Implementation of an open adoption research data management system for clinical studies.

PubMed

Müller, Jan; Heiss, Kirsten Ingmar; Oberhoffer, Renate

2017-07-06

Research institutions need to manage multiple studies with individual data sets, processing rules and different permissions. So far, there is no standard technology that provides an easy to use environment to create databases and user interfaces for clinical trials or research studies. Therefore various software solutions are being used-from custom software, explicitly designed for a specific study, to cost intensive commercial Clinical Trial Management Systems (CTMS) up to very basic approaches with self-designed Microsoft ® databases. The technology applied to conduct those studies varies tremendously from study to study, making it difficult to evaluate data across various studies (meta-analysis) and keeping a defined level of quality in database design, data processing, displaying and exporting. Furthermore, the systems being used to collect study data are often operated redundantly to systems used in patient care. As a consequence the data collection in studies is inefficient and data quality may suffer from unsynchronized datasets, non-normalized database scenarios and manually executed data transfers. With OpenCampus Research we implemented an open adoption software (OAS) solution on an open source basis, which provides a standard environment for state-of-the-art research database management at low cost.

How informative are open-label studies for youth with bipolar disorder? A meta-analysis comparing open-label versus randomized, placebo-controlled clinical trials.

PubMed

Biederman, Joseph; Petty, Carter R; Woodworth, K Yvonne; Lomedico, Alexandra; O'Connor, Katherine B; Wozniak, Janet; Faraone, Stephen V

2012-03-01

To examine the informativeness of open-label trials toward predicting results in subsequent randomized, placebo-controlled clinical trials of psychopharmacologic treatments for pediatric bipolar disorder. We searched journal articles through PubMed at the National Library of Medicine using bipolar disorder, mania, pharmacotherapy, treatment and clinical trial as keywords. This search was supplemented with scientific presentations at national and international scientific meetings and submitted manuscripts from our group. Selection criteria included (1) enrollment of children diagnosed with DSM-IV bipolar disorder; (2) prospective assessment of at least 3 weeks; (3) monotherapy of a pharmacologic treatment for bipolar disorder; (4) use of a randomized placebo-controlled design or an open-label design for the same therapeutic compound; and (5) repeated use of the Young Mania Rating Scale (YMRS) as an outcome. The following information and data were extracted from 14 studies: study design, name of medication, class of medication, dose of medication, sample size, age, sex, trial length, and YMRS mean and standard deviation baseline and follow-up scores. For both study designs, the pooled effect size was statistically significant (open-label studies, z = 8.88, P < .001; randomized placebo-controlled studies, z = 13.75, P < .001), indicating a reduction in the YMRS from baseline to endpoint in both study designs. In a meta-analysis regression, study design was not a significant predictor of mean change in the YMRS. We found similarities in the treatment effects between open-label and randomized placebo-controlled studies in youth with bipolar disorder indicating that open-label studies are useful predictors of the potential safety and efficacy of a given compound in the treatment of pediatric bipolar disorder. © Copyright 2012 Physicians Postgraduate Press, Inc.

Analysis of the process of representing clinical statements for decision-support applications: a comparison of openEHR archetypes and HL7 virtual medical record.

PubMed

González-Ferrer, A; Peleg, M; Marcos, M; Maldonado, J A

2016-07-01

Delivering patient-specific decision-support based on computer-interpretable guidelines (CIGs) requires mapping CIG clinical statements (data items, clinical recommendations) into patients' data. This is most effectively done via intermediate data schemas, which enable querying the data according to the semantics of a shared standard intermediate schema. This study aims to evaluate the use of HL7 virtual medical record (vMR) and openEHR archetypes as intermediate schemas for capturing clinical statements from CIGs that are mappable to electronic health records (EHRs) containing patient data and patient-specific recommendations. Using qualitative research methods, we analyzed the encoding of ten representative clinical statements taken from two CIGs used in real decision-support systems into two health information models (openEHR archetypes and HL7 vMR instances) by four experienced informaticians. Discussion among the modelers about each case study example greatly increased our understanding of the capabilities of these standards, which we share in this educational paper. Differing in content and structure, the openEHR archetypes were found to contain a greater level of representational detail and structure while the vMR representations took fewer steps to complete. The use of openEHR in the encoding of CIG clinical statements could potentially facilitate applications other than decision-support, including intelligent data analysis and integration of additional properties of data items from existing EHRs. On the other hand, due to their smaller size and fewer details, the use of vMR potentially supports quicker mapping of EHR data into clinical statements.

[Static posturography versus clinical tests in elderly people with vestibular pathology].

PubMed

Ortuño-Cortés, Miguel A; Martín-Sanz, Eduardo; Barona-de Guzmán, Rafael

2008-01-01

Balance can be quantified by clinical tests and through instrumental studies. The objective of this paper is to determine the correlation between static posturography and 4 clinical tests of balance in elderly people with vestibular disorders and to identify its capability to discriminate the groups studied. 60 patients with vestibular disorders and 60 healthy subjects performed 4 clinical tests (one leg standing with opened eyes, Timed Up and Go, Tinetti and Berg tests) and a static posturography analysis (NedSVE/IBV system) under 4 conditions: Romberg Test, Eyes Open (REO), Romberg Test, Eyes Closed (REC), Romberg Test on Foam with Eyes Open (RFEO), and Romberg Test on Foam with Eyes Closed (RFEC). RFEO correlated best with the clinical tests and RFEC was the worst. RFEO distinguished between healthy individuals and decompensated patients. RFEO gave the best information about postural balance in the elderly. RFEC was not useful. Static posturography can be useful to distinguish vestibular compensation status.

Total knee arthroplasty after failed high tibial osteotomy: a systematic review of open versus closed wedge osteotomy.

PubMed

Han, Jae Hwi; Yang, Jae-Hyuk; Bhandare, Nikhl N; Suh, Dong Won; Lee, Jong Seong; Chang, Yong Suk; Yeom, Ji Woong; Nha, Kyung Wook

2016-08-01

Medial opening wedge high tibial osteotomy (HTO) has become increasingly popular as an alternative to lateral closing wedge osteotomy for the treatment of medial compartment knee osteoarthritis with varus deformity. The present systematic review was conducted to provide an objective analysis of total knee arthroplasty (TKA) outcomes following previous knee osteotomy (medial opening wedge vs. lateral closing wedge). A literature search of online databases (MEDLINE, EMBASE, Cochrane Library database) was made, in addition to manual search of major orthopaedic journals. The methodological quality of each of the studies was assessed on the Newcastle-Ottawa Scale and Effective Practice and Organization of Care. A total of ten studies were included in the review. There were eight studies with Level IV and two studies with Level III evidence. Eight studies reported clinical and radiologic scores. Comparative studies between TKA following medial opening and lateral closing wedge HTO did not demonstrate statistically significant clinical and radiologic differences. The revision rates were similar. However, more technical issues during TKA surgery after lateral closing wedge HTO were mentioned than the medial open wedge group. The quadriceps snip, tibial tubercle osteotomy, and lateral soft tissue release were more frequently needed in the lateral closing wedge HTO group. In addition, because of loss of proximal tibia bone geometry in the lateral closing wedge HTO group, concerns such as tibia stem impingement in the lateral tibial cortex was noted. The present systematic review suggests that TKA after medial opening and lateral closing wedge HTO showed similar performance. Clinical and radiologic outcome including revision rates did not statistically differ from included studies. However, there are more surgical technical concerns in TKA conversion from lateral closing wedge HTO than from the medial opening wedge HTO group. IV.

Impact of a subsidized spay neuter clinic on impoundments and euthanasia in a community shelter and on service and complaint calls to animal control.

PubMed

Scarlett, Janet; Johnston, Naomi

2012-01-01

Reducing the number of homeless, nonhuman animals entering and being euthanatized in community shelters is the principal motivation for most spay/neuter (S/N) programs in the United States. This study evaluated the impact of a subsidized S/N clinic opened in 2005 in Transylvania County, North Carolina, on the numbers of impoundments (and euthanasia) of dogs and cats and on the number of animal-related service and complaint calls at the community's only animal shelter. Before opening the local S/N clinic, a significant linear decline in the shelter's dog-intake rate per 1,000 human population was evident. This decline did not accelerate after the S/N clinic opened in 2005. The rate of decline in euthanasia did level off after the clinic opened, but the proportion of impounded dogs euthanatized did not change significantly. The median number of cats impounded and euthanatized yearly in the Transylvania County Animal Services shelter decreased significantly after the S/N clinic opened; the proportion of cats euthanatized did not change. The median annual number of service calls and complaints decreased or leveled off. Unfortunately, data regarding many factors essential for conclusively interpreting these results were not available.

An open-label, 12-week clinical and sleep EEG study of nefazodone in chronic combat-related posttraumatic stress disorder.

PubMed

Gillin, J C; Smith-Vaniz, A; Schnierow, B; Rapaport, M H; Kelsoe, J; Raimo, E; Marler, M R; Goyette, L M; Stein, M B; Zisook, S

2001-10-01

We examined the effects of nefazodone on polysomnographic sleep measures and subjective reports of sleep quality and nightmares. as well as other symptoms, in patients with chronic combat-related posttraumatic stress disorder (PTSD) during a 12-week, open-label clinical trial. To our knowledge, this is the first polysomnographic study of treatment in patients with PTSD. The subjects were 12 male veterans (mean age = 54 years) who met DSM-IV diagnostic criteria for PTSD (mean duration = 30 years). All but I patient also met DSM-IV criteria for major depressive disorder. Patients were evaluated weekly with clinical ratings in an open-label clinical trial. Polysomnographic recordings for 2 consecutive nights were obtained before treatment and at 2, 4, 8, and 12 weeks. The dose of nefazodone was adjusted according to individual clinical needs. Final mean daily dose was 441 mg. The patients reported significantly fewer nightmares and sleep problems during treatment. Nevertheless, contrary to studies in depressed patients, nefazodone did not significantly affect polysomnographic sleep measures compared with baseline. In addition, the patients showed significant improvement in the Clinical Global Impressions of PTSD symptoms (global score, hyperarousals and intrusions subscales), the Clinician-Administered PTSD Scale (global, hyperarousal, and intrusions subscales), the Hamilton Rating Scale for Depression (HAM-D). and the Beck Depression Inventory (BDI). These patients with chronic, treatment-resistant, combat-related PTSD showed significant improvement of subjective symptoms of nightmares and sleep disturbance, as well as depression and PTSD symptoms. in this 12-week open-label clinical trial. Nevertheless, objective polysomnographic sleep measures did not change. Further studies, including double-blind. placebo-controlled trials, are needed to extend these findings and to understand the relationships between the physiology of sleep and symptoms of poor sleep and nightmares.

Clinical and Radiological Outcomes Comparing Percutaneous Chevron-Akin Osteotomies vs Open Scarf-Akin Osteotomies for Hallux Valgus.

PubMed

Lai, Mun Chun; Rikhraj, Inderjeet Singh; Woo, Yew Lok; Yeo, William; Ng, Yung Chuan Sean; Koo, Kevin

2018-03-01

Minimally invasive surgeries have gained popularity due to less soft tissue trauma and better wound healing. To date, limited studies have compared the outcomes of percutaneous and open osteotomies. This study aims to investigate the clinical and radiological outcomes of percutaneous chevron-Akin osteotomies vs open scarf-Akin osteotomies at 24-month follow-up. We reviewed a prospectively collected database in a tertiary hospital hallux valgus registry. Twenty-nine feet that underwent a percutaneous technique were matched to 58 feet that underwent open scarf and Akin osteotomies. Clinical outcome measures assessed included visual analog scale (VAS) scores, American Orthopaedic Foot & Ankle Society Hallux Metatarsophalangeal-Interphalangeal score (AOFAS Hallux MTP-IP), and Short Form 36 (SF-36) Health Survey. Radiological outcomes included hallux valgus angle (HVA) and intermetatarsal angle (IMA). All patients were prospectively followed up at 6 and 24 months. Both groups showed comparable clinical and radiological outcomes at the 24-month follow-up. However, the percutaneous group demonstrated less pain in the perioperative period ( P < .001). There were significant differences in the change in HVA between the groups but comparable radiological outcomes in IMA at the 24-month follow-up. The percutaneous group demonstrated shorter length of operation ( P < .001). There were no complications in the percutaneous group but 3 wound complications in the open group. We conclude that clinical and radiological outcomes of third-generation percutaneous chevron-Akin osteotomies were comparable with open scarf and Akin osteotomies at 24 months but with significantly less perioperative pain, shorter length of operation, and less risk of wound complications. Level III, retrospective comparative series.

DigitalVHI--a freeware open-source software application to capture the Voice Handicap Index and other questionnaire data in various languages.

PubMed

Herbst, Christian T; Oh, Jinook; Vydrová, Jitka; Švec, Jan G

2015-07-01

In this short report we introduce DigitalVHI, a free open-source software application for obtaining Voice Handicap Index (VHI) and other questionnaire data, which can be put on a computer in clinics and used in clinical practice. The software can simplify performing clinical studies since it makes the VHI scores directly available for analysis in a digital form. It can be downloaded from http://www.christian-herbst.org/DigitalVHI/.

Economic Impact of Laparoscopic Conversion to Open in Left Colon Resections.

PubMed

Etter, Katherine; Davis, Brad; Roy, Sanjoy; Kalsekar, Iftekhar; Yoo, Andrew

2017-01-01

Studies have shown economic and clinical advantages of laparoscopic left-colon resections. Laparoscopic conversion to open is an important surgical outcome. We estimated conversion incidence, identified risk factors, and measured the clinical and economic impact. In this retrospective study, we used the Premier Perspective database to analyze left-sided colectomies from 2009 to 2014. Operating room time (ORT), length of stay (LOS), total hospital cost (2014 U.S. dollars); along with incidence of in-hospital clinical outcomes (anastomotic leak surrogate [Leak], transfusion, and mortality) were evaluated. Multivariable models accounting for hospital clustering were used to identify conversion risk factors and analyze the effect of conversion on economic and clinical outcomes. A total of 41,417 patients: 8,468 left hemicolectomy and 32,949 sigmoidectomy were identified. Lap-Conversion incidence was 13.3% (95% CI, 12.9-13.7). Adjusted mean LOS (±SE) days was significantly lower for the Lap-Successful group (4.9 compared with Lap-Conversion 6.8 and Open-Planned 7.0), but Lap-Conversion and Open-Planned had similar LOS. Adjusted mean cost was higher for Lap-Conversion $20,165 compared to Open-Planned $18,797; but this difference was smaller than the cost savings for Lap-Successful $16,206 ± $219. Open-Planned had lower odds of Leak compared to Lap-Conversion. Open-Planned and Lap-Conversion had similar odds of transfusion and mortality. Conversion risk factors included inflammatory bowel disease and left-hemicolectomy. Colorectal specialists were associated with 38% decreased odds of conversion. Successful laparoscopic surgery was the most cost effective, with decreased LOS and odds of blood transfusion, leak surrogate, and mortality. Conversion was the most expensive and had increased odds of leak surrogate, but similar LOS compared to Open-Planned. The beneficial effect size of successful laparoscopic surgery was larger than the negative effect of conversion compared to Open-Planned.

Economic Impact of Laparoscopic Conversion to Open in Left Colon Resections

PubMed Central

Etter, Katherine; Davis, Brad; Roy, Sanjoy; Kalsekar, Iftekhar

2017-01-01

Background and Objectives: Studies have shown economic and clinical advantages of laparoscopic left-colon resections. Laparoscopic conversion to open is an important surgical outcome. We estimated conversion incidence, identified risk factors, and measured the clinical and economic impact. Methods: In this retrospective study, we used the Premier Perspective database to analyze left-sided colectomies from 2009 to 2014. Operating room time (ORT), length of stay (LOS), total hospital cost (2014 U.S. dollars); along with incidence of in-hospital clinical outcomes (anastomotic leak surrogate [Leak], transfusion, and mortality) were evaluated. Multivariable models accounting for hospital clustering were used to identify conversion risk factors and analyze the effect of conversion on economic and clinical outcomes. Results: A total of 41,417 patients: 8,468 left hemicolectomy and 32,949 sigmoidectomy were identified. Lap-Conversion incidence was 13.3% (95% CI, 12.9–13.7). Adjusted mean LOS (±SE) days was significantly lower for the Lap-Successful group (4.9 compared with Lap-Conversion 6.8 and Open-Planned 7.0), but Lap-Conversion and Open-Planned had similar LOS. Adjusted mean cost was higher for Lap-Conversion $20,165 compared to Open-Planned $18,797; but this difference was smaller than the cost savings for Lap-Successful $16,206 ± $219. Open-Planned had lower odds of Leak compared to Lap-Conversion. Open-Planned and Lap-Conversion had similar odds of transfusion and mortality. Conversion risk factors included inflammatory bowel disease and left-hemicolectomy. Colorectal specialists were associated with 38% decreased odds of conversion. Conclusions: Successful laparoscopic surgery was the most cost effective, with decreased LOS and odds of blood transfusion, leak surrogate, and mortality. Conversion was the most expensive and had increased odds of leak surrogate, but similar LOS compared to Open-Planned. The beneficial effect size of successful laparoscopic surgery was larger than the negative effect of conversion compared to Open-Planned. PMID:28890650

Learning from hackers: open-source clinical trials.

PubMed

Dunn, Adam G; Day, Richard O; Mandl, Kenneth D; Coiera, Enrico

2012-05-02

Open sharing of clinical trial data has been proposed as a way to address the gap between the production of clinical evidence and the decision-making of physicians. A similar gap was addressed in the software industry by their open-source software movement. Here, we examine how the social and technical principles of the movement can guide the growth of an open-source clinical trial community.

Perioperative outcomes and adverse events of minimally invasive versus open posterior lumbar fusion: meta-analysis and systematic review.

PubMed

Goldstein, Christina L; Macwan, Kevin; Sundararajan, Kala; Rampersaud, Y Raja

2016-03-01

The objective of this study was to determine the clinical comparative effectiveness and adverse event rates of posterior minimally invasive surgery (MIS) compared with open transforaminal or posterior lumbar interbody fusion (TLIF/PLIF). A systematic review of the Medline, EMBASE, PubMed, Web of Science, and Cochrane databases was performed. A hand search of reference lists was conducted. Studies were reviewed by 2 independent assessors to identify randomized controlled trials (RCTs) or comparative cohort studies including at least 10 patients undergoing MIS or open TLIF/PLIF for degenerative lumbar spinal disorders and reporting at least 1 of the following: clinical outcome measure, perioperative clinical or process measure, radiographic outcome, or adverse events. Study quality was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) protocol. When appropriate, a meta-analysis of outcomes data was conducted. The systematic review and reference list search identified 3301 articles, with 26 meeting study inclusion criteria. All studies, including 1 RCT, were of low or very low quality. No significant difference regarding age, sex, surgical levels, or diagnosis was identified between the 2 cohorts (856 patients in the MIS cohort, 806 patients in the open cohort). The meta-analysis revealed changes in the perioperative outcomes of mean estimated blood loss, time to ambulation, and length of stay favoring an MIS approach by 260 ml (p < 0.00001), 3.5 days (p = 0.0006), and 2.9 days (p < 0.00001), respectively. Operative time was not significantly different between the surgical techniques (p = 0.78). There was no significant difference in surgical adverse events (p = 0.97), but MIS cases were significantly less likely to experience medical adverse events (risk ratio [MIS vs open] = 0.39, 95% confidence interval 0.23-0.69, p = 0.001). No difference in nonunion (p = 0.97) or reoperation rates (p = 0.97) was observed. Mean Oswestry Disability Index scores were slightly better in the patients undergoing MIS (n = 346) versus open TLIF/PLIF (n = 346) at a median follow-up time of 24 months (mean difference [MIS - open] = 3.32, p = 0.001). The result of this quantitative systematic review of clinical comparative effectiveness research examining MIS versus open TLIF/PLIF for degenerative lumbar pathology suggests equipoise in patient-reported clinical outcomes. Furthermore, a meta-analysis of adverse event data suggests equivalent rates of surgical complications with lower rates of medical complications in patients undergoing minimally invasive TLIF/PLIF compared with open surgery. The quality of the current comparative evidence is low to very low, with significant inherent bias.

Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies.

PubMed

Shorvon, S D; Trinka, E; Steinhoff, B J; Holtkamp, M; Villanueva, V; Peltola, J; Ben-Menachem, E

2017-03-01

Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug that is approved as adjunctive therapy in adults with focal-onset seizures. Following oral administration, ESL is rapidly metabolized to its active metabolite, eslicarbazepine, which acts primarily by enhancing slow inactivation of voltage-gated sodium channels. The efficacy and safety/tolerability of ESL in the adjunctive setting were established in a comprehensive Phase III program (n = 1702 randomized patients) and this evidence has been supported by several open studies (n = 864). ESL treatment has demonstrated improvements in health-related quality of life, in both randomized clinical trials and open studies. ESL has also been shown to be usually well tolerated and efficacious when used in the adjunctive setting in elderly patients. The effectiveness of ESL as the only add-on to antiepileptic drug monotherapy has been demonstrated in a multinational study (n = 219), subgroup analyses of which have also shown it to be efficacious and generally well tolerated in patients who had previously not responded to carbamazepine therapy. Open studies have also demonstrated improvements in tolerability in patients switched overnight from oxcarbazepine to ESL. Due to differences in pharmacokinetics, pharmacodynamics, and metabolism, there may be clinical situations in which it is appropriate to consider switching patients from oxcarbazepine or carbamazepine to ESL.

Patients' Positive and Negative Responses to Reading Mental Health Clinical Notes Online.

PubMed

Denneson, Lauren M; Chen, Jason I; Pisciotta, Maura; Tuepker, Anais; Dobscha, Steven K

2018-05-01

This study describes responses to OpenNotes, clinical notes available online, among patients receiving mental health care and explores whether responses vary by patient demographic or clinical characteristics. Survey data from 178 veterans receiving mental health treatment at a large Veterans Affairs medical center included patient-reported health self-efficacy, health knowledge, alliance with clinicians, and negative emotional responses after reading OpenNotes. Health care data were extracted from the patient care database. Reading OpenNotes helped many participants feel in control of their health care (49%) and have more trust in clinicians (45%), although a few (8%) frequently felt upset after reading their notes. In multivariate models, posttraumatic stress disorder was associated with increased patient-clinician alliance (p=.046) but also with negative emotional responses (p<.01). Patients receiving mental health care frequently reported benefits from reading OpenNotes, yet some experienced negative responses.

A clinic compatible, open source electrophysiology system.

PubMed

Hermiz, John; Rogers, Nick; Kaestner, Erik; Ganji, Mehran; Cleary, Dan; Snider, Joseph; Barba, David; Dayeh, Shadi; Halgren, Eric; Gilja, Vikash

2016-08-01

Open source electrophysiology (ephys) recording systems have several advantages over commercial systems such as customization and affordability enabling more researchers to conduct ephys experiments. Notable open source ephys systems include Open-Ephys, NeuroRighter and more recently Willow, all of which have high channel count (64+), scalability, and advanced software to develop on top of. However, little work has been done to build an open source ephys system that is clinic compatible, particularly in the operating room where acute human electrocorticography (ECoG) research is performed. We developed an affordable (<; $10,000) and open system for research purposes that features power isolation for patient safety, compact and water resistant enclosures and 256 recording channels sampled up to 20ksam/sec, 16-bit. The system was validated by recording ECoG with a high density, thin film device for an acute, awake craniotomy study at UC San Diego, Thornton Hospital Operating Room.

Obesity is not an independent risk factor for adverse perioperative and long-term clinical outcomes following open AAA repair or EVAR.

PubMed

Park, Brian; Dargon, Phong; Binette, Christopher; Babic, Bruna; Thomas, Tina; Divinagracia, Thomas; Dahn, Michael S; Menzoian, James O

2011-10-01

Moderate (body mass index [BMI] ≥30) and morbid obesity (BMI ≥35) is increasing at an alarming rate in vascular surgery patients. The objective of this study was to determine the impact of obesity on perioperative and long-term clinical outcomes following open abdominal aortic aneurysm (AAA) repair or endovascular aneurysm repair (EVAR). This review includes patients that underwent open AAA repair (n = 403) or EVAR (n = 223) from 1999 to 2009. Specific patient characteristics such as comorbid diseases, medications, and body mass index (BMI) were assessed. Specific perioperative outcomes such as length of stay, myocardial infarctions, and mortality were reviewed. In addition, long-term outcomes such as rates of reintervention, permanent renal dysfunction, and mortality beyond 30 days were also assessed. The incidence of obesity in open AAA patients was 25.3% (documented incidence 1.5%) and for EVAR was 24.6% (documented incidence 4%). Moderate and morbid obesity was associated with longer intensive care unit (ICU) admissions for both open AAA or EVAR patients (P < .05). However, no significant differences in perioperative outcomes in terms of overall length of stay, myocardial infarction, acute renal failure, wound infections, or mortality were noted between obese and nonobese patients underoing open AAA repair or EVAR (P > .05). Similarly, moderate and morbid obesity was not associated with significant differences in rates of reintervention, permanent renal dysfunction, and mortality beyond 30 days for patients undergoing open AAA repair or EVAR (P > .05). The results of this study indicate that moderate and morbid obesity are not independently associated with adverse perioperative and long-term clinical outcomes for patients undergoing open AAA repair or EVAR. Therefore, either open AAA repair or EVAR can be accomplished safely in moderately obese and morbidly obese patients.

Is there any difference between open and arthroscopic treatment for osteochondritis dissecans (OCD) of the humeral capitellum: a systematic review and meta-analysis.

PubMed

Lu, Yi; Li, Yi Jun; Guo, Si Yi; Zhang, Hai Long

2018-03-01

We present a systematic review of the recent literatures regarding the arthroscopic and open technique in fragment fixation for osteochondritis dissecans (OCD) of the humeral capitellum and an analysis of the subjective and objective outcomes between these two procedures. PubMed and EMBASE were reviewed for suitable articles relating to fragment fixation for OCD, both open and arthroscopic. We included all studies reporting on the clinical outcomes of these two procedures that were published in the English language. Data extracted from each study included level of evidence, number of patients, surgical techniques, length of follow-up, clinical outcome measures including outcome scores, range of motion (ROM), return to sports, osseous union and complications. We analyzed each study to determine the primary outcome measurement. A total of ten studies met our inclusion criteria. Among all studies, 35 arthroscopic procedures and 107 open procedures were performed. After the procedure, 70 patients (86.4%) in the open group returned to their sports, and 32 patients (91.4%) in the arthroscopic group returned to their sports. In the arthroscopic group, patients gained 14.1 degrees of flexion and 9.5 degrees of extension after surgery. In the open group, patients gained 8 degrees of flexion and 5.7 degrees of extension. Five patients (4.7%) had complications in the open group. No complication was found in the arthroscopic group. Both open and arthroscopic lesion debridement with fragment fixation are successful in treating unstable OCD. The arthroscopic technique may be a better choice than the open procedure, but we need high-level evidence to determine the superiority of the open or arthroscopic techniques in treating elbow OCD. Level III.

Detection of heart disease by open access echocardiography: a retrospective analysis of general practice referrals

PubMed Central

Chambers, John; Kabir, Saleha; Cajeat, Eric

2014-01-01

Background Heart disease is difficult to detect clinically and it has been suggested that echocardiography should be available to all patients with possible cardiac symptoms or signs. Aim To analyse the results of 2 years of open access echocardiography for the frequency of structural heart disease according to request. Design and setting Retrospective database analysis in a teaching hospital open access echocardiography service. Method Reports of all open access transthoracic echocardiograms between January 2011 and December 2012 were categorised as normal, having minor abnormalities, or significant abnormalities according to the indication. Results There were 2343 open access echocardiograms performed and there were significant abnormalities in 29%, predominantly valve disease (n = 304, 13%), LV systolic dysfunction (n = 179, 8%), aortic dilatation (n = 80, 3%), or pulmonary hypertension (n = 91, 4%). If echocardiography had been targeted at a high-risk group, 267 with valve disease would have been detected (compared to 127 with murmur alone) and 139 with LV systolic dysfunction (compared to 91 with suspected heart failure alone). Most GP practices requested fewer than 10 studies, but 6 practices requested over 70 studies. Conclusion Open access echocardiograms are often abnormal but structural disease may not be suspected from the clinical request. Uptake by individual practices is patchy. A targeted expansion of echocardiography in patients with a high likelihood of disease is therefore likely to increase the detection of clinically important pathology. PMID:24567615

Detection of heart disease by open access echocardiography: a retrospective analysis of general practice referrals.

PubMed

Chambers, John; Kabir, Saleha; Cajeat, Eric

2014-02-01

Heart disease is difficult to detect clinically and it has been suggested that echocardiography should be available to all patients with possible cardiac symptoms or signs. To analyse the results of 2 years of open access echocardiography for the frequency of structural heart disease according to request. Retrospective database analysis in a teaching hospital open access echocardiography service. Reports of all open access transthoracic echocardiograms between January 2011 and December 2012 were categorised as normal, having minor abnormalities, or significant abnormalities according to the indication. There were 2343 open access echocardiograms performed and there were significant abnormalities in 29%, predominantly valve disease (n = 304, 13%), LV systolic dysfunction (n = 179, 8%), aortic dilatation (n = 80, 3%), or pulmonary hypertension (n = 91, 4%). If echocardiography had been targeted at a high-risk group, 267 with valve disease would have been detected (compared to 127 with murmur alone) and 139 with LV systolic dysfunction (compared to 91 with suspected heart failure alone). Most GP practices requested fewer than 10 studies, but 6 practices requested over 70 studies. Open access echocardiograms are often abnormal but structural disease may not be suspected from the clinical request. Uptake by individual practices is patchy. A targeted expansion of echocardiography in patients with a high likelihood of disease is therefore likely to increase the detection of clinically important pathology.

Archetype-based conversion of EHR content models: pilot experience with a regional EHR system.

PubMed

Chen, Rong; Klein, Gunnar O; Sundvall, Erik; Karlsson, Daniel; Ahlfeldt, Hans

2009-07-01

Exchange of Electronic Health Record (EHR) data between systems from different suppliers is a major challenge. EHR communication based on archetype methodology has been developed by openEHR and CEN/ISO. The experience of using archetypes in deployed EHR systems is quite limited today. Currently deployed EHR systems with large user bases have their own proprietary way of representing clinical content using various models. This study was designed to investigate the feasibility of representing EHR content models from a regional EHR system as openEHR archetypes and inversely to convert archetypes to the proprietary format. The openEHR EHR Reference Model (RM) and Archetype Model (AM) specifications were used. The template model of the Cambio COSMIC, a regional EHR product from Sweden, was analyzed and compared to the openEHR RM and AM. This study was focused on the convertibility of the EHR semantic models. A semantic mapping between the openEHR RM/AM and the COSMIC template model was produced and used as the basis for developing prototype software that performs automated bi-directional conversion between openEHR archetypes and COSMIC templates. Automated bi-directional conversion between openEHR archetype format and COSMIC template format has been achieved. Several archetypes from the openEHR Clinical Knowledge Repository have been imported into COSMIC, preserving most of the structural and terminology related constraints. COSMIC templates from a large regional installation were successfully converted into the openEHR archetype format. The conversion from the COSMIC templates into archetype format preserves nearly all structural and semantic definitions of the original content models. A strategy of gradually adding archetype support to legacy EHR systems was formulated in order to allow sharing of clinical content models defined using different formats. The openEHR RM and AM are expressive enough to represent the existing clinical content models from the template based EHR system tested and legacy content models can automatically be converted to archetype format for sharing of knowledge. With some limitations, internationally available archetypes could be converted to the legacy EHR models. Archetype support can be added to legacy EHR systems in an incremental way allowing a migration path to interoperability based on standards.

Clinical characteristics and outcomes of fall-related open globe injuries in Japan.

PubMed

Morikawa, Shohei; Okamoto, Yoshifumi; Okamoto, Fumiki; Inomoto, Naoki; Ishikawa, Hiroto; Harimoto, Kozo; Ueda, Tetsuo; Sakamoto, Taiji; Oshika, Tetsuro

2018-07-01

To investigate the clinical characteristics and visual outcomes in patients with fall-related open globe injuries and to evaluate differences between fall-related and non-fall-related open globe injuries in Japan. A retrospective review of patients with open globe injury who presented to Japan-Clinical Research of Study (J-CREST) hospitals between 2005 and 2015 was enrolled. Clinical information including age, sex, initial visual acuity, final visual acuity, type of injury, status of the crystalline lens, zone of injury, wound length, presence of retinal detachment, proliferative vitreoretinopathy, expulsive hemorrhage, and endophthalmitis was recorded. A total of 374 eyes were enrolled, of which 120 (32.1%) suffered from fall-related injury with average age of 73.7 ± 15.9 years (range, 11-101 years). A majority of patients were female (55.8%). Of 120 patients with fall-related injury, 109 (90.8%) presented with rupture and 11 (9.2%) with laceration. A multiple regression analysis revealed that final visual acuity was significantly associated with initial visual acuity (r = 0.99, P < 0.001). Compared to non-fall-related open globe injuries, fall-related open globe injuries were associated with elderly age, female sex, poorer initial and final visual acuity, rupture, absence of the lens, larger wound size, retinal detachment, expulsive hemorrhage, and absence of endophthalmitis (P < 0.01). Fall-related open globe injuries were more frequent in elderly female and accompanied by larger wound lengths and severer ocular complications. Visual outcomes in patients with fall-related open globe injuries were related to initial visual acuity.

Clinical trials in rheumatoid arthritis: a status report from the ClinicalTrials.gov website.

PubMed

Paul, Jisna R; Ranganathan, Prabha

2012-06-01

The aims of this study are to describe the characteristics of clinical trials in rheumatoid arthritis (RA) listed in ClinicalTrials.gov and examine existing trends in study design, funding sources, outcomes, and drugs under investigation. We conducted a survey of ongoing clinical trials in RA registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, "rheumatoid arthritis", "open studies", "interventional", and "adults 18 years or older". Of 127 eligible trials, 53.5% of the studies were either phase 3 or 4, and 40.2% were phase 1, 2, and 2/3. Two-thirds of the trials were randomized (70.9%), and over half were, in addition, double-blinded (53.5%) and placebo-controlled (53.5%). Universities were listed as the primary sponsor for 18.9% of the trials and pharmaceutical industry for 73.2%. Majority of the trials were multi-center studies (93%) conducted outside the United States (54.3%). The most frequently used endpoint was drug efficacy (54.3%) followed by drug safety (25.2%). Most industry-funded trials were open for less than 12 months, whereas most university-funded trials were open for more than 24 months (58% each). Biologic therapies were the focus of most trials in the registry (78.5%). Randomized, double-blinded, placebo-controlled, phase 3 and 4 trials form the majority of ongoing clinical trials in RA. The preponderance of industry funding of RA trials and the short duration of such trials are troubling trends which need to be addressed.

Minimally Invasive and Open Distal Chevron Osteotomy for Mild to Moderate Hallux Valgus.

PubMed

Brogan, Kit; Lindisfarne, Edward; Akehurst, Harold; Farook, Usama; Shrier, Will; Palmer, Simon

2016-11-01

Minimally invasive surgical (MIS) techniques are increasingly being used in foot and ankle surgery but it is important that they are adopted only once they have been shown to be equivalent or superior to open techniques. We believe that the main advantages of MIS are found in the early postoperative period, but in order to adopt it as a technique longer-term studies are required. The aim of this study was to compare the 2-year outcomes of a third-generation MIS distal chevron osteotomy with a comparable traditional open distal chevron osteotomy for mild-moderate hallux valgus. Our null hypothesis was that the 2 techniques would yield equivalent clinical and radiographic results at 2 years. This was a retrospective cohort study. Eighty-one consecutive feet (49 MIS and 32 open distal chevron osteotomies) were followed up for a minimum 24 months (range 24-58). All patients were clinically assessed using the Manchester-Oxford Foot Questionnaire. Radiographic measures included hallux valgus angle, the intermetatarsal angle, hallux interphalangeal angle, metatarsal phalangeal joint angle, distal metatarsal articular angle, tibial sesamoid position, shape of the first metatarsal head, and plantar offset. Statistical analysis was done using Student t test or Wilcoxon rank-sum test for continuous data and Pearson chi-square test for categorical data. Clinical and radiologic postoperative scores in all domains were substantially improved in both groups (P < .001), but there was no statistically significant difference in improvement of any domain between open and MIS groups (P > .05). There were no significant differences in complications between the 2 groups ( > .5). The midterm results of this third-generation technique show that it was a safe procedure with good clinical outcomes and comparable to traditional open techniques for symptomatic mild-moderate hallux valgus. Level III, retrospective comparative study. © The Author(s) 2016.

Comparison of Occlusive and Open Application in a Psoriasis Plaque Test Design, Exemplarily Using Investigations of Mapracorat 0.1% Ointment versus Vehicle and Reference Drugs.

PubMed

Wigger-Alberti, Walter; Williams, Ragna; von Mackensen, Yi-Ling; Hoffman-Wecker, Maciej; Grossmann, Ulrike; Staedtler, Gerald; Nkulikiyinka, Richard; Shakery, Kaweh

2017-01-01

Psoriasis plaque tests (PPTs) are important tools in the early phases of antipsoriatic drug development. Two distinct PPT design variants (open vs. occluded drug application) are commonly used, but no previous work has aimed to directly compare and contrast their performance. We compared the antipsoriatic efficacy of mapracorat 0.1% ointment and reference drugs reported in 2 separate studies, representing open and occluded PPT designs. The drug effect size was measured by sonography (mean change in echo-poor band thickness), chromametry, and standardized clinical assessment. Antipsoriatic effects were detectable for the study drugs in both occluded and open PPTs. Differences between the potency of antipsoriatic drugs and vehicle were observable. The total antipsoriatic effect size appeared to be higher in the occluded PPT than the open PPT, despite the shorter treatment duration (2 vs. 4 weeks). Effect dynamics over time revealed greater differences between some study drugs in the open PPT compared to the occluded PPT. Taking the higher technical challenges for the open PPT into account, we recommend the occluded PPT as a standard screening setting in early drug development. In special cases, considering certain drug aspects or study objectives that would require procedural adaptations, an open PPT could be the better-suited design. Finally, both PPT models show clear advantages: classification as phase I studies, small number of psoriatic subjects, relatively short study duration, excellent discrimination between compounds and concentrations, parallel measurement of treatment response, and go/no go decisions very early in clinical development. © 2017 S. Karger AG, Basel.

What an open source clinical trial community can learn from hackers

PubMed Central

Dunn, Adam G.; Day, Richard O.; Mandl, Kenneth D.; Coiera, Enrico

2014-01-01

Summary Open sharing of clinical trial data has been proposed as a way to address the gap between the production of clinical evidence and the decision-making of physicians. Since a similar gap has already been addressed in the software industry by the open source software movement, we examine how the social and technical principles of the movement can be used to guide the growth of an open source clinical trial community. PMID:22553248

Narrative thematic analysis of baccalaureate nursing students' reflections: critical thinking in the clinical education context.

PubMed

Naber, Jessica L; Hall, Joanne; Schadler, Craig Matthew

2014-09-01

This study sought to identify characteristics of clinically situated critical thinking in nursing students' reflections, originally part of a study guided by Richard Paul's model of critical thinking. Nurses are expected to apply critical thinking in all practice situations to improve health outcomes, including patient safety and satisfaction. In a previous study, Paul's model of critical thinking was used to develop questions for reflective writing assignments. Within that study, 30 nursing students completed six open-ended narratives of nurse-patient clinical encounters during an 8-week period. Improvements were seen in critical thinking scores after the intervention. This article reports the qualitative analysis of the content of six open-ended narratives. Six overarching themes were identified and combined into a tentative conceptual model. Faculty's understanding of the characteristics of critical thinking in the context of clinical education will help them to teach and evaluate students' progress and competencies for future practice.

Open-source approaches for the repurposing of existing or failed candidate drugs: learning from and applying the lessons across diseases

PubMed Central

Allarakhia, Minna

2013-01-01

Repurposing has the objective of targeting existing drugs and failed, abandoned, or yet-to-be-pursued clinical candidates to new disease areas. The open-source model permits for the sharing of data, resources, compounds, clinical molecules, small libraries, and screening platforms to cost-effectively advance old drugs and/or candidates into clinical re-development. Clearly, at the core of drug-repurposing activities is collaboration, in many cases progressing beyond the open sharing of resources, technology, and intellectual property, to the sharing of facilities and joint program development to foster drug-repurposing human-capacity development. A variety of initiatives under way for drug repurposing, including those targeting rare and neglected diseases, are discussed in this review and provide insight into the stakeholders engaged in drug-repurposing discovery, the models of collaboration used, the intellectual property-management policies crafted, and human capacity developed. In the case of neglected tropical diseases, it is suggested that the development of human capital be a central aspect of drug-repurposing programs. Open-source models can support human-capital development through collaborative data generation, open compound access, open and collaborative screening, preclinical and possibly clinical studies. Given the urgency of drug development for neglected tropical diseases, the review suggests elements from current repurposing programs be extended to the neglected tropical diseases arena. PMID:23966771

Open-source approaches for the repurposing of existing or failed candidate drugs: learning from and applying the lessons across diseases.

PubMed

Allarakhia, Minna

2013-01-01

Repurposing has the objective of targeting existing drugs and failed, abandoned, or yet-to-be-pursued clinical candidates to new disease areas. The open-source model permits for the sharing of data, resources, compounds, clinical molecules, small libraries, and screening platforms to cost-effectively advance old drugs and/or candidates into clinical re-development. Clearly, at the core of drug-repurposing activities is collaboration, in many cases progressing beyond the open sharing of resources, technology, and intellectual property, to the sharing of facilities and joint program development to foster drug-repurposing human-capacity development. A variety of initiatives under way for drug repurposing, including those targeting rare and neglected diseases, are discussed in this review and provide insight into the stakeholders engaged in drug-repurposing discovery, the models of collaboration used, the intellectual property-management policies crafted, and human capacity developed. In the case of neglected tropical diseases, it is suggested that the development of human capital be a central aspect of drug-repurposing programs. Open-source models can support human-capital development through collaborative data generation, open compound access, open and collaborative screening, preclinical and possibly clinical studies. Given the urgency of drug development for neglected tropical diseases, the review suggests elements from current repurposing programs be extended to the neglected tropical diseases arena.

Clinical comparison between the retromandibular approach for reduction and fixation and endoscope-assisted open reduction and internal fixation for mandibular condyle fractures.

PubMed

Nogami, Shinnosuke; Takahashi, Tetsu; Yamauchi, Kensuke; Miyamoto, Ikuya; Kaneuji, Takeshi; Yamamoto, Noriaki; Yoshiga, Daigo; Yamashita, Yoshihiro

2012-11-01

Endoscope-assisted transoral open reduction and internal fixation (EAORIF) for mandibular condyle fractures has recently become popular because it is minimally invasive, provides excellent visibility without a large incision, and reduces surgical scarring and the risk of facial nerve injury. This report describes a retrospective clinical study that compared certain clinical parameters, including postoperative function, between the retromandibular (RM) approach and EAORIF. Fifteen patients were treated by the RM approach, whereas 15 underwent EAORIF between July 2006 and September 2011 at Kyushu Dental College, Japan. Clinical indices comprised fracture line, fracture type, number of plates used, surgical duration, bleeding amount, and functional items, including maximum interincisal opening, mandibular deviation on the opening pathway, malocclusion, facial paresthesia, and temporomandibular joint pain and clicking. The areas subjected to either approach included lower neck and subcondyle. The RM approach was used for mandibular condyle fractures with dislocation of a small bone segment. Both groups used 2 plates in all cases. Surgical duration, maximum interincisal opening, mandibular deviation, occlusion, and temporomandibular joint function at 6 months after surgery were comparable between groups. The average bleeding amount in the EAORIF group was greater than in the RM group. One patient from the RM group developed facial paresthesia that persisted for 6 months after surgery. It was concluded that surgical treatment was suitable for fractures of the lower neck and subcondylar. Both procedures showed good results in the functional items of this study.

Does MIS Surgery Allow for Shorter Constructs in the Surgical Treatment of Adult Spinal Deformity?

PubMed

Uribe, Juan S; Beckman, Joshua; Mummaneni, Praveen V; Okonkwo, David; Nunley, Pierce; Wang, Michael Y; Mundis, Gregory M; Park, Paul; Eastlack, Robert; Anand, Neel; Kanter, Adam; Lamarca, Frank; Fessler, Richard; Shaffrey, Chris I; Lafage, Virginie; Chou, Dean; Deviren, Vedat

2017-03-01

The length of construct can potentially influence perioperative risks in adult spinal deformity (ASD) surgery. A head-to-head comparison between open and minimally invasive surgery (MIS) techniques for treatment of ASD has yet to be performed. To examine the impact of MIS approaches on construct length and clinical outcomes in comparison to traditional open approaches when treating similar ASD profiles. Two multicenter databases for ASD, 1 involving MIS procedures and the other open procedures, were propensity matched for clinical and radiographic parameters in this observational study. Inclusion criteria were ASD and minimum 2-year follow-up. Independent t -test and chi-square test were used to evaluate and compare outcomes. A total of 1215 patients were identified, with 84 patients matched in each group. Statistical significance was found for mean levels fused (4.8 for circumferential MIS [cMIS] and 10.1 for open), mean interbody fusion levels (3.6 cMIS and 2.4 open), blood loss (estimated blood loss 488 mL cMIS and 1762 mL open), and hospital length of stay (6.7 days cMIS and 9.7 days open). There was no significant difference in preoperative radiographic parameters or postoperative clinical outcomes (Owestry Disability Index and visual analog scale) between groups. There was a significant difference in postoperative lumbar lordosis (43.3° cMIS and 49.8° open) and pelvic incidence-lumbar lordosis correction (10.6° cMIS and 5.2° open) in the open group. There was no significant difference in reoperation rate between the 2 groups. MIS techniques for ASD may reduce construct length, reoperation rates, blood loss, and length of stay without affecting clinical and radiographic outcomes when compared to a similar group of patients treated with open techniques. Copyright © 2017 by the Congress of Neurological Surgeons

Open Source Clinical NLP - More than Any Single System.

PubMed

Masanz, James; Pakhomov, Serguei V; Xu, Hua; Wu, Stephen T; Chute, Christopher G; Liu, Hongfang

2014-01-01

The number of Natural Language Processing (NLP) tools and systems for processing clinical free-text has grown as interest and processing capability have surged. Unfortunately any two systems typically cannot simply interoperate, even when both are built upon a framework designed to facilitate the creation of pluggable components. We present two ongoing activities promoting open source clinical NLP. The Open Health Natural Language Processing (OHNLP) Consortium was originally founded to foster a collaborative community around clinical NLP, releasing UIMA-based open source software. OHNLP's mission currently includes maintaining a catalog of clinical NLP software and providing interfaces to simplify the interaction of NLP systems. Meanwhile, Apache cTAKES aims to integrate best-of-breed annotators, providing a world-class NLP system for accessing clinical information within free-text. These two activities are complementary. OHNLP promotes open source clinical NLP activities in the research community and Apache cTAKES bridges research to the health information technology (HIT) practice.

Facilitating secondary use of medical data by using openEHR archetypes.

PubMed

Kohl, Christian D; Garde, Sebastian; Knaup, Petra

2010-01-01

Clinical trials are of high importance for medical progress. But even though more and more clinical data is available in electronic patient records (EPRs) and more and more electronic data capture (EDC) systems are used in trials, there is still a gap which makes EPR / EDC interoperability difficult and hampers secondary use of medical routine data. The openEHR architecture for Electronic Health Records is based on a two level modeling approach which makes use of 'archetypes'. We want to analyze whether archetypes can help to bridge this gap by building an integrated EPR / EDC system based on openEHR archetypes. We used the 'openEHR Reference Framework and Application' (Opereffa) and existing archetypes for medical data. Furthermore, we developed dedicated archetypes to document study meta data. We developed a first prototype implementation of an archetype based integrated EPR / EDC system. Next steps will be the evaluation of an extended prototype in a real clinical trial scenario. Opereffa was a good starting point for our work. OpenEHR archetypes proved useful for secondary use of health data.

Comparative study of open and arthroscopic coracoid transfer for shoulder anterior instability (Latarjet)-clinical results at short term follow-up.

PubMed

Kordasiewicz, Bartłomiej; Małachowski, Konrad; Kicinski, Maciej; Chaberek, Sławomir; Pomianowski, Stanisław

2017-05-01

The aim of this study was to compare early clinical results after open and arthroscopic Latarjet stabilisation in anterior shoulder instability. Our hypothesis was the results of arthroscopic stabilisation were comparable with the results of open procedure. The clinical results of the patients after primary Latarjet procedure were analysed. Patients operated on between 2006 and 2011 using an open technique composed the OPEN group and patients operated on arthroscopically between 2011 and 2013 composed the ARTHRO group; 48 out of 55 shoulders (87%) in OPEN and 62 out of 64 shoulders (97%) in ARTHRO were available to follow-up. The average age at surgery was 28 years in OPEN and 26 years in ARTHRO. The mean follow-up was 54.2 months in OPEN and 23.4 months in ARTHRO. Intra-operative data were analysed regarding time of surgery, concomitant lesions and complications. Patient results were assessed with Walch-Duplay, Rowe, VAS scores and subjective self-evaluation of satisfaction and shoulder function. Computed tomography scan evaluation was used to assess the graft healing. Average time of surgery was significantly shorter in ARTHRO than OPEN: respectively 110 and 120 minutes. The number of intra-operative complications was six (12.5%) in OPEN and five (8.1%) in ARTHRO. The results were comparable in both groups, with no significant difference between OPEN and ARTHRO group: satisfaction rate - 96.8% and 91.9%, shoulder function - 92.2% and 90%, Walch-Duplay score - 83.9 and 76.7 respecively. A significant difference was reported in Rowe score: 87.8 in OPEN and 78.9 in ARTHRO. Another significant difference was found in the presence of "subjective apprehension"-a term referring to the subjective perception of instability with no signs of instability at clinical examination - 28.7% in OPEN and 50% in ARTHRO. Range of motion in both groups were comparable, however patients in OPEN had significantly lower loss of external rotation in adduction to the side comparing to the contralateral shoulder: 7° versus 14° in ARTHRO. Recurrence was reported in three cases in each group: 6.2% in OPEN and 4.8% in ARTHRO. A revision surgery was performed in four patients (9.3%) in OPEN and six (9.7%) in ARTHRO. Radiographic evaluation showed a significantly lower rate (5%) of graft healing problems (fracture, non-union and osteolysis) after arthroscopic stabilisation, however a partial osteolysis of the proximal part of the bone block was significantly more frequent (53.5%). The arthroscopic Latarjet stabilisation showed satisfactory and comparable results to open procedure. We recommend further investigation and development of arthroscopic technique. III.

Monitoring the impact of decentralised chronic care services on patient travel time in rural Africa--methods and results in Northern Malawi.

PubMed

Houben, Rein M G J; Van Boeckel, Thomas P; Mwinuka, Venance; Mzumara, Peter; Branson, Keith; Linard, Catherine; Chimbwandira, Frank; French, Neil; Glynn, Judith R; Crampin, Amelia C

2012-11-15

Decentralised health services form a key part of chronic care strategies in resource-limited settings by reducing the distance between patient and clinic and thereby the time and costs involved in travelling. However, few tools exist to evaluate the impact of decentralisation on patient travel time or what proportion of patients attend their nearest clinic. Here we develop methods to monitor changes in travel time, using data from the antiretroviral therapy (ART) roll-out in a rural district in North Malawi. Clinic position was combined with GPS information on the home village of patients accessing ART services in Karonga District (North Malawi) between July 2005 and July 2009. Potential travel time was estimated as the travel time for an individual attending their nearest clinic, and estimated actual travel time as the time to the clinic attended. This allowed us to calculate changes in potential and actual travel time as new clinics opened and track the proportion and origin of patients not accessing their nearest clinic. The model showed how the opening of further ART clinics in Karonga District reduced median potential travel time from 83 to 43 minutes, and median actual travel time fell from 83 to 47 minutes. The proportion of patients not attending their nearest clinic increased from 6% when two clinics were open, to 12% with four open. Integrating GPS information with patient data shows the impact of decentralisation on travel time and clinic choice to inform policy and research questions. In our case study, travel time decreased, accompanied by an increased uptake of services. However, the model also identified an increasing proportion of ART patients did not attend their nearest clinic.

Open Knee: Open Source Modeling & Simulation to Enable Scientific Discovery and Clinical Care in Knee Biomechanics

PubMed Central

Erdemir, Ahmet

2016-01-01

Virtual representations of the knee joint can provide clinicians, scientists, and engineers the tools to explore mechanical function of the knee and its tissue structures in health and disease. Modeling and simulation approaches such as finite element analysis also provide the possibility to understand the influence of surgical procedures and implants on joint stresses and tissue deformations. A large number of knee joint models are described in the biomechanics literature. However, freely accessible, customizable, and easy-to-use models are scarce. Availability of such models can accelerate clinical translation of simulations, where labor intensive reproduction of model development steps can be avoided. The interested parties can immediately utilize readily available models for scientific discovery and for clinical care. Motivated by this gap, this study aims to describe an open source and freely available finite element representation of the tibiofemoral joint, namely Open Knee, which includes detailed anatomical representation of the joint's major tissue structures, their nonlinear mechanical properties and interactions. Three use cases illustrate customization potential of the model, its predictive capacity, and its scientific and clinical utility: prediction of joint movements during passive flexion, examining the role of meniscectomy on contact mechanics and joint movements, and understanding anterior cruciate ligament mechanics. A summary of scientific and clinically directed studies conducted by other investigators are also provided. The utilization of this open source model by groups other than its developers emphasizes the premise of model sharing as an accelerator of simulation-based medicine. Finally, the imminent need to develop next generation knee models are noted. These are anticipated to incorporate individualized anatomy and tissue properties supported by specimen-specific joint mechanics data for evaluation, all acquired in vitro from varying age groups and pathological states. PMID:26444849

Characterizing the Utility and Limitations of Repurposing an Open-Field Optical Imaging Device for Fluorescence-Guided Surgery in Head and Neck Cancer Patients.

PubMed

Moore, Lindsay S; Rosenthal, Eben L; Chung, Thomas K; de Boer, Esther; Patel, Neel; Prince, Andrew C; Korb, Melissa L; Walsh, Erika M; Young, E Scott; Stevens, Todd M; Withrow, Kirk P; Morlandt, Anthony B; Richman, Joshua S; Carroll, William R; Zinn, Kurt R; Warram, Jason M

2017-02-01

The purpose of this study was to assess the potential of U.S. Food and Drug Administration-cleared devices designed for indocyanine green-based perfusion imaging to identify cancer-specific bioconjugates with overlapping excitation and emission wavelengths. Recent clinical trials have demonstrated potential for fluorescence-guided surgery, but the time and cost of the approval process may impede clinical translation. To expedite this translation, we explored the feasibility of repurposing existing optical imaging devices for fluorescence-guided surgery. Consenting patients (n = 15) scheduled for curative resection were enrolled in a clinical trial evaluating the safety and specificity of cetuximab-IRDye800 (NCT01987375). Open-field fluorescence imaging was performed preoperatively and during the surgical resection. Fluorescence intensity was quantified using integrated instrument software, and the tumor-to-background ratio characterized fluorescence contrast. In the preoperative clinic, the open-field device demonstrated potential to guide preoperative mapping of tumor borders, optimize the day of surgery, and identify occult lesions. Intraoperatively, the device demonstrated robust potential to guide surgical resections, as all peak tumor-to-background ratios were greater than 2 (range, 2.2-14.1). Postresection wound bed fluorescence was significantly less than preresection tumor fluorescence (P < 0.001). The repurposed device also successfully identified positive margins. The open-field imaging device was successfully repurposed to distinguish cancer from normal tissue in the preoperative clinic and throughout surgical resection. This study illuminated the potential for existing open-field optical imaging devices with overlapping excitation and emission spectra to be used for fluorescence-guided surgery. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

Early full weight-bearing versus 6-week partial weight-bearing after open wedge high tibial osteotomy leads to earlier improvement of the clinical results: a prospective, randomised evaluation.

PubMed

Schröter, S; Ateschrang, A; Löwe, W; Nakayama, H; Stöckle, U; Ihle, C

2017-01-01

Open wedge high tibial osteotomy is a widespread treatment option in patients with varus malalignment and medial compartment osteoarthritis. There is no standardised protocol for post-operative rehabilitation available. The purpose of this study was to compare two post-operative rehabilitation protocols and to evaluate the clinical outcome of early full weight-bearing after open wedge HTO. One hundred and twenty consecutive patients with varus malalignment and medial compartment osteoarthritis received an open wedge HTO using an angular locking plate fixation between December 2008 and December 2011. All patients were assigned randomly into one of two groups with different post-operative rehabilitation protocols (11-day vs. 6-week 20-kg partial weight-bearing). Clinical outcome was evaluated using established instruments (Lequesne, Lysholm, HSS and IKDC scores) preoperatively, 6, 12 and 18 months post-operatively. Deformity analysis was performed preoperatively and during follow-up. All clinical scores showed a significant pre- to post-operative improvement. After 6 months, there was a higher improvement in the group of early full weight-bearing. The difference between preoperative and 6-month follow-up for the group with early full weight-bearing and for the group with 20-kg PWB for 6 weeks was 28 ± 26 and 18 ± 22, respectively, for the Lysholm score and -5.0 ± 5.1 and -3.0 ± 3.6, respectively, for the Lequesne score. Early full weight-bearing (11-day 20-kg partial weight-bearing) after open wedge HTO without bone graft leads to earlier improvement of the clinical results and can be recommended for post-operative rehabilitation after open wedge HTO and fixation with an angular locking plate. Therapeutic study, Level I.

Prevalence and Factors Associated with Renal Dysfunction Among HIV-Infected Patients

DTIC Science & Technology

2010-01-01

cross-sectional study at two military clinics with open access to care to determine the impact of HIV factors, including antiretroviral therap¥, on...clinics with open access to care to determine the impact of HIV factors, including antiretroviral therapi, on renal function. Renal dysfunction was...measurement for determination of renal dysfunction rather than measurements over a 3-month or greater period used to establish chronic kidney disease.21

Clinical and radiographic evaluation of intrabony periodontal defect treatment by open flap debridement alone or in combination with nanocrystalline hydroxyapatite bone substitute.

PubMed

Pietruska, Małgorzata; Skurska, Anna; Pietruski, Jan; Dolińska, Ewa; Arweiler, Nicole; Milewski, Robert; Duraj, Ewa; Sculean, Anton

2012-11-01

The aim of this study has been to compare the clinical and radiographic outcome of periodontal intrabony defect treatment by open flap debridement alone or in combination with nanocrystalline hydroxyapatite bone substitute application. Thirty patients diagnosed with advanced periodontits were divided into two groups: the control group (OFD), in which an open flap debridement procedure was performed and the test group (OFD+NHA), in which defects were additionally filled with nanocrystalline hydroxyapatite bone substitute material. Plaque index (PI), gingival index (GI), bleeding on probing (BOP), pocket depth (PD), gingival recession (GR) and clinical attachment level (CAL) were measured prior to, then 6 and 12months following treatment. Radiographic depth and width of defects were also evaluated. There were no differences in any clinical and radiographic parameters between the examined groups prior to treatment. After treatment, BOP, GI, PD, CAL, radiographic depth and width parameter values improved statistically significantly in both groups. The PI value did not change, but the GR value increased significantly after treatment. There were no statistical differences in evaluated parameters between OFD and OFD+NHA groups 6 and 12months after treatment. Within the limits of the study, it can be concluded that the additional use of nanocrystalline hydroxyapatite bone substitute material after open flap procedure does not improve clinical and radiographic treatment outcome. Copyright © 2012 Elsevier GmbH. All rights reserved.

Safety, Tolerability, and Efficacy of Quetiapine in Youth with Schizophrenia or Bipolar I Disorder: A 26-Week, Open-Label, Continuation Study

PubMed Central

Pathak, Sanjeev; Earley, Willie R.; Liu, Sherry; DelBello, Melissa

2013-01-01

Abstract Objective The purpose of this study was to describe the safety, tolerability, and efficacy of quetiapine monotherapy continued for up to 26-weeks in youth with schizophrenia or bipolar I disorder. Methods Medically healthy boys and girls with a baseline Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV-TR) diagnosis of schizophrenia (ages 13–17 years) or a manic episode of bipolar I disorder (ages 10–17 years) who participated in one of two acute, double-blind, placebo-controlled studies of immediate-release quetiapine were potentially eligible to enroll in a 26-week, open-label study. During the open-label study, quetiapine was flexibly dosed at 400–800 mg/day, with options to reduce dosing to 200 mg/day based on tolerability. Safety and tolerability outcomes assessed from open-label baseline to week 26 included adverse events (AEs), metabolic/laboratory parameters, extrapyramidal symptoms, suicidality, and vital signs. Results Of 381 patients enrolled in the open-label study (n=176, schizophrenia; n=205, bipolar disorder diagnosis), 237 patients (62.2%) completed the 26-week study period (71.0%, schizophrenia; 54.6%, bipolar disorder). The most common AEs reported during the study included somnolence, headache, sedation, weight increase, and vomiting. A total of 14.9% of patients experienced a shift to potentially clinically significant low levels of high-density lipoprotein cholesterol and 10.2% of patients experienced a shift to potentially clinically significant high triglyceride levels. Weight gain ≥7% was reported in 35.6% of patients between open-label baseline and final visit. After adjustment for normal growth, 18.3% of study participants experienced clinically significant weight gain (i.e., increase in body mass index ≥0.5 standard deviations from baseline). Conclusions In this 26-week study, quetiapine flexibly dosed at 400–800 mg/day, with options to reduce dosing based on tolerability, was generally safe and well tolerated in youth. Clinicians should monitor lipid profiles and weight gain in youth with schizophrenia or bipolar disorder during treatment with quetiapine. Clinical trial registration information Quetiapine Fumarate (Seroquel) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder (ANCHOR 150). Available at: http://clinicaltrials.gov/ct2/show/NCT00227305 PMID:24024534

ImmPort, toward repurposing of open access immunological assay data for translational and clinical research.

PubMed

Bhattacharya, Sanchita; Dunn, Patrick; Thomas, Cristel G; Smith, Barry; Schaefer, Henry; Chen, Jieming; Hu, Zicheng; Zalocusky, Kelly A; Shankar, Ravi D; Shen-Orr, Shai S; Thomson, Elizabeth; Wiser, Jeffrey; Butte, Atul J

2018-02-27

Immunology researchers are beginning to explore the possibilities of reproducibility, reuse and secondary analyses of immunology data. Open-access datasets are being applied in the validation of the methods used in the original studies, leveraging studies for meta-analysis, or generating new hypotheses. To promote these goals, the ImmPort data repository was created for the broader research community to explore the wide spectrum of clinical and basic research data and associated findings. The ImmPort ecosystem consists of four components-Private Data, Shared Data, Data Analysis, and Resources-for data archiving, dissemination, analyses, and reuse. To date, more than 300 studies have been made freely available through the Shared Data portal (www.immport.org/immport-open), which allows research data to be repurposed to accelerate the translation of new insights into discoveries.

Open-source mobile digital platform for clinical trial data collection in low-resource settings.

PubMed

van Dam, Joris; Omondi Onyango, Kevin; Midamba, Brian; Groosman, Nele; Hooper, Norman; Spector, Jonathan; Pillai, Goonaseelan Colin; Ogutu, Bernhards

2017-02-01

Governments, universities and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In this context we piloted the use of a novel mobile digital health platform, designed specifically for low-resource environments, to support high-quality data collection in a clinical research study. Our primary aim was to assess the feasibility of a using a mobile digital platform for clinical trial data collection in a low-resource setting. Secondarily, we sought to explore the potential benefits of such an approach. The investigative site was a research institute in Nairobi, Kenya. We integrated an open-source platform for mobile data collection commonly used in the developing world with an open-source, standard platform for electronic data capture in clinical trials. The integration was developed using common data standards (Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model), maximising the potential to extend the approach to other platforms. The system was deployed in a pharmacokinetic study involving healthy human volunteers. The electronic data collection platform successfully supported conduct of the study. Multidisciplinary users reported high levels of satisfaction with the mobile application and highlighted substantial advantages when compared with traditional paper record systems. The new system also demonstrated a potential for expediting data quality review. This pilot study demonstrated the feasibility of using a mobile digital platform for clinical research data collection in low-resource settings. Sustainable scientific capabilities and infrastructure are essential to attract and support clinical research studies. Since many research structures in Africa are being developed anew, stakeholders should consider implementing innovative technologies and approaches.

Sialoendoscopically assisted open sialolithectomy for removal of large submandibular hilar calculi.

PubMed

Su, Yu-xiong; Liao, Gui-qing; Zheng, Guang-sen; Liu, Hai-chao; Liang, Yu-jie; Ou, De-ming

2010-01-01

The management of large hilar calculi is a technically challenging issue during sialoendoscopic surgery. The aim of the present study was to evaluate the clinical efficacy of sialoendoscopically assisted open sialolithectomy for the removal of large submandibular hilar calculi to avoid sialoadenectomy. The present study was undertaken among patients with sialolithiasis scheduled for sialoendoscopic surgery from August 2005 to October 2008. When we failed to remove large submandibular hilar stones intraductally, we performed sialoendoscopically assisted open sialolithectomy. The clinical characteristics, pre- and intraoperative data, and outcomes were documented in a prospective fashion. Of 78 consecutive patients with submandibular sialolithiasis, 18 were treated with sialoendoscopically assisted open sialolithectomy immediately after failure of intraductal removal of calculi by sialoendoscopy. For 17 patients, large hilar sialoliths were successfully removed using this surgical technique. The surgery failed in 1 patient with multiple sialoliths, and the procedure was converted to open sialoadenectomy. Temporary numbness of the tongue for 1 week postoperatively was documented in 3 patients. The patients were followed up for a median period of 18 months without any symptoms or signs of recurrence. Our results suggest that sialoendoscopically assisted open sialolithectomy is an effective and safe surgical technique to remove large submandibular hilar calculi.

Open Source Clinical NLP – More than Any Single System

PubMed Central

Masanz, James; Pakhomov, Serguei V.; Xu, Hua; Wu, Stephen T.; Chute, Christopher G.; Liu, Hongfang

2014-01-01

The number of Natural Language Processing (NLP) tools and systems for processing clinical free-text has grown as interest and processing capability have surged. Unfortunately any two systems typically cannot simply interoperate, even when both are built upon a framework designed to facilitate the creation of pluggable components. We present two ongoing activities promoting open source clinical NLP. The Open Health Natural Language Processing (OHNLP) Consortium was originally founded to foster a collaborative community around clinical NLP, releasing UIMA-based open source software. OHNLP’s mission currently includes maintaining a catalog of clinical NLP software and providing interfaces to simplify the interaction of NLP systems. Meanwhile, Apache cTAKES aims to integrate best-of-breed annotators, providing a world-class NLP system for accessing clinical information within free-text. These two activities are complementary. OHNLP promotes open source clinical NLP activities in the research community and Apache cTAKES bridges research to the health information technology (HIT) practice. PMID:25954581

Open Versus Endoscopic Cubital Tunnel In Situ Decompression: A Systematic Review of Outcomes and Complications.

PubMed

Toirac, Alexander; Giugale, Juan M; Fowler, John R

2017-05-01

Endoscopic cubital tunnel release has been proposed as an alternative to open in situ release. However, it is difficult to analyze outcomes after endoscopic release, as only a few small case series exist. The electronic databases of PubMed (1960-June 2014) were systematically screened for studies related to endoscopic cubital tunnel release or open in situ cubital tunnel release. Baseline characteristics, clinical scores, and complication rates were abstracted. The binary outcome was defined as rate of excellent/good response versus fair/poor. Complications were recorded into 3 categories: wound problems, persistent ulnar nerve symptoms, and other. We included 8 articles that reported the clinical outcomes after surgical intervention including a total of 494 patients (344 endoscopic, 150 open in situ). The pooled rate of excellent/good was 92.0% (88.8%-95.2%) for endoscopic and 82.7% (76.15%-89.2%) for open. We identified 18 articles that detailed complications including a total of 1108 patients (691 endoscopic, 417 open). The 4 articles that listed complication rates for both endoscopic and open techniques were analyzed and showed a pooled odds ratio of 0.280 (95% confidence interval, 0.125-0.625), indicating that endoscopic patients have reduced odds of complications. The results of this systematic review suggest that there is a difference in clinical outcomes between the open in situ and endoscopic cubital tunnel release, with the endoscopic technique being superior in regard to both complication rates along with patient satisfaction.

Archetype-based conversion of EHR content models: pilot experience with a regional EHR system

PubMed Central

2009-01-01

Background Exchange of Electronic Health Record (EHR) data between systems from different suppliers is a major challenge. EHR communication based on archetype methodology has been developed by openEHR and CEN/ISO. The experience of using archetypes in deployed EHR systems is quite limited today. Currently deployed EHR systems with large user bases have their own proprietary way of representing clinical content using various models. This study was designed to investigate the feasibility of representing EHR content models from a regional EHR system as openEHR archetypes and inversely to convert archetypes to the proprietary format. Methods The openEHR EHR Reference Model (RM) and Archetype Model (AM) specifications were used. The template model of the Cambio COSMIC, a regional EHR product from Sweden, was analyzed and compared to the openEHR RM and AM. This study was focused on the convertibility of the EHR semantic models. A semantic mapping between the openEHR RM/AM and the COSMIC template model was produced and used as the basis for developing prototype software that performs automated bi-directional conversion between openEHR archetypes and COSMIC templates. Results Automated bi-directional conversion between openEHR archetype format and COSMIC template format has been achieved. Several archetypes from the openEHR Clinical Knowledge Repository have been imported into COSMIC, preserving most of the structural and terminology related constraints. COSMIC templates from a large regional installation were successfully converted into the openEHR archetype format. The conversion from the COSMIC templates into archetype format preserves nearly all structural and semantic definitions of the original content models. A strategy of gradually adding archetype support to legacy EHR systems was formulated in order to allow sharing of clinical content models defined using different formats. Conclusion The openEHR RM and AM are expressive enough to represent the existing clinical content models from the template based EHR system tested and legacy content models can automatically be converted to archetype format for sharing of knowledge. With some limitations, internationally available archetypes could be converted to the legacy EHR models. Archetype support can be added to legacy EHR systems in an incremental way allowing a migration path to interoperability based on standards. PMID:19570196

Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

ERIC Educational Resources Information Center

Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

2013-01-01

Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found between…

A perioperative cost analysis comparing single-level minimally invasive and open transforaminal lumbar interbody fusion.

PubMed

Singh, Kern; Nandyala, Sreeharsha V; Marquez-Lara, Alejandro; Fineberg, Steven J; Oglesby, Mathew; Pelton, Miguel A; Andersson, Gunnar B; Isayeva, Darya; Jegier, Briana J; Phillips, Frank M

2014-08-01

Emerging literature suggests superior clinical short- and long-term outcomes of MIS (minimally invasive surgery) TLIFs (transforaminal lumbar interbody fusion) versus open fusions. Few studies to date have analyzed the cost differences between the two techniques and their relationship to acute clinical outcomes. The purpose of the study was to determine the differences in hospitalization costs and payments for patients treated with primary single-level MIS versus open TLIF. The impact of clinical outcomes and their contribution to financial differences was explored as well. This study was a nonrandomized, nonblinded prospective review. Sixty-six consecutive patients undergoing a single-level TLIF (open/MIS) were analyzed (33 open, 33 MIS). Patients in either cohort (MIS/open) were matched based on race, sex, age, smoking status, medical comorbidities (Charlson Comorbidity index), payer, and diagnosis. Every patient in the study had a diagnosis of either degenerative disc disease or spondylolisthesis and stenosis. Operative time (minutes), length of stay (LOS, days), estimated blood loss (EBL, mL), anesthesia time (minutes), Visual Analog Scale (VAS) scores, and hospital cost/payment amount were assessed. The MIS and open TLIF groups were compared based on clinical outcomes measures and hospital cost/payment data using SPSS version 20.0 for statistical analysis. The two groups were compared using bivariate chi-squared analysis. Mann-Whitney tests were used for non-normal distributed data. Effect size estimate was calculated with the Cohen d statistic and the r statistic with a 95% confidence interval. Average surgical time was shorter for the MIS than the open TLIF group (115.8 minutes vs. 186.0 minutes respectively; p=.001). Length of stay was also reduced for the MIS versus the open group (2.3 days vs. 2.9 days, respectively; p=.018). Average anesthesia time and EBL were also lower in the MIS group (p<.001). VAS scores decreased for both groups, although these scores were significantly lower for the MIS group (p<.001). Financial analysis demonstrated lower total hospital direct costs (blood, imaging, implant, laboratory, pharmacy, physical therapy/occupational therapy/speech, room and board) in the MIS versus the open group ($19,512 vs. $23,550, p<.001). Implant costs were similar (p=.686) in both groups, although these accounted for about two-thirds of the hospital direct costs in the MIS cohort ($13,764) and half of these costs ($13,778) in the open group. Hospital payments were $6,248 higher for open TLIF patients compared with the MIS group (p=.267). MIS TLIF technique demonstrated significant reductions of operative time, LOS, anesthesia time, VAS scores, and EBL compared with the open technique. This reduction in perioperative parameters translated into lower total hospital costs over a 60-day perioperative period. Although hospital reimbursements appear higher in the open group over the MIS group, shorter surgical times and LOS days in the MIS technique provide opportunities for hospitals to reduce utilization of resources and to increase surgical case volume. Copyright © 2014 Elsevier Inc. All rights reserved.

Conservative, minimally invasive and open surgical repair for management of acute ruptures of the Achilles tendon: a clinical and functional retrospective study.

PubMed

Maffulli, Gayle; Buono, Angelo Del; Richards, Paula; Oliva, Francesco; Maffulli, Nicola

2017-01-01

At present, it is unclear which is the best management for Achilles tendon rupture. We assess the clinical, functional and imaging outcomes of active patients undergoing 3 different types of management for acute subcutaneous rupture of the Achilles tendon, including conservative cast immobilization, traditional open surgery and percutaneous repair. 26 active patients were managed for a rupture of the Achilles Tendon from January 2007 to March 2008. Anthropometric measurements, Functional assessment, Isometric strength, Ultrasonographic assessment, Patient satisfaction, Working life, Physical activity, Functional score and Complications were recorded retrospectively. All 23 (21 men, 2 women) patients were reviewed at a minimum follow-up of 24 months (average 25.7, range 24 to 32 months, SD: 6.3) from the index injury. Thermann scores and patient satisfaction were significantly higher following surgery than conservative management with no significance between open and minimally invasive operated patients. Sensitive disturbances occur in up to 12% of open repairs and 1.8% of patients managed nonsurgically. Clinical and functional outcomes following surgical repair, percutaneous and open, of the Achilles tendon are significantly improved than following conservative management. Level III.

[Evaluation of the clinical results of non-surgical treatment for pediatric sagittal fracture of mandibular condyle].

PubMed

Liu, Chang-kui; Tan, Xin-ying; Xu, Juan; Liu, Hua-wei; Liu, San-xia; Hu, Min

2013-11-01

To investigate the clinical results of occlusal splint in the treatment of sagittal fracture of mandibular condyle (SFMC) in children. Thirty-nine patients (48 condyles)aged 3-8 years with sagittal fracture of mandibular condyle were included in this study. All the patients were treated by occlusal splint.Slight open occlusion was maintained by occlusal splint for 3-6 months. Clinical and radiological examination was performed six mouths and every year after treatment. Good mandibular function was observed in 39 patients. Maximal mouth opening over 35 mm was achieved at 6 months. But 11 of the 39 patients presented with deviation on mouth opening at 6 months. The radiology showed an complete remodeling in 32 condyles (28 patients) and partial remodeling in 16 condyles (11 patients). Poor remodelling was not observed in any patients. Good clinical results can be obtained by using occlusal splint in the treatment of pediatric sagittal fracture of mandibular condyle.

Proximal opening wedge osteotomy with wedge-plate fixation compared with proximal chevron osteotomy for the treatment of hallux valgus: a prospective, randomized study.

PubMed

Glazebrook, Mark; Copithorne, Peter; Boyd, Gordon; Daniels, Timothy; Lalonde, Karl-André; Francis, Patricia; Hickey, Michael

2014-10-01

Hallux valgus with an increased intermetatarsal angle is usually treated with a proximal metatarsal osteotomy. The proximal chevron osteotomy is commonly used but is technically difficult. This study compares the proximal opening wedge osteotomy of the first metatarsal with the proximal chevron osteotomy for the treatment of hallux valgus with an increased intermetatarsal angle. This prospective, randomized multicenter (three-center) study was based on the clinical outcome scores of the Short Form-36, the American Orthopaedic Foot & Ankle Society forefoot questionnaire, and the visual analog scale for pain, activity, and patient satisfaction. Subjects were assessed prior to surgery and at three, six, and twelve months postoperatively. Surgeon preference was evaluated based on questionnaires and the operative times required for each procedure. No significant differences were found for any of the patients' clinical outcome measurements between the two procedures. The proximal opening wedge osteotomy was found to lengthen, and the proximal chevron osteotomy was found to shorten, the first metatarsal. The intermetatarsal angles improved (decreased) significantly, from 14.8° ± 3.2° to 9.1° ± 2.9 (mean and standard deviation) after a proximal opening wedge osteotomy and from 14.6° ± 3.9° to 11.3° ± 4.0° after a proximal chevron osteotomy (p < 0.05 for both). Operative time required for performing a proximal opening wedge osteotomy is similar to that required for performing a proximal chevron osteotomy (mean and standard deviation, 67.1 ± 16.5 minutes compared with 69.9 ± 18.6 minutes; p = 0.510). Opening wedge and proximal chevron osteotomies have comparable radiographic outcomes and comparable clinical outcomes for pain, satisfaction, and function. The proximal opening wedge osteotomy lengthens, and the proximal chevron osteotomy shortens, the first metatarsal. The proximal opening wedge osteotomy was subjectively less technically demanding and was preferred by the orthopaedic surgeons in this study. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

Role of OpenEHR as an open source solution for the regional modelling of patient data in obstetrics.

PubMed

Pahl, Christina; Zare, Mojtaba; Nilashi, Mehrbakhsh; de Faria Borges, Marco Aurélio; Weingaertner, Daniel; Detschew, Vesselin; Supriyanto, Eko; Ibrahim, Othman

2015-06-01

This work investigates, whether openEHR with its reference model, archetypes and templates is suitable for the digital representation of demographic as well as clinical data. Moreover, it elaborates openEHR as a tool for modelling Hospital Information Systems on a regional level based on a national logical infrastructure. OpenEHR is a dual model approach developed for the modelling of Hospital Information Systems enabling semantic interoperability. A holistic solution to this represents the use of dual model based Electronic Healthcare Record systems. Modelling data in the field of obstetrics is a challenge, since different regions demand locally specific information for the process of treatment. Smaller health units in developing countries like Brazil or Malaysia, which until recently handled automatable processes like the storage of sensitive patient data in paper form, start organizational reconstruction processes. This archetype proof-of-concept investigation has tried out some elements of the openEHR methodology in cooperation with a health unit in Colombo, Brazil. Two legal forms provided by the Brazilian Ministry of Health have been analyzed and classified into demographic and clinical data. LinkEHR-Ed editor was used to read, edit and create archetypes. Results show that 33 clinical and demographic concepts, which are necessary to cover data demanded by the Unified National Health System, were identified. Out of the concepts 61% were reused and 39% modified to cover domain requirements. The detailed process of reuse, modification and creation of archetypes is shown. We conclude that, although a major part of demographic and clinical patient data were already represented by existing archetypes, a significant part required major modifications. In this study openEHR proved to be a highly suitable tool in the modelling of complex health data. In combination with LinkEHR-Ed software it offers user-friendly and highly applicable tools, although the complexity built by the vast specifications requires expert networks to define generally excepted clinical models. Finally, this project has pointed out main benefits enclosing high coverage of obstetrics data on the Clinical Knowledge Manager, simple modelling, and wide network and support using openEHR. Moreover, barriers described are enclosing the allocation of clinical content to respective archetypes, as well as stagnant adaption of changes on the Clinical Knowledge Manager leading to redundant efforts in data contribution that need to be addressed in future works. Copyright © 2015 Elsevier Inc. All rights reserved.

Metastatic Spine Tumor Surgery: A Comparative Study of Minimally Invasive Approach Using Percutaneous Pedicle Screws Fixation Versus Open Approach.

PubMed

Kumar, Naresh; Malhotra, Rishi; Maharajan, Karthikeyan; Zaw, Aye S; Wu, Pang Hung; Makandura, Milindu C; Po Liu, Gabriel Ka; Thambiah, Joseph; Wong, Hee-Kit

2017-10-01

Prospective cohort study. Minimally invasive spinal surgery (MISS) has been gaining recognition in patients with metastatic spine disease (MSD). The advantages are reduction in blood loss, hospital stay, and postoperative morbidity. Most of the studies were case series with very few comparing the outcomes of MISS to open approaches. To evaluate and compare the clinical and perioperative outcomes of MISS versus open approach in patients with symptomatic MSD, who underwent posterior spinal stabilization and/or decompression. Our study included 45 MSD patients; 27 managed by MISS and 18 by open approach. All patients had MSD presenting with symptoms of neurological deficit, spinal instability, or both. Preoperative, intraoperative, and postoperative data were collected for comparison of the 2 approaches. All patients were followed up until the end of study period (maximum up to 4 years from time of surgery) or till their demise. The clinical outcome measures were pain control, neurological and functional status, whereas perioperative outcomes were blood loss, operative time, length of hospital stay, and time taken to initiate radiotherapy/chemotherapy after index surgery. Majority of patients in both groups showed improvement in pain, neurological status, independent ambulation, and ECOG score in the postoperative period with no significant differences between the 2 groups. There was a significant reduction in intraoperative blood loss (621 mL less, P<0.001) in the MISS group. The average time to initiate radiotherapy after surgery was 13 days (range, 12-16 d) in MISS and 24 days (range, 16-40 d) in the open group. This difference was statistically significant (P<0.001). Operative time and duration of hospital stay were also favorable in the MISS group, although the differences were not significant. MISS is comparable with open approach demonstrating similar improvements in clinical outcomes, that is pain control, neurological and functional status. MISS approaches have also shown promising results due to lesser intraoperative blood loss and allowing earlier radiotherapy/chemotherapy.

Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

PubMed

Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D

2016-02-01

There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. Copyright © 2015 Elsevier Inc. All rights reserved.

Pilot Study Comparing Closed Versus Open Tracheal Suctioning in Postoperative Neonates and Infants With Complex Congenital Heart Disease.

PubMed

Tume, Lyvonne N; Baines, Paul B; Guerrero, Rafael; Hurley, Margaret A; Johnson, Robert; Kalantre, Atul; Ramaraj, Ram; Ritson, Paul C; Walsh, Laura; Arnold, Philip D

2017-07-01

To determine the hemodynamic effect of tracheal suction method in the first 36 hours after high-risk infant heart surgery on the PICU and to compare open and closed suctioning techniques. Pilot randomized crossover study. Single PICU in United Kingdom. Infants undergoing surgical palliation with Norwood Sano, modified Blalock-Taussig shunt, or pulmonary artery banding in the first 36 hours postoperatively. Infants were randomized to receive open or closed (in-line) tracheal suctioning either for their first or second study tracheal suction in the first 36 hours postoperatively. Twenty-four infants were enrolled over 18 months, 11 after modified Blalock-Taussig shunt, seven after Norwood Sano, and six after pulmonary artery banding. Thirteen patients received the open suction method first followed by the closed suction method second, and 11 patients received the closed suction method first followed by the open suction method second in the first 36 hours after their surgery. There were statistically significant larger changes in heart rate (p = 0.002), systolic blood pressure (p = 0.022), diastolic blood pressure (p = 0.009), mean blood pressure (p = 0.007), and arterial saturation (p = 0.040) using the open suction method, compared with closed suctioning, although none were clinically significant (defined as requiring any intervention). There were no clinically significant differences between closed and open tracheal suction methods; however, there were statistically significant greater changes in some hemodynamic variables with open tracheal suctioning, suggesting that closed technique may be safer in children with more precarious physiology.

Group Supervision Attitudes: Supervisory Practices Fostering Resistance to Adoption of Evidence-Based Practices

ERIC Educational Resources Information Center

Brooks, Charles T.; Patterson, David A.; McKiernan, Patrick M.

2012-01-01

The focus of this study was to qualitatively evaluate worker's attitudes about clinical supervision. It is believed that poor attitudes toward clinical supervision can create barriers during supervision sessions. Fifty-one participants within a social services organization completed an open-ended questionnaire regarding their clinical supervision…

Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder.

PubMed

Mattingly, Greg W; Weisler, Richard H; Young, Joel; Adeyi, Ben; Dirks, Bryan; Babcock, Thomas; Lasser, Robert; Scheckner, Brian; Goodman, David W

2013-01-29

Despite the overall high degree of response to pharmacotherapy, consensus is lacking on how to judge clinical response or define optimal treatment/remission when treating adults with attention-deficit/hyperactivity disorder (ADHD). This study examined clinical response and symptomatic remission in analyses of 2 studies of lisdexamfetamine dimesylate (LDX) in adults with ADHD. In a 4-week, double-blind, forced-dose trial, adults with ADHD were randomized to LDX 30, 50, and 70 mg/day (mg/d) or placebo. In a second, open-label, follow-up trial, adults entering from the 4-week study were titrated to an "optimal" LDX dose (30 mg/d [n=44], 50 mg/d [n=112], and 70 mg/d [n=171]) over 4 weeks, and maintained for 11 additional months. The ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts and the Clinical Global Impressions-Improvement (CGI-I) scale assessed efficacy. Clinical response was defined, post hoc, as ≥30% reduction from baseline in ADHD-RS-IV and CGI-I rating of 1 or 2; symptomatic remission was defined as ADHD-RS-IV total score ≤18. Log rank analysis examined overall significance among the treatment groups in time to response or remission. Four hundred and fourteen participants in the 4-week study and 345 in the open-label, extension study were included in the efficacy populations. All LDX groups improved by ADHD-RS-IV and CGI-I scores in both studies. In the 4-week study (n=414), 69.3% responded and 45.5% achieved remission with LDX (all doses); 37.1% responded and 16.1% achieved remission with placebo; time (95% CI) to median clinical response (all LDX doses) was 15.0 (15.0, 17.0) days and to remission was 31.0 (28.0, 37.0) days (P<.0001 overall). In the open-label study, with LDX (all doses), 313 (95.7%) and 278 (85.0%) of 327 participants with evaluable maintenance-phase data met criteria for response and remission, respectively. Of participants who completed dose optimization, 75.2% remained responders and 65.7% remained in remission in the 12-month study. Overall, 285 (82.6%) and 227 (65.8%) of 345 participants were responders and remitters, respectively, at their final visits. In the long-term study, with open-label, dose-optimized LDX treatment, most adults with ADHD achieved clinical response and/or symptomatic remission; almost two-thirds maintained symptomatic remission over the remaining 11 months. Clinical Trial Numbers: NCT00334880 and NCT01070394CLINICAL TRIAL REGISTRY: clinicaltrials.gov.

Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder

PubMed Central

2013-01-01

Background Despite the overall high degree of response to pharmacotherapy, consensus is lacking on how to judge clinical response or define optimal treatment/remission when treating adults with attention-deficit/hyperactivity disorder (ADHD). This study examined clinical response and symptomatic remission in analyses of 2 studies of lisdexamfetamine dimesylate (LDX) in adults with ADHD. Methods In a 4-week, double-blind, forced-dose trial, adults with ADHD were randomized to LDX 30, 50, and 70 mg/day (mg/d) or placebo. In a second, open-label, follow-up trial, adults entering from the 4-week study were titrated to an “optimal” LDX dose (30 mg/d [n=44], 50 mg/d [n=112], and 70 mg/d [n=171]) over 4 weeks, and maintained for 11 additional months. The ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts and the Clinical Global Impressions-Improvement (CGI-I) scale assessed efficacy. Clinical response was defined, post hoc, as ≥30% reduction from baseline in ADHD-RS-IV and CGI-I rating of 1 or 2; symptomatic remission was defined as ADHD-RS-IV total score ≤18. Log rank analysis examined overall significance among the treatment groups in time to response or remission. Results Four hundred and fourteen participants in the 4-week study and 345 in the open-label, extension study were included in the efficacy populations. All LDX groups improved by ADHD-RS-IV and CGI-I scores in both studies. In the 4-week study (n=414), 69.3% responded and 45.5% achieved remission with LDX (all doses); 37.1% responded and 16.1% achieved remission with placebo; time (95% CI) to median clinical response (all LDX doses) was 15.0 (15.0, 17.0) days and to remission was 31.0 (28.0, 37.0) days (P<.0001 overall). In the open-label study, with LDX (all doses), 313 (95.7%) and 278 (85.0%) of 327 participants with evaluable maintenance-phase data met criteria for response and remission, respectively. Of participants who completed dose optimization, 75.2% remained responders and 65.7% remained in remission in the 12-month study. Overall, 285 (82.6%) and 227 (65.8%) of 345 participants were responders and remitters, respectively, at their final visits. Conclusion In the long-term study, with open-label, dose-optimized LDX treatment, most adults with ADHD achieved clinical response and/or symptomatic remission; almost two-thirds maintained symptomatic remission over the remaining 11 months. Trial registration Clinical Trial Numbers: NCT00334880 and NCT01070394 Clinical Trial Registry: clinicaltrials.gov URLs http://www.clinicaltrials.gov/show/NCT00334880 http://www.clinicaltrials.gov/ct2/show/NCT01070394?term=NCT01070394&rank=1 PMID:23356790

Comparative Effectiveness and Economic Evaluations of Open Versus Minimally Invasive Posterior or Transforaminal Lumbar Interbody Fusion: A Systematic Review.

PubMed

Goldstein, Christina L; Phillips, Frank M; Rampersaud, Y Raja

2016-04-01

Systematic review of randomized and nonrandomized comparative studies. To summarize the literature examining comparative effectiveness and economic evaluation of minimally invasive versus open transforaminal/posterior lumbar interbody fusion (T/PLIF). Minimally invasive approaches to lumbar fusion have been proposed as an alternative to open surgery to decrease patient morbidity and improve clinical and patient-reported outcomes, with the possibility of secondary cost-savings. The comparative clinical and economic effectiveness of minimally invasive versus open T/PLIF remains largely undetermined. A systematic review of Medline, EMBASE, Web of Science, and Cochrane from database inception to September 2015 inclusive was performed. Reference lists were manually searched. Studies comparing MIS to open T/PLIF for degenerative lumbar conditions, including at least 10 patients in each arm and reporting at least one clinical, perioperative, radiographic, adverse event, or economic outcome, were included. Between database inception and October 2015, 45 studies meeting inclusion criteria were identified with 3472 subjects undergoing MIS fusion and 5925 having an open procedure. There were no significant differences in operative time between the two groups, whereas patients undergoing MIS fusion consistently demonstrated less blood loss (16.1-88.7%) and shorter hospital stays (15.0-64.0% shorter). There was no difference in variably reported VAS, ODI, SF-36, SF-12, or EQ-5D scores between the two techniques at intermediate to long-term follow-up (12-60 months). Complication rates and fusion rates were also equivalent between the two groups. Economic studies demonstrate cost-savings in favor of MIS fusion ranging from 2.5 to 49.3%. Limited quality comparative observational cohort and randomized controlled studies of MIS versus open T/PLIF consistently demonstrate improved perioperative outcomes including operative time, estimated blood loss, and length of stay with no significant difference in patient-reported outcomes or complication rates between the two groups at final follow-up. Increasing economic data suggest both direct and indirect cost-savings in favor of MIS fusion. N/A.

Exploiting Temporal Constraints of Clinical Guidelines by Applying OpenEHR Archetypes.

PubMed

Cintho, Lilian Mie Mukai; Garcia, Diego; da Silva Santos, Bruno Henrique; Sacchi, Lucia; Quaglini, Silvana; Moro, Claudia Maria Cabral

2017-01-01

Studies describing Computer-Interpretable Clinical Guidelines (CIG) with temporal constrains (TC) generally have not addressed issues related to their integration into Electronic Health Record (EHR) systems. This study aimed to represent TCs contained in clinical guidelines by applying archetypes and Guideline Definition Language (GDL) to incorporate decision support into EHRs. An example of each TC class in the clinical guideline for management of Atrial Fibrillation was represented using archetypes and GDL.

Automated population of an i2b2 clinical data warehouse from an openEHR-based data repository.

PubMed

Haarbrandt, Birger; Tute, Erik; Marschollek, Michael

2016-10-01

Detailed Clinical Model (DCM) approaches have recently seen wider adoption. More specifically, openEHR-based application systems are now used in production in several countries, serving diverse fields of application such as health information exchange, clinical registries and electronic medical record systems. However, approaches to efficiently provide openEHR data to researchers for secondary use have not yet been investigated or established. We developed an approach to automatically load openEHR data instances into the open source clinical data warehouse i2b2. We evaluated query capabilities and the performance of this approach in the context of the Hanover Medical School Translational Research Framework (HaMSTR), an openEHR-based data repository. Automated creation of i2b2 ontologies from archetypes and templates and the integration of openEHR data instances from 903 patients of a paediatric intensive care unit has been achieved. In total, it took an average of ∼2527s to create 2.311.624 facts from 141.917 XML documents. Using the imported data, we conducted sample queries to compare the performance with two openEHR systems and to investigate if this representation of data is feasible to support cohort identification and record level data extraction. We found the automated population of an i2b2 clinical data warehouse to be a feasible approach to make openEHR data instances available for secondary use. Such an approach can facilitate timely provision of clinical data to researchers. It complements analytics based on the Archetype Query Language by allowing querying on both, legacy clinical data sources and openEHR data instances at the same time and by providing an easy-to-use query interface. However, due to different levels of expressiveness in the data models, not all semantics could be preserved during the ETL process. Copyright © 2016 Elsevier Inc. All rights reserved.

Open Knee: Open Source Modeling and Simulation in Knee Biomechanics.

PubMed

Erdemir, Ahmet

2016-02-01

Virtual representations of the knee joint can provide clinicians, scientists, and engineers the tools to explore mechanical functions of the knee and its tissue structures in health and disease. Modeling and simulation approaches such as finite element analysis also provide the possibility to understand the influence of surgical procedures and implants on joint stresses and tissue deformations. A large number of knee joint models are described in the biomechanics literature. However, freely accessible, customizable, and easy-to-use models are scarce. Availability of such models can accelerate clinical translation of simulations, where labor-intensive reproduction of model development steps can be avoided. Interested parties can immediately utilize readily available models for scientific discovery and clinical care. Motivated by this gap, this study aims to describe an open source and freely available finite element representation of the tibiofemoral joint, namely Open Knee, which includes the detailed anatomical representation of the joint's major tissue structures and their nonlinear mechanical properties and interactions. Three use cases illustrate customization potential of the model, its predictive capacity, and its scientific and clinical utility: prediction of joint movements during passive flexion, examining the role of meniscectomy on contact mechanics and joint movements, and understanding anterior cruciate ligament mechanics. A summary of scientific and clinically directed studies conducted by other investigators are also provided. The utilization of this open source model by groups other than its developers emphasizes the premise of model sharing as an accelerator of simulation-based medicine. Finally, the imminent need to develop next-generation knee models is noted. These are anticipated to incorporate individualized anatomy and tissue properties supported by specimen-specific joint mechanics data for evaluation, all acquired in vitro from varying age groups and pathological states. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

A breast cancer clinical registry in an Italian comprehensive cancer center: an instrument for descriptive, clinical, and experimental research.

PubMed

Baili, Paolo; Torresani, Michele; Agresti, Roberto; Rosito, Giuseppe; Daidone, Maria Grazia; Veneroni, Silvia; Cavallo, Ilaria; Funaro, Francesco; Giunco, Marco; Turco, Alberto; Amash, Hade; Scavo, Antonio; Minicozzi, Pamela; Bella, Francesca; Meneghini, Elisabetta; Sant, Milena

2015-01-01

In clinical research, many potentially useful variables are available via the routine activity of cancer center-based clinical registries (CCCR). We present the experience of the breast cancer clinical registry at Fondazione IRCCS "Istituto Nazionale dei Tumori" to give an example of how a CCCR can be planned, implemented, and used. Five criteria were taken into consideration while planning our CCCR: (a) available clinical and administrative databases ought to be exploited to the maximum extent; (b) open source software should be used; (c) a Web-based interface must be designed; (d) CCCR data must be compatible with population-based cancer registry data; (e) CCCR must be an open system, able to be connected with other data repositories. The amount of work needed for the implementation of a CCCR is inversely linked with the amount of available coded data: the fewer data are available in the input databases as coded variables, the more work will be necessary, for information technology staff, text mining analysis, and registrars (for collecting data from clinical records). A cancer registry in a comprehensive cancer center can be used for several research aspects, such as estimate of the number of cases needed for clinical studies, assessment of biobank specimens with specific characteristics, evaluation of clinical practice and adhesion to clinical guidelines, comparative studies between clinical and population sets of patients, studies on cancer prognosis, and studies on cancer survivorship.

Validity of temporomandibular disorder examination procedures for assessment of temporomandibular joint status.

PubMed

Schmitter, Marc; Kress, Bodo; Leckel, Michael; Henschel, Volkmar; Ohlmann, Brigitte; Rammelsberg, Peter

2008-06-01

This hypothesis-generating study was performed to determine which items in the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and additional diagnostic tests have the best predictive accuracy for joint-related diagnoses. One hundred forty-nine TMD patients and 43 symptom-free subjects were examined in clinical examinations and with magnetic resonance imaging (MRI). The importance of each variable of the clinical examination for correct joint-related diagnosis was assessed by using MRI diagnoses. For this purpose, "random forest" statistical software (based on classification trees) was used. Maximum unassisted jaw opening, maximum assisted jaw opening, history of locked jaw, joint sound with and without compression, joint pain, facial pain, pain on palpation of the lateral pterygoid area, and overjet proved suitable for distinguishing between subtypes of joint-related TMD. Measurement of excursion, protrusion, and midline deviation were less important. The validity of clinical TMD examination procedures can be enhanced by using the 16 variables of greatest importance identified in this study. In addition to other variables, maximum unassisted and assisted opening and a history of locked jaw were important when assessing the status of the TMJ.

Students' Experiences of Clinic-Based Learning during a Final Year Veterinary Internship Programme

ERIC Educational Resources Information Center

Matthew, Susan M.; Taylor, Rosanne M.; Ellis, Robert A.

2010-01-01

This study investigated veterinary students' experiences of clinic-based learning (CBL) during a comprehensive final year internship programme. Open-ended surveys (n = 93) were used to gather qualitative data about students' conceptions of what is learned during CBL and their approaches to learning in clinics. Phenomenography was used for detailed…

Amelogenesis imperfecta and anterior open bite: Etiological, classification, clinical and management interrelationships

PubMed Central

Alachioti, Xanthippi Sofia; Dimopoulou, Eleni; Vlasakidou, Anatoli; Athanasiou, Athanasios E

2014-01-01

Although amelogenesis imperfecta is not a common dental pathological condition, its etiological, classification, clinical and management aspects have been addressed extensively in the scientific literature. Of special clinical consideration is the frequent co-existence of amelogenesis imperfecta with the anterior open bite. This paper provides an updated review on amelogenesis imperfecta as well as anterior open bite, in general, and documents the association of these two separate entities, in particular. Diagnosis and treatment of amelogenesis imperfecta patients presenting also with anterior open bite require a lengthy, comprehensive and multidisciplinary approach, which should aim to successfully address all dental, occlusal, developmental, skeletal and soft tissue problems associated with these two serious clinical conditions. PMID:24987656

Amelogenesis imperfecta and anterior open bite: Etiological, classification, clinical and management interrelationships.

PubMed

Alachioti, Xanthippi Sofia; Dimopoulou, Eleni; Vlasakidou, Anatoli; Athanasiou, Athanasios E

2014-01-01

Although amelogenesis imperfecta is not a common dental pathological condition, its etiological, classification, clinical and management aspects have been addressed extensively in the scientific literature. Of special clinical consideration is the frequent co-existence of amelogenesis imperfecta with the anterior open bite. This paper provides an updated review on amelogenesis imperfecta as well as anterior open bite, in general, and documents the association of these two separate entities, in particular. Diagnosis and treatment of amelogenesis imperfecta patients presenting also with anterior open bite require a lengthy, comprehensive and multidisciplinary approach, which should aim to successfully address all dental, occlusal, developmental, skeletal and soft tissue problems associated with these two serious clinical conditions.

OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

PubMed

Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

2016-01-01

Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.

[Accuracy and relevance of CT volumetry in open ocular injuries with intraocular foreign bodies].

PubMed

Maneschg, O A; Volek, E; Lohinai, Z; Resch, M D; Papp, A; Korom, C; Karlinger, K; Németh, J

2015-04-01

The aim of the study was to evaluate the volume of intraocular foreign bodies (IOFB) using computed tomography (CT) volumetry as a prognostic factor for clinical outcome in open ocular injuries. This study compared the volume of 11 IOFBs more than 5 mm(3) in size based on CT volumetry with the real size determined by in vitro measurement. A retrospective evaluation of clinical data, visual acuity, complications and relation of size of IOFBs with clinical outcome in 33 patients (mean age 41.0 ± 13.5 years) with open ocular injuries treated at our department between January 2005 and December 2010 was carried out. No significant differences were found between pairwise in vitro measurement and CT volumetric size (p = 0.07). All patients were surgically treated by pars plana vitrectomy. The mean follow-up time was 7.6± 6.2 months and the mean preoperative best corrected visual acuity (BCVA) was 0.063 ± 0.16 (logMAR 1.2 ± 0.79). Postoperatively, a mean BCVA of 0.25 ± 0.2 (logMAR 0.6 ± 0.69) could be achieved. Clinical outcomes were significantly better in injuries with small IOFBs measuring < 15 mm(3) (p = 0.0098). The use of CT volumetry is an accurate method for measurement of IOFBs. Exact data about the size and measurement of volume are also an important factor for the prognosis of clinical outcome in open ocular injuries with IOFBs and CT volumetry can also provide important information about the localization of IOFBs.

Anxiety Treatment and Targeted Sleep Enhancement to Address Sleep Disturbance in Pre/Early Adolescents with Anxiety.

PubMed

McMakin, Dana L; Ricketts, Emily J; Forbes, Erika E; Silk, Jennifer S; Ladouceur, Cecile D; Siegle, Greg J; Milbert, Melissa; Trubnick, Laura; Cousins, Jennifer C; Ryan, Neal D; Harvey, Allison G; Dahl, Ronald E

2018-06-06

Sleep disturbance is prevalent in anxious youth and prospectively predicts poor emotional adjustment in adolescence. Study 1 examined whether anxiety treatment improves subjective and objective sleep disturbance in anxious youth. Study 2 examined whether a sleep intervention called Sleeping TIGERS can further improve sleep following anxiety treatment. Study 1 examined 133 youth (ages 9-14; 56% female; 11% ethnic/racial minority) with generalized, social, or separation anxiety over the course of anxiety treatment (cognitive behavioral treatment or client-centered treatment). Sleep-related problems (parent-, child-report) and subjective (diary) and objective (actigraphy) sleep patterns were assessed across treatment in an open trial design. Study 2 included 50 youth (ages 9-14; 68% female; 10% ethnic/racial minority) who continued to report sleep-related problems after anxiety treatment and enrolled in an open trial of Sleeping TIGERS. Pre- and postassessments duplicated Study 1 and included the Focal Interview of Sleep to assess sleep disturbance. Study 1 demonstrated small reductions in sleep problems and improvements in subjective sleep patterns (diary) across anxiety treatment, but outcomes were not deemed clinically significant, and 75% of youth stayed above clinical cutoff. Study 2 showed clinically significant, large reductions in sleep problems and small changes in some subjective sleep patterns (diary). Anxiety treatment improves, but does not resolve, sleep disturbance in peri-pubertal youth, which may portend risk for poor emotional adjustment and mental health. The open trial provides preliminary support that Sleeping TIGERS can improve sleep in anxious youth to a clinically significant degree.

Opening our hearts and minds: the meaning of international clinical nursing electives in the personal and professional lives of nurses.

PubMed

Callister, Lynn Clark; Cox, Amy Harmer

2006-06-01

Although international opportunities are the hallmark of nursing education at a large private university, the meaning of participating in such clinical nursing electives has not been described. The purpose of this phenomenological study of nurses was to examine the personal and professional meaning of participating in international clinical nursing electives during their undergraduate nursing studies. Audiotaped interviews were conducted with 20 former nursing students who had had this opportunity. "Opening our hearts and minds" was described by the study's participants, with the following themes: increasing understanding of other cultures and peoples, increasing understanding of global sociopolitical and health issues, increasing the commitment to make a difference, experiencing personal and professional growth, contributing to professional development in the host country, making interpersonal connexions, and developing cultural competence. This study makes an important contribution to the documentation of the meaning of participating in international nursing clinical experiences. Data are being used for long-term curricular planning in the development and refinement of future international clinical nursing electives and to provide outcomes data for professional accreditation. There are broader implications for the movement beyond individual cultural competence to increasing global consciousness and the improvement of global health care.

Open-Label Uridine for Treatment of Depressed Adolescents with Bipolar Disorder

PubMed Central

Sung, Young-Hoon; Hellem, Tracy L.; Delmastro, Kristen K.; Jeong, Eun-Kee; Kim, Namkug; Shi, Xianfeng; Renshaw, Perry F.

2011-01-01

Abstract This report is an open-label case series of seven depressed adolescents with bipolar disorder treated with uridine for 6 weeks. Treatment response was measured with the Children's Depression Rating Scale-Revised and the Clinical Global Impressions scale. Uridine was associated with decreased depressive symptoms, and was well tolerated by study participants. Further systematic studies of uridine are warranted. PMID:21486171

Perimetric progression using the Visual Field Index and the Advanced Glaucoma Intervention Study score and its clinical correlations.

PubMed

Gros-Otero, Juan; Castejón, Miguel; Paz-Moreno, Javier; Mikropoulos, Dimitrios; Teus, Miguel

2015-01-01

To evaluate the association between clinical parameters and the diagnosis of progression using VFI (Visual Field Index) and AGIS (Advanced Glaucoma Intervention Study) score in primary open angle glaucoma. Retrospective study of 517 visual fields of 78 eyes with primary open angle glaucoma analyzed with VFI and AGIS score. Clinical data registered included: age, sphere, pachimetry, basal intraocular pressure (IOP), and IOP during the follow up. Only the AGIS score diagnosis of progression was associated with the clinical parameters registered. Among the analyzed data, the mean IOP during follow up (p = 0.0005) and IOP at the third month of follow up (p = 0.004) were statistically associated with progression using the AGIS criteria. The diagnosis of perimetric progression using the AGIS score in the current study was closer to the real functional progression than the diagnosis using the VFI, as the former was associated with known risk factors for progression in glaucoma. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

Open treatment of unilateral mandibular condyle fractures in adults: a systematic review.

PubMed

Rozeboom, A; Dubois, L; Bos, R; Spijker, R; de Lange, J

2017-10-01

Since the introduction of rigid internal fixation devices, more and more surgeons favour an open approach to treating condylar fractures of the mandible in adult patients. Different indications for open treatment have been published. Open treatment is associated with surgical complications because of the technique employed. The aim of this systematic review was to provide an overview of the studies published exclusively on open treatment, and to summarize the existing open treatment modalities and their clinical outcomes. A total of seventy studies were selected for detailed analysis. Most studies reported good results with regard to the outcome measures of open treatment. Surgical complications including hematoma, wound infection, weakness of the facial nerve, sialocele, salivary fistula, sensory disturbance of the great auricular nerve, unsatisfactory scarring, and fixation failure were reported in the studies. This review suggests that because of the high level of methodological variance in the relevant studies published to date, among other factors, there are currently no evidence-based conclusions or guidelines that can be formulated with regard to the most appropriate open treatment. Establishment of such standards could potentially improve treatment outcomes. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Pasireotide can induce sustained decreases in urinary cortisol and provide clinical benefit in patients with Cushing's disease: results from an open-ended, open-label extension trial.

PubMed

Schopohl, Jochen; Gu, Feng; Rubens, Robert; Van Gaal, Luc; Bertherat, Jérôme; Ligueros-Saylan, Monica; Trovato, Andrew; Hughes, Gareth; Salgado, Luiz R; Boscaro, Marco; Pivonello, Rosario

2015-10-01

Report the efficacy and safety of pasireotide sc in patients with Cushing's disease during an open-ended, open-label extension to a randomized, double-blind, 12-month, Phase III study. 162 patients entered the core study. 58 patients who had mean UFC ≤ ULN at month 12 or were benefiting clinically from pasireotide entered the extension. Patients received the same dose of pasireotide as at the end of the core study (300-1,200 μg bid). Dose titration was permitted according to efficacy or drug-related adverse events. 40 patients completed 24 months' treatment. Of the patients who entered the extension, 50.0% (29/58) and 34.5% (20/58) had controlled UFC (UFC ≤ ULN) at months 12 and 24, respectively. The mean percentage decrease in UFC was 57.3% (95% CI 40.7-73.9; n = 52) and 62.1% (50.8-73.5; n = 33) after 12 and 24 months' treatment, respectively. Improvements in clinical signs of Cushing's disease were sustained up to month 24. The most frequent drug-related adverse events in patients who received ≥1 dose of pasireotide (n = 162) from core baseline until the 24-month cut-off were diarrhea (55.6%), nausea (48.1%), hyperglycemia (38.9%), and cholelithiasis (31.5%). No new safety issues were identified during the extension. Reductions in mean UFC and improvements in clinical signs of Cushing's disease were maintained over 24 months of pasireotide treatment. The safety profile of pasireotide is typical for a somatostatin analogue, except for the frequency and degree of hyperglycemia; patients should be monitored for changes in glucose homeostasis. Pasireotide represents the first approved pituitary-targeted treatment for patients with Cushing's disease.

The Frequency of Optical Coherence Tomography Testing in Glaucoma at a Single Academic Medical Center.

PubMed

Griffith, Joseph F; Goldberg, Jeffrey L

2016-03-01

To determine the frequency of optical coherence tomography (OCT) examinations compared with clinical examinations and visual field (VF) tests in patients with 5 types of glaucoma. A retrospective, longitudinal cohort study was conducted of 5154 patients treated between 2003 and 2010 at a single academic medical center. Patients were classified using billing records as having primary open-angle glaucoma, low-tension open-angle glaucoma (NTG), pigmentary open-angle glaucoma, chronic angle-closure glaucoma, or pseudoexfoliation glaucoma. Analysis of variance, χ test, and exact χ test were performed to identify associations between glaucoma type and test frequency. Pigmentary open-angle glaucoma and NTG patients had a higher rate of undergoing at least 2 VFs (94.4%, 94.9%), and chronic angle-closure glaucoma patients had a lower rate of undergoing at least 2 OCTs (25.3%) than all other glaucoma types. NTG patients also had the highest rate of undergoing at least 2 OCTs and at least 2 VFs (36.6%). Overall, the rate of clinical examinations (2.68 examinations/y) exceeded the rates of OCTs (1.39 examinations/y), which exceeded the rate of VF tests (1.24 tests/y). There were no differences in OCT frequency between glaucoma types (0.91 to 1.63 OCTs/y). Within each glaucoma diagnosis, patients had clinical examinations more frequently than OCTs and clinical examinations more frequently than VFs. Primary open-angle glaucoma and pseudoexfoliation glaucoma patients also had OCTs more frequently than VFs. More patients had at least 2 VF tests than at least 2 OCTs (4481 vs. 1679). The relative use of clinical examinations, VF testing, and OCT imaging varies among glaucoma diagnoses.

Effects of clinically relevant doses of methyphenidate on spatial memory, behavioral sensitization and open field habituation: a time related study.

PubMed

Haleem, Darakhshan Jabeen; Inam, Qurrat-ul-Aen; Haleem, Muhammad Abdul

2015-03-15

The psychostimulant methylphenidate (MPD) is a first-line drug for the treatment of attention deficit hyperactivity disorder (ADHD). Despite acceptable therapeutic efficacy, there is limited data regarding the long-term consequences of MPD exposure over extended periods. The present study concerns effects of clinically relevant doses of MPD, administered orally to rats for an extended period, on spatial memory, behavioral sensitization and habituation to an open field. Water maze test was used to monitor memory acquisition (2 h after training), retention (day next to training), extinction (1 week after training) and reconsolidation (weekly for 4 weeks). Administration of MPD at doses of 0.25-1.0 mg/kg improved memory acquisition, retention, reconsolidation and impaired memory extinction. Treatment with 0.25 and 0.5 mg/kg MPD for 6 weeks produced a sustained increase in motor activity but higher dose (1.0 mg/kg) elicited behavioral sensitization. High as well as low doses MPD impaired open field habituation. We conclude that clinically relevant doses of MPD enhance memory even if used for extended period. It is suggested that higher (1.0 mg/kg) clinically relevant doses of MPD, if used for extended period, may exacerbate hyperactivity and impulsivity associated with the disease. Copyright © 2015 Elsevier B.V. All rights reserved.

ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening.

PubMed

Pfiffner, Pascal B; Oh, JiWon; Miller, Timothy A; Mandl, Kenneth D

2014-01-01

Implementing semi-automated processes to efficiently match patients to clinical trials at the point of care requires both detailed patient data and authoritative information about open studies. To evaluate the utility of the ClinicalTrials.gov registry as a data source for semi-automated trial eligibility screening. Eligibility criteria and metadata for 437 trials open for recruitment in four different clinical domains were identified in ClinicalTrials.gov. Trials were evaluated for up to date recruitment status and eligibility criteria were evaluated for obstacles to automated interpretation. Finally, phone or email outreach to coordinators at a subset of the trials was made to assess the accuracy of contact details and recruitment status. 24% (104 of 437) of trials declaring on open recruitment status list a study completion date in the past, indicating out of date records. Substantial barriers to automated eligibility interpretation in free form text are present in 81% to up to 94% of all trials. We were unable to contact coordinators at 31% (45 of 146) of the trials in the subset, either by phone or by email. Only 53% (74 of 146) would confirm that they were still recruiting patients. Because ClinicalTrials.gov has entries on most US and many international trials, the registry could be repurposed as a comprehensive trial matching data source. Semi-automated point of care recruitment would be facilitated by matching the registry's eligibility criteria against clinical data from electronic health records. But the current entries fall short. Ultimately, improved techniques in natural language processing will facilitate semi-automated complex matching. As immediate next steps, we recommend augmenting ClinicalTrials.gov data entry forms to capture key eligibility criteria in a simple, structured format.

Cost-effectiveness of open versus arthroscopic rotator cuff repair.

PubMed

Adla, Deepthi N; Rowsell, Mark; Pandey, Radhakant

2010-03-01

Economic evaluation of surgical procedures is necessary in view of more expensive newer techniques emerging in an increasingly cost-conscious health care environment. This study compares the cost-effectiveness of open rotator cuff repair with arthroscopic repair for moderately size tears. This was a prospective study of 30 consecutive patients, of whom 15 had an arthroscopic repair and 15 had an open procedure. Clinical effectiveness was assessed using Oxford and Constant shoulder scores. Costs were estimated from departmental and hospital financial data. At last follow-up, no difference Oxford and Constant shoulder scores was noted between the 2 methods of repair. There was no significant difference between the groups in the cost of time in the operating theater, inpatient time, amount of postoperative analgesia, number of postoperative outpatient visits, physiotherapy costs, and time off work. The incremental cost of each arthroscopic rotator cuff repair was pound675 ($1248.75) more than the open procedure. This was mainly in the area of direct health care costs, instrumentation in particular. Health care policy makers are increasingly demanding evidence of cost-effectiveness of a procedure. This study showed both methods of repair provide equivalent clinical results. Open cuff repair is more cost-effective than arthroscopic repair and is likely to have lower cost-utility ratio. In addition, the tariff for the arthroscopic procedure in some health care systems is same as open repair. Copyright 2010 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

Development and validation of an open source quantification tool for DSC-MRI studies.

PubMed

Gordaliza, P M; Mateos-Pérez, J M; Montesinos, P; Guzmán-de-Villoria, J A; Desco, M; Vaquero, J J

2015-03-01

This work presents the development of an open source tool for the quantification of dynamic susceptibility-weighted contrast-enhanced (DSC) perfusion studies. The development of this tool is motivated by the lack of open source tools implemented on open platforms to allow external developers to implement their own quantification methods easily and without the need of paying for a development license. This quantification tool was developed as a plugin for the ImageJ image analysis platform using the Java programming language. A modular approach was used in the implementation of the components, in such a way that the addition of new methods can be done without breaking any of the existing functionalities. For the validation process, images from seven patients with brain tumors were acquired and quantified with the presented tool and with a widely used clinical software package. The resulting perfusion parameters were then compared. Perfusion parameters and the corresponding parametric images were obtained. When no gamma-fitting is used, an excellent agreement with the tool used as a gold-standard was obtained (R(2)>0.8 and values are within 95% CI limits in Bland-Altman plots). An open source tool that performs quantification of perfusion studies using magnetic resonance imaging has been developed and validated using a clinical software package. It works as an ImageJ plugin and the source code has been published with an open source license. Copyright © 2015 Elsevier Ltd. All rights reserved.

Open source posturography.

PubMed

Rey-Martinez, Jorge; Pérez-Fernández, Nicolás

2016-12-01

The proposed validation goal of 0.9 in intra-class correlation coefficient was reached with the results of this study. With the obtained results we consider that the developed software (RombergLab) is a validated balance assessment software. The reliability of this software is dependent of the used force platform technical specifications. Develop and validate a posturography software and share its source code in open source terms. Prospective non-randomized validation study: 20 consecutive adults underwent two balance assessment tests, six condition posturography was performed using a clinical approved software and force platform and the same conditions were measured using the new developed open source software using a low cost force platform. Intra-class correlation index of the sway area obtained from the center of pressure variations in both devices for the six conditions was the main variable used for validation. Excellent concordance between RombergLab and clinical approved force platform was obtained (intra-class correlation coefficient =0.94). A Bland and Altman graphic concordance plot was also obtained. The source code used to develop RombergLab was published in open source terms.

Opening toward life: experiences of basic body awareness therapy in persons with major depression.

PubMed

Danielsson, Louise; Rosberg, Susanne

2015-01-01

Although there is a vast amount of research on different strategies to alleviate depression, knowledge of movement-based treatments focusing on body awareness is sparse. This study explores the experiences of basic body awareness therapy (BBAT) in 15 persons diagnosed with major depression who participated in the treatment in a randomized clinical trial. Hermeneutic phenomenological methodology inspired the approach to interviews and data analysis. The participants' experiences were essentially grasped as a process of enhanced existential openness, opening toward life, exceeding the tangible corporeal dimension to also involve emotional, temporal, and relational aspects of life. Five constituents of this meaning were described: vitality springing forth, grounding oneself, recognizing patterns in one's body, being acknowledged and allowed to be oneself, and grasping the vagueness. The process of enhanced perceptual openness challenges the numbness experienced in depression, which can provide hope for change, but it is connected to hard work and can be emotionally difficult to bear. Inspired by a phenomenological framework, the results of this study illuminate novel clinical and theoretical insight into the meaning of BBAT as an adjunctive approach in the treatment of depression.

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.

Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome.

PubMed

Inoue, Yuichi; Hirata, Koichi; Hayashida, Kenichi; Hattori, Nobutaka; Tomida, Takayuki; Garcia-Borreguero, Diego

2013-01-10

The present study aimed to examine the long-term efficacy and safety of rotigotine treatment for restless legs syndrome (RLS), as well as the rate of clinically significant augmentation, in a 1-year open-label study of Japanese subjects. Japanese patients with RLS who had been treated with rotigotine or placebo in a double-blind trial were enrolled in a 1-year, open-label, uncontrolled extension study and treated with rotigotine at a dose of up to 3 mg/24 h after an 8-week titration phase. Outcomes included International Restless Legs Syndrome Study Group rating scale (IRLS scale), Pittsburgh Sleep Quality Index (PSQI), safety, and investigator-/expert panel-assessed augmentation (including Augmentation Severity Rating Scale). Overall, 185 patients entered the open-label study and 133 completed the study. IRLS and PSQI total scores improved throughout the 52-week treatment period (IRLS, from 23.2±5.1 to 7.8±7.6 and PSQI, from 8.0±3.1 to 5.0±2.9). Treatment-emergent adverse events were mild to moderate in severity, and included application site reactions (52.4%) and nausea (28.6%). Clinically significant augmentation occurred in five patients (2.7%). These results indicate a good long-term efficacy of rotigotine for treating RLS, with a relatively low risk of clinically significant augmentation. Copyright © 2012 Elsevier Inc. All rights reserved.

Robotic Enucleation for Benign or Borderline Tumours of the Pancreas: A Retrospective Analysis and Comparison from a High-Volume Centre in Asia.

PubMed

Jin, Jia-Bin; Qin, Kai; Li, Hua; Wu, Zhi-Chong; Zhan, Qian; Deng, Xia-Xing; Chen, Hao; Shen, Bai-Yong; Peng, Cheng-Hong; Li, Hong-Wei

2016-12-01

Enucleation is increasingly performed for benign or borderline tumours of the pancreas because it is a parenchyma-sparing and less invasive procedure compared to conventional pancreatectomy, which reduces the risk of exocrine and endocrine insufficiency. This study retrospectively evaluated and compared the pre-, intra-, and post-operative clinical characteristics after open and robotic approaches for pancreatic enucleation. Fifty-six cases of enucleation for benign or borderline tumours of the pancreas treated from March 2010 to July 2015 were identified by a retrospective search. These included 25 patients who underwent an open approach and 31 patients who underwent a robotic approach. The clinical characteristics were extracted and compared. The two groups had a similar location and pathology of the tumour. The robotic group had a significantly shorter operation time and significantly less blood loss than the open group. The rates of clinical pancreatic fistula (PF) formation and major complications were similar. The robotic approach could be applied for a tumour on the right side of the pancreas without increasing the incidence of clinical PF or other major complications. The patients with clinical PF had a significantly shorter distance between the lesion and the main pancreatic duct (MPD). Robotic enucleation appears to be a feasible and safe approach for benign or borderline tumours of the pancreas and was associated with similarly favourable surgical outcomes as the open approach. Identifying and avoiding the MPD is an important step during enucleation.

OpenICE medical device interoperability platform overview and requirement analysis.

PubMed

Arney, David; Plourde, Jeffrey; Goldman, Julian M

2018-02-23

We give an overview of OpenICE, an open source implementation of the ASTM standard F2761 for the Integrated Clinical Environment (ICE) that leverages medical device interoperability, together with an analysis of the clinical and non-functional requirements and community process that inspired its design.

[Clinical impact of opening a human milk bank in a neonatal unit].

PubMed

Vázquez-Román, S; Bustos-Lozano, G; López-Maestro, M; Rodríguez-López, J; Orbea-Gallardo, C; Samaniego-Fernández, M; Pallás-Alonso, C R

2014-09-01

The benefits of donor human milk compared with artificial formulas have been well demonstrated; nevertheless the impact in the clinical practice of opening a human milk bank within a neonatal unit has not yet been studied. The main aim of this study was to analyze the impact on the clinical practice of opening a human milk bank in a neonatal unit to provide donor human milk for preterm infants ≤ 32 weeks of gestational age. A before and after study was designed, with the intervention being the opening a human milk bank. Preterm infants ≤ 32 weeks of gestational age born in the Hospital 12 Octubre from July to December 2005 and January to June 2008 (firsts 6 months after opening the human milk bank) were included. After opening the human milk bank, enteral feedings were started 31h before (P<.001), 100ml/kg/day were achieved 59.5h before (P<.001) and 150 ml/kg/day 52 h before (P=.002). Enteral feedings were never started LM with artificial formula, the exposure to formula in the first 15 days of life was reduced from 50% to 16.6%, and it's consumption during the first 28 days of life was significantly reduced. There was a higher consumption of own mother's milk during the hospital stay, and a higher rate of exclusive breastfeeding at hospital discharge (54% vs 40%). The availability of donor human milk has led to quicker progression with enteral feedings and earlier withdrawal of parenteral nutrition. It has reduced the exposure to artificial formulas, and has also increased the intake of own mother's milk during the hospital stay and the rate of exclusive breastfeeding at hospital discharge. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

Integration of a clinical trial database with a PACS

NASA Astrophysics Data System (ADS)

van Herk, M.

2014-03-01

Many clinical trials use Electronic Case Report Forms (ECRF), e.g., from OpenClinica. Trial data is augmented if DICOM scans, dose cubes, etc. from the Picture Archiving and Communication System (PACS) are included for data mining. Unfortunately, there is as yet no structured way to collect DICOM objects in trial databases. In this paper, we obtain a tight integration of ECRF and PACS using open source software. Methods: DICOM identifiers for selected images/series/studies are stored in associated ECRF events (e.g., baseline) as follows: 1) JavaScript added to OpenClinica communicates using HTML with a gateway server inside the hospitals firewall; 2) On this gateway, an open source DICOM server runs scripts to query and select the data, returning anonymized identifiers; 3) The scripts then collects, anonymizes, zips and transmits selected data to a central trial server; 4) Here data is stored in a DICOM archive which allows authorized ECRF users to view and download the anonymous images associated with each event. Results: All integration scripts are open source. The PACS administrator configures the anonymization script and decides to use the gateway in passive (receiving) mode or in an active mode going out to the PACS to gather data. Our ECRF centric approach supports automatic data mining by iterating over the cases in the ECRF database, providing the identifiers to load images and the clinical data to correlate with image analysis results. Conclusions: Using open source software and web technology, a tight integration has been achieved between PACS and ECRF.

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 findings can serve as a reference for clinical teachers and mentors to effectively prevent and reduce the burnout of medical students during clerkship training at clinical workplaces.

Comparison between open and closed methods of herniorrhaphy in calves affected with umbilical hernia

PubMed Central

Hossain, Mohammad Farhad; Das, Bhajan Chandra; Kim, Gonhyung; Hossain, Mohammad Alamgir

2009-01-01

Umbilical hernias in calves commonly present to veterinary clinics, which are normally secondary to failure of the normal closure of the umbilical ring, and which result in the protrusion of abdominal contents into the overlying subcutis. The aim of this study was to compare the suitability of commonly-used herniorrhaphies for the treatment of reducible umbilical hernia in calves. Thirty-four clinical cases presenting to the Veterinary Teaching Hospital, Chittagong Veterinary and Animal Sciences University, Chittagong, Bangladesh from July 2004 to July 2007 were subjected to comprehensive study including history, classification of hernias, size of the hernial rings, presence of adhesion with the hernial sacs, postoperative care and follow-up. They were reducible, non-painful and had no evidence of infection present on palpation. The results revealed a gender influence, with the incidence of umbilical hernia being higher in female calves than in males. Out of the 34 clinical cases, 14 were treated by open method of herniorrhaphy and 20 were treated by closed method. Complications of hernia were higher (21%) in open method-treated cases than in closed method-treated cases (5%). Hernia recurred in three calves treated with open herniorrhaphy within 2 weeks of the procedure, with swelling in situ and muscular weakness at the site of operation. Shorter operation time and excellent healing rate (80%) were found in calves treated with closed herniorrhaphy. These findings suggest that the closed herniorrhaphy is better than the commonly-used open method for the correction of reducible umbilical hernia in calves. PMID:19934601

Changes in patellofemoral alignment do not cause clinical impact after open-wedge high tibial osteotomy.

PubMed

Lee, Yong Seuk; Lee, Sang Bok; Oh, Won Seok; Kwon, Yong Eok; Lee, Beom Koo

2016-01-01

The objectives of this study were (1) to evaluate the clinical and radiologic outcomes of open-wedge high tibial osteotomy focusing on patellofemoral alignment and (2) to search for correlation between variables and patellofemoral malalignment. A total of 46 knees (46 patients) from 32 females and 14 males who underwent open-wedge high tibial osteotomy were included in this retrospective case series. Outcomes were evaluated using clinical scales and radiologic parameters at the last follow-up. Pre-operative and final follow-up values were compared for the outcome analysis. For the focused analysis of the patellofemoral joint, correlation analyses between patellofemoral variables and pre- and post-operative weight-bearing line (WBL), clinical score, posterior slope, Blackburn Peel ratio, lateral patellar tilt, lateral patellar shift, and congruence angle were performed. The minimum follow-up period was 2 years and median follow-up period was 44 months (range 24-88 months). The percentage of weight-bearing line was shifted from 17.2 ± 11.1 to 56.7 ± 12.7%, and it was statistically significant (p < 0.01). Regarding the clinical results, statistical significance was observed using all scores (p < 0.01). In the radiologic evaluation, patellar descent was observed with statistical significance (p < 0.01). Last follow-up lateral patellar tilt was decreased with statistical significance (p < 0.01). In correlation analysis between variables of patellofemoral malalignment, the pre-operative weight-bearing line showed an association with the change in lateral patellar tilt and lateral patellar shift (correlation coefficient: 0.3). After open-wedge high tibial osteotomy, clinical results showed improvement, compared to pre-operative values. The patellar tilt and lateral patellar shift were not changed; however, descent of the patella was observed. Therefore, mild patellofemoral problems should not be a contraindication of the open-wedge high tibial osteotomy. Case series, Level IV.

Open reduction and internal fixation of dislocated condylar fractures in children: long-term clinical and radiologic outcomes.

PubMed

Deleyiannis, Frederic W-B; Vecchione, Lisa; Martin, Brian; Jiang, Shao; Sotereanos, George

2006-11-01

The purpose of this study was to investigate the long-term clinical and radiologic outcomes of treating dislocated condylar fractures sustained in childhood with open reduction and internal fixation (ORIF). Six children 14 years or younger with a condylar neck or subcondylar fracture with dislocation of the condyle from the glenoid fossa were treated with ORIF. Patients were followed for 27 to 92 months post-ORIF (mean: 67.6 months) with routine clinical and radiologic examinations. On the dislocated side, all patients radiographically showed signs of remodeling of the condylar process and shortening of the ramus. Subsequent to their fractures, 3 patients were classified with Angle class II malocclusion, retrognathism, and deviation of the mandibular symphysis. Four patients had objective and/or subjective signs of temporomandibular (TMJ) dysfunction. Until open surgery demonstrates a consistent functional advantage, nonsurgical management should be considered the first treatment option for the dislocated pediatric condylar fracture.

Opening the Black Box of Clinical Collaboration in Integrated Care Models for Frail, Elderly Patients

ERIC Educational Resources Information Center

de Stampa, Matthieu; Vedel, Isabelle; Bergman, Howard; Novella, Jean-Luc; Lechowski, Laurent; Ankri, Joel; Lapointe, Liette

2013-01-01

Purpose: The purpose of the study was to understand better the clinical collaboration process among primary care physicians (PCPs), case managers (CMs), and geriatricians in integrated models of care. Methods: We conducted a qualitative study with semistructured interviews. A purposive sample of 35 PCPs, 7 CMs, and 4 geriatricians was selected in…

Use of a 1.0 Tesla open scanner for evaluation of pediatric and congenital heart disease: a retrospective cohort study.

PubMed

Lu, Jimmy C; Nielsen, James C; Morowitz, Layne; Musani, Muzammil; Ghadimi Mahani, Maryam; Agarwal, Prachi P; Ibrahim, El-Sayed H; Dorfman, Adam L

2015-05-25

Open cardiovascular magnetic resonance (CMR) scanners offer the potential for imaging patients with claustrophobia or large body size, but at a lower 1.0 Tesla magnetic field. This study aimed to evaluate the efficacy of open CMR for evaluation of pediatric and congenital heart disease. This retrospective, cross-sectional study included all patients ≤18 years old or with congenital heart disease who underwent CMR on an open 1.0 Tesla scanner at two centers from 2012-2014. Indications for CMR and clinical questions were extracted from the medical record. Studies were qualitatively graded for image quality and diagnostic utility. In a subset of 25 patients, signal-to-noise (SNR) and contrast-to-noise (CNR) ratios were compared to size- and diagnosis-matched patients with CMR on a 1.5 Tesla scanner. A total of 65 patients (median 17.3 years old, 60% male) were included. Congenital heart disease was present in 32 (50%), with tetralogy of Fallot and bicuspid aortic valve the most common diagnoses. Open CMR was used due to scheduling/equipment issues in 51 (80%), claustrophobia in 7 (11%), and patient size in 3 (5%); 4 patients with claustrophobia had failed CMR on a different scanner, but completed the study on open CMR without sedation. All patients had good or excellent image quality on black blood, phase contrast, magnetic resonance angiography, and late gadolinium enhancement imaging. There was below average image quality in 3/63 (5%) patients with cine images, and 4/15 (27%) patients with coronary artery imaging. SNR and CNR were decreased in cine and magnetic resonance angiography images compared to 1.5 Tesla. The clinical question was answered adequately in all but 2 patients; 1 patient with a Fontan had artifact from an embolization coil limiting RV volume analysis, and in 1 patient the right coronary artery origin was not well seen. Open 1.0 Tesla scanners can effectively evaluate pediatric and congenital heart disease, including patients with claustrophobia and larger body size. Despite minor artifacts and differences in SNR and CNR, the majority of clinical questions can be answered adequately, with some limitations with coronary artery imaging. Further evaluation is necessary to optimize protocols and image quality.

Open-label extension studies: do they provide meaningful information on the safety of new drugs?

PubMed

Day, Richard O; Williams, Kenneth M

2007-01-01

The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently. Most of the value accrued in open-label extension studies is gained from a refinement in the perception of the expected incidence of adverse effects that have most likely already been identified as part of the preclinical and clinical trial programme. We still have to rely heavily on post-marketing safety surveillance systems to alert us to type B (unpredictable) adverse reactions because open-label extension studies are unlikely to provide useful information about these types of often serious and relatively rare adverse reactions. Random allocation into test and control groups is needed to produce precise incidence data on pharmacologically expected, or type A, adverse effects. Some increased confidence about incidence rates might result from the open-label extension study; however, as these studies are essentially uncontrolled and biased, the data are not of great value. Other benefits have been proposed to be gained from open-label extension studies. These include ongoing access to an effective but otherwise unobtainable medicine by the volunteers who participated in the phase III pivotal trials. However, there are unappreciated ethical issues about the appropriateness of enrolling patients whose response to previous treatment is uncertain, largely because treatment allocation in the preceding randomised, double-blind, controlled trial has not been revealed at the time of entry into the open-label extension study. Negative aspects of open-label extension studies revolve around their use as a marketing tool, as they build a market for the drug and generate pressure for subsidised access to the drug from consumers and their physicians. Consumers, institutions where these studies are conducted and research ethics committees need to be convinced of the motives, as well as the quality, of the open-label extension study and its execution before supporting such studies. Open-label extension studies do have a legitimate but limited place in the clinical development of new medicines. The negative perceptions about these studies have arisen because of perversion of acceptable rationales for this type of study and a failure to recognise (or disclose) the limitations resulting from the inherent weaknesses in their design. Increased human exposure to a new medicine under reasonably controlled circumstances to increase confidence in the safety of the medicine is an acceptable rationale for an open-label extension study, and a useful activity to increase the knowledge of the safety profile of a new medicine. However, this goal is increasingly being achieved by means other than open-label extension studies.

Open versus endovascular repair of ruptured abdominal aortic aneurysms: What have we learned after more than 2 decades of ruptured endovascular aneurysm repair?

PubMed

Robinson, William P

2017-12-01

Ruptured abdominal aortic aneurysm is one of the most difficult clinical problems in surgical practice, with extraordinarily high morbidity and mortality. During the past 23 years, the literature has become replete with reports regarding ruptured endovascular aneurysm repair. A variety of study designs and databases have been utilized to compare ruptured endovascular aneurysm repair and open surgical repair for ruptured abdominal aortic aneurysm and studies of various designs from different databases have yielded vastly different conclusions. It therefore remains controversial whether ruptured endovascular aneurysm repair improves outcomes after ruptured abdominal aortic aneurysm in comparison to open surgical repair. The purpose of this article is to review the best available evidence comparing ruptured endovascular aneurysm repair and open surgical repair of ruptured abdominal aortic aneurysm, including single institution and multi-institutional retrospective observational studies, large national population-based studies, large national registries of prospectively collected data, and randomized controlled clinical trials. This article will analyze the study designs and databases utilized with their attendant strengths and weaknesses to understand the sometimes vastly different conclusions the studies have reached. This article will attempt to integrate the data to distill some of the lessons that have been learned regarding ruptured endovascular aneurysm repair and identify ongoing needs in this field. Copyright © 2017 Elsevier Inc. All rights reserved.

Semantic Role Labeling of Clinical Text: Comparing Syntactic Parsers and Features

PubMed Central

Zhang, Yaoyun; Jiang, Min; Wang, Jingqi; Xu, Hua

2016-01-01

Semantic role labeling (SRL), which extracts shallow semantic relation representation from different surface textual forms of free text sentences, is important for understanding clinical narratives. Since semantic roles are formed by syntactic constituents in the sentence, an effective parser, as well as an effective syntactic feature set are essential to build a practical SRL system. Our study initiates a formal evaluation and comparison of SRL performance on a clinical text corpus MiPACQ, using three state-of-the-art parsers, the Stanford parser, the Berkeley parser, and the Charniak parser. First, the original parsers trained on the open domain syntactic corpus Penn Treebank were employed. Next, those parsers were retrained on the clinical Treebank of MiPACQ for further comparison. Additionally, state-of-the-art syntactic features from open domain SRL were also examined for clinical text. Experimental results showed that retraining the parsers on clinical Treebank improved the performance significantly, with an optimal F1 measure of 71.41% achieved by the Berkeley parser. PMID:28269926

New clinical trial opens to determine safety and efficacy of PROSTVAC, nivolumab and ipilimumab in men with localized prostate cancer | Center for Cancer Research

Cancer.gov

A new study is now open to evaluate the safety and effectiveness of a treatment regimen that combines PROSTVAC with ipilimumab and/or nivolumab in men with localized prostate cancer who have elected to undergo surgical resection (prostatectomy).  Learn more...

Medical humanitarianism, human rights and political advocacy: the case of the Israeli Open Clinic.

PubMed

Gottlieb, Nora; Filc, Dani; Davidovitch, Nadav

2012-03-01

In the context of neo-liberal retrenchments humanitarian NGOs have become alternative healthcare providers that partially fill the vacuum left by the welfare state's withdrawal from the provision of services to migrants and other marginalized populations. In many cases they thus help to build legitimacy for the state's retreat from social responsibilities. Human rights organizations play an important role in advocating for migrants' rights, but in many cases they represent a legalistic and individualized conceptualization of the right to health that limits their claims for social justice. This paper analyzes the interactions and tensions between the discourses of medical humanitarianism, human rights and political advocacy using the example of an "Open Clinic" run by an Israeli human rights organization as a case-study: In 2007 dramatically increasing patient numbers provoked an intense internal debate concerning the proposal to temporarily close the "Open Clinic" in order to press the government to take action. Based on protocols from internal meetings and parliamentary hearings and in-depth interviews, we have analyzed divergent contextualizations of the Clinic's closure. These reflect conflicting notions regarding the Clinic's variegated spectrum of roles--humanitarian, political, legitimizing, symbolic, empowering and organizational--and underlying conceptualizations of migrants' "deservingness". Our case-study thus helps to illuminate NGOs' role in the realm of migrant healthcare and points out options for a possible fruitful relationship between the divergent paradigms of medical humanitarianism, human rights and political advocacy. Copyright © 2011. Published by Elsevier Ltd.

Monitoring worksite clinic performance using a cost-benefit tool.

PubMed

Tao, Xuguang; Chenoweth, David; Alfriend, Amy S; Baron, David M; Kirkland, Tracie W; Scherb, Jill; Bernacki, Edward J

2009-10-01

The purpose of this study was to explore the usefulness of continuously assessing the return on investment (ROI) of worksite medical clinics as a means of evaluating clinic performance. Visit data from January 1, 2007, to December 31, 2008, were collected from all the on-site clinics operated for the Pepsi Bottling Group. An average system-wide ROI was calculated from the time of each clinic's opening and throughout the study period. A multivariate linear regression model was used to determine the association of average ROI with penetration/utilization rate and plant size. A total of 26 on-site clinics were actively running as of December 2008. The average ROI at the time of start up was 0.4, which increased to 1.2 at approximately 4 months and 1.6 at the end of the first year of operation. Overall, it seems that the cost of operating a clinic becomes equal to the cost of similar care purchased in the community (ROI = 1) at approximately 3 months after a clinic's opening and flattens out at the end of the first year. The magnitude of the ROI was closely related to the number of visits (a function of the penetration/utilization rate) and the size of the plant population served. Serial monitoring of ROIs is a useful metric in assessing on-site clinic performance and quantifying the effect of new initiatives aimed at increasing a clinic's cost effectiveness.

Revised definition of neuropathic pain and its grading system: an open case series illustrating its use in clinical practice.

PubMed

Geber, Christian; Baumgärtner, Ulf; Schwab, Rainer; Müller, Harald; Stoeter, Peter; Dieterich, Marianne; Sommer, Clemens; Birklein, Frank; Treede, Rolf-Detlef

2009-10-01

The definition of neuropathic pain has recently been revised by an expert committee of the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain (NeuPSIG) as "pain arising as direct consequence of a lesion or disease affecting the somatosensory system," and a grading system of "definite," "probable," and "possible" neuropathic pain has been introduced. This open case series of 5 outpatients (3 men, 2 women; mean age 48 +/- 12 years) demonstrates how the grading system can be applied, in combination with appropriate confirmatory testing, to diagnosis neuropathic conditions in clinical practice. The proposed grading system includes a dynamic algorithm that enhances the physician's ability to determine with a greater level of certainty whether a pain condition is neuropathic. Its clinical use should be further validated in prospective studies.

[Identification of pathologic alcohol use and its prevention. Results of employee interviews in a clinic].

PubMed

Ennenbach, M; Soyka, M

2007-05-01

After a short review of the literature about addiction in the working place, a study is presented that evaluates the alcohol use of all employees (n=301) in a clinic. The readiness to cooperate was very strong (72%). The openness (investigated with the FPI subscale for openness) was also satisfactory. Results showed a surprisingly high proportion of notable alcohol use by employees (26%). Especially the group of young female employees showed a high range of stress indicators: alcohol use (28.6%), nicotine (24.2%) and eating disorders (22.9%), and moderate-to-strong consumption of medication (12.1%). A sex-specific model of the development of addiction will be suggested based on these study results. A program of preventive measures was implemented integrating well-known components of established successful preventive measures and considering the special environment of the clinic.

Multicentric evaluation of the impact of central tumour location when comparing rates of N1 upstaging in patients undergoing video-assisted and open surgery for clinical Stage I non-small-cell lung cancer.

PubMed

Decaluwé, Herbert; Petersen, René Horsleben; Brunelli, Alex; Pompili, Cecilia; Seguin-Givelet, Agathe; Gust, Lucile; Aigner, Clemens; Falcoz, Pierre-Emmanuel; Rinieri, Philippe; Augustin, Florian; Sokolow, Youri; Verhagen, Ad; Depypere, Lieven; Papagiannopoulos, Kostas; Gossot, Dominique; D'Journo, Xavier Benoit; Guerrera, Francesco; Baste, Jean-Marc; Schmid, Thomas; Stanzi, Alessia; Van Raemdonck, Dirk; Bardet, Jeremy; Thomas, Pascal-Alexandre; Massard, Gilbert; Fieuws, Steffen; Moons, Johnny; Dooms, Christophe; De Leyn, Paul; Hansen, Henrik Jessen

2017-09-27

Large retrospective series have indicated lower rates of cN0 to pN1 nodal upstaging after video-assisted thoracic surgery (VATS) compared with open resections for Stage I non-small-cell lung cancer (NSCLC). The objective of our multicentre study was to investigate whether the presumed lower rate of N1 upstaging after VATS disappears after correction for central tumour location in a multivariable analysis. Consecutive patients operated for PET-CT based clinical Stage I NSCLC were selected from prospectively managed surgical databases in 11 European centres. Central tumour location was defined as contact with bronchovascular structures on computer tomography and/or visibility on standard bronchoscopy. Eight hundred and ninety-five patients underwent pulmonary resection by VATS (n = 699, 9% conversions) or an open technique (n = 196) in 2014. Incidence of nodal pN1 and pN2 upstaging was 8% and 7% after VATS and 15% and 6% after open surgery, respectively. pN1 was found in 27% of patients with central tumours. Less central tumours were operated on by VATS compared with the open technique (12% vs 28%, P < 0.001). Logistic regression analysis showed that only tumour location had a significant impact on N1 upstaging (OR 6.2, confidence interval 3.6-10.8; P < 0.001) and that the effect of surgical technique (VATS versus open surgery) was no longer significant when accounting for tumour location. A quarter of patients with central clinical Stage I NSCLC was upstaged to pN1 at resection. Central tumour location was the only independent factor associated with N1 upstaging, undermining the evidence for lower N1 upstaging after VATS resections. Studies investigating N1 upstaging after VATS compared with open surgery should be interpreted with caution due to possible selection bias, i.e. relatively more central tumours in the open group with a higher chance of N1 upstaging. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Applying an Archetype-Based Approach to Electroencephalography/Event-Related Potential Experiments in the EEGBase Resource.

PubMed

Papež, Václav; Mouček, Roman

2017-01-01

The purpose of this study is to investigate the feasibility of applying openEHR (an archetype-based approach for electronic health records representation) to modeling data stored in EEGBase, a portal for experimental electroencephalography/event-related potential (EEG/ERP) data management. The study evaluates re-usage of existing openEHR archetypes and proposes a set of new archetypes together with the openEHR templates covering the domain. The main goals of the study are to (i) link existing EEGBase data/metadata and openEHR archetype structures and (ii) propose a new openEHR archetype set describing the EEG/ERP domain since this set of archetypes currently does not exist in public repositories. The main methodology is based on the determination of the concepts obtained from EEGBase experimental data and metadata that are expressible structurally by the openEHR reference model and semantically by openEHR archetypes. In addition, templates as the third openEHR resource allow us to define constraints over archetypes. Clinical Knowledge Manager (CKM), a public openEHR archetype repository, was searched for the archetypes matching the determined concepts. According to the search results, the archetypes already existing in CKM were applied and the archetypes not existing in the CKM were newly developed. openEHR archetypes support linkage to external terminologies. To increase semantic interoperability of the new archetypes, binding with the existing odML electrophysiological terminology was assured. Further, to increase structural interoperability, also other current solutions besides EEGBase were considered during the development phase. Finally, a set of templates using the selected archetypes was created to meet EEGBase requirements. A set of eleven archetypes that encompassed the domain of experimental EEG/ERP measurements were identified. Of these, six were reused without changes, one was extended, and four were newly created. All archetypes were arranged in the templates reflecting the EEGBase metadata structure. A mechanism of odML terminology referencing was proposed to assure semantic interoperability of the archetypes. The openEHR approach was found to be useful not only for clinical purposes but also for experimental data modeling.

Clinical outcomes of CO2-less single-port video-assisted thoracoscopic thymectomy versus open thymectomy: comparative study.

PubMed

Aragón, Javier; Pérez Méndez, Itzell; Gutiérrez Pérez, Alexia

2016-01-01

Although video-assisted thoracoscopic surgery (VATS) for thymic disorders has been introduced, its oncological outcome and benefits over others open approaches remains unclear. Single-port VATS thymectomy using a flexible port and CO 2 has been described. However, VATS thymectomy is possible by a single incision of 3 cm without CO 2 insufflation or special port device avoiding objections related to CO 2 insufflation and allowing instruments to move more freely making procedure easier and cheaper. Our institutional experience in open and CO 2 -less VATS single-port thymectomy was retrospectively reviewed to evaluate compared to sternotomy, the clinical and oncological outcomes with this novel approach. A retrospective review consisting of 84 patients who underwent thymectomy because different thymic disorders especially thymoma was performed. Eighteen patients underwent CO 2 -less VATS single port thymectomy, while 66 underwent thymectomy through open sternotomy. Many clinical factors associated with the surgical and clinical outcomes, including tumor recurrence and clinical remission, were recorded. Non major postoperative complications were observed in any group. The median operative time and postoperative hospital stay of CO 2 -less VATS single port thymectomy were 95 min and 1 day, respectively and 120 min and 7 days for open sternotomy. The thymoma was the most common thymic disorder with 7 patients (38%) in VATS group and 28 patients (42.4%) for the open approach. The median lesion size was 2.6 cm in the VATS group and 3.2 cm in the open approach. No thymoma recurrence in patients undergoing VATS was observed during the follow-up time, while in the open surgery group 14.28% recurrence was observed, distributed as follows: loco-regional 75% and 25% at distance; free disease period of these patients was 8.3 months. Thymectomy associated with myasthenia gravis (MG) was observed in 6 (33%) patients in the VATS group and 32 (48%) patients for sternotomy; our results regarding thymectomy for the treatment of MG were established by the MG post-intervention status [complete stable remission (CSR), pharmacologic remission, minimal manifestations, improved, unchanged and worse exacerbation, and died of MG] and reflected similar results in both approaches. CO 2 -less VATS single-port thymectomy is a feasible and safe procedure. Oncologic outcomes are similar to open approaches. Complications, surgical time and hospital stay are shorter compared with sternotomy. This is an initial experience, further work is required to evaluate long-term results.

Cognitive Behavioural Analysis System of Psychotherapy (CBASP) for chronic depression: clinical characteristics and six month clinical outcomes in an open case series.

PubMed

Swan, John S; Macvicar, Robert; Christmas, David; Durham, Rob; Rauchhaus, Petra; McCullough, James P; Matthews, Keith

2014-01-01

Evidence-based guidance on how best to treat chronic depression is limited. Cognitive Behavioural Analysis System of Psychotherapy (CBASP) has shown some promise with this 'difficult-to-treat' clinical group. This case series was designed to assess the acceptability and utility of this novel treatment in routine clinical practice within the U.K. National Health Service. We offered an open trial of CBASP to a cohort of 115 referred patients within primary and secondary care. Diagnostic interview and standardised outcome measures were administered before and after 6 months of CBASP with a trained, accredited therapist. Seventy-four patients entered therapy, with 46 completing. 30% met criteria for remission (≤ 8 HRSD-24 score) and a further 30% met criteria for clinically significant change (> 8 and ≤15 HRSD-24 plus 50% reduction in baseline score). Thirty-nine per cent made "No change". Group measures of quality of life, social functioning and interpersonal functioning also improved. This was an open study design with a moderate sample size and no control group. Ratings were not completed using a blinded procedure. CBASP is an acceptable therapy for a large proportion of patients with chronic depression and was associated with clinically significant change in 60% of completers. © 2013 Published by Elsevier B.V.

Evaluation of software maintain ability with open EHR - a comparison of architectures.

PubMed

Atalag, Koray; Yang, Hong Yul; Tempero, Ewan; Warren, James R

2014-11-01

To assess whether it is easier to maintain a clinical information system developed using open EHR model driven development versus mainstream methods. A new open source application (GastrOS) has been developed following open EHR's multi-level modelling approach using .Net/C# based on the same requirements of an existing clinically used application developed using Microsoft Visual Basic and Access database. Almost all the domain knowledge was embedded into the software code and data model in the latter. The same domain knowledge has been expressed as a set of open EHR Archetypes in GastrOS. We then introduced eight real-world change requests that had accumulated during live clinical usage, and implemented these in both systems while measuring time for various development tasks and change in software size for each change request. Overall it took half the time to implement changes in GastrOS. However it was the more difficult application to modify for one change request, suggesting the nature of change is also important. It was not possible to implement changes by modelling only. Comparison of relative measures of time and software size change within each application highlights how architectural differences affected maintain ability across change requests. The use of open EHR model driven development can result in better software maintain ability. The degree to which open EHR affects software maintain ability depends on the extent and nature of domain knowledge involved in changes. Although we used relative measures for time and software size, confounding factors could not be totally excluded as a controlled study design was not feasible. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Comparison of Clinical and Radiologic Results of Mini-Open Transforaminal Lumbar Interbody Fusion and Extreme Lateral Interbody Fusion Indirect Decompression for Degenerative Lumbar Spondylolisthesis

PubMed Central

Gen, Hogaku; Sakuma, Yoshio; Koshika, Yasuhide

2018-01-01

Study Design Retrospective study. Purpose In this study, we compared the postoperative outcomes of extreme lateral interbody fusion (XLIF) indirect decompression with that of mini-open transforaminal lumbar interbody fusion (TLIF) in patients with lumbar degenerative spondylolisthesis. Overview of Literature There are very few reports examining postoperative results of XLIF and minimally invasive TLIF for degenerative lumbar spondylolisthesis, and no reports comparing XLIF and mini-open TLIF. Methods Forty patients who underwent 1-level spinal fusion, either by XLIF indirect decompression (X group, 20 patients) or by mini-open TLIF (T group, 20 patients), for treatment of lumbar degenerative spondylolisthesis were included in this study. Invasiveness of surgery was evaluated on the basis of surgery time, blood loss, hospitalization period, and perioperative complications. The Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ), disc angle (DA), disc height (DH), and slipping length (SL) were evaluated before surgery, immediately after surgery, and at 12 months after surgery. Cross-sectional spinal canal area (CSA) was also measured before surgery and at 1 month after surgery. Results There was no significant difference between the groups in terms of surgery time or hospitalization period; however, X group showed a significant decrease in blood loss (p<0.001). Serious complications were not observed in either group. In clinical assessment, no significant differences were observed between the groups with regard to the JOABPEQ results. The change in DH at 12 months after surgery increased significantly in the X group (p<0.05), and the changes in DA and SL were not significantly different between the two groups. The change in CSA was significantly greater in the T group (p<0.001). Conclusions Postoperative clinical results were equally favorable for both procedures; however, in comparison with mini-open TLIF, less blood loss and greater correction of DH were observed in XLIF. PMID:29713419

Leaderboard Now Open: CPTAC’s DREAM Proteogenomics Computational Challenge | Office of Cancer Clinical Proteomics Research

Cancer.gov

The National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) is pleased to announce the opening of the leaderboard to its Proteogenomics Computational DREAM Challenge. The leadership board remains open for submissions during September 25, 2017 through October 8, 2017, with the Challenge expected to run until November 17, 2017.

Ontology-Based Data Integration of Open Source Electronic Medical Record and Data Capture Systems

ERIC Educational Resources Information Center

Guidry, Alicia F.

2013-01-01

In low-resource settings, the prioritization of clinical care funding is often determined by immediate health priorities. As a result, investment directed towards the development of standards for clinical data representation and exchange are rare and accordingly, data management systems are often redundant. Open-source systems such as OpenMRS and…

Open versus percutaneous repair in the treatment of acute Achilles tendon rupture: a randomized prospective study.

PubMed

Gigante, A; Moschini, A; Verdenelli, A; Del Torto, M; Ulisse, S; de Palma, L

2008-02-01

There is no agreement on the ideal type of surgical management for Achilles tendon rupture. The present randomized prospective study was performed to compare outcome data of open and percutaneous repair in the treatment of Achilles tendon rupture. Forty consecutive patients with acute rupture of Achilles tendon were recruited. Patients were randomized to receive open (group A) or percutaneous repair with Tenolig (group B). All patients followed the same rehabilitation protocol except for slight differences in the duration of immobilization. Follow-up included objective evaluation (at 4 and 12 months), subjective evaluation using the SF-12 questionnaire (at 24 months), and bilateral ultrasound scanning and isokinetic testing (at 12 months). The differences in the parameters evaluated clinically were not significant except for ankle circumference, which was significantly greater in group B. There were two minor complications in the open repair group and one case of failed repair in the percutaneous group. SF-12 questionnaire, ultrasound and isokinetic test data did not show significant differences between the groups. The present study demonstrates that the open and the percutaneous technique are both safe and effective in repairing the ruptured Achilles tendon and that both afford the same degree of restoration of clinical, ultrasound and isokinetic patterns. Medium-term results were substantially comparable. Percutaneous repair is performed on a day-surgery basis, it reduces cutaneous complications and operation times, and enables faster recovery, enhancing overall patient compliance. To us, these characteristics make it preferable to open repair in managing subcutaneous ruptures of Achilles tendon in non-professional sports practicing adults.

Viscoelastic assessment of anal canal function using acoustic reflectometry: a clinically useful technique.

PubMed

Mitchell, Peter J; Klarskov, Niels; Telford, Karen J; Hosker, Gordon L; Lose, Gunnar; Kiff, Edward S

2012-02-01

Anal acoustic reflectometry is a new reproducible technique that allows a viscoelastic assessment of anal canal function. Five new variables reflecting anal canal function are measured: the opening and closing pressure, opening and closing elastance, and hysteresis. The aim of this study was to assess whether the parameters measured in anal acoustic reflectometry are clinically valid between continent and fecally incontinent subjects. This was an age- and sex-matched study of continent and incontinent women. The study was conducted at a university teaching hospital. One hundred women (50 with fecal incontinence and 50 with normal bowel control) were included in the study. Subjects were age matched to within 5 years. Parameters measured with anal acoustic reflectometry and manometry were compared between incontinent and continent groups using a paired t test. Diagnostic accuracy was assessed by the use of receiver operator characteristic curves. Four of the 5 anal acoustic reflectometry parameters at rest were significantly different between continent and incontinent women (eg, opening pressure in fecally incontinent subjects was 31.6 vs 51.5 cm H2O in continent subjects, p = 0.0001). Both anal acoustic reflectometry parameters of squeeze opening pressure and squeeze opening elastance were significantly reduced in the incontinent women compared with continent women (50 vs 99.1 cm H2O, p = 0.0001 and 1.48 vs 1.83 cm H2O/mm, p = 0.012). In terms of diagnostic accuracy, opening pressure at rest measured by reflectometry was significantly superior in discriminating between continent and incontinent women in comparison with resting pressure measured with manometry (p = 0.009). Anal acoustic reflectometry is a new, clinically valid technique in the assessment of continent and incontinent subjects. This technique, which assesses the response of the anal canal to distension and relaxation, provides a detailed viscoelastic assessment of anal canal function. This technique may not only aid the investigation of fecally incontinent subjects, but it may also improve our understanding of anal canal physiology during both the process of defecation and maintenance of continence.

Direct health costs and clinical outcomes of open surgery in patients with abdominal aortic aneurysm in Spain. The RECAPTA study.

PubMed

Egea, Marta; Fernández-Samos, Rafael; Lechón, José Antonio; Reparaz, Luis; Álvarez, María; Cairols, Marc

2018-06-18

Abdominal aortic aneurysm (AAA) is a chronic, progressive disease that often requires surgical repair. This study aimed to assess the healthcare costs and clinical outcomes of open AAA repair in Spain. Observational, retrospective, multicenter study with a one-year follow-up. Healthcare resource use and costs related to the surgical procedure, hospital stay, and follow-up period were assessed. Ninety patients with asymptomatic AAA who underwent open repair were recruited between 2003 and 2009 at three Spanish hospitals. Four patients (4.44%) died in the first 30 postoperative days. Mean [standard deviation] procedure time was 292.83 [72.10] minutes and mean hospital length of stay was 11.44 days [5.42]. Thirty two patients (35.56%) presented in-hospital complications and three patients (3.45%) underwent re-intervention during follow-up. The mean overall cost per patient during the study period was €21,622.59, of which 42.40% (€9,168.19), 52.08% (€11,261.74), and 5.52% (€1,192.66) corresponded to the surgical procedure, the inpatient stay, and the study follow-up period, respectively. Given the economic burden imposed by the treatment of patients admitted with AAA on the Spanish health system, additional efforts comparing the cost of open repair with endovascular treatments are needed to ensure greater efficiency.

Open Versus Closed Septorhinoplasty Approaches for Postoperative Edema and Ecchymosis.

PubMed

Sakallioğlu, Öner; Cingi, Cemal; Polat, Cahit; Soylu, Erkan; Akyigit, Abdulvahap; Soken, Hakan

2015-06-01

The aim of this study was to compare periorbital edema and ecchymosis seen after closed (endonasal) and open (external) septorhinoplasty (SRP). In total, 50 patients undergoing hump extraction and osteotomies were allocated to 2 groups. Group 1 consisted of 25 patients who underwent closed SRP. Group 2 consisted of 25 patients who underwent open SRP. Operation time, amount of intraoperative bleeding, and complications were recorded. Scoring of eyelid edema and periorbital ecchymosis was evaluated on the first, third, and seventh postoperative days using a scale of 0 to 4 by the first author. There was no statistically significant difference between the groups in terms of age, sex, or operation time. No significant difference was observed clinically or statistically in the scores of periorbital edema or ecchymosis between groups 1 and 2 on the first, third, and seventh postoperative days (P > 0.05). The authors observed no clinically or statistically significant difference in comparing periorbital edema and ecchymosis seen after closed and open SRP.

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

PubMed

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

2012-06-01

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

Implementation of a departmental picture archiving and communication system: a productivity and cost analysis.

PubMed

Macyszyn, Luke; Lega, Brad; Bohman, Leif-Erik; Latefi, Ahmad; Smith, Michelle J; Malhotra, Neil R; Welch, William; Grady, Sean M

2013-09-01

Digital radiology enhances productivity and results in long-term cost savings. However, the viewing, storage, and sharing of outside imaging studies on compact discs at ambulatory offices and hospitals pose a number of unique challenges to a surgeon's efficiency and clinical workflow. To improve the efficiency and clinical workflow of an academic neurosurgical practice when evaluating patients with outside radiological studies. Open-source software and commercial hardware were used to design and implement a departmental picture archiving and communications system (PACS). The implementation of a departmental PACS system significantly improved productivity and enhanced collaboration in a variety of clinical settings. Using published data on the rate of information technology problems associated with outside studies on compact discs, this system produced a cost savings ranging from $6250 to $33600 and from $43200 to $72000 for 2 cohorts, urgent transfer and spine clinic patients, respectively, therefore justifying the costs of the system in less than a year. The implementation of a departmental PACS system using open-source software is straightforward and cost-effective and results in significant gains in surgeon productivity when evaluating patients with outside imaging studies.

Percutaneous versus traditional and paraspinal posterior open approaches for treatment of thoracolumbar fractures without neurologic deficit: a meta-analysis.

PubMed

Sun, Xiang-Yao; Zhang, Xi-Nuo; Hai, Yong

2017-05-01

This study evaluated differences in outcome variables between percutaneous, traditional, and paraspinal posterior open approaches for traumatic thoracolumbar fractures without neurologic deficit. A systematic review of PubMed, Cochrane, and Embase was performed. In this meta-analysis, we conducted online searches of PubMed, Cochrane, Embase using the search terms "thoracolumbar fractures", "lumbar fractures", ''percutaneous'', "minimally invasive", ''open", "traditional", "posterior", "conventional", "pedicle screw", "sextant", and "clinical trial". The analysis was performed on individual patient data from all the studies that met the selection criteria. Clinical outcomes were expressed as risk difference for dichotomous outcomes and mean difference for continuous outcomes with 95 % confidence interval. Heterogeneity was assessed using the χ 2 test and I 2 statistics. There were 4 randomized controlled trials and 14 observational articles included in this analysis. Percutaneous approach was associated with better ODI score, less Cobb angle correction, less Cobb angle correction loss, less postoperative VBA correction, and lower infection rate compared with open approach. Percutaneous approach was also associated with shorter operative duration, longer intraoperative fluoroscopy, less postoperative VAS, and postoperative VBH% in comparison with traditional open approach. No significant difference was found in Cobb angle correction, postoperative VBA, VBA correction loss, Postoperative VBH%, VBH correction loss, and pedicle screw misplacement between percutaneous approach and open approach. There was no significant difference in operative duration, intraoperative fluoroscopy, postoperative VAS, and postoperative VBH% between percutaneous approach and paraspianl approach. The functional and the radiological outcome of percutaneous approach would be better than open approach in the long term. Although trans-muscular spatium approach belonged to open fixation methods, it was strictly defined as less invasive approach, which provided less injury to the paraspinal muscles and better reposition effect.

Mouth-opening device as a treatment modality in trismus patients with head and neck cancer and oral submucous fibrosis: a prospective study.

PubMed

Li, Yu-Hsuan; Chang, Wei-Chin; Chiang, Tien-En; Lin, Chiun-Shu; Chen, Yuan-Wu

2018-04-26

This study investigated the clinical effectiveness of intervention with an open-mouth exercise device designed to facilitate maximal interincisal opening (MIO) and improve quality of life in patients with head and neck (H&N) cancer and oral submucous fibrosis (OSF). Sixty patients with H&N cancer, OSF, and trismus (MIO < 35 mm) participated in the functional rehabilitation program. An open-mouth exercise device intervention group and conventional group, each consisting of 20 patients, underwent a 12-week training and exercising program and follow-up. For the control group, an additional 20 patients were randomly selected to match the demographic characteristics of the aforementioned two groups. The patients' MIO improvements in the aforementioned three groups were 14.0, 10.5, and 1.3 mm, respectively. Results of this study confirm the significant improvement in average mouth-opening range. In addition, according to patient feedback, significant improvements in health-related quality of life and reductions in trismus symptoms occurred in the open-mouth exercise device group. This newly designed open-mouth exercise device can facilitate trismus patients with H&N cancer and OSF and improve mouth-opening range and quality of life.

The clinical and radiological results of arthroscopic versus arthroscopy assisted mini-open repair of rotator cuff tears

PubMed Central

Özcan, Muhammed Sefa; Sezer, Hasan Basri; Eren, Osman Tuğrul; Armağan, Raffi; Kanar, Muharrem

2017-01-01

In this study we reported retrospectively the comperative clinical and radiological results of the two most common surgical procedures in rotator cuff tear repair of shoulder, the golden standart arthroscopic and alternative arthroscopically assisted mini-open surgery. We included 58 patients who admitted to our clinic for rotator cuff tear and treated surgically between january 2013 and august 2015. The two groups were composed of arthroscopically treated 29 patients and 29 patients who were treated with arthroscopically assisted mini open surgery. The arthroscopy group included 18 females and 11 males, the mini-open group included 10 females and 19 males. The mean age was 56,0 (39,0-73,0) years, in arthroscopic and 55,0 (40,0-70,0) years in mini-open surgery group. 6 patients in the arthroscopy group(20,7%) and 10 patients in the mini-open group(34,5%) were defining trauma before the beginning of their complaints. The postoperative follow up was 28,9 months in arthroscopy group and 22,6 months in the mini-open surgery group. Preoperative physical or medical treatments were documented. Any additional surgical procedures like biceps long head tenotomy, subacromial decompression and bursectomy were also noted. Patients were evaluated with ASES and Constant shoulder scales before and after the surgery. Patients were evaluated radiologically with MRI at the last follow up for healing and tendon quality. The type 2 acromion was the dominant in both groups constituting the 44,8% of the total number of patients. 24 (82,8%)patients in the arthroscopically treated patients and 18(62,1%) patients in the mini-open group were undergone at least one of the additional surgical treatments. The mean length of the surgical scar was 3,4(3-5) cm in mini open group. None of the patients complained of the surgical scar. 16 patients in the arthroscopy group and 17 patients in the mini-open group had supraspinatus tendon pathology(either tear or degeneration) in the MRI control at the last follow up. Postoperative pain was present in 1 patient in each group who were classified as bad result. There was no statistically meaningful difference between two groups in terms of clinical or radiological results. In conclusion the arthroscopy assisted mini-open surgery may be a useful tool in hands of training surgeons to prevent ineffective treatment of rotator cuff tears.

An evidence-based review of pregabalin for the treatment of fibromyalgia.

PubMed

Arnold, Lesley M; Choy, Ernest; Clauw, Daniel J; Oka, Hiroshi; Whalen, Ed; Semel, David; Pauer, Lynne; Knapp, Lloyd

2018-04-16

Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in the United States, Japan, and 37 other countries. The purpose of this article was to provide an in-depth, evidence-based summary of pregabalin for FM as demonstrated in randomized, placebo-controlled clinical studies, including open-label extensions, meta-analyses, combination studies and post-hoc analyses of clinical study data. PubMed was searched using the term "pregabalin AND fibromyalgia" and the Cochrane Library with the term "pregabalin". Both searches were conducted on 2 March 2017 with no other date limits set. Eleven randomized, double-blind, placebo-controlled clinical studies were identified including parallel group, two-way crossover and randomized withdrawal designs. One was a neuroimaging study. Five open-label extensions were also identified. Evidence of efficacy was demonstrated across the studies identified with significant and clinically relevant improvements in pain, sleep quality and patient status. The safety and tolerability profile of pregabalin is consistent across all the studies identified, including in adolescents, with dizziness and somnolence the most common adverse events reported. These efficacy and safety data are supported by meta-analyses (13 studies). Pregabalin in combination with other pharmacotherapies (7 studies) is also efficacious. Post-hoc analyses have demonstrated the onset of pregabalin efficacy as early as 1-2 days after starting treatment, examined the effect of pregabalin on other aspects of sleep beyond quality, and shown it is effective irrespective of the presence of a wide variety of patient demographic and clinical characteristics. Pregabalin is a treatment option for FM; its clinical utility has been comprehensively demonstrated.

Neuromotor tolerability and behavioural characterisation of cannabidiolic acid, a phytocannabinoid with therapeutic potential for anticipatory nausea.

PubMed

Brierley, Daniel I; Samuels, James; Duncan, Marnie; Whalley, Benjamin J; Williams, Claire M

2016-01-01

Anticipatory nausea (AN) is a poorly controlled side effect experienced by chemotherapy patients. Currently, pharmacotherapy is restricted to benzodiazepine anxiolytics, which have limited efficacy, have significant sedative effects and induce dependency. The non-psychoactive phytocannabinoid, cannabidiolic acid (CBDA), has shown considerable efficacy in pre-clinical AN models, however determination of its neuromotor tolerability profile is crucial to justify clinical investigation. Provisional evidence for appetite-stimulating properties also requires detailed investigation. This study aims to assess the tolerability of CBDA in locomotor activity, motor coordination and muscular strength tests, and additionally for ability to modulate feeding behaviours. Male Lister Hooded rats administered CBDA (0.05-5 mg/kg; p.o.) were assessed in habituated open field (for locomotor activity), static beam and grip strength tests. A further study investigated whether these CBDA doses modulated normal feeding behaviour. Finally, evidence of anxiolytic-like effects in the habituated open field prompted testing of 5 mg/kg CBDA for anxiolytic-like activity in unhabituated open field, light/dark box and novelty-suppressed feeding (NSF) tests. CBDA had no adverse effects upon performance in any neuromotor tolerability test, however anxiolytic-like behaviour was observed in the habituated open field. Normal feeding behaviours were unaffected by any dose. CBDA (5 mg/kg) abolished the increased feeding latency in the NSF test induced by the 5-HT1AR antagonist, WAY-100,635, indicative of anxiolytic-like effects, but had no effect on anxiety-like behaviour in the novel open field or light/dark box. CBDA is very well tolerated and devoid of the sedative side effect profile of benzodiazepines, justifying its clinical investigation as a novel AN treatment.

Clinical Interpretation of Variants in Cancer (CIViC) Knowledgebase | Informatics Technology for Cancer Research (ITCR)

Cancer.gov

CIViC is an open access, open source, community-driven web resource for Clinical Interpretation of Variants in Cancer. Our goal is to enable precision medicine by providing an educational forum for dissemination of knowledge and active discussion of the clinical significance of cancer genome alterations.

Identifying Noncognitive Skills That Contribute to Dental Students' Success: Dental Faculty Perspectives.

PubMed

Virtue, Shannon Myers; Pendergast, Laura; Tellez, Marisol; Waldron, Elizabeth; Ismail, Amid

2017-03-01

The aims of this study were to identify noncognitive factors that dental faculty members perceived to contribute to dental students' success and to assess dental faculty members' ratings of the relative importance of these factors to academic performance, clinical performance, and overall success. Out of 184 eligible faculty members at one U.S. dental school, 43 respondents (23.3%) completed a survey in 2015-16. The survey asked respondents to rank the importance of seven noncognitive factors to academic performance, clinical performance, and overall success. Descriptive analysis was conducted to determine the ratings on importance of each noncognitive factor. Two additional open-ended questions asked faculty members to 1) think of dental students who performed very well and list the noncognitive factors they believed contributed to those students' success and 2) identify the two most important of those factors that contributed to success. Qualitative analysis was conducted to identify themes in the open-ended responses. The respondents rated professionalism and preparedness highest in importance for overall success. Preparedness was rated highest in importance for academic performance, and communication was highest in importance for clinical performance. Six themes were identified in the open-ended responses: communication/interpersonal skills, approach to learning, personal characteristics, professionalism, diverse experiences, and technical abilities. On both open-ended items, the most frequently cited noncognitive skill was communication/interpersonal skills followed by approach to learning. In this study, dental faculty members perceived communication, preparedness, and professionalism as important skills contributing to dental students' success.

An Auto-Ethnographic Study of "Open Dialogue": The Illumination of Snow.

PubMed

Olson, Mary

2015-12-01

This auto-ethnographic study describes the changes in the author's thinking and clinical work connected to her first-hand experience of Open Dialogue, which is an innovative, psychosocial approach to severe psychiatric crises developed in Tornio, Finland. In charting this trajectory, there is an emphasis on three interrelated themes: the micropolitics of U.S. managed mental health care; the practice of "dialogicality" in Open Dialogue; and the historical, cultural, and scientific shifts that are encouraging the adaptation of Open Dialogue in the United States. The work of Gregory Bateson provides a conceptual framework that makes sense of the author's experience and the larger trends. The study portrays and underscores how family and network practices are essential to responding to psychiatric crises and should not be abandoned in favor of a reductionist, biomedical model. © 2015 Family Process Institute.

Personalized-detailed clinical model for data interoperability among clinical standards.

PubMed

Khan, Wajahat Ali; Hussain, Maqbool; Afzal, Muhammad; Amin, Muhammad Bilal; Saleem, Muhammad Aamir; Lee, Sungyoung

2013-08-01

Data interoperability among health information exchange (HIE) systems is a major concern for healthcare practitioners to enable provisioning of telemedicine-related services. Heterogeneity exists in these systems not only at the data level but also among different heterogeneous healthcare standards with which these are compliant. The relationship between healthcare organization data and different heterogeneous standards is necessary to achieve the goal of data level interoperability. We propose a personalized-detailed clinical model (P-DCM) approach for the generation of customized mappings that creates the necessary linkage between organization-conformed healthcare standards concepts and clinical model concepts to ensure data interoperability among HIE systems. We consider electronic health record (EHR) standards, openEHR, and HL7 CDA instances transformation using P-DCM. P-DCM concepts associated with openEHR and HL7 CDA help in transformation of instances among these standards. We investigated two datasets: (1) data of 100 diabetic patients, including 50 each of type 1 and type 2, from a local hospital in Korea and (2) data of a single Alzheimer's disease patient. P-DCMs were created for both scenarios, which provided the basis for deriving instances for HL7 CDA and openEHR standards. For proof of concept, we present case studies of encounter information for type 2 diabetes mellitus patients and monitoring of daily routine activities of an Alzheimer's disease patient. These reflect P-DCM-based customized mappings generation with openEHR and HL7 CDA standards. Customized mappings are generated based on the relationship of P-DCM concepts with CDA and openEHR concepts. The objective of this work is to achieve semantic data interoperability among heterogeneous standards. This would lead to effective utilization of resources and allow timely information exchange among healthcare systems.

Personalized-Detailed Clinical Model for Data Interoperability Among Clinical Standards

PubMed Central

Khan, Wajahat Ali; Hussain, Maqbool; Afzal, Muhammad; Amin, Muhammad Bilal; Saleem, Muhammad Aamir

2013-01-01

Abstract Objective: Data interoperability among health information exchange (HIE) systems is a major concern for healthcare practitioners to enable provisioning of telemedicine-related services. Heterogeneity exists in these systems not only at the data level but also among different heterogeneous healthcare standards with which these are compliant. The relationship between healthcare organization data and different heterogeneous standards is necessary to achieve the goal of data level interoperability. We propose a personalized-detailed clinical model (P-DCM) approach for the generation of customized mappings that creates the necessary linkage between organization-conformed healthcare standards concepts and clinical model concepts to ensure data interoperability among HIE systems. Materials and Methods: We consider electronic health record (EHR) standards, openEHR, and HL7 CDA instances transformation using P-DCM. P-DCM concepts associated with openEHR and HL7 CDA help in transformation of instances among these standards. We investigated two datasets: (1) data of 100 diabetic patients, including 50 each of type 1 and type 2, from a local hospital in Korea and (2) data of a single Alzheimer's disease patient. P-DCMs were created for both scenarios, which provided the basis for deriving instances for HL7 CDA and openEHR standards. Results: For proof of concept, we present case studies of encounter information for type 2 diabetes mellitus patients and monitoring of daily routine activities of an Alzheimer's disease patient. These reflect P-DCM-based customized mappings generation with openEHR and HL7 CDA standards. Customized mappings are generated based on the relationship of P-DCM concepts with CDA and openEHR concepts. Conclusions: The objective of this work is to achieve semantic data interoperability among heterogeneous standards. This would lead to effective utilization of resources and allow timely information exchange among healthcare systems. PMID:23875730

Anticipating epileptic seizures: from mathematics to clinical applications.

PubMed

Le Van Quyen, Michel

2005-02-01

The study of dynamical changes in the neural activity preceding an epileptic seizure allows the characterization of a preictal state several minutes prior to seizure onset. This opens new perspectives for studying the mechanisms of ictogenesis as well as for possible therapeutic interventions that represent a major breakthrough. In this review we present and discuss the results from our group in this domain using nonlinear analysis of brain signals, as well as its limitation and open questions.

CLINICAL AND TREATMENT FEATURES OF OPEN INFECTED FRACTURES IN THE KNEE JOINT REGION IN CONJUNCTION WITH RADIATION SICKNESS (EXPERIMENTAL STUDY)

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

Sakharov, B.V.

1963-08-01

Clinical aspects and the course of treatment of open infected fractures in the knee joint region against a background of moderate and severe radiation sickness are discussed. The experiment involved 35 healthy dogs of both sexes. In all, three experiments were involved: on open infected fractures in the knee joint region in conjunction with radiation sickness; open infected fractures in the knee joint region without radiation sickness; radiation sickness without trauma. Infected open injury to the knee joint against a radiation sickness background is a severe affection. The use of delayed surgical and drug treatment (antibiotics, vitamins, antihistamine preparations) affordedmore » survival of at least one-half of the animals. Oral use of phenoxymethyl-penicillin in large doses established in the blood and synovial fluid of the damaged knee joint a therapeutic concentration of antibiotic of long duration (not less than a day). In radiation damage to knee joint accompanied by fracture of the bone fragment, the best method of surgical treatment is osteosynthesis using metal parts. In open infection of a damaged knee joint against a radiation sickness background, even with proper treatment a tendency toward formation of deforming arthrosis was observed. (OTS)« less

Influence of mouth opening on oropharyngeal humidification and temperature in a bench model of neonatal continuous positive airway pressure.

PubMed

Fischer, Hendrik S; Ullrich, Tim L; Bührer, Christoph; Czernik, Christoph; Schmalisch, Gerd

2017-02-01

Clinical studies show that non-invasive respiratory support by continuous positive airway pressure (CPAP) affects gas conditioning in the upper airways, especially in the presence of mouth leaks. Using a new bench model of neonatal CPAP, we investigated the influence of mouth opening on oropharyngeal temperature and humidity. The model features the insertion of a heated humidifier between an active model lung and an oropharyngeal head model to simulate the recurrent expiration of heated, humidified air. During unsupported breathing, physiological temperature and humidity were attained inside the model oropharynx, and mouth opening had no significant effect on oropharyngeal temperature and humidity. During binasal CPAP, the impact of mouth opening was investigated using three different scenarios: no conditioning in the CPAP circuit, heating only, and heated humidification. Mouth opening had a strong negative impact on oropharyngeal humidification in all tested scenarios, but heated humidification in the CPAP circuit maintained clinically acceptable humidity levels regardless of closed or open mouths. The model can be used to test new equipment for use with CPAP, and to investigate the effects of other methods of non-invasive respiratory support on gas conditioning in the presence of leaks. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Open-source point-of-care electronic medical records for use in resource-limited settings: systematic review and questionnaire surveys

PubMed Central

Bru, Juan; Berger, Christopher A

2012-01-01

Background Point-of-care electronic medical records (EMRs) are a key tool to manage chronic illness. Several EMRs have been developed for use in treating HIV and tuberculosis, but their applicability to primary care, technical requirements and clinical functionalities are largely unknown. Objectives This study aimed to address the needs of clinicians from resource-limited settings without reliable internet access who are considering adopting an open-source EMR. Study eligibility criteria Open-source point-of-care EMRs suitable for use in areas without reliable internet access. Study appraisal and synthesis methods The authors conducted a comprehensive search of all open-source EMRs suitable for sites without reliable internet access. The authors surveyed clinician users and technical implementers from a single site and technical developers of each software product. The authors evaluated availability, cost and technical requirements. Results The hardware and software for all six systems is easily available, but they vary considerably in proprietary components, installation requirements and customisability. Limitations This study relied solely on self-report from informants who developed and who actively use the included products. Conclusions and implications of key findings Clinical functionalities vary greatly among the systems, and none of the systems yet meet minimum requirements for effective implementation in a primary care resource-limited setting. The safe prescribing of medications is a particular concern with current tools. The dearth of fully functional EMR systems indicates a need for a greater emphasis by global funding agencies to move beyond disease-specific EMR systems and develop a universal open-source health informatics platform. PMID:22763661

Validating archetypes for the Multiple Sclerosis Functional Composite.

PubMed

Braun, Michael; Brandt, Alexander Ulrich; Schulz, Stefan; Boeker, Martin

2014-08-03

Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions.This case study provides evidence that both community- and tool-enabled review processes, structured in the Clinical Knowledge Manager, ensure archetype quality. It offers a pragmatic but feasible way to reduce variation in the representation of clinical information models towards a more unified and interoperable model.

Validating archetypes for the Multiple Sclerosis Functional Composite

PubMed Central

2014-01-01

Background Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. Methods A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Results Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. Conclusions The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions. This case study provides evidence that both community- and tool-enabled review processes, structured in the Clinical Knowledge Manager, ensure archetype quality. It offers a pragmatic but feasible way to reduce variation in the representation of clinical information models towards a more unified and interoperable model. PMID:25087081

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

PubMed Central

de León-Casasola, Oscar A; Mayoral, Victor

2016-01-01

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

Managing research and surveillance projects in real-time with a novel open-source eManagement tool designed for under-resourced countries.

PubMed

Steiner, Andreas; Hella, Jerry; Grüninger, Servan; Mhalu, Grace; Mhimbira, Francis; Cercamondi, Colin I; Doulla, Basra; Maire, Nicolas; Fenner, Lukas

2016-09-01

A software tool is developed to facilitate data entry and to monitor research projects in under-resourced countries in real-time. The eManagement tool "odk_planner" is written in the scripting languages PHP and Python. The odk_planner is lightweight and uses minimal internet resources. It was designed to be used with the open source software Open Data Kit (ODK). The users can easily configure odk_planner to meet their needs, and the online interface displays data collected from ODK forms in a graphically informative way. The odk_planner also allows users to upload pictures and laboratory results and sends text messages automatically. User-defined access rights protect data and privacy. We present examples from four field applications in Tanzania successfully using the eManagement tool: 1) clinical trial; 2) longitudinal Tuberculosis (TB) Cohort Study with a complex visit schedule, where it was used to graphically display missing case report forms, upload digitalized X-rays, and send text message reminders to patients; 3) intervention study to improve TB case detection, carried out at pharmacies: a tablet-based electronic referral system monitored referred patients, and sent automated messages to remind pharmacy clients to visit a TB Clinic; and 4) TB retreatment case monitoring designed to improve drug resistance surveillance: clinicians at four public TB clinics and lab technicians at the TB reference laboratory used a smartphone-based application that tracked sputum samples, and collected clinical and laboratory data. The user friendly, open source odk_planner is a simple, but multi-functional, Web-based eManagement tool with add-ons that helps researchers conduct studies in under-resourced countries. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity.

PubMed

Krleža-Jerić, Karmela; Gabelica, Mirko; Banzi, Rita; Martinić, Marina Krnić; Pulido, Bibiana; Mahmić-Kaknjo, Mersiha; Reveiz, Ludovic; Šimić, Josip; Utrobičić, Ana; Hrgović, Irena

2016-10-15

The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 proposal by the International Council of Medical Journal Editors triggered ample discussion about CT data sharing and reconfirmed the need for an ongoing assessment of its dynamics. The IMProving Access to Clinical Trials data (IMPACT) Observatory aims to play such a role, and assess the data sharing culture, policies, and practices of key players, the impact of their interventions on CTs, and contribute to a transformation of research. The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings. Methods include a scoping study of research, surveys, interviews, and an environmental scan of research data repositories. Our preliminary findings indicate that although opening of CT data has not yet been achieved, its evolution is encouraging. Initiatives by key players contribute to increasing of CT data sharing, and many barriers are shrinking or disappearing. The major barrier is the lack of data sharing standards, from preparing data for public sharing to its curatorship, findability and access. However, experiences accumulated by sharing CT data according to "upon request" or "open" mechanisms could inform the development of such standards. The Vivli, CORBEL-ECRIN and Open Trials projects are currently working in this direction.

Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.

PubMed

Rosenberg, Evan C; Louik, Jay; Conway, Erin; Devinsky, Orrin; Friedman, Daniel

2017-08-01

Recent clinical trials indicate that cannabidiol (CBD) may reduce seizure frequency in pediatric patients with certain forms of treatment-resistant epilepsy. Many of these patients experience significant impairments in quality of life (QOL) in physical, mental, and social dimensions of health. In this study, we measured the caregiver-reported Quality of Life in Childhood Epilepsy (QOLCE) in a subset of patients enrolled in a prospective, open-label clinical study of CBD. Results from caregivers of 48 patients indicated an 8.2 ± 9.9-point improvement in overall patient QOLCE (p < 0.001) following 12 weeks of CBD. Subscores with improvement included energy/fatigue, memory, control/helplessness, other cognitive functions, social interactions, behavior, and global QOL. These differences were not correlated to changes in seizure frequency or adverse events. The results suggest that CBD may have beneficial effects on patient QOL, distinct from its seizure-reducing effects; however, further studies in placebo-controlled, double-blind trials are necessary to confirm this finding. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

[Extramedullary fixation combined with intramedullary fixation in the surgical reduction of sagittal mandibular condylar fractures].

PubMed

Chuanjun, Chen; Xiaoyang, Chen; Jing, Chen

2016-10-01

This study aimed to evaluate the clinical effect of extramedullary fixation combined with intramedullary fixation during the surgical reduction of sagittal mandibular condylar fractures. Twenty-four sagittal fractures of the mandibular condyle in18 patients were fixed by two appliances: intramedullary with one long-screw osteosynthesis or Kirschner wire and extramedullary with one micro-plate. The radiologically-recorded post-operative stability-associated com-plications included the screw/micro-plate loosening, micro-plate twisting, micro-plate fractures, and fragment rotation. The occluding relations, the maximalinter-incisal distances upon mouth opening, and the mandibular deflection upon mouth opening were evaluated based on follow-up clinical examination. Postoperative panoramic X-ray and CT scans showed good repositioning of the fragment, with no redislocation or rotation, no screw/plate loosening, and no plate-twisting or fracture. Clinical examination showed that all patients regained normal mandibular movements, ideal occlusion, and normal maximal inter-incisal distances upon mouth opening. Extramedullary fixation combined with intramedullary fixation is highly recommended for sagittal condylar fractures because of the anti-rotation effect of the fragment and the reasonable place-ment of the fixation appliances.

Applying openEHR's Guideline Definition Language to the SITS international stroke treatment registry: a European retrospective observational study.

PubMed

Anani, Nadim; Mazya, Michael V; Chen, Rong; Prazeres Moreira, Tiago; Bill, Olivier; Ahmed, Niaz; Wahlgren, Nils; Koch, Sabine

2017-01-10

Interoperability standards intend to standardise health information, clinical practice guidelines intend to standardise care procedures, and patient data registries are vital for monitoring quality of care and for clinical research. This study combines all three: it uses interoperability specifications to model guideline knowledge and applies the result to registry data. We applied the openEHR Guideline Definition Language (GDL) to data from 18,400 European patients in the Safe Implementation of Treatments in Stroke (SITS) registry to retrospectively check their compliance with European recommendations for acute stroke treatment. Comparing compliance rates obtained with GDL to those obtained by conventional statistical data analysis yielded a complete match, suggesting that GDL technology is reliable for guideline compliance checking. The successful application of a standard guideline formalism to a large patient registry dataset is an important step toward widespread implementation of computer-interpretable guidelines in clinical practice and registry-based research. Application of the methodology gave important results on the evolution of stroke care in Europe, important both for quality of care monitoring and clinical research.

Comparison of Clinical and Radiologic Results of Mini-Open Transforaminal Lumbar Interbody Fusion and Extreme Lateral Interbody Fusion Indirect Decompression for Degenerative Lumbar Spondylolisthesis.

PubMed

Kono, Yutaka; Gen, Hogaku; Sakuma, Yoshio; Koshika, Yasuhide

2018-04-01

Retrospective study. In this study, we compared the postoperative outcomes of extreme lateral interbody fusion (XLIF) indirect decompression with that of mini-open transforaminal lumbar interbody fusion (TLIF) in patients with lumbar degenerative spondylolisthesis. There are very few reports examining postoperative results of XLIF and minimally invasive TLIF for degenerative lumbar spondylolisthesis, and no reports comparing XLIF and mini-open TLIF. Forty patients who underwent 1-level spinal fusion, either by XLIF indirect decompression (X group, 20 patients) or by mini-open TLIF (T group, 20 patients), for treatment of lumbar degenerative spondylolisthesis were included in this study. Invasiveness of surgery was evaluated on the basis of surgery time, blood loss, hospitalization period, and perioperative complications. The Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ), disc angle (DA), disc height (DH), and slipping length (SL) were evaluated before surgery, immediately after surgery, and at 12 months after surgery. Cross-sectional spinal canal area (CSA) was also measured before surgery and at 1 month after surgery. There was no significant difference between the groups in terms of surgery time or hospitalization period; however, X group showed a significant decrease in blood loss ( p <0.001). Serious complications were not observed in either group. In clinical assessment, no significant differences were observed between the groups with regard to the JOABPEQ results. The change in DH at 12 months after surgery increased significantly in the X group ( p <0.05), and the changes in DA and SL were not significantly different between the two groups. The change in CSA was significantly greater in the T group ( p <0.001). Postoperative clinical results were equally favorable for both procedures; however, in comparison with mini-open TLIF, less blood loss and greater correction of DH were observed in XLIF.

Clinical Investigation Program Annual Progress Report

DTIC Science & Technology

1993-09-30

272 93/200A 0 Comparison of Healing Rates of Bones Plated Following Fracture, Among Yucatan Swine Having Open and Closed Physes...Study Objective: Compare two enteral formulas in respect to nutritional aspects. (16) Technical Approach: Protocol will take place in SICU. (17...Protocol #: 93/200A (3) Status: Ongoing (4) Title: Comparison of Healing Rates of Bones Plated Following Fractures, Among Yucatan Swine Having Open and

No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a Phase I Open Label Study to assess safety, tolerability and cytokine responses

USDA-ARS?s Scientific Manuscript database

Although Lactobacillus rhamnosus GG ATCC 53103 (LGG) has been consumed since the mid 1990s by between 2 and 5 million people daily, the scientific literature lacks rigorous clinical trials that describe the potential harms of LGG, particularly in the elderly. The primary objective of this open label...

Short- and long-term clinical outcomes of use of beta-interferon or glatiramer acetate for people with clinically isolated syndrome: a systematic review of randomised controlled trials and network meta-analysis.

PubMed

Armoiry, X; Kan, A; Melendez-Torres, G J; Court, R; Sutcliffe, P; Auguste, P; Madan, J; Counsell, C; Clarke, A

2018-05-01

Beta-interferon (IFN-β) and glatiramer acetate (GA) have been evaluated in people with clinically isolated syndrome (CIS) with the aim to delay a second clinical attack and a diagnosis of clinically definite multiple sclerosis (CDMS). We systematically reviewed trials evaluating the short- and long-term clinical effectiveness of these drugs in CIS. We searched multiple electronic databases. We selected randomised controlled studies (RCTs) conducted in CIS patients and where the interventions were IFN-β and GA. Main outcomes were time to CDMS, and discontinuation due to adverse events (AE). We compared interventions using random-effect network meta-analyses (NMA). We also reported outcomes from long-term open-label extension (OLE) studies. We identified five primary studies. Four had open-label extensions following double-blind periods comparing outcomes between early vs delayed DMT. Short-term clinical results (double-blind period) showed that all drugs delayed CDMS compared to placebo. Indirect comparisons did not suggest superiority of any one active drug over another. We could not undertake a NMA for discontinuation due to AE. Long-term clinical results (OLE studies) showed that the risk of developing CDMS was consistently reduced across studies after early DMT treatment compared to delayed DMT (HR = 0.64, 95% CI 0.55, 0.74). No data supported the benefit of DMTs in reducing the time to, and magnitude of, disability progression. Meta-analyses confirmed that IFN-β and GA delay time to CDMS compared to placebo. In the absence of evidence that early DMTs can reduce disability progression, future research is needed to better identify patients most likely to benefit from long-term DMTs.

Methodology Series Module 4: Clinical Trials.

PubMed

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

Methodology Series Module 4: Clinical Trials

PubMed Central

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an “open trial.” However, many of the trials are not open – they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India. PMID:27512184

Factors associated with the prevalence of anterior open bite among preschool children: A population-based study in Brazil

PubMed Central

Machado, Daniella Borges; Brizon, Valéria Silva Cândido; Ambrosano, Gláucia Maria Bovi; Madureira, Davidson Fróis; Gomes, Viviane Elisângela; de Oliveira, Ana Cristina Borges

2014-01-01

INTRODUCTION: The aim of this study was to identify factors associated with the prevalence of anterior open bite among five-year-old Brazilian children. METHODS: A cross-sectional study was undertaken using data from the National Survey of Oral Health (SB Brazil 2010). The outcome variable was anterior open bite classified as present or absent. The independent variables were classified by individual, sociodemographic and clinical factors. Data were analyzed through bivariate and multivariate analysis using SPSS statistical software (version 18.0) with a 95% level of significance. RESULTS: The prevalence of anterior open bite was 12.1%. Multivariate analysis showed that preschool children living in Southern Brazil had an increased chance of 1.8 more times of having anterior open bite (CI 95%: 1.16 - 3.02). Children identified with alterations in overjet had 14.6 times greater chances of having anterior open bite (CI 95%: 8.98 - 24.03). CONCLUSION: There was a significant association between anterior open bite and the region of Brazil where the children lived, the presence of altered overjet and the prevalence of posterior crossbite. PMID:25715723

Deep Sternal Wound Infection after Open-Heart Surgery: A 13-Year Single Institution Analysis.

PubMed

Juhl, Alexander Andersen; Hody, Sofie; Videbaek, Tina Senholt; Damsgaard, Tine Engberg; Nielsen, Per Hostrup

2017-04-20

The present study aimed to compare the clinical outcome for patients with or without muscle flap reconstruction after deep sternal wound infection due to open-heart surgery. The study was a retrospective cohort study, including patients who developed deep sternal wound infection after open-heart surgery in the Western Denmark Region from 1999 to 2011. Journals of included patients were reviewed for clinical data regarding the treatment of their sternal defect. Patients were divided into two groups depending on whether they received a muscle-flap-based sternal reconstruction or traditional rewiring of the sternum. A total of 130 patients developed deep sternal wound infection in the study period. In all, 12 patients died before being discharged, leaving a total of 118 patients for analysis. Of these, 50 (42%) patients received muscle flap reconstruction. Muscle flap recipients had significantly longer total hospital stays (p <0.001). However, after receiving muscle flap reconstruction, patients were discharged after a median of 14 days, with 74% not needing additional surgery. It is difficult to predict which patients eventually require muscle flap reconstruction after deep sternal wound infection. Although patients receiving muscle flap reconstructions have longer hospital stays, they are quickly discharged after the reconstruction.

Augmentation in the treatment of restless legs syndrome with transdermal rotigotine.

PubMed

Beneš, Heike; García-Borreguero, Diego; Ferini-Strambi, Luigi; Schollmayer, Erwin; Fichtner, Andreas; Kohnen, Ralf

2012-06-01

To assess the risk of augmentation under treatment with the transdermally delivered dopamine agonist rotigotine for restless legs syndrome (RLS). Experts in RLS augmentation retrospectively reviewed data from two double-blind, placebo-controlled 6-month trials (745 rotigotine and 214 placebo subjects, NCT00136045 and NCT00135993) and from two open-label 1-year trials (620 rotigotine subjects, NCT00498108 and NCT00263068). All study visits were systematically evaluated applying the Max Planck Institute (MPI) criteria for the diagnosis of both augmentation and clinically relevant augmentation. MPI criteria for augmentation were met on at least one visit by 8.2% of all subjects in the double-blind trials with 12 subjects meeting the criteria for clinically relevant augmentation: 11 under rotigotine (1.5%) and one under placebo treatment. In the open-label trials, 9.7% of all subjects met the MPI criteria for augmentation and 2.9% met the criteria for clinically relevant augmentation. None of the patients treated with rotigotine for up to 1.5 years (double-blind plus open-label trial) discontinued prematurely owing to augmentation. Neither could dose-dependency or a time pattern for clinically relevant augmentation episodes be detected. Our analyses suggest that the risk for clinically relevant augmentation for the duration of up to 18 months of rotigotine treatment is low. Copyright © 2012 Elsevier B.V. All rights reserved.

Laparoscopic versus open inguinal hernia repair in patients with obesity: an American College of Surgeons NSQIP clinical outcomes analysis.

PubMed

Froylich, Dvir; Haskins, Ivy N; Aminian, Ali; O'Rourke, Colin P; Khorgami, Zhamak; Boules, Mena; Sharma, Gautam; Brethauer, Stacy A; Schauer, Phillip R; Rosen, Michael J

2017-03-01

The laparoscopic approach to inguinal hernia repair (IHR) has proven beneficial in reducing postoperative pain and facilitating earlier return to normal activity. Except for indications such as recurrent or bilateral inguinal hernias, there remains a paucity of data that specifically identities patient populations that would benefit most from the laparoscopic approach to IHR. Nevertheless, previous experience has shown that obese patients have increased wound morbidity following open surgical procedures. The aim of this study was to investigate the effect of a laparoscopic versus open surgical approach to IHR on early postoperative morbidity and mortality in the obese population using the National Surgical Quality Improvement Program (NSQIP) database. All IHRs were identified within the NSQIP database from 2005 to 2013. Obesity was defined as a body mass index ≥30 kg/m 2 . A propensity score matching technique between the laparoscopic and open approaches was used. Association of obesity with postoperative outcomes was investigated using an adjusted and unadjusted model based on clinically important preoperative variables identified by the propensity scoring system. A total of 7346 patients met inclusion criteria; 5573 patients underwent laparoscopic IHR, while 1773 patients underwent open IHR. On univariate analysis, obese patients who underwent laparoscopic IHR were less likely to experience a deep surgical site infection, wound dehiscence, or return to the operating room compared with those who underwent an open IHR. In both the adjusted and unadjusted propensity score models, there was no difference in outcomes between those who underwent laparoscopic versus open IHR. The laparoscopic approach to IHR in obese patients has similar outcomes as an open approach with regard to 30-day wound events. Preoperative risk stratification of obese patients is important to determining the appropriate surgical approach to IHR. Further studies are needed to investigate the long-term effects of the open and laparoscopic approaches to IHR in the obese population.

Ubiquitous information for ubiquitous computing: expressing clinical data sets with openEHR archetypes.

PubMed

Garde, Sebastian; Hovenga, Evelyn; Buck, Jasmin; Knaup, Petra

2006-01-01

Ubiquitous computing requires ubiquitous access to information and knowledge. With the release of openEHR Version 1.0 there is a common model available to solve some of the problems related to accessing information and knowledge by improving semantic interoperability between clinical systems. Considerable work has been undertaken by various bodies to standardise Clinical Data Sets. Notwithstanding their value, several problems remain unsolved with Clinical Data Sets without the use of a common model underpinning them. This paper outlines these problems like incompatible basic data types and overlapping and incompatible definitions of clinical content. A solution to this based on openEHR archetypes is motivated and an approach to transform existing Clinical Data Sets into archetypes is presented. To avoid significant overlaps and unnecessary effort during archetype development, archetype development needs to be coordinated nationwide and beyond and also across the various health professions in a formalized process.

Preclinical evaluation of the effect of the combined use of the Ethicon Securestrap® Open Absorbable Strap Fixation Device and Ethicon Physiomesh™ Open Flexible Composite Mesh Device on surgeon stress during ventral hernia repair

PubMed Central

Sutton, Nadia; MacDonald, Melinda H; Lombard, John; Ilie, Bodgan; Hinoul, Piet; Granger, Douglas A

2018-01-01

Aim To evaluate whether performing ventral hernia repairs using the Ethicon Physiomesh™ Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap® Open Absorbable Strap Fixation Device reduces surgical time and surgeon stress levels, compared with traditional surgical repair methods. Methods To repair a simulated ventral incisional hernia, two surgeries were performed by eight experienced surgeons using a live porcine model. One procedure involved traditional suture methods and a flat mesh, and the other procedure involved a mechanical fixation device and a skirted flexible composite mesh. A Surgery Task Load Index questionnaire was administered before and after the procedure to establish the surgeons’ perceived stress levels, and saliva samples were collected before, during, and after the surgical procedures to assess the biologically expressed stress (cortisol and salivary alpha amylase) levels. Results For mechanical fixation using the Ethicon Physiomesh Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap Open Absorbable Strap Fixation Device, surgeons reported a 46.2% reduction in perceived workload stress. There was also a lower physiological reactivity to the intraoperative experience and the total surgical procedure time was reduced by 60.3%. Conclusions This study provides preliminary findings suggesting that the combined use of a mechanical fixation device and a skirted flexible composite mesh in an open intraperitoneal onlay mesh repair has the potential to reduce surgeon stress. Additional studies are needed to determine whether a reduction in stress is observed in a clinical setting and, if so, confirm that this results in improved clinical outcomes. PMID:29296101

Voice analysis before and after vocal rehabilitation in patients following open surgery on vocal cords.

PubMed

Bunijevac, Mila; Petrović-Lazić, Mirjana; Jovanović-Simić, Nadica; Vuković, Mile

2016-02-01

The major role of larynx in speech, respiration and swallowing makes carcinomas of this region and their treatment very influential for patients' life quality. The aim of this study was to assess the importance of voice therapy in patients after open surgery on vocal cords. This study included 21 male patients and the control group of 19 subjects. The vowel (A) was recorded and analyzed for each examinee. All the patients were recorded twice: firstly, when they contacted the clinic and secondly, after a three-month vocal therapy, which was held twiceper week on an outpatient basis. The voice analysis was carried out in the Ear, Nose and Throat (ENT) Clinic, Clinical Hospital Center "Zvezdara" in Belgrade. The values of the acoustic parameters in the patients submitted to open surgery on the vocal cords before vocal rehabilitation and the control group subjects were significantly different in all specified parameters. These results suggest that the voice of the patients was damaged before vocal rehabilitation. The results of the acoustic parameters of the vowel (A) before and after vocal rehabilitation of the patients with open surgery on vocal cords were statistically significantly different. Among the parameters--Jitter (%), Shimmer (%)--the observed difference was highly statistically significant (p < 0.01). The voice turbulence index and the noise/harmonic ratio were also notably improved, and the observed difference was statistically significant (p < 0.05). The analysis of the tremor intensity index showed no significant improvement and the observed difference was not statistically significant (p > 0.05 ). CONCLUSION. There was a significant improvement of the acoustic parameters of the vowel (A) in the study subjects three months following vocal therapy. Only one out of five representative parameters showed no significant improvement.

OpenTrials: towards a collaborative open database of all available information on all clinical trials.

PubMed

Goldacre, Ben; Gray, Jonathan

2016-04-08

OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data.

Comparison of closed-ended, open-ended, and perceived informed consent comprehension measures for a mock HIV prevention trial among women in Tanzania.

PubMed

MacQueen, Kathleen M; Chen, Mario; Ramirez, Catalina; Nnko, Soori E A; Earp, Kelly M

2014-01-01

Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research. An increasing number of articles assessing methods to improve comprehension have been published, but they use a wide range of outcome measures including open-ended, closed-ended, and self-perceived measures of comprehension. Systematic comparisons of different measures have rarely been reported. This study evaluated the likely direction of bias observed when using open-ended, closed-ended, and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza, Tanzania. Participants were randomized to either a closed-ended or an open-ended assessment of comprehension, administered the consent process for a hypothetical HIV prevention trial in Kiswahili, and then administered a comprehension assessment, per their randomization. They were then asked how easy or hard it was to understand each of the informed consent components measured in the comprehension assessment. Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm. Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms. Findings highlight the importance of comprehension assessments in complex clinical trials that go beyond asking participants if they understand or have any questions. They also indicate the need for continued exploration of objective measures of comprehension in international clinical research settings, so that points in need of clarification can be efficiently and effectively identified and addressed. Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood.

The Contextualization of Archetypes: Clinical Template Governance.

PubMed

Pedersen, Rune; Ulriksen, Gro-Hilde; Ellingsen, Gunnar

2015-01-01

This paper is a status report from a large-scale openEHR-based EPR project from the North Norway Regional Health Authority. It concerns the standardization of a regional ICT portfolio and the ongoing development of a new process oriented EPR systems encouraged by the unfolding of a national repository for openEHR archetypes. Subject of interest; the contextualization of clinical templates is governed over multiple national boundaries which is complex due to the dependency of clinical resources. From the outset of this, we are interested in how local, regional, and national organizers maneuver to standardize while applying OpenEHR technology.

Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research.

PubMed

Morris, Michael J; Basch, Ethan M; Wilding, George; Hussain, Maha; Carducci, Michael A; Higano, Celestia; Kantoff, Philip; Oh, William K; Small, Eric J; George, Daniel; Mathew, Paul; Beer, Tomasz M; Slovin, Susan F; Ryan, Charles; Logothetis, Christopher; Scher, Howard I

2009-01-01

In 2005, the US Department of Defense, through the US Army Medical Research and Materiel Command, Office of the Congressionally Directed Medical Research Programs, created a funding mechanism to form a clinical trials consortium to conduct phase I and II studies in prostate cancer. This is the first report of the Prostate Cancer Clinical Trials Consortium (PCCTC). The Department of Defense award supports a consortium of 10 prostate cancer research centers. Memorial Sloan-Kettering Cancer Center was awarded the Coordinating Center grant for the consortium and charged with creating an infrastructure to conduct early-phase multicenter clinical trials. Each participating center was required to introduce >or=1 clinical trial per year and maintain accrual of a minimum of 35 patients per year. The PCCTC was launched in 2006 and now encompasses 10 leading prostate cancer research centers. Fifty-one trials have been opened, and 1386 patients have been accrued at member sites. Members share an online clinical trial management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, an administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review are established. The PCCTC fulfills a congressional directive to create a clinical trials instrument dedicated to early-phase prostate cancer studies. The member institutions have built an administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. Clinical trials are open and accruing in excess of federally mandated goals.

Closed Versus Open Supracondylar Fractures of the Humerus in Children: A Comparison of Clinical and Radiographic Presentation and Results.

PubMed

Lewine, Eliza; Kim, Jaehon M; Miller, Patricia E; Waters, Peter M; Mahan, Susan T; Snyder, Brian; Hedequist, Daniel; Bae, Donald S

2018-02-01

The purpose of this investigation was to compare the presentation and postoperative results of children treated for open and closed, completely displaced type III supracondylar humerus fractures (SCFs). Thirty patients with open and 66 patients with closed, completely displaced type III SCFs were evaluated. Open fractures underwent irrigation and debridement, and all patients were treated by open or closed reduction and pin fixation. Medical records were reviewed to obtain demographic information as well as preoperative and postoperative clinical data regarding mechanism of injury, neurovascular status, associated injuries, postoperative range of motion, infections, and pain. Radiographs were evaluated to quantify displacement, Baumann's angle, humeral capitellar angle, position of the anterior humeral line, and adequacy of reduction. Outcomes were assessed using Flynn criteria. Mean clinical follow-up for the open and closed fracture groups was 8.9 and 5.7 months, respectively. Both groups were similar with respect to age, sex distribution, weight and body mass index, laterality of involvement, and mechanism of injury. At presentation, 35% of closed SCFs and 23% of open SCFs presented with abnormal neurovascular status. There was a higher prevalence of diminished/absent pulses or distal limb ischemia in patients with open injuries (27%) compared with closed fractures (18%). Conversely, severely displaced closed fractures were more commonly associated with nerve injury/palsy at presentation (35%) than those with open fractures (23%). Spontaneous nerve recovery was seen in 87% within 3 to 6 months. Postoperative loss of reduction and malunion were more common in the closed fracture group. However, 84% of patients achieved good-to-excellent results by Flynn criteria, with no appreciable difference based upon open versus closed fractures. With timely wound and fracture treatment, the clinical and radiographic results of children treated for open SCFs is similar to those with closed type III injuries, with little increased risk for infection, malunion, or neurovascular compromise. Level III.

Junctional ectopic tachycardia after infant heart surgery: incidence and outcomes.

PubMed

Zampi, Jeffrey D; Hirsch, Jennifer C; Gurney, James G; Donohue, Janet E; Yu, Sunkyung; LaPage, Martin J; Hanauer, David A; Charpie, John R

2012-12-01

Junctional ectopic tachycardia (JET) is an arrhythmia observed almost exclusively after open heart surgery in children. Current literature on JET has not focused on patients at the highest risk of both developing and being negatively impacted by JET. The purpose of this study was to determine the overall incidence of JET in an infant patient cohort undergoing open cardiac surgery, to identify patient- and procedure-related factors associated with developing JET, and to assess the clinical impact of JET on patient outcomes. We performed a nested case-control study from the complete cohort of patients at our institution younger than 1 year of age who underwent open heart surgery between 2005 and 2010. JET patients were compared with an age matched control group undergoing open heart surgery without JET regarding potential risk factors and outcomes. The overall incidence of JET in infants after open cardiac surgery was 14.3 %. From multivariate analyses, complete repair of tetralogy of Fallot [adjusted odds ratio (AOR) 2.0, 95 % CI 1.12-3.57] and longer aortic cross clamp times (AOR 1.02, 95 % CI 1.01-1.03) increased the risk of developing JET. Patients with JET had longer length of intubation, intensive care unit stays, and total length of hospitalization, and were more likely to require extracorporeal membrane oxygenation support (13 vs. 4.3 %). JET is a common postoperative arrhythmia in infants after open heart operations. Both anatomic substrate and surgical procedure contribute to the overall risk of developing JET. Developing JET is associated with worse clinical outcomes.

Influence of storage time on vitrified human cleavage-stage embryos froze in open system.

PubMed

Li, Wei; Zhao, Wanqiu; Xue, Xia; Zhang, Silin; Zhang, Xin; Shi, Juanzi

2017-02-01

During in vitro fertilization, rapid growth of vitrification and liquid nitrogen storage of embryos have been well characterized. However, the effect of storage time on vitrified cleavage-stage embryos in an open system is poorly understood. To investigate the influence of storage time on the survival and pregnancy outcomes of vitrified human cleavage-stage embryos froze and stored in an open system. A retrospective study of 786 vitrified-warmed cycles of 735 patients was performed from January 2013 to October 2013. The cycles were divided into five groups according to storage time: 1-3 months, 4-6 months, 7-12 months, 13-24 and 25-60 months. The clinical outcomes of cycles with different storage time were analyzed. There were no significant differences of the survival rate, clinical pregnancy outcomes, birth rate, gestational weeks and singleton birthweights at various storage times. For vitrified embryos froze and stored in an open system, the storage time would not influence the survival rate and pregnancy outcomes by storage time up to 5 years.

Mechanical design of an intracranial stent for treating cerebral aneurysms.

PubMed

Shobayashi, Yasuhiro; Tanoue, Tetsuya; Tateshima, Satoshi; Tanishita, Kazuo

2010-11-01

Endovascular treatment of cerebral aneurysms using stents has advanced markedly in recent years. Mechanically, a cerebrovascular stent must be very flexible longitudinally and have low radial stiffness. However, no study has examined the stress distribution and deformation of cerebrovascular stents using the finite element method (FEM) and experiments. Stents can have open- and closed-cell structures, and open-cell stents are used clinically in the cerebrovasculature because of their high flexibility. However, the open-cell structure confers a risk of in-stent stenosis due to protrusion of stent struts into the normal parent artery. Therefore, a flexible stent with a closed-cell structure is required. To design a clinically useful, highly flexible, closed-cell stent, one must examine the mechanical properties of the closed-cell structure. In this study, we investigated the relationship between mesh patterns and the mechanical properties of closed-cell stents. Several mesh patterns were designed and their characteristics were studied using numerical simulation. The results showed that the bending stiffness of a closed-cell stent depends on the geometric configuration of the stent cell. It decreases when the stent cell is stretched in the circumferential direction. Mechanical flexibility equal to an open-cell structure was obtained in a closed-cell structure by varying the geometric configuration of the stent cell. Copyright © 2010 IPEM. Published by Elsevier Ltd. All rights reserved.

Should essays and other "open-ended"-type questions retain a place in written summative assessment in clinical medicine?

PubMed

Hift, Richard J

2014-11-28

Written assessments fall into two classes: constructed-response or open-ended questions, such as the essay and a number of variants of the short-answer question, and selected-response or closed-ended questions; typically in the form of multiple-choice. It is widely believed that constructed response written questions test higher order cognitive processes in a manner that multiple-choice questions cannot, and consequently have higher validity. An extensive review of the literature suggests that in summative assessment neither premise is evidence-based. Well-structured open-ended and multiple-choice questions appear equivalent in their ability to assess higher cognitive functions, and performance in multiple-choice assessments may correlate more highly than the open-ended format with competence demonstrated in clinical practice following graduation. Studies of construct validity suggest that both formats measure essentially the same dimension, at least in mathematics, the physical sciences, biology and medicine. The persistence of the open-ended format in summative assessment may be due to the intuitive appeal of the belief that synthesising an answer to an open-ended question must be both more cognitively taxing and similar to actual experience than is selecting a correct response. I suggest that cognitive-constructivist learning theory would predict that a well-constructed context-rich multiple-choice item represents a complex problem-solving exercise which activates a sequence of cognitive processes which closely parallel those required in clinical practice, hence explaining the high validity of the multiple-choice format. The evidence does not support the proposition that the open-ended assessment format is superior to the multiple-choice format, at least in exit-level summative assessment, in terms of either its ability to test higher-order cognitive functioning or its validity. This is explicable using a theory of mental models, which might predict that the multiple-choice format will have higher validity, a statement for which some empiric support exists. Given the superior reliability and cost-effectiveness of the multiple-choice format consideration should be given to phasing out open-ended format questions in summative assessment. Whether the same applies to non-exit-level assessment and formative assessment is a question which remains to be answered; particularly in terms of the educational effect of testing, an area which deserves intensive study.

Arthroscopy for treating temporomandibular joint disorders.

PubMed

Currie, Roger

2011-01-01

The Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline Embase, Lilacs, Allied and Complementary Medicine Database (AMED) and CINAHL databases were searched. In addition the reference lists of the included articles were checked and 14 journals hand searched. Randomised controlled clinical trials (RCT) of arthroscopy for treating TMDs were included. There were no restrictions regarding the language or date of publication. Two review authors independently extracted data, and three review authors independently assessed the risk of bias of included trials. The authors of the selected articles were contacted for additional information. Pooling of trials was only attempted if at least two trials of comparable protocols, with the same conditions and similar outcome measurements were available. Statistical analysis was performed in accordance with the Cochrane Collaboration guidelines. Seven RCTs (n = 349) met the inclusion criteria. All the studies were either at high or unclear risk of bias. Pain was evaluated after six months in two studies. No statistically significant differences were found between the arthroscopy versus nonsurgical groups (standardised mean difference (SMD) = 0.004; 95% confidence interval (CI) - 0.46 to 0.55, P = 0.81). Two studies analysed pain 12 months after surgery (arthroscopy and arthrocentesis) in 81 patients. No statistically significant differences were found (mean difference (MD) = 0.10; 95% CI -1.46 to 1.66, P = 0.90). Three studies analysed the same outcome in patients who had been submitted to arthroscopic surgery or to open surgery and a statistically significant difference was found after 12 months (SMD = 0.45; 95% CI 0.01 to 0.89, P = 0.05) in favour of open surgery.The two studies compared the maximum interincisal opening in six different clinical outcomes (interincisal opening over 35 mm; maximum protrusion over 5 mm; click; crepitation; tenderness on palpation in the TMJ and the jaw muscles 12 months after arthroscopy and open surgery). The outcome measures did not present statistically significant differences (odds ratio (OR) = 1.00; 95% CI 0.45 to 2.21, P = 1.00). Two studies compared the maximum interincisal opening after 12 months of postsurgical follow-up. A statistically significant difference in favour of the arthroscopy group was observed (MD = 5.28; 95% CI 3.46 to 7.10, P < 0.0001).The two studies compared the mandibular function after 12 months of follow-up with 40 patients evaluated. The outcome measure was mandibular functionality (MFIQ). This difference was not statistically significant (MD = 1.58; 95% CI -0.78 to 3.94, P = 0.19). Both arthroscopy and nonsurgical treatments reduced pain after six months. When compared with arthroscopy, open surgery was more effective at reducing pain after 12 months. Nevertheless, there were no differences in mandibular functionality or in other outcomes in clinical evaluations. Arthroscopy led to greater improvement in maximum interincisal opening after 12 months than arthrocentesis; however, there was no difference in pain.

ETIB opens clinical trial for patients with HPV-16+ cancers | Center for Cancer Research

Cancer.gov

Dr. Christian Hinrichs, Lasker Clinical Research Scholar in the Experimental Transplantation and Immunology Branch, is leading a study of a new therapy for cancers caused by human papillomavirus (HPV), which include cervical, throat, anal, and genital cancers. HPV-related cancer cells carry a protein called E7.  Learn more...

Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

ERIC Educational Resources Information Center

Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie

2012-01-01

Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

Clinically Relevant Changes in Emotional Expression in Children with ADHD Treated with Lisdexamfetamine Dimesylate

ERIC Educational Resources Information Center

Katic, Alain; Ginsberg, Lawrence; Jain, Rakesh; Adeyi, Ben; Dirks, Bryan; Babcock, Thomas; Scheckner, Brian; Richards, Cynthia; Lasser, Robert; Turgay, Atilla; Findling, Robert L.

2012-01-01

Objective: To describe clinically relevant effects of lisdexamfetamine dimesylate (LDX) on emotional expression (EE) in children with ADHD. Method: Children with ADHD participated in a 7-week, open-label, LDX dose-optimization study. Expression and Emotion Scale for Children (EESC) change scores were analyzed post hoc using two methods to…

Clinical Practice as Natural Laboratory for Psychotherapy Research: A Guide to Case-Based Time-Series Analysis

ERIC Educational Resources Information Center

Borckardt, Jeffrey J.; Nash, Michael R.; Murphy, Martin D.; Moore, Mark; Shaw, Darlene; O'Neil, Patrick

2008-01-01

Both researchers and practitioners need to know more about how laboratory treatment protocols translate to real-world practice settings and how clinical innovations can be systematically tested and communicated to a skeptical scientific community. The single-case time-series study is well suited to opening a productive discourse between practice…

The ecology of medical care on an isolated island in Okinawa, Japan: a retrospective open cohort study.

PubMed

Kaneko, Makoto; Matsushima, Masato; Irving, Greg

2017-01-14

We aimed to describe the ecology of medical care on an isolated island with limited access to secondary care, and to evaluate the gatekeeping function of the island's primary care clinic through comparison with a previous nationwide survey. We conducted this retrospective, open cohort study on Iheya, an isolated island in Okinawa Prefecture that has one primary care clinic. We considered Iheya as unique location in which to examine the role of primary care in Japan. Participants were patients who visited the island's clinic between February 1, 2013 and January 31, 2014. We calculated the number of visits to the clinic and referrals to off-island medical facilities using electronic medical records. We also compared data for Iheya with a nationwide survey conducted in 2003. Iheya had 1314 inhabitants in 2013. Of the 5682 visits to the clinic in the 1-year study period, 290 people were referred to off-island medical institutions. There were 64 referrals to emergency departments; of these, 57 people were admitted to hospital. The rate of visits to the clinic per month per 1000 inhabitants was 360.4 visits (95% confidence interval: 351.0-369.7). Of these, 18.4 (16.3-20.5) were referred off-island, with 4.1 (3.1-5.1) referrals to emergency departments and 3.6 (2.6-4.6) hospitalizations. Despite the high incidence of visits to the primary care clinic, the rates of hospital-based outpatient clinic visits, emergency department visits, and hospitalizations were lower than rates reported in a previous Japanese study. This suggests that several dimensions of primary care, its gatekeeping function in particular, are likely to play important roles in this geographical setting.

Clinical use of closed-system safety peripheral intravenous cannulas.

PubMed

Barton, Andrew

2018-04-26

Peripheral intravenous (IV) cannulas are the quickest and most effective way of gaining venous vascular access and administering IV therapy. Closed-system peripheral IV cannulas have been shown to be safe and more reliable than open, non-valved peripheral cannulas in clinical practice. This article introduces the Smiths Medical DeltaVen closed-system peripheral IV cannula and includes three case studies describing its use in clinical practice and associated patient outcomes.

Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

PubMed

Sugimoto, Shinya; Naganuma, Makoto; Kiyohara, Hiroki; Arai, Mari; Ono, Keiko; Mori, Kiyoto; Saigusa, Keiichiro; Nanki, Kosaku; Takeshita, Kozue; Takeshita, Tatsuya; Mutaguchi, Makoto; Mizuno, Shinta; Bessho, Rieko; Nakazato, Yoshihiro; Hisamatsu, Tadakazu; Inoue, Nagamu; Ogata, Haruhiko; Iwao, Yasushi; Kanai, Takanori

2016-01-01

Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted. © 2016 S. Karger AG, Basel.

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

PubMed

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

2012-09-01

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

Investigation of the Safety of Focused Ultrasound-Induced Blood-Brain Barrier Opening in a Natural Canine Model of Aging.

PubMed

O'Reilly, Meaghan Anne; Jones, Ryan Matthew; Barrett, Edward; Schwab, Anthony; Head, Elizabeth; Hynynen, Kullervo

2017-01-01

Rationale: Ultrasound-mediated opening of the Blood-Brain Barrier(BBB) has shown exciting potential for the treatment of Alzheimer's disease(AD). Studies in transgenic mouse models have shown that this approach can reduce plaque pathology and improve spatial memory. Before clinical translation can occur the safety of the method needs to be tested in a larger brain that allows lower frequencies be used to treat larger tissue volumes, simulating clinical situations. Here we investigate the safety of opening the BBB in half of the brain in a large aged animal model with naturally occurring amyloid deposits. Methods: Aged dogs naturally accumulate plaques and show associated cognitive declines. Low-frequency ultrasound was used to open the BBB unilaterally in aged beagles (9-11yrs, n=10) in accordance with institutionally approved protocols. Animals received either a single treatment or four weekly treatments. Magnetic resonance imaging(MRI) was used to guide the treatments and assess the tissue effects. The animals underwent neurological testing during treatment follow-up, and a follow-up MRI exam 1 week following the final treatment. Results: The permeability of the BBB was successfully increased in all animals (mean enhancement: 19±11% relative to untreated hemisphere). There was a single adverse event in the chronic treatment group that resolved within 24 hrs. Follow-up MRI showed the BBB to be intact with no evidence of tissue damage in all animals. Histological analysis showed comparable levels of microhemorrhage between the treated and control hemispheres in the prefrontal cortex (single/repeat treatment: 1.0±1.4 vs 0.4±0.5/5.2±1.8 vs. 4.0±2.0). No significant differences were observed in beta-amyloid load (single/repeat: p=0.31/p=0.98) although 3/5 animals in each group showed lower Aβ loads in the treated hemisphere. Conclusion: Whole-hemisphere opening of the BBB was well tolerated in the aged large animal brain. The treatment volumes and frequencies used are clinically relevant and indicate safety for clinical translation. Further study is warranted to determine if FUS has positive effects on naturally occurring amyloid pathology.

Modified open-access scheduling for new patient evaluations at an academic chronic pain clinic increased patient access to care, but did not materially reduce their mean cancellation rate: A retrospective, observational study.

PubMed

Sivanesan, Eellan; Lubarsky, David A; Ranasinghe, Chaturani T; Sarantopoulos, Constantine D; Epstein, Richard H

2017-09-01

To determine if open-access scheduling would reduce the cancellation rate for new patient evaluations in a chronic pain clinic by at least 50%. Retrospective, observational study using electronic health records. Chronic pain clinic of an academic anesthesia department. All patients scheduled for evaluation or follow-up appointments in the chronic pain clinic between April 1, 2014, and December 31, 2015. Open-access scheduling was instituted in April 2015 with appointments offered on a date of the patient's choosing ≥1 business day after calling, with no limit on the daily number of new patients. Mean cancellation rates for new patients were compared between the 12-month baseline period prior to and for 7months after the change, following an intervening 2-month washout period. The method of batch means (by month) and the 2-sided Student t-test were used; P<0.01 required for significance. The new patient mean cancellation rate decreased from a baseline of 35.7% by 4.2% (95% confidence interval [CI] 1.4% to 6.9%; P=0.005); however, this failed to reach the 50% reduction target of 17.8%. Appointment lag time decreased by 4.7days (95% CI 2.3 to 7.0days, P<0.001) from 14.1days to 9.4days in the new patient group. More new patients were seen within 1week compared to baseline (50.6% versus 19.1%; P<0.0001). The mean number of new patient visits per month increased from 158.5 to 225.0 (P=0.0004). The cancellation rate and appointment lag times did not decrease for established patient visits, as expected because open-access scheduling was not implemented for this group. Access to care for new chronic pain patients improved with modified open-access scheduling. However, their mean cancellation rate only decreased from 35.7% to 31.5%, making this a marginally effective strategy to reduce cancellations. Copyright © 2017 Elsevier Inc. All rights reserved.

Investigation of the Safety of Focused Ultrasound-Induced Blood-Brain Barrier Opening in a Natural Canine Model of Aging

PubMed Central

O'Reilly, Meaghan Anne; Jones, Ryan Matthew; Barrett, Edward; Schwab, Anthony; Head, Elizabeth; Hynynen, Kullervo

2017-01-01

Rationale: Ultrasound-mediated opening of the Blood-Brain Barrier(BBB) has shown exciting potential for the treatment of Alzheimer's disease(AD). Studies in transgenic mouse models have shown that this approach can reduce plaque pathology and improve spatial memory. Before clinical translation can occur the safety of the method needs to be tested in a larger brain that allows lower frequencies be used to treat larger tissue volumes, simulating clinical situations. Here we investigate the safety of opening the BBB in half of the brain in a large aged animal model with naturally occurring amyloid deposits. Methods: Aged dogs naturally accumulate plaques and show associated cognitive declines. Low-frequency ultrasound was used to open the BBB unilaterally in aged beagles (9-11yrs, n=10) in accordance with institutionally approved protocols. Animals received either a single treatment or four weekly treatments. Magnetic resonance imaging(MRI) was used to guide the treatments and assess the tissue effects. The animals underwent neurological testing during treatment follow-up, and a follow-up MRI exam 1 week following the final treatment. Results: The permeability of the BBB was successfully increased in all animals (mean enhancement: 19±11% relative to untreated hemisphere). There was a single adverse event in the chronic treatment group that resolved within 24 hrs. Follow-up MRI showed the BBB to be intact with no evidence of tissue damage in all animals. Histological analysis showed comparable levels of microhemorrhage between the treated and control hemispheres in the prefrontal cortex (single/repeat treatment: 1.0±1.4 vs 0.4±0.5/5.2±1.8 vs. 4.0±2.0). No significant differences were observed in beta-amyloid load (single/repeat: p=0.31/p=0.98) although 3/5 animals in each group showed lower Aβ loads in the treated hemisphere. Conclusion: Whole-hemisphere opening of the BBB was well tolerated in the aged large animal brain. The treatment volumes and frequencies used are clinically relevant and indicate safety for clinical translation. Further study is warranted to determine if FUS has positive effects on naturally occurring amyloid pathology. PMID:28912896

Body image and self-esteem in disorders of sex development: A European multicenter study.

PubMed

van de Grift, Tim C; Cohen-Kettenis, Peggy T; de Vries, Annelou L C; Kreukels, Baudewijntje P C

2018-04-01

Disorders/differences of sex development (DSD) refer to congenital conditions with atypical sex development and are associated with psychosexual issues. The aim of this study was to assess body image and self-esteem across the DSD spectrum and to study the impact of diagnosis and mediating characteristics. Data collection was part of dsd-LIFE, a cross-sectional study conducted by 14 European expert clinics on wellbeing and health care evaluation of adults diagnosed with DSD. Main outcome measures in the present analyses were the Body Image Scale and Rosenberg Self-Esteem Scale. Additional data were obtained on treatments, openness, body embarrassment, sexual satisfaction, anxiety, and depression. The participating sample (n = 1,040) included 226 classified as Congenital Adrenal Hyperplasia, 225 as Klinefelter Syndrome, 322 as Turner Syndrome, and 267 as conditions with 46,XY karyotype. Many participants had received hormonal and surgical treatments. Participants scored lower on body image and self-esteem compared to control values, whereas each diagnosis showed different areas of concern. Limited openness, body embarrassment, and sexual issues were frequently reported. Overall body satisfaction was associated with BMI, hormone use, openness, body embarrassment, anxiety, and depression; genital satisfaction with age at diagnosis, openness, sexual satisfaction, and body embarrassment. Body embarrassment, anxiety, and depression predicted lower self-esteem. While each DSD showed specific issues related to body image and self-esteem, our findings indicate that the related factors were similar across the conditions. Clinical care on this subject could be improved by giving specific attention to factors like openness, body embarrassment, sexuality, anxiety, and depression. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Dysphagia in infants after open heart procedures.

PubMed

Yi, Sook-Hee; Kim, Sang-Jun; Huh, June; Jun, Tae-Gook; Cheon, Hee Jung; Kwon, Jeong-Yi

2013-06-01

The aims of this study were to evaluate the prevalence and the clinical predictors of dysphagia and to determine the characteristics of videofluoroscopic swallowing study findings in infants after open heart procedures. This study is a retrospective review of 146 infants who underwent open heart surgery. The infants with dysphagia were compared with those without dysphagia. The videofluoroscopic swallowing study findings of the infants with dysphagia were also evaluated. Of the 146 infants who underwent open heart surgery, 35 (24.0%) had dysphagia symptoms. The infants with dysphagia had lower body weight at operation, more malformation syndromes, longer operation times, and more complex operations than did the infants without dysphagia. In addition, the infants with dysphagia required more time to achieve full oral feeding and had longer hospital stays. Thirty-three infants underwent videofluoroscopic swallowing study: 32 (97.0%) exhibited at least one abnormal finding among the videofluoroscopic swallowing study parameters and 21 (63.6%) exhibited tracheal aspiration. Given the high rate of aspiration in the infants who underwent open heart procedures, monitoring and prompt recognition of the signs and the risk factors of dysphagia may substantially improve infant care with oral feeding and reduce the duration of hospital stays.

Disclosing clinical adverse events to patients: can practice inform policy?

PubMed Central

Sorensen, Ros; Iedema, Rick; Piper, Donella; Manias, Elizabeth; Williams, Allison; Tuckett, Anthony

2009-01-01

Abstract Objectives  To understand patients’ and health professionals’ experience of Open Disclosure and how practice can inform policy. Background  Open Disclosure procedures are being implemented in health services worldwide yet empirical evidence on which to base models of patient–clinician communication and policy development is scant. Design, setting and participants  A qualitative method was employed using semi‐structured open‐ended interviews with 154 respondents (20 nursing, 49 medical, 59 clinical/administrative managerial, 3 policy coordinators, 15 patients and 8 family members) in 21 hospitals and health services in four Australian states. Results  Both patients and health professionals were positive about Open Disclosure, although each differed in their assessments of practice effectiveness. We found that five major elements influenced patients’ and professionals’ experience of openly disclosing adverse events namely: initiating the disclosure, apologizing for the adverse event, taking the patient’s perspective, communicating the adverse event and being culturally aware. Conclusions  Evaluating the impact of Open Disclosure refines policy implementation because it provides an evidence base to inform policy. Health services can use specific properties relating to each of the five Open Disclosure elements identified in this study as training standards and to assess the progress of policy implementation. However, health services must surmount their sensitivity to revealing the extent of error so that research into patient experiences can inform practice and policy development. PMID:19804555

Comparative effectiveness of open versus minimally invasive sacroiliac joint fusion.

PubMed

Ledonio, Charles Gt; Polly, David W; Swiontkowski, Marc F; Cummings, John T

2014-01-01

The mainstay of sacroiliac joint disruption/degenerative sacroiliitis therapy has been nonoperative management. This nonoperative management often includes a regimen of physical therapy, chiropractic treatment, therapeutic injections, and possibly radiofrequency ablation at the discretion of the treating physician. When these clinical treatments fail, sacroiliac joint fusion has been recommended as the standard treatment. Open and minimally invasive (MIS) surgical techniques are typical procedures. This study aims to compare the perioperative measures and Oswestry Disability Index (ODI) outcomes associated with each of these techniques. A comparative retrospective chart review of patients with sacroiliac joint fusion and a minimum of 1 year of follow-up was performed. Perioperative measures and ODI scores were compared using the Fisher's exact test and two nonparametric tests, ie, the Mann-Whitney U test and the Wilcoxon signed-rank test. The results are presented as percent or median with range, as appropriate. Forty-nine patients from two institutions underwent sacroiliac joint fusion between 2006 and 2012. Ten patients were excluded because of incomplete data, leaving 39 evaluable patients, of whom 22 underwent open and 17 underwent MIS sacroiliac joint fusion. The MIS group was significantly older (median age 66 [39-82] years) than the open group (median age 51 [34-74] years). Surgical time and hospital stay were significantly shorter in the MIS group than in the open group. Preoperative ODI was significantly greater in the open group (median 64 [44-78]) than in the MIS group (median 53 [14-84]). Postoperative improvement in ODI was statistically significant within and between groups, with MIS resulting in greater improvement. The open and MIS sacroiliac joint fusion techniques resulted in statistically and clinically significant improvement for patients with degenerative sacroiliitis refractory to nonoperative management. However, the number of patients reaching the minimal clinically important difference and those showing overall improvement were greater in the MIS group.

Comparative effectiveness of open versus minimally invasive sacroiliac joint fusion

PubMed Central

Ledonio, Charles GT; Polly, David W; Swiontkowski, Marc F; Cummings, John T

2014-01-01

Background The mainstay of sacroiliac joint disruption/degenerative sacroiliitis therapy has been nonoperative management. This nonoperative management often includes a regimen of physical therapy, chiropractic treatment, therapeutic injections, and possibly radiofrequency ablation at the discretion of the treating physician. When these clinical treatments fail, sacroiliac joint fusion has been recommended as the standard treatment. Open and minimally invasive (MIS) surgical techniques are typical procedures. This study aims to compare the perioperative measures and Oswestry Disability Index (ODI) outcomes associated with each of these techniques. Methods A comparative retrospective chart review of patients with sacroiliac joint fusion and a minimum of 1 year of follow-up was performed. Perioperative measures and ODI scores were compared using the Fisher’s exact test and two nonparametric tests, ie, the Mann–Whitney U test and the Wilcoxon signed-rank test. The results are presented as percent or median with range, as appropriate. Results Forty-nine patients from two institutions underwent sacroiliac joint fusion between 2006 and 2012. Ten patients were excluded because of incomplete data, leaving 39 evaluable patients, of whom 22 underwent open and 17 underwent MIS sacroiliac joint fusion. The MIS group was significantly older (median age 66 [39–82] years) than the open group (median age 51 [34–74] years). Surgical time and hospital stay were significantly shorter in the MIS group than in the open group. Preoperative ODI was significantly greater in the open group (median 64 [44–78]) than in the MIS group (median 53 [14–84]). Postoperative improvement in ODI was statistically significant within and between groups, with MIS resulting in greater improvement. Conclusion The open and MIS sacroiliac joint fusion techniques resulted in statistically and clinically significant improvement for patients with degenerative sacroiliitis refractory to nonoperative management. However, the number of patients reaching the minimal clinically important difference and those showing overall improvement were greater in the MIS group. PMID:24940087

Nasal filters in prevention of seasonal rhinitis induced by allergenic pollen grains. Open clinical study.

PubMed

D'Amato, G; Liccardi, G; Salzillo, A; Russo, M; Narciso, P; Allegra, L

2012-04-01

Nasal filters (Sanispira) might represent a novel approach in preventing exacerbations of symptoms of seasonal allergic rhinitis by reducing pollen access to nasal cavities. Female and male voluntary patients between the ages of 18 and 64 years living in Naples area and affected by allergic rhinitis were recruited in an open clinical study. All were allergic to Parietaria pollen as assessed by skin-prick and/or RAST test with or without associated sensitization to other pollens such as Gramineae and Olea europaea. A pollen count was also carried out from 10th April until 30th of June 2011. The results of our study show positive statistical differences between the scores of common nasal symptoms and the reduced use of antihistaminic drugs in patients using nasal filters in comparison to non users. Nasal filters constitute a useful mean to reduce symptoms of seasonal allergic rhinitis in patients suffering from pollen allergy.

Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial.

PubMed

van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G

2018-01-01

To determine the best operation technique, open versus laparoscopic, for insertion of a peritoneal dialysis (PD) catheter with regard to clinical success. Clinical success was defined as an adequate function of the catheter 2 - 4 weeks after insertion. All patients with end-stage renal disease who were suitable for PD and gave informed consent were randomized for either open surgery or laparoscopic surgery. A previous laparotomy was not considered an exclusion criterion. Laparoscopic placement had the advantage of pre-peritoneal tunneling, the possibility for adhesiolysis, and placement of the catheter under direct vision. Catheter fixation techniques, omentopexy, or other adjunct procedures were not performed. Other measured parameters were in-hospital morbidity and mortality and post-operative infections. Between 2010 and 2016, 95 patients were randomized to this study protocol. After exclusion of 5 patients for various reasons, 44 patients received an open procedure and 46 patients a laparoscopic procedure. Gender, age, body mass index (BMI), hypertension, current hemodialysis, severe heart failure, and previous an abdominal operation were not significantly different between the groups. However, in the open surgery group, fewer patients had a previous median laparotomy compared with the laparoscopic group (6 vs 16 patients; p = 0.027). There was no statistically significant difference in mean operation time (36 ± 24 vs 38 ± 15 minutes) and hospital stay (2.1 ± 2.7 vs 3.1 ± 7.3 days) between the groups. In the open surgery group 77% of the patients had an adequate functioning catheter 2 - 4 weeks after insertion compared with 70% of patients in the laparoscopic group ( p = not significant [NS]). In the open surgery group there was 1 post-operative death (2%) compared with none in the laparoscopic group ( p = NS). The morbidity in both groups was low and not significantly different. In the open surgery group, 2 patients had an exit-site infection and 1 patient had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.

Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open-label study for clinical use experience.

PubMed

Kim, Yoshiharu; Asukai, Nozomu; Konishi, Takako; Kato, Hiroshi; Hirotsune, Hideto; Maeda, Masaharu; Inoue, Hirotaka; Narita, Hiroyasu; Iwasaki, Masaru

2008-12-01

The present study was a 52-week, non-comparative, open-label study of flexible dose paroxetine (20-40 mg) in 52 Japanese post-traumatic stress disorder (PTSD) patients in order to obtain clinical experience regarding efficacy and safety in regular clinical practice. Efficacy was measured using the Clinician-Administered PTSD Scale One Week Symptom Status Version (CAPS-SX). The mean change from baseline in CAPS-SX total score was -19.1, -22.8 and -32.3 at weeks 4, 12 and 52, respectively, and that in the Clinical Global Impression (CGI) Severity of Illness score was -1.1 at week 12 and -1.7 at week 52. A total of 46.9% were CGI responders at week 12, while 67.3% were improved on the CGI at week 52. Of 52 subjects who entered into the drug treatment, 25 completed the study. Only one patient withdrew from the study due to lack of efficacy. In patients who were rated as 'moderately ill' or less at baseline, the proportion of CGI responders at end-point was higher at a dose of 20 mg/day than at higher doses, whereas in patients rated as 'markedly ill' or more, it was higher at 30 and 40 mg/day, suggesting that severely ill patients could benefit from higher doses. Paroxetine appeared generally tolerated in short- and long-term use, and the safety profile in this study was consistent with international trials and other Japanese populations (i.e. patients suffering from depression, panic disorder or obsessive-compulsive disorder). Although the study was not conducted in double-blind fashion, the current findings suggest that paroxetine may contribute to clinically meaningful improvement that is maintained during long-term use and is generally well tolerated.

Outcomes and Resource Utilization of Endoscopic Mass-Closure Technique for Laryngeal Clefts.

PubMed

Balakrishnan, Karthik; Cheng, Esther; de Alarcon, Alessandro; Sidell, Douglas R; Hart, Catherine K; Rutter, Michael J

2015-07-01

To compare resource utilization and clinical outcomes between endoscopic mass-closure and open techniques for laryngeal cleft repair. Case series with chart review. Tertiary academic children's hospital. Pediatric patients undergoing repair for Benjamin-Inglis type 1-3 laryngeal clefts over a 15-year period. All 20 patients undergoing endoscopic repair were included. Eight control patients undergoing open repair were selected using matching by age and cleft type. Demographic, clinical, and resource utilization data were collected. Twenty-eight patients were included (20 endoscopic, 8 open). Mean age, rates of tracheostomy and vocal fold immobility, and distribution of cleft types were not different between the 2 groups (all P > .2). Mean operative time (P = .004) and duration of hospital stay (P < .001) were significantly shorter in the endoscopic group. All repairs were intact in both groups at final postoperative endoscopy. Rates of persistent laryngeal penetration or aspiration on swallow study were not different between groups (P = 1.000), although results were available for only 11 patients. Endoscopic laryngeal cleft repair using a mass-closure technique provides a durable result while requiring significantly shorter operative times and hospital stays than open repair and avoiding the potential morbidity of laryngofissure. However, open repair may allow the simultaneous performance of other airway reconstructive procedures and may be a useful salvage technique when endoscopic repair fails. Postoperative swallowing results require further study. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

International developments in openEHR archetypes and templates.

PubMed

Leslie, Heather

Electronic Health Records (EHRs) are a complex knowledge domain. The ability to design EHRs to cope with the changing nature of health knowledge, and to be shareable, has been elusive. A recent pilot study1 tested the applicability of the CEN 13606 as an electronic health record standard. Using openEHR archetypes and tools2, 650 clinical content specifi cations (archetypes) were created (e.g. for blood pressure) and re-used across all clinical specialties and contexts. Groups of archetypes were aggregated in templates to support clinical information gathering or viewing (e.g. 80 separate archetypes make up the routine antenatal visit record). Over 60 templates were created for use in the emergency department, antenatal care and delivery of an infant, and paediatric hearing loss assessment. The primary goal is to define a logical clinical record architecture for the NHS but potentially, with archetypes as the keystone, shareable EHRs will also be attainable. Archetype and template development work is ongoing, with associated evaluation occurring in parallel.

Open Globe Injury Patient Identification in Warfare Clinical Notes1

PubMed Central

Apostolova, Emilia; White, Helen A.; Morris, Patty A.; Eliason, David A.; Velez, Tom

2017-01-01

The aim of this study is to utilize the Defense and Veterans Eye Injury and Vision Registry clinical data derived from DoD and VA medical systems which include documentation of care while in combat, and develop methods for comprehensive and reliable Open Globe Injury (OGI) patient identification. In particular, we focus on the use of free-form clinical notes, since structured data, such as diagnoses or procedure codes, as found in early post-trauma clinical records, may not be a comprehensive and reliable indicator of OGIs. The challenges of the task include low incidence rate (few positive examples), idiosyncratic military ophthalmology vocabulary, extreme brevity of notes, specialized abbreviations, typos and misspellings. We modeled the problem as a text classification task and utilized a combination of supervised learning (SVMs) and word embeddings learnt in a unsupervised manner, achieving a precision of 92.50% and a recall of89.83%o. The described techniques are applicable to patient cohort identification with limited training data and low incidence rate. PMID:29854104

Open-access MIMIC-II database for intensive care research.

PubMed

Lee, Joon; Scott, Daniel J; Villarroel, Mauricio; Clifford, Gari D; Saeed, Mohammed; Mark, Roger G

2011-01-01

The critical state of intensive care unit (ICU) patients demands close monitoring, and as a result a large volume of multi-parameter data is collected continuously. This represents a unique opportunity for researchers interested in clinical data mining. We sought to foster a more transparent and efficient intensive care research community by building a publicly available ICU database, namely Multiparameter Intelligent Monitoring in Intensive Care II (MIMIC-II). The data harnessed in MIMIC-II were collected from the ICUs of Beth Israel Deaconess Medical Center from 2001 to 2008 and represent 26,870 adult hospital admissions (version 2.6). MIMIC-II consists of two major components: clinical data and physiological waveforms. The clinical data, which include patient demographics, intravenous medication drip rates, and laboratory test results, were organized into a relational database. The physiological waveforms, including 125 Hz signals recorded at bedside and corresponding vital signs, were stored in an open-source format. MIMIC-II data were also deidentified in order to remove protected health information. Any interested researcher can gain access to MIMIC-II free of charge after signing a data use agreement and completing human subjects training. MIMIC-II can support a wide variety of research studies, ranging from the development of clinical decision support algorithms to retrospective clinical studies. We anticipate that MIMIC-II will be an invaluable resource for intensive care research by stimulating fair comparisons among different studies.

Prospective evaluation of short-term impact and recovery of health related quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus open radical prostatectomy.

PubMed

Miller, Javier; Smith, Angela; Kouba, Erik; Wallen, Eric; Pruthi, Raj S

2007-09-01

In the last few years there have been increasing claims that robotic assisted laparoscopic radical prostatectomy decreases short-term morbidity in patients undergoing surgical treatment for prostate cancer. However, there is surprisingly little objective evidence to support this point, which is often used to market the procedure to patients. To address this issue we prospectively evaluated patients undergoing open and robotic assisted laparoscopic radical prostatectomy at baseline and weekly through the postoperative period using a validated questionnaire. A total of 162 men undergoing radical prostatectomy, including open radical prostatectomy in 120 and robotic assisted laparoscopic radical prostatectomy in 42, for clinically localized prostate cancer completed the SF-12, version 2 Physical and Mental Health Survey Acute Form preoperatively and each week postoperatively for 6 weeks. Physical and Mental Component Scores were calculated from the questionnaires at each time point. Comparisons between the 2 surgical approaches were made at each time point. No significant differences were seen between the open and robotic assisted laparoscopic radical prostatectomy groups with regard to patient age, clinical stage or preoperative prostate specific antigen. Mean surgical blood loss was significantly higher in the open group compared to that in the robotic assisted laparoscopic group. Physical Component Scores in the robotic assisted laparoscopic group were significantly higher than those in the open cohort beginning postoperative week 1 and extending through week 6. On statistical extrapolation Physical Component Scores returned to baseline between weeks 5 and 6 postoperatively in the robotic assisted laparoscopic group and between weeks 6 and 7 in the open group. Mental Component Score scores were not statistically different between the groups except preoperatively. This study helps prospectively define short-term health related quality of life in patients undergoing robotic assisted laparoscopic vs open radical prostatectomy. Higher physical scores were seen in the robotic assisted laparoscopic group than the open group beginning postoperative week 1 and continuing weekly throughout the 6-week study period. Physical Component Score scores returned to baseline sooner in the robotic assisted laparoscopic group than in the open group.

Database on veterinary clinical research in homeopathy.

PubMed

Clausen, Jürgen; Albrecht, Henning

2010-07-01

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

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.

Enhancing communication in oncology outpatient consultations: critical reflections from doctors

PubMed Central

Murphy, Roger; Cox, Karen; Steward, William

2011-01-01

Objectives The experiences of patients diagnosed with advanced incurable cancer and the doctors who conducted their medical consultations were studied in order to improve the understanding of what happens in consultations, when bad news is disclosed. The major objective of the study was to critically reflect upon doctor-patient communication, in such situations, with a view to considering future strategies for doctors’ continuing professional development. Methods Sixteen patients and sixteen Oncologists, from a cancer centre in the UK were recruited into this ethnographic study. One hundred and fifteen episodes of data were collected from audio recorded consultations; interviews with doctors and patients and their relatives and observations of consultations. These data were analysed using a constant comparison method. Results Interactions between doctors and patients are complex and consultations can be challenging for both of them. Some doctors spoke openly about their need for additional support to enhance their communication related competencies within Oncology consultations. These doctors wanted to observe their peers conducting consultations. They also wanted to receive feedback about their own clinical practices. These doctors stated that they wanted an open culture whereby they could talk freely about difficult and emotionally challenging consultations without fear of being considered incompetent by their Consultants, who act in a clinical supervisory role. Conclusions To help practitioners consolidate their practice in such settings it is necessary to develop better collaborations among practitioners within clinical practice. Providing individual supervisory sessions or group workshops can facilitate reflective learning and provide an open and supportive learning culture.

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol. PMID:24888266

An Intimate Partner Violence informational program in a hospital fracture clinic: a pre-test post-test intervention study

PubMed Central

PREVAIL, Investigators

2017-01-01

Abstract: Background: Many organizations have conducted Intimate Partner Violence (IPV) informational campaigns, but the extent to which such cost-effective, simple changes to the clinic environment can improve patient perceptions about IPV is largely unknown. Our primary objective was to determine how an IPV informational program affects patients’ perceptions about discussing IPV in a fracture clinic setting. Methods: We conducted a pre-post intervention study to evaluate the impacts of an IPV informational program on patients’ perceptions and willingness to discuss IPV in an orthopaedic fracture clinic setting. During the intervention phase, there were posters and brochures in each bed area and several places in the waiting area, and the surgeons received a button to wear on their lab coat stating their openness to discuss IPV and a set of instructions on how to ask patients about IPV and refer them to resources. Results: A total of 160 patients (80 pre-intervention and 80 post-intervention) have participated in this study. Overall perception of the clinic as an open place in which to discuss IPV did not change as a result of the informational program compared to the control setting. However, more patients exposed to posters and information about IPV believed the clinic staff possessed resources to help IPV victims compared to the control group; however, this difference did not reach statistical significance (62% vs. 53%, respectively, p=0.29). Conclusions: Passive interventions may serve an adjunctive role in facilitating active interventions in a clinic environment, but should not be considered in isolation as an effective approach. PMID:28039685

An intimate partner violence informational program in a hospital fracture clinic: a pre-test post-test intervention study.

PubMed

Investigators, Prevail

2017-01-01

Many organizations have conducted IPV informational campaigns, but the extent to which such cost-effective, simple changes to the clinic environment can improve patient perceptions about IPV is largely unknown. Our primary objective was to determine how an IPV informational program affects patients' perceptions about discussing IPV in a fracture clinic setting. We conducted a pre-post intervention study to evaluate the impacts of an IPV informational program on patients' perceptions and willingness to discuss IPV in an orthopaedic fracture clinic setting. During the intervention phase, there were posters and brochures in each bed area and several places in the waiting area, and the surgeons received a button to wear on their lab coat stating their openness to discuss IPV and a set of instructions on how to ask patients about IPV and refer them to resources. A total of 160 patients (80 pre-intervention and 80 post-intervention) have participated in this study. Overall perception of the clinic as an open place in which to discuss IPV did not change as a result of the informational program compared to the control setting. However, more patients exposed to posters and information about IPV believed the clinic staff possessed resources to help IPV victims compared to the control group; however, this difference did not reach statistical significance (62% vs. 53%, respectively, p=0.29). Passive interventions may serve an adjunctive role in facilitating active interventions in a clinic environment, but should not be considered in isolation as an effective approach. © 2017 KUMS, All rights reserved.

Effect of comorbid tics on a clinically meaningful response to 8-week open-label trial of fluoxetine in obsessive compulsive disorder.

PubMed

Husted, David S; Shapira, Nathan A; Murphy, Tanya K; Mann, Giselle D; Ward, Herbert E; Goodman, Wayne K

2007-01-01

Currently, there are limited published data evaluating the effects of tics on serotonin reuptake inhibitor (SRI) monotherapy responses in treating obsessive-compulsive disorder (OCD). One retrospective case-controlled analysis of OCD patients treated with SRI monotherapy showed lesser improvement in OCD symptoms in patients with tics than those without. However, more recently there were preliminary reports of OCD subjects treated with SRI monotherapy which did not demonstrate poorer response in subjects with tics or Tourette's Syndrome (TS). The specific aim of this study was to investigate whether the presence of comorbid chronic tics affected "clinically meaningful improvement" [McDougle, C.J., Goodman, W.K., Leckman, J.F., Barr, L.C., Heninger, G.R., Price, L.H., 1993. The efficacy of fluvoxamine in obsessive-compulsive disorder: effects of comorbid chronic tic disorder. Journal of Clinical Psychopharmacology 13, 354-358] of OCD in an 8-week open-label trial of fluoxetine monotherapy. Seventy-four adult subjects (13 patients with comorbid chronic tics and 61 patients without tics) with a primary DSM-IV OCD diagnosis were treated with up to 40mg fluoxetine for 8 weeks and had at least one post-baseline evaluation. The results indicate that there was a significant response by time in both fluoxetine-with-tic subjects and fluoxetine-without-tic subjects. Additionally, there were 3 (23.0%) OCD subjects with tics who had clinically meaningful improvement versus 16 (26.2%) OCD subjects without tics that demonstrated similar levels of improvement. These findings indicate that OCD patients with or without chronic tic disorders did not have a differential response to an 8-week open-label trial of fluoxetine. Limitations include the relatively low number of tic subjects and the open-label nature of the study. Additional data are needed on how comorbid tics may affect SRI treatment response in OCD.

Comparison between open plating versus minimally invasive plate osteosynthesis for acute displaced clavicular shaft fractures.

PubMed

Sohn, Hoon-Sang; Kim, Won Ju; Shon, Min Soo

2015-08-01

Current literatures describe good clinical outcomes of acute displaced fracture of clavicle treated with minimally invasive plate osteosynthesis (MIPO). But, there are little comparative data of the outcomes between open plating and MIPO techniques. We compared the outcomes of open plating and MIPO for treatment of acute displaced clavicular shaft fractures. The author performed a retrospective review on a consecutive series of patients with clavicular shaft fracture who underwent open plating or MIPO. Fourteen patients were treated with open plating with interfragmentary screw fixation, and 19 were treated with the MIPO technique without exposing a fracture site itself. A superior plating method was applied to both groups. Patient demographics, clinical outcomes using Constant score and University of California Los Angeles (UCLA) shoulder score, operation time, union rate, complications, and radiographic evaluation were evaluated. There were no statistically significant differences in the demographic data, including patient's variables (age, gender, involved side, smoking, alcohol, and diabetic status) and fracture characteristics (trauma mechanism, distribution of fracture type, presence of polytrauma, and time from trauma to surgery) between the two groups. Mean operation time was 87.5 min in open plating and 77.2 min in MIPO (p=0.129). The mean time to union was 15.7 weeks in patients who underwent open plating and 16.8 weeks in patients who underwent MIPO (p=0.427). Although there was no significant difference, nonunion developed 1 case in MIPO while none was in open plating. Four patients in open plating had skin numbness (none in MIPO, p=0.024). There was no significant difference in the Constant score and UCLA score of the two surgical methods. This study showed that both open plating with interfragmentary screw fixation (Open plating) and minimally invasive plate osteosynthesis (MIPO) are equally effective and safe treatment methods for acute displaced clavicle shaft fracture. Copyright © 2015 Elsevier Ltd. All rights reserved.

Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.

PubMed

Frosini, Francesco; Miniati, Roberto; Grillone, Saverio; Dori, Fabrizio; Gentili, Guido Biffi; Belardinelli, Andrea

2016-11-14

The following study proposes and tests an integrated methodology involving Health Technology Assessment (HTA) and Failure Modes, Effects and Criticality Analysis (FMECA) for the assessment of specific aspects related to robotic surgery involving safety, process and technology. The integrated methodology consists of the application of specific techniques coming from the HTA joined to the aid of the most typical models from reliability engineering such as FMEA/FMECA. The study has also included in-site data collection and interviews to medical personnel. The total number of robotic procedures included in the analysis was 44: 28 for urology and 16 for general surgery. The main outcomes refer to the comparative evaluation between robotic, laparoscopic and open surgery. Risk analysis and mitigation interventions come from FMECA application. The small sample size available for the study represents an important bias, especially for the clinical outcomes reliability. Despite this, the study seems to confirm the better trend for robotics' surgical times with comparison to the open technique as well as confirming the robotics' clinical benefits in urology. More complex situation is observed for general surgery, where robotics' clinical benefits directly measured are the lowest blood transfusion rate.

University of Washington Prostate Cancer Clinical Trials Consortium Application

DTIC Science & Technology

2011-04-01

13-25 Appendix 1: Protocol Evaluation Form Appendix 2: Community Symposia Flyer Appendix 3: Publications...Network Affiliate partners in the community . These and selected local practices receive quarterly correspondence that reviews our open clinical...studies: 09-002 (COU 301), 09-003 (AFFIRM), 09-004 (S0421), 09-005 (COU 302), 09-006 (doc dasatinib). Task 3. Maintain Communications with Consortium

A Case for Pharmacogenomics in Management of Cardiac Arrhythmias

PubMed Central

Kandoi, Gaurav; Nanda, Anjali; Scaria, Vinod; Sivasubbu, Sridhar

2012-01-01

Disorders of the cardiac rhythm are quite prevalent in clinical practice. Though the variability in drug response between individuals has been extensively studied, this information has not been widely used in clinical practice. Rapid advances in the field of pharmacogenomics have provided us with crucial insights on inter-individual genetic variability and its impact on drug metabolism and action. Technologies for faster and cheaper genetic testing and even personal genome sequencing would enable clinicians to optimize prescription based on the genetic makeup of the individual, which would open up new avenues in the area of personalized medicine. We have systematically looked at literature evidence on pharmacogenomics markers for anti-arrhythmic agents from the OpenPGx consortium collection and reason the applicability of genetics in the management of arrhythmia. We also discuss potential issues that need to be resolved before personalized pharmacogenomics becomes a reality in regular clinical practice. PMID:22557843

New treatment directions for IPF: current status of ongoing and upcoming clinical trials.

PubMed

Macagno, Francesco; Varone, Francesco; Leone, Paolo Maria; Mari, Pier-Valerio; Panico, Loredana; Berardini, Ludovica; Richeldi, Luca

2017-07-01

The main objective of this review is to explore the wide and expanding field of new clinical trials in IPF. Recent trials have confirmed the efficacy of the approved drugs pirfenidone and nintedanib; nonetheless, the discovery of new biological pathways has opened new horizons in this field. Areas covered: New strategies against matrix deposition are under study and so is for the role of immunity and autoimmunity. Recent advances in the use of stem cells are opening new possibilities for the recovery of damaged lung tissues. The role of microbioma is under investigation in order to evaluate the use of antibiotics in IPF treatment. Analysing all the new and the upcoming clinical trials, we are trying to offer a comprehensive view of the emerging new frontiers in the treatment of IPF. Expert commentary: The key points for the ongoing and upcoming clinical trials will be to avoid previous mistakes and to choose carefully both study populations and efficacy endpoints. The exciting possibility to enrol patients with progressive lung fibrosis, both idiopathic and not, could be a next step forward. How the existing therapies will fit in a futurist scenario of personalized medicine is still a challenge.

Impact of stress on dentists' clinical performance. A systematic review.

PubMed

Plessas, A; Delgado, M B; Nasser, M; Hanoch, Y; Moles, D R

2018-03-01

Dentistry is recognised as a stressful profession and dentists perceive their profession to be more stressful than other healthcare professions. While earlier studies have shown a link between stress and well-being among dentists, whether stress negatively impacts their clinical performance is an important and open question. We do know, however, that stress is associated with reduced performance in other health (and non-health) related professions. This systematic review aimed to answer the question: how does stress impact on dentists' clinical performance? This systematic review was registered in PROSPERO (CRD42016045756). The CINHAL, Embase, Medline, PsycINFO, EThOS and OpenGrey electronic databases were searched according to PRISMA guidelines. Two reviewers independently screened the citations for relevance. The citation list of potentially eligible papers was also searched. Prospective empirical studies were considered for inclusion. The inclusion criteria were applied at the full-text stage by the two same reviewers independently. The search yielded 3535 titles and abstracts. Twelve publications were considered potentially eligible, eleven of which were excluded as they did not meet the predefined inclusion criteria. This systematic review identified a gap in the literature as it found no empirical evidence quantifying the impact of stress on dentists' clinical performance. Prospective well-designed experimental simulation studies, comparing stress with non-stress situations on clinical performance and decision making, as well studies evaluating prospectively real-life dentists' performance under stress are warranted. Copyright© 2018 Dennis Barber Ltd.

Effects of aripiprazole once-monthly on symptoms of schizophrenia in patients switched from oral antipsychotics.

PubMed

Peters-Strickland, Timothy; Zhao, Cathy; Perry, Pamela P; Eramo, Anna; Salzman, Phyllis M; McQuade, Robert D; Johnson, Brian R; Sanchez, Raymond

2016-12-01

To assess the effects of aripiprazole once-monthly 400 mg (AOM 400) on clinical symptoms and global improvement in schizophrenia after switching from an oral antipsychotic. In a multicenter, open-label, mirror-image, naturalistic study in patients with schizophrenia (>1 year, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR] criteria), changes in efficacy measures were assessed during prospective treatment (6 months) with AOM 400 after switching from standard-of-care oral antipsychotics. During prospective treatment, patients were cross-titrated to oral aripiprazole monotherapy (1-4) weeks followed by open-label AOM 400 (24 weeks). Mean change from baseline of the open-label AOM 400 phase in Positive and Negative Syndrome Scale (PANSS) scores (total, positive and negative subscales) and Clinical Global Impression-Severity (CGI-S) scores; mean CGI-Improvement (CGI-I) score; and proportion of responders (≥30% decrease from baseline in PANSS total score or CGI-I score of 1 [very much improved] or 2 [much improved]) were assessed. PANSS and CGI-S scores improved from baseline (P<0.0001) and CGI-I demonstrated improvement at all time points. By the end of the study, 49.0% of patients were PANSS or CGI-I responders. In a community setting, patients with schizophrenia who were stabilized at baseline and switched to AOM 400 from oral antipsychotics showed clear improvements in clinical symptoms.

[Study of correlation dimension on EEG].

PubMed

Yang, Hao; Fang, Liang; He, Wei

2004-02-01

The study of non-linear EEG is of great significance in clinical practice and research work. This paper has gone into the feasibility of calculating the correlation dimension and has developed some subjects with the characters of correlation dimension and the difference under four conditions: (1) passive eyes closed(PEC); (2) mental arithmetic with eyes closed(MAEC); (3) passive eyes open(PEO); (4) mental reasoning with eyes open (MRED). The results show it is feasible and meaningful to calculate correlation dimension and the correlation dimension can reflect the regular patterns of mental activity.

A prospective clinical study evaluating the development of bowel wall edema during laparoscopic and open visceral surgery.

PubMed

Marjanovic, Goran; Kuvendziska, Jasmina; Holzner, Philipp Anton; Glatz, Torben; Sick, Olivia; Seifert, Gabriel; Kulemann, Birte; Küsters, Simon; Fink, Jodok; Timme, Sylvia; Hopt, Ulrich Theodor; Wellner, Ulrich; Keck, Tobias; Karcz, Wojciech Konrad

2014-12-01

To examine bowel wall edema development in laparoscopic and open major visceral surgery. In a prospective study, 47 consecutively operated patients with gastric and pancreatic resections were included. Twenty-seven patients were operated in a conventional open procedure (open group) and 20 in a laparoscopic fashion (lap group). In all procedures, a small jejunal segment was resected during standard preparation, of which we measured the dry-wet ratio. Furthermore, HE staining was performed for measuring of bowel wall thickness and edema assessment. Mean value (±std) of dry-wet ratio was significantly lower in the open than in the lap group (0.169 ± 0.017 versus 0.179 ± 0.015; p = 0.03) with the same amount of fluid administration in both groups and a longer infusion interval during laparoscopic surgery. Subgroup analyses (only pancreatic resections) still showed similar results. Histologic examination depicted a significantly larger bowel wall thickness in the open group. Laparoscopic surgery does not seem to lead to the bowel wall edema observed to occur in open surgery regardless of the degree of intravenous fluid administration, thus supporting its use even in major visceral surgery.

Mayo clinical Text Analysis and Knowledge Extraction System (cTAKES): architecture, component evaluation and applications

PubMed Central

Masanz, James J; Ogren, Philip V; Zheng, Jiaping; Sohn, Sunghwan; Kipper-Schuler, Karin C; Chute, Christopher G

2010-01-01

We aim to build and evaluate an open-source natural language processing system for information extraction from electronic medical record clinical free-text. We describe and evaluate our system, the clinical Text Analysis and Knowledge Extraction System (cTAKES), released open-source at http://www.ohnlp.org. The cTAKES builds on existing open-source technologies—the Unstructured Information Management Architecture framework and OpenNLP natural language processing toolkit. Its components, specifically trained for the clinical domain, create rich linguistic and semantic annotations. Performance of individual components: sentence boundary detector accuracy=0.949; tokenizer accuracy=0.949; part-of-speech tagger accuracy=0.936; shallow parser F-score=0.924; named entity recognizer and system-level evaluation F-score=0.715 for exact and 0.824 for overlapping spans, and accuracy for concept mapping, negation, and status attributes for exact and overlapping spans of 0.957, 0.943, 0.859, and 0.580, 0.939, and 0.839, respectively. Overall performance is discussed against five applications. The cTAKES annotations are the foundation for methods and modules for higher-level semantic processing of clinical free-text. PMID:20819853

A Review of Pharmacologic Treatment for Compulsive Buying Disorder.

PubMed

Soares, Célia; Fernandes, Natália; Morgado, Pedro

2016-04-01

At present, no treatment recommendations can be made for compulsive buying disorder. Recent studies have found evidence for the efficacy of psychotherapeutic options, but less is known regarding the best pharmacologic treatment. The purpose of this review is to present and analyze the available published evidence on the pharmacological treatment of compulsive buying disorder. To achieve this, we conducted a review of studies focusing on the pharmacological treatment of compulsive buying by searching the PubMed/MEDLINE database. Selection criteria were applied, and 21 studies were identified. Pharmacological classes reported included antidepressants, mood stabilizers, opioid antagonists, second-generation antipsychotics, and N-methyl-D-aspartate receptor antagonists. We found only placebo-controlled trials for fluvoxamine; none showed effectiveness against placebo. Three open-label trials reported clinical improvement with citalopram; one was followed by a double-blind discontinuation. Escitalopram was effective in an open-label trial but did not show efficacy in the double-blind phase. Memantine was identified as effective in a pilot open-label study. Fluoxetine, bupropion, nortriptyline, clomipramine, topiramate and naltrexone were only reported to be effective in clinical cases. According to the available literature, there is no evidence to propose a specific pharmacologic agent for compulsive buying disorder. Future research is required for a better understanding of both pathogenesis and treatment of this disorder.

Effect of EPI-743 on the clinical course of the mitochondrial disease Leber hereditary optic neuropathy.

PubMed

Sadun, Alfredo A; Chicani, Carlos Filipe; Ross-Cisneros, Fred N; Barboni, Piero; Thoolen, Martin; Shrader, William D; Kubis, Kenneth; Carelli, Valerio; Miller, Guy

2012-03-01

To evaluate the safety and efficacy of a new therapeutic agent, EPI-743, in Leber hereditary optic neuropathy (LHON) using standard clinical, anatomic, and functional visual outcome measures. Open-label clinical trial. University medical center. Patients  Five patients with genetically confirmed LHON with acute loss of vision were consecutively enrolled and treated with the experimental therapeutic agent EPI-743 within 90 days of conversion. Intervention  During the course of the study, 5 consecutive patients received EPI-743, by mouth, 3 times daily (100-400 mg per dose). Treatment effect was assessed by serial measurements of anatomic and functional visual indices over 6 to 18 months, including Snellen visual acuity, retinal nerve fiber layer thickness measured by optical coherence tomography, Humphrey visual fields (mean decibels and area with 1-log unit depression), and color vision. Treatment effect in this clinical proof of principle study was assessed by comparison of the prospective open-label treatment group with historical controls. Of 5 subjects treated with EPI-743, 4 demonstrated arrest of disease progression and reversal of visual loss. Two patients exhibited a total recovery of visual acuity. No drug-related adverse events were recorded. In a small open-label trial, EPI-743 arrested disease progression and reversed vision loss in all but 1 of the 5 consecutively treated patients with LHON. Given the known natural history of acute and rapid progression of LHON resulting in chronic and persistent bilateral blindness, these data suggest that the previously described irreversible priming to retinal ganglion cell loss may be reversed.

Laparoscopic versus open distal pancreatectomy for nonfunctioning pancreatic neuroendocrine tumors: a large single-center study.

PubMed

Han, Sang Hyup; Han, In Woong; Heo, Jin Seok; Choi, Seong Ho; Choi, Dong Wook; Han, Sunjong; You, Yung Hun

2018-01-01

Pancreatic neuroendocrine tumors (PNETs) account for 1-2% of all pancreatic neoplasms. Nonfunctioning PNETs (NF-PNETs) account for 60-90% of all PNETs. Laparoscopic distal pancreatectomy (LDP) is becoming the treatment of choice for benign lesions in the body and tail of the pancreas. However, LDP has not yet been widely accepted as the gold standard for NF-PNETs. The purpose of this study is to evaluate the clinical and oncologic outcomes after laparoscopic versus open distal pancreatectomy (ODP) for NF-PNETs. Between April 1995 and September 2016, 94 patients with NF-PNETs underwent open or laparoscopic distal pancreatectomy at Samsung Medical Center. Patients were divided into two groups: those who underwent LDP and those who underwent ODP. Both groups were compared in terms of clinical and oncologic variables. LDP patients had a significantly shorter hospital stay compared with ODP patients, amounting to a mean difference of 2 days (p < 0.001). Overall complication rates did not differ significantly between the ODP and LDP groups (p = 0.379). The 3-year overall survival rates in the ODP and LDP groups were 93.7 and 100%, respectively (p = 0.069). In this study, LDP for NF-PNETs had similar oncologic outcomes compared with ODP. In addition, LDP was associated with a shorter hospital stay compared with ODP. Therefore, LDP is a safe and effective procedure for patients with NF-PNETs. A multicenter study and a randomized controlled trial are needed to better assess the clinical and oncologic outcomes.

Financial Impact of the Robotic Approach in Liver Surgery: A Comparative Study of Clinical Outcomes and Costs Between the Robotic and Open Technique in a Single Institution.

PubMed

Daskalaki, Despoina; Gonzalez-Heredia, Raquel; Brown, Marc; Bianco, Francesco M; Tzvetanov, Ivo; Davis, Myriam; Kim, Jihun; Benedetti, Enrico; Giulianotti, Pier C

2017-04-01

One of the perceived major drawbacks of minimally invasive techniques has always been its cost. This is especially true for the robotic approach and is one of the main reasons that has prevented its wider acceptance among hospitals and surgeons. The aim of our study was to evaluate the clinical outcomes and economic impact of robotic and open liver surgery in a single institution. Sixty-eight robotic and 55 open hepatectomies were performed at our institution between January 1, 2009 and December 31, 2013. Demographics, perioperative data, and postoperative outcomes were collected and compared between the two groups. An independent company performed the financial analysis. The economic parameters comprised direct variable costs, direct fixed costs, and indirect costs. Mean estimated blood loss was significantly less in the robotic group (438 versus 727.8 mL; P = .038). Overall morbidity was significantly lower in the robotic group (22% versus 40%; P = .047). Clavien III/IV complications were also lower, with 4.4% in the robotic versus 16.3% in the open group (P = .043). The length of stay in the intensive care unit (ICU) was shorter for patients who underwent a robotic procedure (2.1 versus 3.3 days; P = .004). The average total cost, including readmissions, was $37,518 for robotic surgery and $41,948 for open technique. Robotic liver resections had less overall morbidity, ICU, and hospital stay. This translates into decreased average costs for robotic surgery. These procedures are financially comparable to open resections and do not represent a financial burden to the hospital.

Financial Impact of the Robotic Approach in Liver Surgery: A Comparative Study of Clinical Outcomes and Costs Between the Robotic and Open Technique in a Single Institution

PubMed Central

Daskalaki, Despoina; Brown, Marc; Bianco, Francesco M.; Tzvetanov, Ivo; Davis, Myriam; Kim, Jihun; Benedetti, Enrico; Giulianotti, Pier C.

2017-01-01

Abstract Background: One of the perceived major drawbacks of minimally invasive techniques has always been its cost. This is especially true for the robotic approach and is one of the main reasons that has prevented its wider acceptance among hospitals and surgeons. The aim of our study was to evaluate the clinical outcomes and economic impact of robotic and open liver surgery in a single institution. Methods: Sixty-eight robotic and 55 open hepatectomies were performed at our institution between January 1, 2009 and December 31, 2013. Demographics, perioperative data, and postoperative outcomes were collected and compared between the two groups. An independent company performed the financial analysis. The economic parameters comprised direct variable costs, direct fixed costs, and indirect costs. Results: Mean estimated blood loss was significantly less in the robotic group (438 versus 727.8 mL; P = .038). Overall morbidity was significantly lower in the robotic group (22% versus 40%; P = .047). Clavien III/IV complications were also lower, with 4.4% in the robotic versus 16.3% in the open group (P = .043). The length of stay in the intensive care unit (ICU) was shorter for patients who underwent a robotic procedure (2.1 versus 3.3 days; P = .004). The average total cost, including readmissions, was $37,518 for robotic surgery and $41,948 for open technique. Conclusions: Robotic liver resections had less overall morbidity, ICU, and hospital stay. This translates into decreased average costs for robotic surgery. These procedures are financially comparable to open resections and do not represent a financial burden to the hospital. PMID:28186429

Monoplanar versus biplanar medial open-wedge proximal tibial osteotomy for varus gonarthrosis: a comparison of clinical and radiological outcomes.

PubMed

Elmalı, Nurzat; Esenkaya, Irfan; Can, Murat; Karakaplan, Mustafa

2013-12-01

We compared clinical and radiological results of two proximal tibial osteotomy (PTO) techniques: monoplanar medial open-wedge osteotomy and biplanar retrotubercle medial open-wedge osteotomy, stabilised by a wedged plate. We evaluated 88 knees in 78 patients. Monoplanar medial open-wedge PTO was performed on 56 knees in 50 patients with a mean age of 55 ± 9 years. Biplanar retrotubercle medial open-wedge PTO was performed on 32 knees in 28 patients with a mean age of 57 ± 7 years. Mean follow-up periods were 40.6 ± 7 months for the monoplanar PTO group and 38 ± 5 months for the biplanar retrotubercle PTO group. Clinical outcome was evaluated using the hospital for special surgery scoring system, and radiological outcome was evaluated by the measurements of femorotibial angle (FTA), patellar height and tibial slope changes. In both groups, post-operative HSS scores increased significantly. No significant difference was found between groups in FTA alteration, but the FTA decreased significantly in both groups. Patellar index ratios decreased significantly in the monoplanar PTO group (Insall-Salvati Index by 0.07, Blackburne-Peel Index by 0.07), but not in the biplanar retrotubercle PTO group. Tibial slopes were increased significantly in the monoplanar PTO group, but not in the retrotubercle PTO group. Biplanar retrotubercle medial open-wedge osteotomy and monoplanar medial open-wedge osteotomy are both clinically effective for the treatment for varus gonarthrosis. Retrotubercle osteotomy also prevents patella infera and tibial slope changes radiologically.

Transformation of standardized clinical models based on OWL technologies: from CEM to OpenEHR archetypes

PubMed Central

Legaz-García, María del Carmen; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás; Chute, Christopher G; Tao, Cui

2015-01-01

Introduction The semantic interoperability of electronic healthcare records (EHRs) systems is a major challenge in the medical informatics area. International initiatives pursue the use of semantically interoperable clinical models, and ontologies have frequently been used in semantic interoperability efforts. The objective of this paper is to propose a generic, ontology-based, flexible approach for supporting the automatic transformation of clinical models, which is illustrated for the transformation of Clinical Element Models (CEMs) into openEHR archetypes. Methods Our transformation method exploits the fact that the information models of the most relevant EHR specifications are available in the Web Ontology Language (OWL). The transformation approach is based on defining mappings between those ontological structures. We propose a way in which CEM entities can be transformed into openEHR by using transformation templates and OWL as common representation formalism. The transformation architecture exploits the reasoning and inferencing capabilities of OWL technologies. Results We have devised a generic, flexible approach for the transformation of clinical models, implemented for the unidirectional transformation from CEM to openEHR, a series of reusable transformation templates, a proof-of-concept implementation, and a set of openEHR archetypes that validate the methodological approach. Conclusions We have been able to transform CEM into archetypes in an automatic, flexible, reusable transformation approach that could be extended to other clinical model specifications. We exploit the potential of OWL technologies for supporting the transformation process. We believe that our approach could be useful for international efforts in the area of semantic interoperability of EHR systems. PMID:25670753

CLINICAL OUTCOMES AND SELF-REPORTED SYMPTOMS IN PATIENTS WITH ACROMEGALY: AN 8-YEAR FOLLOW-UP OF A LANREOTIDE STUDY.

PubMed

Khairi, Shafaq; Sagvand, Babak Torabi; Pulaski-Liebert, Karen J; Tritos, Nicholas A; Klibanski, Anne; Nachtigall, Lisa B

2017-01-01

The aim of this study was to evaluate the proportion of patients with acromegaly who remained on long-term lanreotide depot after completion of an open-label multicenter phase III clinical trial (SALSA: A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel), compare baseline and long-term follow-up symptoms scores, and correlate scores with individual longitudinal clinical outcomes. Records of all subjects previously enrolled at the Massachusetts General Hospital site of SALSA were reviewed. Those who remained on lanreotide were interviewed and asked to complete a questionnaire that they had filled out in SALSA in 2007 regarding their current symptomatology and injection side effects, as well as to complete the Acromegaly Quality of Life Questionnaire. Furthermore, clinical, biochemical, and radiographic data related to acromegaly and its comorbidities were tracked throughout follow-up. Six out of 7 patients chose to remain on lanreotide, and 5 of them continued lanreotide depot through last follow-up, for up to 8 years or in 1 case until death. In all cases, lanreotide remained well tolerated, and insulin-like growth factor-1 levels and pituitary imaging remained well controlled on stable doses. While comorbidities persisted or developed, the self-reported symptom score after up to 8 years of therapy showed a significant decrease in frequency or resolution in symptoms that were reported at baseline. This study shows a significant decrease in frequency or resolution in self-reported symptoms in well-controlled patients receiving long-term lanreotide therapy. AcroQoL = Acromegaly Quality of Life Questionnaire GH = growth hormone GI = gastrointestinal IGF-1 = insulin-like growth factor-1 SALSA = A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel.

New graduate nurses' experiences in a clinical specialty: a follow up study of newcomer perceptions of transitional support.

PubMed

Hussein, Rafic; Everett, Bronwyn; Ramjan, Lucie M; Hu, Wendy; Salamonson, Yenna

2017-01-01

Given the increasing complexity of acute care settings, high patient acuity and demanding workloads, new graduate nurses continue to require greater levels of support to manage rising patient clinical care needs. Little is known about how change in new graduate nurses' satisfaction with clinical supervision and the practice environment impacts on their transitioning experience and expectations during first year of practice. This study aimed to examine change in new graduate nurses' perceptions over the 12-month Transitional Support Program, and identify how organizational factors and elements of clinical supervision influenced their experiences. Using a convergent mixed methods design, a prospective survey with open-ended questions was administered to new graduate nurses' working in a tertiary level teaching hospital in Sydney, Australia. Nurses were surveyed at baseline (8-10 weeks) and follow-up (10-12 months) between May 2012 and August 2013. Two standardised instruments: the Manchester Clinical Supervision Scale (MCSS-26) and the Practice Environment Scale Australia (PES-AUS) were used. In addition to socio-demographic data, single -item measures were used to rate new graduate nurses' confidence, clinical capability and support received. Participants were also able to provide open-ended comments explaining their responses. Free-text responses to the open-ended questions were initially reviewed for emergent themes, then coded as either positive or negative aspects of these preliminary themes. Descriptive and inferential statistics were used to analyse the quantitative data and the qualitative data was analysed using conventional content analysis (CCA). The study was approved by the relevant Human Research Ethics Committees. Eighty seven new graduate nurses completed the follow-up surveys, representing a 76% response rate. The median age was 23 years (Range: 20 to 53). No change was seen in new graduate nurses' satisfaction with clinical supervision (mean MCSS-26 scores: 73.2 versus 72.2, p  = 0.503), satisfaction with the clinical practice environment (mean PES-AUS scores: 112.4 versus 110.7, p  = 0.298), overall satisfaction with the transitional support program (mean: 7.6 versus 7.8, p  = 0.337), satisfaction with the number of study days received, orientation days received (mean: 6.4 versus 6.6, p  = 0.541), unit orientation (mean: 4.4 versus 4.8, p  = 0.081), confidence levels (mean: 3.6 versus 3.5, p  = 0.933) and not practising beyond personal clinical capability (mean: 3.9 versus 4.0, p  = 0.629). Negative responses to the open-ended questions were associated with increasing workload, mismatch in the level of support against clinical demands and expectations. Emergent themes from qualitative data included i) orientation and Transitional Support Program as a foundation for success; and ii) developing clinical competence. While transitional support programs are helpful in supporting new graduate nurses in their first year of practice, there are unmet needs for clinical, social and emotional support. Understanding new graduate nurses' experiences and their unmet needs during their first year of practice will enable nurse managers, educators and nurses to better support new graduate nurses' and promote confidence and competence to practice within their scope.

The incidence of avascular necrosis and the radiographic outcome following medial open reduction in children with developmental dysplasia of the hip: a systematic review.

PubMed

Gardner, R O E; Bradley, C S; Howard, A; Narayanan, U G; Wedge, J H; Kelley, S P

2014-02-01

The incidence of clinically significant avascular necrosis (AVN) following medial open reduction of the dislocated hip in children with developmental dysplasia of the hip (DDH) remains unknown. We performed a systematic review of the literature to identify all clinical studies reporting the results of medial open reduction surgery. A total of 14 papers reporting 734 hips met the inclusion criteria. The mean follow-up was 10.9 years (2 to 28). The rate of clinically significant AVN (types 2 to 4) was 20% (149/734). From these papers 221 hips in 174 children had sufficient information to permit more detailed analysis. The rate of AVN increased with the length of follow-up to 24% at skeletal maturity, with type 2 AVN predominating in hips after five years' follow-up. The presence of AVN resulted in a higher incidence of an unsatisfactory outcome at skeletal maturity (55% vs 20% in hips with no AVN; p < 0.001). A higher rate of AVN was identified when surgery was performed in children aged < 12 months, and when hips were immobilised in ≥ 60° of abduction post-operatively. Multivariate analysis showed that younger age at operation, need for further surgery and post-operative hip abduction of ≥ 60° increased the risk of the development of clinically significant AVN.

Open inferior capsular shift for multidirectional shoulder instability in adolescents with generalized ligamentous hyperlaxity or Ehlers-Danlos syndrome.

PubMed

Vavken, Patrick; Tepolt, Frances A; Kocher, Mininder S

2016-06-01

The objective of this study was to assess the outcome of open inferior capsular shift for multidirectional shoulder instability in patients with generalized ligamentous hyperlaxity or Ehlers-Danlos syndrome. Data were obtained for 18 open inferior capsular shift surgeries in 15 adolescent patients with generalized ligamentous hyperlaxity or Ehlers-Danlos syndrome with a mean follow-up of 7.5 years. End points were subjective clinical outcome (pain, stability, satisfaction, return to sport), objective clinical outcome (recurrence, complications), and functional outcome scores (American Shoulder and Elbow Surgeons, 11-item version of the Disabilities of Arm, Shoulder and Hand). Thirteen patients (87%) reported improved pain and stability and were satisfied with the procedure. Nine patients (64%) were able to return to sports. One patient (7%) was dissatisfied with continuous pain and recurrent instability and considered a surgical failure. Seven patients (47%) reported no further episodes of instability. The mean American Shoulder and Elbow Surgeons score at a mean of 7.5 years of follow-up was 88 ± 10 points, and the mean score for the 11-item version of the Disabilities of Arm, Shoulder and Hand was 14 ± 14 points. The management of multidirectional shoulder instability in adolescent patients with generalized ligamentous hyperlaxity or Ehlers-Danlos syndrome is challenging. Open inferior capsular shift results in improvement in subjective and objective shoulder function and stability in adolescent patients with ligamentous hyperlaxity or Ehlers-Danlos who have failed nonoperative treatment. We found no effect of the recalled number of prior dislocations, laterality, and type of hyperlaxity on subjective and objective clinical outcomes. Level IV; Case Series; Treatment Study. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

[Medial versus lateral plating in distal tibial fractures: a prospective study of 40 fractures].

PubMed

Encinas-Ullán, C A; Fernandez-Fernandez, R; Rubio-Suárez, J C; Gil-Garay, E

2013-01-01

Tibial plafond fractures are one of the most challenging injuries in orthopaedic surgery. Their results could be improved by following the new guidelines for the management, and modern plating techniques. The results and complication rate between anteromedial and anterolateral approach for open reduction and internal fixation of these fractures were compared. A study was conducted on 40 patients treated by open reduction an internal fixation between 2007 and 2008. The surgical approach was selected by the surgeon in charge, depending on fracture pattern and skin situation. Patients were evaluated clinically and radiographically by an independent orthopaedic surgeon, not involved in the surgical procedure, using clinical (American Orthopaedic Foot and Ankle Society score) and radiological criteria at a minimum of two years. The appearance of complications after both approaches was recorded. Forty patients were included. The mean age was 53 years, with 24 males and 16 females. Seventeen of the injuries were of high energy, and there were 8 open fractures (3 of type i, 4 type ii and one type iii), and 12 of the closed injuries were grade ii or iii in the Tscherne classification. Six patients (15%) had associated injuries. At final follow-up there were 33 (82%) excellent or good results. No statistical differences were found between either surgical approach regarding time to bone union, rate of delayed union and infection rate. Three plates of the anteromedial group and none of the anterolateral group needed to be removed. Open reduction and internal fixation of distal tibia fractures produced reliable results, with no statistical differences found between anteromedial and anterolateral surgical approaches. Clinical and radiological results and complication rate were mainly related to the fracture type. Copyright © 2012 SECOT. Published by Elsevier Espana. All rights reserved.

Changes in the retrobulbar arterial circulation after decrease of the elevated intraocular pressure in men and women with primary open angle glaucoma.

PubMed

Marjanović, Ivan; Martinez, Antonio; Marjanović, Marija; Kontić, Djordje; Hentova-Senćanić, Paraskeva; Marković, Vujica; Bozić, Marija

2013-01-01

An altered perfusion of the optic nerve head has been proposed as a pathogenic factor of glaucoma. The aim of this study was to evaluate the changes of the hemodynamic parameters in the retrobulbar arterial circulation after decrease of the elevated intraocular pressure (IOP) in women and men with primary open angle glaucoma. The study included 60 patients (33 males and 27 females) older than 50 years, with diagnosed and treated primary open angle glaucoma (77 eyes of 39 patients had increased IOP, > 25 mm Hg).They were examined at the Clinic of Eye Diseases (complete ophthalmologic exam) and Clinic of Neurology, Clinical Center of Serbia, Belgrade, from December 2009 to December 2010. Imaging of hemodynamic parameters of three retrobulbar arterial vessels: ophthalmic, central retinal and posterior ciliary arteries with color Doppler was performed. Among women, hemodynamic arterial parameter of the peak-systolic velocity was increased in the central retinal artery and decreased in the ophthalmic artery and posterior ciliary arteries; end-diastolic velocity was increased in all three retrobulbar vascular levels; Pourcelot resistivity index was increased, but pulsatility index was decreased in all three vessels. Among men, peak-systolic velocity, end-diastolic velocity and pulsatility index were decreased in all three vessels; resistivity index was increased in the ophthalmic artery, but decreased in the central retinal artery and posterior ciliary arteries. There was a significant change of the ophthalmic artery pulsatility index in women, and the end-diastolic velocity of the ophthalmic artery in men. There was a difference of the retrobulbar arterial circulation between women and men with primary open angle glaucoma after decrease of the elevated intraocular pressure.The role of vascular factors in the supply of the optic disc neuroretinal rim is important.

Building Chronic Kidney Disease Clinical Practice Guidelines Using the openEHR Guideline Definition Language.

PubMed

Lin, Ching-Heng; Lo, Ying-Chih; Hung, Pei-Yuan; Liou, Der-Ming

2016-12-07

As a result of the disease's high prevalence, chronic kidney disease (CKD) has become a global public health problem. A clinical decision support system that integrates with computer-interpretable guidelines (CIGs) should improve clinical outcomes and help to ensure patient safety. The openEHR guideline definition language (GDL) is a formal language used to represent CIGs. This study explores the feasibility of using a GDL approach for CKD; it also attempts to identify any potential gaps between the ideal concept and reality. Using the Kidney Disease Improving Global Outcomes (KDIGO) anemia guideline as material, we designed a development workflow in order to establish a series of GDL guidelines. Focus group discussions were conducted in order to identify important issues related to GDL implementation. Ten GDL guidelines and 37 archetypes were established using the KDIGO guideline document. For the focus group discussions, 16 clinicians and 22 IT experts were recruited and their perceptions, opinions and attitudes towards the GDL approach were explored. Both groups provided positive feedback regarding the GDL approach, but raised various concerns about GDL implementation. Based on the findings of this study, we identified some potential gaps that might exist during implementation between the GDL concept and reality. Three directions remain to be investigated in the future. Two of them are related to the openEHR GDL approach. Firstly, there is a need for the editing tool to be made more sophisticated. Secondly, there needs to be integration of the present approach into non openEHR-based hospital information systems. The last direction focuses on the applicability of guidelines and involves developing a method to resolve any conflicts that occur with insurance payment regulations.

Randomized, Controlled Trial of Therapy Interruption in Chronic HIV-1 Infection

PubMed Central

Papasavvas, Emmanouil; Kostman, Jay R; Mounzer, Karam; Grant, Robert M; Gross, Robert; Gallo, Cele; Azzoni, Livio; Foulkes, Andrea; Thiel, Brian; Pistilli, Maxwell; Mackiewicz, Agnieszka; Shull, Jane; Montaner, Luis J

2004-01-01

Background Approaches to limiting exposure to antiretroviral therapy (ART) drugs are an active area of HIV therapy research. Here we present longitudinal follow-up of a randomized, open-label, single-center study of the immune, viral, and safety outcomes of structured therapy interruptions (TIs) in patients with chronically suppressed HIV-1 infection as compared to equal follow-up of patients on continuous therapy and including a final therapy interruption in both arms. Methods and Findings Forty-two chronically HIV-infected patients on suppressive ART with CD4 counts higher than 400 were randomized 1:1 to either (1) three successive fixed TIs of 2, 4, and 6 wk, with intervening resumption of therapy with resuppression for 4 wk before subsequent interruption, or (2) 40 wk of continuous therapy, with a final open-ended TI in both treatment groups. Main outcome was analysis of the time to viral rebound (>5,000 copies/ml) during the open-ended TI. Secondary outcomes included study-defined safety criteria, viral resistance, therapy failure, and retention of immune reconstitution. There was no difference between the groups in time to viral rebound during the open-ended TI (continuous therapy/single TI, median [interquartile range] = 4 [1–8] wk, n = 21; repeated TI, median [interquartile range] = 5 [4–8] wk, n = 21; p = 0.36). No differences in study-related adverse events, viral set point at 12 or 20 wk of open-ended interruption, viral resistance or therapy failure, retention of CD4 T cell numbers on ART, or retention of lymphoproliferative recall antigen responses were noted between groups. Importantly, resistance detected shortly after initial viremia following the open-ended TI did not result in a lack of resuppression to less than 50 copies/ml after reinitiation of the same drug regimen. Conclusion Cycles of 2- to 6-wk time-fixed TIs in patients with suppressed HIV infection failed to confer a clinically significant benefit with regard to viral suppression off ART. Also, secondary analysis showed no difference between the two strategies in terms of safety, retention of immune reconstitution, and clinical therapy failure. Based on these findings, we suggest that further clinical research on the long-term consequences of TI strategies to decrease drug exposure is warranted. PMID:15630469

The effect of open and closed endotracheal tube suctioning system on respiratory parameters of infants undergoing mechanical ventilation

PubMed Central

Taheri, Parvin; Asgari, Narges; Mohammadizadeh, Majid; Golchin, Mehri

2012-01-01

Aims: Mechanical ventilation is used for some infants in neonatal intensive care units (NICU) due to many physiological and clinical causes. Since these patients have endotracheal tubes, cleaning and keeping the airways open through suctioning should be done to increase oxygenation. This study aimed to evaluate effect of open and closed suctioning methods on respiratory parameters of infants undergoing mechanical ventilation. Materials and Methods: In this crossover clinical trial, 44 infants were selected among those undergone mechanical ventilation in NICU of Isfahan's Al-Zahra Hospital using convenience sampling method. The subjects were randomly divided into two groups. In the first group, open suctioning was carried out and after three hours of cleaning, closed suctioning was done. In the second group, closed suctioning was firstly done and following three hours of cleaning, open suctioning was implemented. Respiratory rate (RR) and percentage of arterial blood oxygen saturation was measured before, during and after each type of suctioning. Data were analyzed using repeated measures ANOVA and independent student's t-test. Findings: There was a significant difference between mean respiratory rate and arterial blood oxygen saturation in infants before, during and after the closed and open suctioning. The percentage of arterial blood oxygen saturation had a significant reduction in open method compared to closed method during suctioning and immediately after it. RR three minutes after suctioning showed a significant reduction in both steps in open method compared to closed method. Conclusions: Close method caused fewer changes in hemodynamic status of infants. Therefore, in order to prevent respiratory complications in infants, nurses are recommended to perform the endotracheal tube suctioning by closed method. PMID:23493041

A Platform for Innovation and Standards Evaluation: a Case Study from the OpenMRS Open-Source Radiology Information System.

PubMed

Gichoya, Judy W; Kohli, Marc; Ivange, Larry; Schmidt, Teri S; Purkayastha, Saptarshi

2018-05-10

Open-source development can provide a platform for innovation by seeking feedback from community members as well as providing tools and infrastructure to test new standards. Vendors of proprietary systems may delay adoption of new standards until there are sufficient incentives such as legal mandates or financial incentives to encourage/mandate adoption. Moreover, open-source systems in healthcare have been widely adopted in low- and middle-income countries and can be used to bridge gaps that exist in global health radiology. Since 2011, the authors, along with a community of open-source contributors, have worked on developing an open-source radiology information system (RIS) across two communities-OpenMRS and LibreHealth. The main purpose of the RIS is to implement core radiology workflows, on which others can build and test new radiology standards. This work has resulted in three major releases of the system, with current architectural changes driven by changing technology, development of new standards in health and imaging informatics, and changing user needs. At their core, both these communities are focused on building general-purpose EHR systems, but based on user contributions from the fringes, we have been able to create an innovative system that has been used by hospitals and clinics in four different countries. We provide an overview of the history of the LibreHealth RIS, the architecture of the system, overview of standards integration, describe challenges of developing an open-source product, and future directions. Our goal is to attract more participation and involvement to further develop the LibreHealth RIS into an Enterprise Imaging System that can be used in other clinical imaging including pathology and dermatology.

Interoperable Archetypes With a Three Folded Terminology Governance.

PubMed

Pederson, Rune; Ellingsen, Gunnar

2015-01-01

The use of openEHR archetypes increases the interoperability of clinical terminology, and in doing so improves upon the availability of clinical terminology for both primary and secondary purposes. Where clinical terminology is employed in the EPR system, research reports conflicting a results for the use of structuring and standardization as measurements of success. In order to elucidate this concept, this paper focuses on the effort to establish a national repository for openEHR based archetypes in Norway where clinical terminology could be included with benefit for interoperability three folded.

Pericardium closure after heart operations: a safety option?

PubMed

Dantas, Carlos Eduardo Pereira; Sá, Mauro Paes Leme de; Bastos, Eduardo Sergio; Magnanini, Monica M F

2010-01-01

Primary pericardium closure may reduce the risk of cardiac injury during chest re opening, especially the right ventricle, aorta and coronary bypass grafts. Nevertheless, concern about adverse hemodynamic effects prevents most heart surgeons of closuring the pericardium. We evaluated 48 patients undergoing open heart surgery consecutively which the pericardium was closed in 30 patients (group A) and 18 patients, as a control group (group B) in which the pericardium was left open. All patients underwent posteroanterior and lateral chest roentgenograms before surgery and one week postoperatively. Postoperative evaluation also included echocardiograms, ECG and postoperative enzyme analysis. There were no deaths or any complications in both groups (acute myocardial infarction, stroke, bleeding or cardiac tamponate). It was observed statistically differences between both groups especially in echocardiogram parameters and cardiothoracic ratio without clinical impact. Pericardium closure is a simple method to facilitate resternotomy during subsequent re operative procedures. However, cardiac surgeons should be aware of the transient deterioration in hemodynamics associated with it, even thought there was no clinical significance in this study.

Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register.

PubMed

Fleminger, Jessica; Goldacre, Ben

2018-01-01

Trial registries are a key source of information for clinicians and researchers. While building OpenTrials, an open database of public trial information, we identified errors and omissions in registries, including discrepancies between descriptions of the same trial in different registries. We set out to ascertain the prevalence of discrepancies in trial completion status using a cohort of trials registered on both the European Union Clinical Trials Register (EUCTR) and ClinicalTrials.gov. We used matching titles and registry IDs provided by both registries to build a cohort of dual-registered trials. Completion statuses were compared; we calculated descriptive statistics on the prevalence of discrepancies. 11,988 dual-registered trials were identified. 1,496 did not provide a comparable completion status, leaving 10,492 trials. 16.2% were discrepant on completion status. The majority of discrepancies (90.5%) were a 'completed' trial on ClinicalTrials.gov inaccurately marked as 'ongoing' on EUCTR. Overall, 33.9% of dual-registered trials described as 'ongoing' on EUCTR were listed as 'completed' on ClinicalTrials.gov. Completion status on registries is commonly inaccurate. Previous work on publication bias may underestimate non-reporting. We describe simple steps registry owners and trialists could take to improve accuracy.

[Early clinical trials in paediatric oncology in Spain: a nationwide perspective].

PubMed

Bautista, Francisco; Gallego, Soledad; Cañete, Adela; Mora, Jaume; Díaz de Heredia, Cristina; Cruz, Ofelia; Fernández, José María; Rives, Susana; Berlanga, Pablo; Hladun, Raquel; Juan Ribelles, Antonio; Madero, Luis; Ramírez, Manuel; Fernández Delgado, Rafael; Pérez-Martínez, Antonio; Mata, Cristina; Llort, Anna; Martín Broto, Javier; Cela, María Elena; Ramírez, Gema; Sábado, Constantino; Acha, Tomás; Astigarraga, Itziar; Sastre, Ana; Muñoz, Ascensión; Guibelalde, Mercedes; Moreno, Lucas

2017-09-01

Cancer is the leading cause of death between the first year of life and adolescence, and some types of diseases are still a major challenge in terms of cure. There is, therefore, a major need for new drugs. Recent findings in cancer biology open the door to the development of targeted therapies against individual molecular changes, as well as immunotherapy. Promising results in adult anti-cancer drug development have not yet been translated into paediatric clinical practice. A report is presented on the activity in early paediatric oncology trials (phase I-II) in Spain. All members of the Spanish Society of Paediatric Haematology Oncology (SEHOP) were contacted in order to identify early clinical trials in paediatric cancer opened between 2005 and 2015. A total of 30 trials had been opened in this period: 21 (70%) in solid tumours, and 9 (30%) in malignant haemopathies. A total of 212 patients have been enrolled. The majority was industry sponsored (53%). Since 2010, four centres have joined the international consortium of Innovative Therapies for Children with Cancer (ITCC), which has as its aim to develop novel therapies for paediatric tumours. A significant number of new studies have opened since 2010, improving the treatment opportunities for our children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents, and their benefits. The activity in clinical trials has increased in the years analysed. The SEHOP is committed to develop and participate in collaborative academic trials, in order to help in the advancement and optimisation of existing therapies in paediatric cancer. Copyright © 2016 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

Comparison of the clinical presentation and visual outcome in open globe injuries in adults and children over 30 months.

PubMed

Gupta, Arvind; Srinivasan, Renuka; Babu, K Ramesh; Setia, Sajita

2010-01-01

To compare the clinical presentation and final visual outcome of open globe injuries in children and adults in a referral hospital over a 30-month period. This is an institutional-based prospective study of open globe injuries cases presenting in the emergency department between July 2003 and December 2005. Patients were divided in 2 groups: group 1, children (2-15 years), and group 2, adults (>15 years). All the patients were admitted and emergency surgical interventions were undertaken. The clinical features at presentation and the final visual acuity are compared. Chi-square and Fisher exact tests were used for statistical analysis. Ninety and 84 patients were included in group 1 and group 2, respectively. The most common places of injuries were home or while playing outdoor games in group 1 (67%) and workplace in group 2 (53.5%). The presenting features were significantly more grave in group 2. These included poor presenting visual acuity (p=0.012), vitreous prolapse (p=0.002), presence of relative afferent pupillary defect (p=0.001), and incidence of endophthalmitis (p=0.004). Time interval between injury and surgical intervention (p=0.018) was better in group 2. Other features, such as presence of hyphema, uveal tissue prolapse, cataract, intraocular foreign body, and length or location of laceration were similar in both groups. The final visual outcome was similar in the groups (p = 0.21), with approximately half of the patients achieving vision of 20/60 or better in each group. The majority of injuries in children and adults occurred in their homes or workplaces, respectively. Although the clinical presentations of open globe injuries were significantly more grave in adults than in children, the final visual outcomes were similar.

ePCR: an R-package for survival and time-to-event prediction in advanced prostate cancer, applied to real-world patient cohorts.

PubMed

Laajala, Teemu D; Murtojärvi, Mika; Virkki, Arho; Aittokallio, Tero

2018-06-15

Prognostic models are widely used in clinical decision-making, such as risk stratification and tailoring treatment strategies, with the aim to improve patient outcomes while reducing overall healthcare costs. While prognostic models have been adopted into clinical use, benchmarking their performance has been difficult due to lack of open clinical datasets. The recent DREAM 9.5 Prostate Cancer Challenge carried out an extensive benchmarking of prognostic models for metastatic Castration-Resistant Prostate Cancer (mCRPC), based on multiple cohorts of open clinical trial data. We make available an open-source implementation of the top-performing model, ePCR, along with an extended toolbox for its further re-use and development, and demonstrate how to best apply the implemented model to real-world data cohorts of advanced prostate cancer patients. The open-source R-package ePCR and its reference documentation are available at the Central R Archive Network (CRAN): https://CRAN.R-project.org/package=ePCR. R-vignette provides step-by-step examples for the ePCR usage. Supplementary data are available at Bioinformatics online.

Combined effects of VX-770 and VX-809 on several functional abnormalities of F508del-CFTR channels.

PubMed

Kopeikin, Z; Yuksek, Z; Yang, H-Y; Bompadre, S G

2014-09-01

The most common cystic fibrosis-associated mutation, the deletion of phenylalanine 508 (F508del), results in channels with poor membrane expression and impaired function. VX-770, a clinically approved drug for treatment of CF patients carrying the G551D mutation, and VX-809, a corrector shown in vitro to increase membrane expression of mutant channels, are currently undergoing clinical trials, but functional data at the molecular level is still lacking. The effect of VX-770 and VX-809 on the multiple functional defects of F508del-CFTR was assessed via excised inside-out patch-clamp experiments. VX-770 completely restores the low opening-rate of F508del-CFTR, with smaller open-time increase, in temperature-corrected and VX-809-treated channels. The shorter locked-open time of hydrolysis-deficient F508del-CFTR is also prolonged by VX-770. VX-809 does not improve channel function by itself as previously reported. The results from these studies can be interpreted as an equilibrium shift toward the open-channel conformation of F508del-CFTR channels. Copyright © 2014 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Validation of the openEHR archetype library by using OWL reasoning.

PubMed

Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás

2011-01-01

Electronic Health Record architectures based on the dual model architecture use archetypes for representing clinical knowledge. Therefore, ensuring their correctness and consistency is a fundamental research goal. In this work, we explore how an approach based on OWL technologies can be used for such purpose. This method has been applied to the openEHR archetype repository, which is the largest available one nowadays. The results of this validation are also reported in this study.

Current Role of Minimally Invasive Radical Cholecystectomy for Gallbladder Cancer

PubMed Central

Manzoni, Alberto; Guerini, Francesca; Ramera, Marco; Aroldi, Francesca; Zaniboni, Alberto; Rosso, Edoardo

2016-01-01

Background. For Tis and T1a gallbladder cancer (GbC), laparoscopic cholecystectomy can provide similar survival outcomes compared to open cholecystectomy. However, for patients affected by resectable T1b or more advanced GbC, open approach radical cholecystectomy (RC), consisting in gallbladder liver bed resection or segment 4b-5 bisegmentectomy, with locoregional lymphadenectomy, is considered the gold standard while minimally invasive RC (MiRC) is skeptically considered. Aim. To analyze current literature on perioperative and oncologic outcomes of MiRC for patients affected by GbC. Methods. A Medline review of published articles until June 2016 concerning MiRC for GbC was performed. Results. Data relevant for this review were presented in 13 articles, including 152 patients undergoing an attempt of MiRC for GbC. No randomized clinical trial was found. The approach was laparoscopic in 147 patients and robotic in five. Conversion was required in 15 (10%) patients. Postoperative complications rate was 10% with no mortality. Long-term survival outcomes were reported by 11 studies, two of them showing similar oncologic results when comparing MiRC with matched open RC. Conclusions. Although randomized clinical trials are still lacking and only descriptive studies reporting on limited number of patients are available, current literature seems suggesting that when performed at highly specialized centers, MiRC for GbC is safe and feasible and has oncologic outcomes comparable to open RC. PMID:27885325

Current Role of Minimally Invasive Radical Cholecystectomy for Gallbladder Cancer.

PubMed

Zimmitti, Giuseppe; Manzoni, Alberto; Guerini, Francesca; Ramera, Marco; Bertocchi, Paola; Aroldi, Francesca; Zaniboni, Alberto; Rosso, Edoardo

2016-01-01

Background . For Tis and T1a gallbladder cancer (GbC), laparoscopic cholecystectomy can provide similar survival outcomes compared to open cholecystectomy. However, for patients affected by resectable T1b or more advanced GbC, open approach radical cholecystectomy (RC), consisting in gallbladder liver bed resection or segment 4b-5 bisegmentectomy, with locoregional lymphadenectomy, is considered the gold standard while minimally invasive RC (MiRC) is skeptically considered. Aim . To analyze current literature on perioperative and oncologic outcomes of MiRC for patients affected by GbC. Methods . A Medline review of published articles until June 2016 concerning MiRC for GbC was performed. Results . Data relevant for this review were presented in 13 articles, including 152 patients undergoing an attempt of MiRC for GbC. No randomized clinical trial was found. The approach was laparoscopic in 147 patients and robotic in five. Conversion was required in 15 (10%) patients. Postoperative complications rate was 10% with no mortality. Long-term survival outcomes were reported by 11 studies, two of them showing similar oncologic results when comparing MiRC with matched open RC. Conclusions . Although randomized clinical trials are still lacking and only descriptive studies reporting on limited number of patients are available, current literature seems suggesting that when performed at highly specialized centers, MiRC for GbC is safe and feasible and has oncologic outcomes comparable to open RC.

Effect of lavender essence inhalation on the level of anxiety and blood cortisol in candidates for open-heart surgery.

PubMed

Hosseini, SeyedAbedin; Heydari, Alemeh; Vakili, MohammadAli; Moghadam, Shahram; Tazyky, SadeghAli

2016-01-01

Surgery, as a treatment, is a stressful experience. The anxiety is more severe in open-heart surgery patients due to its risk and complications. The present study aimed to determine the effect of lavender essence on the levels of anxiety and blood cortisol in candidates for open-heart surgery. This was a single-blind clinical trial, a random allocation study with a control group conducted on 90 candidates for open-heart surgery in two groups of study and control. The study and control groups inhaled two drops of lavender and distilled water for 20 min, respectively. Spielberger questionnaire was filled by the patients. A 2 ml blood sample was taken to measure the cortisol level and patients' vital signs were recorded before and after intervention. Data were analyzed by chi-square in the form of mean, SD, and frequency distribution, independent t-test, paired t-test, and analysis of covariance (ANCOVA), with a significance level of P = 0.05 to modify the pre-test scores. Results showed a significant reduction in mean anxiety score from 56.73 (5.67) to 54.73 (5.42) after intervention in the study group, compared to the control group [1.11 (1.17)] (P < 0.001). There was also a higher difference in cortisol level in the study group compared to the control group [1.88 (0.56) vs. 0.42 (0.45)]. ANCOVA test showed that the 10.8% variance in anxiety score and 69.6% decrease in blood cortisol resulted from inhalation of lavender. Results showed the positive effect of lavender essence on anxiety and blood cortisol level among the patients. Aromatherapy with lavender is suggested to be considered as a nursing intervention in clinical settings.

Effect of lavender essence inhalation on the level of anxiety and blood cortisol in candidates for open-heart surgery

PubMed Central

Hosseini, SeyedAbedin; Heydari, Alemeh; Vakili, MohammadAli; Moghadam, Shahram; Tazyky, SadeghAli

2016-01-01

Background: Surgery, as a treatment, is a stressful experience. The anxiety is more severe in open-heart surgery patients due to its risk and complications. The present study aimed to determine the effect of lavender essence on the levels of anxiety and blood cortisol in candidates for open-heart surgery. Materials and Methods: This was a single-blind clinical trial, a random allocation study with a control group conducted on 90 candidates for open-heart surgery in two groups of study and control. The study and control groups inhaled two drops of lavender and distilled water for 20 min, respectively. Spielberger questionnaire was filled by the patients. A 2 ml blood sample was taken to measure the cortisol level and patients’ vital signs were recorded before and after intervention. Data were analyzed by chi-square in the form of mean, SD, and frequency distribution, independent t-test, paired t-test, and analysis of covariance (ANCOVA), with a significance level of P = 0.05 to modify the pre-test scores. Results: Results showed a significant reduction in mean anxiety score from 56.73 (5.67) to 54.73 (5.42) after intervention in the study group, compared to the control group [1.11 (1.17)] (P < 0.001). There was also a higher difference in cortisol level in the study group compared to the control group [1.88 (0.56) vs. 0.42 (0.45)]. ANCOVA test showed that the 10.8% variance in anxiety score and 69.6% decrease in blood cortisol resulted from inhalation of lavender. Conclusions: Results showed the positive effect of lavender essence on anxiety and blood cortisol level among the patients. Aromatherapy with lavender is suggested to be considered as a nursing intervention in clinical settings. PMID:27563324

[Clinical and economic evaluation of laparoscopic surgery for inguinal hernia. Return of a difficult clinical choice].

PubMed

Bataille, N

2002-06-01

In the year 2000, the ANAES (National Agency for Accreditation and Evaluation of Health Care) published a technological and economic evaluation of the laparascopic approach to the repair of inguinal hernias based principally on the analysis of randomized studies. This analysis was all the more difficult because of the heterogeneity of the studies for which end results had a very weak level of proof. Laparascopic surgical techniques for inguinal hernia repair require the systematic use of mesh prosthesis and also general anesthesia. Published results are insufficient to compare specific laparascopic techniques with each other. The efficacy of laparoscopic repair compared to open repair with regard to hernia recurrence (the principal criteria of efficacy) has not been demonstrated--mainly because longterm results are not yet available. The overall evaluation of complications is too heterogeneous to show a difference between laparascopic and open surgery. There are, however, certain complications specific to laparascopic repair which, though rare, are potentially very serious. Excellent results reported with laparascopic repair may be due more to the systematic placement of mesh than-to to the approach itself--as has been shown in studies of open repairs "with tension" and "tension free." Superiority of the laparoscopic approach for specific types of hernia (primary unilateral, bilateral, recurrent) has not been demonstrated. Open surgery costs less than laparascopic hernia repair. The evaluation to date for laparascopic inguinal hernia repair is insufficient. Controlled studies with rigorous longterm follow-up and analysis of economic impact must be performed in comparable populations of patients.

Ocular Pseudoexfoliation and Cardiovascular Disease: A National Cross-Section Comparison Study

PubMed Central

French, Dustin D; Margo, Curtis E; Harman, Lynn E

2012-01-01

Background: Pseudoexfoliation is a systemic disorder characterized by the deposition of extracellular matrix material. The microfibrillar material that gives rise to the condition is visible clinically in the anterior segment of the eye, and is also found in other tissues, including blood vessels, skin, gallbladder, kidneys, lungs, and heart. Aims: The present study aims to determine whether ocular pseudoexfoliation is associated with selected cardiovascular diseases. Materials and Methods: A cross-section comparison study was conducted with the help of the Veterans Health Administration databases, using the International Classification of Diseases, Ninth revision, Clinical Modification for pseudoexfoliation of lens capsule and pseudoexfoliation glaucoma. Selected cardiovascular diseases and risk factors for cardiovascular disease were identified using the appropriate medical codes. Patients with primary open-angle glaucoma, chronic sinusitis, and benign prostatic hyperplasia served as the comparison groups. A logistic regression model was used to control for age, gender, race, and major cardiovascular risk factors. Results: There were 6,046 case patients with pseudoexfoliation; approximately half were diagnosed with pseudoexfoliation glaucoma. Various stages of ischemic heart disease, cardiomyopathy, and aortic aneurysm were significantly associated with ocular pseudoexfoliation, after controlling for age, gender, race, and major cardiovascular risk factors. Associations, in general, were less demonstrable relative to the primary open-angle glaucoma comparison group. Conclusion: Associations of ocular pseudoexfoliation with cardiovascular diseases were generally fewer and less pronounced when compared to patients with primary open-angle glaucoma. These results add to the results of earlier studies, which suggest that open-angle glaucoma itself might be a risk factor for certain cardiovascular disorders. PMID:23112968

Opening the Blood-Brain Barrier with MR Imaging-guided Focused Ultrasound: Preclinical Testing on a Trans-Human Skull Porcine Model.

PubMed

Huang, Yuexi; Alkins, Ryan; Schwartz, Michael L; Hynynen, Kullervo

2017-01-01

Purpose To develop and test a protocol in preparation for a clinical trial on opening the blood-brain barrier (BBB) with magnetic resonance (MR) imaging-guided focused ultrasound for the delivery of chemotherapy drugs to brain tumors. Materials and Methods The procedures were approved by the institutional animal care committee. A trans-human skull porcine model was designed for the preclinical testing. Wide craniotomies were applied in 11 pigs (weight, approximately 15 kg). A partial human skull was positioned over the animal's brain. A modified clinical MR imaging-guided focused ultrasound brain system was used with a 3.0-T MR unit. The ultrasound beam was steered during sonications over a 3 × 3 grid at 3-mm spacing. Acoustic power levels of 3-20 W were tested. Bolus injections of microbubbles at 4 μL/kg were tested for each sonication. Levels of BBB opening, hemorrhage, and cavitation signal were measured with MR imaging, histologic examination, and cavitation receivers, respectively. A cavitation safety algorithm was developed on the basis of logistic regression of the measurements and tested to minimize the risk of hemorrhage. Results BBB openings of approximately 1 cm 3 in volume were visualized with gadolinium-enhanced MR imaging after sonication at an acoustic power of approximately 5 W. Gross examination of histologic specimens helped confirm Evans blue (bound to macromolecule albumin) extravasation, and hematoxylin-eosin staining helped detect only scattered extravasation of red blood cells. In cases where cavitation signals were higher than thresholds, sonications were terminated immediately without causing hemorrhage. Conclusion With a trans-human skull porcine model, this study demonstrated BBB opening with a 230-kHz system in preparation for a clinical trial. © RSNA, 2016 Online supplemental material is available for this article.

[The psychiatric revolution in Quebec, 1950-1962. From asylum to community psychiatry and the open door].

PubMed

Duprey, Catherine

2011-01-01

Psychiatry opens to the world at a time when the very basis of psychiatric practice, namely the asylum, is called into question. Studies appear in Quebec and Canadian journals concurrent to the introduction of new formulas for care, such as the delivery of psychiatric services in general hospitals and clinics, that allow patients to be treated outside the walls of psychiatric hospitals. In addition, postwar psychiatry takes an optimistic view toward the future of children with impairments through the creation of specialized schools and workshops. From the mid-20th century onward, the thinking in psychiatry centres on the open door.

[Radon therapy in medical rehabilitation of patents with seronegative spondyloatrthritis. An open controlled study].

PubMed

Barnatskiĭ, V V

2009-01-01

A differential approach to the use of selected methods of radon therapy (including dry air and water baths with different radon concentrations) is proposed for the treatment of different nosological forms of seronegative spondyloarthritis taking into consideration their varying clinical manifestations (arthritis, enthesitis, spondylitis), the degree of general clinical activity, functional state, and severity of inflammation (based on laboratory analyses).

Landscape of early clinical trials for childhood and adolescence cancer in Spain.

PubMed

Bautista, F; Gallego, S; Cañete, A; Mora, J; Diaz de Heredia, C; Cruz, O; Fernández, J M; Rives, S; Madero, L; Castel, V; Cela, M E; Ramírez, G; Sábado, C; Acha, T; Astigarraga, I; Sastre, A; Muñoz, A; Guibelalde, M; Moreno, L

2016-07-01

Despite numerous advances, survival remains dismal for children and adolescents with poor prognosis cancers or those who relapse or are refractory to first line treatment. There is, therefore, a major unmet need for new drugs. Recent advances in the knowledge of molecular tumor biology open the door to more adapted therapies according to individual alterations. Promising results in the adult anticancer drug development have not yet been translated into clinical practice. We report the activity in early pediatric oncology trials in Spain. All members of the Spanish Society of Pediatric Hematology Oncology (SEHOP) were contacted to obtain information about early trials open in each center. 22 phase I and II trials were open as of May 2015: 15 for solid tumors (68 %) and 7 for hematological malignancies (32 %). Fourteen (64 %) were industry sponsored. Since 2010, four centers have joined the Innovative Therapies For Children With Cancer, an international consortium whose aim is developing novel therapies for pediatric cancers. A substantial number of studies have opened in these 5 years, improving the portfolio of trials for children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents and their benefits. Clinical trials are the way to evaluate new drugs, avoiding the use of off-label drugs that carry significant risks. The Spanish pediatric oncology community through the SEHOP is committed to develop and participate in collaborative academic trials, to favor the advancement and optimization of existing therapies in pediatric cancer.

Myocardial Protection and Financial Considerations of Custodiol Cardioplegia in Minimally Invasive and Open Valve Surgery.

PubMed

Hummel, Brian W; Buss, Randall W; DiGiorgi, Paul L; Laviano, Brittany N; Yaeger, Nalani A; Lucas, M Lee; Comas, George M

Single-dose antegrade crystalloid cardioplegia with Custodiol-HTK (histidine-tryptophan-ketoglutarate) has been used for many years. Its safety and efficacy were established in experimental and clinical studies. It is beneficial in complex valve surgery because it provides a long period of myocardial protection with a single dose. Thus, valve procedures (minimally invasive or open) can be performed with limited interruption. The aim of this study is to compare the use of Custodiol-HTK cardioplegia with traditional blood cardioplegia in patients undergoing minimally invasive and open valve surgery. A single-institution, retrospective case-control review was performed on patients who underwent valve surgery in Lee Memorial Health System at either HealthPark Medical Center or Gulf Coast Medical Center from July 1, 2011, through March 7, 2015. A total of 181 valve cases (aortic or mitral) performed using Custodiol-HTK cardioplegia were compared with 181 cases performed with traditional blood cardioplegia. Each group had an equal distribution of minimally invasive and open valve cases. Right chest thoracotomy or partial sternotomy was performed on minimally invasive valve cases. Demographics, perioperative data, clinical outcomes, and financial data were collected and analyzed. Patient outcomes were superior in the Custodiol-HTK cardioplegia group for blood transfusion, stroke, and hospital readmission within 30 days (P < 0.05). No statistical differences were observed in the other outcomes categories. Hospital charges were reduced on average by $3013 per patient when using Custodiol-HTK cardioplegia. Use of Custodiol-HTK cardioplegia is safe and cost-effective when compared with traditional repetitive blood cardioplegia in patients undergoing minimally invasive and open valve surgery.

Differential diagnosis of jaw pain using informatics technology.

PubMed

Nam, Y; Kim, H-G; Kho, H-S

2018-05-21

This study aimed to deduce evidence-based clinical clues that differentiate temporomandibular disorders (TMD)-mimicking conditions from genuine TMD by text mining using natural language processing (NLP) and recursive partitioning. We compared the medical records of 29 patients diagnosed with TMD-mimicking conditions and 290 patients diagnosed with genuine TMD. Chief complaints and medical histories were preprocessed via NLP to compare the frequency of word usage. In addition, recursive partitioning was used to deduce the optimal size of mouth opening, which could differentiate TMD-mimicking from genuine TMD groups. The prevalence of TMD-mimicking conditions was more evenly distributed across all age groups and showed a nearly equal gender ratio, which was significantly different from genuine TMD. TMD-mimicking conditions were caused by inflammation, infection, hereditary disease and neoplasm. Patients with TMD-mimicking conditions frequently used "mouth opening limitation" (P < .001), but less commonly used words such as "noise" (P < .001) and "temporomandibular joint" (P < .001) than patients with genuine TMD. A diagnostic classification tree on the basis of recursive partitioning suggested that 12.0 mm of comfortable mouth opening and 26.5 mm of maximum mouth opening were deduced as the most optimal mouth-opening cutoff sizes. When the combined analyses were performed based on both the text mining and clinical examination data, the predictive performance of the model was 96.6% with 69.0% sensitivity and 99.3% specificity in predicting TMD-mimicking conditions. In conclusion, this study showed that AI technology-based methods could be applied in the field of differential diagnosis of orofacial pain disorders. © 2018 John Wiley & Sons Ltd.

Pancreatic cancer clinical trials and accrual in the United States.

PubMed

Hoos, William A; James, Porsha M; Rahib, Lola; Talley, Anitra W; Fleshman, Julie M; Matrisian, Lynn M

2013-09-20

Pancreatic cancer clinical trials open in the United States and their accrual were examined to identify opportunities to accelerate progress in the treatment of pancreatic cancer. Pancreatic cancer-specific clinical trials open in the United States in the years 2011 and 2012 were obtained from the Pancreatic Cancer Action Network database. Accrual information was obtained from trial sponsors. The portfolio of pancreatic cancer clinical trials identified by type (adenocarcinoma or neuroendocrine), phase, disease stage, and treatment approach is reported. More than half of trials for patients with pancreatic ductal adenocarcinoma applied biologic insights to new therapeutic approaches, and 38% focused on optimization of radiation or chemotherapy delivery or regimens. In 2011, pancreatic cancer trials required total enrollment of 11,786 patients. Actual accrual to 93.2% of trials was 1,804 patients, an estimated 4.57% of the patients with pancreatic cancer alive in that year. The greatest need was for patients with resectable cancer. Trials open in 2011 enrolled an average of 15% of their total target accrual. Physician recommendations greatly influenced patients' decision to enroll or not enroll onto a clinical trial. Matching to a clinical trial within a 50-mile radius and identifying trials for recurrent/refractory disease were documented as challenges for patient accrual. Overall trial enrollment indicates that pancreatic cancer trials open in 2011 would require 6.7 years on average to complete accrual. These results suggest that harmonizing patient supply and demand for clinical trials is required to accelerate progress toward improving survival in pancreatic cancer.

Linking guidelines to Electronic Health Record design for improved chronic disease management.

PubMed

Barretto, Sistine A; Warren, Jim; Goodchild, Andrew; Bird, Linda; Heard, Sam; Stumptner, Markus

2003-01-01

The promise of electronic decision support to promote evidence based practice remains elusive in the context of chronic disease management. We examine the problem of achieving a close relationship of Electronic Health Record (EHR) content to other components of a clinical information system (guidelines, decision support and workflow), particularly linking the decisions made by providers back to the guidelines. We use the openEHR architecture, which allows extension of a core Reference Model via Archetypes to refine the detailed information recording options for specific classes of encounter. We illustrate the use of openEHR for tracking the relationship of a series of clinical encounters to a guideline via a case study of guideline-compliant treatment of hypertension in diabetes. This case study shows the contribution guideline content can have on problem-specific EHR structure and demonstrates the potential for a constructive interaction of electronic decision support and the EHR.

Linking Guidelines to Electronic Health Record Design for Improved Chronic Disease Management

PubMed Central

Barretto, Sistine A.; Warren, Jim; Goodchild, Andrew; Bird, Linda; Heard, Sam; Stumptner, Markus

2003-01-01

The promise of electronic decision support to promote evidence based practice remains elusive in the context of chronic disease management. We examine the problem of achieving a close relationship of Electronic Health Record (EHR) content to other components of a clinical information system (guidelines, decision support and work-flow), particularly linking the decisions made by providers back to the guidelines. We use the openEHR architecture, which allows extension of a core Reference Model via Archetypes to refine the detailed information recording options for specific classes of encounter. We illustrate the use of openEHR for tracking the relationship of a series of clinical encounters to a guideline via a case study of guideline-compliant treatment of hypertension in diabetes. This case study shows the contribution guideline content can have on problem-specific EHR structure and demonstrates the potential for a constructive interaction of electronic decision support and the EHR. PMID:14728135

Hydrodynamics of the Certas™ programmable valve for the treatment of hydrocephalus

PubMed Central

2012-01-01

Background The new Certas™ shunt for the treatment of hydrocephalus has seven standard pressure settings that according to the manufacturer range from 36 to 238 mmH2O, and an additional “Virtual Off” setting with an opening pressure >400 mmH2O. Information on actual pressure response and reliability of shunt performance is important in clinical application, especially the “Virtual Off” setting as a non-surgical replacement for shunt ligation. The objective of this study was to evaluate the in-vitro hydrodynamic performance of the Certas™ shunt. Methods Six new Certas™ shunts with proximal and distal catheters were tested with an automated, computerized test system that raised the pressure from zero to a maximum pressure and back to zero at each valve setting. Opening pressure and flow resistance were determined. Results For settings 1–7 the measured opening pressure range was 26 to 247 mmH2O, and the mean change in opening pressure for a one-step adjustment was between 33 and 38 mmH2O. For setting 8 (“Virtual Off”) the measured mean opening pressure was 494 ± 34 mmH2O (range 451 to 556 mmH2O). The mean outflow resistance was 7.0 mmHg/ml/min (outflow conductance 17.9 μl/s/kPa). Conclusions The six shunts had similar characteristics and closely matched the manufacturer’s specifications for opening pressure at settings 1–7. The opening pressure for the “Virtual Off” setting was nearly 500 mmH2O, which is 100 mmH2O higher than the manufacturer’s specification of “>400” and should be functionally off for most patients with communicating hydrocephalus. Clinical studies are needed to evaluate if the CSF dynamic profile persists after implantation in patients. PMID:22643114

Negative pressure wound therapy for Gustilo Anderson grade IIIb open tibial fractures.

PubMed

Park, Chul Hyun; Shon, Oog Jin; Kim, Gi Beom

2016-09-01

Traditionally, Gustilo Anderson grade IIIb open tibial fractures have been treated by initial wide wound debridement, stabilization of fracture with external fixation, and delayed wound closure. The purpose of this study is to evaluate the clinical and radiological results of staged treatment using negative pressure wound therapy (NPWT) for Gustilo Anderson grade IIIb open tibial fractures. 15 patients with Gustilo Anderson grade IIIb open tibial fractures, treated using staged protocol by a single surgeon between January 2007 and December 2011 were reviewed in this retrospective study. The clinical results were assessed using a Puno scoring system for severe open fractures of the tibia at the last followup. The range of motion (ROM) of the knee and ankle joints and postoperative complication were evaluated at the last followup. The radiographic results were assessed using time to bone union, coronal and sagittal angulations and a shortening at the last followup. The mean score of Puno scoring system was 87.4 (range 67-94). The mean ROM of the knee and ankle joints was 121.3° (range 90°-130°) and 37.7° (range 15°-50°), respectively. Bone union developed in all patients and the mean time to union was 25.3 weeks (range 16-42 weeks). The mean coronal angulation was 2.1° (range 0-4°) and sagittal was 2.7° (range 1-4°). The mean shortening was 4.1 mm (range 0-8 mm). Three patients had partial flap necrosis and 1 patient had total flap necrosis. There was no superficial and deep wound infection. Staged treatment using NPWT decreased the risks of infection and requirement of flap surgeries in Gustilo Anderson grade IIIb open tibial fractures. Therefore, staged treatment using NPWT could be a useful treatment option for Gustilo Anderson grade IIIb open tibial fractures.

Open stone surgery: a still-in-use approach for complex stone burden.

PubMed

Çakici, Özer Ural; Ener, Kemal; Keske, Murat; Altinova, Serkan; Canda, Abdullah Erdem; Aldemir, Mustafa; Ardicoglu, Arslan

2017-06-30

Urinary stone disease is a major urological condition. Endourologic techniques have influenced the clinical approach and outcomes. Open surgery holds a historic importance in the management of most conditions. However, complex kidney stone burden may be amenable to successful results with open stone surgery. In this article, we report our eighteen cases of complex urinary stone disease who underwent open stone removal. A total of 1701 patients have undergone surgical treatment for urinary stone disease in our clinic between July 2012 and July 2016, comprising eighteen patients who underwent open stone surgery. Patients' demographic data, stone analysis results, postoperative clinical data, and stone status were evaluated retrospectively. The choice of surgical approach is mostly dependent on the surgeon's preference. In two patients, open surgery was undertaken because of perioperative complications. We did not observe any Clavien-Dindo grade 4 or 5 complications. Three patients were managed with a course of antibiotics due to postoperative fever. One patient had postoperative pleurisy, one patient had urinoma, and two patients had postoperative ileus. Mean operation time was 84 (57-124) minutes and mean hospitalization time was 5.5 (3-8) days. Stone-free status was achieved in 15 patients (83.3%). Endourologic approaches are the first options for treatment of urinary stone disease. However, open stone surgery holds its indispensable position in complicated cases and in complex stone burden. Open stone surgery is also a valid alternative to endourologic techniques in all situations.

Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine: an open-label phase I clinical trial.

PubMed

Hu, Yue-Mei; Huang, Shou-Jie; Chu, Kai; Wu, Ting; Wang, Zhong-Ze; Yang, Chang-Lin; Cai, Jia-Ping; Jiang, Han-Min; Wang, Yi-Jun; Guo, Meng; Liu, Xiao-Hui; Huang, Hong-Jiang; Zhu, Feng-Cai; Zhang, Jun; Xia, Ning-Shao

2014-01-01

An Escherichia coli-expressed recombinant bivalent human papillomavirus (types 16 and 18) vaccine candidate has been shown to be safe and immunogenic in preclinical trials. The safety of this vaccine was analyzed in an open-label phase I clinical trial in Jiangsu province, China. Thirty-eight healthy women from 18 to 55 y of age were enrolled and vaccinated at 0, 1, and 6 mo. Adverse events that occurred within 30 d after each injection and serious adverse events that occurred throughout the study were recorded. In addition, blood parameters were tested before and after each injection. All but one woman received all 3 doses. Thirty-two (84.2%) of the participants reported adverse events, all adverse events of which were mild, of short duration and resolved spontaneously. No serious adverse events occurred during the study. Changes in blood parameters after each injection were random, mild, and not clinically significant. These preliminary results show that a new Escherichia coli-expressed recombinant HPV 16/18 bivalent vaccine is well tolerated in healthy women and support further immunogenicity and efficacy studies for this HPV vaccine candidate.

Comparison of Wiltse's paraspinal approach and open book laminectomy for thoracolumbar burst fractures with greenstick lamina fractures: a randomized controlled trial.

PubMed

Chen, Zhi-da; Wu, Jin; Yao, Xiao-Tao; Cai, Tao-Yi; Zeng, Wen-Rong; Lin, Bin

2018-03-02

Posterior short-segment pedicle screw fixation is used to treat thoracolumbar burst fractures. However, no randomized controlled studies have compared the efficacy of the two approaches--the Wiltse's paraspinal approach and open book laminectomy in the treatment of thoracolumbar burst fractures with greenstick lamina fractures. Patients with burst fractures of the thoracolumbar spine without neurological deficit were randomized to receive either the Wiltse's paraspinal approach (group A, 24 patients) or open book laminectomy (group B, 23 patients). Patients were followed postoperatively for average of 27.4 months. Clinical and radiographic data of the two approaches were collected and compared. Our results showed the anterior segmental height, kyphotic angle, visual analog scale (VAS) score, and Smiley-Webster Scale (SWS) score significantly improved postoperatively in both groups, indicating that both the Wiltse's paraspinal approach and open book laminectomy can effectively treat thoracolumbar burst fractures with greenstick lamina fractures. The Wiltse's paraspinal approach was found to have significantly shorter operating time, less blood loss, and shorter length of hospital stay compared to open book laminectomy. However, there were two (2/24) patients in group A that had neurological deficits postoperatively and required a second exploratory operation. Dural tears and/or cauda equina entrapment were subsequently found in four patients in group B and all two patients of neurological deficits in group A during operation. No screw loosening, plate breakage, or other internal fixation failures were found at final follow-up. The results demonstrated that either of the two surgical approaches can achieve satisfactory results in treating thoracolumbar burst fractures in patients with greenstick lamina fractures. However, if there is any clinical or radiographic suspicion of a dural tear and/or cauda equina entrapment pre-operation, patients should receive an open book laminectomy to avoid a second exploratory operation. More research is still needed to optimize clinical decision-making regarding surgical approach.

Lateral Opening-wedge Distal Femoral Osteotomy: Pain Relief, Functional Improvement, and Survivorship at 5 Years.

PubMed

Cameron, James I; McCauley, Julie C; Kermanshahi, Arash Y; Bugbee, William D

2015-06-01

Distal femoral varus osteotomy may be used to treat valgus knee malalignment or to protect a knee compartment in which cartilage restoration surgery (such as osteochondral or meniscus allografting) has been performed. Medial closing-wedge osteotomy has demonstrated good success in treatment of osteoarthritis in published series, but few studies have evaluated distal femoral lateral opening-wedge osteotomy in terms of correction of deformity, pain and function, and survivorship. (1) Does lateral opening-wedge osteotomy lead to accurate correction? (2) What pain and function levels do patients experience after lateral opening-wedge osteotomy? (3) What are the nonunion, complication, and reoperation rates after lateral opening-wedge osteotomy? Between 2000 and 2010, we performed 40 distal femoral osteotomies. Two knees (two patients) underwent a medial closing-wedge osteotomy and were excluded from the present study. Thirty-eight knees (97%) in 36 patients were lateral opening-wedge varus-producing osteotomies; of those, 31 knees (82%) in 30 patients had followup at a minimum of 2 years (mean, 5 years; SD, 2; range, 2-12 years) and comprised the study population. The indications for osteotomy included symptomatic lateral compartment arthritis with clinical valgus deformity or a cartilage or meniscal defect in the lateral compartment with clinical valgus alignment. The study population was stratified into two groups based on reason for osteotomy: patients with isolated symptomatic lateral compartment arthritis (arthritis group; 19 knees [61%]) and patients who underwent joint preservation procedures including osteochondral allograft transplantation or meniscal allograft transplantation (joint preservation group; 12 knees [39%]). Data collection from our institution's osteotomy database included patient demographics, lower extremity coronal alignment, and operative details. Pain and function were measured preoperatively and postoperatively using the International Knee Documentation Committee (IKDC) score. Time to radiographic union, complications, and reoperations were recorded. Twenty-one of 31 knees had postoperative radiographic data available for review. Of these, seven of 15 knees in the arthritis group and three of six knees in the joint preservation group were within the correction goal of ± 3° from neutral mechanical alignment. In the arthritis group, the mean IKDC total score improved from 47 (SD, 15) preoperatively to 67 (SD, 10) postoperatively. In the joint preservation group, the mean IKDC total score improved from 36 (SD, 12) preoperatively to 62 (SD, 18) postoperatively. One nonunion occurred in the arthritis group. No postoperative complications were experienced. Ten knees in the arthritis group and six knees in the joint preservation group had additional surgery after the osteotomy, consisting primarily of hardware removal, arthroscopy for cartilage-related conditions, or conversion to arthroplasty. Survivorship at 5 years, with conversion to arthroplasty as the endpoint, was 74% in the arthritis group and 92% in the joint preservation group. Lateral opening-wedge distal femoral osteotomy was less accurate in correction of valgus deformity than expected, but the procedure was associated with improved knee pain and function scores. Our clinical and radiographic results are comparable to published series evaluating medial closing-wedge distal femoral osteotomy. Achieving our desired correction of ± 3° from neutral alignment was clinically difficult. An improved method of preoperative templating and refinement of the intraoperative technique may improve this. Future studies with more patients and longer followup will provide clarity on this topic. Level IV, therapeutic study.

Open Notes in Swedish Psychiatric Care (Part 2): Survey Among Psychiatric Care Professionals.

PubMed

Petersson, Lena; Erlingsdóttir, Gudbjörg

2018-06-21

This is the second of two papers presenting the results from a study of the implementation of patient online access to their electronic health records (here referred to as Open Notes) in adult psychiatric care in Sweden. The study contributes an important understanding of both the expectations and concerns that existed among health care professionals before the introduction of the Open Notes Service in psychiatry and the perceived impact of the technology on their own work and patient behavior after the implementation. The results from the previously published baseline survey showed that psychiatric health care professionals generally thought that Open Notes would influence both the patients and their own practice negatively. The objective of this study was to describe and discuss how health care professionals in adult psychiatric care in Region Skåne in southern Sweden experienced the influence of Open Notes on their patients and their own practice, and to compare the results with those of the baseline study. We distributed a full population Web-based questionnaire to psychiatric care professionals in Region Skåne in the spring of 2017, which was one and a half years after the implementation of the service. The response rate was 27.73% (699/2521). Analyses showed that the respondents were representative of the staff as a whole. A statistical analysis examined the relationships between health professional groups and attitudes to the Open Notes Service. A total of 41.5% (285/687) of the health care professionals reported that none of their patients stated that they had read their Open Notes. Few health care professionals agreed with the statements about the potential benefits for patients from Open Notes. Slightly more of the health care professionals agreed with the statements about the potential risks. In addition, the results indicate that there was little impact on practice in terms of longer appointments or health care professionals having to address patients' questions outside of appointments. However, the results also indicate that changes had taken place in clinical documentation. Psychologists (39/63, 62%) and doctors (36/94, 38%) in particular stated that they were less candid in their documentation after the implementation of Open Notes. Nearly 40% of the health care professionals (239/650, 36.8%) reported that the Open Notes Service in psychiatry was a good idea. Most health care professionals who responded to the postimplementation survey did not experience that patients in adult psychiatric care had become more involved in their care after the implementation of Open Notes. The results also indicate that the clinical documentation had changed after the implementation of Open Notes. Finally, the results indicate that it is important to prepare health care professionals before an implementation of Open Notes, especially in medical areas where the service is considered sensitive. ©Lena Petersson, Gudbjörg Erlingsdóttir. Originally published in JMIR Mental Health (http://mental.jmir.org), 21.06.2018.

Open source clinical portals: a model for healthcare information systems to support care processes and feed clinical research. An Italian case of design, development, reuse, and exploitation.

PubMed

Locatelli, Paolo; Baj, Emanuele; Restifo, Nicola; Origgi, Gianni; Bragagia, Silvia

2011-01-01

Open source is a still unexploited chance for healthcare organizations and technology providers to answer to a growing demand for innovation and to join economical benefits with a new way of managing hospital information systems. This chapter will present the case of the web enterprise clinical portal developed in Italy by Niguarda Hospital in Milan with the support of Fondazione Politecnico di Milano, to enable a paperless environment for clinical and administrative activities in the ward. This represents also one rare case of open source technology and reuse in the healthcare sector, as the system's porting is now taking place at Besta Neurological Institute in Milan. This institute is customizing the portal to feed researchers with structured clinical data collected in its portal's patient records, so that they can be analyzed, e.g., through business intelligence tools. Both organizational and clinical advantages are investigated, from process monitoring, to semantic data structuring, to recognition of common patterns in care processes.

Nursing Students' Opinion on the Use of Smartphone Applications (Apps) in Clinical Education and Training: A Study Protocol.

PubMed

O'Connor, Siobhan; Andrews, Tom

2016-01-01

Nurse educators are exploring different mobile technologies to provide additional support to nursing students in clinical practice. However, the view of nursing students on the use of smartphone applications (apps) to enhance clinical education has not been explored. This proposed study will use a self-reported questionnaire to examine the opinions of nursing students on the current and potential use of smartphone apps when training in clinical settings. Descriptive and inferential statistics will be performed on the quantitative data. Qualitative data from open ended questions will be thematically analysed using the framework approach. This will be the first study to examine the use of smartphone apps as a support in clinical teaching from a students' perspective. Their opinion is vital if the right mobile technology is to be designed and implemented.

Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.

PubMed

da Silva, Kátia Regina; Costa, Roberto; Crevelari, Elizabeth Sartori; Lacerda, Marianna Sobral; de Moraes Albertini, Caio Marcos; Filho, Martino Martinelli; Santana, José Eduardo; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo; Barros, Jacson V

2013-01-01

The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries.

Breaking the silence: nurses' understandings of change in clinical practice.

PubMed

Copnell, Beverley; Bruni, Nina

2006-08-01

This paper reports a study exploring critical care nurses' understandings of change in their practice. In contemporary nursing literature, change in clinical nursing practice is generally understood to be a rational process, synonymous with progress. It is seen as invariably contested, and hence difficult to achieve. It is represented as occurring infrequently. This literature effectively silences clinicians as this discourse of change does not recognize or incorporate their views or practices. This study was informed by a Foucauldian poststructuralist framework. The participants were 12 critical care nurses who engaged in three individual in-depth, focused interviews. The transcripts were deconstructed to reveal participants' discourses of change and the implications of these discourses for nursing work. The data were generated between 1996 and 1998 as part of a study whose in-depth analysis was completed in 2003. Change was revealed as a highly complex phenomenon, closely intertwined with understandings of clinical nursing work. Participants showed difficulty in identifying or recalling clinical changes. Several dichotomies shaped their understandings of change, including change/stasis, formal/informal and dramatic/subtle. Their experiences of change frequently conflicted with prevailing dominant understandings, but they did not openly challenge them. Rather, they employed dichotomies, such as abstract/concrete and other/self, to enable them to work with these conflicts. As a result, they engaged in practices such as naming other nurses as 'irrational'. The data provide new understandings of change in clinical nursing practice, some of which challenge many widely held views (for example, that such change is a rare occurrence). It is argued that a lack of open challenge by clinical nurses contributes to their silencing, promotes disharmony amongst nurses and, hence, works against a collaborative approach to decisions about clinical practice.

Transformation of standardized clinical models based on OWL technologies: from CEM to OpenEHR archetypes.

PubMed

Legaz-García, María del Carmen; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás; Chute, Christopher G; Tao, Cui

2015-05-01

The semantic interoperability of electronic healthcare records (EHRs) systems is a major challenge in the medical informatics area. International initiatives pursue the use of semantically interoperable clinical models, and ontologies have frequently been used in semantic interoperability efforts. The objective of this paper is to propose a generic, ontology-based, flexible approach for supporting the automatic transformation of clinical models, which is illustrated for the transformation of Clinical Element Models (CEMs) into openEHR archetypes. Our transformation method exploits the fact that the information models of the most relevant EHR specifications are available in the Web Ontology Language (OWL). The transformation approach is based on defining mappings between those ontological structures. We propose a way in which CEM entities can be transformed into openEHR by using transformation templates and OWL as common representation formalism. The transformation architecture exploits the reasoning and inferencing capabilities of OWL technologies. We have devised a generic, flexible approach for the transformation of clinical models, implemented for the unidirectional transformation from CEM to openEHR, a series of reusable transformation templates, a proof-of-concept implementation, and a set of openEHR archetypes that validate the methodological approach. We have been able to transform CEM into archetypes in an automatic, flexible, reusable transformation approach that could be extended to other clinical model specifications. We exploit the potential of OWL technologies for supporting the transformation process. We believe that our approach could be useful for international efforts in the area of semantic interoperability of EHR systems. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Preclinical and clinical studies on the use of growth factors for bone repair: a systematic review.

PubMed

Fisher, Daniel Mark; Wong, James Min-Leong; Crowley, Conor; Khan, Wasim S

2013-05-01

Bone healing is a complex process. Whilst the majority of fractures heal with conventional treatment, open fractures, large bone defects and non unions still provide great challenges to Orthopaedic Surgeons. Whilst autologous bone graft is seen as the gold standard, the use of growth factors is a growing area of research to find an effective alternative with lower side effects such as donor site morbidity and the finite amount available. This systematic review aims to summarize the pre clinical in-vivo studies and examine the clinical studies on the use of growth factors in bone healing. Databases: PubMed, Medline, OVID, and Cochrane library. The following key words and search terms were used: Growth Factors, Bone Healing, Bone Morphogenic Protein, Transforming Growth Factor Beta, Insulin Like Growth Factor, Platelet Derived Growth Factor, Fracture. All articles were screened based on title with abstracts and full text articles reviewed as appropriate. Reference lists were reviewed from relevant articles to ensure comprehensive and systematic review. Three tables of studies were constructed focussing on Bone Morphogenic Proteins, Platelet Rich Plasma and Growth Factors and Tissue Engineering. Bone Morphogenic Proteins and Platelet Rich Plasma, which contains multiple growth factors, have been shown in preclinical and clinical trials to be an effective alternative to autologous bone graft. Bone Morphogenic Proteins have been shown to be effective in fracture non union, and in open tibial fractures. Platelet Rich Plasma has shown promise in preclinical trials and some small clinical trials, however numbers are limited. Bone Morphogenic Proteins have been shown to be superior to Platelet Rich Protein in one trial. Combining these growth factors with tissue engineering techniques is the focus of ongoing research, and through further clinical trials the most effective techniques for enhancing bone healing will be revealed.

Specialty choice preference of medical students according to personality traits by Five-Factor Model.

PubMed

Kwon, Oh Young; Park, So Youn

2016-03-01

The purpose of this study was to determine the relationship between personality traits, using the Five-Factor Model, and characteristics and motivational factors affecting specialty choice in Korean medical students. A questionnaire survey of Year 4 medical students (n=110) in July 2015 was administered. We evaluated the personality traits of Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness by using the Korean version of Big Five Inventory. Questions about general characteristics, medical specialties most preferred as a career, motivational factors in determining specialty choice were included. Data between five personality traits and general characteristics and motivational factors affecting specialty choice were analyzed using Student t-test, Mann-Whitney test and analysis of variance. Of the 110 eligible medical students, 105 (95.4% response rate) completed the questionnaire. More Agreeableness students preferred clinical medicine to basic medicine (p=0.010) and more Openness students preferred medical departments to others (p=0.031). Personal interest was the significant motivational factors in more Openness students (p=0.003) and Conscientiousness students (p=0.003). Medical students with more Agreeableness were more likely to prefer clinical medicine and those with more Openness preferred medical departments. Personal interest was a significant influential factor determining specialty choice in more Openness and Conscientiousness students. These findings may be helpful to medical educators or career counselors in the specialty choice process.

OC ToGo: bed site image integration into OpenClinica with mobile devices

NASA Astrophysics Data System (ADS)

Haak, Daniel; Gehlen, Johan; Jonas, Stephan; Deserno, Thomas M.

2014-03-01

Imaging and image-based measurements nowadays play an essential role in controlled clinical trials, but electronic data capture (EDC) systems insufficiently support integration of captured images by mobile devices (e.g. smartphones and tablets). The web application OpenClinica has established as one of the world's leading EDC systems and is used to collect, manage and store data of clinical trials in electronic case report forms (eCRFs). In this paper, we present a mobile application for instantaneous integration of images into OpenClinica directly during examination on patient's bed site. The communication between the Android application and OpenClinica is based on the simple object access protocol (SOAP) and representational state transfer (REST) web services for metadata, and secure file transfer protocol (SFTP) for image transfer, respectively. OpenClinica's web services are used to query context information (e.g. existing studies, events and subjects) and to import data into the eCRF, as well as export of eCRF metadata and structural information. A stable image transfer is ensured and progress information (e.g. remaining time) visualized to the user. The workflow is demonstrated for a European multi-center registry, where patients with calciphylaxis disease are included. Our approach improves the EDC workflow, saves time, and reduces costs. Furthermore, data privacy is enhanced, since storage of private health data on the imaging devices becomes obsolete.

Open-angle glaucoma in the Petit Basset Griffon Vendeen.

PubMed

Bedford, Peter G C

2017-03-01

To report the prevalence and clinical characteristics of an open-angle glaucoma in Petit Basset Griffon Vendeen (PBGV) dogs in the United Kingdom (UK). At breed society clinics extending over a 6-year period, 366 dogs of varying ages and both sexes were clinically examined for signs of glaucoma using slit-lamp biomicroscopy, indirect and direct ophthalmoscopy, tonometry, and gonioscopy. The prevalence of glaucoma was 10.4% (38 dogs). Clinical signs of the disease presented from 3 years of age onwards, the commonest initial feature being the elevation of intraocular pressure (IOP) in 15 dogs (39.4%). In addition to elevated IOP, another 13 dogs (34.2%) presented with other features of glaucoma, some with lens subluxation and globe enlargement and all with possible or known vision defects. In the remaining 10 dogs (26.3%), phacodonesis or lens subluxation was observed before subsequent elevation of IOP. High prevalence and similarity to the primary open-angle glaucoma (POAG) seen in the Beagle and Elkhound breeds indicate that an open-angle glaucoma is present in the PBGV in the UK and that this disease may be genetically determined in this breed. Although increased IOP is the commonest early diagnostic feature, lens instability prior to an increase in IOP may be part of the clinical picture. © 2016 American College of Veterinary Ophthalmologists.

Attitudes and preferences toward the provision of medication abortion in an urban academic internal medicine practice.

PubMed

Page, Cameron; Stumbar, Sarah; Gold, Marji

2012-06-01

Mifepristone offers internal medicine doctors the opportunity to greatly expand access to abortion for their patients. Almost 70% of pregnancy terminations, however, still occur in specialized clinics. No studies have examined the preferences of Internal Medicine patients specifically. Determine whether patient preference is a reason for the limited uptake of medication abortion among internal medicine physicians. Women aged 18-45 recruited from the waiting room in an urban academic internal medicine clinic. A semi-structured questionnaire was used to determine risk of unintended pregnancy and attitudes toward abortion. Support for provision of medication abortion in the internal medicine clinic was assessed with a yes/no question, followed by the open-ended question, "Why do you think this clinic should or should not offer medication abortion?" Subjects were asked whether it was very important, somewhat important, or not important for the internal medicine clinic to provide medication abortion. Of 102 women who met inclusion criteria, 90 completed the survey, yielding a response rate of 88%. Twenty-two percent were at risk of unintended pregnancy. 46.7% had had at least one lifetime abortion. Among those who would consider having an abortion, 67.7% responded yes to the question, "Do you think this clinic should offer medication abortions?" and 83.9% stated that it was "very important" or "somewhat important" to offer this service. Of women open to having an abortion, 87.1% stated that they would be interested in receiving a medication abortion from their primary care doctor. A clinically significant proportion of women in this urban internal medicine clinic were at risk of unintended pregnancy. Among those open to having an abortion, a wide majority would consider receiving it from their internal medicine doctor. The provision of medication abortion by internal medicine physicians has the potential to greatly expand abortion access for women.

Treatment of a periorbital cyst in a dog by creation of a permanent drainage opening.

PubMed

Kaiser, S; Driesen, A; Malberg, S; Kramer, M; Thiel, C

2015-01-01

An inflammatory periorbital cyst with secondary pressure atrophy of the maxilla was treated by surgical creation of a drainage opening to the nasal cavity in a 4-year-old Yorkshire Terrier. Following treatment, clinical signs resolved and computed tomography 5 weeks after surgery confirmed the permanence of the drainage opening. Eight months later, the dog showed no clinical abnormalities. Therefore, the procedure described in this report may offer a suitable treatment option in cases where the cyst's size or localization prevents complete excision.

[Normal pressure hydrocephalus: prognostic value of height in patients treated with an identical shunt system].

PubMed

Aguas, Jesús; Rodrigo, Victor; Estupiñan, Francisco; Nogues, Pere; Villalba, Gloria; Villagrasa, Javier; Caral, Luis

2013-01-01

Normal pressure hydrocephalus (NPH) is a clinical entity frequently managed by means of a cerebrospinal fluid shunt. Hydrodynamic hypotheses consider hydrostatic pressure (as well as height) a very important variable for shunt system function. However, we did not find empirical studies supporting the influence of height on clinical response in the literature. Our objective was to study the prognostic value of height, as a variable related to hydrostatic pressure, when an identical shunt system is used. A prospective series of 61 idiopathic NPH cases was analyzed. All cases were shunted by means of a ventricle-peritoneal system with a 100mmH2O opening pressure valve. Anthropometric, clinical, radiological and pressure variables were registered, as well as delay for treatment, improvement and complications. 78.7% of cases improved after shunting. This group of patients was significantly taller (P=.005) than the group without response (median value 165cm versus 152cm). There was also a significant correlation between height and ventricular size decrease after the shunt. In our series opening valve pressure was a constant (100mmHg) and we could consequently focus on the effect of hydrostatic pressure (height). Moreover, we found a positive predictive value for taller patients, probably because we had selected an opening pressure especially suitable for them. Current gravitational valve shunt systems also recommend considering patient height when customising the system. Our study empirically supports this idea. Copyright © 2012 Sociedad Española de Neurocirugía. Published by Elsevier España. All rights reserved.

Open adoption: adoptive parents' reactions two decades later.

PubMed

Siegel, Deborah H

2013-01-01

Unlike in the past, most adoption agencies today offer birth parents and adoptive parents the opportunity to share identifying information and have contact with each other. To understand the impacts of different open adoption arrangements, a qualitative descriptive study using a snowball sample of 44 adoptive parents throughout New England began in 1988. Every seven years these parents who adopted infants in open adoptions have participated in tape-recorded interviews to explore their evolving reactions to their open adoption experiences. This article reports the results of in-depth interviews with these parents now that their children have reached young adulthood. This longitudinal research illuminates how open adoptions change over the course of childhood and adolescence, parents' feelings about open adoption, challenges that emerge in their relationships with their children's birth families, how those challenges are managed and viewed, and parents' advice for others living with open adoption and for clinical social work practice and policy. Findings reveal that regardless of the type of openness, these adoptive parents generally feel positive about knowing the birth parents and having contact with them, are comfortable with open adoption, and see it serving the child's best interests.

Software for MR image overlay guided needle insertions: the clinical translation process

NASA Astrophysics Data System (ADS)

Ungi, Tamas; U-Thainual, Paweena; Fritz, Jan; Iordachita, Iulian I.; Flammang, Aaron J.; Carrino, John A.; Fichtinger, Gabor

2013-03-01

PURPOSE: Needle guidance software using augmented reality image overlay was translated from the experimental phase to support preclinical and clinical studies. Major functional and structural changes were needed to meet clinical requirements. We present the process applied to fulfill these requirements, and selected features that may be applied in the translational phase of other image-guided surgical navigation systems. METHODS: We used an agile software development process for rapid adaptation to unforeseen clinical requests. The process is based on iterations of operating room test sessions, feedback discussions, and software development sprints. The open-source application framework of 3D Slicer and the NA-MIC kit provided sufficient flexibility and stable software foundations for this work. RESULTS: All requirements were addressed in a process with 19 operating room test iterations. Most features developed in this phase were related to workflow simplification and operator feedback. CONCLUSION: Efficient and affordable modifications were facilitated by an open source application framework and frequent clinical feedback sessions. Results of cadaver experiments show that software requirements were successfully solved after a limited number of operating room tests.

Comparison of Clinical and Radiographic Outcomes for Posterior Fossa Decompression with and without Duraplasty for Treatment of Pediatric Chiari I Malformation: A Prospective Study.

PubMed

Jiang, Enze; Sha, Shifu; Yuan, XinXin; Zhu, WeiGuo; Jiang, Jian; Ni, Hongbin; Liu, Zhen; Qiu, Yong; Zhu, Zezhang

2018-02-01

The aim of this study was to prospectively compare the radiographic and clinical outcomes between the posterior fossa decompression (PFD) and PFD with duraplasty (PFDD) procedures in adolescent patients with Chiari malformation type I (CMI). Ninety adolescent patients with CMI were randomly assigned to undergo either PFDD or PFD. In both groups, a dissection from the occipital bone was performed. The dura was not opened in the PFD group, and the outer layer of dura was resected. However, in the PFDD group, the dura mater was opened and expanded. Data were analyzed for clinical outcome, complications, and syrinx resolution. The age, gender, and preoperative neurologic status were similar between the 2 groups. Compared with the PFD group, patients undergoing PFDD had significantly longer operation time, longer postoperative drainage time, and higher drainage volume. At the latest follow-up, no statistically significant difference was found between the 2 groups in terms of syrinx resolution. The clinical outcomes were similar in the PFDD and PFD group. Compared with the PFD group, patients in the PFDD group had a higher incidence of cerebrospinal fluid leak. Compared with the more aggressive decompression with duraplasty, PFD without duraplasty produces comparable radiologic and clinical outcomes and is associated with a lower risk of complications. Copyright © 2017 Elsevier Inc. All rights reserved.

Concordance between actual and pharmacogenetic predicted desvenlafaxine dose needed to achieve remission in major depressive disorder: a 10-week open-label study

PubMed Central

Müller, Daniel J.; Ng, Chee H.; Byron, Keith; Berk, Michael; Singh, Ajeet B.

2017-01-01

Background Pharmacogenetic-based dosing support tools have been developed to personalize antidepressant-prescribing practice. However, the clinical validity of these tools has not been adequately tested, particularly for specific antidepressants. Objective To examine the concordance between the actual dose and a polygene pharmacogenetic predicted dose of desvenlafaxine needed to achieve symptom remission. Materials and methods A 10-week, open-label, prospective trial of desvenlafaxine among Caucasian adults with major depressive disorder (n=119) was conducted. Dose was clinically adjusted and at the completion of the trial, the clinical dose needed to achieve remission was compared with the predicted dose needed to achieve remission. Results Among remitters (n=95), there was a strong concordance (Kendall’s τ-b=0.84, P=0.0001; Cohen’s κ=0.82, P=0.0001) between the actual and the predicted dose need to achieve symptom remission, showing high sensitivity (≥85%), specificity (≥86%), and accuracy (≥89%) of the tool. Conclusion Findings provide initial evidence for the clinical validity of a polygene pharmacogenetic-based tool for desvenlafaxine dosing. PMID:27779571

Concordance between actual and pharmacogenetic predicted desvenlafaxine dose needed to achieve remission in major depressive disorder: a 10-week open-label study.

PubMed

Bousman, Chad A; Müller, Daniel J; Ng, Chee H; Byron, Keith; Berk, Michael; Singh, Ajeet B

2017-01-01

Pharmacogenetic-based dosing support tools have been developed to personalize antidepressant-prescribing practice. However, the clinical validity of these tools has not been adequately tested, particularly for specific antidepressants. To examine the concordance between the actual dose and a polygene pharmacogenetic predicted dose of desvenlafaxine needed to achieve symptom remission. A 10-week, open-label, prospective trial of desvenlafaxine among Caucasian adults with major depressive disorder (n=119) was conducted. Dose was clinically adjusted and at the completion of the trial, the clinical dose needed to achieve remission was compared with the predicted dose needed to achieve remission. Among remitters (n=95), there was a strong concordance (Kendall's τ-b=0.84, P=0.0001; Cohen's κ=0.82, P=0.0001) between the actual and the predicted dose need to achieve symptom remission, showing high sensitivity (≥85%), specificity (≥86%), and accuracy (≥89%) of the tool. Findings provide initial evidence for the clinical validity of a polygene pharmacogenetic-based tool for desvenlafaxine dosing.

B-cell depletion in SLE: clinical and trial experience with rituximab and ocrelizumab and implications for study design.

PubMed

Reddy, Venkat; Jayne, David; Close, David; Isenberg, David

2013-01-01

B cells are believed to be central to the disease process in systemic lupus erythematosus (SLE), making them a target for new therapeutic intervention. In recent years there have been many publications regarding the experience in SLE of B-cell depletion utilising rituximab, an anti-CD20 mAb that temporarily depletes B cells,reporting promising results in uncontrolled open studies and in routine clinical use. However, the two large randomised controlled trials in extra-renal lupus (EXPLORER study) and lupus nephritis (LUNAR study) failed to achieve their primary endpoints. Based on the clinical experience with rituximab this failure was somewhat unexpected and raised a number of questions and concerns, not only into the true level of benefit of B-cell depletion in a broad population but also how to test the true level of effectiveness of an investigational agent as we seek to improve the design of therapeutic trials in SLE. A better understanding of what went wrong in these trials is essential to elucidate the underlying reasons for the disparate observations noted in open studies and controlled trials. In this review, we focus on various factors that may affect the ability to accurately and confidently establish the level of treatment effect of the investigational agent, in this case rituximab, in the tw studies and explore hurdles faced in the randomised controlled trials investigating the efficacy of ocrelizumab, the humanised anti-CD20 mAb, in SLE. Further, based on the lessons learned from the clinical trials, we make suggestions that could be implemented in future clinical trial design to overcome the hurdles faced.

Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors.

PubMed

Checketts, Jake X; Sims, Matthew Thomas; Vassar, Matt

2017-12-01

It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10 000, and 18 accepted more than $50 000. Financial payments amounted to a mean of $157 177 per author. The total reimbursement among the 49 authors from 2013 to 2015 was $7 701 681. Of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. Authors received payments from companies with products directly related to the guideline topic. Violations to the Administrative Regulations were found. Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments. The American Academy of Dermatology policies may benefit from stricter enforcement or the adoption of new standards.

Electronic data capture for registries and clinical trials in orthopaedic surgery: open source versus commercial systems.

PubMed

Shah, Jatin; Rajgor, Dimple; Pradhan, Shreyasee; McCready, Mariana; Zaveri, Amrapali; Pietrobon, Ricardo

2010-10-01

Collection and analysis of clinical data can help orthopaedic surgeons to practice evidence based medicine. Spreadsheets and offline relational databases are prevalent, but not flexible, secure, workflow friendly and do not support the generation of standardized and interoperable data. Additionally these data collection applications usually do not follow a structured and planned approach which may result in failure to achieve the intended goal. Our purposes are (1) to provide a brief overview of EDC systems, their types, and related pros and cons as well as to describe commonly used EDC platforms and their features; and (2) describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system. WHERE ARE WE NOW?: Electronic data capture systems aimed at addressing these issues are widely being adopted at an institutional/national/international level but are lacking at an individual level. A wide array of features, relative pros and cons and different business models cause confusion and indecision among orthopaedic surgeons interested in implementing EDC systems. WHERE DO WE NEED TO GO?: To answer clinical questions and actively participate in clinical studies, orthopaedic surgeons should collect data in parallel to their clinical activities. Adopting a simple, user-friendly, and robust EDC system can facilitate the data collection process. HOW DO WE GET THERE?: Conducting a balanced evaluation of available options and comparing them with intended goals and requirements can help orthopaedic surgeons to make an informed choice.

Interconnecting smartphone, image analysis server, and case report forms in clinical trials for automatic skin lesion tracking in clinical trials

NASA Astrophysics Data System (ADS)

Haak, Daniel; Doma, Aliaa; Gombert, Alexander; Deserno, Thomas M.

2016-03-01

Today, subject's medical data in controlled clinical trials is captured digitally in electronic case report forms (eCRFs). However, eCRFs only insufficiently support integration of subject's image data, although medical imaging is looming large in studies today. For bed-side image integration, we present a mobile application (App) that utilizes the smartphone-integrated camera. To ensure high image quality with this inexpensive consumer hardware, color reference cards are placed in the camera's field of view next to the lesion. The cards are used for automatic calibration of geometry, color, and contrast. In addition, a personalized code is read from the cards that allows subject identification. For data integration, the App is connected to an communication and image analysis server that also holds the code-study-subject relation. In a second system interconnection, web services are used to connect the smartphone with OpenClinica, an open-source, Food and Drug Administration (FDA)-approved electronic data capture (EDC) system in clinical trials. Once the photographs have been securely stored on the server, they are released automatically from the mobile device. The workflow of the system is demonstrated by an ongoing clinical trial, in which photographic documentation is frequently performed to measure the effect of wound incision management systems. All 205 images, which have been collected in the study so far, have been correctly identified and successfully integrated into the corresponding subject's eCRF. Using this system, manual steps for the study personnel are reduced, and, therefore, errors, latency and costs decreased. Our approach also increases data security and privacy.

Pharmacokinetic analysis and drug delivery efficiency of the focused ultrasound-induced blood-brain barrier opening in non-human primates

PubMed Central

Samiotaki, Gesthimani; Karakatsani, Maria Eleni; Buch, Amanda; Papadopoulos, Stephanos; Wu, Shih Ying; Jambawalikar, Sachin; Konofagou, Elisa E.

2016-01-01

Purpose Focused Ultrasound (FUS) in conjunction with systemically administered microbubbles has been shown to open the Blood-Brain Barrier (BBB) locally, non-invasively and reversibly in rodents and non-human primates (NHP), suggesting the immense potential of this technique. The objective of this study entailed the investigation of the physiologic changes in the brain following the FUS-induced BBB opening and their relationship with the underlying anatomy. Materials and Methods Pharmacokinetic analysis was implemented in NHP’s that received FUS at various acoustic pressures. Relaxivity mapping enabled the robust quantitative detection of the BBB opening as well as gray and white matter segmentation. Drug delivery efficiency was measured for pre-clinical validation of the technique. Results Based on our results, the opening volume and the amount of the gadolinium delivered were found mostly contained in the grey matter, while FUS-induced permeability and drug concentration varied depending upon the underlying brain inhomogeneity, and increased with the acoustic pressure. Conclusions Overall, apart from the in vivo protocols for BBB analysis developed here, this study also suggests the important role that FUS can have in efficient drug delivery via localized and transient BBB opening. PMID:27916657

Treatment of attention deficit disorder with DL-phenylalanine.

PubMed

Wood, D R; Reimherr, F W; Wender, P H

1985-09-01

Nineteen patients meeting the criteria for attention deficit disorder, residual type (adult hyperactivity), were given a 2-week double-blind crossover of DL-phenylalanine versus placebo. Thirteen subjects completed the study; the mean global rating of improvement approached significance as compared with placebo. A significant improvement was noted on mood and mood lability. The phenylalanine responders were then continued on open drug, but lost all positive benefits within 3 months. A later open trial of L-phenylalanine produced no clinical effect.

Do Stimulants Reduce the Risk for Alcohol and Substance Use in Youth With ADHD? A Secondary Analysis of a Prospective, 24-Month Open-Label Study of Osmotic-Release Methylphenidate.

PubMed

Hammerness, Paul; Petty, Carter; Faraone, Stephen V; Biederman, Joseph

2017-01-01

The purpose of this study was to examine the impact of stimulant treatment on risk for alcohol and illicit drug use in adolescents with ADHD. Analysis of data derived from a prospective open-label treatment study of adolescent ADHD ( n = 115, 76% male), and a historical, naturalistic sample of ADHD ( n = 44, 68% male) and non-ADHD youth ( n = 52, 73% male) of similar age and sex. Treatment consisted of extended-release methylphenidate in the clinical trial or naturalistic stimulant treatment. Self-report of alcohol and drug use was derived from a modified version of the Drug Use Screening Inventory. Rates of alcohol and drug use in the past year were significantly lower in the clinical trial compared with untreated and treated naturalistic ADHD comparators, and similar to rates in non-ADHD comparators. Well-monitored stimulant treatment may reduce the risk for alcohol and substance use in adolescent ADHD.

Robotic, laparoscopic and open surgery for gastric cancer compared on surgical, clinical and oncological outcomes: a multi-institutional chart review. A study protocol of the International study group on Minimally Invasive surgery for GASTRIc Cancer—IMIGASTRIC

PubMed Central

Desiderio, Jacopo; Jiang, Zhi-Wei; Nguyen, Ninh T; Zhang, Shu; Reim, Daniel; Alimoglu, Orhan; Azagra, Juan-Santiago; Yu, Pei-Wu; Coburn, Natalie G; Qi, Feng; Jackson, Patrick G; Zang, Lu; Brower, Steven T; Kurokawa, Yukinori; Facy, Olivier; Tsujimoto, Hironori; Coratti, Andrea; Annecchiarico, Mario; Bazzocchi, Francesca; Avanzolini, Andrea; Gagniere, Johan; Pezet, Denis; Cianchi, Fabio; Badii, Benedetta; Novotny, Alexander; Eren, Tunc; Leblebici, Metin; Goergen, Martine; Zhang, Ben; Zhao, Yong-Liang; Liu, Tong; Al-Refaie, Waddah; Ma, Junjun; Takiguchi, Shuji; Lequeu, Jean-Baptiste; Trastulli, Stefano; Parisi, Amilcare

2015-01-01

Introduction Gastric cancer represents a great challenge for healthcare providers and requires a multidisciplinary treatment approach in which surgery plays a major role. Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and recently with the spread of robotic surgery, but a number of issues are currently being debated, including the limitations in performing an effective extended lymph node dissection, the real advantages of robotic systems, the role of laparoscopy for Advanced Gastric Cancer, the reproducibility of a total intracorporeal technique and the oncological results achievable during long-term follow-up. Methods and analysis A multi-institutional international database will be established to evaluate the role of robotic, laparoscopic and open approaches in gastric cancer, comprising of information regarding surgical, clinical and oncological features. A chart review will be conducted to enter data of participants with gastric cancer, previously treated at the participating institutions. The database is the first of its kind, through an international electronic submission system and a HIPPA protected real time data repository from high volume gastric cancer centres. Ethics and dissemination This study is conducted in compliance with ethical principles originating from the Helsinki Declaration, within the guidelines of Good Clinical Practice and relevant laws/regulations. A multicentre study with a large number of patients will permit further investigation of the safety and efficacy as well as the long-term outcomes of robotic, laparoscopic and open approaches for the management of gastric cancer. Trial registration number NCT02325453; Pre-results. PMID:26482769

[Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

PubMed

Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

2011-10-01

To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

Acoustic Cavitation-Based Monitoring of the Reversibility and Permeability of Ultrasound-Induced Blood-Brain Barrier Opening

PubMed Central

Sun, Tao; Samiotaki, Gesthimani; Wang, Shutao; Acosta, Camilo; Chen, Cherry C.; Konofagou, Elisa E.

2015-01-01

Cavitation events seeded by microbubbles have been previously reported to be associated with MR- or fluorescent-contrast enhancement after focused ultrasound (FUS)-induced blood-brain barrier (BBB) opening. However, it is still unknown whether bubble activity can be correlated with the reversibility (the duration of opening and the likelihood of safe reinstatement) and the permeability of opened BBB, which is critical for the clinical translation of using passive cavitation detection to monitor, predict and control the opening. In this study, the dependence of acoustic cavitation on the BBB opening duration, permeability coefficient and histological damage occurrence were thus investigated. Transcranial pulsed FUS at 1.5 MHz in the presence of systemically circulating microbubbles was applied in the mouse hippocampi (n = 60). The stable and inertial cavitation activities were monitored during sonication. Contrast-enhanced MRI was performed immediately after sonication and every 24 h up to 6 days thereafter, to assess BBB opening, brain tissue permeability and potential edema. Histological evaluations were used to assess the occurrence of neurovascular damages. It was found that stable cavitation was well correlated with: 1) the duration of the BBB opening (r2 = 0.77); 2) the permeability of the opened BBB (r2 = 0.82); 3) the likelihood of safe opening (P < 0.05, safe opening compared to cases of damage; P < 0.0001, no opening compared to safe opening). The inertial cavitation dose was correlated with the resulting BBB permeability (r2 = 0.72). Stable cavitation was found to be more reliable than inertial cavitation at assessing the BBB opening within the pressure range used in this study. This study demonstrates that the stable cavitation response during BBB opening holds promise for predicting and controlling the restoration and pharmacokinetics of FUS-opened BBB. The stable cavitation response therefore showed great promise in predicting the BBB opening duration, enabling thus control of opening according to the drug circulation time. In addition, avoiding adverse effects in the brain and assessing the pharmacokinetics of the compounds delivered can also be achieved by monitoring and controlling the stable cavitation emissions. PMID:26562661

A Systematic Review of Tennis Elbow Surgery: Open Versus Arthroscopic Versus Percutaneous Release of the Common Extensor Origin.

PubMed

Pierce, Todd P; Issa, Kimona; Gilbert, Benjamin T; Hanly, Brian; Festa, Anthony; McInerney, Vincent K; Scillia, Anthony J

2017-06-01

To compare complications, function, pain, and patient satisfaction after conventional open, percutaneous, or arthroscopic release of the extensor origin for the treatment of lateral epicondylitis. A thorough review of 4 databases-PubMed, EBSCOhost, CINAHL (Cumulative Index to Nursing and Allied Health Literature) Plus, and Scopus-was performed to identify all studies that addressed surgical management of lateral epicondylitis. We included (1) studies published between 2000 and 2015 and (2) studies with clearly defined surgical techniques. We excluded (1) non-English-language manuscripts, (2) isolated case reports, (3) studies with fewer than 10 subjects, (4) animal studies, (5) studies with additional adjunctive procedures aside from release of the extensor origin, (6) clinical or systematic review manuscripts, (7) studies with a follow-up period of 6 months or less, and (8) studies in which less than 80% of patients completed follow-up. Each study was analyzed for complication rates, functional outcomes, pain, and patient satisfaction. Thirty reports were identified that included 848 open, 578 arthroscopic, and 178 percutaneous releases. Patients within each release group had a similar age (46 years vs 46 years vs 48 years; P = .9 and P = .4, respectively), whereas there was a longer follow-up time in patients who underwent surgery by an open technique (49.4 months vs 42.6 months vs 23 months, P < .001). There were no differences in complication rates among these techniques (3.8% vs 2.9% vs 3.9%; P = .5 and P = .9, respectively). However, open techniques were correlated with higher surgical-site infection rates than arthroscopic techniques (0.7% vs 0%, P = .04). Mean Disabilities of the Arm, Shoulder and Hand scores were substantially better with both open and arthroscopic techniques than with percutaneous release (19.9 points vs 21.3 points vs 29 points, P < .001). In addition, there was less pain reported in the arthroscopic and percutaneous release groups as opposed to their open counterparts (1.9 points vs 1.4 points vs 1.3 points, P < .0001). There were no differences among the techniques in patient satisfaction rate (93.7% vs 89% vs 88%; P = .08 and P = .07, respectively). Functional outcomes of open and arthroscopic releases may be superior to those of percutaneous release. In addition, patients may report less pain with arthroscopic and percutaneous techniques. Although the risk of complications is similar regardless of technique, patients may be counseled that their risk of infectious complications may be slightly higher with open releases. However, it is important to note that this statistical difference may not necessarily portend noticeable clinical differences. Level IV, systematic review of Level III and IV evidence. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Tocotrienol Treatment in Familial Dysautonomia: Open-Label Pilot Study.

PubMed

Cheishvili, David; Maayan, Channa; Holzer, Naama; Tsenter, Jeanna; Lax, Elad; Petropoulos, Sophie; Razin, Aharon

2016-07-01

Familial dysautonomia (FD) is an autosomal recessive congenital neuropathy, primarily presented in Ashkenazi Jews. The most common mutation in FD patients results from a single base pair substitution of an intronic splice site in the IKBKAP gene which disrupts normal mRNA splicing and leads to tissue-specific reduction of IKBKAP protein (IKAP). To date, treatment of FD patients remains preventative, symptomatic and supportive. Based on previous in vitro evidence that tocotrienols, members of the vitamin E family, upregulate transcription of the IKBKAP gene, we aimed to investigate whether a similar effects was observed in vivo. In the current study, we assessed the effects of tocotrienol treatment on FD patients' symptoms and IKBKAP expression in white blood cells. The initial daily doses of 50 or 100 mg tocotrienol, doubled after 3 months, was administered to 32 FD patients. Twenty-eight FD patients completed the 6-month study. The first 3 months of tocotrienol treatment was associated with a significant increase in IKBKAP expression level in FD patients' blood. Despite doubling the dose after the initial 3 months of treatment, IKBKAP expression level returned to baseline by the end of the 6-month treatment. Clinical improvement was noted in the reported clinical questionnaire (with regard to dizziness, bloching, sweating, number of pneumonia, cough episodes, and walking stability), however, no significant effect was observed in any clinical measurements (weight, height, oxygen saturation, blood pressure, tear production, histamine test, vibration threshold test, nerve conduction, and heart rate variability) following Tocotrienol treatment. In conclusion, tocotrienol treatment appears significantly beneficial by clinical evaluation for some FD patients in a few clinical parameters; however it was not significant by clinical measurements. This open-label study shows the complexity of effect of tocotrienol treatment on FD patients' clinical outcomes and on IKBKAP expression level compared to in vitro results. A longitudinal study with an increased sample size is required in the future to better understand tocotrienol affect on FD patients.

Comparison between Closing-Wedge and Opening-Wedge High Tibial Osteotomy in Patients with Medial Knee Osteoarthritis: A Systematic Review and Meta-analysis.

PubMed

Sun, Hao; Zhou, Lin; Li, Fengsheng; Duan, Jun

2017-02-01

Young active patients with medial knee osteoarthritis (OA) combined with varus leg alignment can be treated with high tibial osteotomy (HTO) to stop the progression of OA and avoid or postpone total knee arthroplasty (TKA). Closing-wedge osteotomy (CWO) and opening-wedge osteotomy (OWO) are the most commonly used osteotomy techniques. The purpose of this study was to compare the clinical and radiologic outcomes and complications between OWO and CWO. We retrospectively evaluated 23 studies including 17 clinical trials from published databases from their inception to May 2015. We evaluated the clinical outcomes including operation time, visual analog scale (VAS), maximal flexion, and hospital for special surgery knee (HSS) score. The radiologic outcomes included patellar height measured by posterior tibial slope angle, hip-knee-ankle (HKA) angle, femorotibial (FT) axis, and limb length. Complications recorded included the incidence of deep vein thrombosis (DVT), common peroneal nerve injury, opposite cortical fracture, etc. There were no differences in most of the clinical outcomes except the operation time. OWO increased the posterior slope angle and limb length, decreased the patellar height, and provided higher accuracy of correction. CWO led to a higher incidence of opposite cortical fracture. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Effect of zolpidem in chronic disorders of consciousness: a prospective open-label study

PubMed Central

Thonnard, Marie; Gosseries, Olivia; Demertzi, Athena; Lugo, Zulay; Vanhaudenhuyse, Audrey; Bruno, Marie-Aurélie; Chatelle, Camille; Thibaut, Aurore; Charland-Verville, Vanessa; Habbal, Dina; Schnakers, Caroline; Laureys, Steven

2013-01-01

Summary Zolpidem has been reported as an “awakening drug” in some patients with disorders of consciousness (DOC). We here present the results of a prospective open-label study in chronic DOC patients. Sixty patients (35±15 years; 18 females; mean time since insult ± SD: 4±5.5 years; 31 with traumatic etiology) with a diagnosis of vegetative state/unresponsive wakefulness syndrome (n=28) or minimally conscious state (n=32) were behaviorally assessed using the Coma Recovery Scale-Revised (CRS-R) before and one hour after administration of 10 mg of zolpidem. At the group level, the diagnosis did not change after intake of zolpidem (p=0.10) and CRS-R total scores decreased (p=0.01). Twelve patients (20%) showed improved behaviors and/or CRS-R total scores after zolpidem administration but in only one patient was the diagnosis after zolpidem intake found to show a significant improvement (functional object use), which suggested a change of diagnosis. However, in this patient, a double-blind placebo-controlled trial was performed in order to better specify the effects of zolpidem, but the patient, on this trial, failed to show any clinical improvements. The present open-label study therefore failed to show any clinically significant improvement (i.e., change of diagnosis) in any of the 60 studied chronic DOC patients. PMID:24598393

Open cholecystectomy: Exposure and confidence of surgical trainees and new fellows.

PubMed

Campbell, Beth M; Lambrianides, Andreas L; Dulhunty, Joel M

2018-03-01

The laparoscopic approach to cholecystectomy has overtaken open procedures in terms of frequency, despite open procedures playing an important role in certain clinical situations. This study explored exposure and confidence of Australasian surgical trainees and new fellows in performing an open versus laparoscopic cholecystectomy. An online survey was disseminated via the Royal Australasian College of Surgeons to senior general surgery trainees (years 3-5 of surgical training) and new fellows (fellowship within the previous 5 years). The survey included questions regarding level of experience and confidence in performing an open cholecystectomy and converting from a laparoscopic to an open approach. A total of 135 participants responded; 58 (43%) were surgical trainees, 58 (43%) were fellows and 19 (14%) did not specify their level of training. Respondents who were involved in more than 20 open cholecystectomy procedures as an assistant or independent operator compared with those less exposed were more likely to feel confident to independently perform an elective open cholecystectomy (87.8% vs. 57.3%, P = 0.001), independently convert from a laparoscopic to open cholecystectomy (87.8% vs. 58.7%, P = 0.001) and independently perform an open cholecystectomy as a surgical consultant based on their level of exposure as a trainee (73.2% vs. 45.3%, P = 0.004). This study suggests the need to ensure surgical trainees are exposed to sufficient open cholecystectomies to enable confidence and skill with performing these procedures when indicated. Greater recognition of the need for exposure during training, including meaningful simulation, may assist. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

RImmPort: an R/Bioconductor package that enables ready-for-analysis immunology research data.

PubMed

Shankar, Ravi D; Bhattacharya, Sanchita; Jujjavarapu, Chethan; Andorf, Sandra; Wiser, Jeffery A; Butte, Atul J

2017-04-01

: Open access to raw clinical and molecular data related to immunological studies has created a tremendous opportunity for data-driven science. We have developed RImmPort that prepares NIAID-funded research study datasets in ImmPort (immport.org) for analysis in R. RImmPort comprises of three main components: (i) a specification of R classes that encapsulate study data, (ii) foundational methods to load data of a specific study and (iii) generic methods to slice and dice data across different dimensions in one or more studies. Furthermore, RImmPort supports open formalisms, such as CDISC standards on the open source bioinformatics platform Bioconductor, to ensure that ImmPort curated study datasets are seamlessly accessible and ready for analysis, thus enabling innovative bioinformatics research in immunology. RImmPort is available as part of Bioconductor (bioconductor.org/packages/RImmPort). rshankar@stanford.edu. Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Glaucoma and clinical characteristics in Vietnamese Americans.

PubMed

Peng, Pai-Huei; Manivanh, Richard; Nguyen, Ngoc; Weinreb, Robert N; Lin, Shan C

2011-08-01

To assess the proportions of glaucoma types and clinical characteristics in Vietnamese Americans in a single-center, retrospective study. Medical charts of Vietnamese-American patients who visited a single private practice in Northern California from 1998-2007 were reviewed. The main outcome measures included the distribution and characteristics of glaucoma types, and clinical parameters associated with the presence of various glaucomas. Data from 2247 patients aged 18-98 years were reviewed. Glaucoma was determined for 305 patients (13.6%). Among this group, 54.8% had primary open-angle glaucoma (POAG), 26.9% had primary angle-closure glaucoma (PACG), 13.4% had mixed mechanism glaucoma (MMG), and 4.9% had secondary glaucoma. In the MMG group (41 patients), 27 patients who initially had open angles developed narrow angles and underwent laser peripheral iridotomy (LPI) with a mean follow up of 6.4 years from the time of iridotomy. The other 13 patients had glaucoma progression with open angles after LPI. One POAG patient had neovascular glaucoma due to retinal vein occlusion several years later. Compared to the PACG group, the MMG group had significantly lower baseline intraocular pressure (25.0 vs. 20.2 mmHg, p = 0.007) but with no difference in biometry. POAG is the major type of glaucoma in this clinic-based Vietnamese population. However, Vietnamese appear to have a relatively higher proportion of PACG than Caucasians and those of African descent. It is recommended that gonioscopy be part of the regular eye check-up for adult Vietnamese patients.

Developing the First Generally-Available openEHR Archetypes and Templates for Physiotherapy: An Example of Building Clinical Models and Modelling Capacity via Student-Led Academic-Industrial Collaboration.

PubMed

Chihab, Jamila; Franke, Hildegard; McNicoll, Ian; Darlison, Matthew W

2017-01-01

We present the first public openEHR archetypes and templates for physiotherapy, and the context of multidisciplinary academic-industry partnership that has enabled their production by a team led by a clinically trained student on the UCL health informatics MSc programme.

A Clinical Reasoning Tool for Virtual Patients: Design-Based Research Study.

PubMed

Hege, Inga; Kononowicz, Andrzej A; Adler, Martin

2017-11-02

Clinical reasoning is a fundamental process medical students have to learn during and after medical school. Virtual patients (VP) are a technology-enhanced learning method to teach clinical reasoning. However, VP systems do not exploit their full potential concerning the clinical reasoning process; for example, most systems focus on the outcome and less on the process of clinical reasoning. Keeping our concept grounded in a former qualitative study, we aimed to design and implement a tool to enhance VPs with activities and feedback, which specifically foster the acquisition of clinical reasoning skills. We designed the tool by translating elements of a conceptual clinical reasoning learning framework into software requirements. The resulting clinical reasoning tool enables learners to build their patient's illness script as a concept map when they are working on a VP scenario. The student's map is compared with the experts' reasoning at each stage of the VP, which is technically enabled by using Medical Subject Headings, which is a comprehensive controlled vocabulary published by the US National Library of Medicine. The tool is implemented using Web technologies, has an open architecture that enables its integration into various systems through an open application program interface, and is available under a Massachusetts Institute of Technology license. We conducted usability tests following a think-aloud protocol and a pilot field study with maps created by 64 medical students. The results show that learners interact with the tool but create less nodes and connections in the concept map than an expert. Further research and usability tests are required to analyze the reasons. The presented tool is a versatile, systematically developed software component that specifically supports the clinical reasoning skills acquisition. It can be plugged into VP systems or used as stand-alone software in other teaching scenarios. The modular design allows an extension with new feedback mechanisms and learning analytics algorithms. ©Inga Hege, Andrzej A Kononowicz, Martin Adler. Originally published in JMIR Medical Education (http://mededu.jmir.org), 02.11.2017.

Cost-Minimization Analysis of Open and Endoscopic Carpal Tunnel Release.

PubMed

Zhang, Steven; Vora, Molly; Harris, Alex H S; Baker, Laurence; Curtin, Catherine; Kamal, Robin N

2016-12-07

Carpal tunnel release is the most common upper-limb surgical procedure performed annually in the U.S. There are 2 surgical methods of carpal tunnel release: open or endoscopic. Currently, there is no clear clinical or economic evidence supporting the use of one procedure over the other. We completed a cost-minimization analysis of open and endoscopic carpal tunnel release, testing the null hypothesis that there is no difference between the procedures in terms of cost. We conducted a retrospective review using a private-payer and Medicare Advantage database composed of 16 million patient records from 2007 to 2014. The cohort consisted of records with an ICD-9 (International Classification of Diseases, Ninth Revision) diagnosis of carpal tunnel syndrome and a CPT (Current Procedural Terminology) code for carpal tunnel release. Payer fees were used to define cost. We also assessed other associated costs of care, including those of electrodiagnostic studies and occupational therapy. Bivariate comparisons were performed using the chi-square test and the Student t test. Data showed that 86% of the patients underwent open carpal tunnel release. Reimbursement fees for endoscopic release were significantly higher than for open release. Facility fees were responsible for most of the difference between the procedures in reimbursement: facility fees averaged $1,884 for endoscopic release compared with $1,080 for open release (p < 0.0001). Endoscopic release also demonstrated significantly higher physician fees than open release (an average of $555 compared with $428; p < 0.0001). Occupational therapy fees associated with endoscopic release were less than those associated with open release (an average of $237 per session compared with $272; p = 0.07). The total average annual reimbursement per patient for endoscopic release (facility, surgeon, and occupational therapy fees) was significantly higher than for open release ($2,602 compared with $1,751; p < 0.0001). Our data showed that the total average fees per patient for endoscopic release were significantly higher than those for open release, although there currently is no strong evidence supporting better clinical outcomes of either technique. Value-based health-care models that favor delivering high-quality care and improving patient health, while also minimizing costs, may favor open carpal tunnel release.

Opiate Antagonists Do Not Interfere With the Clinical Benefits of Stimulants in ADHD: A Double-Blind, Placebo-Controlled Trial of the Mixed Opioid Receptor Antagonist Naltrexone.

PubMed

Spencer, Thomas J; Bhide, Pradeep; Zhu, Jinmin; Faraone, Stephen V; Fitzgerald, Maura; Yule, Amy M; Uchida, Mai; Spencer, Andrea E; Hall, Anna M; Koster, Ariana J; Biederman, Joseph

Methylphenidate activates μ-opioid receptors, which are linked to euphoria. μ-Opioid antagonists, such as naltrexone, may attenuate the euphoric effects of stimulants, thereby minimizing their abuse potential. This study assessed whether the combination of naltrexone with methylphenidate is well-tolerated while preserving the clinical benefits of stimulants in subjects with attention-deficit/hyperactivity disorder (ADHD). We conducted a 6-week, double-blind, placebo-controlled, randomized clinical trial of naltrexone in adults with DSM-IV ADHD receiving open treatment with a long-acting formulation of methylphenidate from January 2013 to July 2015. Spheroidal Oral Drug Absorption System (SODAS) methylphenidate was administered twice daily, was titrated to approximately 1 mg/kg/d over 3 weeks, and was continued for 3 additional weeks depending on response and adverse effects. Subjects were adults with ADHD preselected for having experienced euphoria with a test dose of immediate-release methylphenidate. The primary outcome measure was the Adult ADHD Investigator Symptom Report Scale (AISRS). Thirty-seven subjects who experienced stimulant-induced (mild) euphoria at a baseline visit were started in the open trial of SODAS methylphenidate and randomly assigned to naltrexone 50 mg or placebo. Thirty-one subjects completed the study through week 3, and 25 completed through week 6. Throughout 6 weeks of blinded naltrexone and open methylphenidate treatment, the coadministration of naltrexone with methylphenidate did not interfere with the clinical effectiveness of methylphenidate for ADHD symptoms. Additionally, the combination of naltrexone and methylphenidate did not produce an increase in adverse events compared with methylphenidate alone. Our findings provide support for the concept of combining opioid receptor antagonists with stimulants to provide an effective stimulant formulation with less abuse potential. ClinicalTrials.gov identifier: NCT01673594​. © Copyright 2017 Physicians Postgraduate Press, Inc.

Personality traits and clinical/biochemical course in the first year after kidney transplant.

PubMed

Thomas, Caroline Venzon; de Castro, Elisa Kern; Antonello, Ivan Carlos Ferreira

2016-10-01

The relationship between personality and health is frequently studied in scientific research. This study investigated the clinical/biochemical course of kidney transplant patients based on personality traits. A longitudinal study assessed 114 kidney transplant patients (men = 68 and women = 46) with an average age of 47.72 years (SD = 11.4). Personality was evaluated using the Brazilian Factorial Personality Inventory (BFP/Big Five Model). Clinical variables were analyzed based on patient charts (estimated glomerular filtration rate (eGFR), hypertension, acute rejection, infection, graft loss, and death). Personality types were assessed by hierarchical cluster analysis. Two groups with personality types were differentiated by psychological characteristics: Cluster 1 - average neuroticism, high surgency, agreeableness and conscientiousness, and low openness; Cluster 2 - high neuroticism, average surgency and agreeableness, average conscientiousness, and low openness. There was no statistically significant difference between the clusters in terms of hypertension, acute infection, graft loss, death, and Human Leukocyte Antigen (HLA) I and II panel reactive antibodies. eGFR was associated with the personality types. Cluster 2 was associated with a better renal function in the 9-month follow-up period after kidney transplantation. In this study, patients from Cluster 2 exhibited higher eGFR 9 months after the transplant procedure compared to those from Cluster 1. Monitoring these patients over a longer period may provide a better understanding of the relationship between personality traits and clinical course during the post-transplant period.

A small-scale open-label study of the treatment of canine flea allergy dermatitis with fluralaner.

PubMed

Fisara, Petr; Shipstone, Michael; von Berky, Andrew; von Berky, Janet

2015-12-01

Fluralaner is an isoxazoline systemic insecticide and acaricide that provides persistent flea-killing activity on dogs for 12 weeks. European and US field studies have shown that fluralaner treatment alleviates the signs of flea allergy dermatitis (FAD) in client-owned dogs. To assess the clinical response in FAD affected dogs over the 12-week period following a single oral fluralaner treatment. Twenty client-owned dogs were diagnosed with FAD on the basis of compatible clinical signs and a positive response in flea antigen tests, using intradermal and or serological methods. An open-label small-scale study with all dogs receiving a single oral fluralaner treatment. All enrolled dogs were diagnosed with FAD and then clinically monitored at 4-week intervals for 12 weeks. Twenty dogs completed the study. All dogs were flea-free at all post-treatment assessments except for one dog that had a single flea at the first post-enrollment assessment at 4 weeks. At the 4-week post-treatment assessment active FAD signs had resolved in all dogs; at 8 weeks post-treatment, two dogs showed mild signs. All clinical signs of FAD had resolved at the final assessment of 12 weeks after treatment. A single administration of fluralaner alleviated or resolved signs associated with FAD in all treated dogs over the recommended 12-week treatment period. © 2015 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of Intervet Australia Pty Ltd.

Tibiotalocalcaneal arthrodesis using an intramedullary nail: a systematic review.

PubMed

Franceschi, Francesco; Franceschetti, Edoardo; Torre, Guglielmo; Papalia, Rocco; Samuelsson, Kristian; Karlsson, Jón; Denaro, Vincenzo

2016-04-01

Tibiotalocalcaneal arthrodesis is aimed to block the ankle joint motion in cases of severe osteoarthritis, avascular necrosis of the talus and/or failure of arthroplasty operations. This systematic review was carried out to evaluate the clinical outcome after tibiotalocalcaneal arthrodesis using intramedullary nail either open and arthroscopically assisted. Focus was on the success rate of the procedure in terms of union and complications and on the comparison between the techniques. The databases PubMed (Medline), EMBASE and Cochrane Library were searched in order to retrieve relevant studies. All therapeutic level 1-4 studies involving humans with intramedullary nail fixation technique were included. Only studies written in English, Italian, French, Spanish and German were included. Data related to the type of surgery, complications and clinical outcomes were extracted and analysed. A total of 83 studies were identified, of which 32 studies were eligible for inclusion; 31 case series and one randomized controlled trial. The main reported outcome score was the American Orthopaedic Foot and Ankle Society scale. Almost, all the included studies reported higher than 50% union rates and a significant improvement in terms of the clinical and mechanical ankle function after treatment. Results suggest that satisfactory outcomes can be achieved by tibiotalocalcaneal arthrodesis using intramedullary nailing. Low complication rates contribute to make this a safe procedure. No comparison can be done between arthroscopic and open technique, due to the lack of scientific works on the first one. IV.

Trajectories of impairment in amyotrophic lateral sclerosis: Insights from the Pooled Resource Open-Access ALS Clinical Trials cohort.

PubMed

Thakore, Nimish J; Lapin, Brittany R; Pioro, Erik P

2018-06-01

Rate of decline of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score is a common outcome measure and a powerful predictor of mortality in ALS. Observed rate of decline (postslope) of ALSFRS-R, its linearity, and its relationship to decline at first visit (preslope) were examined in the Pooled Resource Open-Access ALS Clinical Trials cohort by using longitudinal mixed effects models. Mean ALSFRS-R postslope in 3,367 patients was -0.99 points/month. Preslope and postslope were correlated and had powerful effects on survival. ALSFRS-R trajectories were slightly accelerated overall, but slope and direction/degree of curvature varied. Subscore decline was sequential by site of onset. Respiratory subscore decline was the least steep. Variable curvilinearity of ALSFRS-R trajectories confounds interpretation in clinical studies that assume linear decline. Subscore trajectories recapitulate phenotypic diversity and topographical progression of ALS. ALSFRS-R is better used as a multidimensional measure. Muscle Nerve 57: 937-945, 2018. © 2017 Wiley Periodicals, Inc.

Comparison of 3D reconstruction of mandible for pre-operative planning using commercial and open-source software

NASA Astrophysics Data System (ADS)

Abdullah, Johari Yap; Omar, Marzuki; Pritam, Helmi Mohd Hadi; Husein, Adam; Rajion, Zainul Ahmad

2016-12-01

3D printing of mandible is important for pre-operative planning, diagnostic purposes, as well as for education and training. Currently, the processing of CT data is routinely performed with commercial software which increases the cost of operation and patient management for a small clinical setting. Usage of open-source software as an alternative to commercial software for 3D reconstruction of the mandible from CT data is scarce. The aim of this study is to compare two methods of 3D reconstruction of the mandible using commercial Materialise Mimics software and open-source Medical Imaging Interaction Toolkit (MITK) software. Head CT images with a slice thickness of 1 mm and a matrix of 512x512 pixels each were retrieved from the server located at the Radiology Department of Hospital Universiti Sains Malaysia. The CT data were analysed and the 3D models of mandible were reconstructed using both commercial Materialise Mimics and open-source MITK software. Both virtual 3D models were saved in STL format and exported to 3matic and MeshLab software for morphometric and image analyses. Both models were compared using Wilcoxon Signed Rank Test and Hausdorff Distance. No significant differences were obtained between the 3D models of the mandible produced using Mimics and MITK software. The 3D model of the mandible produced using MITK open-source software is comparable to the commercial MIMICS software. Therefore, open-source software could be used in clinical setting for pre-operative planning to minimise the operational cost.

Characteristics of clinical trials that require participants to be fluent in English

PubMed Central

Egleston, Brian L; Pedraza, Omar; Wong, Yu-Ning; Dunbrack, Roland L; Griffin, Candace L; Ross, Eric A; Beck, J Robert

2015-01-01

Background/Aims Diverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial. Methods We randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with U.S. Census and American Community Survey data to investigate the association of English language restrictions with ZIP-code level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses. Results English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p<0.001 from Chi-squared test). Industry sponsored trials had low rates of English fluency requirements (1.8%) while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the U.S. had the highest regional English requirement rates (10.7%) while trials opening in more than one region had the lowest (3.3%, p<0.001). Since 1995, trials opening in ZIP-codes with larger Hispanic populations were less likely to have English fluency requirements (OR=0.92 for each 10 percent increase in proportion of Hispanics, 95% CI 0.86–0.98, p=0.013). Trials opening in ZIP-codes with more residents self-identifying as Black/African American (OR=1.87, 95% CI 1.36–2.58, p<0.001 for restricted cubic spline term) or Asian (OR=1.16 for linear term, 95% CI 1.07–1.25, p<0.001) were more likely to have English fluency requirements. ZIP-codes with higher poverty rates had trials with more English language restrictions (OR=1.06 for a 10 percent poverty rate increase, 95% CI 1.001–1.11, p=0.045). There was a statistically significant interaction between year and intervention type, such that the increase in English fluency requirements was more common for some interventions than for others. Conclusions The proportion of clinical trials registered with ClinicalTrials.gov that have English fluency requirements for study inclusion has been increasing over time. English language restrictions are associated with a number of characteristics, including the demographic characteristics of communities in which the sponsoring institutions are located. PMID:26152834

Characteristics of clinical trials that require participants to be fluent in English.

PubMed

Egleston, Brian L; Pedraza, Omar; Wong, Yu-Ning; Dunbrack, Roland L; Griffin, Candace L; Ross, Eric A; Beck, J Robert

2015-12-01

Diverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial. We randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with US Census and American Community Survey data to investigate the association of English-language restrictions with ZIP-code-level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses. English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p < 0.001 from Chi-squared test). Industry-sponsored trials had low rates of English fluency requirements (1.8%), while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the United States had the highest regional English requirement rates (10.7%), while trials opening in more than one region had the lowest (3.3%, p<0.001). Since 1995, trials opening in ZIP codes with larger Hispanic populations were less likely to have English fluency requirements (odds ratio=0.92 for each 10% increase in proportion of Hispanics, 95% confidence interval=0.86-0.98, p=0.013). Trials opening in ZIP codes with more residents self-identifying as Black/African American (odds ratio=1.87, 95% confidence interval=1.36-2.58, p<0.001 for restricted cubic spline term) or Asian (odds ratio=1.16 for linear term, 95% confidence interval=1.07-1.25, p<0.001) were more likely to have English fluency requirements. ZIP codes with higher poverty rates had trials with more English-language restrictions (odds ratio=1.06 for a 10% poverty rate increase, 95% confidence interval=1.001-1.11, p=0.045). There was a statistically significant interaction between year and intervention type, such that the increase in English fluency requirements was more common for some interventions than for others. The proportion of clinical trials registered with ClinicalTrials.gov that have English fluency requirements for study inclusion has been increasing over time. English-language restrictions are associated with a number of characteristics, including the demographic characteristics of communities in which the sponsoring institutions are located. © The Author(s) 2015.

Past trauma and present functioning of patients attending a women's psychiatric clinic.

PubMed

Borins, E F; Forsythe, P J

1985-04-01

A women's psychiatric clinic, incorporated within a university teaching general hospital and staffed entirely by women, was opened in March of 1980. The authors studied a sample of 100 women who came to the clinic and characterized them by demographic variables, psychiatric diagnoses, health problems, chronic illness, death in the family, and traumatic incidents. Death in the family before she was 18 was found to predict a woman's subsequent request for or completion of sterilization. Physical or sexual abuse was significantly related to abortion, and abortion and trauma were significantly correlated.

Mathematical multi-scale model of the cardiovascular system including mitral valve dynamics. Application to ischemic mitral insufficiency

PubMed Central

2011-01-01

Background Valve dysfunction is a common cardiovascular pathology. Despite significant clinical research, there is little formal study of how valve dysfunction affects overall circulatory dynamics. Validated models would offer the ability to better understand these dynamics and thus optimize diagnosis, as well as surgical and other interventions. Methods A cardiovascular and circulatory system (CVS) model has already been validated in silico, and in several animal model studies. It accounts for valve dynamics using Heaviside functions to simulate a physiologically accurate "open on pressure, close on flow" law. However, it does not consider real-time valve opening dynamics and therefore does not fully capture valve dysfunction, particularly where the dysfunction involves partial closure. This research describes an updated version of this previous closed-loop CVS model that includes the progressive opening of the mitral valve, and is defined over the full cardiac cycle. Results Simulations of the cardiovascular system with healthy mitral valve are performed, and, the global hemodynamic behaviour is studied compared with previously validated results. The error between resulting pressure-volume (PV) loops of already validated CVS model and the new CVS model that includes the progressive opening of the mitral valve is assessed and remains within typical measurement error and variability. Simulations of ischemic mitral insufficiency are also performed. Pressure-Volume loops, transmitral flow evolution and mitral valve aperture area evolution follow reported measurements in shape, amplitude and trends. Conclusions The resulting cardiovascular system model including mitral valve dynamics provides a foundation for clinical validation and the study of valvular dysfunction in vivo. The overall models and results could readily be generalised to other cardiac valves. PMID:21942971

Interpersonal Psychotherapy with Pregnant Adolescents: Two Pilot Studies

ERIC Educational Resources Information Center

Miller, Lisa; Gur, Merav; Shanok, Arielle; Weissman, Myrna

2008-01-01

The objective of this study was to test the feasibility, acceptability and helpfulness of group Interpersonal Psychotherapy (IPT-PA) for depression in pregnant adolescents. Method: Two open clinical trials were conducted of IPT-PA delivered in group format in a New York City public school for pregnant girls. Study 1 tests IPT-PA for management of…

Indigenous Crisis Counseling in Taiwan: An Exploratory Qualitative Case Study of an Expert Therapist

ERIC Educational Resources Information Center

Kuo, Ben C. H.; Hsu, Wei-Su; Lai, Nien-Hwa

2011-01-01

In this study, we adopted a single qualitative case study method to explore and examine indigenous approaches to crisis counseling in Taiwan, through the distinct lens of an expert Taiwanese counseling psychologist. In-depth, open-ended interviews were conducted with the psychologist (as the case) to document her lived clinical experiences…

Effect of spinal needle characteristics on measurement of spinal canal opening pressure.

PubMed

Bellamkonda, Venkatesh R; Wright, Thomas C; Lohse, Christine M; Keaveny, Virginia R; Funk, Eric C; Olson, Michael D; Laack, Torrey A

2017-05-01

A wide variety of spinal needles are used in clinical practice. Little is currently known regarding the impact of needle length, gauge, and tip type on the needle's ability to measure spinal canal opening pressure. This study aimed to investigate the relationship between these factors and the opening-pressure measurement or time to obtain an opening pressure. Thirteen distinct spinal needles, chosen to isolate the effects of length, gauge, and needle-point type, were prospectively tested on a lumbar puncture simulator. The key outcomes were the opening-pressure measurement and the time required to obtain that measure. Pressures were recorded at 10-s intervals until 3 consecutive, identical readings were observed. Time to measure opening pressure increased with increasing spinal needle length, increasing gauge, and the Quincke-type (cutting) point (P<0.001 for all). The time to measurement ranged from 30s to 530s, yet all needle types were able to obtain a consistent opening pressure measure. Although opening pressure estimates are unlikely to vary markedly by needle type, the time required to obtain the measurement increased with increasing needle length and gauge and with Quincke-type needles. Copyright © 2017 Elsevier Inc. All rights reserved.

Median mandibular flexure at different mouth opening and its relation to different facial types: A prospective clinical study

PubMed Central

Prasad, Mandava; Hussain, Mohammed Z.; Shetty, Sharath K.; Kumar, T. Ashok; Khaur, Mohit; George, Suja A.; Dalwai, Sameen

2013-01-01

Objective: To measure the arch width and Median mandibular flexure (MMF) values at relative rest and maximum jaw opening in young adults with Dolichofacial, Mesofacial, and Brachyfacial types and tested whether the variation in the facial pattern is related to the MMF values in South Indian population. Materials and Methods: This Prospective clinical study consisted of sample of 60 young adults. The subjects were grouped into 3 groups: Group 1: Brachyfacial, Group 2: Mesofacial and types, Group 3: Dolichofacial. Impressions were taken for all the 60 subjects and the casts were scanned and digitized. The intermolar width was measured for Dolichofacial, Mesofacial, and Brachyfacial subjects at relative rest (R) and maximum opening (O). Results: The statistical analysis of the observations included Descriptive and Inferential statistics. The statistical analysis was executed by means of Sigma graph pad prism software, USA Version-4. Kruskal wallis (ANOVA) followed by Dunns post hoc test was performed. Mann Whitney U-test was performed to assess the difference in MMF values between Males and Females of the three groups. The Mean (SD) Mandibular flexure in individuals with Brachyfacial type was 1.12 (0.09), Mesofacial type was 0.69 (0.21), and Dolichofacial type was 0.39 (0.08). Conclusions: The Mean intermolar width was maximum in Brachyfacial type and minimum in Dolichofacial type. MMF was maximum at the maximum mouth opening position and was maximum in individuals with Brachyfacial type. PMID:24082745

Application of hyaluronic acid in the healing of non-experimental open wounds: A pilot study on 12 wounds in 10 client-owned dogs

PubMed Central

Ferrari, Roberta; Boracchi, Patrizia; Romussi, Stefano; Ravasio, Giuliano; Stefanello, Damiano

2015-01-01

Aim: Veterinarians have frequently to deal with wounds to the skin, subcutis, and underlying muscle. The aim was to explore the application of hyaluronic acid (HA)-containing dressing on open skin wounds in dogs. The progress of healing was assessed by wound area reduction and two scoring scales applied in human medicine. Materials and Methods: Ten client-owned dogs with 12 cutaneous open wounds healed by the second intention were included. All wounds were treated using available in commerce HA-containing wound dressing from admission to complete re-epithelialization. At every clinical examination, wound area and scale scoring assessments were performed. Results: After debridement, an increased wound size was obtained while an improvement was determined by both grading systems. The median numbers of return to the clinic for bandage change were 5 times. The median time to complete wound healing was 34.5 days. The mean wound area at day 7, 14, 21, and 28 were, respectively, 90.4%, 47.7%, 22.4%, and 14.8% of the original size (for linear measurement) and 95.5%, 54.4%, 23.10%, and 14.8% of the original size (for software measurement). Regarding wound healing assessment tools, the agreement between two operators was considered high for both scales. Conclusions: HA-containing dressing may be a possible wound treatment for cutaneous open wounds in dogs. The assessment of wound quality using scale scoring system could be useful especially in the 1st week and to direct clinical decision-making process. PMID:27047026

IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity

PubMed Central

Krleža-Jerić, Karmela; Gabelica, Mirko; Banzi, Rita; Martinić, Marina Krnić; Pulido, Bibiana; Mahmić-Kaknjo, Mersiha; Reveiz, Ludovic; Šimić, Josip; Utrobičić, Ana; Hrgović, Irena

2016-01-01

Introduction The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 proposal by the International Council of Medical Journal Editors triggered ample discussion about CT data sharing and reconfirmed the need for an ongoing assessment of its dynamics. The IMProving Access to Clinical Trials data (IMPACT) Observatory aims to play such a role, and assess the data sharing culture, policies, and practices of key players, the impact of their interventions on CTs, and contribute to a transformation of research. The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings. Materials and methods Methods include a scoping study of research, surveys, interviews, and an environmental scan of research data repositories. Results Our preliminary findings indicate that although opening of CT data has not yet been achieved, its evolution is encouraging. Initiatives by key players contribute to increasing of CT data sharing, and many barriers are shrinking or disappearing. Conclusions The major barrier is the lack of data sharing standards, from preparing data for public sharing to its curatorship, findability and access. However, experiences accumulated by sharing CT data according to “upon request” or “open” mechanisms could inform the development of such standards. The Vivli, CORBEL-ECRIN and Open Trials projects are currently working in this direction. PMID:27812300

The current status of emergent laparoscopic colectomy: a population-based study of clinical and financial outcomes.

PubMed

Keller, Deborah S; Pedraza, Rodrigo; Flores-Gonzalez, Juan Ramon; LeFave, Jean Paul; Mahmood, Ali; Haas, Eric M

2016-08-01

Population-based studies evaluating laparoscopic colectomy and outcomes compared with open surgery have concentrated on elective resections. As such, data assessing non-elective laparoscopic colectomies are limited. Our goal was to evaluate the current usage and outcomes of laparoscopic in the urgent and emergent setting in the USA. A national inpatient database was reviewed from 2008 to 2011 for right, left, and sigmoid colectomies in the non-elective setting. Cases were stratified by approach into open or laparoscopic groups. Demographics, perioperative clinical variables, and financial outcomes were compared across each group. A total of 22,719 non-elective colectomies were analyzed. The vast majority (95.8 %) was open. Most cases were performed in an urban setting at non-teaching hospitals by general surgeons. Colorectal surgeons were significantly more likely to perform a case laparoscopic than general surgeons (p < 0.001). Demographics were similar between open and laparoscopic groups; however, the disease distribution by approach varied, with significantly more severe cases in the open colectomy arm (p < 0.001). Cases performed laparoscopically had significantly better mortality and complication rates. Laparoscopic cases also had significantly improved outcomes, including shorter length of stay and hospital costs (all p < 0.001). Our analysis revealed less than 5 % of urgent and emergent colectomies in the USA are performed laparoscopically. Colorectal surgeons were more likely to approach a case laparoscopically than general surgeons. Outcomes following laparoscopic colectomy in this setting resulted in reduced length of stay, lower complication rates, and lower costs. Increased adoption of laparoscopy in the non-elective setting should be considered.

Clinical effects of buprenorphine on open field behaviour and gait symmetry in healthy and lame weaned piglets.

PubMed

Meijer, Ellen; van Nes, Arie; Back, Willem; van der Staay, Franz Josef

2015-12-01

Lameness in pigs decreases animal welfare and economic profit for the farmer. An important reason for impaired welfare in lame animals is pain due to lameness. No direct measurement of pain is possible in animals, and methods to indirectly detect and quantify the amount of pain an animal is experiencing are urgently needed. In this study, two methods to assess pain associated with lameness in pigs were evaluated to determine if they were sensitive enough to detect a lameness reduction as an effect of an experimental analgesic medication. Asymmetry associated with lameness was objectively quantified using pressure mat kinetic parameters: peak vertical force (PVF), load rate (LR), vertical impulse (VI) and peak vertical pressure (PVP). Locomotor activity was assessed in an open field test. A dose of 0.04 mg/kg buprenorphine, a strong analgesic, was used to treat 10 lame pigs, while eight other lame pigs, treated with physiological saline solution, served as controls. Buprenorphine decreased lameness-associated asymmetry for pressure mat LR (P = 0.002), VI (P = 0.003) and PVP (P = 0.001) and increased activity of the lame pigs in the open field (P = 0.023), while saline-treated animals did not show any changes in asymmetry and became less active in the open field (P <0.001). It was concluded that measurement of gait asymmetry by pressure mat analysis and locomotor activity in an open field test are both sensitive enough to detect the analgesic effects of buprenorphine when used to treat moderate to severe clinical pain in a relatively small group of affected pigs. The methods used in this study may also provide promising additional tools for future research into early pain recognition and lameness treatment in pigs. Copyright © 2015 Elsevier Ltd. All rights reserved.

Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2 × 2 factorial designed randomised NEO trial

PubMed Central

2014-01-01

Background Coronary artery bypass grafting using the radial artery has, since the 1990s, gone through a revival. Observational studies have indicated better long-term patency when using radial arteries. Therefore, radial artery might be preferred especially in younger patients where long time patency is important. During the last 10 years different endoscopic techniques to harvest the radial artery have evolved. Endoscopic radial artery harvest only requires a small incision near the wrist in contrast to open harvest, which requires an incision from the elbow to the wrist. However, it is unknown whether the endoscopic technique results in fewer complications or a graft patency comparable to open harvest. When the radial artery has been harvested, there are two ways to use the radial artery as a graft. One way is sewing it onto the aorta and another is sewing it onto the mammary artery. It is unknown which technique is the superior revascularisation technique. Methods/Design The NEO Trial is a randomised clinical trial with a 2 × 2 factorial design. We plan to randomise 300 participants into four intervention groups: (1) mammario-radial endoscopic group; (2) aorto-radial endoscopic group; (3) mammario-radial open surgery group; and (4) aorto-radial open surgery group. The hand function will be assessed by a questionnaire, a clinical examination, the change in cutaneous sensibility, and the measurement of both sensory and motor nerve conduction velocity at 3 months postoperatively. All the postoperative complications will be registered, and we will evaluate muscular function, scar appearance, vascular supply to the hand, and the graft patency including the patency of the central radial artery anastomosis. A patency evaluation by multi-slice computer tomography will be done at one year postoperatively. We expect the nerve conduction studies and the standardised neurological examinations to be able to discriminate differences in hand function comparing endoscopic to open harvest of the radial artery. The trial also aims to show if there is any patency difference between mammario-radial compared to aorto-radial revascularisation techniques but this objective is exploratory. Trial registration ClinicalTrials.gov identifier: NCT01848886. Danish Ethics committee number: H-3-2012-116. Danish Data Protection Agency: 2007-58-0015/jr.n:30–0838. PMID:24754891

An open, self-controlled study on the efficacy of topical indoxacarb for eliminating fleas and clinical signs of flea-allergy dermatitis in client-owned dogs in Queensland, Australia.

PubMed

Fisara, Petr; Sargent, Roger M; Shipstone, Michael; von Berky, Andrew; von Berky, Janet

2014-06-01

Canine flea-allergy dermatitis (FAD), a hypersensitivity response to antigenic material in the saliva of feeding fleas, occurs worldwide and remains a common presentation in companion animal veterinary practice despite widespread availability of effective systemic and topical flea-control products. To evaluate the clinical response in dogs with FAD treated topically with indoxacarb, a novel oxadiazine insecticide. Twenty-five client-owned dogs in Queensland, Australia diagnosed with pre-existing FAD on the basis of clinical signs, flea-antigen intradermal and serological tests. An open-label, noncontrolled study, in which all dogs were treated with topical indoxacarb at 4 week intervals, three times over 12 weeks. Twenty-four dogs completed the study. Complete resolution of clinical signs of FAD was observed in 21 cases (87.5%), with nearly complete resolution or marked improvement in the remaining three cases. Mean clinical scores (Canine Atopic Dermatitis Extent and Severity Index-03) were reduced by 93.3% at week 12. Mean owner-assessed pruritus scores were reduced by 88% by week 12. Mean flea counts reduced by 98.7 and 100% in weeks 8 and 12, respectively. Topical indoxacarb treatment applied every 4 weeks for 12 weeks, without concomitant antipruritic or ectoparasiticide therapy, completely alleviated flea infestations in all dogs and associated clinical signs of FAD in a high proportion of this population of dogs in a challenging flea-infestation environment. © 2014 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and the ACVD.

Adaptation of a web-based, open source electronic medical record system platform to support a large study of tuberculosis epidemiology

PubMed Central

2012-01-01

Background In 2006, we were funded by the US National Institutes of Health to implement a study of tuberculosis epidemiology in Peru. The study required a secure information system to manage data from a target goal of 16,000 subjects who needed to be followed for at least one year. With previous experience in the development and deployment of web-based medical record systems for TB treatment in Peru, we chose to use the OpenMRS open source electronic medical record system platform to develop the study information system. Supported by a core technical and management team and a large and growing worldwide community, OpenMRS is now being used in more than 40 developing countries. We adapted the OpenMRS platform to better support foreign languages. We added a new module to support double data entry, linkage to an existing laboratory information system, automatic upload of GPS data from handheld devices, and better security and auditing of data changes. We added new reports for study managers, and developed data extraction tools for research staff and statisticians. Further adaptation to handle direct entry of laboratory data occurred after the study was launched. Results Data collection in the OpenMRS system began in September 2009. By August 2011 a total of 9,256 participants had been enrolled, 102,274 forms and 13,829 laboratory results had been entered, and there were 208 users. The system is now entirely supported by the Peruvian study staff and programmers. Conclusions The information system served the study objectives well despite requiring some significant adaptations mid-stream. OpenMRS has more tools and capabilities than it did in 2008, and requires less adaptations for future projects. OpenMRS can be an effective research data system in resource poor environments, especially for organizations using or considering it for clinical care as well as research. PMID:23131180

Clinical records anonymisation and text extraction (CRATE): an open-source software system.

PubMed

Cardinal, Rudolf N

2017-04-26

Electronic medical records contain information of value for research, but contain identifiable and often highly sensitive confidential information. Patient-identifiable information cannot in general be shared outside clinical care teams without explicit consent, but anonymisation/de-identification allows research uses of clinical data without explicit consent. This article presents CRATE (Clinical Records Anonymisation and Text Extraction), an open-source software system with separable functions: (1) it anonymises or de-identifies arbitrary relational databases, with sensitivity and precision similar to previous comparable systems; (2) it uses public secure cryptographic methods to map patient identifiers to research identifiers (pseudonyms); (3) it connects relational databases to external tools for natural language processing; (4) it provides a web front end for research and administrative functions; and (5) it supports a specific model through which patients may consent to be contacted about research. Creation and management of a research database from sensitive clinical records with secure pseudonym generation, full-text indexing, and a consent-to-contact process is possible and practical using entirely free and open-source software.

Retrospective checking of compliance with practice guidelines for acute stroke care: a novel experiment using openEHR’s Guideline Definition Language

PubMed Central

2014-01-01

Background Providing scalable clinical decision support (CDS) across institutions that use different electronic health record (EHR) systems has been a challenge for medical informatics researchers. The lack of commonly shared EHR models and terminology bindings has been recognised as a major barrier to sharing CDS content among different organisations. The openEHR Guideline Definition Language (GDL) expresses CDS content based on openEHR archetypes and can support any clinical terminologies or natural languages. Our aim was to explore in an experimental setting the practicability of GDL and its underlying archetype formalism. A further aim was to report on the artefacts produced by this new technological approach in this particular experiment. We modelled and automatically executed compliance checking rules from clinical practice guidelines for acute stroke care. Methods We extracted rules from the European clinical practice guidelines as well as from treatment contraindications for acute stroke care and represented them using GDL. Then we executed the rules retrospectively on 49 mock patient cases to check the cases’ compliance with the guidelines, and manually validated the execution results. We used openEHR archetypes, GDL rules, the openEHR reference information model, reference terminologies and the Data Archetype Definition Language. We utilised the open-sourced GDL Editor for authoring GDL rules, the international archetype repository for reusing archetypes, the open-sourced Ocean Archetype Editor for authoring or modifying archetypes and the CDS Workbench for executing GDL rules on patient data. Results We successfully represented clinical rules about 14 out of 19 contraindications for thrombolysis and other aspects of acute stroke care with 80 GDL rules. These rules are based on 14 reused international archetypes (one of which was modified), 2 newly created archetypes and 51 terminology bindings (to three terminologies). Our manual compliance checks for 49 mock patients were a complete match versus the automated compliance results. Conclusions Shareable guideline knowledge for use in automated retrospective checking of guideline compliance may be achievable using GDL. Whether the same GDL rules can be used for at-the-point-of-care CDS remains unknown. PMID:24886468

Design, Development, and Psychometric Analysis of a General, Organic, and Biological Chemistry Topic Inventory Based on the Identified Main Chemistry Topics Relevant to Nursing Clinical Practice

ERIC Educational Resources Information Center

Brown, Corina E.

2013-01-01

This two-stage study focused on the undergraduate nursing course that covers topics in general, organic, and biological (GOB) chemistry. In the first stage, the central objective was to identify the main concepts of GOB chemistry relevant to the clinical practice of nursing. The collection of data was based on open-ended interviews of both nursing…

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.

Posterior open occlusion management by registration of overlay removable partial denture: A clinical report

PubMed Central

Nosouhian, Saeid; Davoudi, Amin; Derhami, Mohammad

2015-01-01

This clinical report describes prosthetic rehabilitation of posterior open bite relationship in a patient with several missing teeth and skeletal Class III malocclusion. Primary diagnostic esthetic evaluations were performed by mounting casts in centric relation and estimating lost vertical dimension of occlusion. Exclusive treatments were designated by applying overlay removable partial denture with external attachment systems for higher retentions. PMID:26929544

Posterior open occlusion management by registration of overlay removable partial denture: A clinical report.

PubMed

Nosouhian, Saeid; Davoudi, Amin; Derhami, Mohammad

2015-01-01

This clinical report describes prosthetic rehabilitation of posterior open bite relationship in a patient with several missing teeth and skeletal Class III malocclusion. Primary diagnostic esthetic evaluations were performed by mounting casts in centric relation and estimating lost vertical dimension of occlusion. Exclusive treatments were designated by applying overlay removable partial denture with external attachment systems for higher retentions.

Combined microwave ablation and minimally invasive open decompression for the management of thoracic metastasis in breast cancer.

PubMed

Liu, Bin; Yuan, Zhenchao; Wei, Chang Yuan

2018-01-01

The incidence rate of thoracic metastasis from breast cancer is increasing. Microwave ablation is one type of clinical therapy used to treat metastatic spine disease, although it can cause protein denaturation and immediate cell death, and coagulative necrosis can occur. Minimally invasive open decompression is associated with lower rates of surgical complications in comparison to traditional open surgery. Therefore, it is an alternative therapeutic option for spinal metastases. This study aimed to assess the efficacy of microwave ablation with minimally invasive open decompression in the management of breast cancer patients with thoracic metastasis. This single-institution retrospective study investigated 23 cases of thoracic metastasis from breast cancer treated with combined microwave ablation and minimally invasive open decompression. Patients that presented with indications for surgery underwent surgical treatment. Data were collected for pain scores, the Frankel Grade classification system for acute spinal injury, the Karnofsky performance status (KPS) scale and complications due to treatment. Of the 23 patients included in this study, all were successfully treated with microwave ablation and minimal invasive open decompression using our metrics. Of those, 18 patients (78.3%) showed improvement in their KPS results while 5 (21.7%) had alleviation of KPS. All 23 patients showed improvement in their Frankel Grade, suggesting improved neurological function following surgery. Most of the patients reported pain relief. Postoperative complications occurred in 4 patients. Microwave ablation combined with minimally invasive open decompression therapy for breast cancer patients with thoracic metastatic tumors is an alternative treatment that maintains or improves functional outcome in comparison to open surgery.

Kinematics of the human pelvis following open book injury.

PubMed

Hefzy, M S; Ebraheim, N; Mekhail, A; Caruntu, D; Lin, H; Yeasting, R

2003-05-01

The objective of this study is to determine the three dimensional kinematics of the human pelvis including both sacroiliac joints following a simulated open book injury induced on cadavers by applying anterior-posterior compressive loads to the pelvis. An electromagnetic digitizing and motion tracking system was utilized to measure the morphology of the pelvis and the relative movements of its bones during this simulated open book fracture. The screw displacement axis method was used to describe the relative motion between the sacrum and each hipbone. Morphologically, it was found that the articular surfaces forming the sacroiliac joints could be approximated with planar surfaces directed from proximal and lateral to distal and medial and from posteromedial to anterolateral. The kinematic data obtained from this study indicate that there is a direct correlation between the opening of the symphysis pubis and the opening of the sacroiliac joint (SIJ) during open book injury. This suggests that the extent of injury of the SIJ maybe estimated from the degree of opening of the symphysis pubis as demonstrated on anteroposterior (A-P) x-rays. The results obtained from this study also indicate that the motion of the hipbone with respect to the sacrum on the side of the sacroiliac joint opening is almost a pure rotation, which translates clinically on the A-P x-rays as pure opening of the SIJ without vertical displacement. The average axis of rotation was found to be almost parallel to the SIJ planar articular surface. Furthermore, the pubic bone on the side of SIJ opening was found to displace inferiorly and posteriorly. One can thus conclude that in open book pelvic injuries, the pubic bone on the side of injury displaces inferiorly on the outlet projection x-rays with no vertical displacement of the SIJ. This is important since the initial assessment of the open book injury in the emergency room includes outlet projection x-rays. From this study, the relative vertical positions of the pubic bones on these x-rays can help the surgeon in differentiating open book fracture injury from other pelvic injuries.

Associating clinical archetypes through UMLS Metathesaurus term clusters.

PubMed

Lezcano, Leonardo; Sánchez-Alonso, Salvador; Sicilia, Miguel-Angel

2012-06-01

Clinical archetypes are modular definitions of clinical data, expressed using standard or open constraint-based data models as the CEN EN13606 and openEHR. There is an increasing archetype specification activity that raises the need for techniques to associate archetypes to support better management and user navigation in archetype repositories. This paper reports on a computational technique to generate tentative archetype associations by mapping them through term clusters obtained from the UMLS Metathesaurus. The terms are used to build a bipartite graph model and graph connectivity measures can be used for deriving associations.

New Toronto clinic for men may be sign of growing entrepreneurship within medicine.

PubMed Central

Lowry, F

1995-01-01

A Toronto physician has opened a new clinic for male patients, particularly highly stressed executives, who pay to have their physical, mental and nutritional health assessed. The Health Institute for Men, which opened in January, is located close to the Toronto Stock Exchange. It charges $450 for the initial visit, which includes a complete history, mental-assessment exam and thorough physical. The chair of the CMA Board of Directors considers the clinic a sign of growing entrepreneurship within Canadian medicine. Images p204-a p204-b PMID:7600471

Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus

PubMed Central

Hauptmann, Christian; Ströbel, Armin; Williams, Mark; Patel, Nitesh; Wurzer, Hannes; von Stackelberg, Tatjana; Brinkmann, Uwe; Langguth, Berthold; Tass, Peter A.

2015-01-01

Purpose. Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study “RESET Real Life” was commissioned by ANM GmbH. Herein we present the results of this study. Methods. In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder). Results. Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy. Conclusion. The field study “RESET Real Life” provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting. PMID:26568958

Global Health Innovation Technology Models.

PubMed

Harding, Kimberly

2016-01-01

Chronic technology and business process disparities between High Income, Low Middle Income and Low Income (HIC, LMIC, LIC) research collaborators directly prevent the growth of sustainable Global Health innovation for infectious and rare diseases. There is a need for an Open Source-Open Science Architecture Framework to bridge this divide. We are proposing such a framework for consideration by the Global Health community, by utilizing a hybrid approach of integrating agnostic Open Source technology and healthcare interoperability standards and Total Quality Management principles. We will validate this architecture framework through our programme called Project Orchid. Project Orchid is a conceptual Clinical Intelligence Exchange and Virtual Innovation platform utilizing this approach to support clinical innovation efforts for multi-national collaboration that can be locally sustainable for LIC and LMIC research cohorts. The goal is to enable LIC and LMIC research organizations to accelerate their clinical trial process maturity in the field of drug discovery, population health innovation initiatives and public domain knowledge networks. When sponsored, this concept will be tested by 12 confirmed clinical research and public health organizations in six countries. The potential impact of this platform is reduced drug discovery and public health innovation lag time and improved clinical trial interventions, due to reliable clinical intelligence and bio-surveillance across all phases of the clinical innovation process.

Global Health Innovation Technology Models

PubMed Central

Harding, Kimberly

2016-01-01

Chronic technology and business process disparities between High Income, Low Middle Income and Low Income (HIC, LMIC, LIC) research collaborators directly prevent the growth of sustainable Global Health innovation for infectious and rare diseases. There is a need for an Open Source-Open Science Architecture Framework to bridge this divide. We are proposing such a framework for consideration by the Global Health community, by utilizing a hybrid approach of integrating agnostic Open Source technology and healthcare interoperability standards and Total Quality Management principles. We will validate this architecture framework through our programme called Project Orchid. Project Orchid is a conceptual Clinical Intelligence Exchange and Virtual Innovation platform utilizing this approach to support clinical innovation efforts for multi-national collaboration that can be locally sustainable for LIC and LMIC research cohorts. The goal is to enable LIC and LMIC research organizations to accelerate their clinical trial process maturity in the field of drug discovery, population health innovation initiatives and public domain knowledge networks. When sponsored, this concept will be tested by 12 confirmed clinical research and public health organizations in six countries. The potential impact of this platform is reduced drug discovery and public health innovation lag time and improved clinical trial interventions, due to reliable clinical intelligence and bio-surveillance across all phases of the clinical innovation process.

Strong correlation of elastin deletions, detected by FISH, with Williams syndrome: Evaluation of 235 patients

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

Lowery, M.C.; Brothman, L.J.; Leonard, C.O.

1995-07-01

Williams syndrome (WS) is generally characterized by mental deficiency, gregarious personality, dysmorphic facies, supravalvular aortic stenosis, and idiopathic infantile hypercalcemia. Patients with WS show allelic loss of elastin (ELN), exhibiting a submicroscopic deletion, at 7q11.23, detectable by FISH. Hemizygosity is likely the cause of vascular abnormalities in WS patients. A series of 235 patients was studied, and molecular cytogenetic deletions were seen in 96% of patients with classic WS. Patients included 195 solicited through the Williams Syndrome Association (WSA), plus 40 clinical cytogenetics cases referred by primary-care physicians. Photographs and medical records of most WSA subjects were reviewed, and patientsmore » were identified as {open_quotes}classic{open_quotes} (n = 114) or{open_quotes}uncertain{close_quotes} (n = 39). An additional 42 WSA patients were evaluated without clinical information. FISH was performed with biotinylated ELN cosmids on metaphase cells from immortalized lymphoblastoid lines from WSA patients and after high-resolution banding analysis on clinical referral patients. An alpha-satellite probe for chromosome 7 was included in hybridizations, as an internal control. Ninety-six percent of the patients with classic WS showed a deletion in one ELN allele; four of these did not show a deletion. Of the uncertain WS patients, only 3 of 39 showed a deletion. Of the 42 who were not classified phenotypically, because of lack of clinical information, 25 patients (60%) showed a deletion. Thirty-eight percent (15/40) of clinical cytogenetics cases showed an ELN deletion and no cytogenetic deletion by banded analysis. These results support the usefulness of FISH for the detection of elastin deletions as an initial diagnostic assay for WS. 14 refs., 2 figs., 4 tabs.« less

The cost-effectiveness of fine-needle aspiration cytology and 14-gauge core needle biopsy compared with open surgical biopsy in the diagnosis of breast carcinoma.

PubMed

Logan-Young, W; Dawson, A E; Wilbur, D C; Avila, E E; Tomkiewicz, Z M; Sheils, L A; Laczin, J A; Taylor, A S

1998-05-15

Judicious utilization of fine-needle aspiration cytology (FNAC) and 14-gauge core needle biopsy (CB) theoretically should result in greater accuracy in breast carcinoma diagnosis and fewer unnecessary open surgical biopsies (OSBs), thus lowering health care costs. In 1995 in Rochester, New York, the ratio of open surgical breast biopsies per each verified breast carcinoma (OSB/Ca) in a freestanding breast clinic (EWBC) was compared with the OSB/Ca ratio of all physicians in the remainder of the city. The EWBC differs from all other diagnostic facilities in Rochester in that it routinely performs FNAC and CB. The EWBC recommended 462 OSBs resulting in 310 verified carcinomas, for a OSB/Ca ratio of 1.5. The physicians in the remainder of the city recommended 2036 OSBs resulting in 513 verified carcinomas, for a OSB/Ca ratio of 4.0. If the EWBC OSB/Ca ratio had been identical to the remainder of the city, the number of extra OSBs recommended by the clinic would have been 778, resulting in an additional cost of $1,712,082. When the added cost of the 2594 FNACs ($256,285) and 403 CBs ($252,278) performed by the clinic was subtracted from the $1,712,082, the freestanding breast clinic cost savings was $1,203,519. The lymph node metastasis rate of 19% for the breast carcinomas diagnosed in clinic patients was identical to that of the women with breast carcinoma in the remainder of the city. Utilization of FNAC and CB allows radiologists to lower their OSB/Ca ratio without sacrificing early detection. In this study, these less expensive procedures result in lowered medical costs for the health care system.

Reproductive traits of Holsteins and Jerseys. Effects of age, milk yield, and clinical abnormalities on involution of cervix and uterus, ovulation, estrous cycles, detection of estrus, conception rate, and days open.

PubMed

Fonseca, F A; Britt, J H; McDaniel, B T; Wilk, J C; Rakes, A H

1983-05-01

Two hundred and twelve Holstein and Jersey cows were in a study to determine factors that affected reproductive traits. First ovulation occurred about 3 wk postpartum, and interval to first ovulation was greater in cows that had clinical abnormalities postpartum than in normal cows. Jerseys producing more milk ovulated sooner postpartum than lower producing herdmates. Involution of cervix and uterus occurred later postpartum in cows that had clinical problems postpartum. Involution of genital tract occurred later postpartum in older cows and sooner postpartum in cows that had higher milk yields. Duration of first postpartum estrous cycle was 4 days less than for second postpartum cycle. Percentages of estrous cycles detected by standing estrus were 43 and 73% for Holsteins and Jerseys. Estrous detection rates were highest for cows that produced slightly above the mean milk yield and did not differ between cows in highest and lowest milk production quartiles. First detected estrus and days to first insemination occurred later postpartum in Holsteins as milk yield deviation from herdmates increased, regardless of sign. In Jerseys, days to first insemination and days open increased linearly as milk yield increased. Days to first insemination and conception were greater in cows with postpartum clinical problems. Conception rate at first insemination postpartum increased in proportion to concentration of progesterone in blood samples collected during 12 days before first insemination. Overall, clinical problems at parturition and postpartum lowered reproductive performance in both breeds. There was a slight antagonism between milk yield and reproductive performance (days open) in Jerseys but not in Holsteins.

A dose-response study of dexmedetomidine administered as the primary sedative in infants following open heart surgery.

PubMed

Su, Felice; Nicolson, Susan C; Zuppa, Athena F

2013-06-01

To evaluate the dose-response relationship of dexmedetomidine in infants with congenital heart disease postoperative from open heart surgery. Prospective open-label dose-escalation pharmacokinetic-pharmacodynamic study. Tertiary pediatric cardiac ICU. Thirty-six evaluable infants, 1-24 months old, postoperative from open heart surgery requiring mechanical ventilation. Cohorts of 12 infants were enrolled sequentially to one of the three IV loading doses of dexmedetomidine (0.35, 0.7, and 1 mcg/kg) over 10 minutes followed by respective continuous infusions (0.25, 0.5, and 0.75 mcg/kg/hr) for up to 24 hours. Dexmedetomidine plasma concentrations were obtained at timed intervals during and following discontinuation of infusion. Pharmacodynamic variables evaluated included sedation scores, supplemental sedation and analgesia medication administration, time to tracheal extubation, respiratory function, and hemodynamic parameters. Infants achieved a deeper sedation measured by the University of Michigan Sedation Scale score (2.6 vs 1) despite requiring minimal supplemental sedation (0 unit doses/hr) and fewer analgesic medications (0.07 vs 0.15 unit doses/hr) while receiving dexmedetomidine compared with the 12-hour follow-up period. Thirty-one patients were successfully extubated while receiving the dexmedetomidine infusion. Only one patient remained intubated due to oversedation during the infusion. While receiving dexmedetomidine, there was a decrease in heart rate compared with baseline, 132 versus 161 bpm, but there was an increase in heart rate compared with postinfusion values, 132 versus 128 bpm. There was no statistically or clinically significant change in mean arterial blood pressure. Dexmedetomidine administration in infants following open heart surgery can provide improved sedation with reduction in supplemental medication requirements, leading to successful extubation while receiving a continuous infusion. The postoperative hemodynamic changes that occur in infants postoperative from open heart surgery are multifactorial. Although dexmedetomidine may play a role in decreasing heart rate immediately postoperative, the changes were not clinically significant and did not fall below postinfusion heart rates.

Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy).

PubMed

Harrop, Emily; Kelly, John; Griffiths, Gareth; Casbard, Angela; Nelson, Annmarie

2016-01-19

Surgical trials have typically experienced recruitment difficulties when compared with other types of oncology trials. Qualitative studies have an important role to play in exploring reasons for low recruitment, although to date few such studies have been carried out that are embedded in surgical trials. The BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy) is a study to determine the feasibility of randomisation to open versus laparoscopic access/robotic cystectomy in patients with bladder cancer. We describe the results of a qualitative study embedded within the clinical trial that explored why patients decline randomisation. Ten semi-structured interviews with patients who declined randomisation to the clinical trial, and two interviews with recruiting research nurses were conducted. Data were analysed for key themes. The majority of patients declined the trial because they had preferences for a particular treatment arm, and in usual practice could choose which surgical method they would be given. In most cases the robotic option was preferred. Patients described an intuitive 'sense' that favoured the new technology and had carried out their own inquiries, including Internet research and talking with previous patients and friends and family with medical backgrounds. Medical histories and lifestyle considerations also shaped these personalised choices. Of importance too, however, were the messages patients perceived from their clinical encounters. Whilst some patients felt their surgeon favoured the robotic option, others interpreted 'indirect' cues such as the 'established' reputation of the surgeon and surgical method and comments made during clinical assessments. Many patients expressed a wish for greater direction from their surgeon when making these decisions. For trials where the 'new technology' is available to patients, there will likely be difficulties with recruitment. Greater attention could be paid to how messages about treatment options and the trial are conveyed across the whole clinical setting. However, if it is too difficult to challenge such messages, then questions should be asked about whether genuine and convincing equipoise can be presented and perceived in such trials. This calls for consideration of whether alternative methods of generating evidence could be used when evaluating surgical techniques which are established and routinely available. ISRCTN38528926 (11 December 2008).

Ketamine for cancer pain: what is the evidence?

PubMed

Jonkman, Kelly; van de Donk, Tine; Dahan, Albert

2017-06-01

In this review, we assess the benefit of ketamine in the treatment of terminal cancer pain that is refractory to opioid treatment and/or complicated by neuropathy. While randomized controlled trials consistently show lack of clinical efficacy of ketamine in treating cancer pain, a large number of open-label studies and case series show benefit. Ketamine is an N-methyl-D-aspartate receptor antagonist that at low-dose has effective analgesic properties. In cancer pain, ketamine is usually prescribed as adjuvant to opioid therapy when pain becomes opioid resistant or when neuropathic pain symptoms dominate the clinical picture. A literature search revealed four randomized controlled trials that examined the benefit of oral, subcutaneous or intravenous ketamine in opioid refractory cancer pain. None showed clinically relevant benefit in relieving pain or reducing opioid consumption. This suggests absence of evidence of benefit for ketamine as adjuvant analgesic in cancer pain. These findings contrast the benefit from ketamine observed in a large number of open-label studies and (retrospective) case series. We relate the opposite outcomes to methodological issues. The complete picture is such that there is still insufficient evidence to state with certainty that ketamine is not effective in cancer pain.

Simultaneous Pure Laparoscopic Resection of Primary Colorectal Cancer and Synchronous Liver Metastases: A Single Institution Experience with Propensity Score Matching Analysis.

PubMed

Ivanecz, Arpad; Krebs, Bojan; Stozer, Andraz; Jagric, Tomaz; Plahuta, Irena; Potrc, Stojan

2018-03-01

The aim of the study was to compare the outcome of pure laparoscopic and open simultaneous resection of both the primary colorectal cancer and synchronous colorectal liver metastases (SCLM). From 2000 to 2016 all patients treated by simultaneous resection were assessed for entry in this single center, clinically nonrandomized trial. A propensity score matching was used to compare the laparoscopic group (LAP) to open surgery group (OPEN). Primary endpoints were perioperative and oncologic outcomes. Secondary endpoints were overall survival (OS) and disease-free survival (DFS). Of the 82 patients identified who underwent simultaneous liver resection for SCLM, 10 patients underwent LAP. All these consecutive patients from LAP were matched to 10 comparable OPEN. LAP reduced the length of hospital stay (P = 0.044) and solid food oral intake was faster (P = 0.006) in this group. No patient undergoing the laparoscopic procedure experienced conversion to the open technique. No difference was observed in operative time, blood loss, transfusion rate, narcotics requirement, clinical risk score, resection margin, R0 resections rate, morbidity, mortality and incisional hernias rate. The two groups did not differ significantly in terms of the 3-year OS rate (90 vs. 75%; P = 0.842) and DFS rate (60 vs. 57%; P = 0.724). LAP reduced the length of hospital stay and offers faster solid food oral intake. Comparable oncologic and survival outcomes can be achieved. LAP is beneficial for well selected patients in high volume centers with appropriate expertise.

PACS for Bhutan: a cost effective open source architecture for emerging countries.

PubMed

Ratib, Osman; Roduit, Nicolas; Nidup, Dechen; De Geer, Gerard; Rosset, Antoine; Geissbuhler, Antoine

2016-10-01

This paper reports the design and implementation of an innovative and cost-effective imaging management infrastructure suitable for radiology centres in emerging countries. It was implemented in the main referring hospital of Bhutan equipped with a CT, an MRI, digital radiology, and a suite of several ultrasound units. They lacked the necessary informatics infrastructure for image archiving and interpretation and needed a system for distribution of images to clinical wards. The solution developed for this project combines several open source software platforms in a robust and versatile archiving and communication system connected to analysis workstations equipped with a FDA-certified version of the highly popular Open-Source software. The whole system was implemented on standard off-the-shelf hardware. The system was installed in three days, and training of the radiologists as well as the technical and IT staff was provided onsite to ensure full ownership of the system by the local team. Radiologists were rapidly capable of reading and interpreting studies on the diagnostic workstations, which had a significant benefit on their workflow and ability to perform diagnostic tasks more efficiently. Furthermore, images were also made available to several clinical units on standard desktop computers through a web-based viewer. • Open source imaging informatics platforms can provide cost-effective alternatives for PACS • Robust and cost-effective open architecture can provide adequate solutions for emerging countries • Imaging informatics is often lacking in hospitals equipped with digital modalities.

[Basic and clinical studies of pressure-independent damaging factors of open angle glaucoma].

PubMed

Araie, Makoto

2011-03-01

Pathogenesis of open-angle glaucoma involves both pressure-dependent damaging factors and pressure-independent damaging factors. The high prevalence of open-angle glaucoma with normal pressure (normal-tension glaucoma) in Japan implies that treatment of pressure-independent damaging factors in Japanese open-angle glaucoma patients is of importance. In an attempt to investigate the roles of pressure-independent damaging factors in open-angle glaucoma, we carried out basic and clinical studies and obtained the following results. 1. The rate of deterioration of visual field after trabeculectomy in normal tension glaucoma patients with post-operative intraocular pressure (IOP) of 10 mmHg was found to be -0.25 dB/year of mean deviation (MD), suggesting that contribution of pressure-independent damaging factors to the deterioration of MD in open-angle glaucoma is around -0.25 dB/year of mean deviation (MD). 2. Experiments using isolated purified cultured retinal ganglion cells (RGCs) indicated that calcium-channel blockers and some of antiglaucoma drugs showed neuroprotective effects on RGCs at concentrations of 0.01 microM or higher. 3. In mice, damage to RGCs resulted in secondary degeneration of neurons and activation of glial cells in the lateral geniculate nucleous (LGN) and superior colliculus, and these secondary changes in the central nervous system (CNS) due to RGC damage was partly ameliorated by systemic administration of memantine. 4. Mice experimental high IOP glaucoma models could be established using laser irradiation of the limbal area, and the usefulness of Tonolab in IOP measurements of mice eye was confirmed. 5. Monkey experimental high IOP glaucoma models revealed that in the glaucomatous optic nerve head vaso-constrictive reactions to an alpha-1 agonist was abolished, while vasodilative reaction to a prostaglandin FP receptor agonist was retained. 6. In monkeys with experimental high IOP glaucoma, secondary damage to neurons in the LGN and the glial reaction to it were also found, similar to the mice experiments. In living monkeys the glial reaction in the LGN could be observed by means of positron emission tomography. 7. In the LGN of monkeys with experimental high IOP glaucoma, the M-cell system was preferentially damaged in the early stage, while in the later stages both the M- and P-cell systems were damaged. 8. In a single-instituted prospective double-blinded clinical trial, oral administration of nilvadipine at 4 mg/day, a DHP calcium-channel blocker, was found to significantly retard the visual field progression in normal tension glaucoma patients over 3 years, while significantly increasing the choroidal and optic nerve blood flow by about 35%. 9. A multi-instituted prospective double-blinded clinical trial in normal tension glaucoma patients revealed that the rate of MD deterioration under monotherapy with either topical nipradilol or timolol was around -0.05 dB/year, thought to be considerably slower than -0.25 dB/year, the commonly estimated rate of MD deterioration by pressure-independent damaging factors. The current results indicate the possibility of treatment of pressure-independent damaging factors of open-angle glaucoma in Japanese open-angle glaucoma patients with oral nilvadipine and topical anti-glaucoma agents.

Glutamate-Mediated Blood-Brain Barrier Opening: Implications for Neuroprotection and Drug Delivery.

PubMed

Vazana, Udi; Veksler, Ronel; Pell, Gaby S; Prager, Ofer; Fassler, Michael; Chassidim, Yoash; Roth, Yiftach; Shahar, Hamutal; Zangen, Abraham; Raccah, Ruggero; Onesti, Emanuela; Ceccanti, Marco; Colonnese, Claudio; Santoro, Antonio; Salvati, Maurizio; D'Elia, Alessandro; Nucciarelli, Valter; Inghilleri, Maurizio; Friedman, Alon

2016-07-20

The blood-brain barrier is a highly selective anatomical and functional interface allowing a unique environment for neuro-glia networks. Blood-brain barrier dysfunction is common in most brain disorders and is associated with disease course and delayed complications. However, the mechanisms underlying blood-brain barrier opening are poorly understood. Here we demonstrate the role of the neurotransmitter glutamate in modulating early barrier permeability in vivo Using intravital microscopy, we show that recurrent seizures and the associated excessive glutamate release lead to increased vascular permeability in the rat cerebral cortex, through activation of NMDA receptors. NMDA receptor antagonists reduce barrier permeability in the peri-ischemic brain, whereas neuronal activation using high-intensity magnetic stimulation increases barrier permeability and facilitates drug delivery. Finally, we conducted a double-blind clinical trial in patients with malignant glial tumors, using contrast-enhanced magnetic resonance imaging to quantitatively assess blood-brain barrier permeability. We demonstrate the safety of stimulation that efficiently increased blood-brain barrier permeability in 10 of 15 patients with malignant glial tumors. We suggest a novel mechanism for the bidirectional modulation of brain vascular permeability toward increased drug delivery and prevention of delayed complications in brain disorders. In this study, we reveal a new mechanism that governs blood-brain barrier (BBB) function in the rat cerebral cortex, and, by using the discovered mechanism, we demonstrate bidirectional control over brain endothelial permeability. Obviously, the clinical potential of manipulating BBB permeability for neuroprotection and drug delivery is immense, as we show in preclinical and proof-of-concept clinical studies. This study addresses an unmet need to induce transient BBB opening for drug delivery in patients with malignant brain tumors and effectively facilitate BBB closure in neurological disorders. Copyright © 2016 the authors 0270-6474/16/367727-13$15.00/0.

Cytokines as biomarkers of inflammatory response after open versus endovascular repair of abdominal aortic aneurysms: a systematic review.

PubMed

Tsilimigras, Diamantis I; Sigala, Fragiska; Karaolanis, Georgios; Ntanasis-Stathopoulos, Ioannis; Spartalis, Eleftherios; Spartalis, Michael; Patelis, Nikolaos; Papalampros, Alexandros; Long, Chandler; Moris, Demetrios

2018-05-17

The repair of an abdominal aortic aneurysm (AAA) is a high-risk surgical procedure related to hormonal and metabolic stress-related response with an ensuing activation of the inflammatory cascade. In contrast to open repair (OR), endovascular aortic aneurysm repair (EVAR) seems to decrease the postoperative stress by offering less extensive incisions, dissection, and tissue manipulation. However, these beneficial effects may be offset by the release of cytokines and arachidonic acid metabolites during intra-luminal manipulation of the thrombus using catheters in endovascular repair, resulting in systemic inflammatory response (SIR), which is clinically called post-implantation syndrome. In this systematic review we compared OR with EVAR in terms of the post-interventional inflammatory response resulting from alterations in the circulating cytokine levels. We sought to summarize all the latest evidence regarding post-implantation syndrome after EVAR. We searched Medline (PubMed), ClinicalTrials.gov and the Cochrane library for clinical studies reporting on the release of cytokines as part of the inflammatory response after both open/conventional and endovascular repair of the AAA. We identified 17 studies examining the cytokine levels after OR versus EVAR. OR seemed to be associated with a greater SIR than EVAR, as evidenced by the increased cytokine levels, particularly IL-6 and IL-8, whereas IL-1β, IL-10 and TNF-α showed conflicting results or no difference between the two groups. Polyester endografts appear to be positively correlated with the incidence of post-implantation syndrome after EVAR. Future large prospective studies are warranted to delineate the underlying mechanisms of the cytokine interaction in the post-surgical inflammatory response setting.

Glutamate-Mediated Blood–Brain Barrier Opening: Implications for Neuroprotection and Drug Delivery

PubMed Central

Vazana, Udi; Veksler, Ronel; Pell, Gaby S.; Prager, Ofer; Fassler, Michael; Chassidim, Yoash; Roth, Yiftach; Shahar, Hamutal; Zangen, Abraham; Raccah, Ruggero; Onesti, Emanuela; Ceccanti, Marco; Colonnese, Claudio; Santoro, Antonio; Salvati, Maurizio; D'Elia, Alessandro; Nucciarelli, Valter; Inghilleri, Maurizio

2016-01-01

The blood–brain barrier is a highly selective anatomical and functional interface allowing a unique environment for neuro-glia networks. Blood–brain barrier dysfunction is common in most brain disorders and is associated with disease course and delayed complications. However, the mechanisms underlying blood–brain barrier opening are poorly understood. Here we demonstrate the role of the neurotransmitter glutamate in modulating early barrier permeability in vivo. Using intravital microscopy, we show that recurrent seizures and the associated excessive glutamate release lead to increased vascular permeability in the rat cerebral cortex, through activation of NMDA receptors. NMDA receptor antagonists reduce barrier permeability in the peri-ischemic brain, whereas neuronal activation using high-intensity magnetic stimulation increases barrier permeability and facilitates drug delivery. Finally, we conducted a double-blind clinical trial in patients with malignant glial tumors, using contrast-enhanced magnetic resonance imaging to quantitatively assess blood–brain barrier permeability. We demonstrate the safety of stimulation that efficiently increased blood–brain barrier permeability in 10 of 15 patients with malignant glial tumors. We suggest a novel mechanism for the bidirectional modulation of brain vascular permeability toward increased drug delivery and prevention of delayed complications in brain disorders. SIGNIFICANCE STATEMENT In this study, we reveal a new mechanism that governs blood–brain barrier (BBB) function in the rat cerebral cortex, and, by using the discovered mechanism, we demonstrate bidirectional control over brain endothelial permeability. Obviously, the clinical potential of manipulating BBB permeability for neuroprotection and drug delivery is immense, as we show in preclinical and proof-of-concept clinical studies. This study addresses an unmet need to induce transient BBB opening for drug delivery in patients with malignant brain tumors and effectively facilitate BBB closure in neurological disorders. PMID:27445149

Cohort profile: the German ClinSurv HIV project--a multicentre open clinical cohort study supplementing national HIV surveillance.

PubMed

Bätzing-Feigenbaum, J; Kollan, C; Kühne, A; Matysiak-Klose, D; Gunsenheimer-Bartmeyer, B; Hamouda, O

2011-05-01

New forms of HIV/AIDS therapy require new surveillance instruments to meet shifting public health demands. The Clinical Surveillance of HIV Disease (ClinSurv HIV) project was established in 1999 as a collaboration between major HIV treatment centres in Germany and the Robert Koch Institute (RKI). The project contributes to national HIV surveillance and focuses on the changing epidemiology of HIV/AIDS after the introduction of new therapies in 1995. ClinSurv HIV is designed as an open multicentre observational cohort study of HIV-infected patients. Anonymized data on diagnoses, treatment and laboratory parameters are collected in a standardized format. Data are currently sampled biannually via 11 centres specializing in HIV diagnosis and care within the legal framework of the German Protection against Infection Act [Infektionsschutzgesetz (IfSG)]. A total of 14874 patients were enrolled in the study by 30 June 2009. Of these, 10221 patients (68.7%) were enrolled after 1 January 1999 and 6006 patients (40.4%) were known to have been diagnosed as positive for HIV before 1999. Evaluation indicators, such as the number of newly enrolled patients per half-year period, loss to follow-up, completeness of data per case, availability of data per possible clinical contact, and internal quality control parameters, show a very stable evolution in the cohort, which although open, can be observed. Comparison with the national HIV surveillance data suggests a high degree of representativeness according to major demographic variables. Bearing in mind the obvious strengths and weaknesses discussed, the German ClinSurv HIV cohort provides a broad range of research opportunities in the field of HIV/AIDS both within Germany and in international collaborative research.

Clinical software development for the Web: lessons learned from the BOADICEA project

PubMed Central

2012-01-01

Background In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. Results We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web Application version 1 was released for general use in November 2007. By May 2010, we had > 1200 registered users based in the UK, USA, Canada, South America, Europe, Africa, Middle East, SE Asia, Australia and New Zealand. Conclusions We found that an evolutionary software process was effective when we developed the BOADICEA Web Application. The key clinical software development issues identified during the BOADICEA Web Application project were: software reliability, Web security, clinical data protection and user feedback. PMID:22490389

Clinical software development for the Web: lessons learned from the BOADICEA project.

PubMed

Cunningham, Alex P; Antoniou, Antonis C; Easton, Douglas F

2012-04-10

In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web Application version 1 was released for general use in November 2007. By May 2010, we had > 1200 registered users based in the UK, USA, Canada, South America, Europe, Africa, Middle East, SE Asia, Australia and New Zealand. We found that an evolutionary software process was effective when we developed the BOADICEA Web Application. The key clinical software development issues identified during the BOADICEA Web Application project were: software reliability, Web security, clinical data protection and user feedback.

Antibacterial resistance leadership group: open for business.

PubMed

Chambers, Henry F; Bartlett, John G; Bonomo, Robert A; Chiou, Christine; Cosgrove, Sara E; Cross, Heather R; Daum, Robert S; Downing, Michele; Evans, Scott R; Knisely, Jane; Kreiswirth, Barry N; Lautenbach, Ebbing; Mickley, Brenda S; Patel, Robin; Pettigrew, Melinda M; Rodvold, Keith A; Spellberg, Brad; Fowler, Vance G

2014-06-01

Funded by the National Institute of Allergy and Infectious Diseases, the Antibacterial Resistance Leadership Group (ARLG) is tasked with developing a clinical research agenda and conducting clinical studies to address the growing public health threat of antibacterial resistance. The ARLG has identified 4 high-priority areas of research: infections caused by gram-negative bacteria, infections caused by gram-positive bacteria, antimicrobial stewardship and infection prevention, and diagnostics. The ARLG will be accepting proposals from the scientific community for clinical research that addresses 1 or more of these high-priority areas. These studies should have the potential to transform medical practice and be unlikely to occur without ARLG support. The purpose of this article is to make interested parties aware of clinical research opportunities made available by ARLG and to encourage submission of clinical research proposals that address the problem of antibacterial resistance.

Acetyl-L-Carnitine Augmentation of Clozapine in Partial-Responder Schizophrenia: A 12-Week, Open-Label Uncontrolled Preliminary Study.

PubMed

Bruno, Antonio; Pandolfo, Gianluca; Crucitti, Manuela; Lorusso, Simona; Zoccali, Rocco Antonio; Muscatello, Maria Rosaria Anna

This was the first 12-week, open-label, uncontrolled trial aimed at exploring the efficacy of acetyl-L-carnitine (ALC) add-on pharmacotherapy on clinical symptoms and cognitive functioning in 15 schizophrenia patients with suboptimal clinical response despite receiving clozapine (CLZ) monotherapy at the highest tolerated dosage. After clinical (Positive and Negative Symptoms Scale [PANSS]) and neuropsychological (Wisconsin Card Sorting Test, Stroop Color-Word Test, Verbal Fluency Test) assessments, patients received 1 g/d of ALC for 12 weeks. A final sample of 9 subjects completed the study. Acetyl-L-carnitine augmentation of CLZ significantly reduced only PANSS domains "positive" (P = 0.049); at end point, only 2 subjects (22.2% of the completers) reached a minimal improvement (25% reduction in PANSS total score). No significant differences emerged in cognitive performances at the end of the study; effect sizes were small in each explored cognitive dimension. The findings provide preliminary evidence that ALC added to ongoing CLZ treatment appeared to be ineffective to improve symptoms in schizophrenia patients who have failed to respond sufficiently to CLZ. Further trials with adequately powered methodology are needed to identify which augmentation strategies are more effective in schizophrenia patients showing a suboptimal response to CLZ.

CISUS: an integrated 3D ultrasound system for IGT using a modular tracking API

NASA Astrophysics Data System (ADS)

Boctor, Emad M.; Viswanathan, Anand; Pieper, Steve; Choti, Michael A.; Taylor, Russell H.; Kikinis, Ron; Fichtinger, Gabor

2004-05-01

Ultrasound has become popular in clinical/surgical applications, both as the primary image guidance modality and also in conjunction with other modalities like CT or MRI. Three dimensional ultrasound (3DUS) systems have also demonstrated usefulness in image-guided therapy (IGT). At the same time, however, current lack of open-source and open-architecture multi-modal medical visualization systems prevents 3DUS from fulfilling its potential. Several stand-alone 3DUS systems, like Stradx or In-Vivo exist today. Although these systems have been found to be useful in real clinical setting, it is difficult to augment their functionality and integrate them in versatile IGT systems. To address these limitations, a robotic/freehand 3DUS open environment (CISUS) is being integrated into the 3D Slicer, an open-source research tool developed for medical image analysis and surgical planning. In addition, the system capitalizes on generic application programming interfaces (APIs) for tracking devices and robotic control. The resulting platform-independent open-source system may serve as a valuable tool to the image guided surgery community. Other researchers could straightforwardly integrate the generic CISUS system along with other functionalities (i.e. dual view visualization, registration, real-time tracking, segmentation, etc) to rapidly create their medical/surgical applications. Our current driving clinical application is robotically assisted and freehand 3DUS-guided liver ablation, which is fully being integrated under the CISUS-3D Slicer. Initial functionality and pre-clinical feasibility are demonstrated on phantom and ex-vivo animal models.

[Alcohol withdrawal syndrome dynamics during treatment with nooclerin (deanoli aceglumas)].

PubMed

Agibalova, T V; Buzik, O Zh; Rychkova, O V; Smyshlyaev, A V; Rumbesht, V V

2018-01-01

To study the efficacy of nooclerin (deanoli aceglumas) in alcohol withdrawal syndrome assessed by clinical and biochemical characteristics. A multicenter, open, randomized, comparative study of nooclerin in the complex treatment of alcohol withdrawal syndrome included 90 patients. The patients were randomized into nooclerin group (n=55) and control group (n=35). Nooclerin reduced alcohol withdrawal symptoms more significantly throughout the whole study period. There were significant between-group differences on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) and the Multidimensional Fatigue Inventory (МFI-20). However, patients exhibited no excessive activity. No adverse side-effects were observed.

A Case for Crowd Sourcing in Stem Cell Research

PubMed Central

Mummery, Christine L.; Rabelink, Ton J.

2014-01-01

SUMMARY Thousands of patients and placebo-treated controls have been included in many clinical trials of stem cell therapy over the last decade or so, but often the study groups have been small. Their scientific value may therefore be limited and their ethical justification questionable. Would “crowd sourcing” for data sharing be a means of increasing the collective value of clinical trials? Here, we make a case for open access of all data emerging from stem cell studies (trials but also observational studies) independent of whether they are investigator-initiated or commercially driven. PMID:25232185

An open-label tolerability study of BL-1020 antipsychotic: a novel gamma aminobutyric acid ester of perphenazine.

PubMed

Anand, Ravi; Geffen, Yona; Vasile, Daniel; Dan, Irina

2010-01-01

BL-1020, a novel gamma aminobutyric acid (GABA) ester of perphenazine, is a new oral antipsychotic with a strong affinity for dopamine and serotonin receptors. Unlike first- and second-generation antipsychotics, it has agonist activity at GABA(A). This is the first study to examine tolerability and safety of BL-1020 in schizophrenia. This was a phase-II, open-label, multicenter, 6-week study treating patients (n = 36) with chronic schizophrenia. Dosing started at 20 mg/d and increased over 7 days to 40 mg/d. Weekly assessments were conducted. All but 1 patient was titrated to 30 mg/d at day 4; on day 7, 30 were titrated to 40 mg/d. Four patients discontinued the study prematurely. There was no clinically relevant increase in vital signs, sedation, dizziness, or other central nervous system effects or electrocardiogram or laboratory abnormalities and a small increase in weight. Ten patients experienced extrapyramidal symptoms (EPS) requiring treatment with an anticholinergic; 4 patients were unable to reach maximum dose because of EPS. Extrapyramidal Symptom Rating Scale did not indicate clinically significant changes in EPS. The most common adverse event was insomnia (6 patients); other frequent adverse effects (all n = 3) were extrapyramidal disorder, headache, parkinsonism, tremor, and hyperprolactinemia. There was improvement on Positive and Negative Syndrome Scale and Clinical Global Impression of Change with 22 patients showing at least 20% decrease by end point on Positive and Negative Syndrome Scale and 31 patients showing at least minimal improvement on Clinical Global Impression of Change. These data suggest that 20 to 40 mg/d of BL-1020 is associated with clinically relevant improvement of psychosis with no worsening of EPS and support further testing in randomized controlled trials.

Visual disability in newly diagnosed primary open angle glaucoma (POAG) patients in a tertiary hospital in Nigeria.

PubMed

Awoyesuku, E A; Ejimadu, C S

2012-01-01

Glaucoma remains the second leading cause of blindness worldwide and the highes cause of irreversible blindness worldwide. In N Glaucoma accounts for 16% of blindness and primary open angle glaucoma is the most prevalent clinical type. The aim of this study is to assess the visual disability resulting from glaucoma in newly diagnosed POAG patients in University of Port Harcourt Teaching Hospital. This is a retrospective study of newly diagnosed glaucoma patients referred from the general ophthalmology clinic to the glaucoma clinic over a 12 month period (January-December 2010). All patients had a glaucoma workup includin Snellen distant visual acuity, slit lamp examination, Goldman applanation tonometry, gonioscopy, dilated fundoscopy with +78 diopter lens as well as perimetry. All examinations were carried out by both authors. Patients with other co-morbidities such as cataract and retinal/macular pathologies were excluded from the study. A total of 98 patients were reviewed. The were 34 males and 27 females, giving a male to female ratio of 1.3:1. The average age was 54.2 years and most patients (>80%) were in the 40-59 year age group. Of the 98 patients reviewed, 62.2% had POAG. 30 patients were-blind by distant visual acuity criteria while 45 patients were blind by central visual field criteria. POAG is the most prevalent clinical subtype of glaucoma in Nigeria and sub-Saharan Africa Paucity of symptoms in early stages of the disease at late presentation is a characteristic finding in our clinic environment. Our study showed that POAG in our environment is associated with marked visual disability at the time of presentation.

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

PubMed

Kass, Nancy E; Taylor, Holly A; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

2015-02-01

Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

Acute cholecystitis: comparing clinical outcomes with TG13 severity and intended laparoscopic versus open cholecystectomy in difficult operative cases.

PubMed

Gerard, Justin; Luu, Minh B; Poirier, Jennifer; Deziel, Daniel J

2018-03-09

The revised Tokyo Guidelines include criteria for determining the severity of acute cholecystitis with treatment algorithms based on severity. The aim of this study was to investigate the relationship of the revised Tokyo Guidelines severity grade to clinical outcomes of cholecystectomy for acute cholecystitis. We identified 66 patients with acute cholecystitis from a prior study of difficult cholecystectomy cases. We examined the relationship between severity grade and multiple variables related to perioperative and postoperative outcomes. A more severe revised Tokyo Guidelines grade was associated with a higher number of complications (p = 0.03) and a higher severity of complications (p = 0.01). Severity grade did not predict operative time, estimated blood loss, intensive care unit admission or length of stay. Compared to planned open cholecystectomy, intended laparoscopic cholecystectomy was associated with significantly fewer total and Clavien-Dindo grade 3 complications, fewer intensive care unit admissions, and shorter length of stay (p values range from 0.03 to < 0.0001). In technically difficult operations for acute cholecystitis, the revised Tokyo guidelines severity grade correlates with the number and severity of complications. However, intended performance of laparoscopic cholecystectomy rather than open cholecystectomy in difficult operations predicts broader beneficial outcomes than severity grade.

Exposure of wide cerebellomedullary cisterns for vascular lesion surgeries in cerebellomedullary cisterns: opening of unilateral cerebellomedullary fissures combined with lateral foramen magnum approach.

PubMed

Matsushima, Toshio; Kawashima, Masatou; Inoue, Kohei; Matsushima, Ken; Miki, Koichi

2014-11-01

To clarify microsurgical anatomic features of the cerebellomedullary fissure (CMF), the natural cleavage plane between the cerebellum and the medulla, and its relationship to the cerebellomedullary cistern (CMC) and to describe a surgical technique that uses the unilateral trans-CMF approach for CMC surgeries. In the anatomic study, 2 formalin-fixed cadaver heads were used. In the clinical study, 3 patients with vertebral artery-posterior inferior cerebellar artery aneurysms and 3 patients with glossopharyngeal neuralgia were surgically treated through the unilateral trans-CMF approach combined with the transcondylar fossa approach, which is a lateral foramen magnum approach. The CMC was present at the lateral end of the CMF. The CMF was closed by arachnoidal adhesion, and the cerebellar hemisphere was superiorly attached to the cerebellar peduncle. After the unilateral CMF was completely opened, the cerebellar hemisphere was easily retracted rostrodorsally. Clinically, almost completely opening the unilateral CMF markedly enabled the retraction of the biventral lobule to obtain a wide surgical field safely for vascular CMC lesions. We present 2 representative cases. Combined unilateral trans-CMF/lateral foramen magnum approaches provide a wide and close surgical field in the CMC, allowing easy and safe CMC surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids.

PubMed

Simillis, C; Thoukididou, S N; Slesser, A A P; Rasheed, S; Tan, E; Tekkis, P P

2015-12-01

The aim was to compare the clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Randomized clinical trials were identified by means of a systematic review. A Bayesian network meta-analysis was performed using the Markov chain Monte Carlo method in WinBUGS. Ninety-eight trials were included with 7827 participants and 11 surgical treatments for grade III and IV haemorrhoids. Open, closed and radiofrequency haemorrhoidectomies resulted in significantly more postoperative complications than transanal haemorrhoidal dearterialization (THD), LigaSure™ and Harmonic® haemorrhoidectomies. THD had significantly less postoperative bleeding than open and stapled procedures, and resulted in significantly fewer emergency reoperations than open, closed, stapled and LigaSure™ haemorrhoidectomies. Open and closed haemorrhoidectomies resulted in more pain on postoperative day 1 than stapled, THD, LigaSure™ and Harmonic® procedures. After stapled, LigaSure™ and Harmonic® haemorrhoidectomies patients resumed normal daily activities earlier than after open and closed procedures. THD provided the earliest time to first bowel movement. The stapled and THD groups had significantly higher haemorrhoid recurrence rates than the open, closed and LigaSure™ groups. Recurrence of haemorrhoidal symptoms was more common after stapled haemorrhoidectomy than after open and LigaSure™ operations. No significant difference was identified between treatments for anal stenosis, incontinence and perianal skin tags. Open and closed haemorrhoidectomies resulted in more postoperative complications and slower recovery, but fewer haemorrhoid recurrences. THD and stapled haemorrhoidectomies were associated with decreased postoperative pain and faster recovery, but higher recurrence rates. The advantages and disadvantages of each surgical treatment should be discussed with the patient before surgery to allow an informed decision to be made. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.

Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach.

PubMed

Sarli, L; Iusco, D R; Sansebastiano, G; Costi, R

2001-08-01

No randomized trial exists that specifically addresses the issue of laparoscopic bilateral inguinal hernia repair. The purpose of the present prospective, randomized, controlled, clinical study was to assess short- and long-term results when comparing simultaneous bilateral hernia repair by an open, tension-free anterior approach with laparoscopic "bikini mesh" posterior repair. Forty-three low-risk male patients with bilateral primary inguinal hernia were randomly assigned to undergo either laparoscopic preperitoneal "bikini mesh" hernia repair (TAPP) or open Lichtenstein hernioplasty. There was no difference in operating time between the two groups. The mean cost of laparoscopic hernioplasty was higher (P < 0.001). The intensity of postoperative pain was greater in the open hernia repair group at 24 hours, 48 hours, and 7 days after surgery (P < 0.001), with a greater consumption of pain medication among these patients (P < 0.05). The median time to return to work was 30 days for the open hernia repair group and 16 days for the laparoscopic "bikini mesh" repair group (P < 0.05). Only 1 asymptomatic recurrence (4.3%) was discovered in the open group. The laparoscopic approach to bilateral hernia with "bikini mesh" appears to be preferable to the open Lichtenstein tension-free hernioplasty in terms of the postoperative quality of life and interruption of occupational activity.

[The effectiveness of endonasal electrophoresis of neuroprotective agents used in the rehabilitative treatment of the patients presenting with primary open angle glaucoma].

PubMed

Nazarova, G A; Konchugova, T V; Iurova, O V; Sichinava, N V; Turova, E A; Rassulova, M A; Morozova, N E

2013-01-01

The objective of the present study was to estimate the effectiveness of the peptide drug cortexin used to treat primary open angle glaucoma. It was shown that endonasal electrophoresis of cortexin resulted in more pronounced positive changes in the dynamics of clinical, functional, perimetric, and electrophysiological characteristics compared with intramuscular administration of the same drug to the patients of the control group. This difference was apparent both immediately after the termination of the treatment and during the long-term follow-up.

Generating optimal control simulations of musculoskeletal movement using OpenSim and MATLAB.

PubMed

Lee, Leng-Feng; Umberger, Brian R

2016-01-01

Computer modeling, simulation and optimization are powerful tools that have seen increased use in biomechanics research. Dynamic optimizations can be categorized as either data-tracking or predictive problems. The data-tracking approach has been used extensively to address human movement problems of clinical relevance. The predictive approach also holds great promise, but has seen limited use in clinical applications. Enhanced software tools would facilitate the application of predictive musculoskeletal simulations to clinically-relevant research. The open-source software OpenSim provides tools for generating tracking simulations but not predictive simulations. However, OpenSim includes an extensive application programming interface that permits extending its capabilities with scripting languages such as MATLAB. In the work presented here, we combine the computational tools provided by MATLAB with the musculoskeletal modeling capabilities of OpenSim to create a framework for generating predictive simulations of musculoskeletal movement based on direct collocation optimal control techniques. In many cases, the direct collocation approach can be used to solve optimal control problems considerably faster than traditional shooting methods. Cyclical and discrete movement problems were solved using a simple 1 degree of freedom musculoskeletal model and a model of the human lower limb, respectively. The problems could be solved in reasonable amounts of time (several seconds to 1-2 hours) using the open-source IPOPT solver. The problems could also be solved using the fmincon solver that is included with MATLAB, but the computation times were excessively long for all but the smallest of problems. The performance advantage for IPOPT was derived primarily by exploiting sparsity in the constraints Jacobian. The framework presented here provides a powerful and flexible approach for generating optimal control simulations of musculoskeletal movement using OpenSim and MATLAB. This should allow researchers to more readily use predictive simulation as a tool to address clinical conditions that limit human mobility.

Generating optimal control simulations of musculoskeletal movement using OpenSim and MATLAB

PubMed Central

Lee, Leng-Feng

2016-01-01

Computer modeling, simulation and optimization are powerful tools that have seen increased use in biomechanics research. Dynamic optimizations can be categorized as either data-tracking or predictive problems. The data-tracking approach has been used extensively to address human movement problems of clinical relevance. The predictive approach also holds great promise, but has seen limited use in clinical applications. Enhanced software tools would facilitate the application of predictive musculoskeletal simulations to clinically-relevant research. The open-source software OpenSim provides tools for generating tracking simulations but not predictive simulations. However, OpenSim includes an extensive application programming interface that permits extending its capabilities with scripting languages such as MATLAB. In the work presented here, we combine the computational tools provided by MATLAB with the musculoskeletal modeling capabilities of OpenSim to create a framework for generating predictive simulations of musculoskeletal movement based on direct collocation optimal control techniques. In many cases, the direct collocation approach can be used to solve optimal control problems considerably faster than traditional shooting methods. Cyclical and discrete movement problems were solved using a simple 1 degree of freedom musculoskeletal model and a model of the human lower limb, respectively. The problems could be solved in reasonable amounts of time (several seconds to 1–2 hours) using the open-source IPOPT solver. The problems could also be solved using the fmincon solver that is included with MATLAB, but the computation times were excessively long for all but the smallest of problems. The performance advantage for IPOPT was derived primarily by exploiting sparsity in the constraints Jacobian. The framework presented here provides a powerful and flexible approach for generating optimal control simulations of musculoskeletal movement using OpenSim and MATLAB. This should allow researchers to more readily use predictive simulation as a tool to address clinical conditions that limit human mobility. PMID:26835184

Clinical implications of recent breakthroughs in amyotrophic lateral sclerosis.

PubMed

Van Damme, Philip; Robberecht, Wim

2013-10-01

This review examines the clinical implications of recent breakthroughs in amyotrophic lateral sclerosis (ALS). ALS has been found to be a highly variable condition at the clinical, genetic and mechanistic level. The study of newly discovered genetic causes for ALS has demonstrated that in addition to the effect of toxic mutant proteins, abnormalities of RNA householding contribute to motor neuron degeneration. Furthermore, the classic distinction between gain of function and loss of function may be an oversimplification of the biological reality. The most important clinical breakthrough was the finding of intronic hexanucleotide repeat expansions in chromosome 9 open reading frame 72 (C9orf72) as a common cause of ALS, frontotemporal lobar degeneration (FTLD) and ALS with concomitant FTLD. This provides unambiguous evidence that ALS and FTLD represent the ends of one spectrum of neurodegenerative diseases. The high prevalence of C9orf72 mutations in patients without family history further blurs the distinction between sporadic and familial forms of ALS and FTLD. It also opens opportunities for stratified clinical trials in ALS and for the development of targeted therapies. ALS is a heterogeneous disorder that overlaps with FTLD. C9orf72 mutations are the most common cause of ALS, and add to the evidence that disturbances in RNA householding contribute to ALS.

Lubrication Theory Model to Evaluate Surgical Alterations in Flow Mechanics of the Lower Esophageal Sphincter

NASA Astrophysics Data System (ADS)

Ghosh, Sudip K.; Brasseur, James G.; Zaki, Tamer; Kahrilas, Peter J.

2003-11-01

Surgery is commonly used to rebuild a weak lower esophageal sphincter (LES) and reduce reflux. Because the driving pressure (DP) is proportional to muscle tension generated in the esophagus, we developed models using lubrication theory to evaluate the consequences of surgery on muscle force required to open the LES and drive the flow. The models relate time changes in DP to lumen geometry and trans-LES flow with a manometric catheter. Inertial effects were included and found negligible. Two models, direct (opening specified) and indirect (opening predicted), were combined with manometric pressure and imaging data from normal and post-surgery LES. A very high sensitivity was predicted between the details of the DP and LES opening. The indirect model accurately captured LES opening and predicted a 3-phase emptying process, with phases I and III requiring rapid generation of muscle tone to open the LES and empty the esophagus. Data showed that phases I and III are adversely altered by surgery causing incomplete emptying. Parametric model studies indicated that changes to the surgical procedure can positively alter LES flow mechanics and improve clinical outcomes.

ODM Data Analysis-A tool for the automatic validation, monitoring and generation of generic descriptive statistics of patient data.

PubMed

Brix, Tobias Johannes; Bruland, Philipp; Sarfraz, Saad; Ernsting, Jan; Neuhaus, Philipp; Storck, Michael; Doods, Justin; Ständer, Sonja; Dugas, Martin

2018-01-01

A required step for presenting results of clinical studies is the declaration of participants demographic and baseline characteristics as claimed by the FDAAA 801. The common workflow to accomplish this task is to export the clinical data from the used electronic data capture system and import it into statistical software like SAS software or IBM SPSS. This software requires trained users, who have to implement the analysis individually for each item. These expenditures may become an obstacle for small studies. Objective of this work is to design, implement and evaluate an open source application, called ODM Data Analysis, for the semi-automatic analysis of clinical study data. The system requires clinical data in the CDISC Operational Data Model format. After uploading the file, its syntax and data type conformity of the collected data is validated. The completeness of the study data is determined and basic statistics, including illustrative charts for each item, are generated. Datasets from four clinical studies have been used to evaluate the application's performance and functionality. The system is implemented as an open source web application (available at https://odmanalysis.uni-muenster.de) and also provided as Docker image which enables an easy distribution and installation on local systems. Study data is only stored in the application as long as the calculations are performed which is compliant with data protection endeavors. Analysis times are below half an hour, even for larger studies with over 6000 subjects. Medical experts have ensured the usefulness of this application to grant an overview of their collected study data for monitoring purposes and to generate descriptive statistics without further user interaction. The semi-automatic analysis has its limitations and cannot replace the complex analysis of statisticians, but it can be used as a starting point for their examination and reporting.

Effects of Art Therapy on Distress Levels of Adults with Cancer: A Proxy Pretest Study

ERIC Educational Resources Information Center

Glinzak, Leara

2016-01-01

This study identified decreased distress after art therapy in a proxy pretest study with a convenience sample of 73 patients being treated for cancer. Art therapy outcomes from 4 settings (oncology unit, infusion clinic, individual sessions, and open studio) were measured via the self-report Distress Thermometer, which was collected as part of an…

An Open Middle-Term Study of Combined Vitamin B6-Magnesium in a Subgroup of Autistic Children Selected on Their Sensitivity to this Treatment. Brief Report.

ERIC Educational Resources Information Center

Martineau, J.; And Others

1988-01-01

The study examined effects of eight weeks of treatment with Vitamin B6-Magnesium on 11 autistic children sensitive to this treatment over a shorter term. The study found significant modifications in the electrophysiological, clinical, and biochemical data gathered before, during, and after treatment. (DB)

Open-label study of duloxetine for the treatment of obsessive-compulsive disorder.

PubMed

Dougherty, Darin D; Corse, Andrew K; Chou, Tina; Duffy, Amanda; Arulpragasam, Amanda R; Deckersbach, Thilo; Jenike, Michael A; Keuthen, Nancy J

2015-01-01

This study sought to investigate the efficacy of duloxetine for the treatment of obsessive-compulsive disorder (DSM-IV). Twenty individuals were enrolled in a 17-week, open-label trial of duloxetine at Massachusetts General Hospital. Data were collected between March 2007 and September 2012. Study measures assessing obsessive-compulsive disorder symptoms, quality of life, depression, and anxiety were administered at baseline and weeks 1, 5, 9, 13, and 17. The primary outcome measures were the Yale-Brown Obsessive Compulsive Scale and Clinical Global Improvement scale. For the 12 study completers, pre- and posttreatment analyses revealed significant improvements (P<.05) on clinician- and self-rated measures of obsessive-compulsive disorder symptoms and quality of life. Among the 12 completers, more than one-half (n=7) satisfied full medication response criteria. Intention-to-treat analyses (n=20) showed similar improvements (P<.05) on primary and secondary study outcome measures. The results of this study suggest that duloxetine may provide a significant reduction in symptoms for patients with obsessive-compulsive disorder. ClinicalTrials.gov NCT00464698; http://clinicaltrials.gov/ct2/show/NCT00464698?term=NCT00464698&rank=1. © The Author 2015. Published by Oxford University Press on behalf of CINP.

Laparoscopic Complete Mesocolic Excision versus Open Complete Mesocolic Excision for Transverse Colon Cancer: Long-Term Survival Results of a Prospective Single Centre Non-Randomized Study.

PubMed

Storli, Kristian Eeg; Eide, Geir Egil

2016-01-01

Laparoscopic complete mesocolic excision (CME) used in the treatment of transverse colon cancer has been questioned on the basis of the technical challenges. The aim of this study was to evaluate the medium- and long-term clinical and survival outcomes after laparoscopic and open CME for transverse colon cancer and to compare the 2 approaches. This study was a retrospective non-randomized study of patients with prospectively registered data on open and laparoscopic CME for transverse colon cancer tumour-node-metastasis stages I-III operated on between 2007 and 2014. This was a single-centre study in a community teaching hospital. A total of 56 patients with transverse colon cancer were included, excluding those with tumours in the colonic flexures. The outcome aims were 4-year time to recurrence (TTR) and cancer-specific survival (CSS). Morbidity was also measured. The 4-year TTR was 93.9% in the laparoscopic group and 91.3% in the open group (p = 0.71). The 4-year CSS was 97.0% in the laparoscopic group and 91.3% in the open group (p = 0.42). This was a prospective single-institution study with a small sample size. Results of the study suggest that the laparoscopic CME approach might be the preferred approach for transverse colon cancer, especially regarding its benefits in terms of short-term morbidity, length of stay and oncological outcome. © 2016 S. Karger AG, Basel.

Timely publication and sharing of trial data: opportunities and challenges for comparative effectiveness research in cardiovascular disease.

PubMed

Naci, Huseyin; Cooper, Jacob; Mossialos, Elias

2015-11-01

There is growing enthusiasm for the timely publication and sharing of clinical trial data. The rationale for open access includes greater transparency, reproducibility, and efficiency of the research enterprise. In cardiovascular diseases, routinely sharing clinical trial data would create opportunities for undertaking comparative effectiveness research, providing much needed evidence on how different interventions compare to each other on key outcomes. Access to individual patient-level data would strengthen the validity of such research. Novel methodological approaches like network meta-analyses using individual patient-level data could reliably compare interventions that have not been compared with each other in head-to-head trials. However, there are significant practical, methodological, financial, and legal challenges to this utopian open access that need to be continually addressed. Sharing clinical trial data openly will only occur when the previously tolerated process of clinical research involving direct ownership and secrecy is abandoned for a new culture in which medical science is open to all of its stakeholders. With this new culture, data will be accessible, reanalysis will be considered commonplace, and comparative effectiveness research through novel synthesis approaches, such as network meta-analyses, can thrive-as long as measures are taken to adequately ensure the goal remains to promote public health.

Implementing an Open Source Electronic Health Record System in Kenyan Health Care Facilities: Case Study

PubMed Central

Magare, Steve; Monda, Jonathan; Kamau, Onesmus; Houston, Stuart; Fraser, Hamish; Powell, John; English, Mike; Paton, Chris

2018-01-01

Background The Kenyan government, working with international partners and local organizations, has developed an eHealth strategy, specified standards, and guidelines for electronic health record adoption in public hospitals and implemented two major health information technology projects: District Health Information Software Version 2, for collating national health care indicators and a rollout of the KenyaEMR and International Quality Care Health Management Information Systems, for managing 600 HIV clinics across the country. Following these projects, a modified version of the Open Medical Record System electronic health record was specified and developed to fulfill the clinical and administrative requirements of health care facilities operated by devolved counties in Kenya and to automate the process of collating health care indicators and entering them into the District Health Information Software Version 2 system. Objective We aimed to present a descriptive case study of the implementation of an open source electronic health record system in public health care facilities in Kenya. Methods We conducted a landscape review of existing literature concerning eHealth policies and electronic health record development in Kenya. Following initial discussions with the Ministry of Health, the World Health Organization, and implementing partners, we conducted a series of visits to implementing sites to conduct semistructured individual interviews and group discussions with stakeholders to produce a historical case study of the implementation. Results This case study describes how consultants based in Kenya, working with developers in India and project stakeholders, implemented the new system into several public hospitals in a county in rural Kenya. The implementation process included upgrading the hospital information technology infrastructure, training users, and attempting to garner administrative and clinical buy-in for adoption of the system. The initial deployment was ultimately scaled back due to a complex mix of sociotechnical and administrative issues. Learning from these early challenges, the system is now being redesigned and prepared for deployment in 6 new counties across Kenya. Conclusions Implementing electronic health record systems is a challenging process in high-income settings. In low-income settings, such as Kenya, open source software may offer some respite from the high costs of software licensing, but the familiar challenges of clinical and administration buy-in, the need to adequately train users, and the need for the provision of ongoing technical support are common across the North-South divide. Strategies such as creating local support teams, using local development resources, ensuring end user buy-in, and rolling out in smaller facilities before larger hospitals are being incorporated into the project. These are positive developments to help maintain momentum as the project continues. Further integration with existing open source communities could help ongoing development and implementations of the project. We hope this case study will provide some lessons and guidance for other challenging implementations of electronic health record systems as they continue across Africa. PMID:29669709

Cerebrospinal Fluid Lumbar Tapping Utilization for Suspected Ventriculoperitoneal Shunt Under-Drainage Malfunctions.

PubMed

Lee, Jong-Beom; Ahn, Ho-Young; Lee, Hong-Jae; Yang, Ji-Ho; Yi, Jin-Seok; Lee, Il-Woo

2017-01-01

The diagnosis of shunt malfunction can be challenging since neuroimaging results are not always correlated with clinical outcomes. The purpose of this study was to evaluate the efficacy of a simple, minimally invasive cerebrospinal fluid (CSF) lumbar tapping test that predicts shunt under-drainage in hydrocephalus patients. We retrospectively reviewed the clinical and radiological features of 48 patients who underwent routine CSF lumbar tapping after ventriculoperitoneal shunt (VPS) operation using a programmable shunting device. We compared shunt valve opening pressure and CSF lumbar tapping pressure to check under-drainage. The mean pressure difference between valve opening pressure and CSF lumbar tapping pressure of all patients were 2.21±24.57 mmH 2 O. The frequency of CSF lumbar tapping was 2.06±1.26 times. Eighty five times lumbar tapping of 41 patients showed that their VPS function was normal which was consistent with clinical improvement and decreased ventricle size on computed tomography scan. The mean pressure difference in these patients was -3.69±19.20 mmH 2 O. The mean frequency of CSF lumbar tapping was 2.07±1.25 times. Fourteen cases of 10 patients revealed suspected VPS malfunction which were consistent with radiological results and clinical symptoms, defined as changes in ventricle size and no clinical improvement. The mean pressure difference was 38.07±23.58 mmH 2 O. The mean frequency of CSF lumbar tapping was 1.44±1.01 times. Pressure difference greater than 35 mmH 2 O was shown in 2.35% of the normal VPS function group (2 of 85) whereas it was shown in 64.29% of the suspected VPS malfunction group (9 of 14). The difference was statistically significant ( p =0.000001). Among 10 patients with under-drainage, 5 patients underwent shunt revision. The causes of the shunt malfunction included 3 cases of proximal occlusion and 2 cases of distal obstruction and valve malfunction. Under-drainage of CSF should be suspected if CSF lumbar tapping pressure is 35 mmH 2 O higher than the valve opening pressure and shunt malfunction evaluation or adjustment of the valve opening pressure should be made.

First branchial cleft fistula presenting with internal opening on the Eustachian tube: Illustrated cases and literature review.

PubMed

Liu, Yuhe; Li, Tiancheng; Xue, Junfang; Jia, Jun; Xiao, Shuifang; Zhao, Enmin

2012-05-01

Two cases of first branchial cleft fistula with internal opening on the Eustachian tube are reported and the diagnosis, management and embryological hypothesis are discussed. Retrospective study and review of the literature. Both patients were young boys with first branchial cleft anomaly clearly identified by computed tomography fistulography scan and direct Methylene Blue dye injection. In both cases, surgical removal revealed a fistula with internal opening located on the Eustachian tube near the nasopharynx. The main embryological theories and classification are reviewed. A connection between the theories of first branchial apparatus development and the classification by Work might explain the reported clinical association. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Memorandum "Open Metadata". Open Access to Documentation Forms and Item Catalogs in Healthcare.

PubMed

Dugas, M; Jöckel, K-H; Friede, T; Gefeller, O; Kieser, M; Marschollek, M; Ammenwerth, E; Röhrig, R; Knaup-Gregori, P; Prokosch, H-U

2015-01-01

At present, most documentation forms and item catalogs in healthcare are not accessible to the public. This applies to assessment forms of routine patient care as well as case report forms (CRFs) of clinical and epidemiological studies. On behalf of the German chairs for Medical Informatics, Biometry and Epidemiology six recommendations to developers and users of documentation forms in healthcare were developed. Open access to medical documentation forms could substantially improve information systems in healthcare and medical research networks. Therefore these forms should be made available to the scientific community, their use should not be unduly restricted, they should be published in a sustainable way using international standards and sources of documentation forms should be referenced in scientific publications.

Application of Bayes' to the prediction of referral decisions made by specialist optometrists in relation to chronic open angle glaucoma.

PubMed

Gurney, J C; Ansari, E; Harle, D; O'Kane, N; Sagar, R V; Dunne, M C M

2018-02-09

To determine the accuracy of a Bayesian learning scheme (Bayes') applied to the prediction of clinical decisions made by specialist optometrists in relation to the referral refinement of chronic open angle glaucoma. This cross-sectional observational study involved collection of data from the worst affected or right eyes of a consecutive sample of cases (n = 1,006) referred into the West Kent Clinical Commissioning Group Community Ophthalmology Team (COT) by high street optometrists. Multilevel classification of each case was based on race, sex, age, family history of chronic open angle glaucoma, reason for referral, Goldmann Applanation Tonometry (intraocular pressure and interocular asymmetry), optic nerve head assessment (vertical size, cup disc ratio and interocular asymmetry), central corneal thickness and visual field analysis (Hodapp-Parrish-Anderson classification). Randomised stratified tenfold cross-validation was applied to determine the accuracy of Bayes' by comparing its output to the clinical decisions of three COT specialist optometrists; namely, the decision to discharge, follow-up or refer each case. Outcomes of cross-validation, expressed as means and standard deviations, showed that the accuracy of Bayes' was high (95%, 2.0%) but that it falsely discharged (3.4%, 1.6%) or referred (3.1%, 1.5%) some cases. The results indicate that Bayes' has the potential to augment the decisions of specialist optometrists.

Acoustic cavitation-based monitoring of the reversibility and permeability of ultrasound-induced blood-brain barrier opening

NASA Astrophysics Data System (ADS)

Sun, Tao; Samiotaki, Gesthimani; Wang, Shutao; Acosta, Camilo; Chen, Cherry C.; Konofagou, Elisa E.

2015-12-01

Cavitation events seeded by microbubbles have been previously reported to be associated with MR- or fluorescent-contrast enhancement after focused ultrasound (FUS)-induced blood-brain barrier (BBB) opening. However, it is still unknown whether bubble activity can be correlated with the reversibility (the duration of opening and the likelihood of safe reinstatement) and the permeability of opened BBB, which is critical for the clinical translation of using passive cavitation detection to monitor, predict and control the opening. In this study, the dependence of acoustic cavitation on the BBB opening duration, permeability coefficient and histological damage occurrence were thus investigated. Transcranial pulsed FUS at 1.5 MHz in the presence of systemically circulating microbubbles was applied in the mouse hippocampi (n  =  60). The stable and inertial cavitation activities were monitored during sonication. Contrast-enhanced MRI was performed immediately after sonication and every 24 h up to 6 d thereafter, to assess BBB opening, brain tissue permeability and potential edema. Histological evaluations were used to assess the occurrence of neurovascular damages. It was found that stable cavitation was well correlated with: (1) the duration of the BBB opening (r2  =  0.77) (2) the permeability of the opened BBB (r2  =  0.82) (3) the likelihood of safe opening (P  <  0.05, safe opening compared to cases of damage; P  <  0.0001, no opening compared to safe opening). The inertial cavitation dose was correlated with the resulting BBB permeability (r2  =  0.72). Stable cavitation was found to be more reliable than inertial cavitation at assessing the BBB opening within the pressure range used in this study. This study demonstrates that the stable cavitation response during BBB opening holds promise for predicting and controlling the restoration and pharmacokinetics of FUS-opened BBB. The stable cavitation response therefore showed great promise in predicting the BBB opening duration, enabling thus control of opening according to the drug circulation time. In addition, avoiding adverse effects in the brain and assessing the pharmacokinetics of the compounds delivered can also be achieved by monitoring and controlling the stable cavitation emissions.

Acoustic cavitation-based monitoring of the reversibility and permeability of ultrasound-induced blood-brain barrier opening.

PubMed

Sun, Tao; Samiotaki, Gesthimani; Wang, Shutao; Acosta, Camilo; Chen, Cherry C; Konofagou, Elisa E

2015-12-07

Cavitation events seeded by microbubbles have been previously reported to be associated with MR- or fluorescent-contrast enhancement after focused ultrasound (FUS)-induced blood-brain barrier (BBB) opening. However, it is still unknown whether bubble activity can be correlated with the reversibility (the duration of opening and the likelihood of safe reinstatement) and the permeability of opened BBB, which is critical for the clinical translation of using passive cavitation detection to monitor, predict and control the opening. In this study, the dependence of acoustic cavitation on the BBB opening duration, permeability coefficient and histological damage occurrence were thus investigated. Transcranial pulsed FUS at 1.5 MHz in the presence of systemically circulating microbubbles was applied in the mouse hippocampi (n  =  60). The stable and inertial cavitation activities were monitored during sonication. Contrast-enhanced MRI was performed immediately after sonication and every 24 h up to 6 d thereafter, to assess BBB opening, brain tissue permeability and potential edema. Histological evaluations were used to assess the occurrence of neurovascular damages. It was found that stable cavitation was well correlated with: (1) the duration of the BBB opening (r(2)  =  0.77); (2) the permeability of the opened BBB (r(2)  =  0.82); (3) the likelihood of safe opening (P  <  0.05, safe opening compared to cases of damage; P  <  0.0001, no opening compared to safe opening). The inertial cavitation dose was correlated with the resulting BBB permeability (r(2)  =  0.72). Stable cavitation was found to be more reliable than inertial cavitation at assessing the BBB opening within the pressure range used in this study. This study demonstrates that the stable cavitation response during BBB opening holds promise for predicting and controlling the restoration and pharmacokinetics of FUS-opened BBB. The stable cavitation response therefore showed great promise in predicting the BBB opening duration, enabling thus control of opening according to the drug circulation time. In addition, avoiding adverse effects in the brain and assessing the pharmacokinetics of the compounds delivered can also be achieved by monitoring and controlling the stable cavitation emissions.

Risk Factors for Open Malleolar Fractures: An Analysis of the National Trauma Data Bank (2007 to 2011).

PubMed

Shibuya, Naohiro; Liu, George T; Davis, Matthew L; Grossman, Jordan P; Jupiter, Daniel C

2016-01-01

A limited number of studies have described the epidemiology of open fractures, and the epidemiology of open ankle fractures is not an exception. Therefore, the risk factors associated with open ankle fractures have not been extensively evaluated. The frequencies and proportions of open ankle fractures among all the recorded malleolar fractures in the US National Trauma Data Bank data set from January 2007 to December 2011 were analyzed. Clinically relevant variables captured in the data set were also used to evaluate the risk factors associated with open ankle fractures, adjusting for other covariates. The entire cohort was further subdivided into "lower" and "higher" energy trauma groups and the same analysis performed for each group separately. We found that a body mass index of >40 kg/m(2) and farm location were risk factors for open ankle fractures and impaired sensorium was protective against open ankle fractures. In the "lower energy" group, male gender, alcohol use, peripheral vascular disease, other injuries, and injury occurring at a farm location were risk factors for open fractures. In the "higher energy" group, female gender, work-related injury, and injury at a farm or industry location demonstrated statistically significantly associations with open fractures. Copyright © 2016 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

Fluid Lavage of Open Wounds (FLOW): A Multicenter, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients with Open Fractures

DTIC Science & Technology

2013-10-01

Multicenter, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients with Open Fractures PRINCIPAL...Solutions and Pressures in Patients with Open Fractures 5b. GRANT NUMBER W81XWH-12-1-0530 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Kyle J. Jeray...important initial step in preventing infection in open fractures . However, there is little clinical evidence as to the best irrigation methods and additives

Clinical Outcomes and Complications of Percutaneous Achilles Repair System Versus Open Technique for Acute Achilles Tendon Ruptures.

PubMed

Hsu, Andrew R; Jones, Carroll P; Cohen, Bruce E; Davis, W Hodges; Ellington, J Kent; Anderson, Robert B

2015-11-01

Limited incision techniques for acute Achilles tendon ruptures have been developed in recent years to improve recovery and reduce postoperative complications compared with traditional open repair. The purpose of this retrospective cohort study was to analyze the clinical outcomes and postoperative complications between acute Achilles tendon ruptures treated using a percutaneous Achilles repair system (PARS [Arthrex, Inc, Naples, FL]) versus open repair and evaluate the overall outcomes for operatively treated Achilles ruptures. Between 2005 and 2014, 270 consecutive cases of operatively treated acute Achilles tendon ruptures were reviewed (101 PARS, 169 open). Patients with Achilles tendinopathy, insertional ruptures, chronic tears, or less than 3-month follow-up were excluded. Operative treatment consisted of a percutaneous technique (PARS) using a 2-cm transverse incision with FiberWire (Arthrex, Inc, Naples, FL) sutures or open repair using a 5- to 8-cm posteromedial incision with FiberWire in a Krackow fashion reinforced with absorbable sutures. Patient demographics were recorded along with medical comorbidities, activity at injury, time from injury to surgery, length of follow-up, return to baseline activities by 5 months, and postoperative complications. The most common activity during injury for both groups was basketball (PARS: 39%, open: 47%). A greater number of patients treated with PARS were able to return to baseline physical activities by 5 months compared with the open group (PARS: 98%, open: 82%; P = .0001). There were no significant differences (P > .05) between groups in rates of rerupture (P = 1.0), sural neuritis (P = .16), wound dehiscence (P = .74), superficial (P = .29) and/or deep infection (P = .29), or reoperation (P = .13). There were no deep vein thromboses (DVTs) or reruptures in either group. In the PARS group, there were no cases of sural neuritis, 3 cases (3%) of superficial wound dehiscence, and 2 reoperations (2%) for superficial foreign-body reaction to FiberWire. In the open group, there were 5 cases (3%) of sural neuritis, 7 cases (4%) of superficial wound dehiscence, 3 cases (2%) of superficial infection, and 3 reoperations (2%) for deep infection. The present study reports the largest single-center series of acute Achilles tendon ruptures in the literature with lower complication rates for operatively treated Achilles ruptures compared with previous reports. The overall complication rate for all operatively treated Achilles ruptures was 8.5% with no reruptures, and most patients (88%) were able to return to baseline activities by 5 months after surgery. There were no significant differences in rates of postoperative complications between PARS and open repair for acute Achilles tendon ruptures. Level III, retrospective cohort study. © The Author(s) 2015.

[Autism Spectrum Disorder in DSM-5 - concept, validity, and reliability, impact on clinical care and future research].

PubMed

Freitag, Christine M

2014-05-01

Autism Spectrum Disorder (ASD) in DSM-5 comprises the former DSM-IV-TR diagnoses of Autistic Disorder, Asperger's Disorder and PDD-nos. The criteria for ASD in DSM-5 were considerably revised from those of ICD-10 and DSM-IV-TR. The present article compares the diagnostic criteria, presents studies on the validity and reliability of ASD, and discusses open questions. It ends with a clinical and research perspective.

The characterization of a full-thickness excision open foot wound model in n5-streptozotocin (STZ)-induced type 2 diabetic rats that mimics diabetic foot ulcer in terms of reduced blood circulation, higher C-reactive protein, elevated inflammation, and reduced cell proliferation.

PubMed

Yu, Caroline Oi-Ling; Leung, Kwok-Sui; Fung, Kwok-Pui; Lam, Francis Fu-Yuen; Ng, Ethel Sau-Kuen; Lau, Kit-Man; Chow, Simon Kwoon-Ho; Cheung, Wing-Hoi

2017-08-05

Delayed foot wound healing is a major complication attributed to hyperglycemia in type 2 diabetes mellitus (DM) patients, and these wounds may develop into foot ulcers. There are at least two types of DM wound models used in rodents to study delayed wound healing. However, clinically relevant animal models are not common. Most models use type 1 DM rodents or wounds created on the back rather than on the foot. An open full-thickness excision wound on the footpad of type 2 DM rats is more clinically relevant, but such a model has not yet been characterized systematically. The objective of this study was to investigate and characterize how DM affected a full-thickness excision open foot wound in n5-streptozotocin (n5-STZ)-induced type 2 DM rats. We hypothesized that elevated inflammation, reduced blood circulation, and cell proliferation due to hyperglycemia could delay the wound healing of DM rats. The wounds of DM rats were compared with those of non-DM rats (Ctrl) at Days 1 and 8 post wounding. The wound healing process of the DM rats was significantly delayed compared with that of the Ctrl rats. The DM rats also had higher C-reactive protein (CRP) and lower blood circulation and proliferating cell nuclear antigen (PCNA) in DM wounds. This confirmed that elevated inflammation and reduced blood flow and cell proliferation delayed foot wound healing in the n5-STZ rats. Hence, this open foot wound animal model provides a good approach to study the process of delayed wound healing.

Peri-operative comparison between daVinci-assisted radical prostatectomy and open radical prostatectomy in obese patients

NASA Astrophysics Data System (ADS)

Le, Carter Q.; Ho, Khai-Linh V.; Slezak, Jeffrey M.; Blute, Michael L.; Gettman, Matthew T.

2007-02-01

Introduction: While the effects of increasing body mass index on prostate cancer epidemiology and surgical approach have recently been studied, its effects on surgical outcomes are less clear. We studied the perioperative outcomes of obese (BMI >= 30) men treated with daVinci-assisted laparoscopic radical prostatectomy (DLP) and compared them to those treated with open radical retropubic prostatectomy (RRP) in a contemporary time frame. Method: After Institutional Review Board approval, we used the Mayo Clinic Radical Prostatectomy database to identify patients who had undergone DLP by a single surgeon and those who had undergone open RRP by a single surgeon between December 2002 and March 2005. Baseline demographics, peri- and post-operative courses, and complications were collected by retrospective chart review, and variables from the two cohorts compared using chi-square method and least-squares method of linear regression where appropriate. Results: 59 patients who had DLP and 76 undergoing RRP were available for study. Baseline demographics were not statistically different between the two cohorts. Although DLP had a significantly lower clinical stage than RRP (p=0.02), pathological stage was not statistically different (p=0.10). Transfusion rates, hospital stay, overall complications, and pathological Gleason were also not significantly different, nor were PSA progression, positive margin rate, or continence at 1 year. After bilateral nerve-sparing, erections suitable for intercourse with or without therapy at 1 year was 88.5% (23/26) for DLP and 61.2% (30/49) for RRP (p=0.01). Follow-up time was similar. Conclusion: For obese patients, DLP appears to have similar perioperative, as well as short-term oncologic and functional outcomes when compared to open RRP.

Clinical feasibility of pre-operative neurodevelopmental assessment of infants undergoing open heart surgery.

PubMed

Campbell, Miranda; Rabbidge, Bridgette; Ziviani, Jenny; Sakzewski, Leanne

2017-08-01

Assessing the neurodevelopmental status of infants with congenital heart disease before surgery provides a means of identifying those at heightened risk of developmental delay. This study aimed to investigate factors impacting clinical feasibility of pre-operative neurodevelopmental assessment of infants undergoing early open heart surgery. Infants who underwent open heart surgery prior to 4 months of age participated in this cross-sectional study. The Test of Infant Motor Performance and Prechtl's Assessment of General Movements were undertaken on infants pre-operatively. When assessments could not be undertaken, reasons were ascribed to either infant or environmental circumstances. Demographic data and Aristotle scores were compared between groups of infants who did or did not undergo assessment. Binary logistic regression was used to explore associations. A total of 60 infants participated in the study. Median gestational age was 38.78 weeks (interquartile range: 36.93-39.72). Of these infants, 37 (62%) were unable to undergo pre-operative assessment. Twenty-four (40%) could not complete assessment due to infant-related factors and 13 (22%) due to environmental-related factors. For every point increase in the Aristotle Patient-Adjusted Complexity score, the infants likelihood of being unable to undergo assessment increased by 35% (odds ratio: 0.35; 95% confidence interval: 1.03-1.77, P = 0.03). Over half of the infants undergoing open heart surgery were unable to complete pre-operative neurodevelopmental assessment. The primary reason for this was infant-related medical instability. Findings suggest further research is warranted to investigate whether the Aristotle Patient-Adjusted Complexity score might serve as an indicator to inform developmental surveillance with this medically fragile cohort. © 2017 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

The characterization of a full-thickness excision open foot wound model in n5-streptozotocin (STZ)-induced type 2 diabetic rats that mimics diabetic foot ulcer in terms of reduced blood circulation, higher C-reactive protein, elevated inflammation, and reduced cell proliferation

PubMed Central

Yu, Caroline Oi-Ling; Leung, Kwok-Sui; Fung, Kwok-Pui; Lam, Francis Fu-Yuen; Ng, Ethel Sau-Kuen; Lau, Kit-Man; Chow, Simon Kwoon-Ho; Cheung, Wing-Hoi

2017-01-01

Delayed foot wound healing is a major complication attributed to hyperglycemia in type 2 diabetes mellitus (DM) patients, and these wounds may develop into foot ulcers. There are at least two types of DM wound models used in rodents to study delayed wound healing. However, clinically relevant animal models are not common. Most models use type 1 DM rodents or wounds created on the back rather than on the foot. An open full-thickness excision wound on the footpad of type 2 DM rats is more clinically relevant, but such a model has not yet been characterized systematically. The objective of this study was to investigate and characterize how DM affected a full-thickness excision open foot wound in n5-streptozotocin (n5-STZ)-induced type 2 DM rats. We hypothesized that elevated inflammation, reduced blood circulation, and cell proliferation due to hyperglycemia could delay the wound healing of DM rats. The wounds of DM rats were compared with those of non-DM rats (Ctrl) at Days 1 and 8 post wounding. The wound healing process of the DM rats was significantly delayed compared with that of the Ctrl rats. The DM rats also had higher C-reactive protein (CRP) and lower blood circulation and proliferating cell nuclear antigen (PCNA) in DM wounds. This confirmed that elevated inflammation and reduced blood flow and cell proliferation delayed foot wound healing in the n5-STZ rats. Hence, this open foot wound animal model provides a good approach to study the process of delayed wound healing. PMID:28413186

Integrated Community Strategies for Linking Youth to Adolescent Reproductive Health Services: A Case Study.

PubMed

Sotolongo, Joy; House, L Duane; Swanson, Sally; Davis, Sarah E H

2017-03-01

This article describes the development and promotion of a full-service adolescent health center at a local health department intended to increase teen access to contraceptive and reproductive health care. This work was conducted as part of a multicomponent, community-based teen pregnancy prevention initiative in Gaston County, North Carolina. To increase access to adolescent reproductive health services, we implemented multiple integrated strategies: (1) building community support for adolescent reproductive health services; (2) providing technical assistance to the health department in opening the Teen Wellness Center (TWC), a teen-centered, full-service clinic; (3) strengthening referral partnerships between community organizations and clinical services; and (4) educating teens on how to access reproductive health services. Data were collected to examine the change in the number of adolescent reproductive health clients after the opening of the TWC. In the first year, the TWC was opened, 1,675 adolescent clients received reproductive health services, for a 12.5% increase compared with the prior year. The number of adolescent clients who received more than one type of reproductive health services (e.g., wellness visit and family planning services) increased by 133%. The number of adolescent clients who received family planning services increased by 3.8%. The project achieved an increase in adolescent reproductive health clients. Establishment of a teen-centered, full-service clinic and working with youth-serving agencies to increase knowledge of the clinic's services are promising approaches to increasing teen access to reproductive health care. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Randomized, placebo-controlled trial of low molecular weight heparin in active ulcerative colitis.

PubMed

de Bièvre, M A; Vrij, A A; Schoon, E J; Dijkstra, G; de Jong, A E; Oberndorff-Klein Woolthuis, A H; Hemker, H C; Stockbrügger, R W

2007-06-01

In several open and 1 controlled trial, unfractionated heparin was effective in the treatment of active ulcerative colitis (UC). Low molecular weight heparin (LMWH) had a similar effect in several open studies. We studied the efficacy, safety, and tolerability of LMWH in mild to moderately active UC in a randomized, double-blind, placebo-controlled trial. In all, 29 patients with a mild or moderate recurrence of UC during salicylate treatment were randomized to receive either reviparin 3,436 IU (n = 15) subcutaneously twice daily or placebo (n = 14). The study period was 8 weeks. Treatment was discontinued if there was no improvement at 4 weeks or at any disease progression. Primary outcome measure was clinical improvement at 8 weeks measured by the Colitis Activity Index (CAI) and the Clinical Symptoms Grading (CSG, based on the CAI). Endoscopic and histologic grading and quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) were secondary outcome measures. Patients were closely monitored for adverse events. Twenty of 29 patients finished the 8-week treatment period (reviparin versus placebo: 11 versus 9; P = 0.70). There was no difference in CSG, CAI, endoscopic and histologic grading, or IBDQ. Treatment was well tolerated and no serious adverse events occurred. In this study, treatment with LMWH showed no significant clinical advantage compared to placebo in mild to moderately active UC.

Long-term safety and effectiveness of brexpiprazole in Japanese patients with schizophrenia: A 52-week, open-label study.

PubMed

Ishigooka, Jun; Iwashita, Shuichi; Tadori, Yoshihiro

2018-06-01

This study assessed the long-term safety, tolerability, and maintenance of the therapeutic effect of brexpiprazole in Japanese patients with schizophrenia. This 52-week, open-label, flexible-dose (1-4 mg/day) study included patients with schizophrenia who continued treatment from a short-term randomized placebo-controlled fixed-dose (1, 2, or 4 mg/day) trial and de novo patients who switched from other antipsychotics. A total of 282 patients (184 de novo and 98 rolled over from short-term trial) entered the 52-week treatment with brexpiprazole, and 150 (53.2%) patients completed the week-52 assessment. Treatment-emergent adverse events (TEAE) were experienced by 235/281 patients (83.6%), and TEAE reported by ≥10% of all patients were nasopharyngitis (23.1%) and worsening of schizophrenia (22.4%). During the study, most of the TEAE were mild or moderate in severity, and there were no deaths, and no clinically meaningful mean changes in laboratory values, vital signs, or electrocardiogram parameters. Mean scores for the Positive and Negative Syndrome Scale total and Clinical Global Impression-Severity remained stable until week 52. Brexpiprazole was generally safe and well tolerated and maintained therapeutic effects in the long-term treatment of Japanese patients with schizophrenia. © 2018 The Authors. Psychiatry and Clinical Neurosciences © 2018 Japanese Society of Psychiatry and Neurology.

Cannabis (medical marijuana) treatment for motor and non-motor symptoms of Parkinson disease: an open-label observational study.

PubMed

Lotan, Itay; Treves, Therese A; Roditi, Yaniv; Djaldetti, Ruth

2014-01-01

The use of cannabis as a therapeutic agent for various medical conditions has been well documented. However, clinical trials in patients with Parkinson disease (PD) have yielded conflicting results. The aim of the present open-label observational study was to assess the clinical effect of cannabis on motor and non-motor symptoms of PD. Twenty-two patients with PD attending the motor disorder clinic of a tertiary medical center in 2011 to 2012 were evaluated at baseline and 30 minutes after smoking cannabis using the following battery: Unified Parkinson Disease Rating Scale, visual analog scale, present pain intensity scale, Short-Form McGill Pain Questionnaire, as well as Medical Cannabis Survey National Drug and Alcohol Research Center Questionnaire. Mean (SD) total score on the motor Unified Parkinson Disease Rating Scale score improved significantly from 33.1 (13.8) at baseline to 23.2 (10.5) after cannabis consumption (t = 5.9; P < 0.001). Analysis of specific motor symptoms revealed significant improvement after treatment in tremor (P < 0.001), rigidity (P = 0.004), and bradykinesia (P < 0.001). There was also significant improvement of sleep and pain scores. No significant adverse effects of the drug were observed. The study suggests that cannabis might have a place in the therapeutic armamentarium of PD. Larger, controlled studies are needed to verify the results.

Mini-open anterior instrumentation with diaphragm sparing for thoracolumbar idiopathic scoliosis: its technique and clinical results

PubMed Central

Zhu, Feng; Wang, Bin; Zhu, Zezhang; Yu, Yang; Sun, Xu; Ma, Weiwei

2010-01-01

The traditional method of thoracoabdominal retroperitoneal approach requires dissection of diaphragm which bears potential complications such as postoperatively weakened abdominal breathing and dysfunction of diaphragm. Mini-open anterior instrumentation with diaphragm sparing is designed to minimize the damage to diaphragm and improve cosmesis. This study compared the traditional anterior instrumentation and mini-open anterior instrumentation under the hypothesis that both results in similar surgical outcomes in treating thoracolumbar scoliosis. In Group A, 38 patients with an average age of 16.5 years underwent mini-open anterior instrumentation with diaphragm sparing. The average standing coronal Cobb angle was 56.4° in Group A. Thirty-eight patients with average age of 16.7 years in Group B received traditional open approach. The preoperative average Cobb angle was 55.8° in Group B. The average correction rate of coronal curve was 78% in group A while 75% in group B. No statistical difference between the two groups in terms of coronal curve correction, sagittal profile restoration and estimated blood loss was observed. The operation time was significantly higher in Group A than that in Group B. All patients in the two groups had good healing of incisions without neurological and instrumental complications during minimal 2 year follow-up. In Groups A and B, two patients suffered from pleural effusion, respectively. The wedging of the vertebral discs distal to the lowest fused level occurred in three and four patients in Group A and B, respectively. One case in group B was found to be suspicious pseudoarthrosis without loss of correction. Mini-open anterior instrumentation with diaphragm sparing could minimize the surgical invasion as well as achieve similar clinical outcomes compared with classical anterior approach. PMID:21181213

Multicenter, open-label, exploratory clinical trial with Rhodiola rosea extract in patients suffering from burnout symptoms

PubMed Central

Kasper, Siegfried; Dienel, Angelika

2017-01-01

Purpose This study is the first clinical trial aiming to explore the clinical outcomes in burnout patients treated with Rhodiola rosea. The reported capacity of R. rosea to strengthen the organism against stress and its good tolerability offer a promising approach in the treatment of stress-related burnout. The aim of the treatment was to increase stress resistance, thus addressing the source rather than the symptoms of the syndrome and preventing subsequent diseases associated with a history of burnout. The objective of the trial was to provide the exploratory data required for planning future randomized trials in burnout patients in order to investigate the clinical outcomes of treatment with R. rosea dry extract in this target group. Methods The study was planned as an exploratory, open-label, multicenter, single-arm trial. A wide range of rating scales were assessed and evaluated in an exploratory data analysis to generate hypotheses regarding clinical courses and to provide a basis for the planning of subsequent studies. A total of 118 outpatients were enrolled. A daily dose of 400 mg R. rosea extract (WS® 1375, Rosalin) was administered over 12 weeks. Clinical outcomes were assessed by the German version of the Maslach Burnout Inventory, Burnout Screening Scales I and II, Sheehan Disability Scale, Perceived Stress Questionnaire, Number Connection Test, Multidimensional Mood State Questionnaire, Numerical Analogue Scales for different stress symptoms and impairment of sexual life, Patient Sexual Function Questionnaire, and the Clinical Global Impression Scales. Results The majority of the outcome measures showed clear improvement over time. Several parameters had already improved after 1 week of treatment and continued to improve further up to the end of the study. The incidence of adverse events was low with 0.015 events per observation day. Discussion The trial reported here was the first to investigate clinical outcomes in patients suffering from burnout symptoms when treated with R. rosea. During administration of the study drug over the course of 12 weeks, a wide range of outcome measures associated with the syndrome clearly improved. Conclusion The results presented provide an encouraging basis for clinical trials further investigating the clinical outcomes of R. rosea extract in patients with the burnout syndrome. PMID:28367055

An Open Study of Internet-Based Bibliotherapy with Minimal Therapist Contact via Email for Social Phobia

ERIC Educational Resources Information Center

Carlbring, Per; Furmark, Tomas; Steczko, Johan; Ekselius, Lisa; Andersson, Gerhard

2006-01-01

This study evaluated a 9-week Internet-based self-help program for people suffering from social phobia. After confirming the diagnosis with a structured clinical interview for the "DSM-IV" (SCID) by telephone, 26 participants were treated with a multimodal treatment package based on cognitive behavioural therapy plus weekly therapist…

Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial).

PubMed

van der Sluis, Pieter C; Ruurda, Jelle P; van der Horst, Sylvia; Verhage, Roy J J; Besselink, Marc G H; Prins, Margriet J D; Haverkamp, Leonie; Schippers, Carlo; Rinkes, Inne H M Borel; Joore, Hans C A; Ten Kate, Fiebo Jw; Koffijberg, Hendrik; Kroese, Christiaan C; van Leeuwen, Maarten S; Lolkema, Martijn P J K; Reerink, Onne; Schipper, Marguerite E I; Steenhagen, Elles; Vleggaar, Frank P; Voest, Emile E; Siersema, Peter D; van Hillegersberg, Richard

2012-11-30

For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer. This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥ 18 and ≤ 80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications. This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient. Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790.

Physical examination tests and imaging studies based on arthroscopic assessment of the long head of biceps tendon are invalid.

PubMed

Jordan, Robert W; Saithna, Adnan

2017-10-01

The aim of this study was to evaluate whether glenohumeral arthroscopy is an appropriate gold standard for the diagnosis of long head of biceps (LHB) tendon pathology. The objectives were to evaluate whether the length of tendon that can be seen at arthroscopy allows visualisation of areas of predilection of pathology and also to determine the rates of missed diagnoses at arthroscopy when compared to an open approach. A systematic review of cadaveric and clinical studies was performed. The search strategy was applied to MEDLINE, PubMed and Google Scholar databases. All relevant articles were included. Critical appraisal of clinical studies was performed using a validated quality assessment scale. Five articles were identified for inclusion in the review. This included both clinical and cadaveric studies. The overall population comprised 18 cadaveric specimens and 575 patients. Out of the five included studies, three reported the length of LHB tendon visualised during arthroscopy and four reported the rate of missed LHB diagnosis. Cadaveric studies showed that the use of a hook probe allowed arthroscopic visualisation of between 34 and 48 % of the overall length of the LHB. In the clinical series, the rate of missed diagnoses at arthroscopy when compared to open exploration ranged between 33 and 49 %. Arthroscopy allows visualisation of only a small part of the extra-articular LHB tendon. This leads to a high rate of missed pathology in the distal part of the tendon. Published figures for sensitivities and specificities of common physical examination and imaging tests for LHB pathology that are based on arthroscopy as the gold standard are therefore invalid. In clinical practice, it is important to note that a "negative" arthroscopic assessment does not exclude a lesion of the LHB tendon as this technique does not allow visualisation of common sites of distal pathology. IV.

Urate levels predict survival in amyotrophic lateral sclerosis: Analysis of the expanded Pooled Resource Open-Access ALS clinical trials database.

PubMed

Paganoni, Sabrina; Nicholson, Katharine; Chan, James; Shui, Amy; Schoenfeld, David; Sherman, Alexander; Berry, James; Cudkowicz, Merit; Atassi, Nazem

2018-03-01

Urate has been identified as a predictor of amyotrophic lateral sclerosis (ALS) survival in some but not all studies. Here we leverage the recent expansion of the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database to study the association between urate levels and ALS survival. Pooled data of 1,736 ALS participants from the PRO-ACT database were analyzed. Cox proportional hazards regression models were used to evaluate associations between urate levels at trial entry and survival. After adjustment for potential confounders (i.e., creatinine and body mass index), there was an 11% reduction in risk of reaching a survival endpoint during the study with each 1-mg/dL increase in uric acid levels (adjusted hazard ratio 0.89, 95% confidence interval 0.82-0.97, P < 0.01). Our pooled analysis provides further support for urate as a prognostic factor for survival in ALS and confirms the utility of the PRO-ACT database as a powerful resource for ALS epidemiological research. Muscle Nerve 57: 430-434, 2018. © 2017 Wiley Periodicals, Inc.

A Survey of Established Veterinary Clinical Skills Laboratories from Europe and North America: Present Practices and Recent Developments.

PubMed

Dilly, Marc; Read, Emma K; Baillie, Sarah

Developing competence in clinical skills is important if graduates are to provide entry-level care, but it is dependent on having had sufficient hands-on practice. Clinical skills laboratories provide opportunities for students to learn on simulators and models in a safe environment and to supplement training with animals. Interest in facilities for developing veterinary clinical skills has increased in recent years as many veterinary colleges face challenges in training their students with traditional methods alone. For the present study, we designed a survey to gather information from established veterinary clinical skills laboratories with the aim of assisting others considering opening or expanding their own facility. Data were collated from 16 veterinary colleges in North America and Europe about the uses of their laboratory, the building and associated facilities, and the staffing, budgets, equipment, and supporting learning resources. The findings indicated that having a dedicated veterinary clinical skills laboratory is a relatively new initiative and that colleges have adopted a range of approaches to implementing and running the laboratory, teaching, and assessments. Major strengths were the motivation and positive characteristics of the staff involved, providing open access and supporting self-directed learning. However, respondents widely recognized the increasing demands placed on the facility to provide more space, equipment, and staff. There is no doubt that veterinary clinical skills laboratories are on the increase and provide opportunities to enhance student learning, complement traditional training, and benefit animal welfare.

Periadventitial drug delivery for the prevention of intimal hyperplasia following open surgery.

PubMed

Chaudhary, Mirnal A; Guo, Lian-Wang; Shi, Xudong; Chen, Guojun; Gong, Shaoqin; Liu, Bo; Kent, K Craig

2016-07-10

Intimal hyperplasia (IH) remains a major cause of poor patient outcomes after surgical revascularization to treat atherosclerosis. A multitude of drugs have been shown to prevent the development of IH. Moreover, endovascular drug delivery following angioplasty and stenting has been achieved with a marked diminution in the incidence of restenosis. Despite advances in endovascular drug delivery, there is currently no clinically available method of periadventitial drug delivery suitable for open vascular reconstructions. Herein we provide an overview of the recent literature regarding innovative polymer platforms for periadventitial drug delivery in preclinical models of IH as well as insights about barriers to clinical translation. A comprehensive PubMed search confined to the past 15years was performed for studies of periadventitial drug delivery. Additional searches were performed for relevant clinical trials, patents, meeting abstracts, and awards of NIH funding. Most of the research involving direct periadventitial delivery without a drug carrier was published prior to 2000. Over the past 15years there have been a surge of reports utilizing periadventitial drug-releasing polymer platforms, most commonly bioresorbable hydrogels and wraps. These methods proved to be effective for the inhibition of IH in various animal models (e.g. balloon angioplasty, wire injury, and vein graft), but very few have advanced to clinical trials. There are a number of barriers that may account for this lack of translation. Promising new approaches including the use of nanoparticles will be described. No periadventitial drug delivery system has reached clinical application. For periadventitial delivery, polymer hydrogels, wraps, and nanoparticles exhibit overlapping and complementary properties. The ideal periadventitial delivery platform would allow for sustained drug release yet exert minimal mechanical and inflammatory stresses to the vessel wall. A clinically applicable strategy for periadventitial drug delivery would benefit thousands of patients undergoing open vascular reconstruction each year. Copyright © 2016 Elsevier B.V. All rights reserved.

Normalization and standardization of electronic health records for high-throughput phenotyping: the SHARPn consortium

PubMed Central

Pathak, Jyotishman; Bailey, Kent R; Beebe, Calvin E; Bethard, Steven; Carrell, David S; Chen, Pei J; Dligach, Dmitriy; Endle, Cory M; Hart, Lacey A; Haug, Peter J; Huff, Stanley M; Kaggal, Vinod C; Li, Dingcheng; Liu, Hongfang; Marchant, Kyle; Masanz, James; Miller, Timothy; Oniki, Thomas A; Palmer, Martha; Peterson, Kevin J; Rea, Susan; Savova, Guergana K; Stancl, Craig R; Sohn, Sunghwan; Solbrig, Harold R; Suesse, Dale B; Tao, Cui; Taylor, David P; Westberg, Les; Wu, Stephen; Zhuo, Ning; Chute, Christopher G

2013-01-01

Research objective To develop scalable informatics infrastructure for normalization of both structured and unstructured electronic health record (EHR) data into a unified, concept-based model for high-throughput phenotype extraction. Materials and methods Software tools and applications were developed to extract information from EHRs. Representative and convenience samples of both structured and unstructured data from two EHR systems—Mayo Clinic and Intermountain Healthcare—were used for development and validation. Extracted information was standardized and normalized to meaningful use (MU) conformant terminology and value set standards using Clinical Element Models (CEMs). These resources were used to demonstrate semi-automatic execution of MU clinical-quality measures modeled using the Quality Data Model (QDM) and an open-source rules engine. Results Using CEMs and open-source natural language processing and terminology services engines—namely, Apache clinical Text Analysis and Knowledge Extraction System (cTAKES) and Common Terminology Services (CTS2)—we developed a data-normalization platform that ensures data security, end-to-end connectivity, and reliable data flow within and across institutions. We demonstrated the applicability of this platform by executing a QDM-based MU quality measure that determines the percentage of patients between 18 and 75 years with diabetes whose most recent low-density lipoprotein cholesterol test result during the measurement year was <100 mg/dL on a randomly selected cohort of 273 Mayo Clinic patients. The platform identified 21 and 18 patients for the denominator and numerator of the quality measure, respectively. Validation results indicate that all identified patients meet the QDM-based criteria. Conclusions End-to-end automated systems for extracting clinical information from diverse EHR systems require extensive use of standardized vocabularies and terminologies, as well as robust information models for storing, discovering, and processing that information. This study demonstrates the application of modular and open-source resources for enabling secondary use of EHR data through normalization into standards-based, comparable, and consistent format for high-throughput phenotyping to identify patient cohorts. PMID:24190931

Fostering EMA's transparency policy.

PubMed

Banzi, Rita; Bertele', Vittorio; Demotes-Mainard, Jacques; Garattini, Silvio; Gluud, Christian; Kubiak, Christine; Ohmann, Christian

2014-10-01

The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also promote and develop standard practices for data sharing. The release of the EMA draft policy on publication and access to clinical trial data in 2013 has fueled a lively debate among academia, industry, and the public in general that is still ongoing. As clinical researchers and producers and users of clinical trial data, we endorse the European Medicines Agency's opening and offer a few suggestions for complete, safe, and effective data sharing. Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

SemEHR: A general-purpose semantic search system to surface semantic data from clinical notes for tailored care, trial recruitment, and clinical research.

PubMed

Wu, Honghan; Toti, Giulia; Morley, Katherine I; Ibrahim, Zina M; Folarin, Amos; Jackson, Richard; Kartoglu, Ismail; Agrawal, Asha; Stringer, Clive; Gale, Darren; Gorrell, Genevieve; Roberts, Angus; Broadbent, Matthew; Stewart, Robert; Dobson, Richard J B

2018-05-01

Unlocking the data contained within both structured and unstructured components of electronic health records (EHRs) has the potential to provide a step change in data available for secondary research use, generation of actionable medical insights, hospital management, and trial recruitment. To achieve this, we implemented SemEHR, an open source semantic search and analytics tool for EHRs. SemEHR implements a generic information extraction (IE) and retrieval infrastructure by identifying contextualized mentions of a wide range of biomedical concepts within EHRs. Natural language processing annotations are further assembled at the patient level and extended with EHR-specific knowledge to generate a timeline for each patient. The semantic data are serviced via ontology-based search and analytics interfaces. SemEHR has been deployed at a number of UK hospitals, including the Clinical Record Interactive Search, an anonymized replica of the EHR of the UK South London and Maudsley National Health Service Foundation Trust, one of Europe's largest providers of mental health services. In 2 Clinical Record Interactive Search-based studies, SemEHR achieved 93% (hepatitis C) and 99% (HIV) F-measure results in identifying true positive patients. At King's College Hospital in London, as part of the CogStack program (github.com/cogstack), SemEHR is being used to recruit patients into the UK Department of Health 100 000 Genomes Project (genomicsengland.co.uk). The validation study suggests that the tool can validate previously recruited cases and is very fast at searching phenotypes; time for recruitment criteria checking was reduced from days to minutes. Validated on open intensive care EHR data, Medical Information Mart for Intensive Care III, the vital signs extracted by SemEHR can achieve around 97% accuracy. Results from the multiple case studies demonstrate SemEHR's efficiency: weeks or months of work can be done within hours or minutes in some cases. SemEHR provides a more comprehensive view of patients, bringing in more and unexpected insight compared to study-oriented bespoke IE systems. SemEHR is open source, available at https://github.com/CogStack/SemEHR.

Safety and Efficacy of Bupropion Extended Release in Treating a Community Sample of Hispanic and African American Adults With Major Depressive Disorder: An Open-Label Study

PubMed Central

Gross, Paul K.; Nourse, Rosemary; Wasser, Thomas E.; Bukenya, Deo

2007-01-01

Objectives: Many publications and federal agencies call for more trials and research on the effectiveness of medications and treatment needs in diverse patient populations with psychiatric disorders. This study investigates the effectiveness of bupropion extended release (XL) on a community sample of men and women of either Hispanic or African American heritage with major depressive disorder (MDD). Method: Twenty-six patients of Hispanic or African American descent with MDD as diagnosed by means of the Structured Clinical Interview for DSM-IV Axis I Disorders were required to have a score of 20 or greater on the Hamilton Rating Scale for Depression (17-item) (HAM-D-17) at baseline and prior to randomization. Patients were also required to have a score of 4 or greater on the Clinical Global Impressions-Severity of Illness scale (CGI-S) at baseline and prior to initiation of treatment. Patients were treated openly for an optimum of 9 weeks. Bupropion XL was initiated at 150 mg daily and then increased to 300 mg daily after 1 week and 450 mg daily 4 weeks later if judged clinically necessary by the investigator. Tools utilized for repeated-measures methodology indicating efficacy were the HAM-D-17, CGI-S, Clinical Global Impressions-Improvement scale (CGI-I), Change in Sexual Functioning Questionnaire (CSFQ), and the 18-item Motivation and Energy Inventory. The study was conducted from February 9, 2005, to March 23, 2006. Results: Efficacy was demonstrated on the HAM-D-17, CGI-S, CGI-I, and CSFQ (p < .05). Mean times ranged from 50% symptom reduction in about 2 weeks to 90% symptom reduction in less than 2 months. Dry mouth, transient stomach discomfort, and headache were the most commonly reported side effects. Conclusions: Data from this 10-week open-label study suggest bupropion XL is an effective and well tolerated treatment for depressive symptoms in the moderately to markedly ill Hispanic and African American community. PMID:17607332

Studying the effect of clinical uncertainty on physicians' decision-making using ILIAD.

PubMed

Anderson, J D; Jay, S J; Weng, H C; Anderson, M M

1995-01-01

The influence of uncertainty on physicians' practice behavior is not well understood. In this research, ILIAD, a diagnostic expert system, has been used to study physicians' responses to uncertainty and how their responses affected clinical performance. The simulation mode of ILIAD was used to standardize the presentation and scoring of two cases to 46 residents in emergency medicine, internal medicine, family practice and transitional medicine at Methodist Hospital of Indiana. A questionnaire was used to collect additional data on how physicians respond to clinical uncertainty. A structural equation model was developed, estimated, and tested. The results indicate that stress that physicians experience in dealing with clinical uncertainty has a negative effect on their clinical performance. Moreover, the way that physicians respond to uncertainty has positive and negative effects on their performance. Open discussions with patients about clinical decisions and the use of practice guidelines improves performance. However, when the physician's clinical decisions are influenced by patient demands or their peers, their performance scores decline.

The Advanced Glaucoma Intervention Study (AGIS): 3. Baseline characteristics of black and white patients.

PubMed

1998-07-01

The purpose of this report is to examine the differences at baseline in demographic, medical, and ophthalmic characteristics between blacks and whites enrolled in the Advanced Glaucoma Intervention Study (AGIS), a multicenter, randomized, clinical trial. Multicenter, randomized, controlled trial. A total of 332 black patients (451 eyes), 249 white patients (325 eyes), and 10 patients of other races (13 eyes) with open-angle glaucoma that could not be controlled by medical therapy alone participated. There was no intervention performed. The investigators compare the baseline demographic, medical, and ophthalmic characteristics of black and white patients, adjusting the comparisons for age and gender. Blacks in the study were younger than whites and had more systemic hypertension and diabetes than whites. The visual field defects of blacks on average were substantially more severe than those of whites. Intraocular pressures and visual acuity scores were similar in the two groups. Blacks were more hyperopic and had relatively fewer disk rim hemorrhages than whites. The findings of the current study concur with those of previous clinical studies of open-angle glaucoma that visual field defects are more severe in blacks than whites.

Surgical treatment of open pilon fractures.

PubMed

Zeng, Xian-tie; Pang, Gui-gen; Ma, Bao-tong; Mei, Xiao-long; Sun, Xiang; Wang, Jia; Jia, Peng

2011-02-01

To discuss the methods, timing and clinical outcomes of surgical treatment for open pilon fractures. From April 2003 to July 2008, 28 patients with open pilon fractures were treated. All had type C fractures according to the Arbeitsgemeinschaft für osteosynthesefragen-Association for the Study of Internal Fixation (AO/ASIF) classification. Three operative methods were applied, the methods being determined by the types of fracture, soft tissue damage and time interval after injury. Seven cases were treated by debridement and internal fixation with plate; 19 by limited internal fixation combined with external fixation; and 2 by delayed surgery. The clinical outcomes were evaluated by the Burwell-Charnley score. All cases were followed up for from 6 to 48 months (average 24 months). The Burwell-Charnley score of clinical outcomes: anatomic reduction achieved in 12 cases, functional reduction in 15, and unsatisfactory reduction in 1. The healing time was from 2.5 to 11 months (average 4.7 months). Two cases had delayed union. According to the American Orthopaedic Foot and Ankle Society (AOFAS) scale for the ankle joint, there were excellent results in 8 cases, good in 14, fair in 5 and poor in 1. Complications included four cases of skin superficial sloughing, two of superficial infection, one of deep infection, two of delayed fracture union and ten of post-traumatic arthritis. It is important to perform appropriate surgeries for open pilon fracture according to fracture classification, different damage to skin and tissue and time interval after injury. Thorough debridement, proper use of anti-infective medication, appropriate bone grafting, and postoperative ankle function exercise can reduce the occurrence of complications. © 2011 Tianjin Hospital and Blackwell Publishing Asia Pty Ltd.

Behavioral and locomotor measurements using an open field activity monitoring system for skeletal muscle diseases.

PubMed

Tatem, Kathleen S; Quinn, James L; Phadke, Aditi; Yu, Qing; Gordish-Dressman, Heather; Nagaraju, Kanneboyina

2014-09-29

The open field activity monitoring system comprehensively assesses locomotor and behavioral activity levels of mice. It is a useful tool for assessing locomotive impairment in animal models of neuromuscular disease and efficacy of therapeutic drugs that may improve locomotion and/or muscle function. The open field activity measurement provides a different measure than muscle strength, which is commonly assessed by grip strength measurements. It can also show how drugs may affect other body systems as well when used with additional outcome measures. In addition, measures such as total distance traveled mirror the 6 min walk test, a clinical trial outcome measure. However, open field activity monitoring is also associated with significant challenges: Open field activity measurements vary according to animal strain, age, sex, and circadian rhythm. In addition, room temperature, humidity, lighting, noise, and even odor can affect assessment outcomes. Overall, this manuscript provides a well-tested and standardized open field activity SOP for preclinical trials in animal models of neuromuscular diseases. We provide a discussion of important considerations, typical results, data analysis, and detail the strengths and weaknesses of open field testing. In addition, we provide recommendations for optimal study design when using open field activity in a preclinical trial.

Open for business: a comparative study of websites selling autologous stem cells in Australia and Japan.

PubMed

Munsie, Megan; Lysaght, Tamra; Hendl, Tereza; Tan, Hui-Yin Lynn; Kerridge, Ian; Stewart, Cameron

2017-11-10

This article examines online marketing practices of Japanese and Australian clinics offering putative autologous stem cell treatments. We conducted google searches for keywords related to stem cell therapy and stem cell clinics in English and Japanese. We identified websites promoting 88 point-of-sale clinics in Japan and 70 in Australia. Our findings provide further evidence of the rapid global growth in clinics offering unproven stem cell interventions. We also show that these clinics adopt strategies to promote their services as though they are consistent with evidentiary and ethical standards of science, research and medicine. Unless addressed, these practices risk harming not only vulnerable patients but also undermining public trust in science and medicine.

Optimal optic nerve sheath diameter threshold for the identification of elevated opening pressure on lumbar puncture in a Chinese population.

PubMed

Wang, Lijuan; Feng, Liangshu; Yao, Yan; Wang, Yuzhi; Chen, Ying; Feng, Jiachun; Xing, Yingqi

2015-01-01

Ultrasonography of the optic nerve sheath diameter (ONSD) is a non-invasive and rapid method that might be helpful in the identification of increased intracranial pressure (ICP). The use of an ONSD greater than 5 mm on ultrasound as an indicator of increased ICP in a Caucasian population has been studied. However, the cut-off point of this predictor in Chinese patients has not been established. Thus, we conducted this study to identify the ONSD criterion for the detection of elevated opening pressure on lumbar puncture (LP) in a Chinese population and to investigate the influencing factors. This study was a blind cross-sectional study. Patients who presented with suspected increased ICP were included. The opening pressure on LP of each participant was confirmed. We analyzed the clinical differences between the groups of patients with abnormal and normal opening pressures on LP. A receiver operating characteristic curve was constructed to determine the ONSD cut-off point for the identification of abnormal opening pressure on LP. In total, 279 patients were recruited, and 101 patients presented with elevated opening pressure on LP. ONSD was a significant independent predictor of elevated opening pressure on LP (p<0.001). However, no statistical significance was observed regarding the factors that might have affected this relationship including gender, age, body mass index, waistline, head circumference, hypertension and pathological subtype. The ONSD cut-off point for the identification of elevated opening pressure on LP was 4.1 mm; this cut-off yielded a sensitivity of 95% and a specificity of 92%. ONSD is a strong and accurate predictor of elevated opening pressure on LP. The cut-off point of this predictor in a Chinese population was remarkably lower than that found in a Caucasian population. Thus, ethnic differences should be noted when using the ONSD as an indicator of increased ICP.

The KATP channel in migraine pathophysiology: a novel therapeutic target for migraine.

PubMed

Al-Karagholi, Mohammad Al-Mahdi; Hansen, Jakob Møller; Severinsen, Johanne; Jansen-Olesen, Inger; Ashina, Messoud

2017-08-23

To review the distribution and function of K ATP channels, describe the use of K ATP channels openers in clinical trials and make the case that these channels may play a role in headache and migraine. K ATP channels are widely present in the trigeminovascular system and play an important role in the regulation of tone in cerebral and meningeal arteries. Clinical trials using synthetic K ATP channel openers report headache as a prevalent-side effect in non-migraine sufferers, indicating that K ATP channel opening may cause headache, possibly due to vascular mechanisms. Whether K ATP channel openers can provoke migraine in migraine sufferers is not known. We suggest that K ATP channels may play an important role in migraine pathogenesis and could be a potential novel therapeutic anti-migraine target.

Ventricular shunt tap as a predictor of proximal shunt malfunction in children: a prospective study.

PubMed

Rocque, Brandon G; Lapsiwala, Samir; Iskandar, Bermans J

2008-06-01

The clinical diagnosis of cerebrospinal fluid (CSF) shunt malfunction can be challenging. In this prospective study, the authors evaluated a common method of interrogating shunts: the shunt tap; specifically, its ability to predict proximal malfunction. The authors performed standardized shunt taps in a consecutive series of cases involving children with suspected or proven shunt malfunction, assessing flow and, when possible, opening pressure. Data were collected prospectively, and results analyzed in light of surgical findings. A shunt tap was performed prior to 68 operative explorations in 51 patients. Of the 68 taps, 28 yielded poor or no CSF flow on aspiration. After 26 of these 28 procedures, proximal catheter obstruction was identified. After 28 taps with good CSF return and normal or low opening pressure, 18 shunts were found to have a proximal obstruction, 8 had no obstruction, and 2 had a distal obstruction. Another 12 taps with good CSF flow had high opening pressure; subsequent surgery showed distal obstruction in 11 of the shunts, and proximal obstruction in 1. The positive predictive value of poor flow was 93%, while good flow on shunt tap predicted adequate proximal catheter function in only 55% of cases. Poor flow of CSF on shunt tap is highly predictive of obstruction of the proximal catheter. Because not all patients with good flow on shunt tap underwent surgical shunt exploration, the specificity of this test cannot be determined. Nonetheless, a shunt tap that reveals good flow with a normal opening pressure can be misleading, and management of such cases should be based on clinical judgment.

Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration – Methodology and Case Study

PubMed Central

da Silva, Kátia Regina; Costa, Roberto; Crevelari, Elizabeth Sartori; Lacerda, Marianna Sobral; de Moraes Albertini, Caio Marcos; Filho, Martino Martinelli; Santana, José Eduardo; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo; Barros, Jacson V.

2013-01-01

Background The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. Purpose Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. Methods and Results We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. Conclusion This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries. PMID:23936257

ImTK: an open source multi-center information management toolkit

NASA Astrophysics Data System (ADS)

Alaoui, Adil; Ingeholm, Mary Lou; Padh, Shilpa; Dorobantu, Mihai; Desai, Mihir; Cleary, Kevin; Mun, Seong K.

2008-03-01

The Information Management Toolkit (ImTK) Consortium is an open source initiative to develop robust, freely available tools related to the information management needs of basic, clinical, and translational research. An open source framework and agile programming methodology can enable distributed software development while an open architecture will encourage interoperability across different environments. The ISIS Center has conceptualized a prototype data sharing network that simulates a multi-center environment based on a federated data access model. This model includes the development of software tools to enable efficient exchange, sharing, management, and analysis of multimedia medical information such as clinical information, images, and bioinformatics data from multiple data sources. The envisioned ImTK data environment will include an open architecture and data model implementation that complies with existing standards such as Digital Imaging and Communications (DICOM), Health Level 7 (HL7), and the technical framework and workflow defined by the Integrating the Healthcare Enterprise (IHE) Information Technology Infrastructure initiative, mainly the Cross Enterprise Document Sharing (XDS) specifications.

An approach for the semantic interoperability of ISO EN 13606 and OpenEHR archetypes.

PubMed

Martínez-Costa, Catalina; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás

2010-10-01

The communication between health information systems of hospitals and primary care organizations is currently an important challenge to improve the quality of clinical practice and patient safety. However, clinical information is usually distributed among several independent systems that may be syntactically or semantically incompatible. This fact prevents healthcare professionals from accessing clinical information of patients in an understandable and normalized way. In this work, we address the semantic interoperability of two EHR standards: OpenEHR and ISO EN 13606. Both standards follow the dual model approach which distinguishes information and knowledge, this being represented through archetypes. The solution presented here is capable of transforming OpenEHR archetypes into ISO EN 13606 and vice versa by combining Semantic Web and Model-driven Engineering technologies. The resulting software implementation has been tested using publicly available collections of archetypes for both standards.

PhysioNet: physiologic signals, time series and related open source software for basic, clinical, and applied research.

PubMed

Moody, George B; Mark, Roger G; Goldberger, Ary L

2011-01-01

PhysioNet provides free web access to over 50 collections of recorded physiologic signals and time series, and related open-source software, in support of basic, clinical, and applied research in medicine, physiology, public health, biomedical engineering and computing, and medical instrument design and evaluation. Its three components (PhysioBank, the archive of signals; PhysioToolkit, the software library; and PhysioNetWorks, the virtual laboratory for collaborative development of future PhysioBank data collections and PhysioToolkit software components) connect researchers and students who need physiologic signals and relevant software with researchers who have data and software to share. PhysioNet's annual open engineering challenges stimulate rapid progress on unsolved or poorly solved questions of basic or clinical interest, by focusing attention on achievable solutions that can be evaluated and compared objectively using freely available reference data.

[Modularization by the open standard. (I)].

PubMed

Hirano, H

2000-10-01

We are proceeding with the project called "Open LA21 Project" in the course of the clinical laboratory automation toward the 21st century. With the modular system that realizes integration, downsizing, a reasonable price, and is the future course in the clinical testing automation system as well, we aim to establish common standards among manufacturers as the only way to create user friendly market environments where the proper competition exists among the manufacturers. The common standards which are in preparation by the participating companies as "Open module system standards" are the standards which are going to be made public. They are intended to guarantee connection, compatibility of the products in conformity with the standards. In this project, we intend to realize the modular system that integrates each field, such as chemistry, hematology, coagulation/fibrinolysis, immunology, urinalysis in an early stage, and contribute positively to restructuring and upgrading the "raison d'etre" of the 21st century clinical testing.

Clinical Knowledge Governance Framework for Nationwide Data Infrastructure Projects.

PubMed

Wulff, Antje; Haarbrandt, Birger; Marschollek, Michael

2018-01-01

The availability of semantically-enriched and interoperable clinical information models is crucial for reusing once collected data across institutions like aspired in the German HiGHmed project. Funded by the Federal Ministry of Education and Research, this nationwide data infrastructure project adopts the openEHR approach for semantic modelling. Here, strong governance is required to define high-quality and reusable models. Design of a clinical knowledge governance framework for openEHR modelling in cross-institutional settings like HiGHmed. Analysis of successful practices from international projects, published ideas on archetype governance and own modelling experiences as well as modelling of BPMN processes. We designed a framework by presenting archetype variations, roles and responsibilities, IT support and modelling workflows. Our framework has great potential to make the openEHR modelling efforts manageable. Because practical experiences are rare, prospectively our work will be predestinated to evaluate the benefits of such structured governance approaches.

From bench to bedside: An overview of rotigotine for the treatment of restless legs syndrome.

PubMed

Bogan, Richard K

2014-03-01

Restless legs syndrome (RLS) is a common chronic neurologic disorder. Symptoms are most prevalent during the evening and at night, although daytime symptoms may emerge as the disease progresses. Dopamine agonists are currently considered first-line therapy for moderate to severe idiopathic RLS. Most dopamine agonists have short half-lives and are administered in the evening, shortly before the onset of RLS symptoms. Rotigotine is a non-ergot dopamine receptor agonist that has been specifically developed as a transdermal patch to provide continuous drug delivery over a 24-hour period. This review details the development of rotigotine, from the preclinical studies that established its pharmacokinetic profile to large-scale clinical trials in patients with RLS. Placebo-controlled trials that demonstrated the efficacy and tolerability of rotigotine are discussed, in addition to open-label studies that investigated long-term therapy. Studies were identified by a PubMed search using the key word rotigotine in conjunction with restless legs syndrome and by reviewing reference lists of retrieved publications. All clinical trials of rotigotine in RLS published before September 2013 were included. Preclinical studies have established activity of rotigotine as a dopamine receptor agonist, and pharmacokinetic data have shown that transdermal delivery maintains stable plasma levels over 24 hours. Rotigotine has demonstrated efficacy in improving moderate to severe RLS symptoms in randomized, placebo-controlled trials, based on scores on the International RLS Study Group rating scale, the RLS-6 scale, and the Clinical Global Impression-Severity subscale. Results of an open-label extension study suggest that efficacy may be maintained for up to 5 years. A polysomnographic study demonstrated an improvement in periodic limb movement index with rotigotine, and subjective assessments have suggested beneficial effects in terms of amelioration of sleep disturbances. Premature discontinuations from rotigotine treatment have ranged from 8% to 38% in studies of 6 weeks to 12 months in duration; 57% of patients discontinued prematurely during a 5-year study. In each trial, adverse events were typical of dopaminergic stimulation and use of a transdermal patch. The most common adverse events were application-site reactions, with a reported prevalence ranging from 17% (1-month sleep laboratory trial) to 58% (5-year open-label extension study). Clinically significant augmentation was recorded in 39 of 295 patients (13%) receiving rotigotine during the 5-year study, of whom 15 (5%) were receiving a dose within the US Food and Drug Administration-approved range of 1 to 3 mg/24 h. Findings from clinical studies have suggested that rotigotine is efficacious in improving RLS symptoms and is generally well-tolerated. The risk of developing clinically significant augmentation appears to be low. As such, rotigotine represents an important addition for RLS treatment. Copyright © 2014 The Authors. Published by EM Inc USA.. All rights reserved.

Lamina cribrosa position and Bruch's membrane opening differences between anterior ischemic optic neuropathy and open-angle glaucoma.

PubMed

Rebolleda, Gema; Pérez-Sarriegui, Ane; Díez-Álvarez, Laura; De Juan, Victoria; Muñoz-Negrete, Francisco J

2018-06-01

To compare the optic nerve head morphology among primary open-angle glaucoma, non-arteritic anterior ischemic optic neuropathy eyes, their fellow healthy eyes and control eyes, using spectral-domain optical coherence tomography with enhanced depth imaging. Observational cross-sectional study including 88 eyes of 68 patients. In this study, 23 non-arteritic anterior ischemic optic neuropathy eyes, 17 fellow unaffected eyes, 25 primary open-angle glaucoma eyes, and 23 age-matched control eyes were included. Peripapillary retinal nerve fiber layer thickness and optic disk area were evaluated. Bruch's membrane opening diameter, optic cup depth, anterior lamina cribrosa depth, and prelaminar tissue thickness were assessed. Non-arteritic anterior ischemic optic neuropathy and primary open-angle glaucoma eyes had similar visual field mean deviation and peripapillary retinal nerve fiber layer thickness (P = 0.6 and P = 0.56, respectively). Bruch's membrane opening diameter was significantly larger in primary open-angle glaucoma eyes than in control eyes (P = 0.02). Lamina cribrosa and disk cup were deeper in eyes with primary open-angle glaucoma than both control and non-arteritic anterior ischemic optic neuropathy eyes (P < 0.001). Prelaminar tissue thickness was significantly thinner in primary open-angle glaucoma eyes than in non-arteritic anterior ischemic optic neuropathy eyes (P < 0.001). Lamina cribrosa was shallower in both non-arteritic anterior ischemic optic neuropathy and unaffected fellow eyes compared to healthy eyes (P < 0.001 and P = 0.04, respectively). No differences were found in the optic disk area. A forward lamina cribrosa placement and not a smaller disk could be involved in the pathogenesis of non-arteritic anterior ischemic optic neuropathy. A significantly larger Bruch's membrane opening diameter was found in primary open-angle glaucoma eyes compared with control eyes. This issue has clinical implications because Bruch's membrane opening has been considered a stable reference for disk-related measures.

Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data: A case study in haemato-oncology.

PubMed

Kibbelaar, R E; Oortgiesen, B E; van der Wal-Oost, A M; Boslooper, K; Coebergh, J W; Veeger, N J G M; Joosten, P; Storm, H; van Roon, E N; Hoogendoorn, M

2017-11-01

Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aiming at substitution of RCT databases by improved population-based registries (PBRs) or by improved electronic health record (EHR) systems to provide significant data for clinical science are discussed. A novel approach exemplified by the HemoBase haemato-oncology project is presented. In this approach, a PBR is combined with an advanced EHR, providing high-quality data for observational studies and support of best practice development. This PBR + EHR approach opens a perspective on randomised registry trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

ACL reconstruction with hamstring tendon autograft and accelerated brace-free rehabilitation: a systematic review of clinical outcomes

PubMed Central

van Melick, Nicky; van Mourik, Jan B A; Reijman, Max; van Rhijn, Lodewijk W

2018-01-01

Objective To investigate the clinical outcomes after hamstring tendon autograft ACL reconstruction (ACLR) with accelerated, brace-free rehabilitation. Design Systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Data sources Embase, MEDLINE Ovid, Web of Science, Cochrane CENTRAL and Google scholar from 1 January 1974 to 31 January 2017. Eligibility criteria for selecting studies Study designs reporting outcomes in adults after arthroscopic, primary ACLR with hamstring autograft and accelerated, brace-free rehabilitation. Results Twenty-four studies were included in the review. The clinical outcomes after hamstring tendon autograft ACLR with accelerated brace-free rehabilitation were the following: (1) early start of open kinetic exercises at 4 weeks in a limited range of motion (ROM, 90°−45°) and progressive concentric and eccentric exercises from 12 weeks did not alter outcomes, (2) gender and age did not influence clinical outcomes, (3) anatomical reconstructions showed better results than non-anatomical reconstructions, (4) there was no difference between single-bundle and double-bundle reconstructions, (5) femoral and tibial tunnel widening occurred, (6) hamstring tendons regenerated after harvest and (7) biological knowledge did not support return to sports at 4–6 months. Conclusions After hamstring tendon autograft ACLR with accelerated brace-free rehabilitation, clinical outcome is similar after single-bundle and double-bundle ACLR. Early start of open kinetic exercises at 4 weeks in a limited ROM (90°−45°) and progressive concentric and eccentric exercises from 12 weeks postsurgery do not alter clinical outcome. Further research should focus on achievement of best balance between graft loading and graft healing in the various rehabilitation phases after ACLR as well as on validated, criterion-based assessments for safe return to sports. Level of evidence Level 2b; therapeutic outcome studies. PMID:29682311

Melaleuca alternifolia and its application against dental plaque and periodontal diseases: A systematic review.

PubMed

Casarin, Maísa; Pazinatto, Josiele; Santos, Roberto Christ Vianna; Zanatta, Fabricio Batistin

2018-02-01

This is a systematic review of clinical and laboratory studies evaluating the effect of Melaleuca alternifolia on periodontopathogens, dental plaque, gingivitis, periodontitis, and inflammatory responses. The PubMed, Cochrane, Web of science, Bireme, Lilacs, Prospero, Open Grey, and Clinical Trials databases were searched to identify potentially eligible studies through October 2016. Of 1,654 potentially eligible studies, 25 were included in the systematic review. Their methodology was evaluated through the Cochrane Handbook for clinical studies and the GRADE system for in vivo/in vitro studies. Although clinical studies must be interpreted with caution due to methodological limitations, laboratory studies have found promising results. In vitro evidences showed that M. alternifolia has bactericidal and bacteriostatic effects against the most prevalent periodontopathogens. Clinical studies found comparable effects to chlorhexidine 0.12% in reducing gingival inflammation, although the antiplaque effect was lower. M. alternifolia also showed antioxidant properties, which are beneficial to the host, allied to the reduction on immune-inflammatory responses to pathogens. This systematic review suggests that the M. alternifolia has potential anti-inflammatory and antimicrobial properties, which can be easily applied to the periodontal tissues. However, further clinical trials are needed to elucidate the clinical relevance of its application. Copyright © 2017 John Wiley & Sons, Ltd.

[The Clinical Investigation Centers in France: Whatzat? What for? How does it work?].

PubMed

Montagne, O; Le Corvoisier, P

2008-01-01

For the last 15 years, French university-affiliated hospitals have dramatically modified how biomedical research is conducted in France. Multidisciplinary and technically complex research projects are increasingly difficult to conduct in clinical units. To ensure quality, good clinical practice, and security, platforms dedicated to clinical research with specific staff have been implanted. These units, called Clinical Investigation Centers (CICs), are open to academic and industrial investigators working in the medical fields involving patients and healthy volunteers. The CICs' activities are always closely related to the university hospital research programs and can also serve as a tool for locally implanted clinical and fundamental research teams (INSERM). Nowadays, clinical research requires specific tools and platforms. To enhance French university hospital research efficiency and provide a more open research environment, all investigators, on-site as well as from other institutions, are invited to use these cohesive research facilities and skills to conduct protocols that are fully adapted to their needs in optimal conditions of professional clinical research.

Openness to experience is related to better memory ability in older adults with questionable dementia.

PubMed

Terry, Douglas P; Puente, Antonio N; Brown, Courtney L; Faraco, Carlos C; Miller, L Stephen

2013-01-01

The personality traits Openness to experience and Neuroticism of the five-factor model have previously been associated with memory performance in nondemented older adults, but this relationship has not been investigated in samples with memory impairment. Our examination of 50 community-dwelling older adults (29 cognitively intact; 21 with questionable dementia as determined by the Clinical Dementia Rating Scale) showed that demographic variables (age, years of education, gender, and estimated premorbid IQ) and current depressive symptoms explained a significant amount of variance of Repeatable Battery of Neuropsychological Status Delayed Memory (adjusted R (2) = 0.23). After controlling for these variables, a measure of global cognitive status further explained a significant portion of variance in memory performance (ΔR(2) = 0.13; adjusted R(2) = 0.36; p < .01). Finally, adding Openness to this hierarchical linear regression model explained a significant additional portion of variance (ΔR(2) = 0.08; adjusted R(2) = 0.44; p < .01) but adding Neuroticism did not explain any additional variance. This significant relationship between Openness and better memory performance above and beyond one's cognitive status and demographic variables may suggest that a lifelong pattern of involvement in new cognitive activities could be preserved in old age or protect from memory decline. This study suggests that personality may be a powerful predictor of memory ability and clinically useful in this heterogeneous population.

Clinical experience with intravenous Augmentin in the treatment of paediatric infections.

PubMed

Ploechl, E; Huber, E G

1986-01-01

The clinical efficacy of intravenous Augmentin (a formulation containing amoxycillin plus clavulanic acid) was investigated in an open study in fifty-eight children with a mean age of 6 years (range 1-15 years). The normal dosage was in the range 100-200 mg/kg/day Augmentin, administered parenterally by short i.v. infusion in 3 or 4 divided doses. Most patients were hospitalised for lower respiratory tract infections. Complete clinical cure or distinct clinical improvement was achieved in all assessable cases. Bacteriological success was obtained in 92% of the assessable cases. In two patients, mild, transient exanthema was noted after i.v. Augmentin was replaced by oral Augmentin. No additional therapeutic measures were required.

Surgical Treatment of Rotator Cuff Tears After 65 Years of Age: A Systematic Review.

PubMed

Silva, Bruno Mota; Cartucho, António; Sarmento, Marco; Moura, Nuno

2017-04-28

The objective of this study was to analyze current evidence regarding surgical management of rotator cuff tears in patients of 65 years of age and above. Our hypothesis was that surgical repair of rotator cuff tears, in patients older than 65 years, conveys good outcome scores. We have not found a similar systematic review in current literature. Medline®, PubMed, Scopus, and the Cochrane Register of Controlled Trials were searched from January 1999 unto December 2015 for studies, regardless of language, including the words 'rotator cuff' and '65 years' or '70 years'. Inclusion criteria were studies (level I to IV) that reported clinical outcomes in patients older than 65 years, having undertaken surgical repair of a symptomatic rotator cuff tears. Arthroscopic, mini open and open techniques were included. Exclusion criteria were: studies with patients younger than 65 years, studies that did not use validated outcome evaluation scores as primary assessment tools and those with follow up under one year. This work followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - PRISMA guidelines. Data abstracted included patient demographics, tear pattern, surgical procedures, clinical and repair results. Outcome scores were converted to percentages, allowing comparison of data between studies. After deep analysis, 14 studies met the inclusion criteria: 11 level IV studies, 1 level III study and 2 level II studies. Seven studies found statistically significant outcome improvements between pre and postoperative evaluations. All studies reported good or excellent surgical outcomes. Better results would probably be achieved if all studies had rigorous and homogeneous patient selection criteria, but the fact is, that even though this was not the case, the clinical scores remained favorable, and with statistically significant outcome improvement in all studies with prospectively collected data. Based on current literature, rotator cuff repair in patients older than 65 years imparts favorable improvement in clinical outcome scores and overall patient satisfaction.

Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.

PubMed

Kreuzer, Peter M; Landgrebe, Michael; Resch, Markus; Husser, Oliver; Schecklmann, Martin; Geisreiter, Florian; Poeppl, Timm B; Prasser, Sarah J; Hajak, Goeran; Rupprecht, Rainer; Langguth, Berthold

2014-01-01

Vagus nerve stimulation represents an established treatment strategy for epilepsy and affective disorders. Recently, positive effects were also shown in animals and humans with tinnitus. Here we report the results of an open pilot study exploring feasibility, safety and efficacy of tVNS in the treatment of chronic tinnitus. Fifty patients with chronic tinnitus underwent tVNS in an open single-armed pilot study which was conducted in two phases applying two different stimulating devices (Cerbomed CM02 and NEMOS). Clinical assessment was based on Tinnitus Questionnaire (TQ), Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), WHO Quality of Life, and various numeric rating scales. Primary outcome was defined as change in TQ (baseline vs. final visit in week 24). The study has been registered with clinicaltrials.gov (NCT01176734). Primary analysis indicated mean TQ reductions of 3.7 points (phase 1) and 2.8 points (phase 2) significant for the first study phase. Secondary analyses indicated a significant BDI reduction for phase 1 (uncorrected for multiple testing), but no further systematic or significant effects. Adverse events included twitching and pressure at electrode placement site. The occurrence of one hospitalization because of palpations and the development of a left bundle branch block were considered as unrelated to the intervention. Cognitive testing revealed no significant changes. Our data demonstrate the feasibility of tVNS over a period of 6 months. There was no clinically relevant improvement of tinnitus complaints. Our data suggest tVNS to be considered safe in patients without a history of cardiac disease. Copyright © 2014 Elsevier Inc. All rights reserved.

Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia?

PubMed

Tang, Hsin-Yi Jean; Riegel, Barbara; McCurry, Susan M; Vitiello, Michael V

2016-03-01

Audio Visual Stimulation (AVS), a form of neurofeedback, is a non-pharmacological intervention that has been used for both performance enhancement and symptom management. We review the history of AVS, its two sub-types (close- and open-loop), and discuss its clinical implications. We also describe a promising new application of AVS to improve sleep, and potentially decrease pain. AVS research can be traced back to the late 1800s. AVS's efficacy has been demonstrated for both performance enhancement and symptom management. Although AVS is commonly used in clinical settings, there is limited literature evaluating clinical outcomes and mechanisms of action. One of the challenges to AVS research is the lack of standardized terms, which makes systematic review and literature consolidation difficult. Future studies using AVS as an intervention should; (1) use operational definitions that are consistent with the existing literature, such as AVS, Audio-visual Entrainment, or Light and Sound Stimulation, (2) provide a clear rationale for the chosen training frequency modality, (3) use a randomized controlled design, and (4) follow the Consolidated Standards of Reporting Trials and/or related guidelines when disseminating results.

De novo tandem duplication of chromosome segement 22q11-q12: Clinical, cytogenetic, and molecular characterization

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

Lindsay, E.A.; Shaffer, L.G.; Carrozzo, R.

We report on a case of duplication of the segment 22q11-q12 due to a de novo duplication. Molecular cytogenetics studies demonstrated this to be a tandem duplication, flanked proximally by the marker D22Z4, a centromeric alpha satellite DNA repeat, and distally by D22S260, an anonymous DNA marker proximal to the Ewing sarcoma breakpoint. The segment includes the regions responsible for the {open_quotes}cat-eye{close_quotes}, Di George, and velo-cardio-facial syndromes and extends distal to the breakpoint cluster region (BCR). The clinical picture is dominated by the cardiac defects and includes findings reminiscent of {open_quotes}cat-eye{close_quotes} syndrome. These findings reinforce the hypothesis that the proximalmore » 22q region contains dosage-sensitive genes involved in development. 20 refs., 3 figs.« less

Laparoscopic versus Open Repair of Para-Umbilical Hernia- A Prospective Comparative Study of Short Term Outcomes.

PubMed

Korukonda, Sreeharsha; Amaranathan, Anandhi; Ramakrishnaiah, Vishnu Prasad Nelamangala

2017-08-01

Para-Umbilical Hernia (PUH) is one of the most common surgical problems. Since the prosthetic repair has become the standard of practice for inguinal hernia management, the same has been adapted for para-umbilical hernia management with better outcome. There is still debate going on regarding the optimal surgical approach. There are very few prospective studies comparing the laparoscopic and open method of para-umbilical hernia mesh repair. This study compared the short term outcomes following laparoscopic versus open mesh repair of PUH. To compare the early complications of open repair with laparoscopic repair of PUH. To compare the post-operative hospital stay of open repair with laparoscopic repair of PUH. This was a prospective comparative clinical study done from August 2014 to August 2016. All the patients above the age of 13 who attended our surgical outpatient department with PUH were taken into our study. Exclusion criteria included 1) Patients with obstructed or strangulated PUH 2) Patients with abdominal malignancies 3) Patients with coagulopathy, severe cardiopulmonary disease, ascites and renal failure 4) Patients who had PUH repair in combination with another major surgical operation such as laparoscopic cholecystectomy and inguinal hernia repair 5) Patients with recurrent PUH. Institute Ethical Committee clearance was obtained for this study. Out of 40 patients with PUH, 20 received open meshplasty and 20 patients received laparoscopic meshplasty. Postoperative pain and length of hospital stay is significantly less in laparoscopic PUH repair. Postoperative complications like wound infection, seroma, and haematoma are relatively less in laparoscopic group though statistically not significant. Laparoscopic PUH repair has significantly better outcome in terms of postoperative pain and postoperative hospital stay.

Factors associated with anterior open bite in children with developmental disabilities.

PubMed

de Castilho, Lia Silva; Abreu, Mauro Henrique Nogueira Guimarães; Pires E Souza, Luiz Gustavo de Almeida; Romualdo, Leiliane Teresinha de Almeida; Souza E Silva, Maria Elisa; Resende, Vera Lúcia Silva

2018-01-01

To investigate factors associated with anterior open bite in individuals aged from 2 to 33 years with developmental disabilities. This is a cross-sectional study. A total of 271 dental records were examined. The anterior open bite analyzed was determined based on clinic exam. These variables were also analyzed: gender, age, education level of mother, International Code of Diseases (ICD), mouth breathing, use of anticonvulsant drugs, hyperkinesis, pacifier use, thumb sucking, seizure, and involuntary movements. For the purposes of analysis, the individuals were categorized as being with and without anterior open bite. Variables with a p-value of < 0.25 in the bivariate analysis were incorporated into the logistic regression models. Mouth breathers had a 2.60-fold (95% CI: 1.35-5.01) greater chance of exhibiting anterior open bite than nasal breathers. Pacifier users are more likely to have an anterior open bite (3.32-fold, 95% CI: 1.62-6.77). Individuals with reported involuntary movements had a 2.66-fold (95% CI: 1.26-5.63) greater chance of exhibiting anterior open bite. Users of anticonvulsants drugs had a 3.05 (95% CI: 1.57-5.92) greater chance of showing anterior open bite. Involuntary movements, mouth breathing, using anticonvulsant drugs, and using pacifier are factors associated with anterior open bite in patients with developmental disabilities. © 2017 Special Care Dentistry Association and Wiley Periodicals, Inc.

Attention Training for School-Aged Children with ADHD: Results of an Open Trial

ERIC Educational Resources Information Center

Tamm, Leanne; Hughes, Carroll; Ames, Laure; Pickering, Joyce; Silver, Cheryl H.; Stavinoha, Peter; Castillo, Christine L.; Rintelmann, Jeanne; Moore, Jarrette; Foxwell, Aleksandra; Bolanos, S. Gina; Hines, Tabatha; Nakonezny, Paul A.; Emslie, Graham

2010-01-01

Objective: The article discusses a feasibility study conducted to examine whether Pay Attention!, an intervention training sustained, selective, alternating, and divided attention, could be utilized in a clinical setting with children diagnosed with ADHD, and whether children who received the intervention made attention and executive functioning…

Effect of steroids on inflammatory markers and clinical parameters in congenital open heart surgery: a randomised controlled trial.

PubMed

Amanullah, Muhammad M; Hamid, Mohammad; Hanif, Hashim M; Muzaffar, Marium; Siddiqui, Maria T; Adhi, Fatima; Ahmad, Khabir; Khan, Shahjahan; Hasan, Zahra

2016-03-01

Cardiopulmonary bypass is associated with systemic inflammatory response. Steroids suppress this response, although the therapeutic evidence remains controversial. We hypothesised that intravenous steroids in children undergoing open-heart surgery would decrease inflammation leading to better early post-operative outcomes. We conducted a randomised controlled trial to evaluate the trends in the levels of immunomodulators and their effects on clinical parameters. To assess the effects of intravenous steroids on early post-operative inflammatory markers and clinical parameters in children undergoing open-heart surgery. A randomised controlled trial involving 152 patients, from one month up to 18 years of age, who underwent open-heart surgery for congenital heart disease from April 2010-2012 was carried out. Patients were randomised and administered either three scheduled intravenous pulse doses of dexamethasone (1 mg/kg) or placebo. Blood samples were drawn at four time intervals and serum levels of inflammatory cytokines - Interleukin-6, 8, 10, 18, and tumour necrosis factor-alpha - were measured. Clinical parameters were also assessed. Blood cytokine levels were compared between the dexamethasone (n=65) and placebo (n=64) groups. Interleukin-6 levels were lower at 6 and 24 hours post-operatively (p<0.001), and Interleukin-10 levels were higher 6 hours post-operatively (p<0.001) in the steroid group. Interleukin-8, 18, and tumour necrosis factor-alpha levels did not differ between the groups at any time intervals. The clinical parameters were similar in both the groups. Dexamethasone caused quantitative suppression of Interleukin-6 and increased Interleukin-10 activation, contributing to reduced immunopathology, but it did not translate into clinical benefit in the short term.

Is minimal access spine surgery more cost-effective than conventional spine surgery?

PubMed

Lubelski, Daniel; Mihalovich, Kathryn E; Skelly, Andrea C; Fehlings, Michael G; Harrop, James S; Mummaneni, Praveen V; Wang, Michael Y; Steinmetz, Michael P

2014-10-15

Systematic review. To summarize and critically review the economic literature evaluating the cost-effectiveness of minimal access surgery (MAS) compared with conventional open procedures for the cervical and lumbar spine. MAS techniques may improve perioperative parameters (length of hospital stay and extent of blood loss) compared with conventional open approaches. However, some have questioned the clinical efficacy of these differences and the associated cost-effectiveness implications. When considering the long-term outcomes, there seem to be no significant differences between MAS and open surgery. PubMed, EMBASE, the Cochrane Collaboration database, University of York, Centre for Reviews and Dissemination (NHS-EED and HTA), and the Tufts CEA Registry were reviewed to identify full economic studies comparing MAS with open techniques prior to December 24, 2013, based on the key questions established a priori. Only economic studies that evaluated and synthesized the costs and consequences of MAS compared with conventional open procedures (i.e., cost-minimization, cost-benefit, cost-effectiveness, or cost-utility) were considered for inclusion. Full text of the articles meeting inclusion criteria were reviewed by 2 independent investigators to obtain the final collection of included studies. The Quality of Health Economic Studies instrument was scored by 2 independent reviewers to provide an initial basis for critical appraisal of included economic studies. The search strategy yielded 198 potentially relevant citations, and 6 studies met the inclusion criteria, evaluating the costs and consequences of MAS versus conventional open procedures performed for the lumbar spine; no studies for the cervical spine met the inclusion criteria. Studies compared MAS tubular discectomy with conventional microdiscectomy, minimal access transforaminal lumbar interbody fusion versus open transforaminal lumbar interbody fusion, and multilevel hemilaminectomy via MAS versus open approach. Overall, the included cost-effectiveness studies generally supported no significant differences between open surgery and MAS lumbar approaches. However, these conclusions are preliminary because there was a paucity of high-quality evidence. Much of the evidence lacked details on methodology for modeling, related assumptions, justification of economic model chosen, and sources and types of included costs and consequences. The follow-up periods were highly variable, indirect costs were not frequently analyzed or reported, and many of the studies were conducted by a single group, thereby limiting generalizability. Prospective studies are needed to define differences and optimal treatment algorithms. 3.

Use of the initial trauma CT scan to aid in diagnosis of open pelvic fractures.

PubMed

Scolaro, John A; Wilson, David J; Routt, Milton Lee Chip; Firoozabadi, Reza

2015-10-01

Open pelvic disruptions represent high-energy injuries. The prompt identification and management of these injuries decreases their associated morbidity and mortality. Computed tomography (CT) scans are routinely obtained in the initial evaluation of patients with pelvic injuries. The purpose of this study is to identify the incidence and source of air densities noted on computed tomography (CT) scans of the abdominal and pelvic region in patients with pelvic fractures and evaluate the use of initial CT imaging as an adjunctive diagnostic tool to identify open injuries. A retrospective review of a prospectively collected database was performed at a single institution. Seven hundred and twenty-two consecutive patients with a pelvic disruption over a two-year period were included. Review of initial injury CT scans was performed using bone and lung viewing algorithms to identify the presence of extra-luminal air. The primary outcome was the presence, location and source of air identified on pre-operative CT scans. Secondary measurements were identification of air by plain radiograph and correlation between identified air densities on CT and clinically diagnosed open pelvic fractures. Ninety-eight patients were identified as having extra-luminal air densities on CT scans. Eighty-one patients were included in the final analysis following application of inclusion and exclusion criteria. Air was noted by the radiologist in forty-five (55.6%) instances. Six patients (7.4%) were clinically diagnosed with an open pelvic ring disruption; in two patients (2.4%) this diagnosis was delayed. In all patients, the CT was able to track air from its origin. In patients with pelvic disruptions, the injury CT should also be evaluated for the presence and source of extra-luminal air. In some patients, this finding may represent an open pelvic ring disruption. A complete physical exam and CT evaluation should be used to decrease the missed or delayed diagnosis of an open pelvic ring injury. Copyright © 2015 Elsevier Ltd. All rights reserved.

An investigation of survivorship clinic attendance among childhood cancer survivors living in a five-state rural region.

PubMed

Ou, Judy Y; Smits-Seemann, Rochelle R; Wu, Yelena P; Wright, Jennifer; Kirchhoff, Anne C

2018-04-01

Cancer survivorship clinics manage cancer-related health complications and are available primarily in urban areas. We examine how demographic, clinical, and geographic-based characteristics are associated with attendance at the only pediatric survivorship clinic in a largely rural, multistate region. One thousand eight hundred sixteen cancer survivors were diagnosed at age ≤ 25 from 1986 to 2005 while living in the region. Cox models incorporating death as a competing risk and generalized estimating equations calculated hazards ratios (HR) for characteristics measured at the clinic's opening. Subjects were followed from the clinic opening their first visit, death, emigration from the catchment area, or December 31, 2014. Five percent of survivors visited the clinic. Attendance is positively associated with a leukemia or lymphoma diagnosis (HR = 3.32, 95% confidence interval [CI] = 1.72-6.78 vs CNS tumors), previous relapse (HR = 1.78, 95% CI = 1.00-3.19), and residing >100 mi from the clinic (HR = 2.05, 95% CI 1.03-4.10). Survivors aged ≥ 31 years at clinic opening (HR = 0.19, 95% CI = 0.07-0.54) are less likely to attend than younger survivors. Residence between 16 and 100 mi had an inverse association with attendance, although not significant. Survivorship clinics are not widely attended by survivors in this catchment region. Efforts should be made to recruit survivors aged ≥ 31 and diagnosed with CNS tumors. Distance has a complex association with attendance, which could be attributed to the limited availability of preventative services in regions > 100 mi from the clinic. Survivors living in this catchment region may not be receiving care necessary to prevent severe late effects.

Closed treatment of unilateral mandibular condyle fractures in adults: a systematic review.

PubMed

Rozeboom, A V J; Dubois, L; Bos, R R M; Spijker, R; de Lange, J

2017-04-01

Of all mandibular fractures, 25-35% are condylar. Many studies have focused on whether to treat such fractures via open or closed modalities. A uniform protocol for closed treatment is lacking, but such a protocol could ensure good clinical practice. The aims of this systematic review were to provide an overview of the published studies exclusively pertaining to closed treatment and to summarize the existing modalities for closed treatment and their clinical outcomes. Sixteen studies were selected for detailed analysis. The treatments given were highly variable, ranging from doing nothing to applying maxillomandibular fixation with stainless steel wires. The results of the different studies and the treatment modalities used were difficult to interpret; however no clear differences in the outcome measures were seen between the treatment modalities applied. Complications encountered after closed treatment included malocclusion, limited mouth opening, reduced range of motion, and persistent pain. Due to the heterogeneity between groups, high loss-to-follow-up, poor descriptions of the treatments given, and variability in outcome measurement methods, no clear associations between adverse outcomes and the treatments applied could be determined. This review suggests that due to the high level of methodological variability in the relevant studies published to date, there are currently no uniform standards for the closed treatment of condylar fractures that can be expected to yield good clinical results. The establishment of such standards could potentially improve treatment outcomes. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

A Prospective Comparative Study of Arthroscopic Versus Mini-Open Latarjet Procedure With a Minimum 2-Year Follow-up.

PubMed

Marion, Blandine; Klouche, Shahnaz; Deranlot, Julien; Bauer, Thomas; Nourissat, Geoffroy; Hardy, Philippe

2017-02-01

To compare postoperative pain during the first postoperative week and the position of the coracoid bone block at the anterior aspect of the glenoid after the arthroscopic and the mini-open Latarjet procedure. The secondary purpose was to assess functional results and recurrence after at least 2 years of follow-up. This comparative prospective study included patients who underwent a Latarjet-Bristow procedure for anterior shoulder instability in 2012. The Latarjet procedure was performed by a mini-open approach (G1) in one center and by an arthroscopic approach (G2) in the other. The main evaluation criterion was average shoulder pain during the first postoperative week assessed by the patient on a standard 10-cm visual analog scale (0-10). Secondary criteria were consumption of analgesics during the first week, the position of the coracoid bone block on radiograph and computed tomography scan at the 3-month follow-up and clinical outcomes (Western Ontario Score Index and new surgery) after at least 2 years of follow-up. Fifty-eight patients were included, 22 G1 and 36 G2, 13 women and 45 men, mean age 26.9 ± 7.7 years. The mean follow-up was 29.8 ± 4.4 months. There was significantly less pain in the arthroscopic Latarjet group than in the mini-open group during the first postoperative week (2.5 ± 1.4 vs 1.2 ± 1.2, P = .002) with comparable consumption of analgesics (P > .05). The arthroscopic Latarjet procedure resulted in a more lateral coracoid bone block (P = .04) and a better equatorial position than the mini-open technique (P = .02). Three patients underwent revision surgery (1 recurrence [2.8%], 1 block fracture, 1 screw ablation) in the arthroscopic group, none in the mini-open group (P = .54). At the final follow-up, the Western Ontario Score Index score was good in all patients (G1: 78.5 ± 7.5% vs G2: 82.3 ± 7%, P = .03). This prospective comparative study showed that the arthroscopic Latarjet procedure was significantly less painful than the mini-open procedure during the first postoperative week. The clinical outcomes were comparable after at least 2 years of follow-up. Level II, prospective comparative study. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Effects of increase in temperature and open water on transmigration and access to health care by the Nenets reindeer herders in northern Russia

PubMed Central

Amstislavski, Philippe; Zubov, Leonid; Chen, Herman; Ceccato, Pietro; Pekel, Jean-Francois; Weedon, Jeremy

2013-01-01

Background The indigenous Nenets reindeer herders in northern Russia annually migrate several hundred kilometers between summer and winter pastures. In the warming climate, ice-rich permafrost and glaciers are being significantly reduced and will eventually disappear from parts of the Arctic. The emergent changes in hydrological cycles have already led to substantial increases in open water that stays unfrozen for longer periods of time. This environmental change has been reported to compromise the nomadic Nenets’ traditional way of life because the presence of new water in the tundra reduces the Nenets’ ability to travel by foot, sled, or motor vehicle from the summer transitory tundra campsites in order to access healthcare centers in villages. New water can also impede their access to family and community at other herder camps and in the villages. Although regional and global models predicting hydrologic changes due to climate changes exist, the spatial resolution of these models is too coarse for studying how increases in open water affect health and livelihoods. To anticipate the full health impact of hydrologic changes, the current gap between globally forecasted scenarios and locally forecasted hydrologic scenarios needs to be bridged. Objectives We studied the effects of the autumn temperature anomalies and increases in open water on health care access and transmigration of reindeer herders on the Kanin Peninsula. Design Correlational and time series analyses were completed. Methods The study population consisted of 370 full-time, nomadic reindeer herders. We utilized clinical visit records, studied surface temperature anomalies during autumn migrations, and used remotely sensed imagery to detect water bodies. Spearman correlation was used to measure the relationship between temperature anomalies and the annual arrival of the herders at the Nes clinic for preventive and primary care. Piecewise regression was used to model change in mean autumnal temperature anomalies over time. We also created a water body product to detect inter-annual changes in water area. Results Correlation between arrivals to the Nes clinic and temperature anomalies during the fall transmigration (1979–2011) was r = 0.64, p = 0.0004; 95% CI (0.31; 0.82). Regression analysis estimated that mean temperature anomalies during the fall migration in September–December were stochastically stationary pre-1991 and have been rising significantly (p < 0.001) since then. The rate of change was estimated at +0.1351°C/year, SE = 0.0328, 95% CI (+0.0694, +0.2007). The amount of detected water fluctuated significantly interannually (620–800 km2). Conclusions Later arrival of freezing temperatures in the autumn followed by the earlier spring thaws and more open water delay transmigration and reduce herders’ access to health care. The recently observed delays in arrival to the clinic are likely related to the warming trend and to concomitant hydrologic changes. PMID:23971018

Effects of increase in temperature and open water on transmigration and access to health care by the Nenets reindeer herders in northern Russia.

PubMed

Amstislavski, Philippe; Zubov, Leonid; Chen, Herman; Ceccato, Pietro; Pekel, Jean-Francois; Weedon, Jeremy

2013-01-01

The indigenous Nenets reindeer herders in northern Russia annually migrate several hundred kilometers between summer and winter pastures. In the warming climate, ice-rich permafrost and glaciers are being significantly reduced and will eventually disappear from parts of the Arctic. The emergent changes in hydrological cycles have already led to substantial increases in open water that stays unfrozen for longer periods of time. This environmental change has been reported to compromise the nomadic Nenets' traditional way of life because the presence of new water in the tundra reduces the Nenets' ability to travel by foot, sled, or motor vehicle from the summer transitory tundra campsites in order to access healthcare centers in villages. New water can also impede their access to family and community at other herder camps and in the villages. Although regional and global models predicting hydrologic changes due to climate changes exist, the spatial resolution of these models is too coarse for studying how increases in open water affect health and livelihoods. To anticipate the full health impact of hydrologic changes, the current gap between globally forecasted scenarios and locally forecasted hydrologic scenarios needs to be bridged. We studied the effects of the autumn temperature anomalies and increases in open water on health care access and transmigration of reindeer herders on the Kanin Peninsula. Correlational and time series analyses were completed. The study population consisted of 370 full-time, nomadic reindeer herders. We utilized clinical visit records, studied surface temperature anomalies during autumn migrations, and used remotely sensed imagery to detect water bodies. Spearman correlation was used to measure the relationship between temperature anomalies and the annual arrival of the herders at the Nes clinic for preventive and primary care. Piecewise regression was used to model change in mean autumnal temperature anomalies over time. We also created a water body product to detect inter-annual changes in water area. Correlation between arrivals to the Nes clinic and temperature anomalies during the fall transmigration (1979-2011) was r = 0.64, p = 0.0004; 95% CI (0.31; 0.82). Regression analysis estimated that mean temperature anomalies during the fall migration in September-December were stochastically stationary pre-1991 and have been rising significantly (p < 0.001) since then. The rate of change was estimated at +0.1351°C/year, SE = 0.0328, 95% CI (+0.0694, +0.2007). The amount of detected water fluctuated significantly interannually (620-800 km(2)). Later arrival of freezing temperatures in the autumn followed by the earlier spring thaws and more open water delay transmigration and reduce herders' access to health care. The recently observed delays in arrival to the clinic are likely related to the warming trend and to concomitant hydrologic changes.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact

PubMed Central

2012-01-01

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The ‘open access’ approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The ‘restricted access’ approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who ‘needs to know’ about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results. PMID:23270486

Protecting intellectual property associated with Canadian academic clinical trials--approaches and impact.

PubMed

Ross, Sue; Magee, Laura; Walker, Mark; Wood, Stephen

2012-12-27

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The 'open access' approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The 'restricted access' approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who 'needs to know' about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.

Expressing clinical data sets with openEHR archetypes: a solid basis for ubiquitous computing.

PubMed

Garde, Sebastian; Hovenga, Evelyn; Buck, Jasmin; Knaup, Petra

2007-12-01

The purpose of this paper is to analyse the feasibility and usefulness of expressing clinical data sets (CDSs) as openEHR archetypes. For this, we present an approach to transform CDS into archetypes, and outline typical problems with CDS and analyse whether some of these problems can be overcome by the use of archetypes. Literature review and analysis of a selection of existing Australian, German, other European and international CDSs; transfer of a CDS for Paediatric Oncology into openEHR archetypes; implementation of CDSs in application systems. To explore the feasibility of expressing CDS as archetypes an approach to transform existing CDSs into archetypes is presented in this paper. In case of the Paediatric Oncology CDS (which consists of 260 data items) this lead to the definition of 48 openEHR archetypes. To analyse the usefulness of expressing CDS as archetypes, we identified nine problems with CDS that currently remain unsolved without a common model underpinning the CDS. Typical problems include incompatible basic data types and overlapping and incompatible definitions of clinical content. A solution to most of these problems based on openEHR archetypes is motivated. With regard to integrity constraints, further research is required. While openEHR cannot overcome all barriers to Ubiquitous Computing, it can provide the common basis for ubiquitous presence of meaningful and computer-processable knowledge and information, which we believe is a basic requirement for Ubiquitous Computing. Expressing CDSs as openEHR archetypes is feasible and advantageous as it fosters semantic interoperability, supports ubiquitous computing, and helps to develop archetypes that are arguably of better quality than the original CDS.

Shiny FHIR: An Integrated Framework Leveraging Shiny R and HL7 FHIR to Empower Standards-Based Clinical Data Applications.

PubMed

Hong, Na; Prodduturi, Naresh; Wang, Chen; Jiang, Guoqian

2017-01-01

In this study, we describe our efforts in building a clinical statistics and analysis application platform using an emerging clinical data standard, HL7 FHIR, and an open source web application framework, Shiny. We designed two primary workflows that integrate a series of R packages to enable both patient-centered and cohort-based interactive analyses. We leveraged Shiny with R to develop interactive interfaces on FHIR-based data and used ovarian cancer study datasets as a use case to implement a prototype. Specifically, we implemented patient index, patient-centered data report and analysis, and cohort analysis. The evaluation of our study was performed by testing the adaptability of the framework on two public FHIR servers. We identify common research requirements and current outstanding issues, and discuss future enhancement work of the current studies. Overall, our study demonstrated that it is feasible to use Shiny for implementing interactive analysis on FHIR-based standardized clinical data.

A national evaluation of clinical and economic outcomes in open versus laparoscopic colorectal surgery.

PubMed

Keller, Deborah S; Delaney, Conor P; Hashemi, Lobat; Haas, Eric M

2016-10-01

Surgical value is based on optimizing clinical and financial outcomes. The clinical benefits of laparoscopic surgery are well established; however, many patients are still not offered a laparoscopic procedure. Our objective was to compare the modern clinical and financial outcomes of laparoscopic and open colorectal surgery. The Premier Perspective database identified patients undergoing elective colorectal resections from January 1, 2013 to December 31, 2013. Cases were stratified by operative approach into laparoscopic and open cohorts. Groups were controlled on all demographics, diagnosis, procedural, hospital characteristics, surgeon volume, and surgeon specialty and then compared for clinical and financial outcomes. The main outcome measures were length of stay (LOS), complications, readmission rates, and cost by surgical approach. A total of 6343 patients were matched and analyzed in each cohort. The most common diagnosis was diverticulitis (p = 0.0835) and the most common procedure a sigmoidectomy (p = 0.0962). The LOS was significantly shorter in laparoscopic compared to open (mean 5.78 vs. 7.80 days, p < 0.0001). The laparoscopic group had significantly lower readmission (5.82 vs. 7.68 %, p < 0.0001), complication (32.60 vs. 42.28 %, p < 0.0001), and mortality rates (0.52 vs. 1.28 %, p < 0.0001). The total cost was significantly lower in laparoscopic than in open (mean $17,269 vs. $20,552, p < 0.0001). By category, laparoscopy was significantly more cost-effective for pharmacy (p < 0.0001), room and board (p < 0.0001), recovery room (p = 0.0058), ICU (p < 0.0001), and laboratory and imaging services (both p < 0.0001). Surgical supplies (p < 0.0001), surgery (p < 0.0001), and anesthesia (p = 0.0053) were higher for the laparoscopic group. Laparoscopy is more cost-effective and produces better patient outcomes than open colorectal surgery. Minimally invasive colorectal surgery is now the standard that should be offered to patients, providing value to both patient and provider.

Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial.

PubMed

Koeneman, M M; Kruse, A J; Kooreman, L F S; Zur Hausen, A; Hopman, A H N; Sep, S J S; Van Gorp, T; Slangen, B F M; van Beekhuizen, H J; van de Sande, A J M; Gerestein, C G; Nijman, H W; Kruitwagen, R F P M

2017-02-07

The "TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia" (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia (CIN). The lagging inclusions were mainly due to a strong patient preference for either of the two treatment modalities. This prompted us to initiate a new study on the same subject, with a non-randomized, open-label design: the 'TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC)-3' study. Original TOPIC-trial: Medical Ethics Committee approval number METC13231; ClinicalTrials.gov Identifier: NCT02329171, 22 December 2014. TOPIC-3 study: Medical Ethics Committee approval number METC162025; ClinicalTrials.gov Identifier: NCT02917746, 16 September 2016.

Cannabinoids and Epilepsy.

PubMed

Rosenberg, Evan C; Tsien, Richard W; Whalley, Benjamin J; Devinsky, Orrin

2015-10-01

Cannabis has been used for centuries to treat seizures. Recent anecdotal reports, accumulating animal model data, and mechanistic insights have raised interest in cannabis-based antiepileptic therapies. In this study, we review current understanding of the endocannabinoid system, characterize the pro- and anticonvulsive effects of cannabinoids [e.g., Δ9-tetrahydrocannabinol and cannabidiol (CBD)], and highlight scientific evidence from pre-clinical and clinical trials of cannabinoids in epilepsy. These studies suggest that CBD avoids the psychoactive effects of the endocannabinoid system to provide a well-tolerated, promising therapeutic for the treatment of seizures, while whole-plant cannabis can both contribute to and reduce seizures. Finally, we discuss results from a new multicenter, open-label study using CBD in a population with treatment-resistant epilepsy. In all, we seek to evaluate our current understanding of cannabinoids in epilepsy and guide future basic science and clinical studies.

Improving site selection in clinical studies: a standardised, objective, multistep method and first experience results.

PubMed

Hurtado-Chong, Anahí; Joeris, Alexander; Hess, Denise; Blauth, Michael

2017-07-12

A considerable number of clinical studies experience delays, which result in increased duration and costs. In multicentre studies, patient recruitment is among the leading causes of delays. Poor site selection can result in low recruitment and bad data quality. Site selection is therefore crucial for study quality and completion, but currently no specific guidelines are available. Selection of sites adequate to participate in a prospective multicentre cohort study was performed through an open call using a newly developed objective multistep approach. The method is based on use of a network, definition of objective criteria and a systematic screening process. Out of 266 interested sites, 24 were shortlisted and finally 12 sites were selected to participate in the study. The steps in the process included an open call through a network, use of selection questionnaires tailored to the study, evaluation of responses using objective criteria and scripted telephone interviews. At each step, the number of candidate sites was quickly reduced leaving only the most promising candidates. Recruitment and quality of data went according to expectations in spite of the contracting problems faced with some sites. The results of our first experience with a standardised and objective method of site selection are encouraging. The site selection method described here can serve as a guideline for other researchers performing multicentre studies. ClinicalTrials.gov: NCT02297581. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pulse perfusion value predicts eye opening after sevoflurane anaesthesia: an explorative study.

PubMed

Enekvist, Bruno; Johansson, Anders

2015-08-01

The variables measured in modern pulse oximetry apparatuses include a graphical pulse curve and a specified perfusion value (PV) that could be a sensitive marker for detecting differences in sympathetic activity. We hypothesized that there is a correlation between a reduction of PV and the time to eye opening after general anaesthesia. The objective was to investigate whether PV can predict eye opening after sevoflurane anaesthesia. Prospective, explorative clinical study included 20 patients, ASA physical status 1 or 2, at Skåne University Hospital, Lund, Sweden, from November 2012 to January 2013 scheduled for elective breast tumour surgery. A general anaesthesia was delivered with inhalation of oxygen, nitrous oxide and sevoflurane anaesthesia to a depth of 1.2 minimal alveolar concentration. Sevoflurane inspiratory and expiratory concentrations were measured. Bispectral index monitoring, PV as measured by pulse oximeter, heart rate and carbon dioxide were registered at before anaesthesia, 15 min after induction (at 1.2 minimal alveolar concentration), at end of surgery and at eye opening at the end of anaesthesia. PV values were lower before anaesthesia and at eye opening compared to at 15 min after induction and at end of surgery (P < 0.05). The reduction of PV between end of surgery and eye opening was 0.76. We conclude that the pulse oximeter PV could be a useful variable to assess the timing of recovery, in terms of eye opening after a general anaesthesia.

How characteristic routines of clinical departments influence students' self-regulated learning: A grounded theory study.

PubMed

Berkhout, J J; Slootweg, I A; Helmich, E; Teunissen, P W; van der Vleuten, C P M; Jaarsma, A D C

2017-11-01

In clerkships, students are expected to self-regulate their learning. How clinical departments and their routine approach on clerkships influences students' self-regulated learning (SRL) is unknown. This study explores how characteristic routines of clinical departments influence medical students' SRL. Six focus groups including 39 purposively sampled participants from one Dutch university were organized to study how characteristic routines of clinical departments influenced medical students' SRL from a constructivist paradigm, using grounded theory methodology. The focus groups were audio recorded, transcribed verbatim and were analyzed iteratively using constant comparison and open, axial and interpretive coding. Students described that clinical departments influenced their SRL through routines which affected the professional relationships they could engage in and affected their perception of a department's invested effort in them. Students' SRL in a clerkship can be supported by enabling them to engage others in their SRL and by having them feel that effort is invested in their learning. Our study gives a practical insight in how clinical departments influenced students' SRL. Clinical departments can affect students' motivation to engage in SRL, influence the variety of SRL strategies that students can use and how meaningful students perceive their SRL experiences to be.

An Experimental Study on the Effects of a Simulation Game on Students' Clinical Cognitive Skills and Motivation

ERIC Educational Resources Information Center

Dankbaar, Mary E. W.; Alsma, Jelmer; Jansen, Els E. H.; van Merrienboer, Jeroen J. G.; van Saase, Jan L. C. M.; Schuit, Stephanie C. E.

2016-01-01

Simulation games are becoming increasingly popular in education, but more insight in their critical design features is needed. This study investigated the effects of fidelity of open patient cases in adjunct to an instructional e-module on students' cognitive skills and motivation. We set up a three-group randomized post-test-only design: a…

Comparable perioperative mortality outcomes in younger patients undergoing elective open and endovascular abdominal aortic aneurysm repair.

PubMed

Liang, Nathan L; Reitz, Katherine M; Makaroun, Michel S; Malas, Mahmoud B; Tzeng, Edith

2018-05-01

Evidence for benefit of endovascular aneurysm repair (EVAR) over open surgical repair for de novo infrarenal abdominal aortic aneurysms (AAAs) in younger patients remains conflicting because of heterogeneous study populations and small sample sizes. The objective of this study was to compare perioperative and short-term outcomes for EVAR and open surgery in younger patients using a large national disease and procedure-specific data set. We identified patients 65 years of age or younger undergoing first-time elective EVAR or open AAA repair from the Vascular Quality Initiative (2003-2014). We excluded patients with pararenal or thoracoabdominal aneurysms, those medically unfit for open repair, and those undergoing EVAR for isolated iliac aneurysms. Clinical and procedural characteristics were balanced using inverse propensity of treatment weighting. A supplemental analysis extended the study to those younger than 70 years. We identified 2641 patients, 73% (n = 1928) EVAR and 27% (n = 713) open repair. The median age was 62 years (interquartile range, 59-64 years), and 13% were female. The median follow-up time was 401 days (interquartile range, 357-459 days). Unadjusted perioperative survival was 99.6% overall (open repair, 99.1%; EVAR, 99.8%; P < .001), with 97.4% 1-year survival overall (open repair, 97.3%; EVAR, 97.4%; P = .9). Unadjusted reintervention rates were five (open repair) and seven (EVAR) reinterventions per 100 person-years (P = .8). After propensity weighting, the absolute incidence of perioperative mortality was <1% in both groups (open repair, 0.9%, EVAR, 0.2%; P < .001), and complication rates were low. Propensity-weighted survival (hazard ratio, 0.88; 95% confidence interval, 0.56-1.38; P = .6) and reintervention rates (open repair, 6; EVAR, 8; reinterventions per 100 person-years; P = .8) did not differ between the two interventions. The analysis of those younger than 70 years showed similar results. In this study of younger patients undergoing repair of infrarenal AAA, 30-day morbidity and mortality for both open surgery and EVAR are low, and the absolute mortality difference is small. The prior published perioperative mortality and 1-year survival benefit of EVAR over open AAA repair is not observed in younger patients. Further studies of long-term durability are needed to guide decision-making for open repair vs EVAR in this population. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with Depressive or Anxiety Disorders

PubMed Central

Robb, Adelaide S.; DelBello, Melissa P.; Huss, Michael; McNamara, Nora K.; Sarkis, Elias H.; Scheffer, Russell E.; Poulsen, Lis H.; Chen, Grace; Lemming, Ole M.; Auby, Philippe

2018-01-01

Abstract Objectives: In this 6-month open-label extension (OLE) of NCT01491035 (a 14-day, open-label, pharmacokinetic/safety lead-in study), the long-term safety and tolerability of vortioxetine (5–20 mg/day) were investigated in children and adolescents with a DSM-IV-TR™ diagnosis of depressive or anxiety disorder in the United States or Germany. The study also was designed to provide data to inform dose selection and titration in future pediatric studies with vortioxetine. Methods: Safety evaluations included spontaneously reported adverse events (AEs), the Columbia Suicide Severity Rating Scale (C-SSRS), and the Pediatric Adverse Events Rating Scale (PAERS; clinician administered). Clinical effectiveness was determined by Clinical Global Impressions. Comorbid attention-deficit/hyperactivity disorder was permitted, including concomitant use of stimulant medication (US sites only). Results: Of the 47 patients who completed the lead-in period, 41 continued into the OLE. Most patients (n = 39 [95%]) continued their previous dose regimen. Twenty-one patients (51%) withdrew during the OLE; the most common primary reasons were administrative [n = 8], AEs [n = 4], and lack of efficacy [n = 3]. Thirty-five patients (85%) had ≥1 AE, 86% of which were mild or moderate in severity. Five patients (12%) reported a severe AE, none of which was considered related to study medication. The most common AEs (≥10%) were headache (27%), nausea (20%), dysmenorrhea (females; 19%), and vomiting (15%), with no relationship between AE intensity and age or dose. Five patients reported instances of suicidal ideation during the OLE, one of whom also reported this during the lead-in period. Two patients had nonsuicidal self-injurious behavior; one had a nonfatal suicide attempt. Throughout the study, there was a decrease over time in the incidence and intensity of AEs collected using the PAERS. Effectiveness assessment indicated a trend toward improvement based on numeric results. Conclusion: This OLE confirms the findings from the lead-in study, which concluded that a dosing strategy of 5–20 mg/day is safe, well tolerated, and suitable for future clinical studies of vortioxetine in pediatric patients. PMID:29035574

Comparisons of external fixator combined with limited internal fixation and open reduction and internal fixation for Sanders type 2 calcaneal fractures: Finite element analysis and clinical outcome.

PubMed

Pan, M; Chai, L; Xue, F; Ding, L; Tang, G; Lv, B

2017-07-01

The aim of this study was to compare the biomechanical stability and clinical outcome of external fixator combined with limited internal fixation (EFLIF) and open reduction and internal fixation (ORIF) in treating Sanders type 2 calcaneal fractures. Two types of fixation systems were selected for finite element analysis and a dual cohort study. Two fixation systems were simulated to fix the fracture in a finite element model. The relative displacement and stress distribution were analysed and compared. A total of 71 consecutive patients with closed Sanders type 2 calcaneal fractures were enrolled and divided into two groups according to the treatment to which they chose: the EFLIF group and the ORIF group. The radiological and clinical outcomes were evaluated and compared. The relative displacement of the EFLIF was less than that of the plate (0.1363 mm to 0.1808 mm). The highest von Mises stress value on the plate was 33% higher than that on the EFLIF. A normal restoration of the Böhler angle was achieved in both groups. No significant difference was found in the clinical outcome on the American Orthopedic Foot and Ankle Society Ankle Hindfoot Scale, or on the Visual Analogue Scale between the two groups (p > 0.05). Wound complications were more common in those who were treated with ORIF (p = 0.028). Both EFLIF and ORIF systems were tested to 160 N without failure, showing the new construct to be mechanically safe to use. Both EFLIF and ORIF could be effective in treating Sanders type 2 calcaneal fractures. The EFLIF may be superior to ORIF in achieving biomechanical stability and less blood loss, shorter surgical time and hospital stay, and fewer wound complications. Cite this article : M. Pan, L. Chai, F. Xue, L. Ding, G. Tang, B. Lv. Comparisons of external fixator combined with limited internal fixation and open reduction and internal fixation for Sanders type 2 calcaneal fractures: Finite element analysis and clinical outcome. Bone Joint Res 2017;6:433-438. DOI: 10.1302/2046-3758.67.2000640. © 2017 Xue et al.

Meaning of Pharmacological Treatment for Families of People With Depression.

PubMed

Vedana, Kelly Graziani Giacchero; Magrini, Daniel Fernando; Souza, Jacqueline de; Zanetti, Ana Carolina Guidorizzi; Miasso, Adriana Inocenti; Telles Filho, Paulo Celso Prado; Borges, Tatiana Longo

2016-01-01

Medication adherence is related to patient satisfaction with family support. This research aimed to understand the meaning of pharmacotherapy to families of people with major depressive disorder. This qualitative study employed Grounded Theory and Symbolic Interactionism. Seventeen families of people with depression from a Brazilian clinic were included. Data was collected from 2013 to 2014, using open interviews, which were analyzed by open, axial, and selective coding. Medication represented "Tranquility and worry" because it re-established tranquility in family routine, but generated concerns. Thus, families were conflicted and ambivalent about medications, and they interfered with the promotion or impairment of adherence.

A novel surgical management of hypopharyngeal branchial anomalies.

PubMed

Givens, Daniel J; Buchmann, Luke O; Park, Albert H

2015-04-01

To review our experience treating hypopharyngeal branchial anomalies utilizing an open transcervical approach that: (1) includes recurrent laryngeal nerve (RLN) monitoring and identification if needed; (2) resection of tract if present; and (3) a superiorly based sternothyroid muscle flap for closure. A retrospective chart review was performed to identify all patients at a tertiary level children's hospital with branchial anomalies from 2005 to 2014. The clinical presentation, evaluation, treatment and outcome were analyzed for those patients with hypopharyngeal branchial anomalies. Forty-seven patients who underwent excision of branchial anomalies with a known origin were identified. Thirteen patients had hypopharyngeal branchial anomalies. Six of these patients were treated by the authors of this study and are the focus of this analysis. All six underwent an open transcervical procedure with a sternothyroid muscle flap closure of a piriform sinus opening over a nine year period. Definitive surgery included a microlaryngoscopy and an open transcervical approach to close a fistula between the piriform sinus and neck with recurrent laryngeal nerve monitoring or dissection. A superiorly based sternothyroid muscle flap was used to close the sinus opening. There were no recurrences, recurrent laryngeal nerve injuries or other complications from these procedures. This study supports complete surgical extirpation of the fistula tract using an open cervical approach, recurrent laryngeal nerve monitoring or identification, and rotational muscle flap closure to treat patients with hypopharyngeal branchial anomalies. Published by Elsevier Ireland Ltd.

Clinical Utilization of Repeated Open Application Test Among American Contact Dermatitis Society Members.

PubMed

Brown, Gabrielle E; Botto, Nina; Butler, Daniel C; Murase, Jenny E

2015-01-01

The repeated open application test (ROAT) provides useful information regarding allergens in suspected cases of allergic contact dermatitis; however, standardized methodology has not been established. The aim of this study was to assess how ROAT is used in clinical and research settings. We distributed a survey regarding ROAT practice to the American Contact Dermatitis Society and conducted a literature review of ROAT utilization in research. A total of 67 American Contact Dermatitis Society members participated in the survey. Respondents most frequently recommend application of leave-on products twice daily (46.0%) and rinse-off products once daily (43.5%). The most commonly used anatomical sites include the forearm (38.7%) and antecubital fossa (32.3%). Most respondents continue ROAT for 1 (49.2%) or 2 weeks (31.7%). Literature review of 32 studies (26 leave-on, 6 rinse-off) revealed that application frequency is most common at twice daily for both leave-on (96.2%) and rinse-off (50.0%) products. The most common anatomical site is the forearm (62.5%), with an overall study duration of 3 to 4 weeks (65.6%). When comparing ROAT clinical and research practice, the majority trend was consistent for leave-on product application frequency and anatomical site, but not for rinse-off product application frequency, or overall duration. Further research is needed to determine best practice recommendations.

Perinatal asphyxia in the guinea pig leads to morphologic but not neurologic, cognitive, or behavioral changes.

PubMed

Hoeger, Harald; Bubna-Littitz, Herrmann; Engelmann, Mario; Schwerdtner, Ingrid; Schmid, Diethard; Lahoda, Robert; Seidl, Rainer; Lubec, Gert; Lubec, Barbara

2003-07-01

In a recent publication, we described neurodegeneration along with neurotransmitter deficits and impaired differentiation in the guinea pig 3 months following severe perinatal asphyxia (PA). We were therefore interested in the clinical features in terms of neurology, cognitive functions, and behavior. We tested the long-term effects of PA in an animal model, which in the rat are well documented and resemble the clinical situation. Examinations consisted of an observational battery for motor and reflex functions and the acoustic startle response setting. We tested cognitive functions in the multiple T-maze and evaluated behavior using the elevated plus maze and open field studies. No neurologic deficits were observed in the observational battery, including the acoustic startle response. Cognitive functions of memory and learning were not impaired in the multiple T-maze. In the open field and in the elevated plus maze, the system to test anxiety-related behavior, guinea pigs performed well. Our findings of patent neurology, cognitive functions, and behavior do not reflect the prominent morphologic findings of neurodegeneration. This is in agreement with corresponding studies on PA in the rat at the identical time point. We learned from this study that both test systems, although representing the standard in neuroscience, are either not sensitive enough or central nervous system lesions are clinically fully compensated.

RETRACTED ARTICLE: Clinical effectiveness of continuous passive motion (CPM) following femoroacetabular impingement surgery in adolescents.

PubMed

Hosalkar, Harish; Bomar, James D

2012-08-01

This study hypothesizes that the use of continuous passive motion (CPM) following open femoroacetabular impingement (FAI) surgery in the adolescent population improves clinical outcomes in terms of the modified Harris hip score (mHHS). Twenty-nine symptomatic adolescent FAI patients were postoperatively divided into one of three groups; no CPM, two days of inpatient CPM, and two weeks of CPM. mHHS was used preoperatively and postoperatively at six weeks, three months, six months, and nine months in all cases. Kruskal-Wallis (KW) analysis was performed to determine statistical differences in mHHS. mHHS was then re-evaluated using the Mann-Whitney test. There were no statistically significant differences in hip scores between the three groups preoperatively (p = 0.158). There were statistically significant differences (p < 0.001) in mHHS between the three groups at all postoperative time periods. The group that received two weeks of CPM had the best outcome scores. The results of this study suggest that postoperative CPM use following open hip preservation surgery for symptomatic FAI in adolescents improves clinical outcomes. These benefits seem to be related to the duration of CPM. Retrospective comparative study, Level III. Patients treated one way compared with patients treated another way at the same institution.

Phynx: an open source software solution supporting data management and web-based patient-level data review for drug safety studies in the general practice research database and other health care databases.

PubMed

Egbring, Marco; Kullak-Ublick, Gerd A; Russmann, Stefan

2010-01-01

To develop a software solution that supports management and clinical review of patient data from electronic medical records databases or claims databases for pharmacoepidemiological drug safety studies. We used open source software to build a data management system and an internet application with a Flex client on a Java application server with a MySQL database backend. The application is hosted on Amazon Elastic Compute Cloud. This solution named Phynx supports data management, Web-based display of electronic patient information, and interactive review of patient-level information in the individual clinical context. This system was applied to a dataset from the UK General Practice Research Database (GPRD). Our solution can be setup and customized with limited programming resources, and there is almost no extra cost for software. Access times are short, the displayed information is structured in chronological order and visually attractive, and selected information such as drug exposure can be blinded. External experts can review patient profiles and save evaluations and comments via a common Web browser. Phynx provides a flexible and economical solution for patient-level review of electronic medical information from databases considering the individual clinical context. It can therefore make an important contribution to an efficient validation of outcome assessment in drug safety database studies.

Diagnostic index: an open-source tool to classify TMJ OA condyles

NASA Astrophysics Data System (ADS)

Paniagua, Beatriz; Pascal, Laura; Prieto, Juan; Vimort, Jean Baptiste; Gomes, Liliane; Yatabe, Marilia; Ruellas, Antonio Carlos; Budin, Francois; Pieper, Steve; Styner, Martin; Benavides, Erika; Cevidanes, Lucia

2017-03-01

Osteoarthritis (OA) of temporomandibular joints (TMJ) occurs in about 40% of the patients who present TMJ disorders. Despite its prevalence, OA diagnosis and treatment remain controversial since there are no clear symptoms of the disease, especially in early stages. Quantitative tools based on 3D imaging of the TMJ condyle have the potential to help characterize TMJ OA changes. The goals of the tools proposed in this study are to ultimately develop robust imaging markers for diagnosis and assessment of treatment efficacy. This work proposes to identify differences among asymptomatic controls and different clinical phenotypes of TMJ OA by means of Statistical Shape Modeling (SSM), obtained via clinical expert consensus. From three different grouping schemes (with 3, 5 and 7 groups), our best results reveal that that the majority (74.5%) of the classifications occur in agreement with the groups assigned by consensus between our clinical experts. Our findings suggest the existence of different disease-based phenotypic morphologies in TMJ OA. Our preliminary findings with statistical shape modeling based biomarkers may provide a quantitative staging of the disease. The methodology used in this study is included in an open source image analysis toolbox, to ensure reproducibility and appropriate distribution and dissemination of the solution proposed.

Oromandibular Dystonia: Demographics and Clinical Data from 240 Patients.

PubMed

Slaim, Linda; Cohen, Myriam; Klap, Patrick; Vidailhet, Marie; Perrin, Alain; Brasnu, Daniel; Ayache, Denis; Mailly, Marie

2018-05-01

To report demographic data from a large cohort of patients with oromandibular dystonia (OMD). This is a retrospective review of patients with OMD referred to our institution between 1989 and 2015. Demographic (age of onset, gender, and familial history of dystonia) and clinical (type of OMD, associated dystonia, and etiology of dystonia) data were collected from a cohort of 240 individuals. The mean age of onset of OMD was 51.6 years old, with a female predominance (2:1). A family history of dystonia was found in 6 patients (2.5%). One hundred and forty-nine patients (62.1%) had the jaw-opening type of OMD, 48 patients (20.0%) had the jaw-closing type, and 43 patients (17.9%) had a mixed form of OMD. Lingual dystonia was also present in 64 (26.7%) of these patients. Eighty-two patients (34.2%) had a focal dystonia, 131 patients (54.6%) had a segmental dystonia, and 27 patients (11.3%) had a generalized dystonia. One hundred and seventy-one patients (71.3%) had idiopathic OMD. OMD is a chronic and disabling focal dystonia. Our study found a prevalence of female patients, an onset in middle age and a predominantly idiopathic etiology. Unlike other studies, jaw-opening was found to be the most frequent clinical type of OMD.

Companion animal veterinarians' use of clinical communication skills.

PubMed

McArthur, M L; Fitzgerald, J R

2013-09-01

To describe the communication techniques used by clients and veterinarians during companion animal visits in Australia. A cross-sectional descriptive study. A total of 64 veterinary consultations were audiotaped and analysed with the Roter Interaction Analysis System (RIAS); clients completed appointment level measures, including their satisfaction and perceptions of relational communication. Participants were 24 veterinarians and 64 clients. Statements intended to reassure clients were expressed frequently in the consultations, but in 59% of appointments empathy statements were not expressed towards either the client or the patient. In 10% of appointments, veterinarians did not used any open-ended questions. Overall client satisfaction was high and veterinarians' expressions of empathy directed to the client resulted in higher levels of client satisfaction. Clients' perceptions of relational communication were related to several veterinarian and client nonverbal scales. A focus on developing evidence-based clinical communication skills is expected to further enhance the veterinarian-client-patient relationship and associated clinical outcomes. Particular recommendations include the development of a broader emotion-handling repertoire, increased emphasis on the use of open-ended enquiry, including assessment of the client's perspective, as well as attention to aspects of nonverbal communication. The study provides preliminary evidence for the importance of verbal expressions of empathy during the companion animal consultation. © 2013 Australian Veterinary Association.

Cost comparison of laparoscopic colectomy versus open colectomy in colon cancer.

PubMed

Fitch, Kathryn; Bochner, Andrew; Keller, Deborah S

2017-07-01

Laparoscopic colectomy has been shown to be safe, oncologically comparable, and clinically beneficial over open colectomy for colon cancer, but utilization remains low. Objectives To evaluate the cost of laparoscopic colectomy vs open colectomy for colon cancer. The authors conducted a retrospective claims data analysis using the 2012 and 2013 Truven Health Analytics MarketScan Commercial Claims and Encounter Database. The denominator population consisted of individuals who had commercial insurance coverage in all months of 2012 and >1 month in 2013 and pharmacy coverage throughout eligibility. The study population included individuals aged 18-64 years who were identified with colon cancer in 2013 and underwent an elective inpatient open colectomy or laparoscopic colectomy between January and November 2013. The cost and re-admission rate of open vs laparoscopic colectomy were compared after risk, adjusting for comorbidities, demographics, and geographic region. During the study period, 1299 elective inpatient colon cancer colectomies were performed (open, n = 558; laparoscopic, n = 741). After risk adjustment, the laparoscopic vs open group was shown to have lower re-admission rates (6.61 and 10.93 per 100 cases, respectively, p = .0165), lower average re-admission costs ($1676 and $3151, respectively, p = .0309), and lower 30-day post-discharge healthcare utilization costs ($4842 and $7121, respectively, p = .0047). Average allowed cost for the combined inpatient and 30-day post-discharge period was lower for laparoscopic vs open colectomy cases ($36,395 and $44,226, respectively, p < .001). The cost of laparoscopic colectomy was found to be statistically significantly less than that of open colectomy in patients undergoing elective surgery for colon cancer.

Graphical overview and navigation of electronic health records in a prototyping environment using Google Earth and openEHR archetypes.

PubMed

Sundvall, Erik; Nyström, Mikael; Forss, Mattias; Chen, Rong; Petersson, Håkan; Ahlfeldt, Hans

2007-01-01

This paper describes selected earlier approaches to graphically relating events to each other and to time; some new combinations are also suggested. These are then combined into a unified prototyping environment for visualization and navigation of electronic health records. Google Earth (GE) is used for handling display and interaction of clinical information stored using openEHR data structures and 'archetypes'. The strength of the approach comes from GE's sophisticated handling of detail levels, from coarse overviews to fine-grained details that has been combined with linear, polar and region-based views of clinical events related to time. The system should be easy to learn since all the visualization styles can use the same navigation. The structured and multifaceted approach to handling time that is possible with archetyped openEHR data lends itself well to visualizing and integration with openEHR components is provided in the environment.

A Qualitative Study of the Influences on Clinical Academic Physicians' Postdoctoral Career Decision-Making.

PubMed

Ranieri, Veronica F; Barratt, Helen; Rees, Geraint; Fulop, Naomi J

2018-01-23

To describe the influences on clinical academic physicians' postdoctoral career decision-making. Thirty-five doctoral trainee physicians from University College London took part in semi-structured interviews in 2015 and 2016. Participants were asked open-ended questions about their career to-date, their experiences undertaking a PhD, and their career plans post-PhD. The interviews were audio-recorded and transcribed. Thematic analysis was used to generate, review, and define themes from the transcripts. Emerging differences and similarities in participants' reasons for pursuing a PhD were then grouped to produce typologies to explore how their experiences influenced their career decision-making. Participants described four key reasons for undertaking a PhD, which formed the basis of the four typologies identified. These reasons included: to pursue a clinical academic career; to complete an extensive period of research to understand whether a clinical academic career was the desired path forward; to improve clinical career prospects; and to take a break from clinical training. These findings highlight the need to target efforts at retaining clinical academic physicians according to their reasons for pursuing a PhD and their subsequent experiences with the process. Those responsible for overseeing clinical training must be well-informed of the long-term benefits of training academically-qualified physicians. In light of current political uncertainty, universities, hospitals, and external agencies alike must increase their efforts to inspire and assuage early-career clinical academic physicians' fears regarding their academic future.This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

[Effectiveness of Vitex agnus-castus preparations].

PubMed

Gorkow, C; Wuttke, W; März, R W

2002-01-01

The prolactin-inhibiting effect of ACF-preparations, which is due to dopaminergic activities, has been shown in humans too and gives a pharmacological rationale for the clinical effects observed in the different indications (2, 11, 25, 26, 35, 41). Confirmation of efficacy in the treatment of mastalgia has been best endorsed by two recently published double-blind studies conducted according to the principles of GCP (14, 41). One double-blind study, several open and postmarketing surveillance studies have shown that the premenstrual syndrome, or individual symptoms, can be influenced positively (3, 6, 7, 9, 19, 21, 37). Design shortcomings in a second double-blind study should be eliminated in future studies in this indication to improve the body of evidence (18). Hither to there has been one controlled double-blind study of cycle disorders in the case of corpus luteum insufficiency with significant results and a number of non-controlled open studies (1, 4, 15, 16, 20, 24, 26, 27, 32, 35, 36). The high success rates in the open studies indicate therapeutic effects, and it should be possible to reproduce these results under double-blind conditions. The success rates on fertility disorders should be confirmed in controlled double-blind studies (10, 33, 34).

Long-term treatment of Cushing's disease with pasireotide: 5-year results from an open-label extension study of a Phase III trial.

PubMed

Petersenn, S; Salgado, L R; Schopohl, J; Portocarrero-Ortiz, L; Arnaldi, G; Lacroix, A; Scaroni, C; Ravichandran, S; Kandra, A; Biller, B M K

2017-07-01

Treating hypercortisolism in patients with Cushing's disease after failed surgery often requires chronic medication, underlining the need for therapies with favourable long-term efficacy and safety profiles. In a randomised, double-blind study, 162 adult patients with persistent/recurrent or de novo Cushing's disease received pasireotide. Patients with mean urinary free cortisol at/below the upper limit of normal or clinical benefit at month 12 could continue receiving pasireotide during an open-ended, open-label phase, the outcomes of which are described herein. Sixteen patients received 5 years of pasireotide treatment. Among these, median (95% confidence interval) percentage change from baseline in mean urinary free cortisol was -82.6% (-89.0, -41.9) and -81.8% (-89.8, -67.4) at months 12 and 60. Eleven patients had mean urinary free cortisol ≤ upper limit of normal at month 60. Improvements in clinical signs were sustained during long-term treatment. The safety profile of pasireotide at 5 years was similar to that reported after 12 months. Fifteen of 16 patients experienced a hyperglycaemia-related adverse event; glycated haemoglobin levels were stable between months 6 and 60. Adverse events related to hyperglycaemia, bradycardia, gallbladder/biliary tract, and liver safety were most likely to first occur by month 6; adverse event severity did not tend to worsen over time. This represents the longest prospective trial of a medical therapy for Cushing's disease to date. A subset of patients treated with pasireotide maintained biochemical and clinical improvements for 5 years, with no new safety signals emerging. These data support the use of pasireotide as an effective long-term therapy for some patients with Cushing's disease.

Risk assessment analysis of the future technical unit dedicated to the evaluation and treatment of motor disabilities.

PubMed

Grelier, S; Thetio, M; Quentin, V; Achache, V; Sanchez, N; Leroux, V; Durand, E; Pequignot, R

2011-03-01

The National Hospital of Saint Maurice (HNSM) for Physical Medicine and Rehabilitation aims at strengthening its position as a pivot rehabilitation and physical therapy center. The opening in 2011 of a new unit for the evaluation and treatment of motor disabilities meets this objective. This project includes several parts: clinical, financial, architectural, organizational, applied clinical research as well as dealing with medical equipments and information system. This study focuses on the risk assessment of this future technical unit. This study was conducted by a group of professionals working for the hospital. It started with the design of a functional model to better comprehend the system to be analyzed. Risk assessment consists in confronting this functional model to a list of dangers in order to determine the vulnerable areas of the system. Then the team designed some scenarios to identify the causes, securities barriers and consequences in order to rank the risks. The analysis targeted various dangers, e.g. political, strategic, financial, economical, marketing, clinical and operational. The team identified more than 70 risky scenarios. For 75% of them the criticality level was deemed initially tolerable and under control or unacceptable. The implementation of an action plan for reducing the level of risks before opening this technical unit brought the system down to an acceptable level at 66%. A year prior to opening this technical unit for the evaluation and treatment of motor disabilities, conducting this preliminary risk assessment, with its exhaustive and rigorous methodology, enabled the concerned professionals to work together around an action plan for reducing the risks. 2011 Elsevier Masson SAS. All rights reserved.

Ventilation and cardiac related impedance changes in children undergoing corrective open heart surgery.

PubMed

Schibler, Andreas; Pham, Trang M T; Moray, Amol A; Stocker, Christian

2013-10-01

Electrical impedance tomography (EIT) can determine ventilation and perfusion relationship. Most of the data obtained so far originates from experimental settings and in healthy subjects. The aim of this study was to demonstrate that EIT measures the perioperative changes in pulmonary blood flow after repair of a ventricular septum defect in children with haemodynamic relevant septal defects undergoing open heart surgery. In a 19 bed intensive care unit in a tertiary children's hospital ventilation and cardiac related impedance changes were measured using EIT before and after surgery in 18 spontaneously breathing patients. The EIT signals were either filtered for ventilation (ΔZV) or for cardiac (ΔZQ) related impedance changes. Impedance signals were then normalized (normΔZV, normΔZQ) for calculation of the global and regional impedance related ventilation perfusion relationship (normΔZV/normΔZQ). We observed a trend towards increased normΔZV in all lung regions, a significantly decreased normΔZQ in the global and anterior, but not the posterior lung region. The normΔZV/normΔZQ was significantly increased in the global and anterior lung region. Our study qualitatively validates our previously published modified EIT filtration technique in the clinical setting of young children with significant left-to-right shunt undergoing corrective open heart surgery, where perioperative assessment of the ventilation perfusion relation is of high clinical relevance.

Healthcare professionals’ perceptions of clinical governance implementation: a qualitative New Zealand study of 3205 open-ended survey comments

PubMed Central

Gauld, Robin; Horsburgh, Simon

2015-01-01

Objectives To investigate healthcare professional perceptions of local implementation of a national clinical governance policy in New Zealand. Design Respondent comments written at the end of a national healthcare professional survey designed to assess implementation of core components of the clinical governance policy. Setting The written comments were provided by respondents to a survey distributed to over 41 000 registered healthcare professionals employed in 19 of New Zealand's government-funded District Health Boards. Comments were analysed and categorised within emerging themes. Results 3205 written comments were received. Five key themes illustrating barriers to clinical governance implementation were found, representing problems with: developing management–clinical relations; clinicians stepping up into clinical governance and leadership activities; interprofessional relations; training needs for governance and leadership; and having insufficient time to get involved. Conclusions Despite a national policy on clinical governance which New Zealand's government launched in 2009, this study found that considerable effort is required to build clinical governance at the local level. This finding parallels with other studies in the field. Two areas demand attention: building systems for organisational governance and leadership; and building professional governance arrangements. PMID:25564142

What are the primary concerns of nursing students as they prepare for and contemplate their first clinical placement experience?

PubMed

Levett-Jones, Tracy; Pitt, Victoria; Courtney-Pratt, Helen; Harbrow, Gwyneth; Rossiter, Rachel

2015-07-01

Nursing students' first clinical placement experience can be a critical turning point -reinforcing professional aspirations for some, and for others, a time of emotional turbulence. There is a paucity of research focusing on students' perceptions and concerns prior to their first placement experience. Thus, the aim of this study was to explore the concerns of first year bachelor of nursing students from one Australian university as they prepared for their first clinical placement. Participants completed an online 'readiness for practice' survey consisting of 22 items. This paper focuses on participants' responses to the one open ended question: 'Please comment on any concerns that you have in relation to being prepared for your first clinical placement'. Summative qualitative content analysis was used for analysis. 144 students (55%) responded to the open ended question. Responses were categorised into six themes including: Not prepared for placement; feeling nervous, anxious and worried; bullying and belonging; practicalities; patient safety and making mistakes; and working outside of my scope of practice. It appears that activities designed to equip students with the capacity to manage the inherent challenges of undertaking a clinical placement may sometimes have a paradoxical effect by increasing students' level of stress and anxiety. An enhanced understanding of students' concerns may help educators implement appropriate support strategies. Copyright © 2015 Elsevier Ltd. All rights reserved.

Open referral policy within a nurse-led memory clinic: patient demographics, assessment scores, and diagnostic profiles.

PubMed

Minstrell, Melinda; Bentley, Michael; Bucher, Hazel; Morrissey, Martin; Higgs, Carl; Robinson, Andrew; Stirling, Christine

2015-06-01

Memory clinics, typically led by multidisciplinary teams and requiring health professional referral, are one means of providing diagnosis and care coordination for dementia. Nurse-led clinics may provide an effective and alternative means to dementia diagnosis, and open referral policies may minimize existing barriers to accessing a diagnosis, but evidence is needed. Patients attending a one-day per week nurse-led memory clinic over a 25-month period during 2011-2013 (n = 106) completed comprehensive cognitive assessments and were diagnosed by an aged care nurse practitioner. Descriptive statistics detail the demographics, assessment scores, and diagnostic profiles of patients. Comparable data from published literature was identified, and the differences were analyzed qualitatively. One hundred and six patients were assessed with the key differences from other data sets being history of falls more common, higher mean Mini-Mental State Examination scores, and fewer dementia diagnoses. Sixty-four patients (60%) were self-referred to the nurse-led memory clinic, of which 19 (30%) were diagnosed with mild cognitive impairment (MCI) or dementia. Overall, forty-eight patients (45%) received diagnoses of MCI or dementia. An open referral policy led to a high proportion of patients being self-referred, and nearly a third of these were diagnosed with cognitive impairment or dementia. Open referral policies and nurse-led services may overcome some of the barriers to early diagnosis that are currently experienced. Considering an aging population worldwide and the associated increases in cognitive impairment, which benefits from early identification and intervention, this paper provides an alternative model of nurse-led assessment.

Open access gastroscopy: too much to swallow?

PubMed Central

Kerrigan, D D; Brown, S R; Hutchinson, G H

1990-01-01

OBJECTIVES--To ascertain the proportion of endoscopic examinations with normal findings in patients referred for gastroscopy through hospital medical staff or directly by their general practitioner and to assess the likely effect of targeting endoscopy in older patients. DESIGN--Retrospective audit of the gastroscopy practice of one consultant from 1986 to 1988 from information recorded on a standard form completed at the time of the examination, which contained details of patients, their endoscopic findings, and mode of referral (open access or clinic). SETTING--One district general hospital. PATIENTS--1545 Consecutive patients from primary catchment area attending for their first gastroscopy; 454 were referred through the outpatient clinic or by hospital colleagues (clinic group) and 1091 were accepted for endoscopy solely on their general practitioner's clinical diagnosis (open access group). RESULTS--Similar numbers (about 40%) of examinations with normal findings were performed in each group, although in patients aged over 40 the proportion with normal findings was significantly higher in the clinic group (p less than 0.03). Endoscopic evidence of gastro-oesophageal reflux disease, peptic ulceration, and gastroduodenal inflammation was equally common in each group; upper gastrointestinal malignancy, however, was significantly more common in patients referred through hospital doctors (5%, 23/454 v 2%, 22/1091 respectively; p less than 0.005) (although many of these patients had already been extensively investigated). IMPLICATIONS--Open access gastroscopy does not increase the number of unnecessary examinations and should become more widely available. Targeting this service to patients aged over 40 would reduce the number of requests but increase the diagnostic yield. PMID:2106992

A Handheld Open-Field Infant Keratometer (An American Ophthalmological Society Thesis)

PubMed Central

Miller, Joseph M.

2010-01-01

Purpose: To design and evaluate a new infant keratometer that incorporates an unobstructed view of the infant with both eyes (open-field design). Methods: The design of the open-field infant keratometer is presented, and details of its construction are given. The design incorporates a single-ring keratoscope for measurement of corneal astigmatism over a 4-mm region of the cornea and includes a rectangular grid target concentric within the ring to allow for the study of higher-order aberrations of the eye. In order to calibrate the lens and imaging system, a novel telecentric test object was constructed and used. The system was bench calibrated against steel ball bearings of known dimensions and evaluated for accuracy while being used in handheld mode in a group of 16 adult cooperative subjects. It was then evaluated for testability in a group of 10 infants and toddlers. Results: Results indicate that while the device achieved the goal of creating an open-field instrument containing a single-ring keratoscope with a concentric grid array for the study of higher-order aberrations, additional work is required to establish better control of the vertex distance. Conclusion: The handheld open-field infant keratometer demonstrates testability suitable for the study of infant corneal astigmatism. Use of collimated light sources in future iterations of the design must be incorporated in order to achieve the accuracy required for clinical investigation. PMID:21212850

A handheld open-field infant keratometer (an american ophthalmological society thesis).

PubMed

Miller, Joseph M

2010-12-01

To design and evaluate a new infant keratometer that incorporates an unobstructed view of the infant with both eyes (open-field design). The design of the open-field infant keratometer is presented, and details of its construction are given. The design incorporates a single-ring keratoscope for measurement of corneal astigmatism over a 4-mm region of the cornea and includes a rectangular grid target concentric within the ring to allow for the study of higher-order aberrations of the eye. In order to calibrate the lens and imaging system, a novel telecentric test object was constructed and used. The system was bench calibrated against steel ball bearings of known dimensions and evaluated for accuracy while being used in handheld mode in a group of 16 adult cooperative subjects. It was then evaluated for testability in a group of 10 infants and toddlers. Results indicate that while the device achieved the goal of creating an open-field instrument containing a single-ring keratoscope with a concentric grid array for the study of higher-order aberrations, additional work is required to establish better control of the vertex distance. The handheld open-field infant keratometer demonstrates testability suitable for the study of infant corneal astigmatism. Use of collimated light sources in future iterations of the design must be incorporated in order to achieve the accuracy required for clinical investigation.

Effects of Inhalation of Lavender Essential Oil on Open-heart Surgery Pain.

PubMed

Salamati, Armaiti; Mashouf, Soheyla; Sahbaei, Faezeh; Mojab, Faraz

2014-01-01

This study evaluated the effects of inhalation of lavender essential oil on the pain of open-heart surgery. The main complaint of patients after open-heart surgery is chest pain. Due to the side effects of opioids, it is important to use a non-invasive way to effectively relieve pain including aromatherapy with analgesics. This study was a clinical single-blind trial and was conducted on 40 patients who had open-heart surgery in the cardiac ICU of 2 Hospitals of Tehran University of Medical Sciences, 2012. Criteria included: full consciousness, spontaneous breathing ability and not using synthetic opioids within 2 hours before extubation. After extubation, the patients were asked to mark the intensity of their pain using the visual analogue scale. Then, a cotton swab which was impregnated with 2 drops of lavender essential oil 2% was placed in their oxygen mask, and they got breath for 10 minutes. 30 minutes after aromatherapy, they were asked to re-mark their pain intensity. The level of patient's pain before and after aroma therapy were compared. The pain mean level before and after inhaling lavender essential oil was 5.60 (SD = 2.262) and 4.98 (SD = 2.293), respectively (p-value>0.05). Therefore, there is no significant difference and the result of study proves that lavender essential oil inhalation has no effect on reducing the pain of open-heart surgery.

Effects of Inhalation of Lavender Essential Oil on Open-heart Surgery Pain

PubMed Central

Salamati, Armaiti; Mashouf, Soheyla; Sahbaei, Faezeh; Mojab, Faraz

2014-01-01

This study evaluated the effects of inhalation of lavender essential oil on the pain of open-heart surgery. The main complaint of patients after open-heart surgery is chest pain. Due to the side effects of opioids, it is important to use a non-invasive way to effectively relieve pain including aromatherapy with analgesics. This study was a clinical single-blind trial and was conducted on 40 patients who had open-heart surgery in the cardiac ICU of 2 Hospitals of Tehran University of Medical Sciences, 2012. Criteria included: full consciousness, spontaneous breathing ability and not using synthetic opioids within 2 hours before extubation. After extubation, the patients were asked to mark the intensity of their pain using the visual analogue scale. Then, a cotton swab which was impregnated with 2 drops of lavender essential oil 2% was placed in their oxygen mask, and they got breath for 10 minutes. 30 minutes after aromatherapy, they were asked to re-mark their pain intensity. The level of patient’s pain before and after aroma therapy were compared. The pain mean level before and after inhaling lavender essential oil was 5.60 (SD = 2.262) and 4.98 (SD = 2.293), respectively (p-value>0.05). Therefore, there is no significant difference and the result of study proves that lavender essential oil inhalation has no effect on reducing the pain of open-heart surgery. PMID:25587315

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

PubMed

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

2017-06-01

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

Hip arthroscopy versus open surgical dislocation for femoroacetabular impingement

PubMed Central

Zhang, Dagang; Chen, Long; Wang, Guanglin

2016-01-01

Abstract Background: This meta-analysis aims to evaluate the efficacy and safety of hip arthroscopy versus open surgical dislocation for treating femoroacetabular impingement (FAI) through published clinical trials. Methods: We conducted a comprehensive literature search using PUBMED, EMBASE, and the Cochrane Central Register of Controlled Trials databases for relevant studies on hip arthroscopy and open surgical dislocation as treatment options for FAI. Results: Compared with open surgical dislocation, hip arthroscopy resulted in significantly higher Nonarthritic Hip Scores (NAHS) at 3- and 12-month follow-ups, a significant improvement in NAHS from preoperation to 3 months postoperation, and a significantly lower reoperation rate. Open surgical dislocation resulted in a significantly improved alpha angle by the Dunn view in patients with cam osteoplasty from preoperation to postoperation, compared with hip arthroscopy. This meta-analysis demonstrated no significant differences in the modified Harris Hip Score, Hip Outcome Score-Activities of Daily Living, or Hip Outcome Score-Sport Specific Subscale at 12 months of follow-up, or in complications (including nerve damage, wound infection, and wound dehiscence). Conclusion: Hip arthroscopy resulted in higher NAHS and lower reoperation rates, but had less improvement in alpha angle in patients with cam osteoplasty, than open surgical dislocation. PMID:27741133

The association between clinical parameters and glaucoma-specific quality of life in Chinese primary open-angle glaucoma patients.

PubMed

Lee, Jacky W Y; Chan, Catherine W S; Chan, Jonathan C H; Li, Q; Lai, Jimmy S M

2014-08-01

OBJECTIVE. To investigate the association between clinical measurements and glaucoma-specific quality of life in Chinese glaucoma patients. DESIGN. Cross-sectional study. SETTING. An academic hospital in Hong Kong. PATIENTS. A Chinese translation of the Glaucoma Quality of Life-15 questionnaire was completed by 51 consecutive patients with bilateral primary open-angle glaucoma. The binocular means of several clinical measurements were correlated with Glaucoma Quality of Life-15 findings using Pearson's correlation coefficient and linear regression. The measurements were the visual field index and pattern standard deviation from the Humphrey Field Analyzer, Snellen best-corrected visual acuity, presenting intra-ocular pressure, current intra-ocular pressure, average retinal nerve fibre layer thickness via optical coherence tomography, and the number of topical anti-glaucoma medications being used. RESULTS. In these patients, there was a significant correlation and linear relationship between a poorer Glaucoma Quality of Life-15 score and a lower visual field index (r=0.3, r(2)=0.1, P=0.01) and visual acuity (r=0.3, r(2)=0.1, P=0.03). A thinner retinal nerve fibre layer also correlated with a poorer Glaucoma Quality of Life-15 score, but did not attain statistical significance (r=0.3, P=0.07). There were no statistically significant correlations for the other clinical parameters with the Glaucoma Quality of Life-15 scores (all P values being >0.7). The three most problematic activities affecting quality of life were "adjusting to bright lights", "going from a light to a dark room or vice versa", and "seeing at night". CONCLUSION. For Chinese primary open-angle glaucoma patients, binocular visual field index and visual acuity correlated linearly with glaucoma-specific quality of life, and activities involving dark adaptation were the most problematic.

Minimally invasive, nonendoscopic thyroidectomy: a cosmetic alternative to robotic-assisted thyroidectomy.

PubMed

Govednik, Cara M; Snyder, Samuel K; Quinn, Courtney E; Saxena, Saurabh; Jupiter, Daniel C

2014-10-01

The desire to improve cosmesis has driven the introduction of robotic-assisted and video-assisted thyroidectomy techniques. We report on minimally invasive thyroidectomy (MIT) through a 2-cm incision without the added need for video assistance and hypothesize similar clinical results to standard open thyroidectomy. Between May 2012 and December 2013, 62 nonendoscopic MIT were evaluated for demographics, clinical outcomes, and patient satisfaction on a 1-10 scale. The results were compared with a case-matched control group who underwent conventional open thyroidectomy by the same surgeon. The 124 study patients demonstrated no differences between groups for demographics or clinical outcomes except a smaller thyroid lobe in the MIT group (9.2 vs 11.7 g; P = .05). There were longer operative times in the MIT group (135.4 vs 119.6 minutes; P = .07) that were not equivalent by equivalence testing (P = .534). In MIT patients, transient recurrent laryngeal nerve injury occurred per nerves at risk (1.1% vs 3.4%; P = .62) with no permanent injuries in either group. There was no difference in symptomatic hypocalcemia (9.7% vs 11.3%; P = .77) and postoperative hematoma (0% vs 3.2%; P = .50). On follow-up, the measured MIT scar was significantly shorter (2.22 vs 3.98 cm; P < .00001), which resulted in significantly improved cosmetic satisfaction ratings (9.56 vs 8.66; P = .03). In selected patients, MIT through a 2-cm incision without endoscopic assistance is a safe alternative to standard open thyroidectomy in the hands of an experienced endocrine surgeon. The operating time is slightly increased, but clinical results are equivalent and patient satisfaction is significantly improved. Copyright © 2014 Elsevier Inc. All rights reserved.

Complex and open fractures: a straightforward approach to management in the cat.

PubMed

Corr, Sandra

2012-01-01

Cats often present with traumatic injuries of the limbs, including complex and open fractures, frequently as a result of road traffic accidents. On initial assessment, complex and open fractures may appear to require expertise beyond the experience of the general practitioner and, in some cases, referral to a specialist may be indicated or amputation should be considered. Many cases, however, can be managed using straightforward principles. This review describes a logical and practical approach to treating such injuries. It discusses general principles of fracture management, highlights the treatment of open fractures, and describes the use of external skeletal fixation for stabilisation of both open and complex fractures. Most fractures can be stabilised using equipment and expertise available in general practice if the basic principles of fracture fixation are understood and rigorously applied. Many textbooks and journal articles have been published on the management of fractures in companion animals, presenting case studies, case series and original biomechanical research. The simple strategy for managing complex injuries that is provided in this review is based on the published literature and the author's clinical experience.

[Predicting the probability of development and progression of primary open angle glaucoma by regression modeling].

PubMed

Likhvantseva, V G; Sokolov, V A; Levanova, O N; Kovelenova, I V

2018-01-01

Prediction of the clinical course of primary open-angle glaucoma (POAG) is one of the main directions in solving the problem of vision loss prevention and stabilization of the pathological process. Simple statistical methods of correlation analysis show the extent of each risk factor's impact, but do not indicate the total impact of these factors in personalized combinations. The relationships between the risk factors is subject to correlation and regression analysis. The regression equation represents the dependence of the mathematical expectation of the resulting sign on the combination of factor signs. To develop a technique for predicting the probability of development and progression of primary open-angle glaucoma based on a personalized combination of risk factors by linear multivariate regression analysis. The study included 66 patients (23 female and 43 male; 132 eyes) with newly diagnosed primary open-angle glaucoma. The control group consisted of 14 patients (8 male and 6 female). Standard ophthalmic examination was supplemented with biochemical study of lacrimal fluid. Concentration of matrix metalloproteinase MMP-2 and MMP-9 in tear fluid in both eyes was determined using 'sandwich' enzyme-linked immunosorbent assay (ELISA) method. The study resulted in the development of regression equations and step-by-step multivariate logistic models that can help calculate the risk of development and progression of POAG. Those models are based on expert evaluation of clinical and instrumental indicators of hydrodynamic disturbances (coefficient of outflow ease - C, volume of intraocular fluid secretion - F, fluctuation of intraocular pressure), as well as personalized morphometric parameters of the retina (central retinal thickness in the macular area) and concentration of MMP-2 and MMP-9 in the tear film. The newly developed regression equations are highly informative and can be a reliable tool for studying of the influence vector and assessment of pathogenic potential of the independent risk factors in specific personalized combinations.

Laparoscopic versus open 1-stage resection of synchronous liver metastases and primary colorectal cancer

PubMed Central

Yazici, Pinar; Onder, Akin; Benlice, Cigdem; Yigitbas, Hakan; Kahramangil, Bora; Tasci, Yunus; Aksoy, Erol; Aucejo, Federico; Quintini, Cristiano; Miller, Charles; Berber, Eren

2017-01-01

Background The aim of this study is to compare the perioperative and oncologic outcomes of open and laparoscopic approaches for concomitant resection of synchronous colorectal cancer and liver metastases. Methods Between 2006 and 2015, all patients undergoing combined resection of primary colorectal cancer and liver metastases were included in the study (n=43). Laparoscopic and open groups were compared regarding clinical, perioperative and oncologic outcomes. Results There were 29 patients in the open group and 14 patients in the laparoscopic group. The groups were similar regarding demographics, comorbidities, histopathological characteristics of the primary tumor and liver metastases. Postoperative complication rate (44.8% vs. 7.1%, P=0.016) was higher, and hospital stay (10 vs. 6.4 days, P=0.001) longer in the open compared to the laparoscopic group. Overall survival (OS) was comparable between the groups (P=0.10); whereas, disease-free survival (DFS) was longer in laparoscopic group (P=0.02). Conclusions According to the results, in patients, whose primary colorectal cancer and metastatic liver disease was amenable to a minimally invasive resection, a concomitant laparoscopic approach resulted in less morbidity without compromising oncologic outcomes. This suggests that a laparoscopic approach may be considered in appropriate patients by surgeons with experience in both advanced laparoscopic liver and colorectal techniques. PMID:28861371

Laparoscopic versus open 1-stage resection of synchronous liver metastases and primary colorectal cancer.

PubMed

Gorgun, Emre; Yazici, Pinar; Onder, Akin; Benlice, Cigdem; Yigitbas, Hakan; Kahramangil, Bora; Tasci, Yunus; Aksoy, Erol; Aucejo, Federico; Quintini, Cristiano; Miller, Charles; Berber, Eren

2017-08-01

The aim of this study is to compare the perioperative and oncologic outcomes of open and laparoscopic approaches for concomitant resection of synchronous colorectal cancer and liver metastases. Between 2006 and 2015, all patients undergoing combined resection of primary colorectal cancer and liver metastases were included in the study (n=43). Laparoscopic and open groups were compared regarding clinical, perioperative and oncologic outcomes. There were 29 patients in the open group and 14 patients in the laparoscopic group. The groups were similar regarding demographics, comorbidities, histopathological characteristics of the primary tumor and liver metastases. Postoperative complication rate (44.8% vs . 7.1%, P=0.016) was higher, and hospital stay (10 vs . 6.4 days, P=0.001) longer in the open compared to the laparoscopic group. Overall survival (OS) was comparable between the groups (P=0.10); whereas, disease-free survival (DFS) was longer in laparoscopic group (P=0.02). According to the results, in patients, whose primary colorectal cancer and metastatic liver disease was amenable to a minimally invasive resection, a concomitant laparoscopic approach resulted in less morbidity without compromising oncologic outcomes. This suggests that a laparoscopic approach may be considered in appropriate patients by surgeons with experience in both advanced laparoscopic liver and colorectal techniques.

Effect of methylphenidate on the quality of life in children with epilepsy and attention deficit hyperactivity disorder: and open-label study using an osmotic-controlled release oral delivery system.

PubMed

Yoo, Hanik K; Park, Subin; Wang, Hee-Ryung; Lee, Joong Sun; Kim, Kunwoo; Paik, Kyoung-Won; Yum, Mi Sun; Ko, Tae-Sung

2009-12-01

This open study explored whether methylphenidate could be tolerated and effective in improving the quality of life (QOL) and attention deficit hyperactivity disorder (ADHD) symptoms of children with epilepsy and ADHD. Twenty-five subjects (aged 10.1 +/- 3.0 years) with ADHD and epilepsy were recruited at an outpatient clinic in Seoul, Korea. We used the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE), ADHD rating scale (ARS) and clinical global impression (CGI) in this study. Osmotic-controlled release oral delivery system (OROS) methylphenidate, 1.0 +/- 0.4 mg/kg/day, was administered for 55.2 +/- 7.5 days. The QOL subscales including physical restriction (p = 0.005), self-esteem (p = 0.002), memory (p < 0.001), language (p = 0.005), other cognition (p < 0.001), social interaction (p = 0.002), behaviour (p < 0.001), general health (p = 0.002) and QOL (p < 0.001) were significantly increased and the ARS (p < 0.001) and CGI-Severity of illness scores (p < 0.001) were significantly reduced after medication. Although 60% of subjects had experienced adverse effects, most were tolerable and only two subjects withdrew from the study owing to unbearable adverse effects (anorexia and insomnia). Two subjects had seizure attacks during the study period without having to discontinue the trial drug. Despite limitations related to the small sample size and the open design of the present pilot study, our results suggest that OROS methylphenidate may be well tolerated and effective in reducing ADHD symptoms and improving QOL in this patient population.

A multicentre, open-label, follow-on study to assess the long-term maintenance of effect, tolerance and safety of THC/CBD oromucosal spray in the management of neuropathic pain.

PubMed

Hoggart, B; Ratcliffe, S; Ehler, E; Simpson, K H; Hovorka, J; Lejčko, J; Taylor, L; Lauder, H; Serpell, M

2015-01-01

Peripheral neuropathic pain (PNP) poses a significant clinical challenge. The long-term efficacy of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was investigated in this 38-week open-label extension study. In total, 380 patients with PNP associated with diabetes or allodynia entered this study from two parent randomised, controlled trials. Patients received THC/CBD spray for a further 38 weeks in addition to their current analgesic therapy. Neuropathic pain severity was the primary efficacy measure using a pain 0-10 numerical rating scale (NRS). Additional efficacy, safety and tolerability outcomes were also investigated. In total, 234 patients completed the study (62 %). The pain NRS showed a decrease in score over time in patients from a mean of 6.9 points (baseline in the parent studies) to a mean of 4.2 points (end of open-label follow-up). The proportion of patients who reported at least a clinically relevant 30 % improvement in pain continued to increase with time (up to 9 months); at least half of all patients reported a 30 % improvement at all time points. Improvements were observed for all secondary efficacy outcomes, including sleep quality 0-10 NRS scores, neuropathic pain scale scores, subject global impression of change and EQ-5D questionnaire scores. THC/CBD spray was well tolerated for the study duration and patients did not seek to increase their dose with time, with no new safety concerns arising from long-term use. In this previously difficult to manage patient population, THC/CBD spray was beneficial for the majority of patients with PNP associated with diabetes or allodynia.

Oral Disease Profiles in Chronic Graft versus Host Disease

PubMed Central

Fassil, H.; Mays, J.W.; Edwards, D.; Baird, K.; Steinberg, S.M.; Cowen, E.W.; Naik, H.; Datiles, M.; Stratton, P.; Gress, R.E.; Pavletic, S.Z.

2015-01-01

At least half of patients with chronic graft-versus-host-disease (cGVHD), the leading cause of morbidity and non-relapse mortality after allogeneic stem cell transplantation, have oral manifestations: mucosal lesions, salivary dysfunction, and limited mouth-opening. cGVHD may manifest in a single organ or affect multiple organ systems, including the mouth, eyes, and the skin. The interrelationship of the 3 oral manifestations of cGVHD with each other and with the specific manifestations of extraoral cGVHD has not been studied. In this analysis, we explored, in a large group of patients with cGVHD, the potential associations between: (1) oral mucosal disease and erythematous skin disease, (2) salivary gland dysfunction and lacrimal gland dysfunction, and (3) limited mouth-opening and sclerotic skin cGVHD. Study participants, enrolled in a cGVHD Natural History Protocol (NCT00331968, n = 212), underwent an oral examination evaluating: (1) mucosal cGVHD [NIH Oral Mucosal Score (OMS)], (2) salivary dysfunction (saliva flow and xerostomia), and (3) maximum mouth-opening measurement. Parameters for dysfunction (OMS > 2, saliva flow ≤ 1 mL/5 min, mouth-opening ≤ 35 mm) were analyzed for association with skin cGVHD involvement (erythema and sclerosis, skin symptoms), lacrimal dysfunction (Schirmer’s tear test, xerophthalmia), Lee cGVHD Symptom Scores, and NIH organ scores. Oral mucosal disease (31% prevalence) was associated with skin erythema (P < 0.001); salivary dysfunction (11% prevalence) was associated with lacrimal dysfunction (P = 0.010) and xerostomia with xerophthalmia (r = 0.32, P = 0.001); and limited mouth-opening (17% prevalence) was associated with skin sclerosis (P = 0.008) and skin symptoms (P = 0.001). There was no association found among these 3 oral cGVHD manifestations. This analysis supports the understanding of oral cGVHD as 3 distinct diseases: mucosal lesions, salivary gland dysfunction, and mouth sclerosis. Clear classification of oral cGVHD as 3 separate manifestations will improve clinical diagnosis, observational research data collection, and the definitions of outcome measures in clinical trials. PMID:25740857

Nursing students' perceptions of learning in practice environments: a review.

PubMed

Henderson, Amanda; Cooke, Marie; Creedy, Debra K; Walker, Rachel

2012-04-01

Effective clinical learning requires integration of nursing students into ward activities, staff engagement to address individual student learning needs, and innovative teaching approaches. Assessing characteristics of practice environments can provide useful insights for development. This study identified predominant features of clinical learning environments from nursing students' perspectives across studies using the same measure in different countries over the last decade. Six studies, from three different countries, using the Clinical Leaning Environment Inventory (CLEI) were reviewed. Studies explored consistent trends about learning environment. Students rated sense of task accomplishment high. Affiliation also rated highly though was influenced by models of care. Feedback measuring whether students' individual needs and views were accommodated consistently rated lower. Across different countries students report similar perceptions about learning environments. Clinical learning environments are most effective in promoting safe practice and are inclusive of student learners, but not readily open to innovation and challenges to routine practices. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

[Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].

PubMed

Ershova, O B; Lesniak, O M; Belova, K Iu; Nazarova, A V; Manovitskaia, A V; Musaeva, T M; Musraev, R M; Nurlygaianov, R Z; Rozhinskaia, L Ia; Skripnikova, I A; Toroptsova, N V

2014-01-01

To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.