (P = 0.034, PFDR < 0.05, Cohen's d = 0.78). Critically, the improvement of this clinical score was accompanied by oxytocin-induced enhancement of task-independent resting-state functional connectivity between anterior cingulate cortex and dorso-medial prefrontal cortex (rho = -0.60, P = 0.011), which was measured by functional magnetic resonance imaging. Moreover, using the same social-judgement task as used in our previous single-dose oxytocin trial, we confirmed that the current continual administration also significantly mitigated behavioural and neural responses during the task, both of which were originally impaired in autistic individuals (judgement tendency: P = 0.019, d = 0.62; eye-gaze effect: P = 0.03, d = 0.56; anterior cingulate activity: P = 0.00069, d = 0.97; dorso-medial prefrontal activity: P = 0.0014, d = 0.92; all, PFDR < 0.05). Furthermore, despite its longer administration, these effect sizes of the 6-week intervention

The tilt effect in DOAS observations

NASA Astrophysics Data System (ADS)

Lampel, Johannes; Wang, Yang; Hilboll, Andreas; Beirle, Steffen; Sihler, Holger; Puķīte, Janis; Platt, Ulrich; Wagner, Thomas

2017-12-01

Experience of differential atmospheric absorption spectroscopy (DOAS) shows that a spectral shift between measurement spectra and reference spectra is frequently required in order to achieve optimal fit results, while the straightforward calculation of the optical density proves inferior. The shift is often attributed to temporal instabilities of the instrument but implicitly solved the problem of the tilt effect discussed/explained in this paper. Spectral positions of Fraunhofer and molecular absorption lines are systematically shifted for different measurement geometries due to an overall slope - or tilt - of the intensity spectrum. The phenomenon has become known as the tilt effect for limb satellite observations, where it is corrected for in a first-order approximation, whereas the remaining community is less aware of its cause and consequences. It is caused by the measurement process, because atmospheric absorption and convolution in the spectrometer do not commute. Highly resolved spectral structures in the spectrum will first be modified by absorption and scattering processes in the atmosphere before they are recorded with a spectrometer, which convolves them with a specific instrument function. In the DOAS spectral evaluation process, however, the polynomial (or other function used for this purpose) accounting for broadband absorption is applied after the convolution is performed. In this paper, we derive that changing the order of the two modifications of the spectra leads to different results. Assuming typical geometries for the observations of scattered sunlight and a spectral resolution of 0.6 nm, this effect can be interpreted as a spectral shift of up to 1.5 pm, which is confirmed in the actual analysis of the ground-based measurements of scattered sunlight as well as in numerical radiative transfer simulations. If no spectral shift is allowed by the fitting routine, residual structures of up to 2.5 × 10-3 peak-to-peak are observed. Thus, this effect

Religion, Spirituality, and Medicine: Psychiatrists’ and Other Physicians’ Differing Observations, Interpretations, and Clinical Approaches

PubMed Central

Curlin, Farr A.; Lawrence, Ryan E.; Odell, Shaun; Chin, Marshall H.; Lantos, John D.; Koenig, Harold G.; Meador, Keith G.

2010-01-01

Objective This study compared the ways in which psychiatrists and nonpsychiatrists interpret the relationship between religion/spirituality and health and address religion/spirituality issues in the clinical encounter. Method The authors mailed a survey to a stratified random sample of 2,000 practicing U.S. physicians, with an oversampling of psychiatrists. The authors asked the physicians about their beliefs and observations regarding the relationship between religion/spirituality and patient health and about the ways in which they address religion/spirituality in the clinical setting. Results A total of 1,144 physicians completed the survey. Psychiatrists generally endorse positive influences of religion/spirituality on health, but they are more likely than other physicians to note that religion/spirituality sometimes causes negative emotions that lead to increased patient suffering (82% versus 44%). Compared to other physicians, psychiatrists are more likely to encounter religion/spirituality issues in clinical settings (92% versus 74% report their patients sometimes or often mention religion/spirituality issues), and they are more open to addressing religion/spirituality issues with patients (93% versus 53% say that it is usually or always appropriate to inquire about religion/spirituality). Conclusions This study suggests that the vast majority of psychiatrists appreciate the importance of religion and/or spirituality at least at a functional level. Compared to other physicians, psychiatrists also appear to be more comfortable, and have more experience, addressing religion/spirituality concerns in the clinical setting. PMID:18056237

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.

Updated Priorities Among Effective Clinical Preventive Services

PubMed Central

Maciosek, Michael V.; LaFrance, Amy B.; Dehmer, Steven P.; McGree, Dana A.; Flottemesch, Thomas J.; Xu, Zack; Solberg, Leif I.

2017-01-01

PURPOSE The Patient Protection and Affordable Care Act’s provisions for first-dollar coverage of evidence-based preventive services have reduced an important barrier to receipt of preventive care. Safety-net providers, however, still serve a substantial uninsured population, and clinician and patient time remain limited in all primary care settings. As a consequence, decision makers continue to set priorities to help focus their efforts. This report updates estimates of relative health impact and cost-effectiveness for evidence-based preventive services. METHODS We assessed the potential impact of 28 evidence-based clinical preventive services in terms of their cost-effectiveness and clinically preventable burden, as measured by quality-adjusted life years (QALYs) saved. Each service received 1 to 5 points on each of the 2 measures—cost-effectiveness and clinically preventable burden—for a total score ranging from 2 to 10. New microsimulation models were used to provide updated estimates of 12 of these services. Priorities for improving delivery rates were established by comparing the ranking with what is known of current delivery rates nationally. RESULTS The 3 highest-ranking services, each with a total score of 10, are immunizing children, counseling to prevent tobacco initiation among youth, and tobacco-use screening and brief intervention to encourage cessation among adults. Greatest population health improvement could be obtained from increasing utilization of clinical preventive services that address tobacco use, obesity-related behaviors, and alcohol misuse, as well as colorectal cancer screening and influenza vaccinations. CONCLUSIONS This study identifies high-priority preventive services and should help decision makers select which services to emphasize in quality-improvement initiatives. PMID:28376457

The Hotel Study-Clinical and Health Service Effectiveness in a Cohort of Homeless or Marginally Housed Persons.

PubMed

Honer, William G; Cervantes-Larios, Alejandro; Jones, Andrea A; Vila-Rodriguez, Fidel; Montaner, Julio S; Tran, Howard; Nham, Jimmy; Panenka, William J; Lang, Donna J; Thornton, Allen E; Vertinsky, Talia; Barr, Alasdair M; Procyshyn, Ric M; Smith, Geoffrey N; Buchanan, Tari; Krajden, Mel; Krausz, Michael; MacEwan, G William; Gicas, Kristina M; Leonova, Olga; Langheimer, Verena; Rauscher, Alexander; Schultz, Krista

2017-07-01

The Hotel Study was initiated in Vancouver's Downtown East Side (DTES) neighborhood to investigate multimorbidity in homeless or marginally housed people. We evaluated the clinical effectiveness of existing, illness-specific treatment strategies and assessed the effectiveness of health care delivery for multimorbid illnesses. For context, we mapped the housing locations of patients presenting for 552,062 visits to the catchment hospital emergency department (2005-2013). Aggregate data on 22,519 apprehensions of mentally ill people were provided by the Vancouver Police Department (2009-2015). The primary strategy was a longitudinal cohort study of 375 people living in the DTES (2008-2015). We analysed mortality and evaluated the clinical and health service delivery effectiveness for infection with human immunodeficiency virus or hepatitis C virus, opioid dependence, and psychosis. Mapping confirmed the association between poverty and greater number of emergency visits related to substance use and mental illness. The annual change in police apprehensions did not differ between the DTES and other policing districts. During 1581 person-years of cohort observation, the standardized mortality ratio was 8.43 (95% confidence interval, 6.19 to 11.50). Physician visits were common (84.3% of participants over 6 months). Clinical treatment effectiveness was highest for HIV/AIDS, intermediate for opioid dependence, and lowest for psychosis. Health service delivery mechanisms provided examples of poor access, poor treatment adherence, and little effect on multimorbid illnesses. Clinical effectiveness was variable, and illness-specific service delivery appeared to have little effect on multimorbidity. New models of care may need to be implemented.

The Hotel Study—Clinical and Health Service Effectiveness in a Cohort of Homeless or Marginally Housed Persons

PubMed Central

Cervantes-Larios, Alejandro; Jones, Andrea A.; Vila-Rodriguez, Fidel; Montaner, Julio S.; Tran, Howard; Nham, Jimmy; Panenka, William J.; Lang, Donna J.; Thornton, Allen E.; Vertinsky, Talia; Barr, Alasdair M.; Procyshyn, Ric M.; Smith, Geoffrey N.; Buchanan, Tari; Krajden, Mel; Krausz, Michael; MacEwan, G. William; Gicas, Kristina M.; Leonova, Olga; Langheimer, Verena; Rauscher, Alexander; Schultz, Krista

2017-01-01

Objective: The Hotel Study was initiated in Vancouver’s Downtown East Side (DTES) neighborhood to investigate multimorbidity in homeless or marginally housed people. We evaluated the clinical effectiveness of existing, illness-specific treatment strategies and assessed the effectiveness of health care delivery for multimorbid illnesses. Method: For context, we mapped the housing locations of patients presenting for 552,062 visits to the catchment hospital emergency department (2005-2013). Aggregate data on 22,519 apprehensions of mentally ill people were provided by the Vancouver Police Department (2009-2015). The primary strategy was a longitudinal cohort study of 375 people living in the DTES (2008-2015). We analysed mortality and evaluated the clinical and health service delivery effectiveness for infection with human immunodeficiency virus or hepatitis C virus, opioid dependence, and psychosis. Results: Mapping confirmed the association between poverty and greater number of emergency visits related to substance use and mental illness. The annual change in police apprehensions did not differ between the DTES and other policing districts. During 1581 person-years of cohort observation, the standardized mortality ratio was 8.43 (95% confidence interval, 6.19 to 11.50). Physician visits were common (84.3% of participants over 6 months). Clinical treatment effectiveness was highest for HIV/AIDS, intermediate for opioid dependence, and lowest for psychosis. Health service delivery mechanisms provided examples of poor access, poor treatment adherence, and little effect on multimorbid illnesses. Conclusions: Clinical effectiveness was variable, and illness-specific service delivery appeared to have little effect on multimorbidity. New models of care may need to be implemented. PMID:28199798

Neuroprotective effect of lidocaine: is there clinical potential?

PubMed Central

Leng, Tiandong; Gao, Xiuren; Dilger, James P; Lin, Jun

2016-01-01

Local anesthetic lidocaine has been shown to be protective in animal models of focal and global ischemia as well as in in vitro hypoxic models. Lidocaine has been tested in patients for its potential protective effect on postoperative cognitive dysfunction. This mini-review summarizes the laboratory and clinical evidences and discusses its clinical applications as neuroprotective agent. PMID:27186318

Direct observation of the skyrmion Hall effect

DOE PAGES

Jiang, Wanjun; Zhang, Xichao; Yu, Guoqiang; ...

2016-09-19

The well-known Hall effect describes the transverse deflection of charged particles (electrons/holes) as a result of the Lorentz force. Similarly, it is intriguing to examine if quasi-particles without an electric charge, but with a topological charge, show related transverse motion. Magnetic skyrmions with a well-defined spin texture with a unit topological charge serve as good candidates to test this hypothesis. In spite of the recent progress made on investigating magnetic skyrmions, direct observation of the skyrmion Hall effect has remained elusive. Here, by using a current-induced spin Hall spin torque, we experimentally demonstrate the skyrmion Hall effect, and the resultantmore » skyrmion accumulation, by driving skyrmions from the creep-motion regime (where their dynamics are influenced by pinning defects) into the steady-flow-motion regime. Lastly, the experimental observation of transverse transport of skyrmions due to topological charge may potentially create many exciting opportunities, such as topological selection.« less

Direct observation of the skyrmion Hall effect

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

Jiang, Wanjun; Zhang, Xichao; Yu, Guoqiang

The well-known Hall effect describes the transverse deflection of charged particles (electrons/holes) as a result of the Lorentz force. Similarly, it is intriguing to examine if quasi-particles without an electric charge, but with a topological charge, show related transverse motion. Magnetic skyrmions with a well-defined spin texture with a unit topological charge serve as good candidates to test this hypothesis. In spite of the recent progress made on investigating magnetic skyrmions, direct observation of the skyrmion Hall effect has remained elusive. Here, by using a current-induced spin Hall spin torque, we experimentally demonstrate the skyrmion Hall effect, and the resultantmore » skyrmion accumulation, by driving skyrmions from the creep-motion regime (where their dynamics are influenced by pinning defects) into the steady-flow-motion regime. Lastly, the experimental observation of transverse transport of skyrmions due to topological charge may potentially create many exciting opportunities, such as topological selection.« less

Clinical Effects of Prebiotics in Pediatric Population.

PubMed

Orel, Rok; Reberšak, Lea Vodušek

2016-12-15

Prebiotics are non-digestible components of food that in a selective manner trigger the expansion of microbes in the gut with valuable effects for the health of the host. In our document, current literature pertaining to the clinical effects of the use of prebiotics for the treatment and prevention of some common pediatric pathology such as infantile colic, constipation, absorption of minerals, weight gain, diarrhea, respiratory infections, and eczema is reviewed. Data was collected through search of the MEDLINE, PubMed, UpToDate, Cochrane Database of Systemic Reviews, and the Cochrane Controlled Trials Register database as well as through references from relevant articles, all until September 2015. However, only the results of publications with adequate methodological quality were included. Prebiotics seem to be very appealing in treatment of many clinical conditions, explicitly in the fight against constipation, poor weight gain in preterm infants, and eczema in atopic children. In contrast to probiotics, the evidence of true clinical efficacy of prebiotics, supported with exact type and dose information are rather sparse, and there are a limited number of randomized controlled trials concerning prebiotics in children, especially beyond the age of infancy. Large well-designed, controlled, confirmatory clinical trials are required, using commercially available products, to help healthcare providers in making an appropriate decision concerning the appropriate use of prebiotics in different conditions.

Athletic Training Clinical Instructors as Situational Leaders.

PubMed

Meyer, Linda Platt

2002-12-01

OBJECTIVE: To present Situational Leadership as a model that can be implemented by clinical instructors during clinical education. Effective leadership occurs when the leadership style is matched with the observed followers' characteristics. Effective leaders anticipate and assess change and adapt quickly and grow with the change, all while leading followers to do the same. As athletic training students' levels of readiness change, clinical instructors also need to transform their leadership styles and strategies to match the students' ever-changing observed needs in different situations. DATA SOURCES: CINAHL (1982-2002), MEDLINE (1990-2001), SPORT Discus (1949-2002), ERIC (1966-2002), and Internet Web sites were searched. Search terms included leadership, situational leadership, clinical instructors and leadership, teachers as leaders, and clinical education. DATA SYNTHESIS: Situational Leadership is presented as a leadership model to be used by clinical instructors while teaching and supervising athletic training students in the clinical setting. This model can be implemented to improve the clinical-education process. Situational leaders, eg, clinical instructors, must have the flexibility and range of skills to vary their leadership styles to match the challenges that occur while teaching athletic training students. CONCLUSIONS/RECOMMENDATIONS: This leadership style causes the leader to carry a substantial responsibility to lead while giving power away. Communication is one of the most important leadership skills to develop to become an effective leader. It is imperative for the future of the profession that certified athletic trainers continue to develop effective leadership skills to address the changing times in education and expectations of the athletic training profession.

Athletic Training Clinical Instructors as Situational Leaders

PubMed Central

Meyer, Linda Platt

2002-01-01

Objective: To present Situational Leadership as a model that can be implemented by clinical instructors during clinical education. Effective leadership occurs when the leadership style is matched with the observed followers' characteristics. Effective leaders anticipate and assess change and adapt quickly and grow with the change, all while leading followers to do the same. As athletic training students' levels of readiness change, clinical instructors also need to transform their leadership styles and strategies to match the students' ever-changing observed needs in different situations. Data Sources: CINAHL (1982–2002), MEDLINE (1990–2001), SPORT Discus (1949–2002), ERIC (1966–2002), and Internet Web sites were searched. Search terms included leadership, situational leadership, clinical instructors and leadership, teachers as leaders, and clinical education. Data Synthesis: Situational Leadership is presented as a leadership model to be used by clinical instructors while teaching and supervising athletic training students in the clinical setting. This model can be implemented to improve the clinical-education process. Situational leaders, eg, clinical instructors, must have the flexibility and range of skills to vary their leadership styles to match the challenges that occur while teaching athletic training students. Conclusions/Recommendations: This leadership style causes the leader to carry a substantial responsibility to lead while giving power away. Communication is one of the most important leadership skills to develop to become an effective leader. It is imperative for the future of the profession that certified athletic trainers continue to develop effective leadership skills to address the changing times in education and expectations of the athletic training profession. PMID:12937555

The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

PubMed

Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

2018-03-12

We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P < 0.0001) than at baseline, and levels of the bone turnover markers BAP and TRACP-5b were reduced (-14.64%; P = 0.0009, and - 29.51%; P < 0.0001, respectively). In conclusion, the safety and effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

Alpha Lipoic Acid (ALA) effects on subchorionic hematoma: preliminary clinical results.

PubMed

Porcaro, G; Brillo, E; Giardina, I; Di Iorio, R

2015-09-01

The clinic use of alpha Lipoic Acid (ALA) is linked to its capability to exert antioxidant effects and, more interestingly, to counteract the pathologic changes of complex networks of cytokines, chemokines and growth factors, restoring their physiological state. The aim of this randomized controlled clinical trial was to test the contribution of oral supplementation of ALA to the standard treatment with Progesterone vaginal suppositories, in healing subchorionic hematomas in patients with threatened miscarriage. Controls were administered only Progesterone suppositories. Nineteen pregnant women in the first trimester of gestation, with threatened miscarriage and ultrasound evidence of subchorionic hematoma, were included in the trial and randomly divided in two groups: controls, treated with 400 mg Progesterone (200 mg 2 times per day), given by vaginal suppositories, and case study treated with the same Progesterone dosage, plus ALA, given orally at the dose of 600 mg (300 mg 2 times per day, DAV®, Lo.Li. Pharma srl, Italy). Sixteen patients completed the trial. Treatment was performed until complete resolution of the clinical picture. In both groups, the subjects improved significantly but, in general, a better and faster evolution in the major signs of threatened miscarriage was observed in the subjects treated with ALA and Progesterone. In these patients, the speed of resorption of subchorionic hematoma was significantly (p ≤ 0.05) superior compared to controls. The ALA and Progesterone group showed a faster decrease or disappearance of all symptoms than that observed in the control group, however the difference was not significant. These preliminary results suggest that ALA supplementation significantly contributes to speed up the process of restoration of physiological conditions in threatened miscarriage and ameliorates the medical conditions of both the mothers and the foetus, probably modulating the networks of cytokines, growth factors and other

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.

[Observation on therapeutic effect of moxibustion with thunder-fire herbal moxa stick on xerophthalmia of oligodacrya].

PubMed

Chen, Lu-Quan

2008-08-01

To observe clinical therapeutic effect of moxibustion with thunder-fire herbal moxa stick on xerophthalmia of oligodacrya. Seventy cases were randomly divided into an observation group and a control group. The observation group (n=36) were treated with moxibustion with thunder-fire herbal moxa stick at Cuanzhu (BL 2), Yuyao (EX-HN 4), Tongziliao (GB 1), Taiyang (EX-HN 5), Sibai (ST 2), Jingming (BL 1), etc. and massage of acupoints and lacrimal gland around the eye. The control group (n=34) were treated with local dripping Leiran Diyanye. Changes of the main symptoms, tears secretion test, lacrimal membrane breaking time and corneal fluorescent staining before and after treatment were observed in the two groups. After treatment, sensation of dryness and foreign body sensation in the eye, asthenopia and gross symptoms significantly improved (P<0.01) in the two groups, and the observation group in the improvement of the sensation of dryness and foreign body sensation in the eye and the gross symptoms was better than the control group (P<0.05); tears secretion test significantly improved and was better in the observation group than that in the control group (P<0.05); lacrimal membrane breaking time and corneal fluorescent staining were improved in the two groups (P<0.05), and the improvement of lacrimal membrane breaking time in the observation group was more obvious than that in the control group (P<0.05). Moxibustion with thunder-fire herbal moxa stick has good therapeutic effect on xerophthalmia of oligodacrya.

Challenges in translating endpoints from trials to observational cohort studies in oncology

PubMed Central

Ording, Anne Gulbech; Cronin-Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John; Rørth, Mikael; Sørensen, Henrik Toft

2016-01-01

Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. PMID:27354827

Implementation of cognitive therapy for PTSD in routine clinical care: effectiveness and moderators of outcome in a consecutive sample.

PubMed

Ehlers, Anke; Grey, Nick; Wild, Jennifer; Stott, Richard; Liness, Sheena; Deale, Alicia; Handley, Rachel; Albert, Idit; Cullen, Deborah; Hackmann, Ann; Manley, John; McManus, Freda; Brady, Francesca; Salkovskis, Paul; Clark, David M

2013-11-01

Trauma-focused psychological treatments are recommended as first-line treatments for Posttraumatic Stress Disorder (PTSD), but clinicians may be concerned that the good outcomes observed in randomized controlled trials (RCTs) may not generalize to the wide range of traumas and presentations seen in clinical practice. This study investigated whether Cognitive Therapy for PTSD (CT-PTSD) can be effectively implemented into a UK National Health Service Outpatient Clinic serving a defined ethnically mixed urban catchment area. A consecutive sample of 330 patients with PTSD (age 17-83) following a wide range of traumas were treated by 34 therapists, who received training and supervision in CT-PTSD. Pre and post treatment data (PTSD symptoms, anxiety, depression) were collected for all patients, including dropouts. Hierarchical linear modeling investigated candidate moderators of outcome and therapist effects. CT-PTSD was well tolerated and led to very large improvement in PTSD symptoms, depression and anxiety. The majority of patients showed reliable improvement/clinically significant change: intent-to-treat: 78.8%/57.3%; completer: 84.5%/65.1%. Dropouts and unreliable attenders had worse outcome. Statistically reliable symptom exacerbation with treatment was observed in only 1.2% of patients. Treatment gains were maintained during follow-up (M=280 days, n=220). Few of the selection criteria used in some RCTs, demographic, diagnostic and trauma characteristics moderated treatment outcome, and only social problems and needing treatment for multiple traumas showed unique moderation effects. There were no random effects of therapist on symptom improvement, but therapists who were inexperienced in CT-PTSD had more dropouts than those with greater experience. The results support the effectiveness of CT-PTSD and suggest that trauma-focused cognitive behavior therapy can be successfully implemented in routine clinical services treating patients with a wide range of traumas

Implementation of Cognitive Therapy for PTSD in routine clinical care: Effectiveness and moderators of outcome in a consecutive sample☆

PubMed Central

Ehlers, Anke; Grey, Nick; Wild, Jennifer; Stott, Richard; Liness, Sheena; Deale, Alicia; Handley, Rachel; Albert, Idit; Cullen, Deborah; Hackmann, Ann; Manley, John; McManus, Freda; Brady, Francesca; Salkovskis, Paul; Clark, David M.

2013-01-01

Objective Trauma-focused psychological treatments are recommended as first-line treatments for Posttraumatic Stress Disorder (PTSD), but clinicians may be concerned that the good outcomes observed in randomized controlled trials (RCTs) may not generalize to the wide range of traumas and presentations seen in clinical practice. This study investigated whether Cognitive Therapy for PTSD (CT-PTSD) can be effectively implemented into a UK National Health Service Outpatient Clinic serving a defined ethnically mixed urban catchment area. Method A consecutive sample of 330 patients with PTSD (age 17–83) following a wide range of traumas were treated by 34 therapists, who received training and supervision in CT-PTSD. Pre and post treatment data (PTSD symptoms, anxiety, depression) were collected for all patients, including dropouts. Hierarchical linear modeling investigated candidate moderators of outcome and therapist effects. Results CT-PTSD was well tolerated and led to very large improvement in PTSD symptoms, depression and anxiety. The majority of patients showed reliable improvement/clinically significant change: intent-to-treat: 78.8%/57.3%; completer: 84.5%/65.1%. Dropouts and unreliable attenders had worse outcome. Statistically reliable symptom exacerbation with treatment was observed in only 1.2% of patients. Treatment gains were maintained during follow-up (M = 280 days, n = 220). Few of the selection criteria used in some RCTs, demographic, diagnostic and trauma characteristics moderated treatment outcome, and only social problems and needing treatment for multiple traumas showed unique moderation effects. There were no random effects of therapist on symptom improvement, but therapists who were inexperienced in CT-PTSD had more dropouts than those with greater experience. Conclusions The results support the effectiveness of CT-PTSD and suggest that trauma-focused cognitive behavior therapy can be successfully implemented in routine clinical services

Ideal-observer analysis of lesion detectability in planar, conventional SPECT, and dedicated SPECT scintimammography using effective multi-dimensional smoothing

NASA Astrophysics Data System (ADS)

La Riviere, P. J.; Pan, X.; Penney, B. C.

1998-06-01

Scintimammography, a nuclear-medicine imaging technique that relies on the preferential uptake of Tc-99m-sestamibi and other radionuclides in breast malignancies, has the potential to provide differentiation of mammographically suspicious lesions, as well as outright detection of malignancies in women with radiographically dense breasts. In this work we use the ideal-observer framework to quantify the detectability of a 1-cm lesion using three different imaging geometries: the planar technique that is the current clinical standard, conventional single-photon emission computed tomography (SPECT), in which the scintillation cameras rotate around the entire torso, and dedicated breast SPECT, in which the cameras rotate around the breast alone. We also introduce an adaptive smoothing technique for the processing of planar images and of sinograms that exploits Fourier transforms to achieve effective multidimensional smoothing at a reasonable computational cost. For the detection of a 1-cm lesion with a clinically typical 6:1 tumor-background ratio, we find ideal-observer signal-to-noise ratios (SNR) that suggest that the dedicated breast SPECT geometry is the most effective of the three, and that the adaptive, two-dimensional smoothing technique should enhance lesion detectability in the tomographic reconstructions.

Professional opinion concerning the effectiveness of bracing relative to observation in adolescent idiopathic scoliosis.

PubMed

Dolan, Lori A; Donnelly, Melanie J; Spratt, Kevin F; Weinstein, Stuart L

2007-01-01

To determine if community equipoise exists concerning the effectiveness of bracing in adolescent idiopathic scoliosis. Bracing is the standard of care for adolescent idiopathic scoliosis despite the lack of strong reasearch evidence concerning its effectiveness. Thus, some researchers support the idea of a randomized trial, whereas others think that randomization in the face of a standard of care would be unethical. A random of Scoliosis Research Society and Pediatric Orthopaedic Society of North America members were asked to consider 12 clinical profiles and to give their opinion concerning the radiographic outcomes after observation and bracing. An expert panel was created from the respondents. They expressed a wide array of opinions concerning the percentage of patients within each scenario who would benefit from bracing. Agreement was noted concerning the risk due to bracing for post-menarchal patients only. : This study found a high degree of variability in opinion among clinicians concerning the effectiveness of bracing, suggesting that a randomized trial of bracing would be ethical.

Clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones or cholecystitis: a systematic review and economic evaluation.

PubMed

Brazzelli, Miriam; Cruickshank, Moira; Kilonzo, Mary; Ahmed, Irfan; Stewart, Fiona; McNamee, Paul; Elders, Andrew; Fraser, Cynthia; Avenell, Alison; Ramsay, Craig

2014-08-01

Approximately 10-15% of the adult population suffer from gallstone disease, cholelithiasis, with more women than men being affected. Cholecystectomy is the treatment of choice for people who present with biliary pain or acute cholecystitis and evidence of gallstones. However, some people do not experience a recurrence after an initial episode of biliary pain or cholecystitis. As most of the current research focuses on the surgical management of the disease, less attention has been dedicated to the consequences of conservative management. To determine the clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management in people presenting with uncomplicated symptomatic gallstones (biliary pain) or cholecystitis. We searched all major electronic databases (e.g. MEDLINE, EMBASE, Science Citation Index, Bioscience Information Service, Cochrane Central Register of Controlled Trials) from 1980 to September 2012 and we contacted experts in the field. Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies that enrolled people with symptomatic gallstone disease (pain attacks only and/or acute cholecystitis). Two reviewers independently extracted data and assessed the risk of bias of included studies. Standard meta-analysis techniques were used to combine results from included studies. A de novo Markov model was developed to assess the cost-effectiveness of the interventions. Two Norwegian RCTs involving 201 participants were included. Eighty-eight per cent of people randomised to surgery and 45% of people randomised to observation underwent cholecystectomy during the 14-year follow-up period. Participants randomised to observation were significantly more likely to experience gallstone-related complications [risk ratio = 6.69; 95% confidence interval (CI) 1.57 to 28.51; p = 0.01], in particular acute cholecystitis (risk ratio = 9.55; 95% CI 1.25 to 73.27; p = 0

Clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones or cholecystitis: a systematic review and economic evaluation.

PubMed Central

Brazzelli, Miriam; Cruickshank, Moira; Kilonzo, Mary; Ahmed, Irfan; Stewart, Fiona; McNamee, Paul; Elders, Andrew; Fraser, Cynthia; Avenell, Alison; Ramsay, Craig

2014-01-01

BACKGROUND Approximately 10-15% of the adult population suffer from gallstone disease, cholelithiasis, with more women than men being affected. Cholecystectomy is the treatment of choice for people who present with biliary pain or acute cholecystitis and evidence of gallstones. However, some people do not experience a recurrence after an initial episode of biliary pain or cholecystitis. As most of the current research focuses on the surgical management of the disease, less attention has been dedicated to the consequences of conservative management. OBJECTIVES To determine the clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management in people presenting with uncomplicated symptomatic gallstones (biliary pain) or cholecystitis. DATA SOURCES We searched all major electronic databases (e.g. MEDLINE, EMBASE, Science Citation Index, Bioscience Information Service, Cochrane Central Register of Controlled Trials) from 1980 to September 2012 and we contacted experts in the field. REVIEW METHODS Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies that enrolled people with symptomatic gallstone disease (pain attacks only and/or acute cholecystitis). Two reviewers independently extracted data and assessed the risk of bias of included studies. Standard meta-analysis techniques were used to combine results from included studies. A de novo Markov model was developed to assess the cost-effectiveness of the interventions. RESULTS Two Norwegian RCTs involving 201 participants were included. Eighty-eight per cent of people randomised to surgery and 45% of people randomised to observation underwent cholecystectomy during the 14-year follow-up period. Participants randomised to observation were significantly more likely to experience gallstone-related complications [risk ratio = 6.69; 95% confidence interval (CI) 1.57 to 28.51; p = 0.01], in particular acute

Clinical effectiveness and cost-effectiveness of immediate angioplasty for acute myocardial infarction: systematic review and economic evaluation.

PubMed

Hartwell, D; Colquitt, J; Loveman, E; Clegg, A J; Brodin, H; Waugh, N; Royle, P; Davidson, P; Vale, L; MacKenzie, L

2005-05-01

To review the clinical evidence comparing immediate angioplasty with thrombolysis, and to consider whether it would be cost-effective. Electronic databases. Experts in the field. For clinical effectiveness, a comprehensive review of randomised control trials (RCTs) was used for efficacy, and a selection of observational studies such as case series or audit data used for effectiveness in routine practice. RCTs of thrombolysis were used to assess the relative value of prehospital and hospital thrombolysis. Observational studies were used to assess the representativeness of patients in the RCTs, and to determine whether different groups have different capacity to benefit. Clinical effectiveness was synthesised through a narrative review with full tabulation of results of all included studies and a meta-analysis to provide a precise estimate of absolute clinical benefit. Consideration was given to the effect of the growing use of stents. The economic modelling adopted an NHS perspective to develop a decision-analytical model of cost-effectiveness focusing on opportunity costs over the short term (6 months). The results were consistent in showing an advantage of immediate angioplasty over hospital thrombolysis. The updated meta-analysis showed that mortality is reduced by about one-third, from 7.6% to 4.9% in the first 6 months, and by about the same in studies of up to 24 months. Reinfarction is reduced by over half, from 7.6% to 3.1%. Stroke is reduced by about two-thirds, from 2.3% with thrombolysis to 0.7% with percutaneous coronary intervention (PCI), with the difference being due to haemorrhagic stroke. The need for coronary artery bypass graft is reduced by about one-third, from 13.2% to 8.4%. Caution is needed in interpreting some of the older trials, as changes such as an increase in stenting and the use of the glycoprotein IIb/IIa inhibitors may improve the results of PCI. There is little evidence comparing prehospital thrombolysis with immediate PCI. Research

Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

PubMed

Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

2017-06-01

The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

[Learning in clinical simulation: observational study on satisfaction perceived by students of nursing].

PubMed

Rubbi, Ivan; Ferri, Paola; Andreina, Giulia; Cremonini, Valeria

2016-01-01

Simulation in the context of the educational workshop is becoming an important learning method, as it allows to play realistic clinical-care situations. These vocational training activities promote the development of cognitive, affective and psychomotor skills in a pedagogical context safe and risk-free, but need to be accounted for using by valid and reliable instruments. To inspect the level of satisfaction of the students of a Degree in Nursing in northern Italy about static and high-fidelity exercises with simulators and clinical cases. A prospective observational study has been conducted involving a non-probabili- stic sample of 51 third-year students throughout the academic year 2013/14. The data collection instrument consists of three questionnaires Student Satisfaction and Self-confidence in Learning Scale, Educational Practices Questionnaire, Simulation Design Scale and 3 questions on overall satisfaction. Statistical analysis was performed with SPSS 20.0 and Office 2003 Excel. The response rate of 89.5% is obtained. The Cronbach Alfa showed a good internal reliability (α = .982). The students were generally satisfied with the activities carried out in the teaching laboratory, showing more enthusiasm for the simulation with static mannequins (71%) and with high-fidelity simulators (60%), activities for which they have experienced a significant involvement and active learning. The teaching with clinical cases scored a lesser degree of satisfaction (38%) and for this method it was found the largest number of elements of weakness.

Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study.

PubMed

Yahno, Nikolay N; Fedotova, Anastasia V

2017-01-01

In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50-300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant ( P <0.0001) improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85%) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment ( P <0.0001 vs baseline for both). No death or serious adverse drug reactions were reported during the study. The results of this observational study affirm that fluvoxamine is effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials.

[Comparison of early clinical effects of two hip prosthesis designs between ceramics to ceramics and metal to polyethylene].

PubMed

Yang, Li-qing; Li, Xi; Fu, Qin; Wang, Cheng

2013-07-01

To retrospectively study early therapeutic effects of the ceramics to ceramics prosthesis design in treating hip disease. From October 2007 to September 2010, 42 patients (44 hips) with hip disease underwent replacement of total hip. Hip prosthesis designs included the Pinnacle ceramics to ceramics and the Duraloc metal to polyethylene,produced by DePuy Company, all were non-bone cement type of artificial hip joint. Twenty patients (22 hips) were performed with ceramics to ceramics total hip prosthesis (CoC group, there were 12 males and 8 females, aged from 21 to 49 years) and 22 patients (22 hips) were performed with metal to polyethylene total hip prosthesis (MoP group, there were 13 males and 9 females, aged from 42 to 55 years). All the surgical approachs were posterolateral, and the routine anticoagulation and the corresponding functional exercise were performed after operation. The follow-up time was 6 months at least including clinical and radiographic observation. Measured the motion of joint and evaluated the function of hip joint according to Harris classification. All clinical effects were satisfactory and no dislocation ,loosening,infection, deep venous thrombosis and other complications occurred. There was no statistical significance in Harris scoring and the motion of joint between two groups before and after operation (P>0.05). The clinical effect of ceramics to ceramics prosthesis design in improving clinical symptoms and the motion of joint is coordinate with metal to polyethylene total hip prosthesis, however, its advantages and long-term efficacy need further observing. The ceramics to ceramics prosthesis design may be a good choice for the young patients with hip disease because of its good wear resistance.

Effective Thermodynamics for a Marginal Observer

NASA Astrophysics Data System (ADS)

Polettini, Matteo; Esposito, Massimiliano

2017-12-01

Thermodynamics is usually formulated on the presumption that the observer has complete information about the system he or she deals with: no parasitic current, exact evaluation of the forces that drive the system. For example, the acclaimed fluctuation relation (FR), relating the probability of time-forward and time-reversed trajectories, assumes that the measurable transitions suffice to characterize the process as Markovian (in our case, a continuous-time jump process). However, most often the observer only measures a marginal current. We show that he or she will nonetheless produce an effective description that does not dispense with the fundamentals of thermodynamics, including the FR and the 2nd law. Our results stand on the mathematical construction of a hidden time reversal of the dynamics, and on the physical requirement that the observed current only accounts for a single transition in the configuration space of the system. We employ a simple abstract example to illustrate our results and to discuss the feasibility of generalizations.

Effect of anti-TNF and conventional synthetic disease-modifying anti-rheumatic drug treatment on work disability and clinical outcome in a multicentre observational cohort study of psoriatic arthritis.

PubMed

Tillett, William; Shaddick, Gavin; Jobling, Amelia; Askari, Ayman; Cooper, Annie; Creamer, Paul; Clunie, Gavin; Helliwell, Philip S; James, Jana; Kay, Lesley; Korendowych, Eleanor; Lane, Suzanne; Packham, Jonathon; Shaban, Ragai; Thomas, Matthew L; Williamson, Lyn; McHugh, Neil

2017-04-01

To determine the effect of medical treatment on work disability in patients with active PsA in a real-world setting. Four hundred patients with active PsA commencing or switching to anti-TNF or conventional synthetic DMARD (csDMARD) were recruited to a multicentre UK prospective observational cohort study. Work disability was measured using the work productivity and activity-specific health problem instrument and peripheral joint activity was measured with the disease activity in PsA composite measure. Four hundred patients were recruited, of whom 229 (57.25%) were working (of any age). Sixty-two patients of working age (24%) were unemployed. At 6 months there was a 10% improvement in presenteeism ( P = 0.007) and a 15% improvement in work productivity ( P = 0.001) among working patients commenced on csDMARDs ( n = 164) vs a larger and more rapid 30% improvement in presenteeism ( P < 0.001) and 40% improvement in work productivity ( P < 0.001) among those commenced on anti-TNF therapy ( n = 65). Clinical response was poor among patients commenced on a csDMARD ( n = 272), with an 8.4 point improvement in disease activity in PsA ( P < 0.001) vs those commenced on anti-TNF therapy ( n = 121), who had a 36.8 point improvement ( P < 0.001). We report significant and clinically meaningful improvements in both work disability and clinical outcomes after commencement of anti-TNF therapy in a real-world setting. Improvements in all outcomes among those commencing csDMARDs were slower and of a smaller magnitude. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

PubMed

Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

2010-10-01

In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

[Clinical observation of using composite resin to fill dental attrition on occlusal surface].

PubMed

Guo, Li-juan; Xu, Yan; Chen, Guang-quan

2005-10-01

The purpose of this study was to evaluate the clinical effect of using composite resin to fill dental attrition on occlusal surface. Whether the dental attrition had enough space to the material was determined first. Sometimes grinding the sharp and steep cusps or ridges of the opposite teeth was needed. Then the dental attrition was cleaned thoroughly, and finally filled with CLEARFIL bond and composite resin without preparing cavity. The follow-up period was 1 year. Out of 70 teeth from 25 patients, 52 were successful, 16 were curative, and 2 were failed. The curative rate was 97.14%. The method avoids endangering the dental pulp. It was easily accepted by the patients and operated by dentists, and can be widely applied in clinical cases.

A Temporal Mining Framework for Classifying Un-Evenly Spaced Clinical Data: An Approach for Building Effective Clinical Decision-Making System.

PubMed

Jane, Nancy Yesudhas; Nehemiah, Khanna Harichandran; Arputharaj, Kannan

2016-01-01

Clinical time-series data acquired from electronic health records (EHR) are liable to temporal complexities such as irregular observations, missing values and time constrained attributes that make the knowledge discovery process challenging. This paper presents a temporal rough set induced neuro-fuzzy (TRiNF) mining framework that handles these complexities and builds an effective clinical decision-making system. TRiNF provides two functionalities namely temporal data acquisition (TDA) and temporal classification. In TDA, a time-series forecasting model is constructed by adopting an improved double exponential smoothing method. The forecasting model is used in missing value imputation and temporal pattern extraction. The relevant attributes are selected using a temporal pattern based rough set approach. In temporal classification, a classification model is built with the selected attributes using a temporal pattern induced neuro-fuzzy classifier. For experimentation, this work uses two clinical time series dataset of hepatitis and thrombosis patients. The experimental result shows that with the proposed TRiNF framework, there is a significant reduction in the error rate, thereby obtaining the classification accuracy on an average of 92.59% for hepatitis and 91.69% for thrombosis dataset. The obtained classification results prove the efficiency of the proposed framework in terms of its improved classification accuracy.

Metformin effects on the heart and the cardiovascular system: A review of experimental and clinical data.

PubMed

Nesti, L; Natali, A

2017-08-01

Metformin, the eldest and most widely used glucose lowering drug, is likely to be effective also on cardiac and vascular disease prevention. Nonetheless, uncertainty still exists with regard to its effects on the cardiovascular system as a whole and specifically on the myocardium, both at the organ and cellular levels. We reviewed the available data on the cardiac and vascular effects of metformin, encompassing both in vitro, either tissue or isolated organ, and in vivo studies in experimental animals and humans, as well as the evidence generated by major clinical trials. At the cellular level metformin's produces both AMP-activated kinase (AMPK) dependent and independent effects. At the systemic level, possibly also through other pathways, this drug improves endothelial function, protects from oxidative stress and inflammation, and from the negative effects of angiotensin II. On the myocardium it attenuates ischemia-reperfusion injury and prevents adverse remodeling induced by humoral and hemodynamic factors. The effects on myocardial cell metabolism and contractile function being not evident at rest or in more advanced stages of cardiac dysfunction, could be relevant during transient ischemia, during an acute increase in workload and in the early stages of diabetic/hypertensive cardiomyopathy as confirmed by few small clinical trials and some observational studies. The overall evidence emerging from both clinical trials and real world registry is in favor of a protective effect of metformin with respect to both coronary events and progression to heart failure. Given this potential, its efficacy and its safety (and also its low cost) metformin remains the central pillar of the therapy of diabetes. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

The effects of stereotypes and observer pressure on athletic performance.

PubMed

Krendl, Anne; Gainsburg, Izzy; Ambady, Nalini

2012-02-01

Although the effects of negative stereotypes and observer pressure on athletic performance have been well researched, the effects of positive stereotypes on performance, particularly in the presence of observers, is not known. In the current study, White males watched a video either depicting Whites basketball players as the best free throwers in the NBA (positive stereotype), Black basketball players as the best free throwers in the NBA (negative stereotype), or a neutral sports video (control). Participants then shot a set of free throws, during which half the participants were also videotaped (observer condition), whereas the other half were not (no observer condition). Results demonstrated that positive stereotypes improved free throw performance, but only in the no observer condition. Interestingly, observer pressure interacted with the positive stereotype to lead to performance decrements. In the negative stereotype condition, performance decrements were observed both in the observer and no observer conditions.

Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a.

PubMed

Rudick, R A; Pace, A; Rani, M R S; Hyde, R; Panzara, M; Appachi, S; Shrock, J; Maurer, S L; Calabresi, P A; Confavreux, C; Galetta, S L; Lublin, F D; Radue, E-W; Ransohoff, R M

2009-06-09

Findings from a small clinical study suggested that statins may counteract the therapeutic effects of interferon beta (IFNbeta) in patients with relapsing-remitting multiple sclerosis (RRMS). We conducted a post hoc analysis of data from the Safety and Efficacy of Natalizumab in Combination With IFNbeta-1a in Patients With Relapsing-Remitting Multiple Sclerosis (SENTINEL) study to determine the effects of statins on efficacy of IFNbeta. SENTINEL was a prospective trial of patients with RRMS treated with natalizumab (Tysabri, Biogen Idec, Inc., Cambridge, MA) plus IM IFNbeta-1a (Avonex, Biogen Idec, Inc.) 30 microg compared with placebo plus IM IFNbeta-1a 30 microg. Clinical and MRI outcomes in patients treated with IM IFNbeta-1a only (no-statins group, n = 542) were compared with those of patients taking IM IFNbeta-1a and statins at doses used to treat hyperlipidemia (statins group, n = 40). No significant differences were observed between treatment groups in adjusted annualized relapse rate (p = 0.937), disability progression (p = 0.438), number of gadolinium-enhancing lesions (p = 0.604), or number of new or enlarging T2-hyperintense lesions (p = 0.802) at 2 years. More patients in the statins group reported fatigue, extremity pain, muscle aches, and increases in hepatic transaminases compared with patients in the no-statins group. Statin treatment had no ex vivo or in vitro effect on induction of IFN-stimulated genes. Statin therapy does not appear to affect clinical effects of IM interferon beta-1a in patients with relapsing-remitting multiple sclerosis or the primary molecular response to interferon beta treatment.

Machine-learning model observer for detection and localization tasks in clinical SPECT-MPI

NASA Astrophysics Data System (ADS)

Parages, Felipe M.; O'Connor, J. Michael; Pretorius, P. Hendrik; Brankov, Jovan G.

2016-03-01

In this work we propose a machine-learning MO based on Naive-Bayes classification (NB-MO) for the diagnostic tasks of detection, localization and assessment of perfusion defects in clinical SPECT Myocardial Perfusion Imaging (MPI), with the goal of evaluating several image reconstruction methods used in clinical practice. NB-MO uses image features extracted from polar-maps in order to predict lesion detection, localization and severity scores given by human readers in a series of 3D SPECT-MPI. The population used to tune (i.e. train) the NB-MO consisted of simulated SPECT-MPI cases - divided into normals or with lesions in variable sizes and locations - reconstructed using filtered backprojection (FBP) method. An ensemble of five human specialists (physicians) read a subset of simulated reconstructed images, and assigned a perfusion score for each region of the left-ventricle (LV). Polar-maps generated from the simulated volumes along with their corresponding human scores were used to train five NB-MOs (one per human reader), which are subsequently applied (i.e. tested) on three sets of clinical SPECT-MPI polar maps, in order to predict human detection and localization scores. The clinical "testing" population comprises healthy individuals and patients suffering from coronary artery disease (CAD) in three possible regions, namely: LAD, LcX and RCA. Each clinical case was reconstructed using three reconstruction strategies, namely: FBP with no SC (i.e. scatter compensation), OSEM with Triple Energy Window (TEW) SC method, and OSEM with Effective Source Scatter Estimation (ESSE) SC. Alternative Free-Response (AFROC) analysis of perfusion scores shows that NB-MO predicts a higher human performance for scatter-compensated reconstructions, in agreement with what has been reported in published literature. These results suggest that NB-MO has good potential to generalize well to reconstruction methods not used during training, even for reasonably dissimilar datasets (i

Effect of vitamin D supplementation on knee osteoarthritis: A systematic review and meta-analysis of randomized clinical trials.

PubMed

Diao, Naicheng; Yang, Bo; Yu, Fei

2017-12-01

To provide evidence regarding the effect of vitamin D supplementation on symptomatic knee osteoarthritis (OA). A systematic review and meta-analysis was performed to quantitatively pool the results from randomized clinical trials. Studies were identified from a search of the Embase, MEDLINE and Web of Science databases up to January 22, 2017, and also from conference abstracts, ClinicalTrials.gov and the reference lists of identified studies. A standardized mean difference (SMD) was used to assess effect sizes, as outcomes were reported on different scales. Depending on the degree of heterogeneity, random-effects or fixed-effects models were used to pool outcomes. Up to January 22, 2017, four clinical trials containing 570 subjects in the vitamin D supplementation group and 560 subjects in the placebo group were identified. All of the included studies were of high quality and had a low risk of bias for each domain. The results indicated that vitamin D supplementation had a statistically significant but small-to-moderate effect on pain control in patients with knee OA (SMD=-0.32, 95% CI: -0.63 to -0.02). However, no effects were observed for the change in tibial cartilage volume (SMD=0.12, 95% CI: -0.05 to 0.29) or joint space width (SMD=0.07, 95% CI: -0.08 to 0.23). The subgroup analysis indicated that vitamin D supplementation had no significant effect regardless of whether patients had sufficient or insufficient serum 25(OH)D levels at baseline. The results of this study indicate that vitamin D supplementation may not have a clinically significant effect on pain control or structure progression among patients with knee OA. Longer-term clinical trials with rigorous measurement of symptom and radiologic changes are required to further clarify the effect of vitamin D supplementation in patients with symptomatic knee OA and low serum 25(OH)D levels. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2010-12-01

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

[Clinical observation on common peroneal nerve palsy treated with comprehensive therapy].

PubMed

Yang, Li-Juan; Liu, Ya-Li; Wang, Shu-Bin; Jin, Zhi-Gao

2014-04-01

To compare the difference of the clinical efficacy on common peroneal palsy between the comprehensive therapy of electroacupuncture, moxibustion and moving cupping method and western medication. Ninety cases of common peroneal nerve palsy were randomized into a comprehensive therapy group and a western medication group, 45 cases in each one. In the comprehensive therapy group, electroacupuncture was applied to Yanglingquan (GB 34), Zusanli (ST 36), Xuanzhong (GB 39), Jiexi (ST 41), Taichong (LR 3), Zulinqi (GB 41) and the others, combined with warm moxibustion and moving cupping on the lateral side of the affected leg. The comprehensive therapy was used once a day. In the western medication group, vitamin B1 , 10 mg each time, 3 times a day; and mecobalamine, 0. 5 mg each time, three times a day were prescribed for oral administration. In the two groups, 15 days made one session, and the efficacy was observed after 2 sessions treatment. The total effective rate of the improvement of sensory function and motor nerve function was 97. 8% (44/45) in the comprehensive therapy group and was 82. 2% (37/ 45) in the western medication. The efficacy in the comprehensive therapy group was better than that of the western medication (P<0. 01). The electrophysiological examination showed that the amplitude of motor conduction of deep peroneal nerve and that of sensory conduction of surficial peroneal nerve after treatment were improved remarkably as compared with those before treatment in the comprehensive therapy group (both P<0. 05). The amplitude of motor conduction of deep peroneal nerve was improved significantly in the comprehensive therapy group as compared with that in the western medication group (P<0. 05). The comprehensive therapy of electroacupuncture, moxibustion and moving cupping method achieves the significant efficacy on common peroneal nerve palsy as compared with western medication.

Evaluating the effects of variation in clinical practice: a risk adjusted cost-effectiveness (RAC-E) analysis of acute stroke services.

PubMed

Pham, Clarabelle; Caffrey, Orla; Ben-Tovim, David; Hakendorf, Paul; Crotty, Maria; Karnon, Jonathan

2012-08-21

Methods for the cost-effectiveness analysis of health technologies are now well established, but such methods may also have a useful role in the context of evaluating the effects of variation in applied clinical practice. This study illustrates a general methodology for the comparative analysis of applied clinical practice at alternative institutions--risk adjusted cost-effectiveness (RAC-E) analysis--with an application that compares acute hospital services for stroke patients admitted to the main public hospitals in South Australia. Using linked, routinely collected data on all South Australian hospital separations from July 2001 to June 2008, an analysis of the RAC-E of services provided at four metropolitan hospitals was undertaken using a decision analytic framework. Observed (plus extrapolated) and expected lifetime costs and survival were compared across patient populations, from which the relative cost-effectiveness of services provided at the different hospitals was estimated. Unadjusted results showed that at one hospital patients incurred fewer costs and gained more life years than at the other hospitals (i.e. it was the dominant hospital). After risk adjustment, the cost minimizing hospital incurred the lowest costs, but with fewer life-years gained than one other hospital. The mean incremental cost per life-year gained of services provided at the most effective hospital was under $20,000, with an associated 65% probability of being cost-effective at a $50,000 per life year monetary threshold. RAC-E analyses can be used to identify important variation in the costs and outcomes associated with clinical practice at alternative institutions. Such data provides an impetus for further investigation to identify specific areas of variation, which may then inform the dissemination of best practice service delivery and organisation.

Nursing students' perspectives on clinical instructors' effective teaching strategies: A descriptive study.

PubMed

Valiee, Sina; Moridi, Glorokh; Khaledi, Shahnaz; Garibi, Fardin

2016-01-01

An important factor contributing to the quality of clinical education is instructors' teaching performance. The aim of this study was to identify clinical instructors' most effective teaching strategies from nursing and midwifery students' perspectives. This was a descriptive cross-sectional study. All third- and fourth-year bachelor's nursing and midwifery students studying at the Nursing and Midwifery Faculty of Kurdistan University of Medical Sciences were recruited to the study by using the census method. The study instrument consisted of a demographic questionnaire and the self-report 30-item Clinical Instructors' Effective Teaching Strategies Inventory. The SPSS v.16.0 was used for data analysis. The most effective teaching strategies of clinical instructors from nursing and midwifery students' perspectives were respectively 'treating students, clients, and colleagues with respect' and 'being eager for guiding students and manage their problems'. Clinical instructors need to be eager for education and also be able to establish effective communication with students. Empowering clinical instructors in specialized and technical aspects of clinical education seems necessary. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Clinical observation of peptic ulcer treated with acupuncture based on theory of "the compatibility of the five meridians" in Huxiang].

PubMed

Li, Cuiying; Li, Jinxiang; Pan, Shimin; Zhang, Xi; Li, Ying

2017-08-12

To compare the effects differences for peptic ulcer between acupuncture based on the theory of "the compatibility of the five meridians" in Huxiang and conventional western medication. Sixty patients with peptic ulcer of liver-stomach disharmony type (LSDT) and weakness of spleen and stomach type (WSST) were assigned into an observation group and a control group by block randomization according to syndrome differentiation.Finally,28 cases (17 with LSDT and 11 with WSST) in the observation group,29 cases (18 with LSDT and 11 with WSST) in the control group were included.In the observation group,patients with LSDT were treated with acupuncture at Zhongwan (CV 12),Taichong (LR 3),Xingjian (LR 2),Qimen (LR 14),Zusanli (ST 36),Gongsun (SP 4),Shaofu (HT 8),Jingqu (LU 8),Neiguan (PC 6); those with WSST,at Zhongwan (CV 12),Dadu (SP 2),Taibai (SP 3),Yinlingquan (SP 9),Zusanli (ST 36),Shaofu (HT 8), Taichong (LR 3),Yingu (KI 10),Taixi (KI 3),Taiyuan (LU 9) according to the theory of "the compatibility of the five meridians" in Huxiang .Reinforcing and reducing were according to syndrome differentiation.The treatment was given once a day with needle retained for 30 min,5 days a week,2 days at interval.In the control group,the conventional triple drugs (omeprazole,amoxicillin and clarithromycin) were prescribed orally for Hp positive patients,and omeprazole for Hp negative patients.All the patients were treated for 4 weeks.The clinical syndrome score,ulcer healing under gastroscope,anti-Hp infection and Hp negative conversion ratio rate were observed in the two groups before and after treatment as well as 1 month after treatment.The total effects were evaluated. The syndrome scores after treatment and at 1 month ofter treatment decreased in the two groups (all P <0.05),while without significant difference between the two groups (both P >0.05).The scores within the group between the two syndromes showed no significance in the two groups (both P >0.05).The cure rates under

The clinical effectiveness of healing touch.

PubMed

Wilkinson, Dawn S; Knox, Pamela L; Chatman, James E; Johnson, Terrance L; Barbour, Nilufer; Myles, Yvonne; Reel, Antonio

2002-02-01

(1) to determine the clinical effectiveness of Healing Touch (HT) on variables assumed to be related to health enhancement; (2) to determine whether practitioner training level moderates treatment effectiveness. Mixed-method repeated measures design with quasi-experimental and naturalistic approaches, paired with nomothetic and idiographic analyses. Practitioner's offices or client's home. Twenty-two (22) clients who had never experienced HT. Three treatment conditions: no treatment (NT), HT only (standard HT care), and HT+ (Standard HT care plus music plus guided imagery). Secretory immunoglobulin A (sIgA) concentrations in saliva, self-reports of stress levels, client perceptions of health enhancement, and qualitative questionnaires about individual effects. Clients of practitioners with more training experienced statistically significant positive sIgA change over the HT treatment series, while clients of practitioners with less experience did not. Clients reported a statistically significant reduction of stress level after both HT conditions. Perceived enhancement of health was reported by 13 of 22 clients (59%). Themes of relaxation, connection, and enhanced awareness were identified in the qualitative analysis of the HT experience. Pain relief was reported by 6 of 11 clients (55%) experiencing pain. The data support the clinical effectiveness of HT in health enhancement, specifically for raising sIgA concentrations, lowering stress perceptions and relieving pain. The evidence indicates that positive responses were not exclusively as a result of placebo, that is, client beliefs, expectations, and behaviors regarding HT.

Validating an Observation Protocol to Measure Special Education Teacher Effectiveness

ERIC Educational Resources Information Center

Johnson, Evelyn S.; Semmelroth, Carrie L.

2015-01-01

This study used Kane's (2013) Interpretation/Use Argument (IUA) to measure validity on the Recognizing Effective Special Education Teachers (RESET) observation tool. The RESET observation tool is designed to evaluate special education teacher effectiveness using evidence-based instructional practices as the basis for evaluation. In alignment with…

Clinical spectrum of psychogenic non epileptic seizures in children; an observational study.

PubMed

Madaan, Priyanka; Gulati, Sheffali; Chakrabarty, Biswaroop; Sapra, Savita; Sagar, Rajesh; Mohammad, Akbar; Pandey, R M; Tripathi, Manjari

2018-07-01

The current study was designed to analyze the clinical spectrum of Psychogenic non-epileptic seizures (PNES) in children. Children aged 6-16years with clinically suspected PNES, confirmed by short-term VEEG (STVEEG{video electroencephalogram}) and induction were classified as per Seneviratne classification. Stressors, associated co morbidities, Verbal IQ (Intelligence Quotient) and behavioral abnormalities were assessed using HTP(House tree person) test, DSM IV (Diagnostic and statistical manual of mental disorders) TR criteria, MISIC (Malin intelligence scale for Indian children) and CBCL (Child behaviour checklist). Eighty children with PNES {45 boys; mean age: 10.5 (±1.6) years} were enrolled. Median delay in diagnosis was 5 months {IQR(interquartile range)- 0.5 to 48 months}) and 45% patients were already on AEDs (antiepileptic drugs). Commonest semiology was dialeptic (42.5%), followed by mixed (28.8%), motor (15%) and nonepileptic aura (13.8%). Family stressors were the commonest followed by school related issues. The most common psychiatric comorbidity was adjustment disorder. Somatic complaints were observed in 50% children. Dialeptic PNES is commonest in children. In resource constrained settings, STVEEG along with induction is a reliable method to diagnose PNES. A comprehensive assessment protocol (including assessment of stressors) is needed for holistic management of pediatric PNES. Copyright © 2018 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Peer Observation of Rounds Leads to Collegial Discussion of Teaching.

PubMed

Pierce, J Rush; Rendón, Patrick; Rao, Deepti

2018-01-01

Faculty in the Division of Hospital Medicine provide most of the clinical teaching for learners at our institution. The majority of these faculty are Assistant Professors with limited formal instruction in clinical teaching. Previous Divisional strategies to improve clinical teaching ability included discussion of effective teaching behaviors, developing written expectations for teaching faculty, and instituting seminars on effective clinical teaching. Heretofore, the Division had not utilized a direct observation exercise. We developed a direct observation exercise to encourage discussion of teaching techniques and contemplation of change. Using a social learning model, we developed a peer-to-peer observation followed by a nonevaluative discussion. We created a tool for describing teaching behaviors in 5 domains that were similar to or different from the usual behavior of the observing peer: learner presentations, team leadership, bedside teaching, professionalism, and other. After the observation, the observing and observed faculty met to discuss observed teaching behaviors. Both faculty members discussed and then recorded any teaching behaviors that they planned to adopt or change. We implemented this intervention in a 22-member Academic Division of Hospital Medicine at a tertiary care medical center in the United States. A high proportion were junior faculty and graduates of our residency program. We reviewed records of 28 of 31 observations that were completed during the initial 9-month period of implementation and later surveyed faculty. The exercise resulted in planned changes in teaching behaviors that included instituting new methods to improve teaching team leadership, triaging of patients seen on rounds, faculty behaviors during oral presentations, giving real-time feedback, use of technology and humor, demonstrating physical examination findings, and modeling professional behaviors. Faculty later reported adoption of new teaching behaviors that were

Observational studies in systematic [corrected] reviews of comparative effectiveness: AHRQ and the Effective Health Care Program.

PubMed

Norris, Susan L; Atkins, David; Bruening, Wendy; Fox, Steven; Johnson, Eric; Kane, Robert; Morton, Sally C; Oremus, Mark; Ospina, Maria; Randhawa, Gurvaneet; Schoelles, Karen; Shekelle, Paul; Viswanathan, Meera

2011-11-01

Systematic reviewers disagree about the ability of observational studies to answer questions about the benefits or intended effects of pharmacotherapeutic, device, or procedural interventions. This study provides a framework for decision making on the inclusion of observational studies to assess benefits and intended effects in comparative effectiveness reviews (CERs). The conceptual model and recommendations were developed using a consensus process by members of the methods workgroup of the Effective Health Care Program of the Agency for Healthcare Research and Quality. In considering whether to use observational studies in CERs for addressing beneficial effects, reviewers should answer two questions: (1) Are there gaps in the evidence from randomized controlled trials (RCTs)? (2) Will observational studies provide valid and useful information? The latter question involves the following: (a) refocusing the study questions on gaps in the evidence from RCTs, (b) assessing the risk of bias of the body of evidence of observational studies, and (c) assessing whether available observational studies address the gap review questions. Because it is unusual to find sufficient evidence from RCTs to answer all key questions concerning benefit or the balance of benefits and harms, comparative effectiveness reviewers should routinely assess the appropriateness of inclusion of observational studies for questions of benefit. Furthermore, reviewers should explicitly state the rationale for inclusion or exclusion of observational studies when conducting CERs. Copyright © 2011 Elsevier Inc. All rights reserved.

Efficacy and Safety of Daikenchuto for Constipation and Dose-Dependent Differences in Clinical Effects.

PubMed

Hirose, Tatsuya; Shinoda, Yasutaka; Kuroda, Ayaka; Yoshida, Aya; Mitsuoka, Machiko; Mori, Kouki; Kawachi, Yuki; Moriya, Akihiro; Tanaka, Kouji; Takeda, Atsuko; Yoshimura, Tomoaki; Sugiyama, Tadashi

2018-01-01

Daikenchuto (DKT) is a Kampo medicine used for the treatment of constipation. In this study, we evaluated the effectiveness of DKT against constipation. Thirty-three patients administered DKT for constipation were selected and divided into low-dose (7.5 g DKT; n = 22) and high-dose (15 g DKT; n = 11) groups. We retrospectively evaluated weekly defaecation frequency, side effects, and clinical laboratory data. Median defaecation frequencies after DKT administration (5, 5.5, 5, and 8 for the first, second, third, and fourth weeks, resp.) were significantly higher than that before DKT administration (2) in all 33 cases ( P < 0.01). One case (3%) of watery stool, one case of loose stools (3%), and no cases of abdominal pain (0%) were observed. Median defaecation frequencies in the high-dose group (7 and 9) were significantly higher than those in the low-dose group (4 and 3) in the first ( P = 0.0133) and second ( P = 0.0101) weeks, respectively. There was no significant change in clinical laboratory values. We suggest that DKT increases defaecation frequency and is safe for treating constipation.

Do health economic evaluations using observational data provide reliable assessment of treatment effects?

PubMed Central

2013-01-01

Economic evaluation in modern health care systems is seen as a transparent scientific framework that can be used to advance progress towards improvements in population health at the best possible value. Despite the perceived superiority that trial-based studies have in terms of internal validity, economic evaluations often employ observational data. In this review, the interface between econometrics and economic evaluation is explored, with emphasis placed on highlighting methodological issues relating to the evaluation of cost-effectiveness within a bivariate framework. Studies that satisfied the eligibility criteria exemplified the use of matching, regression analysis, propensity scores, instrumental variables, as well as difference-in-differences approaches. All studies were reviewed and critically appraised using a structured template. The findings suggest that although state-of-the-art econometric methods have the potential to provide evidence on the causal effects of clinical and policy interventions, their application in economic evaluation is subject to a number of limitations. These range from no credible assessment of key assumptions and scarce evidence regarding the relative performance of different methods, to lack of reporting of important study elements, such as a summary outcome measure and its associated sampling uncertainty. Further research is required to better understand the ways in which observational data should be analysed in the context of the economic evaluation framework. PMID:24229445

Influence of clerks' personality on their burnout in the clinical workplace: a longitudinal observation.

PubMed

Lin, Cheng-Chieh; Lin, Blossom Yen-Ju; Lin, Chia-Der

2016-01-28

The clinical training of medical students in clerkship is crucial to their future practice in healthcare services. This study investigates burnout during a 2-year clerkship training period as well as the role of personality traits on burnout during training. Ninety-four clerks at a tertiary medical centre who provided at least 10 responses to a routine survey on clinical rotation were included in this study, which spanned September 2013 to April 2015. Web-based, validated, structured, self-administered questionnaires were used to evaluate the clerks' personalities at the beginning of the first clerkship year, and regular surveys were conducted to evaluate their burnout at each clinical specialty rotation throughout the 2-year clerkship period. Overall, 2230 responses were analysed, and linear mixed-effects models were used to examine the repeated measures of the clerks. Our findings revealed that medical student burnout scores were lower in the second year than they were in the first year of clerkships. Using the Big Five personality factors, all of the propensities, namely extroversion, agreeableness, consciousness, emotional stability, and openness were related to different extents of burnout reduction in the first clerkship year (P < .05). However, only emotional stability and openness were related to clerks' reduced burnout in the second clerkship year. Furthermore, being female, older, and with accompanied living were more closely related to lower burnout compared with being male, younger, and living alone throughout the clerkship period. The students in the first-year clerkship, particularly those with higher burnout levels, had tendencies in the Big Five personality characteristics, exhibiting higher levels of introversion, antagonism, lack of direction, neuroticism, and not open to new experiences. The students in the second-year clerkship who do not exhibit a high propensity for emotional stability and openness should be of particular concern. The

A clinically meaningful training effect in walking speed using functional electrical stimulation for motor-incomplete spinal cord injury.

PubMed

Street, Tamsyn; Singleton, Christine

2018-05-01

The study aimed to investigate the presence of a training effect for rehabilitation of walking function in motor-incomplete spinal cord injury (SCI) through daily use of functional electrical stimulation (FES). A specialist FES outpatient centre. Thirty-five participants (mean age 53, SD 15, range 18-80; mean years since diagnosis 9, range 5 months - 39 years) with drop foot and motor-incomplete SCI (T12 or higher, ASIA Impairment Scale C and D) able to ambulate 10 metres with the use of a walking stick or frame. FES of the peroneal nerve, glutei and hamstrings as clinically indicated over six months in the community. The data was analysed for a training effect (difference between unassisted ten metre walking speed at baseline and after six months) and orthotic effects (difference between walking speed with and without FES) initially on day one and after six months. The data was further analysed for a minimum clinically important difference (MCID) (>0.06 m/s). A clinically meaningful, significant change was observed for initial orthotic effect (0.13m/s, CI: 0.04-0.17, P = 0.013), total orthotic effect (0.11m/s, CI: 0.04-0.18, P = 0.017) and training effect (0.09m/s, CI: 0.02-0.16, P = 0.025). The results suggest that daily independent use of FES may produce clinically meaningful changes in walking speed which are significant for motor-incomplete SCI. Further research exploring the mechanism for the presence of a training effect may be beneficial in targeting therapies for future rehabilitation.

Massage has no observable effect on distress in children with burns: A randomized, observer-blinded trial.

PubMed

van Dijk, Monique; O'Flaherty, Linda Anne; Hoedemaker, Tessa; van Rosmalen, Joost; Rode, Heinz

2018-02-01

In a previous observational study we found that massage therapy reduced anxiety and stress in pediatric burn patients. We aimed to test this effect in a randomized controlled trial. To determine whether (1) aromatherapy massage can provide relaxation to hospitalized children with burns; (2) massage with aromatherapy oil is more effective than without; and (3) massage sessions are more effective when repeated. Randomized controlled clinical trial with 3 arms conducted in a burns unit from April 2013 to December 2014 in Cape Town, South Africa. Massage with carrier oil, massage with aromatherapy oil, and standard nursing care only. Scores on the Muscle Tension Inventory (MTI) and Behavioral Relaxation Scale (BRS) to assess level of relaxation. Scores on the COMFORT behaviour scale and Numeric Rating Scale Distress to assess level of distress. Secondary outcomes were heart rate and oxygen saturation levels. Linear mixed models were used to determine the effect of condition and session number (1 to a maximum of 5 sessions per child) correcting for baseline outcomes of COMFORT behaviour scores and heart rates after sessions. Secondary analyses included the addition of sex, age, and total body surface area (TBSA) burned as covariates. We included 284 children aged 5 weeks to 13 years with TBSA burned between 10 and 45%. Two-thirds (65.5%) were under the age of 3 years. Mixed model analyses revealed no significant difference in reduction of COMFORT behavior scores (p=0.18), or heart rates (p=0.18) between the three study arms. These outcomes were also not associated with the session number (p=0.92 and p=0.13, respectively). Level of relaxation could not be reliably assessed with the MTI and BRS because 119 patients (41.9%) had bandages covering the larger part of the face, and in 40.1% of cases the child was not in the required position. Massage therapy with or without essential oil was not effective in reducing distress behavior or heart rate in hospitalized children

Clinical observations and risk factors for tinnitus in a Sicilian cohort.

PubMed

Martines, Francesco; Sireci, Federico; Cannizzaro, Emanuele; Costanzo, Roberta; Martines, Enrico; Mucia, Mariana; Plescia, Fulvio; Salvago, Pietro

2015-10-01

The aims of this study were to determine the distribution of risk factors associated with tinnitus analysing their role in the development of tinnitus and the effects of their interaction; to evidence the importance of a suitable and adequate clinical and audiologic assessment to avoid those modifiable risk factors responsible for cochlear dysfunction and tinnitus onset. 46 subjects with tinnitus and 74 controls were studied according to: age, sex, Body Mass Index (BMI), neck circumference, tobacco smoking, feeling fatigue or headache, self reporting snoring, hypertension, diabetes, coronary heart disease, and/or hyperlipidemia, and laboratory finding as lipid profile and levels of reactive oxygen metabolites (d-ROM). Audiological assessment was performed by multi-frequency audiometry (PTA(0.5-16 kHz)) and transient-evoked otoacoustic emissions (TEOAE diagnostic). Univariate analysis was performed to examine the association between determinants and occurrence of tinnitus; Mantel-Haenszel test (G.or) was used to investigate the joint effect of determinants on tinnitus. Tinnitus was more frequent among males with age >50 years; BMI >30 kg/m(2), neck circumference >40 cm, headache, hypertension, hypercholesterolemia resulted significant risk factors for tinnitus (P < 0.0001). Tinnitus group had more comorbidity (P < 0.0001) and worse audiometric thresholds (60.87 Vs 21.62% hearing loss; P < 0.0001) with respect to control group. The interaction between hypertension-BMI ≥ 30 kg/m(2) (G.or = 8.45) and smoking-hypercholesterolemia (G.or = 5.08) increases the risk of tinnitus (P < 0.0001). Our results underline that several factors either individually or jointly contribute to tinnitus onset; a comprehensive knowledge about tinnitus risk factors and associated clinical conditions could contribute to minimizing this disorder.

Unslumping Our Sophomores. Some Clinical Observations and Strategies

ERIC Educational Resources Information Center

Margolis, Gary

1976-01-01

Failure to understand the dynamics of "sophomore slump" and to be able then to counsel from that understanding can lead to more serious clinical problems such as depression or paralyzing self-consciousness. (MB)

Increased healing in diabetic toe ulcers in a multidisciplinary foot clinic-An observational cohort study.

PubMed

Almdal, T; Nielsen, A Anker; Nielsen, K E; Jørgensen, M E; Rasmussen, A; Hangaard, S; Siersma, V; Holstein, P E

2015-12-01

To study toe ulcer healing in patients with diabetic foot ulcers attending a multidisciplinary foot clinic over a 10 years period. The study was retrospective, consecutive and observational during 2001 through 2011. The patients were treated according to the International Consensus on the Diabetic Foot. During the period the chiropodist staffing in the foot clinic was doubled; new offloading material and orthopedic foot corrections for recalcitrant ulcers were introduced. Healing was investigated in toe ulcers in Cox regression models. 2634 patients developed foot ulcers, of which 1461 developed toe ulcers; in 790 patients these were neuropathic, in 551 they were neuro-ischemic and in 120 they were critically ischemic. One-year healing rates increased in the period 2001-2011 from 75% to 91% for neuropathic toe ulcers and from 72% to 80% for neuro-ischemic toe ulcers, while no changes was observed for ischemic toe ulcers. Adjusted for changes in the patient population, the overall rate of healing for neuropathic and neuro-ischemic toe ulcers almost doubled (HR=1.95 [95% CI: 1.36-2.80]). The results show that the healing of toe ulcers improved. This outcome could not be explained by changes in the patient characteristics, but coincided with a number of improvements in organization and therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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

The Effects of Clinically Relevant Multiple-Choice Items on the Statistical Discrimination of Physician Clinical Competence.

ERIC Educational Resources Information Center

Downing, Steven M.; Maatsch, Jack L.

To test the effect of clinically relevant multiple-choice item content on the validity of statistical discriminations of physicians' clinical competence, data were collected from a field test of the Emergency Medicine Examination, test items for the certification of specialists in emergency medicine. Two 91-item multiple-choice subscales were…

Rater Effects in Clinical Performance Ratings of Surgery Residents

ERIC Educational Resources Information Center

Iramaneerat, Cherdsak; Myford, Carol M.

2006-01-01

A multi-faceted Rasch measurement (MFRM) approach was used to analyze clinical performance ratings of 24 first-year residents in one surgery residency program in Thailand to investigate three types of rater effects: leniency, rater inconsistency, and restriction of range. Faculty from 14 surgical services rated the clinical performance of…

Video observation of hand hygiene practices during routine companion animal appointments and the effect of a poster intervention on hand hygiene compliance

PubMed Central

2014-01-01

Background Hand hygiene is considered one of the most important infection control measures in human healthcare settings, but there is little information available regarding hand hygiene frequency and technique used in veterinary clinics. The objectives of this study were to describe hand hygiene practices associated with routine appointments in companion animal clinics in Ontario, and the effectiveness of a poster campaign to improve hand hygiene compliance. Results Observation of hand hygiene practices was performed in 51 clinics for approximately 3 weeks each using 2 small wireless surveillance cameras: one in an exam room, and one in the most likely location for hand hygiene to be performed outside the exam room following an appointment. Data from 38 clinics were included in the final analysis, including 449 individuals, 1139 appointments before and after the poster intervention, and 10894 hand hygiene opportunities. Overall hand hygiene compliance was 14% (1473/10894), while before and after patient contact compliance was 3% (123/4377) and 26% (1145/4377), respectively. Soap and water was used for 87% (1182/1353) of observed hand hygiene attempts with a mean contact time of 4 s (median 2 s, range 1-49 s), while alcohol-based hand rub (ABHR) was used for 7% (98/1353) of attempts with a mean contact time of 8 s (median 7 s, range 1-30 s). The presence of the posters had no significant effect on compliance, although some staff reported that they felt the posters did increase their personal awareness of the need to perform hand hygiene, and the posters had some effect on product contact times. Conclusions Overall hand hygiene compliance in veterinary clinics in this study was low, and contact time with hand hygiene products was frequently below current recommendations. Use of ABHR was low despite its advantages over hand washing and availability in the majority of clinics. The poster campaign had a limited effect on its own, but could still be used as a

Video observation of hand hygiene practices during routine companion animal appointments and the effect of a poster intervention on hand hygiene compliance.

PubMed

Anderson, Maureen E C; Sargeant, Jan M; Weese, J Scott

2014-05-07

Hand hygiene is considered one of the most important infection control measures in human healthcare settings, but there is little information available regarding hand hygiene frequency and technique used in veterinary clinics. The objectives of this study were to describe hand hygiene practices associated with routine appointments in companion animal clinics in Ontario, and the effectiveness of a poster campaign to improve hand hygiene compliance. Observation of hand hygiene practices was performed in 51 clinics for approximately 3 weeks each using 2 small wireless surveillance cameras: one in an exam room, and one in the most likely location for hand hygiene to be performed outside the exam room following an appointment. Data from 38 clinics were included in the final analysis, including 449 individuals, 1139 appointments before and after the poster intervention, and 10894 hand hygiene opportunities. Overall hand hygiene compliance was 14% (1473/10894), while before and after patient contact compliance was 3% (123/4377) and 26% (1145/4377), respectively. Soap and water was used for 87% (1182/1353) of observed hand hygiene attempts with a mean contact time of 4 s (median 2 s, range 1-49 s), while alcohol-based hand rub (ABHR) was used for 7% (98/1353) of attempts with a mean contact time of 8 s (median 7 s, range 1-30 s). The presence of the posters had no significant effect on compliance, although some staff reported that they felt the posters did increase their personal awareness of the need to perform hand hygiene, and the posters had some effect on product contact times. Overall hand hygiene compliance in veterinary clinics in this study was low, and contact time with hand hygiene products was frequently below current recommendations. Use of ABHR was low despite its advantages over hand washing and availability in the majority of clinics. The poster campaign had a limited effect on its own, but could still be used as a component of a multimodal hand

Observation of the Spin Nernst Effect in Platinum

NASA Astrophysics Data System (ADS)

Goennenwein, Sebastian

Thermoelectric effects - arising from the interplay between thermal and charge transport phenomena - have been extensively studied and are considered well established. Upon taking into account the spin degree of freedom, however, qualitatively new phenomena arise. A prototype example for these so-called magneto-thermoelectric or spin-caloritronic effects is the spin Seebeck effect, in which a thermal gradient drives a pure spin current. In contrast to their thermoelectric counterparts, not all the spin-caloritronic effects predicted from theory have yet been observed in experiment. One of these `missing' phenomena is the spin Nernst effect, in which a thermal gradient gives rise to a transverse pure spin current. We have observed the spin Nernst effect in yttrium iron garnet/platinum (YIG/Pt) thin film bilayers. Upon applying a thermal gradient within the YIG/Pt bilayer plane, a pure spin current flows in the direction orthogonal to the thermal drive. We detect this spin current as a thermopower voltage, generated via magnetization-orientation dependent spin transfer into the adjacent YIG layer. Our data shows that the spin Nernst and the spin Hall effect in in Pt have different sign, but comparable magnitude, in agreement with first-principles calculations. Financial support via Deutsche Forschungsgemeinschaft Priority Programme SPP 1538 Spin-Caloric Transport is gratefully acknowledged.

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

Aloe vera: a systematic review of its clinical effectiveness.

PubMed Central

Vogler, B K; Ernst, E

1999-01-01

BACKGROUND: The use of aloe vera is being promoted for a large variety of conditions. Often general practitioners seem to know less than their patients about its alleged benefits. AIM: To define the clinical effectiveness of aloe vera, a popular herbal remedy in the United Kingdom. METHOD: Four independent literature searches were conducted in MEDLINE, EMBASE, Biosis, and the Cochrane Library. Only controlled clinical trials (on any indication) were included. There were no restrictions on the language of publication. All trials were read by both authors and data were extracted in a standardized, pre-defined manner. RESULTS: Ten studies were located. They suggest that oral administration of aloe vera might be a useful adjunct for lowering blood glucose in diabetic patients as well as for reducing blood lipid levels in patients with hyperlipidaemia. Topical application of aloe vera is not an effective preventative for radiation-induced injuries. It might be effective for genital herpes and psoriasis. Whether it promotes wound healing is unclear. There are major caveats associated with all of these statements. CONCLUSION: Even though there are some promising results, clinical effectiveness of oral or topical aloe vera is not sufficiently defined at present. PMID:10885091

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 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.

Examining the validity of the unitary theory of clinical relationships: comparison of observed and experienced parent-doctor interaction.

PubMed

Young, Bridget; Ward, Jo; Forsey, Mary; Gravenhorst, Katja; Salmon, Peter

2011-10-01

We explored parent-doctor relationships in the care of children with leukaemia from three perspectives simultaneously: parents', doctors' and observers'. Our aim was to investigate convergence and divergence between these perspectives and thereby examine the validity of unitary theory of emotionality and authority in clinical relationships. 33 audiorecorded parent-doctor consultations and separate interviews with parents and doctors, which we analysed qualitatively and from which we selected three prototype cases. Across the whole sample doctors' sense of relationship generally converged with our observations of consultation, but parents' sense of relationship diverged strongly from each. Contrary to current assumptions, parents' sense of emotional connection with doctors did not depend on doctors' emotional behaviour, and parents did not feel disempowered by doctors' authority. Moreover, authority and emotionality were not conceptually distinct for parents, who gained emotional support from doctors' exercise of authority. The relationships looked very different from the three perspectives. These divergences indicate weaknesses in current ideas of emotionality and authority in clinical relationships and the necessity of multisource datasets to develop these ideas in a way that characterises clinical relationships from all perspectives. Methodological development will be needed to address the challenges posed by multisource datasets. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

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

Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation.

PubMed

Dario, Claudio; Delise, Pietro; Gubian, Lorenzo; Saccavini, Claudio; Brandolino, Glauco; Mancin, Silvia

2016-01-13

Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3-12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a "real world" context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per

Genome-wide association study of clinical dimensions of schizophrenia: polygenic effect on disorganized symptoms.

PubMed

Fanous, Ayman H; Zhou, Baiyu; Aggen, Steven H; Bergen, Sarah E; Amdur, Richard L; Duan, Jubao; Sanders, Alan R; Shi, Jianxin; Mowry, Bryan J; Olincy, Ann; Amin, Farooq; Cloninger, C Robert; Silverman, Jeremy M; Buccola, Nancy G; Byerley, William F; Black, Donald W; Freedman, Robert; Dudbridge, Frank; Holmans, Peter A; Ripke, Stephan; Gejman, Pablo V; Kendler, Kenneth S; Levinson, Douglas F

2012-12-01

Multiple sources of evidence suggest that genetic factors influence variation in clinical features of schizophrenia. The authors present the first genome-wide association study (GWAS) of dimensional symptom scores among individuals with schizophrenia. Based on the Lifetime Dimensions of Psychosis Scale ratings of 2,454 case subjects of European ancestry from the Molecular Genetics of Schizophrenia (MGS) sample, three symptom factors (positive, negative/disorganized, and mood) were identified with exploratory factor analysis. Quantitative scores for each factor from a confirmatory factor analysis were analyzed for association with 696,491 single-nucleotide polymorphisms (SNPs) using linear regression, with correction for age, sex, clinical site, and ancestry. Polygenic score analysis was carried out to determine whether case and comparison subjects in 16 Psychiatric GWAS Consortium (PGC) schizophrenia samples (excluding MGS samples) differed in scores computed by weighting their genotypes by MGS association test results for each symptom factor. No genome-wide significant associations were observed between SNPs and factor scores. Most of the SNPs producing the strongest evidence for association were in or near genes involved in neurodevelopment, neuroprotection, or neurotransmission, including genes playing a role in Mendelian CNS diseases, but no statistically significant effect was observed for any defined gene pathway. Finally, polygenic scores based on MGS GWAS results for the negative/disorganized factor were significantly different between case and comparison subjects in the PGC data set; for MGS subjects, negative/disorganized factor scores were correlated with polygenic scores generated using case-control GWAS results from the other PGC samples. The polygenic signal that has been observed in cross-sample analyses of schizophrenia GWAS data sets could be in part related to genetic effects on negative and disorganized symptoms (i.e., core features of chronic

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

The effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model.

PubMed

Maddineshat, Maryam; Hashemi, Mitra; Besharati, Reza; Gholami, Sepideh; Ghavidel, Fatemeh

2018-01-01

Clinical experience associated with the fear and anxiety of nursing students in the psychiatric unit. Mental health nursing instructors find it challenging to teach nursing students to deal with patients with mental disorders in an environment where they need to provide patient teaching and clinical decision-making based on evidence and new technology. To measure the effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model evaluation in the psychiatry unit of Imam Reza Hospital, Bojnurd, Iran. This cross-sectional study was carried out from 2011 to 2016 on 76 nursing students from a university as part of a clinical mental health course in two semesters. The students were selected by a non-probable convenient sampling method. After completing their clinical education, each student responded to checklist questions based on the four-level Kirkpatrick's model evaluation and open questions relating to clinical supervision. Finally, all data was analyzed using the SPSS version 16. The students have evaluated clinical supervision as a useful approach, and appreciated the instructor's supportive behavior during teaching and imparting clinical skills. This has made them feel relaxed at the end of the clinical teaching course. In addition, in the evaluation through Kirkpatrick's model, more than 70% of the students have been satisfied with the method of conducting the teaching and average score of nursing students' attitude toward mental health students: Their mean self-confidence score was 18.33±1.69, and the mean score of their performance in the study was evaluated to be 93.74±5.3 from 100 points. The results of clinical mental health teaching through clinical supervision and Kirkpatrick's model evaluation show that the satisfaction, self-esteem, attitude, and skill of nursing students are excellent, thereby portraying the effectiveness of clinical teaching. But this program still needs to be reformed. To

Positive state observer for the automatic control of the depth of anesthesia-Clinical results.

PubMed

Nogueira, Filipa N; Mendonça, T; Rocha, P

2016-09-13

The depth of anesthesia (DoA) is a crucial feature in general anesthesia. Nowadays the DoA is usually evaluated by the bispectral index (BIS). According to the surgical procedure, different reference levels for the BIS may be clinically required. This can be achieved by the simultaneous administration of an analgesic (e.g. remifentanil) and an hypnotic (eg propofol). As a contribution to the effort of automating the processes of drug delivery in general anesthesia, in this paper, a positive state observer is designed for the implementation of a control scheme proposed for the automatic administration of propofol and of remifentanil, in order to track a desired level for the BIS. It is proved and illustrated by simulations that the controller-observer scheme has a very good performance. This scheme was implemented, tested and evaluated both by means of simulations and for a set of patients during surgical procedures. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A Causal Model for Joint Evaluation of Placebo and Treatment-Specific Effects in Clinical Trials

PubMed Central

Zhang, Zhiwei; Kotz, Richard M.; Wang, Chenguang; Ruan, Shiling; Ho, Martin

2014-01-01

Summary Evaluation of medical treatments is frequently complicated by the presence of substantial placebo effects, especially on relatively subjective endpoints, and the standard solution to this problem is a randomized, double-blinded, placebo-controlled clinical trial. However, effective blinding does not guarantee that all patients have the same belief or mentality about which treatment they have received (or treatmentality, for brevity), making it difficult to interpret the usual intent-to-treat effect as a causal effect. We discuss the causal relationships among treatment, treatmentality and the clinical outcome of interest, and propose a causal model for joint evaluation of placebo and treatment-specific effects. The model highlights the importance of measuring and incorporating patient treatmentality and suggests that each treatment group should be considered a separate observational study with a patient's treatmentality playing the role of an uncontrolled exposure. This perspective allows us to adapt existing methods for dealing with confounding to joint estimation of placebo and treatment-specific effects using measured treatmentality data, commonly known as blinding assessment data. We first apply this approach to the most common type of blinding assessment data, which is categorical, and illustrate the methods using an example from asthma. We then propose that blinding assessment data can be collected as a continuous variable, specifically when a patient's treatmentality is measured as a subjective probability, and describe analytic methods for that case. PMID:23432119

Professional Opinion Concerning the Effectiveness of Bracing Relative to Observation in Adolescent Idiopathic Scoliosis

PubMed Central

Dolan, Lori A.; Donnelly, Melanie J.; Spratt, Kevin F.; Weinstein, Stuart L.

2015-01-01

Objective To determine if community equipoise exists concerning the effectiveness of bracing in adolescent idiopathic scoliosis. Background Data Bracing is the standard of care for adolescent idiopathic scoliosis despite the lack of strong reasearch evidence concerning its effectiveness. Thus, some researchers support the idea of a randomized trial, whereas others think that randomization in the face of a standard of care would be unethical. Methods A random of Scoliosis Research Society and Pediatric Orthopaedic Society of North America members were asked to consider 12 clinical profiles and to give their opinion concerning the radiographic outcomes after observation and bracing. Results An expert panel was created from the respondents. They expressed a wide array of opinions concerning the percentage of patients within each scenario who would benefit from bracing. Agreement was noted concerning the risk due to bracing for post-menarchal patients only. Conclusions This study found a high degree of variability in opinion among clinicians concerning the effectiveness of bracing, suggesting that a randomized trial of bracing would be ethical. PMID:17414008

"Lies, damned lies ..." and observational studies in comparative effectiveness research.

PubMed

Albert, Richard K

2013-06-01

A new federal initiative has allocated $1.1 billion to comparative effectiveness research, and many have emphasized the importance of including observational studies in this effort. The rationale for using observational studies to assess comparative effectiveness is based on concerns that randomized controlled trials (RCTs) are not "real world" because they enroll homogeneous patient populations, measure study outcomes that are not important to patients, use protocols that are overly complex, are conducted in specialized centers, and use study treatments that are not consistent with usual care, and that RCTs are not always feasible because of a lack of equipoise, the need to assess delayed endpoints, and concerns that they take years to complete and are expensive. This essay questions the validity of each of these proposed limitations, summarizes concerns raised about the accuracy of results generated by observational studies, provides some examples of discrepancies between results of observational studies and RCTs that pertain to pulmonary and critical care, and suggests that using observational studies for comparative effectiveness research may increase rather than decrease the cost of health care and may harm patients.

Changes in Protein Structure and Distribution Observed at Pre-Clinical Stages of Scrapie Pathogenesis

PubMed Central

Kretlow, Ariane; Wang, Qi; Beekes, Michael; Naumann, Dieter; Miller, Lisa M.

2011-01-01

Scrapie is a neurodegenerative disorder that involves the misfolding, aggregation and accumulation of the prion protein (PrP). The normal cellular PrP (PrPC) is rich in α-helical secondary structure, whereas the disease-associated pathogenic form of the protein (PrPSc) has an anomalously high β-sheet content. In this study, protein structural changes were examined in situ in the dorsal root ganglia from perorally 263K scrapie-infected and mock-infected hamsters using synchrotron Fourier Transform InfraRed Microspectroscopy (FTIRM) at four time points over the course of the disease (preclinical, 100 & 130 days post-infection (dpi); first clinical signs (~145 dpi); and terminal (~170 dpi)). Results showed clear changes in the total protein content, structure, and distribution as the disease progressed. At pre-clinical time points, the scrapie-infected animals exhibited a significant increase in protein expression, but the β-sheet protein content was significantly lower than controls. Based on these findings, we suggest that the pre-clinical stages of scrapie are characterized by an overexpression of proteins low in β-sheet content. As the disease progressed, the β-sheet content increased significantly. Immunostaining with a PrP-specific antibody, 3F4, confirmed that this increase was partly – but not solely – due to the formation of PrPSc in the tissue and indicated that other proteins high in β-sheet were produced, either by overexpression or misfolding. Elevated β-sheet was observed near the cell membrane at pre-clinical time points and also in the cytoplasm of infected neurons at later stages of infection. At the terminal stage of the disease, the protein expression declined significantly, likely due to degeneration and death of neurons. These dramatic changes in protein content and structure, especially at pre-clinical time points, emphasize the possibility for identifying other proteins involved in early pathogenesis, which are important for further

Evidence of the clinical effectiveness of cognitive pharmaceutical services for aged patients.

PubMed

Sáez-Benito, Loreto; Fernandez-Llimos, Fernando; Feletto, Eleonora; Gastelurrutia, Miguel Angel; Martinez-Martinez, Fernando; Benrimoj, Shalom I

2013-07-01

cognitive pharmaceutical services (CPSs) encompass a variety of pharmacists' interventions to optimise pharmacotherapy. The clinical effectiveness of CPSs for aged patients remains controversial. to analyse and describe the evidence of the clinical effectiveness of CPSs in aged patients by means of performing a systematic review of systematic reviews. using the recommended methodology by Cochrane, a search was undertaken for systematic reviews of the clinical effectiveness of CPSs in MEDLINE, EMBASE, DOAJ, SCIELO and COCHRANE LIBRARY. Reviews were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) instrument. Quality of the evidence in the reviews was ranked using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. a total of 14 systematic reviews and one meta-analysis were analysed. The overall quality of the reviews was moderate. High and moderate strength of evidence was found for the positive effect of certain CPSs on reducing the number and improving the appropriateness of medicines. There was conflicting evidence of the effect on adherence. There was limited evidence of high and moderate strength on clinical outcomes. No positive evidence was found on mortality, hospitalisations, functional capacity and cognitive function. No systematic reviews reported the effect on the level of control of health problems. certain types of CPSs reduce the number of medicines and improve the appropriateness of prescriptions. Longer follow-up periods and/or the use of surrogate clinical variables measuring the short-term impact are required to demonstrate the effect on clinical outcomes.

Power analysis to detect treatment effects in longitudinal clinical trials for Alzheimer's disease.

PubMed

Huang, Zhiyue; Muniz-Terrera, Graciela; Tom, Brian D M

2017-09-01

Assessing cognitive and functional changes at the early stage of Alzheimer's disease (AD) and detecting treatment effects in clinical trials for early AD are challenging. Under the assumption that transformed versions of the Mini-Mental State Examination, the Clinical Dementia Rating Scale-Sum of Boxes, and the Alzheimer's Disease Assessment Scale-Cognitive Subscale tests'/components' scores are from a multivariate linear mixed-effects model, we calculated the sample sizes required to detect treatment effects on the annual rates of change in these three components in clinical trials for participants with mild cognitive impairment. Our results suggest that a large number of participants would be required to detect a clinically meaningful treatment effect in a population with preclinical or prodromal Alzheimer's disease. We found that the transformed Mini-Mental State Examination is more sensitive for detecting treatment effects in early AD than the transformed Clinical Dementia Rating Scale-Sum of Boxes and Alzheimer's Disease Assessment Scale-Cognitive Subscale. The use of optimal weights to construct powerful test statistics or sensitive composite scores/endpoints can reduce the required sample sizes needed for clinical trials. Consideration of the multivariate/joint distribution of components' scores rather than the distribution of a single composite score when designing clinical trials can lead to an increase in power and reduced sample sizes for detecting treatment effects in clinical trials for early AD.

The clinical characteristics of patients with glaucoma presenting to Botswana healthcare facilities: an observational study.

PubMed

Jackson, Daniel J; Razai, Mohammad S; Falama, Rosemary; Mongwa, Matlhogonolo; Mutapanduwa, Mishell; Baemisi, Chao; Josiah, Engelinah; Nkomazana, Oathokwa; Lehasa, Alice; Brealey, Evelyn; White, Andrew J; Jankowski, Deborah; Kerr-Muir, Malcolm G; Martin, Keith R; Ngondi, Jeremiah M

2014-12-03

This study aimed to establish the clinical characteristics of patients with glaucoma attending eye care facilities in Botswana, and management of glaucoma among patients who received care in these facilities. The study also aimed to calculate the number of new diagnoses of glaucoma within the glaucoma service. A prospective, hospital-based, observational study. A multicentre study was undertaken in government-run eye departments in Botswana from June to August 2012. All patients with a diagnosis of glaucoma attending clinics at seven study sites were invited to participate. Examination findings, diagnosis and management were extracted from individual patient-held medical charts. Sociodemographic characteristics, patient knowledge and understanding of glaucoma were assessed through face-to-face interviews. In addition, details of outpatient attendances for 2011 were collected from 21 government-run hospitals. The majority of the 366 patients interviewed had a diagnosis of primary glaucoma (86.6%). The diagnoses were mainly made by ophthalmologists (48.6%) and ophthalmic nurses (44.0%). Many patients (38.5%) had been symptomatic for over 6 months before visiting an eye clinic. The mean presenting intraocular pressure was 28.2 mm Hg (SD 11.9 mm Hg). Most follow-up patients (79.2%) had not received surgery, however, many (89.5%) would accept surgery. Only 11.5% of participants had heard of glaucoma prior to diagnosis. Many participants (35.9%) did not understand glaucoma after being diagnosed. The majority (94.9%) of living first-degree relatives had never been examined. The number of newly diagnosed glaucoma cases for 2011 in the south of the country was 14.1/100,000; 95% CI (12.0 to 16.5), in the north it was 16.2/100,000; 95% CI (13.8 to 19.0). Glaucoma is a significant burden that presents challenges to ophthalmic services in Botswana. Many patients have limited understanding of the condition and poor access to services. There is a need to develop a treatment

The clinical characteristics of patients with glaucoma presenting to Botswana healthcare facilities: an observational study

PubMed Central

Jackson, Daniel J; Razai, Mohammad S; Falama, Rosemary; Mongwa, Matlhogonolo; Mutapanduwa, Mishell; Baemisi, Chao; Josiah, Engelinah; Nkomazana, Oathokwa; Lehasa, Alice; Brealey, Evelyn; White, Andrew J; Jankowski, Deborah; Kerr-Muir, Malcolm G; Martin, Keith R; Ngondi, Jeremiah M

2014-01-01

Objective This study aimed to establish the clinical characteristics of patients with glaucoma attending eye care facilities in Botswana, and management of glaucoma among patients who received care in these facilities. The study also aimed to calculate the number of new diagnoses of glaucoma within the glaucoma service. Design A prospective, hospital-based, observational study. Setting A multicentre study was undertaken in government-run eye departments in Botswana from June to August 2012. Participants All patients with a diagnosis of glaucoma attending clinics at seven study sites were invited to participate. Outcome measures Examination findings, diagnosis and management were extracted from individual patient-held medical charts. Sociodemographic characteristics, patient knowledge and understanding of glaucoma were assessed through face-to-face interviews. In addition, details of outpatient attendances for 2011 were collected from 21 government-run hospitals. Results The majority of the 366 patients interviewed had a diagnosis of primary glaucoma (86.6%). The diagnoses were mainly made by ophthalmologists (48.6%) and ophthalmic nurses (44.0%). Many patients (38.5%) had been symptomatic for over 6 months before visiting an eye clinic. The mean presenting intraocular pressure was 28.2 mm Hg (SD 11.9 mm Hg). Most follow-up patients (79.2%) had not received surgery, however, many (89.5%) would accept surgery. Only 11.5% of participants had heard of glaucoma prior to diagnosis. Many participants (35.9%) did not understand glaucoma after being diagnosed. The majority (94.9%) of living first-degree relatives had never been examined. The number of newly diagnosed glaucoma cases for 2011 in the south of the country was 14.1/100 000; 95% CI (12.0 to 16.5), in the north it was 16.2/100 000; 95% CI (13.8 to 19.0). Conclusions Glaucoma is a significant burden that presents challenges to ophthalmic services in Botswana. Many patients have limited understanding

Clinical therapeutic effects of AO/ASIF clavicle hook plate on distal clavicle fractures and acromioclavicular joint dislocations.

PubMed

Dou, Qingjun; Ren, Xiaofeng

2014-07-01

The aim of this study was to evaluate the security and effectiveness of AO/ASIF clavicle hook plate in the treatment of distal clavicle fractures and acromioclavicular joint dislocations. One hundred patients with distal clavicle fractures and acromioclavicular joint dislocations who were admitted in our hospital from January 2012 to January 2013 were selected as the study subjects. They were then randomly divided into a control group and an observation group (n=50). The observation group was treated with AO/ASIF clavicle hook plates, and the control group was treated with Kirschner-wire tension bands. The outcomes were recorded and compared. The JOA scores of the two groups were similar before surgery (P>0.05). The two groups both had obviously increased JOA scores in the postoperative 6th and 12th weeks, and the score in the postoperative 12th week was higher. There were statistically significant intra-group differences (P<0.05). The postoperative 6th-week and 12th-week JOA scores of the observation group were (83.2±1.8) and (97.4±1.5) respectively, and those of the control group were (71.6±2.2) and (82.3±2.6) respectively, with statistically significant inter-group differences (P<0.05). Significantly more patients in the observation group (100%) were evaluated as excellent or good outcomes after fixation than those in the control group (60%). After removal of the surgical apparatus, the recurrence rates of bone fracture and joint dislocation in the observation group were significantly lower than those of the control group (P<0.05). AO/ASIF clavicle hook plate functioned more effectively than Kirschner-wire tension band in clinical treatment of distal clavicle fractures and acromioclavicular joint dislocations. The former protocol enjoyed small incisions, firm fixation and early shoulder mobility. Therefore, it is a safe and effective surgical method that is worthy of being widely applied in clinical practice.

[Anatomic observation of the prostate for clinical application of local drug injection through the rectum for chronic prostatitis].

PubMed

Cheng, Jun-ping; Dai, Jing-xing; Liu, Yong-qian; Hong, Hui-wen; Zhang, Xiu-lian; Zhang, Mei-rong; Ye, Qiu-yue

2003-06-01

To provide anatomic evidences for local drug injection through the rectum for treating chronic prostatitis and observe the therapeutic effect of this treatment. Anatomic observation of the median sagittal plane of 16 male pelvic specimens was conducted, with special attention to the structures between the prostate and the rectum. The distance from the posterior wall of the prostate to the anterior wall of the rectum, the scope that allowed the entry of the puncture needle, the appropriate puncture depth, and the distance from the anus to the safe were carefully measured. Analysis of the clinical record was performed in 51 chronic prostatitis cases treated with local injection of prednisolone, antibiotic and lidocaine through the rectum. Only some fat tissues and venous plexus were found between the prostate and the anterior wall of the rectum, and the distance from posterior wall of the prostate to the anterior wall of the rectum averaged 5.773+/-0.710 mm. The scope for possible puncture was 15.408 8+/-1.438 2 mm with a depth of 15.703 1+/-0.944 1 mm. The maximum and minimum distances from the anus to the puncture were 47.594+/-2.432 mm and 35.781+/-1.850 mm, respectively. Among the 51 cases investigated, the total cure rate was 84.31%, and improvement was achieved in 13.73% of the case, with only one case (2%) failed to respond to the treatment. Local drug injection through the rectum can be ideal for the treatment of prostatitis for its safety and effectiveness.

Comparing the cost-effectiveness of rituximab maintenance and radioimmunotherapy consolidation versus observation following first-line therapy in patients with follicular lymphoma.

PubMed

Chen, Qiushi; Ayer, Turgay; Nastoupil, Loretta J; Rose, Adam C; Flowers, Christopher R

2015-03-01

Phase 3 randomized trials have shown that maintenance rituximab (MR) therapy or radioimmunotherapy (RIT) consolidation following frontline therapy can improve progression-free survival for patients with follicular lymphoma (FL), but the cost-effectiveness of these approaches with respect to observation has not been examined using a common modeling framework. To evaluate and compare the economic impact of MR and RIT consolidation versus observation, respectively, following the first-line induction therapy for patients with advanced-stage FL. We developed Markov models to estimate patients' lifetime costs, quality-adjusted life-years (QALYs), and life-years (LYs) after MR, RIT, and observation following frontline FL treatment from the US payer's perspective. Progression risks, adverse event probabilities, costs, and utilities were estimated from clinical data of Primary RItuximab and MAintenance (PRIMA) trial, Eastern Cooperative Oncology Group (ECOG) trial (for MR), and First-line Indolent Trial (for RIT) and the published literature. We evaluated the incremental cost-effectiveness ratio for direct comparisons between MR/RIT and observation. Model robustness was addressed by one-way and probabilistic sensitivity analyses. Compared with observation, MR provided an additional 1.089 QALYs (1.099 LYs) and 1.399 QALYs (1.391 LYs) on the basis of the PRIMA trial and the ECOG trial, respectively, and RIT provided an additional 1.026 QALYs (1.034 LYs). The incremental cost per QALY gained was $40,335 (PRIMA) or $37,412 (ECOG) for MR and $40,851 for RIT. MR and RIT had comparable incremental QALYs before first progression, whereas RIT had higher incremental costs of adverse events due to higher incidences of cytopenias. MR and RIT following frontline FL therapy demonstrated favorable and similar cost-effectiveness profiles. The model results should be interpreted within the specific clinical settings of each trial. Selection of MR, RIT, or observation should be based on

A clinically observed discrepancy between image-based and log-based MLC positions

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

Neal, Brian, E-mail: bpn2p@virginia.edu; Ahmed, Mahmoud; Kathuria, Kunal

2016-06-15

Purpose: To present a clinical case in which real-time intratreatment imaging identified an multileaf collimator (MLC) leaf to be consistently deviating from its programmed and logged position by >1 mm. Methods: An EPID-based exit-fluence dosimetry system designed to prevent gross delivery errors was used to capture cine during treatment images. The author serendipitously visually identified a suspected MLC leaf displacement that was not otherwise detected. The leaf position as recorded on the EPID images was measured and log-files were analyzed for the treatment in question, the prior day’s treatment, and for daily MLC test patterns acquired on those treatment days.more » Additional standard test patterns were used to quantify the leaf position. Results: Whereas the log-file reported no difference between planned and recorded positions, image-based measurements showed the leaf to be 1.3 ± 0.1 mm medial from the planned position. This offset was confirmed with the test pattern irradiations. Conclusions: It has been clinically observed that log-file derived leaf positions can differ from their actual position by >1 mm, and therefore cannot be considered to be the actual leaf positions. This cautions the use of log-based methods for MLC or patient quality assurance without independent confirmation of log integrity. Frequent verification of MLC positions through independent means is a necessary precondition to trust log-file records. Intratreatment EPID imaging provides a method to capture departures from MLC planned positions.« less

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.

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.

Clinical effectiveness and cost-effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling.

PubMed

Connock, M; Stevens, C; Fry-Smith, A; Jowett, S; Fitzmaurice, D; Moore, D; Song, F

2007-10-01

To examine the clinical effectiveness and cost-effectiveness of self-testing and self-management of oral anticoagulation treatment compared with clinic-based monitoring. Major electronic databases were searched up to September 2005. A systematic review was undertaken of relevant data from selected studies. Results about complication events and deaths were pooled in meta-analyses using risk difference (RD) as the outcome statistic. Heterogeneity across trials and possible publication bias were statistically measured. Subgroup analyses (post hoc) were conducted to compare results of self-testing versus self-management, low versus high trial quality, trials conducted in the UK versus trials in other countries and industry versus other sponsors. A Markov-type, state-transition model was developed. Stochastic simulations using the model were conducted to investigate uncertainty in estimated model parameters. In the 16 randomised and eight non-randomised trials selected, patient self-monitoring of oral anticoagulation therapy was found to be more effective than poor-quality usual care provided by family doctors and as effective as good-quality specialised anticoagulation clinics in maintaining the quality of anticoagulation therapy. There was no significant RD of major bleeding events between patient self-monitoring and usual care controls and pooled analyses found that compared with primary care or anticoagulation control (AC) clinics, self-monitoring was statistically significantly associated with fewer thromboembolic events. However, the reduction in complication events and deaths was not consistently associated with the improvement of AC; in some trials this may be due to alternative explanations, including patient education and patient empowerment. Also, the improved AC and the reduction of major complications and deaths by patient self-monitoring were mainly observed in trials conducted outside the UK. According to UK-specific data, for every 100 eligible patients

The differences in the assessments of side effects at an oncology outpatient clinic.

PubMed

Bayraktar-Ekincioglu, A; Kucuk, E

2018-04-01

Background There is a growing interest in the use of targeted and immunotherapies in oncology. However, the assessment of side effects can be different due to interpretation of patients' health status by healthcare professionals in oncology outpatient clinics. Objective To demonstrate the differences in the assessments of side effects conducted independently by a clinical pharmacist and nurses in patients who receive targeted therapies at an oncology outpatient clinic. Setting The study was conducted at the University Oncology Hospital in an outpatient clinic from October 2015 to March 2016. Method Patients receiving ipilimumab, nivolumab, pembrolizumab, bevacizumab, panitumumab or cetuximab during study period were included. The assessment of side effects was conducted by a pharmacist and nurse independently using the NCI-CTCAE version-2. Main outcome measure To compare the severity assessments of side effects between a clinical pharmacist and nurses in an outpatient clinic. Results During the study, 204 visits for 43 patients with a total of 5508 side effect assessments were recorded where 1137 (20.64%) assessments were graded differently. Out of 1137 assessments, 473 of them were graded higher by a clinical pharmacist whereas 664 were graded higher by nurses. Statistically significant differences were detected in the assessment of vomiting, taste changes, sense changes, alopecia, fatigue, mood changes, anxiety, hearing impairment, and allergic reactions. Conclusion An assessment of side effects by healthcare providers in patients with cancer may be challenging due to an increased workload in clinics and undistinguishable symptoms of side effects and cancer itself. Therefore, a new care model which increases an interprofessional communication may improve pharmaceutical care in oncology outpatient clinics.

Observation of the chiral magnetic effect in ZrTe₅

DOE PAGES

Li, Qiang; Kharzeev, Dmitri E.; Zhang, Cheng; ...

2015-02-08

The chiral magnetic effect is the generation of electric current induced by chirality imbalance in the presence of magnetic field. It is a macroscopic manifestation of the quantum anomaly in relativistic field theory of chiral fermions (massless spin 1/2 particles with a definite projection of spin on momentum) – a dramatic phenomenon arising from a collective motion of particles and antiparticles in the Dirac sea. The recent discovery of Dirac semimetals with chiral quasi-particles opens a fascinating possibility to study this phenomenon in condensed matter experiments. Here we report on the first observation of chiral magnetic effect through the measurementmore » of magneto-transport in zirconium pentatelluride, ZrTe₅. Our angle-resolved photoemission spectroscopy experiments show that this material’s electronic structure is consistent with a 3D Dirac semimetal. We observe a large negative magnetoresistance when magnetic field is parallel with the current. The measured quadratic field dependence of the magnetoconductance is a clear indication of the chiral magnetic effect. Furthermore, the observed phenomenon stems from the effective transmutation of Dirac semimetal into a Weyl semimetal induced by the parallel electric and magnetic fields that represent a topologically nontrivial gauge field background.« less

How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?

PubMed

Naci, Huseyin; Ioannidis, John P A

2015-01-01

Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making.

Effects of food or sleep deprivation during civilian survival training on clinical chemistry variables.

PubMed

Ståhle, Lars; Granström, Elisabeth; Ljungdahl Ståhle, Ewa; Isaksson, Sven; Samuelsson, Anders; Rudling, Mats; Sepp, Harry

2013-06-01

To describe clinical chemistry and weight changes after short-term food or sleep deprivation or multiple deprivations during civilian survival training. Data from one baseline-controlled two-period crossover study designed to compare sleep deprivation for up to 50 hours with food deprivation for up to 66 hours (n = 12) and data from regular multiple-deprivations survival training comparing participants (n = 33) with nondeprived instructors (n = 10). Food deprivation was associated with decreased body weight, blood glucose, serum triglycerides, sodium, chloride, and urine pH, and there were increases in blood and urine ketones and serum free fatty acids. Sleep deprivation was associated with a minor decrease in hemoglobin and erythrocyte particle count and volume fraction and an increase in leukocytes. The clinical chemistry and body weight changes associated with food deprivation were qualitatively similar to those observed in fasting obese patients but developed quicker in the survival training setting. Sleep deprivation had few effects on the clinical chemistry profile except for hematological variables. Physicians evaluating clinical chemistry data from patients subjected to short-term food or sleep deprivation should take the physiological state into account in their assessment. Copyright © 2013 Wilderness Medical Society. Published by 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.

Confidence Intervals for Effect Sizes: Compliance and Clinical Significance in the "Journal of Consulting and Clinical Psychology"

ERIC Educational Resources Information Center

Odgaard, Eric C.; Fowler, Robert L.

2010-01-01

Objective: In 2005, the "Journal of Consulting and Clinical Psychology" ("JCCP") became the first American Psychological Association (APA) journal to require statistical measures of clinical significance, plus effect sizes (ESs) and associated confidence intervals (CIs), for primary outcomes (La Greca, 2005). As this represents the single largest…

Causal inference from observational data.

PubMed

Listl, Stefan; Jürges, Hendrik; Watt, Richard G

2016-10-01

Randomized controlled trials have long been considered the 'gold standard' for causal inference in clinical research. In the absence of randomized experiments, identification of reliable intervention points to improve oral health is often perceived as a challenge. But other fields of science, such as social science, have always been challenged by ethical constraints to conducting randomized controlled trials. Methods have been established to make causal inference using observational data, and these methods are becoming increasingly relevant in clinical medicine, health policy and public health research. This study provides an overview of state-of-the-art methods specifically designed for causal inference in observational data, including difference-in-differences (DiD) analyses, instrumental variables (IV), regression discontinuity designs (RDD) and fixed-effects panel data analysis. The described methods may be particularly useful in dental research, not least because of the increasing availability of routinely collected administrative data and electronic health records ('big data'). © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Clinical effects of the transfusion of leukocytes isolated by filtration from continuous flux].

PubMed

Malinvaud, G; Gailiard, S; Gualde, N

1977-09-01

The present work studies clinical effects of leukocyte transfusions to patients with medular aplasis. Leukocytes were collected by filtration on a continuous flow, according to the technique earlier described in this review [9]. Two major points are stressed on tolerance by the patients of the injected products and clinical efficiency. Seventy eight suspensions were prepared and transfused to 30 patients in the course of 36 incidents of myeloid insufficiency. All patients but two evidenced by the time of transfusion a number of polynuclears inferior to 500 per cubic millimeter. The infection was quite serious with increased gravity despite the antibiotherapy. Intolerance was noticeable in about one third of the cases, half of which consisted only in chillis by the end or after transfusion. Only one accident consisting in acute respiration troubles and shock was observed. This however does not occur by chance. It involves sensitization which may be related to HLA system but may also be of different nature, although not clearly identified. Nevertheless is efficiency of the injected products demonstrated by recirculation of the transfused leukocytes. This was noticed within an hour following transfusion for more than 50 percent of the cases. Furthermore it lasted for 16 hours in more than one fourth of the patients. In addition following results are in favour of real clinical efficiency. Certainly in the course of 16 aplasic incidents, no improvement was observed. For most patients however transfusions were late and not renewed or the patients were highly immunized. Conversely the infection state did improve in 8 patients, the disease responsible for aplasia running its course on its own. Lastly in the course of 12 aplasic incidents, infection and acute aplasia did cure. All these observations should lead one to study with great care the immunological state of the recipient. Instructions being known, the number of transfused leukocytes should be sufficient and

Cost-effectiveness analysis of microdose clinical trials in drug development.

PubMed

Yamane, Naoe; Igarashi, Ataru; Kusama, Makiko; Maeda, Kazuya; Ikeda, Toshihiko; Sugiyama, Yuichi

2013-01-01

Microdose (MD) clinical trials have been introduced to obtain human pharmacokinetic data early in drug development. Here we assessed the cost-effectiveness of microdose integrated drug development in a hypothetical model, as there was no such quantitative research that weighed the additional effectiveness against the additional time and/or cost. First, we calculated the cost and effectiveness (i.e., success rate) of 3 types of MD integrated drug development strategies: liquid chromatography-tandem mass spectrometry, accelerator mass spectrometry, and positron emission tomography. Then, we analyzed the cost-effectiveness of 9 hypothetical scenarios where 100 drug candidates entering into a non-clinical toxicity study were selected by different methods as the conventional scenario without MD. In the base-case, where 70 drug candidates were selected without MD and 30 selected evenly by one of the three MD methods, incremental cost-effectiveness ratio per one additional drug approved was JPY 12.7 billion (US$ 0.159 billion), whereas the average cost-effectiveness ratio of the conventional strategy was JPY 24.4 billion, which we set as a threshold. Integrating MD in the conventional drug development was cost-effective in this model. This quantitative analytical model which allows various modifications according to each company's conditions, would be helpful for guiding decisions early in clinical development.