Redesign of a university hospital preanesthesia evaluation clinic using a queuing theory approach.

PubMed

Zonderland, Maartje E; Boer, Fredrik; Boucherie, Richard J; de Roode, Annemiek; van Kleef, Jack W

2009-11-01

Changes in patient length of stay (the duration of 1 clinic visit) as a result of the introduction of an electronic patient file system forced an anesthesia department to change its outpatient clinic organization. In this study, we sought to demonstrate how the involvement of essential employees combined with mathematical techniques to support the decision-making process resulted in a successful intervention. The setting is the preanesthesia evaluation clinic (PAC) of a university hospital, where patients consult several medical professionals, either by walk-in or appointment. Queuing theory was used to model the initial set-up of the clinic, and later to model possible alternative designs. With the queuing model, possible improvements in efficiency could be investigated. Inputs to the model were patient arrival rates and expected service times with clinic employees, collected from the clinic's logging system and by observation. The performance measures calculated with the model were patient length of stay and employee utilization rate. Supported by the model outcomes, a working group consisting of representatives of all clinic employees decided whether the initial design should be maintained or an intervention was needed. The queuing model predicted that 3 of the proposed alternatives would result in better performance. Key points in the intervention were the rescheduling of appointments and the reallocation of tasks. The intervention resulted in a shortening of the time the anesthesiologist needed to decide upon approving the patient for surgery. Patient arrivals increased sharply over 1 yr by more than 16%; however, patient length of stay at the clinic remained essentially unchanged. If the initial set-up of the clinic would have been maintained, the patient length of stay would have increased dramatically. Queuing theory provides robust methods to evaluate alternative designs for the organization of PACs. In this article, we show that queuing modeling is an adequate approach for redesigning processes in PACs.

Patient costs in anticoagulation management: a comparison of primary and secondary care.

PubMed Central

Parry, D; Bryan, S; Gee, K; Murray, E; Fitzmaurice, D

2001-01-01

BACKGROUND: The demand for anticoagulation management is increasing. This has led to care being provided in non-hospital settings. While clinical studies have similarly demonstrated good clinical care in these settings, it is still unclear as to which alternative is the most efficient. AIM: To determine the costs borne by patients when attending an anticoagulation management clinic in either primary or secondary care and to use this information to consider the cost-effectiveness of anticoagulation management in primary and secondary care, both from the National Health Service and patient perspectives. DESIGN OF STUDY: Observational study comparing two cohorts of patients currently attending anticoagulation management clinics. SETTING: Four primary care clinics in Birmingham and one in Warwickshire, and the haematology clinics at the University of Birmingham Hospitals Trust and the City Hospital NHS Trust. METHOD: The survey of patients attending the clinics was used to ascertain patient costs. This information was then used in conjunction with the findings of a recent randomised controlled trial to establish cost-effectiveness. RESULTS: Patient costs were lower in primary care than in secondary care settings; the mean (standard deviation) costs per visit were Pound Sterling6.78 (Pound Sterling5.04) versus Pound Sterling14.58 (Pound Sterling9.08). While a previous cost-effectiveness analysis from a health sector perspective alone found a higher cost for primary care, the adoption of the societal perspective lead to a marked change in the result: a similar total cost per patient in both sectors. CONCLUSION: There are significantly higher costs borne by patients attending secondary care anticoagulation management clinics than similar patients attending primary care clinics. This study also demonstrates that the perspective adopted in an economic evaluation can influence the final result. PMID:11766869

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

PubMed

Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

Results of extracorporeal life support implementation in routine clinical practice: single center experience

PubMed Central

Biočina, Bojan; Petričević, Mate; Belina, Dražen; Gašparović, Hrvoje; Svetina, Lucija; Konosić, Sanja; White, Alexandra; Ivančan, Višnja; Kopjar, Tomislav; Miličić, Davor

2014-01-01

Aim To describe our experience in the clinical application of extracorporeal life support (ECLS) and analyze whether ECLS leads to acceptable clinical outcomes in patients with cardiac failure. Methods Data from clinical database of University Hospital Center Zagreb, Croatia, on 75 patients undergoing ECLS support from 2009 to 2014 due to cardiac failure were retrospectively analyzed. Outcomes were defined as procedural and clinical outcomes. ECLS as a primary procedure and ECLS as a postcardiotomy procedure due to inability to wean from cardiopulmonary bypass were analyzed. Results ECLS was used in 75 adult patients, and in 24 (32%) of those procedural success was noted. ECLS was implemented as a primary procedure in 36 patients and as a postcardiotomy procedure in 39 patients. Nine out of 39 (23.08%) patients had postcardiotomy ECLS after heart transplantation. Bleeding complications occurred in 30 (40%) patients, both in primary (11/36 patients) and postcardiotomy group (19/39 patients). ECLS was established by peripheral approach in 46 patients and by central cannulation in 27 patients. In 2 patients, combined cannulation was performed, with an inflow cannula placed into the right atrium and an outflow cannula placed into the femoral artery. Eleven patients treated with peripheral approach had ischemic complications. Conclusion ECLS is a useful tool in the treatment of patients with refractory cardiac failure and its results are encouraging in patients who otherwise have an unfavorable prognosis. PMID:25559831

A comparison of patients with major depressive disorder recruited through newspaper advertising versus consultation referrals for clinical drug trials.

PubMed

Miller, C A; Hooper, C L; Bakish, D

1997-01-01

Difficulties in recruiting patients for clinical trials have plagued investigators for many years. One concern is the generalizability of clinical trial results to community practice, that is, whether volunteers recruited through advertising are homogeneous with those seeking treatment in a clinical setting. This article retrospectively compares the baseline characteristics of patients recruited through newspaper advertisements with those recruited through consultation referrals by reviewing the charts of 54 patients enrolled in two clinical trials for major depressive disorder (MDD). We examined demographic data, background information, clinical histories, and baseline status. Results indicated homogeneity for most variables. The consultation group was significantly more likely to have had previous treatment for the current episode of depression. These results suggest that, although the advertisement and consultation groups were very similar, the drug naivety of the advertisement group may make them a preferred source in terms of generalizability to community practice.

[Laparoscopic Heller myotomy for esophageal achalasia].

PubMed

Ibáñez, Luis; Butte, Jean Michel; Pimentel, Fernando; Escalona, Alex; Pérez, Gustavo; Crovari, Fernando; Guzmán, Sergio; Llanos, Osvaldo

2007-04-01

Achalasia is characterized by an incomplete relaxation of the lower esophageal sphincter. The best treatment is surgical and the laparoscopic approach may have good results. To assess the results of laparoscopic Heller myotomy among patients with achalasia. Prospective study of patients subjected to a laparoscopic Heller myotomy between 1995 and 2004. Clinical features, early and late operative results were assessed. Twenty seven patients aged 12 to 74 years (12 females) were operated. All had disphagia lasting for a mean of 32 months. Mean lower esophageal sphincter pressure ranged from 18 to 85 mmHg. Eight patients received other treatments prior to surgery but symptoms persisted or reappeared. The preoperative clinical score was 7. No patient died and no procedure had to be converted to open surgery. In a follow up of 21 to 131 months, all patients are satisfied with the surgical results and the postoperative clinical score is 1. Only one patient with a mega esophagus maintained a clinical score of six. In this series of patients, laparoscopic Heller myotomy was an effective and safe treatment for esophageal achalasia.

Prevalence and relevance of the positivity of skin prick testing in patients with chronic urticaria.

PubMed

Kulthanan, Kanokvalai; Jiamton, Sukhum; Rutnin, Ni-on; Insawang, Metavee; Pinkaew, Sumrauy

2008-06-01

Many patients with chronic urticaria (CU) worry that foods or other allergens are responsible for their urticaria. Skin prick testing (SPT) may be one of the investigations used to provide a clear illustration. The purpose of our study was to assess the prevalence of positivity of SPT to food allergens and aeroallergens and their relevance in patients with CU, in order to demonstrate the diagnostic value of SPT in CU. We retrospectively reviewed case record forms of patients with chronic ordinary urticaria who underwent SPT in the Urticaria Clinic, Siriraj Hospital, during the period 2000-2004. The studied allergens included 16 food allergens and 12 aeroallergens. Eighty-eight patients were enrolled. The prevalence of positive SPT among patients with CU was 47.7%. Patients who had personal histories of atopy had statistically significant positive SPT results compared with patients who had negative SPT. Of 88 patients, 26 patients (30%) gave positive results to food allergens, 36 patients (41%) gave positive results to aeroallergens and 20 patients (22.7%) gave positive results to both food and aeroallergens. One-third of the subjects (34.6%) who had positive SPT results to food allergens had clinical relevance of food allergy in some systems but only one patient had clinical relevance of food-induced urticaria. Half of the patients who had a history of aeroallergen sensitivity gave a positive SPT response for aeroallergens; however, there was no clinical relevance to their CU. Our study showed that the prevalence of positive SPT to food allergens and aeroallergens in patients with CU was common but had little clinical relevance to CU.

So different, yet so similar: meta-analysis and policy modeling of willingness to participate in clinical trials among Brazilians and Indians.

PubMed

Zammar, Guilherme; Meister, Henrique; Shah, Jatin; Phadtare, Amruta; Cofiel, Luciana; Pietrobon, Ricardo

2010-12-16

With the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research. We conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model. Five studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians. Our study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme.

Instructor and Dental Student Perceptions of Clinical Communication Skills via Structured Assessments.

PubMed

McKenzie, Carly T

2016-05-01

The aim of this study was to use structured assessments to assess dental students' clinical communication skills exhibited during patient appointments. Fourth-year dental students (n=55) at the University of Alabama at Birmingham evaluated their own interpersonal skills in a clinical setting utilizing the Four Habits Coding Scheme. An instructor also assessed student-patient clinical communication. These assessments were used to identify perceived strengths and weaknesses in students' clinical communication. Both instructor assessments and student self-assessments pinpointed the following clinical communication skills as effective the most often: patient greeting, avoidance of jargon, and non-verbal behavior. There was also relative agreement between instructor assessments and student self-assessments regarding clinical communication skills that were rated as not effective most frequently: ensuring patient comprehension, identification of patient feelings, and exploration of barriers to treatment. These resulted pointed to strengths and weaknesses in the portion of the curriculum designed to prepare students for effective provider-patient communication. These results may suggest a need for the school's current behavioral science curriculum to better address discussion of potential treatment barriers and patient feelings as well as techniques to ensure patient comprehension.

Clinical Assessment of a Nocardia PCR-Based Assay for Diagnosis of Nocardiosis.

PubMed

Rouzaud, Claire; Rodriguez-Nava, Véronica; Catherinot, Emilie; Méchaï, Frédéric; Bergeron, Emmanuelle; Farfour, Eric; Scemla, Anne; Poirée, Sylvain; Delavaud, Christophe; Mathieu, Daniel; Durupt, Stéphane; Larosa, Fabrice; Lengelé, Jean-Philippe; Christophe, Jean-Louis; Suarez, Felipe; Lortholary, Olivier; Lebeaux, David

2018-06-01

The diagnosis of nocardiosis, a severe opportunistic infection, is challenging. We assessed the specificity and sensitivity of a 16S rRNA Nocardia PCR-based assay performed on clinical samples. In this multicenter study (January 2014 to April 2015), patients who were admitted to three hospitals and had an underlying condition favoring nocardiosis, clinical and radiological signs consistent with nocardiosis, and a Nocardia PCR assay result for a clinical sample were included. Patients were classified as negative control (NC) (negative Nocardia culture results and proven alternative diagnosis or improvement at 6 months without anti- Nocardia treatment), positive control (PC) (positive Nocardia culture results), or probable nocardiosis (positive Nocardia PCR results, negative Nocardia culture results, and no alternative diagnosis). Sixty-eight patients were included; 47 were classified as NC, 8 as PC, and 13 as probable nocardiosis. PCR results were negative for 35/47 NC patients (74%). For the 12 NC patients with positive PCR results, the PCR assay had been performed with respiratory samples. These NC patients had chronic bronchopulmonary disease more frequently than did the NC patients with negative PCR results (8/12 patients [67%] versus 11/35 patients [31%]; P = 0.044). PCR results were positive for 7/8 PC patients (88%). There were 13 cases of probable nocardiosis, diagnosed solely using the PCR results; 9 of those patients (69%) had lung involvement (consolidation or nodule). Nocardia PCR testing had a specificity of 74% and a sensitivity of 88% for the diagnosis of nocardiosis. Nocardia PCR testing may be helpful for the diagnosis of nocardiosis in immunocompromised patients but interpretation of PCR results from respiratory samples is difficult, because the PCR assay may also detect colonization. Copyright © 2018 American Society for Microbiology.

What is the clinical significance of chest CT when the chest x-ray result is normal in patients with blunt trauma?

PubMed

Kea, Bory; Gamarallage, Ruwan; Vairamuthu, Hemamalini; Fortman, Jonathan; Lunney, Kevin; Hendey, Gregory W; Rodriguez, Robert M

2013-08-01

Computed tomography (CT) has been shown to detect more injuries than plain radiography in patients with blunt trauma, but it is unclear whether these injuries are clinically significant. This study aimed to determine the proportion of patients with normal chest x-ray (CXR) result and injury seen on CT and abnormal initial CXR result and no injury on CT and to characterize the clinical significance of injuries seen on CT as determined by a trauma expert panel. Patients with blunt trauma older than 14 years who received emergency department chest imaging as part of their evaluation at 2 urban level I trauma centers were enrolled. An expert trauma panel a priori classified thoracic injuries and subsequent interventions as major, minor, or no clinical significance. Of 3639 participants, 2848 (78.3%) had CXR alone and 791 (21.7%) had CXR and chest CT. Of 589 patients who had chest CT after a normal CXR result, 483 (82.0% [95% confidence interval [CI], 78.7-84.9%]) had normal CT results, and 106 (18.0% [95% CI, 15.1%-21.3%]) had CTs diagnosing injuries-primarily rib fractures, pulmonary contusion, and incidental pneumothorax. Twelve patients had injuries classified as clinically major (2.0% [95% CI, 1.2%-3.5%]), 78 were clinically minor (13.2% [95% CI, 10.7%-16.2%]), and 16 were clinically insignificant (2.7% (95% CI, 1.7%-4.4%]). Of 202 patients with CXRs suggesting injury, 177 (87.6% [95% CI, 82.4%-91.5%]) had chest CTs confirming injury and 25 (12.4% [95% CI, 8.5%-17.6%]) had no injury on CT. Chest CT after a normal CXR result in patients with blunt trauma detects injuries, but most do not lead to changes in patient management. Copyright © 2013 Elsevier Inc. All rights reserved.

HIV drug resistance early warning indicators in cohorts of individuals starting antiretroviral therapy between 2004 and 2009: World Health Organization global report from 50 countries.

PubMed

Bennett, Diane E; Jordan, Michael R; Bertagnolio, Silvia; Hong, Steven Y; Ravasi, Giovanni; McMahon, James H; Saadani, Ahmed; Kelley, Karen F

2012-05-01

The World Health Organization developed a set of human immunodeficiency virus drug resistance (HIVDR) early warning indicators (EWIs) to assess antiretroviral therapy clinic and program factors associated with HIVDR. EWIs are monitored by abstracting data routinely recorded in clinical records, and the results enable clinics and program managers to identify problems that should be addressed to minimize preventable emergence of HIVDR in clinic populations. As of June 2011, 50 countries monitored EWIs, covering 131 686 patients initiating antiretroviral treatment between 2004 and 2009 at 2107 clinics. HIVDR prevention is associated with patient care (appropriate prescribing and patient monitoring), patient behavior (adherence), and clinic/program management efforts to reduce treatment interruptions (follow up, retention on first-line ART, procurement and supply management of antiretroviral drugs). EWIs measure these factors and the results have been used to optimize patient and population treatment outcomes.

Clinical Information Systems – From Yesterday to Tomorrow

PubMed Central

2016-01-01

Summary Objectives To review the history of clinical information systems over the past twenty-five years and project anticipated changes to those systems over the next twenty-five years. Methods Over 250 Medline references about clinical information systems, quality of patient care, and patient safety were reviewed. Books, Web resources, and the author’s personal experience with developing the HELP system were also used. Results There have been dramatic improvements in the use and acceptance of clinical computing systems and Electronic Health Records (EHRs), especially in the United States. Although there are still challenges with the implementation of such systems, the rate of progress has been remarkable. Over the next twenty-five years, there will remain many important opportunities and challenges. These opportunities include understanding complex clinical computing issues that must be studied, understood and optimized. Dramatic improvements in quality of care and patient safety must be anticipated as a result of the use of clinical information systems. These improvements will result from a closer involvement of clinical informaticians in the optimization of patient care processes. Conclusions Clinical information systems and computerized clinical decision support have made contributions to medicine in the past. Therefore, by using better medical knowledge, optimized clinical information systems, and computerized clinical decision, we will enable dramatic improvements in both the quality and safety of patient care in the next twenty-five years. PMID:27362589

[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.

Anaphylaxis to dyes during the perioperative period: reports of 14 clinical cases.

PubMed

Mertes, Paul Michel; Malinovsky, Jean Marc; Mouton-Faivre, Claudie; Bonnet-Boyer, Marie Caroline; Benhaijoub, Abdelhaouad; Lavaud, François; Valfrey, Jocelyne; O'Brien, James; Pirat, Philippe; Lalourcey, Laurent; Demoly, Pascal

2008-08-01

Vital dyes are widely used for lymphatic mapping and sentinel lymph node biopsy in patients with malignant tumors, and reports of anaphylactic reactions are becoming more frequent. Our aims were to describe specific clinical features of hypersensitivity reactions to Patent Blue (Guerbet, Roissy, France), results of the allergy workup, and their consequences for patient management. We report a series of 14 clinical cases of dye-induced anaphylaxis recorded between 2004 and 2006 in 4 member centers of a network of French allergoanesthesia outpatient clinics. Reactions appeared to be relatively severe (6/14 grade III reactions). An average 30 +/- 6-minute delay was observed between dye injection and symptom onset. In 9 (65%) patients reactions were sustained for several hours, requiring prolonged continuous epinephrine infusion and transfer to an intensive care unit. Prick test results were positive in 8 patients. In 5 patients prick test results were negative, whereas intradermal test results were positive. Anesthesiologists and allergologists must be aware of this specific risk and of the clinical characteristics of these reactions, which are usually delayed and long lasting.

Clinical pharmacogenomics: patient perspectives of pharmacogenomic testing and the incidence of actionable test results in a chronic disease cohort.

PubMed

Mukherjee, Chandrama; Sweet, Kevin M; Luzum, Jasmine A; Abdel-Rasoul, Mahmoud; Christman, Michael F; Kitzmiller, Joseph P

2017-09-01

This study aimed to examine pharmacogenomic test results and patient perspectives at an academic cardiovascular medicine clinic. Test results for three common cardiovascular drug-gene tests (warfarin- CYP2C9-VKORC1 , clopidogrel- CYP2C19 and simvastatin- SLCO1B1 ) of 208 patients in the Ohio State University-Coriell Personalized Medicine Collaborative were examined to determine the incidence of potentially actionable test results. A post-hoc, anonymous, patient survey was also conducted. Potentially actionable test results for at least one of the three drug-gene tests were determined in 170 (82%) patients. Survey responses (n = 134) suggested that patients generally considered their test results to be important (median of 7.5 on a 10-point scale of importance) and were interested (median of 7.3 on a 10-point scale of interest) in a Clinical Pharmacogenomic Service. Attitudes toward pharmacogenomic testing were generally favorable, and potentially actionable test results were not uncommon in this cardiovascular medicine cohort.

Clinic flow for STI, HIV, and TB patients in an urban infectious disease clinic offering point-of-care testing services in Durban, South Africa.

PubMed

Stime, Katrina J; Garrett, Nigel; Sookrajh, Yukteshwar; Dorward, Jienchi; Dlamini, Ntuthu; Olowolagba, Ayo; Sharma, Monisha; Barnabas, Ruanne V; Drain, Paul K

2018-05-11

Many clinics in Southern Africa have long waiting times. The implementation of point-of-care (POC) tests to accelerate diagnosis and improve clinical management in resource-limited settings may improve or worsen clinic flow and waiting times. The objective of this study was to describe clinic flow with special emphasis on the impact of POC testing at a large urban public healthcare clinic in Durban, South Africa. We used time and motion methods to directly observe patients and practitioners. We created patient flow maps and recorded individual patient waiting and consultation times for patients seeking STI, TB, or HIV care. We conducted semi-structured interviews with 20 clinic staff to ascertain staff opinions on clinic flow and POC test implementation. Among 121 observed patients, the total number of queues ranged from 4 to 7 and total visit times ranged from 0:14 (hours:minutes) to 7:38. Patients waited a mean of 2:05 for standard-of-care STI management, and approximately 4:56 for STI POC diagnostic testing. Stable HIV patients who collected antiretroviral therapy refills waited a mean of 2:42 in the standard queue and 2:26 in the fast-track queue. A rapid TB test on a small sample of patients with the Xpert MTB/RIF assay and treatment initiation took a mean of 6:56, and 40% of patients presenting with TB-related symptoms were asked to return for an additional clinic visit to obtain test results. For all groups, the mean clinical assessment time with a nurse or physician was 7 to 9 min, which accounted for 2 to 6% of total visit time. Staff identified poor clinic flow and personnel shortages as areas of concern that may pose challenges to expanding POC tests in the current clinic environment. This busy urban clinic had multiple patient queues, long clinical visits, and short clinical encounters. Although POC testing ensured patients received a diagnosis sooner, it more than doubled the time STI patients spent at the clinic and did not result in same-day diagnosis for all patients screened for TB. Further research on implementing POC testing efficiently into care pathways is required to make these promising assays a success.

Clinical, Endoscopic, and Radiologic Features of Three Subtypes of Achalasia, Classified Using High-Resolution Manometry

PubMed Central

Khan, Mohammed Q.; AlQaraawi, Abdullah; Al-Sohaibani, Fahad; Al-Kahtani, Khalid; Al-Ashgar, Hamad I.

2015-01-01

Background/Aims: High-resolution manometry (HRM) has improved the accuracy of manometry in detecting achalasia and determining its subtypes. However, the correlation of achalasia subtypes with clinical, endoscopic, and radiologic findings has not been assessed. We aimed to evaluate and compare the clinical, endoscopic, and fluoroscopy findings associated with three subtypes of achalasia using HRM. Patients and Methods: The retrospective clinical data, HRM, endoscopy, and radiologic findings were obtained from the medical records of untreated achalasia patients. Results: From 2011 to 2013, 374 patients underwent HRM. Fifty-two patients (14%) were diagnosed with achalasia, but only 32 (8.5%) of these patients had not received treatment and were therefore included in this study. The endoscopy results were normal in 28% of the patients, and a barium swallow was inconclusive in 31% of the achalasia patients. Ten patients (31%) were classified as having type I achalasia, 17 (53%) were classified as type II, and 5 (16%) were classified as type III. Among the three subtypes, type I patients were on average the youngest and had the longest history of dysphagia, mildest chest pain, most significant weight loss, and most dilated esophagus with residual food. Chest pain was most common in type III patients, and frequently had normal fluoroscopic and endoscopic results. Conclusion: The clinical, radiologic, and endoscopic findings were not significantly different between patients with type I and type II untreated achalasia. Type III patients had the most severe symptoms and were the most difficult to diagnose based on varied clinical, radiologic, and endoscopic findings. PMID:26021774

Design and methodology of the NorthStar Study: NT-proBNP stratified follow-up in outpatient heart failure clinics -- a randomized Danish multicenter study.

PubMed

Schou, Morten; Gustafsson, Finn; Videbaek, Lars; Markenvard, John; Ulriksen, Hans; Ryde, Henrik; Jensen, Jens C H; Nielsen, Tonny; Knudsen, Anne S; Tuxen, Christian D; Handberg, Jens; Sørensen, Per J; Espersen, Geert; Lind-Rasmussen, Søren; Keller, Niels; Egstrup, Kenneth; Nielsen, Olav W; Abdulla, Jawdat; Nyvad, Ole; Toft, Jens; Hildebrandt, Per R

2008-10-01

Randomized clinical trials have shown that newly discharged and symptomatic patients with chronic heart failure (CHF) benefit from follow-up in a specialized heart failure clinic (HFC). Clinical stable and educated patients are usually discharged from the HFC when on optimal therapy. It is unknown if risk stratification using natriuretic peptides could identify patients who would benefit from longer-term follow-up. Furthermore, data on the use of natriuretic peptides for monitoring of stable patients with CHF are sparse. The aims of this study are to test the hypothesis that clinical stable, educated, and medical optimized patients with CHF with N-terminal pro-brain natriuretic peptide (NT-proBNP) levels > or = 1,000 pg/mL benefit from long-term follow-up in an HFC and to assess the efficacy of NT-proBNP monitoring. A total of 1,250 clinically stable, medically optimized, and educated patients with CHF will be enrolled from 18 HFCs in Denmark. The patients will be randomized to treatment in general practice, to a standard follow-up program in the HFC, or to NT-proBNP monitoring in the HFC. The patients will be followed for 30 months (median). Data will be collected from 2006 to 2009. At present (March 2008), 720 patients are randomized. Results expect to be presented in the second half of 2010. This article outlines the design of the NorthStar study. If our hypotheses are confirmed, the results will help cardiologists and nurses in HFCs to identify patients who may benefit from long-term follow-up. Our results may also indicate whether patients with CHF will benefit from adding serial NT-proBNP measurements to usual clinical monitoring.

[Correlation of clinical and radiologic results of complete subtalar release in congenital clubfoot].

PubMed

Kalenderer, Onder; Ağuş, Haluk; Ak, Mümtaz; Ozlük, Serkan

2003-01-01

We evaluated the mid-term results in patients who underwent complete subtalar release with the use of the Cincinnati incision for congenital clubfoot. Complete subtalar release was performed in 30 feet of 23 patients (16 boys, 7 girls; 7 bilateral cases). The mean age at surgery was 17.5 months (range 2 to 84 months). Clinically, cosmetic appearance, adduction of the forefoot, the range of motion of the ankle joint, and muscle strength were evaluated. Radiologic evaluations included talocalcaneal angles on antero-posterior and lateral views, talocalcaneal index, talar-first metatarsal angles, calcaneal-fifth metatarsal angles, and Bohler angles. Talar and navicular bone lengths were compared with the other side in unilateral patients. The results were evaluated according to the Simons' criteria. The mean follow-up was 9 years and 8 months (range 7 years to 14 years). The mean range of motion of the ankle joint was measured as 47 degrees (range 10 degrees to 60 degrees ). The parents of three patients were not satisfied with the clinical results. Clinically, six patients had metatarsus adductus. Radiologically, flattening of the talar head (7 patients) and the talar dome (2 patients) were detected in unilateral patients. Navicular dorsal subluxation was found in seven feet. Compared to the normal side, the mean navicular shortening was 2.6 mm (range 0 to 4 mm), the mean talar shortening was 4.8 mm (range 2 to 11 mm). According to the Simons' criteria, the results were satisfactory in 27 feet (90%) and unsatisfactory in three feet (10%). Our results suggest that complete subtalar release for the treatment of clubfoot enables correction of all components of the deformity at a single session, and that its clinical results are more favorable than radiologic results, without requiring a close cooperation of the parents.

A study to derive a clinical decision rule for triage of emergency department patients with chest pain: design and methodology

PubMed Central

Hess, Erik P; Wells, George A; Jaffe, Allan; Stiell, Ian G

2008-01-01

Background Chest pain is the second most common chief complaint in North American emergency departments. Data from the U.S. suggest that 2.1% of patients with acute myocardial infarction and 2.3% of patients with unstable angina are misdiagnosed, with slightly higher rates reported in a recent Canadian study (4.6% and 6.4%, respectively). Information obtained from the history, 12-lead ECG, and a single set of cardiac enzymes is unable to identify patients who are safe for early discharge with sufficient sensitivity. The 2007 ACC/AHA guidelines for UA/NSTEMI do not identify patients at low risk for adverse cardiac events who can be safely discharged without provocative testing. As a result large numbers of low risk patients are triaged to chest pain observation units and undergo provocative testing, at significant cost to the healthcare system. Clinical decision rules use clinical findings (history, physical exam, test results) to suggest a diagnostic or therapeutic course of action. Currently no methodologically robust clinical decision rule identifies patients safe for early discharge. Methods/design The goal of this study is to derive a clinical decision rule which will allow emergency physicians to accurately identify patients with chest pain who are safe for early discharge. The study will utilize a prospective cohort design. Standardized clinical variables will be collected on all patients at least 25 years of age complaining of chest pain prior to provocative testing. Variables strongly associated with the composite outcome acute myocardial infarction, revascularization, or death will be further analyzed with multivariable analysis to derive the clinical rule. Specific aims are to: i) apply standardized clinical assessments to patients with chest pain, incorporating results of early cardiac testing; ii) determine the inter-observer reliability of the clinical information; iii) determine the statistical association between the clinical findings and the composite outcome; and iv) use multivariable analysis to derive a highly sensitive clinical decision rule to guide triage decisions. Discussion The study will derive a highly sensitive clinical decision rule to identify low risk patients safe for early discharge. This will improve patient care, lower healthcare costs, and enhance flow in our busy and overcrowded emergency departments. PMID:18254973

The role of FDG PET/CT in patients with locoregional breast cancer recurrence: a comparison to conventional imaging techniques.

PubMed

Aukema, T S; Rutgers, E J Th; Vogel, W V; Teertstra, H J; Oldenburg, H S; Vrancken Peeters, M T F D; Wesseling, J; Russell, N S; Valdés Olmos, R A

2010-04-01

The aim of this study was to evaluate the impact of (18)F-fluorodeoxyglucose positron-emission tomography/computed tomography (FDG PET/CT) on clinical management in patients with locoregional breast cancer recurrence amenable for locoregional treatment and to compare the PET/CT results with the conventional imaging data. From January 2006 to August 2008, all patients with locoregional breast cancer recurrence underwent whole-body PET/CT. PET/CT findings were compared with results of the conventional imaging techniques and final pathology. The impact of PET/CT results on clinical management was evaluated based on clinical decisions obtained from patient files. 56 patients were included. In 32 patients (57%) PET/CT revealed additional tumour localisations. Distant metastases were detected in 11 patients on conventional imaging and in 23 patients on PET/CT images (p < 0.01). In 25 patients (45%), PET/CT detected additional lesions not visible on conventional imaging. PET/CT had an impact on clinical management in 27 patients (48%) by detecting more extensive locoregional disease or distant metastases. In 20 patients (36%) extensive surgery was prevented and treatment was changed to palliative treatment. The sensitivity, specificity, accuracy, positive and negative predictive values of FDG PET/CT were respectively 97%, 92%, 95%, 94% and 96%. PET/CT, in addition to conventional imaging techniques, plays an important role in staging patients with locoregional breast cancer recurrence since its result changed the clinical management in almost half of the patients. PET/CT could potentially replace conventional staging imaging in patients with a locoregional breast cancer recurrence. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

A novel virtual motor rehabilitation system for Guillain-Barré syndrome. Two single case studies.

PubMed

Albiol-Pérez, S; Forcano-García, M; Muñoz-Tomás, M T; Manzano-Fernández, P; Solsona-Hernández, S; Mashat, M A; Gil-Gómez, J A

2015-01-01

This article is part of the Focus Theme of Methods of Information in Medicine on "New Methodologies for Patients Rehabilitation". For Guillain-Barré patients, motor rehabilitation programs are helpful at the onset to prevent the complications of paralysis and in cases of persistent motor impairment. Traditional motor rehabilitation programs may be tedious and monotonous, resulting in low adherence to the treatments. A Virtual Motor Rehabilitation system has been tested in Guillain-Barré patients to increase patient adherence and to improve clinical results. Two people with Guillain-Barré performed 20 rehabilitation sessions. We tested a novel system based on Motor Virtual Rehabilitation in three periods of time (baseline evaluation, final evaluation, and follow-up. In the training program, the participants carried out a specific treatment using the Active Balance Rehabilitation system (ABAR). The system is composed of customizable virtual games to perform static and dynamic balance rehabilitation. Significant improvements in clinical results were obtained by both participants, with significant results in the static balance clinical test of the Anterior Reach test in the standing position and unipedal stance time. Other significant results were found in dynamic balance clinical tests in the Berg Balance Scale test and the 30-second Sit-to-Stand test. With regard to acceptance of the system, both patients enjoyed the experience, and both patients thought that this system was helpful for their rehabilitation. The results show that Virtual Motor Rehabilitation for Guillain-Barré patients provides clinical improvements in an entertaining way.

Mass Medication Clinic (MMC) Patient Medical Assistant (PMA) System Training Initiative

DTIC Science & Technology

2007-06-01

AD_________________ Award Number: W81XWH-06-2-0045 TITLE: Mass Medication Clinic (MMC) Patient ...SUBTITLE 5a. CONTRACT NUMBER Mass Medication Clinic (MMC) Patient Medical Assistant (PMA) System Training Initiative 5b. GRANT NUMBER W81XWH-06-2...sections will describe the events, results, and accomplishments of this study. With validation through this project the Patient Medical Assistant

Interexaminer reliability in physical examination of patients with low back pain.

PubMed

Strender, L E; Sjöblom, A; Sundell, K; Ludwig, R; Taube, A

1997-04-01

Seventy-one patients with low back pain were examined by two physiotherapists (50 patients) and two physicians (21 patients). The two physiotherapists had worked together for many years, but the two physicians had not. The interexaminer reliability of the clinical tests included in the physical examination was evaluated. To evaluate the interexaminer reliability of clinical tests used in the physical examination of patients with low back pain under ideal circumstances, which was the case for the physiotherapists. Numerous clinical tests are used in the evaluation of patients with low back pain. To reach the correct diagnosis, only tests with an acceptable validity and reliability should be used. Previous studies have mainly shown low reliability. It is important that clinical tests not be rejected because of low reliability caused by differences between examiners in performance of the examination and in their definition of normal results. Two examiners, either two physiotherapists or two physicians, independently examined patients with low back pain. In approximately half of the clinical tests studied, an acceptable reliability was demonstrated. On the basis of the physiotherapists series, the reliability was acceptable for a number of clinical tests that are used in the evaluation of patients with low back pain. The results suggest that clinical tests should be standardized to a much higher degree than they are today.

Radioallergosorbent testing for penicillin allergy in family practice.

PubMed Central

Worrall, G J; Hull, C; Briffett, E

1994-01-01

OBJECTIVES: To determine (a) the prevalence of patients supposedly allergic to penicillin who have a positive radioallergosorbent test (RAST) result for penicillin G or V and (b) the predictive power of family physicians' clinical judgement that a patient who is supposedly allergic to penicillin will have a positive RAST result. DESIGN: Prospective multicentre cross-sectional observational study. SETTING: Eleven primary care practices in Newfoundland; 10 were in a rural setting. PATIENTS: Of 110 consecutive adult patients with a supposed allergy to penicillin 97 agreed to participate in the study; 92 underwent RAST. INTERVENTIONS: Patients helped physicians complete a questionnaire and had a venous blood sample taken for the RAST. Physicians examined the clinical history and judged whether the patient was likely to have a positive RAST result. MEAN OUTCOME MEASURES: Rates of positive and negative RAST results for penicillin V and G. RESULTS: Of the 92 patients 8 had a positive RAST result and 84 a negative one. The positive predictive power of a "good" clinical history (e.g., urticaria, swollen eyes, tongue or lips, or an anaphylactic reaction witnessed by a physician) was low (10%); the negative predictive power of a "poor" clinical history (e.g., nausea, vomiting, diarrhea, fever, nonspecific rash or fainting) was 92%. CONCLUSIONS: Less than 10% of primary care patients with a supposed allergy to penicillin will have a positive RAST result. In addition, physicians' predictions of allergy in such patients are imprecise. PMID:8275407

Comparison of clinical diagnosis and microbiological test results in vaginal infections.

PubMed

Karaca, M; Bayram, A; Kocoglu, M E; Gocmen, A; Eksi, F

2005-01-01

Lower genital tract infections continue to be a problem due to the fact that the clinical diagnosis is usually inadequate, and subsequent care is suboptimal. This study aimed at evaluating the accuracy of clinical diagnosis by comparing it with microbiologic test results, and to determine the causative agents of vaginal infections. Sixty-seven nonpregnant women (18-45 years of age) with the clinical diagnosis of lower genital tract infection were enrolled in the study. Patients were not included if they had a history of vaginal infection during the previous three-month period or intrauterine device. The clinical diagnosis was based on the combinations of symptoms, direct observation of wet mount, homogeneous discharge, vaginal pH > 4.5, and detection of the amine odor after exposure of vaginal secretions to 10% KOH. Vaginal samples were taken with two cotton swabs, one was used for pH determination, and the second was utilized for microbiological tests. Gram staining and cultures with Sabouraud agar and chocolate agar were performed for microbiological diagnosis, and the results were compared. The clinical diagnoses included 26 (38.8%) candidiasis, 18 (26.8%) bacterial vaginosis, three (4.5%) trichomoniasis, and 20 (29.9%) mixed vaginal infections. Of the 26 patients with clinical diagnoses of candidiasis, 12 (46.1%) revealed Candiada albicans, nine (34.6) patients revealed microorganisms other than candida species, and five (19.2%) patients had no growth. Five (27.8%) bacterial vaginosis patients revealed Gardnarella vaginalis and 12 patients (66.6%) did not grow any microorganism. The overall rate of accurate clinical diagnoses confirmed by microbiological test results was 43.2%. Seventeen (43.6) of the 39 microbiological test results correlated with clinical diagnosis, and no growth was observed in 28 (41.8%) cultures. We conclude that the clinical diagnosis of vaginal infection is inadequate and should be confirmed with microbiological testing if the resources are avaliable.

Use of reflectance spectrophotometry to predict the response of port wine stains to pulsed dye laser.

PubMed

Halachmi, Shlomit; Azaria, Ron; Inbar, Roy; Ad-El, Dean; Lapidoth, Moshe

2014-01-01

Reflectance spectroscopy can be used to quantitate subtle differences in color. We applied a portable reflectance spectrometer to determine its utility in the evaluation of pulsed dye laser treatment of port wine stains (PWS) and in prediction of clinical outcome, in a prospective study. Forty-eight patients with PWS underwent one to nine pulsed dye laser treatments. Patient age and skin color as well as PWS surface area, anatomic location, and color were recorded. Pretreatment spectrophotometric measurements were performed. The subjective clinical results of treatment and the quantitative spectrophotometry results were evaluated by two independent teams, and the findings were correlated. The impact of the clinical characteristics on the response to treatment was assessed as well. Patients with excellent to good clinical results of laser treatments had pretreatment spectrophotometric measurements which differed by more than 10%, whereas patients with fair to poor results had spectrophotometric measurements with a difference of of less than 10%. The correlation between the spectrophotometric results and the clinical outcome was 73% (p < 0.01). The impact of the other clinical variables on outcome agreed with the findings in the literature. Spectrophotometry has a higher correlation with clinical outcome and a better predictive value than other nonmeasurable, nonquantitative, dependent variables.

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

Smeets, Albert J., E-mail: radiol@eztilburg.nl; Nijenhuis, Robbert J.; Rooij, Willem Jan van

Uterine artery embolization (UAE) in patients with a large fibroid burden is controversial. Anecdotal reports describe serious complications and limited clinical results. We report the long-term clinical and magnetic resonance (MR) results in a large series of women with a dominant fibroid of >10 cm and/or an uterine volume of >700 cm{sup 3}. Seventy-one consecutive patients (mean age, 42.5 years; median, 40 years; range, 25-52 years) with a large fibroid burden were treated by UAE between August 2000 and April 2005. Volume reduction and infarction rate of dominant fibroid and uterus were assessed by comparing the baseline and latest follow-upmore » MRIs. Patients were clinically followed at various time intervals after UAE with standardized questionnaires. There were no serious complications of UAE. During a mean follow-up of 48 months (median, 59 months; range, 6-106 months), 10 of 71 patients (14%) had a hysterectomy. Mean volume reduction of the fibroid and uterus was 44 and 43%. Mean infarction rate of the fibroid and overall fibroid infarction rate was 86 and 87%. In the vast majority of patients there was a substantial improvement of symptoms. Clinical results were similar in patients with a dominant fibroid >10 cm and in patients with large uterine volumes by diffuse fibroid disease. In conclusion, our results indicate that the risk of serious complications after UAE in patients with a large fibroid burden is not increased. Moreover, clinical long-term results are as good as in other patients who are treated with UAE. Therefore, a large fibroid burden should not be considered a contraindication for UAE.« less

Case-based reasoning using electronic health records efficiently identifies eligible patients for clinical trials

PubMed Central

Miotto, Riccardo

2015-01-01

Objective To develop a cost-effective, case-based reasoning framework for clinical research eligibility screening by only reusing the electronic health records (EHRs) of minimal enrolled participants to represent the target patient for each trial under consideration. Materials and Methods The EHR data—specifically diagnosis, medications, laboratory results, and clinical notes—of known clinical trial participants were aggregated to profile the “target patient” for a trial, which was used to discover new eligible patients for that trial. The EHR data of unseen patients were matched to this “target patient” to determine their relevance to the trial; the higher the relevance, the more likely the patient was eligible. Relevance scores were a weighted linear combination of cosine similarities computed over individual EHR data types. For evaluation, we identified 262 participants of 13 diversified clinical trials conducted at Columbia University as our gold standard. We ran a 2-fold cross validation with half of the participants used for training and the other half used for testing along with other 30 000 patients selected at random from our clinical database. We performed binary classification and ranking experiments. Results The overall area under the ROC curve for classification was 0.95, enabling the highlight of eligible patients with good precision. Ranking showed satisfactory results especially at the top of the recommended list, with each trial having at least one eligible patient in the top five positions. Conclusions This relevance-based method can potentially be used to identify eligible patients for clinical trials by processing patient EHR data alone without parsing free-text eligibility criteria, and shows promise of efficient “case-based reasoning” modeled only on minimal trial participants. PMID:25769682

Obtaining patient test results from clinical laboratories: a survey of state law for pharmacists.

PubMed

Witry, Matthew J; Doucette, William R

2009-01-01

To identify states with laws that restrict to whom clinical laboratories may release copies of laboratory test results and to describe how these laws may affect pharmacists' ability to obtain patient laboratory test results. Researchers examined state statutes and administrative codes for all 50 states and the District of Columbia at the University of Iowa Law Library between June and July 2007. Researchers also consulted with lawyers, state Clinical Laboratory Improvement Amendments officers, and law librarians. Laws relating to the study objective were analyzed. 34 jurisdictions do not restrict the release of laboratory test results, while 17 states have laws that restrict to whom clinical laboratories can send copies of test results. In these states, pharmacists will have to use alternative sources, such as physician offices, to obtain test results. Pharmacists must consider state law before requesting copies of laboratory test results from clinical laboratories. This may be an issue that state pharmacy associations can address to increase pharmacist access to important patient information.

The role of clinical pharmacology in molecular genetics

NASA Technical Reports Server (NTRS)

Robertson, D.

1997-01-01

PROBLEM: Discovering the causes of unusual phenotypes in human subjects is an important aspect of patient-oriented research. MATERIAL: The tools of clinical pharmacology are uniquely useful in addressing these problems. PATIENTS, SUBJECTS, OR CASE HISTORIES: We evaluated a 42-year-old patient with lifelong orthostatic hypotension and ptosis of the eyelids. He underwent a series of biochemical, physiological, and pharmacological tests outlined in this article. RESULTS: These studies indicated that sympathetic innervation was intact but that the sympathetic neurotransmitter was dopamine rather than norepinephrine. These results demonstrated that dopamine-beta-hydroxylase deficiency underlies the clinical abnormalities of this patient. CONCLUSION: In selected individuals with unusual phenotypes, the techniques of clinical chemistry and clinical pharmacology can define the nature of the defect at almost the resolution of the human genome.

Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program.

PubMed

Held, Peter; Himmelmann, Anders; Ditmarsch, Marc

2016-07-01

Ticagrelor (P2Y12 receptor antagonist) is presently indicated for preventing atherothrombotic events in patients with acute coronary syndrome and patients with a history of myocardial infarction. The PARTHENON clinical development program comprises five randomized, controlled, cardiovascular, indication-seeking outcome studies, aiming to evaluate ticagrelor across the spectrum of patients with atherothrombotic disease. Results of two large-scale trials support a benefit for ticagrelor in patients with acute coronary syndrome (PLATO; ClinicalTrials.gov: NCT00391872) and in patients with a history of myocardial infarction (PEGASUS-TIMI 54; ClinicalTrials.gov: NCT01225562). Ongoing trials will provide information on the efficacy and safety of ticagrelor in patients with acute ischemic stroke or transient ischemic attack (SOCRATES; ClinicalTrials.gov: NCT01994720), peripheral artery disease (EUCLID; ClinicalTrials.gov: NCT01732822) and coronary artery disease in patients with Type 2 diabetes mellitus (THEMIS: ClinicalTrials.gov: NCT01991795).

Impact of molecular imaging on the diagnostic process in a memory clinic.

PubMed

Ossenkoppele, Rik; Prins, Niels D; Pijnenburg, Yolande A L; Lemstra, Afina W; van der Flier, Wiesje M; Adriaanse, Sofie F; Windhorst, Albert D; Handels, Ron L H; Wolfs, Claire A G; Aalten, Pauline; Verhey, Frans R J; Verbeek, Marcel M; van Buchem, Mark A; Hoekstra, Otto S; Lammertsma, Adriaan A; Scheltens, Philip; van Berckel, Bart N M

2013-07-01

[(11)C]Pittsburgh compound B ([(11)C]PIB) and [(18)F]-2-fluoro-2-deoxy-D-glucose ([(18)F]FDG) PET measure fibrillar amyloid-β load and glucose metabolism, respectively. We evaluated the impact of these tracers on the diagnostic process in a memory clinic population. One hundred fifty-four patients underwent paired dynamic [(11)C]PIB and static [(18)F]FDG PET scans shortly after completing a standard dementia screening. Two-year clinical follow-up data were available for 39 patients. Parametric PET images were assessed visually and results were reported to the neurologists responsible for the initial diagnosis. Outcome measures were (change in) clinical diagnosis and confidence in that diagnosis before and after disclosing PET results. [(11)C]PIB scans were positive in 40 of 66 (61%) patients with a clinical diagnosis of Alzheimer's disease (AD), 5 of 18 (28%) patients with frontotemporal dementia (FTD), 4 of 5 (80%) patients with Lewy body dementia, and 3 of 10 (30%) patients with other dementias. [(18)F]FDG uptake patterns matched the clinical diagnosis in 38 of 66 (58%) of AD patients, and in 6 of 18 (33%) FTD patients. PET results led to a change in diagnosis in 35 (23%) patients. This only occurred when prior diagnostic certainty was <90%. Diagnostic confidence increased from 71 ± 17% before to 87 ± 16% after PET (p < .001). Two-year clinical follow-up (n = 39) showed that [(11)C]PIB and [(18)F]FDG predicted progression to AD for patients with mild cognitive impairment, and that the diagnosis of dementia established after PET remained unchanged in 96% of patients. In a memory clinic setting, combined [(11)C]PIB and [(18)F]FDG PET are of additional value on top of the standard diagnostic work-up, especially when prior diagnostic confidence is low. Copyright © 2013 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

A Low-Effort, Clinic-Wide Intervention Improves Attendance for HIV Primary Care

PubMed Central

Gardner, Lytt I.; Marks, Gary; Craw, Jason A.; Wilson, Tracey E.; Drainoni, Mari-Lynn; Moore, Richard D.; Mugavero, Michael J.; Rodriguez, Allan E.; Bradley-Springer, Lucy A.; Holman, Susan; Keruly, Jeanne C.; Sullivan, Meg; Skolnik, Paul R.; Malitz, Faye; Metsch, Lisa R.; Raper, James L.; Giordano, Thomas P.

2012-01-01

Background. Retention in care for human immunodeficiency virus (HIV)–infected patients is a National HIV/AIDS Strategy priority. We hypothesized that retention could be improved with coordinated messages to encourage patients' clinic attendance. We report here the results of the first phase of the Centers for Disease Control and Prevention/Health Resources and Services Administration Retention in Care project. Methods. Six HIV-specialty clinics participated in a cross-sectionally sampled pretest-posttest evaluation of brochures, posters, and messages that conveyed the importance of regular clinic attendance. 10 018 patients in 2008–2009 (preintervention period) and 11 039 patients in 2009–2010 (intervention period) were followed up for clinic attendance. Outcome variables were the percentage of patients who kept 2 consecutive primary care visits and the mean proportion of all primary care visits kept. Stratification variables were: new, reengaging, and active patients, HIV RNA viral load, CD4 cell count, age, sex, race or ethnicity, risk group, number of scheduled visits, and clinic site. Data were analyzed by multivariable log-binomial and linear models using generalized estimation equation methods. Results. Clinic attendance for primary care was significantly higher in the intervention versus preintervention year. Overall relative improvement was 7.0% for keeping 2 consecutive visits and 3.0% for the mean proportion of all visits kept (P < .0001). Larger relative improvement for both outcomes was observed for new or reengaging patients, young patients and patients with elevated viral loads. Improved attendance among the new or reengaging patients was consistent across the 6 clinics, and less consistent across clinics for active patients. Conclusion. Targeted messages on staying in care, which were delivered at minimal effort and cost, improved clinic attendance, especially for new or reengaging patients, young patients, and those with elevated viral loads. PMID:22828593

Patient engagement and attrition in pediatric obesity clinics and programs: results and recommendations.

PubMed

Hampl, Sarah; Paves, Heather; Laubscher, Katie; Eneli, Ihuoma

2011-09-01

Pediatric tertiary care institutions are well positioned to provide multidisciplinary, intensive interventions for pediatric obesity known as stage 3 treatment. One contributor to the difficulty in administering this treatment is the high rate of patient attrition. Little is known about the practices used by pediatric weight-management clinics and group-based programs to minimize attrition. Hospital members and nonmembers of FOCUS on a Fitter Future were surveyed on the methods used to engage and retain obese children in their clinics and programs. Shortly thereafter, a benchmarking activity that centered on rates of patient nonattendance at initial and follow-up clinic visits was initiated among FOCUS-group-participating hospitals. Clinic- and group-based program results were contrasted. Staff from group-based programs reported that the majority of patients did not complete even 50% of program follow-up visits. Multiple patient/family- and clinic/program-level barriers to retention were identified. Attention to successful techniques should be paid during planning for new programs and improvement of established ones.

Clinical Information Systems - From Yesterday to Tomorrow.

PubMed

Gardner, R M

2016-06-30

To review the history of clinical information systems over the past twenty-five years and project anticipated changes to those systems over the next twenty-five years. Over 250 Medline references about clinical information systems, quality of patient care, and patient safety were reviewed. Books, Web resources, and the author's personal experience with developing the HELP system were also used. There have been dramatic improvements in the use and acceptance of clinical computing systems and Electronic Health Records (EHRs), especially in the United States. Although there are still challenges with the implementation of such systems, the rate of progress has been remarkable. Over the next twenty-five years, there will remain many important opportunities and challenges. These opportunities include understanding complex clinical computing issues that must be studied, understood and optimized. Dramatic improvements in quality of care and patient safety must be anticipated as a result of the use of clinical information systems. These improvements will result from a closer involvement of clinical informaticians in the optimization of patient care processes. Clinical information systems and computerized clinical decision support have made contributions to medicine in the past. Therefore, by using better medical knowledge, optimized clinical information systems, and computerized clinical decision, we will enable dramatic improvements in both the quality and safety of patient care in the next twenty-five years.

Reducing the Clinical and Socioeconomic Burden of Narcolepsy by Earlier Diagnosis and Effective Treatment.

PubMed

Thorpy, Michael; Morse, Anne Marie

2017-03-01

The burden of narcolepsy is likely the result of 2 main aspects: the clinical difficulties and disability incurred as a direct effect of the disorder and the socioeconomic burden. The clinical burden includes the symptoms, diagnosis, comorbidities, treatment, and even mortality that can be associated with narcolepsy. Lifelong therapy is necessary for these patients. Effective treatment results in long-term benefits from both patient and societal perspectives by improving clinical outcomes, potentially enabling improved education and increased employment and work productivity, and quality of life. Thus, reducing the time to appropriate management results in improved outcomes in these patients. Copyright © 2017 Elsevier Inc. All rights reserved.

No need for a urine culture in elderly hospitalized patients with a negative dipstick test result.

PubMed

Shimoni, Zvi; Hermush, Vered; Glick, Joseph; Froom, Paul

2018-05-18

To determine the clinical utility/disutility of canceling urine cultures in elderly patients with a negative dipstick. The cohort included consecutive patients aged ≥ 65 years hospitalized in internal medicine departments with an admission urinalysis and urine culture (January 1, 2014 to December 31, 2016). We calculated the sensitivity of the dipstick (either a trace leukocyte esterase or a positive nitrite test result) to detect patients with bacteriuria, and the decrease in urine cultures resulting from cancelation in patients with a negative dipstick. We reviewed the charts of patients with a positive culture but negative dipstick to determine if they received appropriate antibiotic therapy and if the culture results had clinical utility, defined as changes in antibiotic therapy made according to culture results in a patient who did not respond to initial antibiotic therapy. The sensitivity of the dipstick for bacteriuria was 90.8% (95% CI, 89.6-92.0%). Of the 210 patients with a positive culture but negative dipstick, 132 (62.9%) had a diagnosis clearly outside the urinary tract. Thirty-five patients (16.7%) received inappropriate differential antibiotic therapy. Urine cultures did not have clinical utility and canceling urine cultures in those with a negative dipstick would result in a 41.5% (95% CI, 40.3-42.7%) decrease in urine cultures. We conclude that canceling orders for urine cultures in the elderly patient with a negative dipstick did not have clinical disutility and would decrease inappropriate antibiotic therapy. Extrapolation to other settings is dependent on urinalysis methodology, patient selection, and physician ordering and treatment behaviors.

Using simulation modeling to improve patient flow at an outpatient orthopedic clinic.

PubMed

Rohleder, Thomas R; Lewkonia, Peter; Bischak, Diane P; Duffy, Paul; Hendijani, Rosa

2011-06-01

We report on the use of discrete event simulation modeling to support process improvements at an orthopedic outpatient clinic. The clinic was effective in treating patients, but waiting time and congestion in the clinic created patient dissatisfaction and staff morale issues. The modeling helped to identify improvement alternatives including optimized staffing levels, better patient scheduling, and an emphasis on staff arriving promptly. Quantitative results from the modeling provided motivation to implement the improvements. Statistical analysis of data taken before and after the implementation indicate that waiting time measures were significantly improved and overall patient time in the clinic was reduced.

Neuroimaging findings in pediatric sports-related concussion.

PubMed

Ellis, Michael J; Leiter, Jeff; Hall, Thomas; McDonald, Patrick J; Sawyer, Scott; Silver, Norm; Bunge, Martin; Essig, Marco

2015-09-01

The goal in this review was to summarize the results of clinical neuroimaging studies performed in patients with sports-related concussion (SRC) who were referred to a multidisciplinar ypediatric concussion program. The authors conducted a retrospective review of medical records and neuroimaging findings for all patients referred to a multidisciplinary pediatric concussion program between September 2013 and July 2014. Inclusion criteria were as follows: 1) age ≤ 19 years; and 2) physician-diagnosed SRC. All patients underwent evaluation and follow-up by the same neurosurgeon. The 2 outcomes examined in this review were the frequency of neuroimaging studies performed in this population (including CT and MRI) and the findings of those studies. Clinical indications for neuroimaging and the impact of neuroimaging findings on clinical decision making were summarized where available. This investigation was approved by the local institutional ethics review board. A total of 151 patients (mean age 14 years, 59% female) were included this study. Overall, 36 patients (24%) underwent neuroimaging studies, the results of which were normal in 78% of cases. Sixteen percent of patients underwent CT imaging; results were normal in 79% of cases. Abnormal CT findings included the following: arachnoid cyst (1 patient), skull fracture (2 patients), suspected intracranial hemorrhage (1 patient), and suspected hemorrhage into an arachnoid cyst (1 patient). Eleven percent of patients underwent MRI; results were normal in 75% of cases. Abnormal MRI findings included the following: intraparenchymal hemorrhage and sylvian fissure arachnoid cyst (1 patient); nonhemorrhagic contusion (1 patient); demyelinating disease (1 patient); and posterior fossa arachnoid cyst, cerebellar volume loss, and nonspecific white matter changes (1 patient). Results of clinical neuroimaging studies are normal in the majority of pediatric patients with SRC. However, in selected cases neuroimaging can provide information that impacts decision making about return to play and retirement from the sport.

[Implantation of the paclitaxel-eluting stent Apollo in patients with stable angina pectoris: long-term angiographic and clinical results].

PubMed

Batyraliev, T A; Fettser, D V; Samko, A N; Sidorenko, B A

2010-01-01

to assess the long-term angiographic and clinical results of percutaneous coronary interventions (PCI) with implantation of the drug-eluting stent (DES) Apollo in patients with stable angina pectoris. The study enrolled 48 patients with stable angina who had been implanted with 59 stents. A follow-up of the patients lasted 12 months. The intervention was successful in 100% patients. Following 12 months, 81.3% of the patients underwent angiography that demonstrated that the vascular diameter decreased by 0.32 +/- 0.45 mm and the rate of restenosis was reduced by only 5.3%. The frequency of evident cardiac complications over 12 months was as high as 11.6%. The DES Apollo provides a way of safely performing PCI, by achieving a high of angiographic success rate. The application of this stent yields long-term good angiographic and clinical results in patients with stable angina pectoris.

Neither hereditary periodic fever nor periodic fever, aphthae, pharingitis, adenitis: Undifferentiated periodic fever in a tertiary pediatric center

PubMed Central

De Pauli, Silvia; Lega, Sara; Pastore, Serena; Grasso, Domenico Leonardo; Bianco, Anna Monica Rosaria; Severini, Giovanni Maria; Tommasini, Alberto; Taddio, Andrea

2018-01-01

AIM To describe the frequency and clinical characteristics of patients with undifferentiated periodic fever (UPF) and to investigate whether a clinical classification of UPF based on the PRINTO-Eurofever score can help predicting the response to treatment and the outcome at follow-up. METHODS Clinical and therapeutic information of patients with recurrent fever who presented at a single pediatric rheumatology center from January 2006 through April 2016 were retrospectively collected. Patients with a clinical suspicion of hereditary periodic fever (HPF) syndrome and patients with clinical picture of periodic fever, aphthae, pharingitis, adenitis (PFAPA) who were refractory to tonsillectomy underwent molecular analysis of five HPF-related genes: MEFV (NM_000243.2), MVK (NM_000431.3), TNFRSF1A (NM_001065.3), NLRP3 (NM_001079821.2), NLRP12 (NM_001277126.1). All patients who had a negative genetic result were defined as UPF and further investigated. PRINTO-Eurofever score for clinical diagnosis of HPF was calculated in all cases. RESULTS Of the 221 patients evaluated for periodic fever, twelve subjects with a clinical picture of PFAPA who were refractory to tonsillectomy and 22 subjects with a clinical suspicion of HPF underwent genetic analysis. Twenty-three patients (10.4%) resulted negative and were classified as UPF. The median age at presentation of patients with UPF was 9.5 mo (IQR 4-24). Patients with UPF had a higher frequency of aphthae (52.2% vs 0%, P = 0.0026) and musculoskeletal pain (65.2% vs 18.2%, P = 0.0255) than patients with genetic confirmed HPF. Also, patients with UPF had a higher frequency of aphthous stomatitis (52.2% vs 10.7%, P < 0.0001), musculoskeletal pain (65.2% vs 8,0%, P < 0.0001), and abdominal pain (52.2% vs 4.8%, P < 0.0001) and a lower frequency of pharyngitis (56.6% vs 81.3%, P = 0.0127) compared with typical PFAPA in the same cohort. Twenty-one of 23 patients with UPF (91.3%) received steroids, being effective in 16; 13 (56.2%) were given colchicine, which was effective in 6. Symptoms resolution occurred in 2 patients with UPF at last follow-up. Classification according to the PRINTO-Eurofever score did not correlate with treatment response and prognosis. CONCLUSION UPF is not a rare diagnosis among patients with periodic fever. Clinical presentation place UPF half way on a clinical spectrum between PFAPA and HPF. The PRINTO-Eurofever score is not useful to predict clinical outcome and treatment response in these patients. PMID:29456932

Medical sieve: a cognitive assistant for radiologists and cardiologists

NASA Astrophysics Data System (ADS)

Syeda-Mahmood, T.; Walach, E.; Beymer, D.; Gilboa-Solomon, F.; Moradi, M.; Kisilev, P.; Kakrania, D.; Compas, C.; Wang, H.; Negahdar, R.; Cao, Y.; Baldwin, T.; Guo, Y.; Gur, Y.; Rajan, D.; Zlotnick, A.; Rabinovici-Cohen, S.; Ben-Ari, R.; Guy, Amit; Prasanna, P.; Morey, J.; Boyko, O.; Hashoul, S.

2016-03-01

Radiologists and cardiologists today have to view large amounts of imaging data relatively quickly leading to eye fatigue. Further, they have only limited access to clinical information relying mostly on their visual interpretation of imaging studies for their diagnostic decisions. In this paper, we present Medical Sieve, an automated cognitive assistant for radiologists and cardiologists designed to help in their clinical decision-making. The sieve is a clinical informatics system that collects clinical, textual and imaging data of patients from electronic health records systems. It then analyzes multimodal content to detect anomalies if any, and summarizes the patient record collecting all relevant information pertinent to a chief complaint. The results of anomaly detection are then fed into a reasoning engine which uses evidence from both patient-independent clinical knowledge and large-scale patient-driven similar patient statistics to arrive at potential differential diagnosis to help in clinical decision making. In compactly summarizing all relevant information to the clinician per chief complaint, the system still retains links to the raw data for detailed review providing holistic summaries of patient conditions. Results of clinical studies in the domains of cardiology and breast radiology have already shown the promise of the system in differential diagnosis and imaging studies summarization.

Volumetric modulated arc therapy with flattening filter free beams for isolated abdominal/pelvic lymph nodes: report of dosimetric and early clinical results in oligometastatic patients

PubMed Central

2012-01-01

Background SBRT is a safe and efficient strategy to locally control multiple metastatic sites. While research in the physics domain for Flattening Filter Free Beams (FFF) beams is increasing, there are few clinical data of FFF beams in clinical practice. Here we reported dosimentric and early clinical data of SBRT and FFF delivery in isolated lymph node oligometastatic patients. Methods Between October 2010 and March 2012, 34 patients were treated with SBRT for oligometastatic lymph node metastasis on a Varian TrueBeamTM treatment machine using Volumetric Modulated Arc Therapy (RapidArc). We retrospectively evaluated a total of 25 patients for isolated lymph node metastases in abdomen and/or pelvis treated with SBRT and FFF (28 treatments). Acute toxicity was recorded. Local control evaluation was scored by means of CT scan and/or PET scan. Results All dosimetric results are in line with what published for the same type of stereotactic abdominal lymph node metastases treatments and fractionation, using RapidArc. All 25 FFF SBRT patients completed the treatment. Acute gastrointestinal toxicity was minimal: one patient showed Grade 1 gastrointestinal toxicity. Three other patients presented Grade 2 toxicity. No Grade 3 or higher was recorded. All toxicities were recovered within one week. The preliminary clinical results at the median follow up of 195 days are: complete response in 12 cases, partial response in 11, stable disease in 5, with an overall response rate of 82%; no local progression was recorded. Conclusions Data of dosimetrical findings and acute toxicity are excellent for patients treated with SBRT with VMAT using FFF beams. Preliminary clinical results showed a high rate of local control in irradiated lesion. Further data and longer follow up are needed to assess late toxicity and definitive clinical outcomes. PMID:23216821

How Primary Care Providers Talk to Patients about Genome Sequencing Results: Risk, Rationale, and Recommendation.

PubMed

Vassy, Jason L; Davis, J Kelly; Kirby, Christine; Richardson, Ian J; Green, Robert C; McGuire, Amy L; Ubel, Peter A

2018-06-01

Genomics will play an increasingly prominent role in clinical medicine. To describe how primary care physicians (PCPs) discuss and make clinical recommendations about genome sequencing results. Qualitative analysis. PCPs and their generally healthy patients undergoing genome sequencing. Patients received clinical genome reports that included four categories of results: monogenic disease risk variants (if present), carrier status, five pharmacogenetics results, and polygenic risk estimates for eight cardiometabolic traits. Patients' office visits with their PCPs were audio-recorded, and summative content analysis was used to describe how PCPs discussed genomic results. For each genomic result discussed in 48 PCP-patient visits, we identified a "take-home" message (recommendation), categorized as continuing current management, further treatment, further evaluation, behavior change, remembering for future care, or sharing with family members. We analyzed how PCPs came to each recommendation by identifying 1) how they described the risk or importance of the given result and 2) the rationale they gave for translating that risk into a specific recommendation. Quantitative analysis showed that continuing current management was the most commonly coded recommendation across results overall (492/749, 66%) and for each individual result type except monogenic disease risk results. Pharmacogenetics was the most common result type to prompt a recommendation to remember for future care (94/119, 79%); carrier status was the most common type prompting a recommendation to share with family members (45/54, 83%); and polygenic results were the most common type prompting a behavior change recommendation (55/58, 95%). One-fifth of recommendation codes associated with monogenic results were for further evaluation (6/24, 25%). Rationales for these recommendations included patient context, family context, and scientific/clinical limitations of sequencing. PCPs distinguish substantive differences among categories of genome sequencing results and use clinical judgment to justify continuing current management in generally healthy patients with genomic results.

Patients' Attitudes and Preferences About Participation and Recruitment Strategies in Clinical Trials

PubMed Central

Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S.; Loehrer, Laura L.; Wahner-Roedler, Dietlind L.

2009-01-01

OBJECTIVE: To assess attitudes of patients about participation in clinical trials. PATIENTS AND METHODS: This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. RESULTS: Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. CONCLUSION: Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results. PMID:19252111

Vascular Plug Assisted Retrograde Transvenous Obliteration (PARTO) for Gastric Varix Bleeding Patients in the Emergent Clinical Setting

PubMed Central

Yang, Heechul; Lee, Chun Kyon; Kim, Gun Bea

2016-01-01

Purpose To evaluate the technical feasibility and safety of vascular plug assisted retrograde transvenous obliteration (PARTO) for bleeding gastric varix performed in the emergent clinical setting and describe the mid-term clinical results. Materials and Methods From April 2012 to January 2015, emergent PARTO was tried in total 9 patients presented with active gastric varix bleeding. After initial insufficient or failure of endoscopic approach, they underwent PARTO in the emergent clinical setting. Gelatin sponge embolization of both gastrorenal (GR) shunt and gastric varix was performed after retrograde transvenous placement of a vascular plug in GR shunt. Coil assisted RTO (CARTO) was performed in one patient who had challenging GR shunt anatomy for vascular plug placement. Additional embolic materials, such as microcoils and NBCA glue-lipiodol mixture, were required in three patients to enhance complete occlusion of GR shunt or obliteration of competitive collateral vessels. Clinical success was defined as no variceal rebleeding and disappearance of gastric varix. Results All technical and clinical success–i.e., complete GR shunt occlusion and offending gastric varix embolization with immediate bleeding control–was achieved in all 9 patients. There was no procedure-related complication. All cases showed successful clinical outcome during mean follow up of 17 months (12–32 months), evidenced by imaging studies, endoscopy and clinical data. In 4 patients, mild worsening of esophageal varices or transient ascites was noted as portal hypertensive related change. Conclusion Emergent PARTO is technically feasible and safe, with acceptable mid-term clinical results, in treating active gastric varix bleeding. PMID:27189294

Specific lymphocyte subsets predict response to adoptive cell therapy using expanded autologous tumor-infiltrating lymphocytes in metastatic melanoma patients

PubMed Central

Radvanyi, Laszlo G.; Bernatchez, Chantale; Zhang, Minying; Fox, Patricia S.; Miller, Priscilla; Chacon, Jessica; Wu, Richard; Lizee, Gregory; Mahoney, Sandy; Alvarado, Gladys; Glass, Michelle; Johnson, Valen E.; McMannis, John D.; Shpall, Elizabeth; Prieto, Victor; Papadopoulos, Nicholas; Kim, Kevin; Homsi, Jade; Bedikian, Agop; Hwu, Wen-Jen; Patel, Sapna; Ross, Merrick I.; Lee, Jeffrey E.; Gershenwald, Jeffrey E.; Lucci, Anthony; Royal, Richard; Cormier, Janice N.; Davies, Michael A.; Mansaray, Rahmatu; Fulbright, Orenthial J.; Toth, Christopher; Ramachandran, Renjith; Wardell, Seth; Gonzalez, Audrey; Hwu, Patrick

2012-01-01

Purpose Adoptive cell therapy (ACT) using autologous tumor-infiltrating lymphocytes (TIL) is a promising treatment for metastatic melanoma unresponsive to conventional therapies. We report here on the results of an ongoing Phase II clinical trial testing the efficacy of ACT using TIL in metastatic melanoma patients and the association of specific patient clinical characteristics and the phenotypic attributes of the infused TIL with clinical response. Experimental Design Altogether, 31 transiently lymphodepleted patients were treated with their expanded TIL followed by two cycles of high-dose (HD) IL-2 therapy. The effects of patient clinical features and the phenotypes of the T-cells infused on clinical response were determined. Results Overall, 15/31 (48.4%) patients had an objective clinical response using immune-related response criteria (irRC), with two patients (6.5%) having a complete response. Progression-free survival of >12 months was observed for 9/15 (60%) of the responding patients. Factors significantly associated with objective tumor regression included a higher number of TIL infused, a higher proportion of CD8+ T-cells in the infusion product, a more differentiated effector phenotype of the CD8+ population and a higher frequency of CD8+ T-cells co-expressing the negative costimulation molecule “B- and T-lymphocyte attenuator” (BTLA). No significant difference in telomere lengths of TIL between responders and non-responders was identified. Conclusion These results indicate that immunotherapy with expanded autologous TIL is capable of achieving durable clinical responses in metastatic melanoma patients and that CD8+ T-cells in the infused TIL, particularly differentiated effectors cells and cells expressing BTLA, are associated with tumor regression. PMID:23032743

Clinical outcomes of a stepped care program for borderline personality disorder.

PubMed

Laporte, Lise; Paris, Joel; Bergevin, Tanya; Fraser, Ronald; Cardin, Jean-François

2018-04-30

This study examines the clinical outcomes of two clinics for borderline personality disorder (BPD) in a naturalistic setting, offering a stepped care model with both short-term (ST) treatment lasting 12 weeks and extended care (EC) up to 24 months. A total of 479 patients attending the ST clinic and 145 attending the EC clinic were assessed on depression, impulsivity, self-esteem, emotion dysregulation, substance abuse, self-harm and suicidality. There were significant reductions in all symptoms in both clinics with the exception that substance abuse was only reduced in the EC clinic. On all symptoms, no significant differences in magnitude of changes were observed between patients who stayed in EC clinic for 6-12 months in comparison to those who stayed for 18-24 months. These results support the concept that for the majority of patients with BPD, brief treatment can be effective. While some patients still need longer treatment, the results are encouraging for brief treatment as a first step for the majority of patients with BPD. While this study adds to the weight of evidence to support ST interventions for patients with BPD, further research using a control group is needed. Copyright © 2018 John Wiley & Sons, Ltd. Copyright © 2018 John Wiley & Sons, Ltd.

Impact of navigation on knowledge and attitudes about clinical trials among Chinese patients undergoing treatment for breast and gynecologic cancers.

PubMed

Clair McClung, E; Davis, Sharon Watkins; Jeffrey, Stefanie S; Kuo, Mei-Chin; Lee, Marion M; Teng, Nelson N H

2015-06-01

Racial, ethnic and economic disparities in cancer rates, outcomes, and clinical trials participation persist despite significant research. We examined barriers to clinical trials enrollment among Chinese patients, and developed a navigation program for Chinese gynecologic and breast cancer patients. Six bilingual navigators were trained and a navigator assigned to each patient for at least 2 months. All patients received a clinical trials booklet in Chinese and English. Data collection included pre-and post-navigation surveys, intake forms, and documentation of navigation encounters. Between July 2010 and May 31, 2011, we recruited 28 breast and gynecologic cancer patients. Patients averaged 317 min of navigation (range 63-1,852) during 8 sessions (range 3-28). They improved in 4 of 10 true-false knowledge statements about clinical trials. A patient navigation program for Chinese-speaking cancer patients is feasible. It results in high patient satisfaction rates and modest improvements in clinical trials knowledge and participation.

Streptococcal Pharyngitis: Impact of a High-Sensitivity Antigen Test on Physician Outcome

PubMed Central

Needham, Cynthia A.; McPherson, Kenneth A.; Webb, Kenneth H.

1998-01-01

The purpose of the present study was to determine whether the availability of results from a high-sensitivity, rapid test for group A streptococci (Strep A OIA; BioStar, Inc., Boulder, Colo.) improves physician outcome. The study population included 465 consecutive patients with symptoms of acute pharyngitis seen in two outpatient clinics in a large suburban medical center; one clinic, a walk-in clinic (WIC), primarily saw adult patients, and one clinic, a pediatric and adolescent medicine clinic (PED), primarily saw pediatric patients. We measured improvement in physician outcome by comparing physician intent for prescribing an antibiotic based on clinical impression with physician practice once the results of the Strep A OIA were known. Based upon intent, the physicians seeing WIC patients (WIC physicians) would have prescribed an appropriate antibiotic course for 42% of patients with cultures positive for group A beta-hemolytic streptococci (GABHS) and 61% of patients with cultures negative for GABHS. After receiving the results of the Strep A OIA, WIC physicians prescribed an appropriate antibiotic course for 81% of patients with positive cultures and 72% of patients with negative cultures. Based upon intent, the physicians seeing PED patients (PED physicians) would have prescribed an appropriate antibiotic course for 35% of patients with positive cultures and 77% of patients with negative cultures. After receiving the results of the Strep A OIA, PED physicians prescribed an appropriate antibiotic course for 90% of patients with positive cultures and 81% of patients with negative cultures. Based on a 14.5% prevalence of GABHS among WIC patients, Strep A OIA improved the overall WIC physician outcome from 58 to 74%. Based on a 31.5% prevalence of GABHS among PED patients, Strep A OIA improved the PED physician outcome from 64 to 84%. Had Strep A OIA alone guided therapeutic choice, physicians would have prescribed an appropriate antibiotic course for 95% of the patients at the time of the initial encounter. We conclude that the use of Strep A OIA improves physician outcome. PMID:9817856

PG4KDS: A Model for the Clinical Implementation of Pre-emptive Pharmacogenetics

PubMed Central

Hoffman, James M.; Haidar, Cyrine E.; Wilkinson, Mark R.; Crews, Kristine R.; Baker, Donald K.; Kornegay, Nancy M.; Yang, Wenjian; Pui, Ching-Hon; Reiss, Ulrike M.; Gaur, Aditya H.; Howard, Scott C.; Evans, William E.; Broeckel, Ulrich; Relling, Mary V.

2014-01-01

Pharmacogenetics is frequently cited as an area for initial focus of the clinical implementation of genomics. Through the PG4KDS protocol, St. Jude Children’s Research Hospital pre-emptively genotypes patients for 230 genes using the Affymetrix Drug Metabolizing Enzymes and Transporters (DMET) Plus array supplemented with a CYP2D6 copy number assay. The PG4KDS protocol provides a rational, stepwise process for implementing gene/drug pairs, organizing data, and obtaining consent from patients and families. Through August 2013, 1559 patients have been enrolled, and 4 gene tests have been released into the electronic health record (EHR) for clinical implementation: TPMT, CYP2D6, SLCO1B1, and CYP2C19. These genes are coupled to 12 high-risk drugs. Of the 1016 patients with genotype test results available, 78% of them had at least one high-risk (i.e., actionable) genotype result placed in their EHR. Each diplotype result released to the EHR is coupled with an interpretive consult that is created in a concise, standardized format. To support-gene based prescribing at the point of care, 55 interruptive clinical decision support (CDS) alerts were developed. Patients are informed of their genotyping result and its relevance to their medication use through a letter. Key elements necessary for our successful implementation have included strong institutional support, a knowledgeable clinical laboratory, a process to manage any incidental findings, a strategy to educate clinicians and patients, a process to return results, and extensive use of informatics, especially CDS. Our approach to pre-emptive clinical pharmacogenetics has proven feasible, clinically useful, and scalable. PMID:24619595

PG4KDS: a model for the clinical implementation of pre-emptive pharmacogenetics.

PubMed

Hoffman, James M; Haidar, Cyrine E; Wilkinson, Mark R; Crews, Kristine R; Baker, Donald K; Kornegay, Nancy M; Yang, Wenjian; Pui, Ching-Hon; Reiss, Ulrike M; Gaur, Aditya H; Howard, Scott C; Evans, William E; Broeckel, Ulrich; Relling, Mary V

2014-03-01

Pharmacogenetics is frequently cited as an area for initial focus of the clinical implementation of genomics. Through the PG4KDS protocol, St. Jude Children's Research Hospital pre-emptively genotypes patients for 230 genes using the Affymetrix Drug Metabolizing Enzymes and Transporters (DMET) Plus array supplemented with a CYP2D6 copy number assay. The PG4KDS protocol provides a rational, stepwise process for implementing gene/drug pairs, organizing data, and obtaining consent from patients and families. Through August 2013, 1,559 patients have been enrolled, and four gene tests have been released into the electronic health record (EHR) for clinical implementation: TPMT, CYP2D6, SLCO1B1, and CYP2C19. These genes are coupled to 12 high-risk drugs. Of the 1,016 patients with genotype test results available, 78% of them had at least one high-risk (i.e., actionable) genotype result placed in their EHR. Each diplotype result released to the EHR is coupled with an interpretive consult that is created in a concise, standardized format. To support-gene based prescribing at the point of care, 55 interruptive clinical decision support (CDS) alerts were developed. Patients are informed of their genotyping result and its relevance to their medication use through a letter. Key elements necessary for our successful implementation have included strong institutional support, a knowledgeable clinical laboratory, a process to manage any incidental findings, a strategy to educate clinicians and patients, a process to return results, and extensive use of informatics, especially CDS. Our approach to pre-emptive clinical pharmacogenetics has proven feasible, clinically useful, and scalable. © 2014 Wiley Periodicals, Inc.

Novel fluorescence in situ hybridization-based definition of bacille Calmette-Guérin (BCG) failure for use in enhancing recruitment into clinical trials of intravesical therapies.

PubMed

Kamat, Ashish M; Willis, Daniel L; Dickstein, Rian J; Anderson, Rooselvelt; Nogueras-González, Graciela; Katz, Ruth L; Wu, Xifeng; Barton Grossman, H; Dinney, Colin P

2016-05-01

To present a molecular definition of bacille Calmette-Guérin (BCG) failure that incorporates fluorescence in situ hybridization (FISH) testing to predict BCG failure before it becomes clinically evident, which can be used to enhance trial designs for patients with non-muscle-invasive bladder cancer. We used data from 143 patients who were followed prospectively for 2 years during intravesical BCG therapy, during which time FISH assays were collected and correlated to clinical outcomes. Of the 95 patients with no evidence of tumour at 3-month cystoscopy, 23 developed tumour recurrence and 17 developed disease progression by 2 years. Patients with a positive FISH test at both 6 weeks and 3 months were more likely to develop tumour recurrence (17/37 patients [46%] and 16/28 patients [57%], respectively) than patients with a negative FISH test (6/58 patients [10%] and 3/39 patients [8%], respectively; both P < 0.001). Using hazard ratios for recurrence with positive 6-week and 3-month FISH results, we constructed clinical trial scenarios whereby patients with a negative 3-month cystoscopy and positive FISH result could be considered to have 'molecular BCG failure' and could be enrolled in prospective, randomized clinical trials comparing BCG therapy (control) with an experimental intravesical therapy. Patients with positive early FISH and negative 3-month cystoscopy results can be considered to have molecular BCG failure based on their high rates of recurrence and progression. This definition is intended for use in designing clinical trials, thus potentially allowing continued use of BCG as an ethical comparator arm. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

Improved continuity of care in a resident clinic.

PubMed

Butler, Melissa; Kim, Hyungkoo; Sansone, Randy

2017-02-01

For residents in the out-patient clinic, continuity in patient care is an integral and vital aspect of internal medicine training, but is frequently compromised by resident in-patient schedules, the structure of the out-patient clinic and the need to comply with the increasing regulation of duty hours. In this study, we examined whether the creation and implementation of a new team approach, the Firms Model, would improve the continuity of patient care in the internal medicine resident out-patient clinic. Before the implementation of the Firms Model, an examination of a consecutive clinic sample indicated that patients were seen by their assigned resident providers 41.9 per cent of the time (n = 1319 clinic visits). After implementation of the Firms Model, an examination of a consecutive clinic sample indicated that patients were seen by their assigned Firm resident providers 88.9 per cent of the time (n = 1341 clinic visits). Implementation of the Firms Model resulted in a statistically significant increase in the percentage of patients seen by assigned resident providers in an internal medicine out-patient clinic, culminating in a substantial improvement in continuity of care within our resident out-patient clinic. We discuss the implications of these findings. Continuity in patient care is an integral and vital aspect of internal medicine training, but is frequently compromised. © 2016 John Wiley & Sons Ltd.

Profiles of Urine Drug Test in Clinical Pain Patients vs Pain Research Study Subjects.

PubMed

Lee, Cheng-ting; Vo, Trang T; Cohen, Abigail S; Ahmed, Shihab; Zhang, Yi; Mao, Jianren; Chen, Lucy

2016-04-01

To examine similarities and differences in urine drug test (UDT) results in clinical pain patients and pain subjects participating in pain research studies. An observational study with retrospective chart review and data analysis. We analyzed 1,874 UDT results obtained from 1) clinical pain patients (Clinical Group; n = 1,529) and 2) pain subjects consented to participate in pain research studies (Research Group; n = 345). Since several medications such as opioids used in pain management are drugs of abuse (DOA) and can result in a positive UDT, we specifically identified those cases of positive UDT due to nonprescribed DOA and designated these cases as positive UDT with DOA (PUD). We found that 1) there was a higher rate of PUD in clinical pain patients (41.3%) than in pain research study subjects (14.8%); 2) although subjects in the Research Group were informed ahead of time that UDT will be conducted as a screening test, a substantial number (14.8%) of pain research study subjects still showed PUD; 3) there were different types of DOA between clinical pain patients (cannabinoids as the top DOA) and research study subjects (cocaine as the top DOA); and 4) a common factor associated with PUD was opioid therapy in both Clinical Group and Research Group. These results support previous findings that PUD is a common finding in clinical pain patients, particularly in those prescribed opioid therapy, and we suggest that UDT be used as routine screening testing in pain research studies. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

TEXTINFO: a tool for automatic determination of patient clinical profiles using text analysis.

PubMed Central

Borst, F.; Lyman, M.; Nhàn, N. T.; Tick, L. J.; Sager, N.; Scherrer, J. R.

1991-01-01

The clinical data contained in narrative patient documents is made available via grammatical and semantic processing. Retrievals from the resulting relational database tables are matched against a set of clinical descriptors to obtain clinical profiles of the patients in terms of the descriptors present in the documents. Discharge summaries of 57 Dept. of Digestive Surgery patients were processed in this manner. Factor analysis and discriminant analysis procedures were then applied, showing the profiles to be useful for diagnosis definitions (by establishing relations between diagnoses and clinical findings), for diagnosis assessment (by viewing the match between a definition and observed events recorded in a patient text), and potentially for outcome evaluation based on the classification abilities of clinical signs. PMID:1807679

Integrative clinical sequencing in the management of children and young adults with refractory or relapsed cancer

PubMed Central

Mody, Rajen J.; Wu, Yi-Mi; Lonigro, Robert J.; Cao, Xuhong; Roychowdhury, Sameek; Vats, Pankaj; Frank, Kevin M.; Prensner, John R.; Asangani, Irfan; Palanisamy, Nallasivam; Dillman, Jonathan R.; Rabah, Raja M.; Kunju, Laxmi Priya; Everett, Jessica; Raymond, Victoria M.; Ning, Yu; Su, Fengyun; Wang, Rui; Stoffel, Elena M.; Innis, Jeffrey W.; Roberts, J. Scott; Robertson, Patricia L.; Yanik, Gregory; Chamdin, Aghiad; Connelly, James A.; Choi, Sung; Harris, Andrew C.; Kitko, Carrie; Rao, Rama Jasty; Levine, John E.; Castle, Valerie P.; Hutchinson, Raymond J.; Talpaz, Moshe; Robinson, Dan R.; Chinnaiyan, Arul M.

2016-01-01

Importance Cancer is caused by a diverse array of somatic and germline genomic aberrations. Advances in genomic sequencing technologies have improved the ability to detect these molecular aberrations with greater sensitivity. However, integrating them into clinical management in an individualized manner has proven challenging. Objective To evaluate the use of integrative clinical sequencing and genetic counseling in the assessment and treatment of children and young adults with cancer. Design, Settings and Participants An observational, consecutive case series (May 2012–October 2014) of 102 children and young adults (mean age, 10.6; median age, 11.5, range: 0–22 years) with relapsed, refractory, or rare cancer at a single major academic medical center. Exposures Each participant underwent integrative clinical exome (tumor and germline DNA) and transcriptome (tumor RNA) sequencing along with genetic counseling. Results were discussed in a multi-disciplinary Precision Medicine Tumor Board (PMTB) and recommendations were reported to treating physicians and families. Main Outcomes and Measures Proportion of patients with potentially actionable findings (PAF), results of clinical actions based on integrative clinical sequencing (ICS), and estimated proportion of patients or their families at risk for future cancer. PAF was defined as any genomic findings discovered during sequencing analysis that could lead to a 1) change in patient management by providing a targetable molecular aberration, 2) change in diagnosis or risk stratification or 3) provides cancer-related germline findings, which inform patients/families about a potential future risk of various cancers; Results We screened 104 patients and enrolled 102 patients of which 91 (89%) had adequate tumor tissue available to complete sequencing and only these patients were included in all subsequent calculations, including 28 (31%) with hematological malignancies and 63 (69%) with solid tumors. Overall, 42 (46%) patients had PAFs which changed patient management including, 54% (15/28) with hematological malignancies and 43% (27/63) with solid tumors. Overall, individualized actions were taken in 23 of the 91 (25%) patients and families based on actionable ICS findings, including change in treatment in 14 (15%) and genetic counseling for future cancer risk in 9 (10%) patients. 9/91 (10%) of these personalized clinical interventions resulted in ongoing partial clinical remission of 8–16 months duration or help sustain complete clinical remission of 6–21 months duration. All 9 (10%) patients and families with actionable incidental genetic findings agreed to formal genetic counseling and screening. Conclusions and Relevance In this single center case series of children and young adults with relapsed or refractory cancer, incorporation of data from integrative clinical sequencing into clinical management was feasible, revealed potentially actionable findings in 46% of patients, and was associated with change in treatment and family genetic counseling in a small proportion of patients. The lack of a control group limited our ability to judge whether better clinical outcomes were achieved compared to standard care. PMID:26325560

Clinical and vascular features of Takayasu arteritis at the time of ischemic stroke.

PubMed

de Paula, Luiz Eduardo; Alverne, Andrea Rocha; Shinjo, Samuel K

2013-01-01

Takayasus arteritis (TA) is a systemic vasculitis whose clinical presentation varies from asymptomatic to serious neurovascular events, including stroke. However, few studies are currently available assessing stroke in TA. Thus, we described the clinical and laboratory characteristics and vascular imaging features in patients with TA at the time of stroke. This is a single center retrospective cohort study investigating the clinical and demographic data of 18 (15.0%) patients with a history of stroke confirmed by imaging methods, among 120 patients with TA, assessed in the 1985-2012 period. The mean age of the 18 patients at the time of stroke was 29.4+/-10.9 years, with 94.4% female and 88.9% Caucasian. Of these patients, 14 (77.8%) had previous stroke at diagnosis of TA, while in four cases the stroke occurred after confirmed TA diagnosis. Regarding the clinical course, 12 (66.7%) had peripheral neurological sequelae and one patient died as a result of cerebral hyperperfusion syndrome after carotid revascularization. Our results showed a high prevalence of stroke in TA and revealed most of these events occurred concomitantly with diagnosed TA. Moreover, although four patients had strokes after diagnosis of TA, these occurred at a young age, demonstrating they were most likely the result of vascular changes secondary to TA.

Impact of live interactive teledermatology on diagnosis, disease management, and clinical outcomes.

PubMed

Lamel, Sonia; Chambers, Cindy J; Ratnarathorn, Mondhipa; Armstrong, April W

2012-01-01

To assess the impact of live interactive teledermatology consultations on changes in diagnosis, disease management, and clinical outcomes. We conducted a retrospective analysis of 1500 patients evaluated via live interactive teledermatology between 2003 and 2005 at the University of California, Davis. We compared diagnoses and treatment plans between the referring physicians and the teledermatologists. Patients with 2 or more teledermatology visits within a 1-year period were assessed for changes in clinical outcomes. Academic medical center with an established teledermatology program since 1996. Medical records were evaluated for 1500 patients who underwent live interactive teledermatology consultation. Patients seen for more than 1 teledermatology visit were included in the clinical outcome assessment. Live interactive teledermatology consultation. Changes in diagnosis, disease management, and clinical outcome. Compared with diagnoses and treatment plans from referring physicians, the 1500 live interactive teledermatology consultations resulted in changes in diagnosis in 69.9% of patients and changes in disease management in 97.7% of patients. Among 313 patients with at least 2 teledermatology visits within 1 year, clinical improvement was observed in 68.7% of patients. Multivariate analysis showed that changes in diagnosis (P = .01), changes in disease management (P < .001), and the number of teledermatology visits (P < .001) were significantly associated with improved clinical outcomes. Live interactive teledermatology consultations result in changes in diagnosis and disease management in most consultations. The numbers of live interactive teledermatology visits and changes in diagnosis and disease management are significantly associated with improved clinical outcomes.

Does language ambiguity in clinical practice justify the introduction of standard terminology? An integrative review.

PubMed

Stallinga, Hillegonda A; ten Napel, Huib; Jansen, Gerard J; Geertzen, Jan H B; de Vries Robbé, Pieter F; Roodbol, Petrie F

2015-02-01

To research the use of ambiguous language in written information concerning patients' functioning and to identify problems resulting from the use of ambiguous language in clinical practice. Many projects that aimed to introduce standard terminology concerning patients' functioning in clinical practice are unsuccessful because standard terminology is rarely used in clinical practice. These projects mainly aim to improve communication by reducing ambiguous language. Considering their lack of success, the validity of the argument that language ambiguity is used in clinical practice is questioned. An integrative literature review. A systematic search of the MEDLINE (1950-2012) and CINAHL (1982-2012) databases was undertaken, including empirical and theoretical literature. The selected studies were critically appraised using a data assessment and extraction form. Seventeen of 767 papers were included in the review and synthesis. The use of ambiguous language in written information concerning patients' functioning was demonstrated. Problems resulting from the use of ambiguous language in clinical practice were not identified. However, several potential problems were suggested, including hindered clinical decision-making and limited research opportunities. The results of this review demonstrated the use of ambiguous language concerning patients' functioning, but health professionals in clinical practice did not experience this issue as a problem. This finding might explain why many projects aimed at introducing standard terminology concerning functioning in clinical practice to solve problems caused by ambiguous language are often unsuccessful. Language ambiguity alone is not a valid argument to justify the introduction of standard terminology. The introduction of standard terminology concerning patients' functioning will only be successful when clinical practice requires the aggregation and reuse of data from electronic patient records for different purposes, including multidisciplinary decision-making and research. © 2014 John Wiley & Sons Ltd.

Deep Patient: An Unsupervised Representation to Predict the Future of Patients from the Electronic Health Records

PubMed Central

Miotto, Riccardo; Li, Li; Kidd, Brian A.; Dudley, Joel T.

2016-01-01

Secondary use of electronic health records (EHRs) promises to advance clinical research and better inform clinical decision making. Challenges in summarizing and representing patient data prevent widespread practice of predictive modeling using EHRs. Here we present a novel unsupervised deep feature learning method to derive a general-purpose patient representation from EHR data that facilitates clinical predictive modeling. In particular, a three-layer stack of denoising autoencoders was used to capture hierarchical regularities and dependencies in the aggregated EHRs of about 700,000 patients from the Mount Sinai data warehouse. The result is a representation we name “deep patient”. We evaluated this representation as broadly predictive of health states by assessing the probability of patients to develop various diseases. We performed evaluation using 76,214 test patients comprising 78 diseases from diverse clinical domains and temporal windows. Our results significantly outperformed those achieved using representations based on raw EHR data and alternative feature learning strategies. Prediction performance for severe diabetes, schizophrenia, and various cancers were among the top performing. These findings indicate that deep learning applied to EHRs can derive patient representations that offer improved clinical predictions, and could provide a machine learning framework for augmenting clinical decision systems. PMID:27185194

Deep Patient: An Unsupervised Representation to Predict the Future of Patients from the Electronic Health Records

NASA Astrophysics Data System (ADS)

Miotto, Riccardo; Li, Li; Kidd, Brian A.; Dudley, Joel T.

2016-05-01

Secondary use of electronic health records (EHRs) promises to advance clinical research and better inform clinical decision making. Challenges in summarizing and representing patient data prevent widespread practice of predictive modeling using EHRs. Here we present a novel unsupervised deep feature learning method to derive a general-purpose patient representation from EHR data that facilitates clinical predictive modeling. In particular, a three-layer stack of denoising autoencoders was used to capture hierarchical regularities and dependencies in the aggregated EHRs of about 700,000 patients from the Mount Sinai data warehouse. The result is a representation we name “deep patient”. We evaluated this representation as broadly predictive of health states by assessing the probability of patients to develop various diseases. We performed evaluation using 76,214 test patients comprising 78 diseases from diverse clinical domains and temporal windows. Our results significantly outperformed those achieved using representations based on raw EHR data and alternative feature learning strategies. Prediction performance for severe diabetes, schizophrenia, and various cancers were among the top performing. These findings indicate that deep learning applied to EHRs can derive patient representations that offer improved clinical predictions, and could provide a machine learning framework for augmenting clinical decision systems.

Serial Liver Stiffness Measurements and Monitoring of Liver-Transplanted Patients in a Real-Life Clinical Practice

PubMed Central

Rinaldi, Luca; Valente, Giovanna; Piai, Guido

2016-01-01

Background Liver transplanted patients need close surveillance for early signs of graft disease. Objectives Transient elastography can safely be repeated over time, offering serial liver stiffness measurement values. Serial stiffness measurements were compared to single baseline stiffness measurements in predicting the appearance of liver-related clinical events and guiding subsequent clinical decisions. Methods One hundred and sixty liver transplanted patients were observed for three years in our real-life practice. Results Liver stiffness measurements were stable in 75% of patients, decreased in 4% of patients, and increased in 21% of patients. The pattern of increased stiffness measurements was associated with both HCV-RNA positive status and the presence of an active biliary complication of liver transplantation and was more predictive of a clinically significant event resulting from any disease of the transplanted liver when compared to a stable pattern or to a single liver stiffness measurement. The procedures that were consequently performed were often diagnostic for unexpected situations, both in HCV-RNA positive and HCV-RNA negative patients. Conclusions The pattern of longitudinally increased liver stiffness measurements efficiently supported clinical decisions for individualized management strategies. Repeated transient elastography in real-life clinical practice appears to have a practical role in monitoring liver transplanted patients. PMID:28123442

[The external patello-tibial transfixation (EPTT). Part II: Clinical application and results].

PubMed

Ishaque, B; Gotzen, L; Ziring, E; Petermann, J

1999-07-01

In part I of the paper the biomechanical and technical background of the EPTT using the MPT fixator and the indications for this procedure have been described. In part II we report about the clinical application of the EPTT in 67 patients with a wide spectrum of repairs and reconstructions of the extensor mechanism. 48 patients had fresh injuries, 18 of them with severe concomitant knee lesions and 19 patients had neglected rsp. unsuccessfully operated injuries. There were 4 deep infections, two of them related to the MPT fixator. In the patients with uneventful healing the fixator remained in place for 7.3 weeks in average. The clinical, isokinetic and radiological results were reviewed in 17 patients with an average follow-up time of 37.3 months. There were 5 patients with partial patellectomy and tendon reattachment because of lower patella pole comminution and 12 patients with tendon reattachment ruptured at the inferior patella pole or suture repair in midsubstance rupture. The clinical results according to the IKDC score were rated in 3 patients as normal, in 10 patients as nearly normal and in 4 patients as abnormal. This rating was highly dependend on the subjective judgement by the patients who considered their operated knees not as normal as the contralateral knees. From our clinical experiences and results we can derive that the EPTT enables the surgical management of extensor mechanism disruptions with a minimum of internal fixation material and provides a safe protection of the repairs and reconstructions during the healing period. The EPTT allows immediate unrestricted functional rehabilitation and early walking without crutches. Thus the EPTT represents an effective alternative to the patello-tibial cerclage with a wire or synthetic ligaments.

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

[The importance of x-ray cinematography of deglutition for indicating the need for myotomy of the pharyngoesophageal sphincter].

PubMed

Augustiny, N; Schmid, H; Brühlmann, W F

1987-05-01

Fourteen patients were examined one to four years after cricopharyngeal myotomy that had been carried out because of dysfunction of the pharyngo-esophageal sphincter. Twelve patients were examined radiologically. Eleven of the 14 patients were clinically improved or cured. In two patients who were not improved, the underlying condition was a polymyositis. The other patients suffered from an idiopathic dysfunction. Because of the small numbers involved, no detailed statistical analysis was carried out. Nevertheless, our results indicate that: Cricopharyngeus myotomy produces marked improvement or cure in patients with idiopathic dysfunction. Weak propulsive peristalsis of the pharyngeal constrictors is a prognostic factor indicating a poor clinical result of surgery. There is little chance of clinical improvement in patients with polymyositis.

Poor Positive Predictive Value of Lyme Disease Serologic Testing in an Area of Low Disease Incidence

PubMed Central

Lantos, Paul M.; Branda, John A.; Boggan, Joel C.; Chudgar, Saumil M.; Wilson, Elizabeth A.; Ruffin, Felicia; Fowler, Vance; Auwaerter, Paul G.; Nigrovic, Lise E.

2015-01-01

Background. Lyme disease is diagnosed by 2-tiered serologic testing in patients with a compatible clinical illness, but the significance of positive test results in low-prevalence regions has not been investigated. Methods. We reviewed the medical records of patients who tested positive for Lyme disease with standardized 2-tiered serologic testing between 2005 and 2010 at a single hospital system in a region with little endemic Lyme disease. Based on clinical findings, we calculated the positive predictive value of Lyme disease serology. Next, we reviewed the outcome of serologic testing in patients with select clinical syndromes compatible with disseminated Lyme disease (arthritis, cranial neuropathy, or meningitis). Results. During the 6-year study period 4723 patients were tested for Lyme disease, but only 76 (1.6%) had positive results by established laboratory criteria. Among 70 seropositive patients whose medical records were available for review, 12 (17%; 95% confidence interval, 9%–28%) were found to have Lyme disease (6 with documented travel to endemic regions). During the same time period, 297 patients with a clinical illness compatible with disseminated Lyme disease underwent 2-tiered serologic testing. Six of them (2%; 95% confidence interval, 0.7%–4.3%) were seropositive, 3 with documented travel and 1 who had an alternative diagnosis that explained the clinical findings. Conclusions. In this low-prevalence cohort, fewer than 20% of positive Lyme disease tests are obtained from patients with clinically likely Lyme disease. Positive Lyme disease test results may have little diagnostic value in this setting. PMID:26195017

Evaluation of Correlation between Pretest Probability for Clostridium difficile Infection and Clostridium difficile Enzyme Immunoassay Results

PubMed Central

Reske, Kimberly A.; Hink, Tiffany; Dubberke, Erik R.

2016-01-01

ABSTRACT The objective of this study was to evaluate the clinical characteristics and outcomes of hospitalized patients tested for Clostridium difficile and determine the correlation between pretest probability for C. difficile infection (CDI) and assay results. Patients with testing ordered for C. difficile were enrolled and assigned a high, medium, or low pretest probability of CDI based on clinical evaluation, laboratory, and imaging results. Stool was tested for C. difficile by toxin enzyme immunoassay (EIA) and toxigenic culture (TC). Chi-square analyses and the log rank test were utilized. Among the 111 patients enrolled, stool samples from nine were TC positive and four were EIA positive. Sixty-one (55%) patients had clinically significant diarrhea, 19 (17%) patients did not, and clinically significant diarrhea could not be determined for 31 (28%) patients. Seventy-two (65%) patients were assessed as having a low pretest probability of having CDI, 34 (31%) as having a medium probability, and 5 (5%) as having a high probability. None of the patients with low pretest probabilities had a positive EIA, but four were TC positive. None of the seven patients with a positive TC but a negative index EIA developed CDI within 30 days after the index test or died within 90 days after the index toxin EIA date. Pretest probability for CDI should be considered prior to ordering C. difficile testing and must be taken into account when interpreting test results. CDI is a clinical diagnosis supported by laboratory data, and the detection of toxigenic C. difficile in stool does not necessarily confirm the diagnosis of CDI. PMID:27927930

Data quality assurance: an analysis of patient non-response.

PubMed

Derby, Dustin C; Haan, Andrea; Wood, Kurt

2011-01-01

Patient satisfaction is paramount to maintaining high clinical quality assurance. This study seeks to compare response rates, response bias, and the completeness of data between paper and electronic collection modes of a chiropractic patient satisfaction survey. A convenience sample of 206 patients presenting to a chiropractic college clinic were surveyed concerning satisfaction with their chiropractic care. Paper (in-clinic and postal) and electronic modes of survey administration were compared for response rates and non-response bias. The online data collection mode resulted in fewer non-responses and a higher response rate, and did not evince response bias when compared to paper modes. The postal paper mode predicted non-response rates over the in-clinic paper and online modalities and exhibited a gender bias. This current study was a single clinic study; future studies should consider multi-clinic data collections. Busy clinic operations and available staff resources restricted the ability to conduct a random sampling of patients or to invite all eligible patients, therefore limiting the generalizability of collected survey data. Results of this study will provide data to aid development of survey protocols that efficiently, account for available human resources, and are convenient for patients while allowing for the most complete and accurate data collection possible in an educational clinic setting. Understanding patient responses across survey modes is critical for the cultivation of quality business intelligence within college teaching clinic settings. This study bridges measurement evidence from three popular data collection modalities and offers support for higher levels of quality for web-based data collection.

Why Lumbar Artificial Disk Replacements (LADRs) Fail.

PubMed

Pettine, Kenneth; Ryu, Robert; Techy, Fernando

2017-07-01

A retrospective review of prospectively collected data. To determine why artificial disk replacements (ADRs) fail by examining results of 91 patients in FDA studies performed at a single investigational device exemption (IDE) site with minimum 2-year follow-up. Patients following lumbar ADR generally achieve their 24-month follow-up results at 3 months postoperatively. Every patient undergoing ADR at 1 IDE site by 2 surgeons was evaluated for clinical success. Failure was defined as <50% improvement in ODI and VAS or any additional surgery at index or adjacent spine motion segment. Three ADRs were evaluated: Maverick, 25 patients; Charité, 31 patients; and Kineflex, 35 patients. All procedures were 1-level operations performed at L4-L5 or L5-S1. Demographics and inclusion/exclusion criteria were similar and will be discussed. Overall clinical failure occurred in 26% (24 of 91 patients) at 2-year follow-up. Clinical failure occurred in: 28% (Maverick) (7 of 25 patients), 39% (Charité) (12 of 31 patients), and 14% (Kineflex) (5 of 35 patients). Causes of failure included facet pathology, 50% of failure patients (12 of 24). Implant complications occurred in 5% of total patients and 21% of failure patients (5 of 24). Only 5 patients went from a success to failure after 3 months. Only 1 patient went from a failure to success after a facet rhizotomy 1 year after ADR. Seventy-four percent of patients after ADR met strict clinical success after 2-year follow-up. The clinical success versus failure rate did not change from their 3-month follow-up in 85 of the 91 patients (93%). Overall clinical success may be improved most by patient selection and implant type.

Clinical and histopathological results of the adult patients with unilateral cryptorchidism

PubMed Central

Ateş, Ferhat; Soydan, Hasan; Okçelik, Sezgin; Çırakoğlu, Abdullah; Yılmaz, İsmail; Malkoç, Ercan; Karademir, Kenan

2016-01-01

Objective To evaluate the clinical and histopathological results of adult unilateral cryptorchidism patients. Material and methods Data from adult unilateral cryptorchidism patients that underwent orchiectomy in our clinic between between January 2004 and March 2013 were retrospectively evaluated. Patients were divided into three groups as intra-abdominal, inguinal canal and superficial inguinal region according to the location of the undescended testes. Patients were also grouped according to their testicular volume (<4 cc, 4.1–12 cc, and >12 cc). Histopathology results of orchiectomy specimens were classified as follows: 1. Sertoli cells only, testicular atrophy and vanished testis (anorchia) 2. Hypospermatogenesis, and 3. Maturation arrest. Patients were grouped as normospermia, azoospermia and oligo/astheno/teratospermia groups according to semen analysis results. Correlations between testicular localization, testicular size, semen analysis and pathology results were evaluated. Incidental tumor detection rates were also calculated. Results Two hundred and forty-four adult unilateral cryptorchidism patients underwent orchiectomy in our clinic. There was no a significant relationship between location of the testis and testicular pathology results (p=0.707). Most common semen analysis results was normospermia in patients with high testicular volume group however azoospermia and oligoasthenospermia observed commonly in patients with low testicular volume group. There was a significant relationship between testicular volume and semen analysis results (p=0.023). No significant relationship was observed between semen analysis and pathological results (p=0.929). After an evaluation of all factors with possible effects on the semen analysis results, only testicular volume (p=0.036) was found to have a significant impact. Only one case (0.4%) was incidentally diagnosed seminoma after a review of 233 patients with available histopathological results on record. Conclusion Adult unilateral cryptorchidism has a minimal effect on male fertility or even this effect can be overlooked. Low detection rates of incidental germ cell tumors also make an orchiectomy decision questionable in such cases. PMID:27274891

Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

PubMed

Roehle, Robert; Wieske, Viktoria; Schuetz, Georg M; Gueret, Pascal; Andreini, Daniele; Meijboom, Willem Bob; Pontone, Gianluca; Garcia, Mario; Alkadhi, Hatem; Honoris, Lily; Hausleiter, Jörg; Bettencourt, Nuno; Zimmermann, Elke; Leschka, Sebastian; Gerber, Bernhard; Rochitte, Carlos; Schoepf, U Joseph; Shabestari, Abbas Arjmand; Nørgaard, Bjarne; Sato, Akira; Knuuti, Juhani; Meijs, Matthijs F L; Brodoefel, Harald; Jenkins, Shona M M; Øvrehus, Kristian Altern; Diederichsen, Axel Cosmus Pyndt; Hamdan, Ashraf; Halvorsen, Bjørn Arild; Mendoza Rodriguez, Vladimir; Wan, Yung Liang; Rixe, Johannes; Sheikh, Mehraj; Langer, Christoph; Ghostine, Said; Martuscelli, Eugenio; Niinuma, Hiroyuki; Scholte, Arthur; Nikolaou, Konstantin; Ulimoen, Geir; Zhang, Zhaoqi; Mickley, Hans; Nieman, Koen; Kaufmann, Philipp A; Buechel, Ronny Ralf; Herzog, Bernhard A; Clouse, Melvin; Halon, David A; Leipsic, Jonathan; Bush, David; Jakamy, Reda; Sun, Kai; Yang, Lin; Johnson, Thorsten; Laissy, Jean-Pierre; Marcus, Roy; Muraglia, Simone; Tardif, Jean-Claude; Chow, Benjamin; Paul, Narinder; Maintz, David; Hoe, John; de Roos, Albert; Haase, Robert; Laule, Michael; Schlattmann, Peter; Dewey, Marc

2018-03-19

To analyse the implementation, applicability and accuracy of the pretest probability calculation provided by NICE clinical guideline 95 for decision making about imaging in patients with chest pain of recent onset. The definitions for pretest probability calculation in the original Duke clinical score and the NICE guideline were compared. We also calculated the agreement and disagreement in pretest probability and the resulting imaging and management groups based on individual patient data from the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT). 4,673 individual patient data from the CoMe-CCT Consortium were analysed. Major differences in definitions in the Duke clinical score and NICE guideline were found for the predictors age and number of risk factors. Pretest probability calculation using guideline criteria was only possible for 30.8 % (1,439/4,673) of patients despite availability of all required data due to ambiguity in guideline definitions for risk factors and age groups. Agreement regarding patient management groups was found in only 70 % (366/523) of patients in whom pretest probability calculation was possible according to both models. Our results suggest that pretest probability calculation for clinical decision making about cardiac imaging as implemented in the NICE clinical guideline for patients has relevant limitations. • Duke clinical score is not implemented correctly in NICE guideline 95. • Pretest probability assessment in NICE guideline 95 is impossible for most patients. • Improved clinical decision making requires accurate pretest probability calculation. • These refinements are essential for appropriate use of cardiac CT.

Factors Influencing Physician-Referrals of Patients to Clinical Trials

PubMed Central

Mainous, Arch G.; Smith, Daniel W.; Geesey, Mark E.; Tilley, Barbara C.

2009-01-01

Purpose Initial trials in the NIH Parkinson’s Disease (PD) network (NET-PD) included 91% Caucasian Non-Latino patients although PD is thought to be as common among African Americans and Latinos. Our purpose was to assess physicians’ attitudes and beliefs about patient-recruitment, particularly minorities, into clinical trials. Methods We surveyed 200 physicians from areas near the NET-PD clinics with ≥40% African Americans or Latinos. Physicians were asked about attitudes toward research, likelihood of referring patients to PD trials, and past research participation and administered the Trust in Medical Researchers Scale (TIMRS). Using logistic regressions we identified physician characteristics associated patient-referral to clinical trials. Results The TIMRS was lower among African American physicians and physicians with high proportions of minority patients. Likelihood of trial referral was associated with previous referral to trials (OR 4.24, 95% CI 2.09–8.62) and higher TIMRS (OR 1.06, 95% CI 1.001–1.12). TIMRS results were similar among physicians not previously referring to trials. Conclusions Study results emphasize the importance of developing a trusting relationship with local physicians if investigators expect these physicians to refer their patients to clinical trials. The trust-related barriers for minority-serving physicians, regardless of their own race/ethnicity, seem to mirror the trust-related issues for their minority patients. PMID:19024226

Location of residence associated with the likelihood of patient visit to the preoperative assessment clinic

PubMed Central

Seidel, Judy E; Beck, Cynthia A; Pocobelli, Gaia; Lemaire, Jane B; Bugar, Jennifer M; Quan, Hude; Ghali, William A

2006-01-01

Background Outpatient preoperative assessment clinics were developed to provide an efficient assessment of surgical patients prior to surgery, and have demonstrated benefits to patients and the health care system. However, the centralization of preoperative assessment clinics may introduce geographical barriers to utilization that are dependent on where a patient lives with respect to the location of the preoperative assessment clinic. Methods The association between geographical distance from a patient's place of residence to the preoperative assessment clinic, and the likelihood of a patient visit to the clinic prior to surgery, was assessed for all patients undergoing surgery at a tertiary health care centre in a major Canadian city. The odds of attending the preoperative clinic were adjusted for patient characteristics and clinical factors. Results Patients were less likely to visit the preoperative assessment clinic prior to surgery as distance from the patient's place of residence to the clinic increased (adjusted OR = 0.52, 95% CI 0.44–0.63 for distances between 50–100 km, and OR = 0.26, 95% CI 0.21–0.31 for distances greater than 250 km). This 'distance decay' effect was remarkable for all surgical specialties. Conclusion The present study demonstrates that the likelihood of a patient visiting the preoperative assessment clinic appears to depend on the geographical location of patients' residences. Patients who live closest to the clinic tend to be seen more often than patients who live in rural and remote areas. This observation may have implications for achieving the goals of equitable access, and optimal patient care and resource utilization in a single universal insurer health care system. PMID:16504058

Appointment Template Redesign in a Women’s Health Clinic Using Clinical Constraints to Improve Service Quality and Efficiency

PubMed Central

Verduzco, S.

2015-01-01

Summary Background Patient wait time is a critical element of access to care that has long been recognized as a major problem in modern outpatient health care delivery systems. It impacts patient and medical staff productivity, stress, quality and efficiency of medical care, as well as health-care cost and availability. Objectives This study was conducted in a Women’s Health Clinic. The objective was to improve clinic service quality by redesigning patient appointment template using the clinical constraints. Methods The proposed scheduling template consisted of two key elements: the redesign of appointment types and the determination of the length of time slots using defined constraints. The re-classification technique was used for the redesign of appointment visit types to capture service variation for scheduling purposes. Then, the appointment length was determined by incorporating clinic constraints or goals, such as patient wait time, physician idle time, overtime, finish time, lunch hours, when the last appointment was scheduled, and the desired number of appointment slots, to converge the optimal length of appointment slots for each visit type. Results The redesigned template was implemented and the results indicated a 73% reduction in average patient waiting from the reported 40 to 11 minutes. The patient no-show rate was reduced by 4% from 24% to 20%. The morning section on average finished about 11:50 am. The clinic day was finished around 4:45 pm. Provider average idle time was estimated to be about 5 minutes, which can be used for charting/documenting patients. Conclusions This study provided an alternative method of redesigning appointment scheduling templates using only the clinical constraints rather than the traditional way that required an objective function. This paper also documented the employed methods step by step in a real clinic setting. The implementation results concluded a significant improvement on patient wait time and no-show rate. PMID:26171075

Increasing Colonoscopy Screening in Disparate Populations: Results From an Evaluation of Patient Navigation in the New Hampshire Colorectal Cancer Screening Program

PubMed Central

Rice, Ketra; Gressard, Lindsay; DeGroff, Amy; Gersten, Joanne; Robie, Janene; Leadbetter, Steven; Glover-Kudon, Rebecca; Butterly, Lynn

2018-01-01

BACKGROUND To investigate uniformly successful results from a statewide program of patient navigation (PN) for colonoscopy, this comparison study evaluated the effectiveness of the PN intervention by comparing outcomes for navigated versus non-navigated patients in one of the community health clinics included in the statewide program. Outcomes measured included screening completion, adequacy of bowel preparation, missed appointments and cancellations, communication of test results, and consistency of follow-up recommendations with clinical guidelines. METHODS The authors compared a subset of 131 patients who were navigated to a screening or surveillance colonoscopy with a similar subset of 75 non-navigated patients at one endoscopy clinic. The prevalence and prevalence odds ratios were computed to measure the association between PN and each study outcome measure. RESULTS Patients in the PN intervention group were 11.2 times more likely to complete colonoscopy than control patients (96.2% vs 69.3%; P<.001), and were 5.9 times more likely to have adequate bowel preparation (P =.010). In addition, intervention patients had no missed appointments compared with 15.6% of control patients, and were 24.8 times more likely to not have a cancellation <24 hours before their appointment (P<.001). All navigated patients and their primary care providers received test results, and all follow-up recommendations were consistent with clinical guidelines compared with 82.4% of patients in the control group (P<.001). CONCLUSIONS PN appears to be effective for improving colonoscopy screening completion and quality in the disparate populations most in need of intervention. To the best of our knowledge, the results of the current study demonstrate some of the strongest evidence for the effectiveness of PN to date, and highlight its value for public health. PMID:28464213

Clinical, Functional and Health-Related Quality of Life Correlates of Clinically Significant Symptoms of Anxiety and Depression in Patients with Systemic Sclerosis: A Cross-Sectional Survey

PubMed Central

Nguyen, Christelle; Ranque, Brigitte; Baubet, Thierry; Bérezné, Alice; Mestre-Stanislas, Caroline; Rannou, François; Papelard, Agathe; Morell-Dubois, Sandrine; Revel, Michel; Moro, Marie-Rose; Guillevin, Loïc; Poiraudeau, Serge; Mouthon, Luc

2014-01-01

Objectives To identify clinical, functional and health-related quality of life (HRQoL) correlates of clinically significant symptoms of anxiety and depression in patients with systemic sclerosis (SSc). Methods Three-hundred-and-eighty-one patients fulfilling the American College of Rheumatology and/or the Leroy and Medsger criteria for SSc were assessed for visceral involvement, disability and HRQoL (assessed by SF-36). Clinically significant symptoms of anxiety and depression were evaluated with the Hospital Anxiety Depression Scale (HAD) (defined cut-off≥8). Results 9.2% the patients had limited SSc, 50.5% limited cutaneous SSc (lcSSc), and 40.3% diffuse cutaneous SSc (dcSSc). Overall, 40.4% and 58.8% of the patients had clinically significant symptoms of depression and anxiety, respectively. Compared to patients without clinically significant symptoms of depression, patients with clinically significant symptoms of depression had poorer health status, HRQoL mental and physical component, and greater global disability, hand disability and aesthetic impairment. Compared to patients without clinically significant symptoms of anxiety, patients with clinically significant symptoms of anxiety had poorer SF-36 mental and physical component scores. On multivariable analysis, excluding mental component score of SF-36, variables independently associated with clinically significant symptoms of depression and anxiety were global disability and physical component of SF-36, plus female gender for clinically significant symptoms of anxiety only. Remarkably, patients with and without clinically significant psychiatric symptoms were comparable for all disease-related clinical features assessed. Conclusion High levels of clinically significant symptoms of anxiety and depression are observed among SSc patients. Clinically significant psychiatric symptoms are rather associated with increased disability and altered HRQoL, than with disease-specific organ manifestations. PMID:24587375

Using phrases and document metadata to improve topic modeling of clinical reports.

PubMed

Speier, William; Ong, Michael K; Arnold, Corey W

2016-06-01

Probabilistic topic models provide an unsupervised method for analyzing unstructured text, which have the potential to be integrated into clinical automatic summarization systems. Clinical documents are accompanied by metadata in a patient's medical history and frequently contains multiword concepts that can be valuable for accurately interpreting the included text. While existing methods have attempted to address these problems individually, we present a unified model for free-text clinical documents that integrates contextual patient- and document-level data, and discovers multi-word concepts. In the proposed model, phrases are represented by chained n-grams and a Dirichlet hyper-parameter is weighted by both document-level and patient-level context. This method and three other Latent Dirichlet allocation models were fit to a large collection of clinical reports. Examples of resulting topics demonstrate the results of the new model and the quality of the representations are evaluated using empirical log likelihood. The proposed model was able to create informative prior probabilities based on patient and document information, and captured phrases that represented various clinical concepts. The representation using the proposed model had a significantly higher empirical log likelihood than the compared methods. Integrating document metadata and capturing phrases in clinical text greatly improves the topic representation of clinical documents. The resulting clinically informative topics may effectively serve as the basis for an automatic summarization system for clinical reports. Copyright © 2016 Elsevier Inc. All rights reserved.

A comparison of revisional and primary bariatric surgery

PubMed Central

Fulton, Courtney; Sheppard, Caroline; Birch, Daniel; Karmali, Shazeer; de Gara, Christopher

2017-01-01

Background Revisional surgery is an important component of addressing weight regain and complications following primary bariatric surgery. Owing to provincial need and the complexity of this patient population, a specialized multidisciplinary revision clinic was developed. We sought to characterize patients who undergo revision surgery and compare their outcomes with primary bariatric surgery clinic data. Methods We completed a retrospective chart review of bariatric revision clinic patients compared with primary bariatric surgery patients from December 2009 to June 2014. Results We reviewed the charts of 2769 primary bariatric clinic patients, 886 of whom had bariatric surgery, and 534 revision bariatric clinic patients, 83 of whom had revision surgery. Fewer revision clinic patients underwent surgery than primary clinic patients (22% v. 32%). The mean preoperative body mass index (BMI) was 44.7 ± 9.5 in revision patients compared with 45.7 ± 7.6 in primary bariatric surgery patients. Most revision patients had a prior vertical banded gastroplasty (VBG; 48%) or a laparoscopic adjustable gastric band (LAGB; 24%). Bands were removed in 36% of all LAGB patients presenting to clinic. Of the 134 procedures performed in the revision clinic, 83 were bariatric weight loss surgeries, and 51 were band removals. Revision clinic patients experienced a significant decrease in BMI (from 44.7 ± 9.5 to 33.8 ± 7.5, p < 0.001); their BMI at 12-month follow-up was similar to that of primary clinic patients (34.5 ± 7.0, p = 0.7). Complications were significantly more frequent in revision patients than primary patients (41% v. 15%, p < 0.001). Conclusion A bariatric revision clinic manages a wide variety of complex patients distinct from those seen in a primary clinic. Operative candidates at the revision clinic are chosen based on favourable medical, anatomic and psychosocial factors, keeping in mind the resource constraints of a public health care system. PMID:28570215

Feasibility of computed tomography-guided core needle biopsy in producing state-of-the-art clinical management in Chinese lung cancer

PubMed Central

Chen, Hua-Jun; Yang, Jin-Ji; Fang, Liang-Yi; Huang, Min-Min; Yan, Hong-Hong; Zhang, Xu-Chao; Xu, Chong-Rui; Wu, Yi-Long

2014-01-01

Background A satisfactory biopsy determines the state-of-the-art management of lung cancer in this era of personalized medicine. This study aimed to investigate the suitability and efficacy of computed tomography (CT)-guided core needle biopsy in clinical management. Methods A cohort of 353 patients with clinically suspected lung cancer was enrolled in the study. Patient factors and biopsy variables were recorded. Epidermal growth factor receptor (EGFR) gene mutations and echinoderm microtubule-associated protein-like 4 (EML4)-anaplastic lymphoma kinase (ALK) rearrangement were detected in tumor specimens. Adequacy of biopsic obtainment for clinical trial screening and tissue bank establishment were reviewed. Results Overall diagnostic accuracy of malignancy achieved 98.5%. The median biopsy time of the cohort was 20 minutes. In patients with non-small cell lung cancer (NSCLC), 99.3% (287/289) were diagnosed as specific histologic subtypes, and two patients (0.7%) were determined as NSCLC not otherwise specified (NOS). EGFR mutations were analyzed in 81.7% (236/289) of patients with NSCLC, and 98.7% (233/236) showed conclusive results. EML4-ALK gene fusion was tested in 43.9% (127/289) of NSCLC patients, and 98.4% (125/127) showed conclusive results: 6.4% (8/125) of those had gene fusion. Ninety-six NSCLC patients participated in clinical trial screening and provided mandatory tumor slides for molecular profiling. Pathological evaluation was fulfilled in 90 patients (93.8%); 99.4% (320/322) of patients with malignancy provided extra tissue for the establishment of a tumor bank. Conclusions CT-guided core needle biopsy provided optimal clinical management in this era of translational medicine. The biopsic modality should be prioritized in selected lung cancer patients. PMID:26766993

Detection and genotyping of rubella virus from exanthematous patients suspected of having measles using reverse transcription-PCR.

PubMed

Yasui, Yoshihiro; Mori, Yoshio; Adachi, Hirokazu; Kobayashi, Shinichi; Yamashita, Teruo; Minagawa, Hiroko

2014-01-01

Between July 2012 and March 2013, a total of 133 clinical specimens from 47 patients suspected of having measles were collected for virological surveillance in Aichi Prefecture, Japan. Facing the rubella epidemic, the reverse transcription (RT)-PCR protocol for measles virus (MeV) was modified to simultaneously detect rubella virus (RUBV) in these clinical specimens. As a result, 30 specimens from 15 patients were positive for RUBV and 8 specimens from 3 patients were positive for MeV. The RUBV genotype analysis for the samples from 13 patients revealed 12 samples as 2B and 1 sample as 1E. The results provided additional evidence for the difficulty in the diagnosis of exanthematous diseases based on clinical manifestations alone and the necessity of virological diagnosis to maintain the accuracy of case-based surveillance. Furthermore, the results indicated that the modified RT-PCR protocol could be useful as a routine procedure to simultaneously detect MeV and RUBV in clinical specimens of patients suspected of having exanthematous disease caused by these viruses.

A Large Outbreak of Hepatitis C Virus Infections in a Hemodialysis Clinic.

PubMed

Nguyen, Duc B; Gutowski, Jennifer; Ghiselli, Margherita; Cheng, Tabitha; Bel Hamdounia, Shadia; Suryaprasad, Anil; Xu, Fujie; Moulton-Meissner, Heather; Hayden, Tonya; Forbi, Joseph C; Xia, Guo-Liang; Arduino, Matthew J; Patel, Ami; Patel, Priti R

2016-02-01

BACKGROUND In November and December 2012, 6 patients at a hemodialysis clinic were given a diagnosis of new hepatitis C virus (HCV) infection. OBJECTIVE To investigate the outbreak to identify risk factors for transmission. METHODS A case patient was defined as a patient who was HCV-antibody negative on clinic admission but subsequently was found to be HCV-antibody positive from January 1, 2008, through April 30, 2013. Patient charts were reviewed to identify and describe case patients. The hypervariable region 1 of HCV from infected patients was tested to assess viral genetic relatedness. Infection control practices were evaluated via observations. A forensic chemiluminescent agent was used to identify blood contamination on environmental surfaces after cleaning. RESULTS Eighteen case patients were identified at the clinic from January 1, 2008, through April 30, 2013, resulting in an estimated 16.7% attack rate. Analysis of HCV quasispecies identified 4 separate clusters of transmission involving 11 case patients. The case patients and previously infected patients in each cluster were treated in neighboring dialysis stations during the same shift, or at the same dialysis station on 2 consecutive shifts. Lapses in infection control were identified. Visible and invisible blood was identified on multiple surfaces at the clinic. CONCLUSIONS Epidemiologic and laboratory data confirmed transmission of HCV among numerous patients at the dialysis clinic over 6 years. Infection control breaches were likely responsible. This outbreak highlights the importance of rigorous adherence to recommended infection control practices in dialysis settings.

A Large Outbreak of Hepatitis C Virus Infections in a Hemodialysis Clinic

PubMed Central

Nguyen, Duc B.; Gutowski, Jennifer; Ghiselli, Margherita; Cheng, Tabitha; Hamdounia, Shadia Bel; Suryaprasad, Anil; Xu, Fujie; Moulton-Meissner, Heather; Hayden, Tonya; Forbi, Joseph C.; Xia, Guo-liang; Arduino, Matthew J.; Patel, Ami; Patel, Priti R.

2016-01-01

BACKGROUND In November and December 2012, 6 patients at a hemodialysis clinic were given a diagnosis of new hepatitis C virus (HCV) infection. OBJECTIVE To investigate the outbreak to identify risk factors for transmission. METHODS A case patient was defined as a patient who was HCV-antibody negative on clinic admission but subsequently was found to be HCV-antibody positive from January 1, 2008, through April 30, 2013. Patient charts were reviewed to identify and describe case patients. The hypervariable region 1 of HCV from infected patients was tested to assess viral genetic relatedness. Infection control practices were evaluated via observations. A forensic chemiluminescent agent was used to identify blood contamination on environmental surfaces after cleaning. RESULTS Eighteen case patients were identified at the clinic from January 1, 2008, through April 30, 2013, resulting in an estimated 16.7% attack rate. Analysis of HCV quasispecies identified 4 separate clusters of transmission involving 11 case patients. The case patients and previously infected patients in each cluster were treated in neighboring dialysis stations during the same shift, or at the same dialysis station on 2 consecutive shifts. Lapses in infection control were identified. Visible and invisible blood was identified on multiple surfaces at the clinic. CONCLUSIONS Epidemiologic and laboratory data confirmed transmission of HCV among numerous patients at the dialysis clinic over 6 years. Infection control breaches were likely responsible. This outbreak highlights the importance of rigorous adherence to recommended infection control practices in dialysis settings. PMID:26573412

Outreach syncope clinic managed by a nurse practitioner: Outcome and cost effectiveness.

PubMed

Hamdan, Mohamed H; Walsh, Kathleen E; Brignole, Michele; Key, Jamie

2017-01-01

Introduction The purpose of this study was to assess the clinical and financial outcomes of a novel outreach syncope clinic. Methods We compared the clinical outcome of the Faint and Fall Clinic at the American Center (January-June 2016) with that of the University of Wisconsin Health and Clinics Faint and Fall Clinic (January 2013-December 2014). The American Center-Faint and Fall Clinic is run solely by a nurse practitioner, assisted by online faint-decision software and consultancy of a faint specialist through video-conferencing. Results Five hundred and twenty-eight consecutive patients were seen at the University of Wisconsin Hospital and Clinics-Faint and Fall Clinic and 68 patients at the American Center-Faint and Fall Clinic. The patients' clinical characteristics were similar except for a lower age in the American Center patients (45 ± 18 vs 51 ± 22, p = 0.03). Overall, a diagnosis was made within 45 days in 70% (95% confidence interval 66-74%) of the University of Wisconsin Hospital and Clinics patients and 69% (95% confidence interval 58-80%) of the American Center patients, ( p = 0.9). A mean of 3.0 ± 1.6 tests per patient was used in the University of Wisconsin Hospital and Clinics group compared to 1.5 ± 0.8 tests per patient in the American Center group, p = 0.001. Over the six-month study period, the total revenue at the American Center was US$152,597 (contribution margin of US$122,393 plus professional revenue of US$30,204). The total cost of the nurse practitioner including benefits was US$66,662 ((US$98,466 salary/year + 35.4% benefits)/2). Total revenue minus expenses resulted in a net profit of US$85,935. Discussion A nurse practitioner-run outreach syncope-clinic equipped with online faint-decision software and consultancy of a faint specialist through vedio-conferencing is feasible and financially self-sustainable. It allows the dissemination of standardized high-quality syncope care to patients who have no immediate access to a tertiary teaching hospital.

Clinical assessment and management of general surgery patients via synchronous telehealth.

PubMed

Cain, Steven M; Moore, Robert; Sturm, Lauren; Mason, Travis; Fuhrman, Caitlin; Smith, Robin; Bojicic, Irfan; Carter, Brandon

2017-02-01

Objective This paper describes how a clinical team at Landstuhl Regional Medical Center (LRMC) successfully integrated synchronous telehealth (TH) into their routine clinical practice. Methods and materials Synchronous TH encounters were performed using Polycom® software on surgeons' computers with high-definition (HD) cameras on monitors at distant sites and PolyCom HDX9000® Telehealth Practitioner Carts at originating sites. Patients provided consented and were presented to general surgeons by nurses and medical technicians at Army health clinics throughout the European Theater. Results In calendar year (CY) 2014, five general surgeons and two surgical physician assistants (PAs) at Landstuhl Regional Medical Center along with registered nurses (RNs) at six originating clinic sites throughout Europe completed 130 synchronous TH encounters for 101 general surgery patients resulting in 73 completed and 16 recommended surgeries. Eighty-eight percent of patients had a completed or recommended surgery. No surgeries or procedures planned after initial TH evaluation were cancelled. Originating site clinics ranged in distance from 68 miles to 517 miles. Acceptance by providers, patients and clinic staff was high. Conclusion Synchronous TH was effective and safe in evaluating common general surgical conditions. We excluded sensitive and complex conditions requiring a nuanced physical examination. The TH efforts of the general surgery staff have resulted in high-quality, seamless and predictable TH activities that continue to expand into other surgical and medical specialties beyond general surgery. Seven surgeons and two PAs use synchronous TH regularly serving patients over a broad geographic area.

Changing Patient Needs and Their Impact on Clinical Education.

ERIC Educational Resources Information Center

Colman, Harvey L.; And Others

1985-01-01

Results of an analysis of changes in dental clinic patient needs and characteristics in the period of 1978-82 are presented, and their implications for the availability of experiences for the clinical training of dental students in specific areas are discussed. (MSE)

Catatonia in Psychotic Patients: Clinical Features and Treatment Response

PubMed Central

England, Mary L.; Öngür, Dost; Konopaske, Glenn T.; Karmacharya, Rakesh

2012-01-01

We report clinical features and treatment response in 25 patients with catatonia admitted to an inpatient psychiatric unit specializing in psychotic disorders. ECT, benzodiazepines, and clozapine had beneficial effects on catatonic features, while typical antipsychotics resulted in clinical worsening. PMID:21677256

Family Physician Clinical Inertia in Glycemic Control among Patients with Type 2 Diabetes

PubMed Central

Lang, Valerija Bralić; Marković, Biserka Bergman; Kranjčević, Ksenija

2015-01-01

Background Many patients with diabetes do not achieve target values. One of the reasons for this is clinical inertia. The correct explanation of clinical inertia requires a conjunction of patient with physician and health care system factors. Our aim was to determine the rate of clinical inertia in treating diabetes in primary care and association of patient, physician, and health care setting factors with clinical inertia. Material/Methods This was a national, multicenter, observational, cross-sectional study in primary care in Croatia. Each family physician (FP) provided professional data and collected clinical data on 15–25 type 2 diabetes (T2DM) patients. Clinical inertia was defined as a consultation in which treatment change based on glycated hemoglobin (HbA1c) levels was indicated but did not occur. Results A total of 449 FPs (response rate 89.8%) collected data on 10275 patients. Mean clinical inertia per FP was 55.6% (SD ±26.17) of consultations. All of the FPs were clinically inert with some patients, and 9% of the FPs were clinically inert with all patients. The main factors associated with clinical inertia were: higher percentage of HbA1c, oral anti-diabetic drug initiated by diabetologist, increased postprandial glycemia and total cholesterol, physical inactivity of patient, and administration of drugs other than oral antidiabetics. Conclusions Clinical inertia in treating patients with T2DM is a serious problem. Patients with worse glycemic control and those whose therapy was initiated by a diabetologist experience more clinical inertia. More research on causes of clinical inertia in treating patients with T2DM should be conducted to help achieve more effective diabetes control. PMID:25652941

Clinical implementation of integrated whole-genome copy number and mutation profiling for glioblastoma

PubMed Central

Ramkissoon, Shakti H.; Bi, Wenya Linda; Schumacher, Steven E.; Ramkissoon, Lori A.; Haidar, Sam; Knoff, David; Dubuc, Adrian; Brown, Loreal; Burns, Margot; Cryan, Jane B.; Abedalthagafi, Malak; Kang, Yun Jee; Schultz, Nikolaus; Reardon, David A.; Lee, Eudocia Q.; Rinne, Mikael L.; Norden, Andrew D.; Nayak, Lakshmi; Ruland, Sandra; Doherty, Lisa M.; LaFrankie, Debra C.; Horvath, Margaret; Aizer, Ayal A.; Russo, Andrea; Arvold, Nils D.; Claus, Elizabeth B.; Al-Mefty, Ossama; Johnson, Mark D.; Golby, Alexandra J.; Dunn, Ian F.; Chiocca, E. Antonio; Trippa, Lorenzo; Santagata, Sandro; Folkerth, Rebecca D.; Kantoff, Philip; Rollins, Barrett J.; Lindeman, Neal I.; Wen, Patrick Y.; Ligon, Azra H.; Beroukhim, Rameen; Alexander, Brian M.; Ligon, Keith L.

2015-01-01

Background Multidimensional genotyping of formalin-fixed paraffin-embedded (FFPE) samples has the potential to improve diagnostics and clinical trials for brain tumors, but prospective use in the clinical setting is not yet routine. We report our experience with implementing a multiplexed copy number and mutation-testing program in a diagnostic laboratory certified by the Clinical Laboratory Improvement Amendments. Methods We collected and analyzed clinical testing results from whole-genome array comparative genomic hybridization (OncoCopy) of 420 brain tumors, including 148 glioblastomas. Mass spectrometry–based mutation genotyping (OncoMap, 471 mutations) was performed on 86 glioblastomas. Results OncoCopy was successful in 99% of samples for which sufficient DNA was obtained (n = 415). All clinically relevant loci for glioblastomas were detected, including amplifications (EGFR, PDGFRA, MET) and deletions (EGFRvIII, PTEN, 1p/19q). Glioblastoma patients ≤40 years old had distinct profiles compared with patients >40 years. OncoMap testing reliably identified mutations in IDH1, TP53, and PTEN. Seventy-seven glioblastoma patients enrolled on trials, of whom 51% participated in targeted therapeutic trials where multiplex data informed eligibility or outcomes. Data integration identified patients with complete tumor suppressor inactivation, albeit rarely (5% of patients) due to lack of whole-gene coverage in OncoMap. Conclusions Combined use of multiplexed copy number and mutation detection from FFPE samples in the clinical setting can efficiently replace singleton tests for clinical diagnosis and prognosis in most settings. Our results support incorporation of these assays into clinical trials as integral biomarkers and their potential to impact interpretation of results. Limited tumor suppressor variant capture by targeted genotyping highlights the need for whole-gene sequencing in glioblastoma. PMID:25754088

Screening protocol for dysphagia in adults: comparison with videofluoroscopic findings.

PubMed

Sassi, Fernanda C; Medeiros, Gisele C; Zilberstein, Bruno; Jayanthi, Shri Krishna; de Andrade, Claudia R F

2017-12-01

To compare the videofluoroscopic findings of patients with suspected oropharyngeal dysphagia with the results of a clinical screening protocol. A retrospective observational cohort study was conducted on all consecutive patients with suspected oropharyngeal dysphagia between March 2015 and February 2016 who were assigned to receive a videofluoroscopic assessment of swallowing. All patients were first submitted to videofluoroscopy and then to the clinical assessment of swallowing. The clinical assessment was performed within the first 24 hours after videofluoroscopy. The videofluoroscopy results were analyzed regarding penetration/aspiration using an 8-point multidimensional perceptual scale. The accuracy of the clinical protocol was analyzed using the sensitivity, specificity, likelihood ratios and predictive values. The selected sample consisted of 50 patients. The clinical protocol presented a sensitivity of 50% and specificity of 95%, with an accuracy of 88%. "Cough" and "wet-hoarse" vocal quality after/during swallowing were clinical indicators that appeared to correctly identify the presence of penetration/aspiration risk. The clinical protocol used in the present study is a simple, rapid and reliable clinical assessment. Despite the absence of a completely satisfactory result, especially in terms of the sensitivity and positive predictive values, we suggest that lower rates of pneumonia can be achieved using a formal dysphagia screening method.

Clinical and personality profiles and survival in patients with COPD.

PubMed

Ashutosh, K; Haldipur, C; Boucher, M L

1997-01-01

To assess the relationship of personality and clinical characteristics with survival in patients with advanced chronic obstructive pulmonary disease (COPD). Prospective double-blind study. Outpatient clinic of a teaching Veterans Affairs Hospital in central New York. PATIENT PARTICIPATION: Sixteen male patients (mean age, 62.2 +/- 2.5 years) with severe COPD INTERVENTIONS: Patients were administered Minnesota Multiphasic Personality Inventory (MMPI) test; their clinical features were recorded from hospital records at the time of admission into the study. All were followed up for 4 years after the initial assessment or until their death. The nine survivors and seven nonsurvivors were similar in age, pulmonary function test (PFT) results, oxygenation, number of medications, or concomitant illnesses. However, the nonsurvivors had higher MMPI and clinical illness scores compared with the survivors (p < 0.01 and < 0.05, respectively). The 4-year mortality in male veterans with severe COPD is influenced by overall psychological distress and difficulty in coping with their disease, which seem to be important prognostic indicators irrespective of PFT results or oxygenation.

Trial Prospector: Matching Patients with Cancer Research Studies Using an Automated and Scalable Approach

PubMed Central

Sahoo, Satya S; Tao, Shiqiang; Parchman, Andrew; Luo, Zhihui; Cui, Licong; Mergler, Patrick; Lanese, Robert; Barnholtz-Sloan, Jill S; Meropol, Neal J; Zhang, Guo-Qiang

2014-01-01

Cancer is responsible for approximately 7.6 million deaths per year worldwide. A 2012 survey in the United Kingdom found dramatic improvement in survival rates for childhood cancer because of increased participation in clinical trials. Unfortunately, overall patient participation in cancer clinical studies is low. A key logistical barrier to patient and physician participation is the time required for identification of appropriate clinical trials for individual patients. We introduce the Trial Prospector tool that supports end-to-end management of cancer clinical trial recruitment workflow with (a) structured entry of trial eligibility criteria, (b) automated extraction of patient data from multiple sources, (c) a scalable matching algorithm, and (d) interactive user interface (UI) for physicians with both matching results and a detailed explanation of causes for ineligibility of available trials. We report the results from deployment of Trial Prospector at the National Cancer Institute (NCI)-designated Case Comprehensive Cancer Center (Case CCC) with 1,367 clinical trial eligibility evaluations performed with 100% accuracy. PMID:25506198

Are Comparisons of Patient Experiences Across Hospitals Fair? A Study in Veterans Health Administration Hospitals

PubMed Central

Cleary, Paul D.; Meterko, Mark; Wright, Steven M.; Zaslavsky, Alan M.

2015-01-01

Background Surveys are increasingly used to assess patient experiences with health care. Comparisons of hospital scores based on patient experience surveys should be adjusted for patient characteristics that might affect survey results. Such characteristics are commonly drawn from patient surveys that collect little, if any, clinical information. Consequently some hospitals, especially those treating particularly complex patients, have been concerned that standard adjustment methods do not adequately reflect the challenges of treating their patients. Objectives To compare scores for different types of hospitals after making adjustments using only survey-reported patient characteristics and using more complete clinical and hospital information. Research Design We used clinical and survey data from a national sample of 1858 veterans hospitalized for an initial acute myocardial infarction (AMI) in a Department of Veterans Affairs (VA) medical center during fiscal years 2003 and 2004. We used VA administrative data to characterize hospitals. The survey asked patients about their experiences with hospital care. The clinical data included 14 measures abstracted from medical records that are predictive of survival after an AMI. Results Comparisons of scores across hospitals adjusted only for patient-reported health status and sociodemographic characteristics were similar to those that also adjusted for patient clinical characteristics; the Spearman rank-order correlations between the 2 sets of adjusted scores were >0.97 across 9 dimensions of inpatient experience. Conclusions This study did not support concerns that measures of patient care experiences are unfair because commonly used models do not adjust adequately for potentially confounding patient clinical characteristics. PMID:24926709

Expert searcher, teacher, content manager, and patient advocate: an exploratory study of clinical librarian roles

PubMed Central

Tan, Maria C.; Maggio, Lauren A.

2013-01-01

Objective: The research explored the roles of practicing clinical librarians embedded in a patient care team. Methods: Six clinical librarians from Canada and one from the United States were interviewed to elicit detailed descriptions of their clinical roles and responsibilities and the context in which these were performed. Results: Participants were embedded in a wide range of clinical service areas, working with a diverse complement of health professionals. As clinical librarians, participants wore many hats, including expert searcher, teacher, content manager, and patient advocate. Unique aspects of how these roles played out included a sense of urgency surrounding searching activities, the broad dissemination of responses to clinical questions, and leverage of the roles of expert searcher, teacher, and content manager to advocate for patients. Conclusions: Detailed role descriptions of clinical librarians embedded in patient care teams suggest possible new practices for existing clinical librarians, provide direction for training new librarians working in patient care environments, and raise awareness of the clinical librarian specialty among current and budding health information professionals. PMID:23405048

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

PubMed

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

2015-01-01

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

Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study.

PubMed

Arpino, Grazia; Michelotti, Andrea; Truini, Mauro; Montemurro, Filippo; Russo, Stefania; Palumbo, Raffaella; Zamagni, Claudio; Latorre, Agnese; Bruzzese, Dario; Riccardi, Ferdinando; De Laurentiis, Michelino; Beano, Alessandra; Biganzoli, Laura; Zaniboni, Alberto; Laudadio, Lucio; Malagoli, Maria; Bilancia, Domenico; Schettini, Francesco; Giuliano, Mario; Cazzaniga, Marina Elena; De Placido, Sabino

2016-03-01

Several randomized clinical trials (RCTs) have demonstrated the efficacy of trastuzumab-based adjuvant therapy in HER2-positive breast cancer (BC). However, RCT patients may not invariably be representative of patients routinely seen in clinical practice (CP). To address this issue, we compared the clinical and tumor features of RCT and CP patients with HER2-positive BC. From January to December 2012, 650 consecutive patients with HER2-positive early BC, treated in 36 different types of Italian healthcare facilities, were enrolled in this study. Age, treatment, tumor size (T), nodes (N), grade (G), estrogen receptor (ER) and progesterone receptor (PgR) status were prospectively collected in these CP patients. The same data were extracted from the main adjuvant trastuzumab RCTs and pooled using the random-effects model of DerSimonian and Laird. RCT and CP patients were compared by using the Cochran Q statistics. Versus RCT patients, CP patients were more likely to be older than 50 years (65 vs. 49 %; p < 0.0001) and to have HR (ER and/or PgR)-positive (72 vs. 54 %; p < 0.0001) BC and less likely to have tumor >2 cm (T ≥ 2 cm 39 vs. 59 %; p < 0.0001), positive N (47 vs. 89 %; p < 0.0001) and a high G (61 vs. 67 %; p = 0.0241). CP patients more frequently received adjuvant endocrine therapy (70 vs. 57 %; p < 0.0003) and less frequently adjuvant chemotherapy (97 vs. 99.7 %; p < 0.0001). Most tumor and clinical features differed significantly between CP and RCT patients. These data raise concerns about the applicability of RCT results to CP patients.

Pharmacists' interventions on clinical asthma outcomes: a systematic review.

PubMed

Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

2016-04-01

The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

Patient satisfaction with the clinical pharmacist and prescribers during hepatitis C virus management.

PubMed

Martin, M T; Faber, D M

2016-12-01

Clinical pharmacists play an important role in the management of patients undergoing hepatitis C virus (HCV) treatment. No satisfaction surveys have been published on clinical pharmacist interventions in HCV management. The objective was to evaluate patient satisfaction with clinical pharmacist and prescriber services in the HCV patient population at an urban academic hepatology clinic. An anonymous patient satisfaction survey was offered to patients who were initiating or receiving HCV treatment under the care of a clinical pharmacist. Survey items assessed demographics and satisfaction with HCV care. Satisfaction was assessed with 17 or 20 Likert-scale questions (1 = poor, 2 = fair, 3 = okay, 4 = good, 5 = great) and two or three open-ended questions. Survey results were analysed via comparative and descriptive statistics. A qualitative content analysis was used for the open-ended survey questions. Sixty-four patients completed 77 (24 pharmacist and 53 prescriber) patient satisfaction surveys. The mean age was 53 (±9·72) years. Patients reported high levels of satisfaction with the pharmacist and prescribers. All 24 (100%) patients ranked overall satisfaction with services provided by pharmacists as 'great', and 36 (69%) of 52 patients ranked overall satisfaction with services provided by prescribers as 'great'. Patients supported the inclusion of a clinical pharmacist on health care teams for other disease states. Patients reported high levels of satisfaction with the clinical pharmacist involved in HCV treatment management at an urban academic medical centre. Clinical pharmacist services were highly valued and recommended by the patients surveyed. The survey was able to identify areas in need of improvement in the clinic. Clinical pharmacists play an important role in the treatment and management of HCV. This survey may serve as a model for assessment of satisfaction in other pharmacist-run clinic settings. © 2016 John Wiley & Sons Ltd.

Patient and provider attitudes toward genomic testing for prostate cancer susceptibility: a mixed method study.

PubMed

Birmingham, Wendy C; Agarwal, Neeraj; Kohlmann, Wendy; Aspinwall, Lisa G; Wang, Mary; Bishoff, Jay; Dechet, Christopher; Kinney, Anita Y

2013-07-20

The strong association between family history and prostate cancer (PCa) suggests a significant genetic contribution, yet specific highly penetrant PCa susceptibility genes have not been identified. Certain single-nucleotide-polymorphisms have been found to correlate with PCa risk; however uncertainty remains regarding their clinical utility and how to best incorporate this information into clinical decision-making. Genetic testing is available directly to consumers and both patients and healthcare providers are becoming more aware of this technology. Purchasing online allows patients to bypass their healthcare provider yet patients may have difficulty interpreting test results and providers may be called upon to interpret results. Determining optimal ways to educate both patients and providers, and strategies for appropriately incorporating this information into clinical decision-making are needed. A mixed-method study was conducted in Utah between October 2011 and December 2011. Eleven focus group discussions were held and surveys were administered to 23 first-degree relatives of PCa patients living in Utah and 24 primary-care physicians and urologists practicing in Utah to present specific information about these assessments and determine knowledge and attitudes regarding health implications of using these assessments. Data was independently coded by two researchers (relative Kappa = .88; provider Kappa = .77) and analyzed using a grounded theory approach. Results indicated differences in attitudes and behavioral intentions between patient and provider. Despite the test's limitations relatives indicated interest in genetic testing (52%) while most providers indicated they would not recommend the test for their patients (79%). Relatives expected providers to interpret genetic test results and use results to provide personalized healthcare recommendations while the majority of providers did not think the information would be useful in patient care (92%) and indicated low-levels of genetic self-efficacy. Although similarities exist, discordance between provider and patient attitudes may influence the effective translation of novel genomic tests into clinical practice suggesting both patient and provider perceptions and expectations be considered in development of clinical decision-support tools.

[A clinical investigation of new patients who had already received treatment with dental implants at other clinics in seventeen years].

PubMed

Yukawa, Ken; Tachikawa, Noriko; Munakata, Motohiro; Shiota, Makoto; Kasugai, Shohei

2014-03-01

The purpose of this study was to investigate new patients who had already received treatment with dental implants. The subjects were patients who visited the clinic for oral implants at Tokyo Medical and Dental University Hospital from April 1995 to March 2012. The results were as follows: 1) Of the total number of patients, there were 2,419 patients (14.0%) with dental implants. 2) Of the 2,419 patients, 252 patients (10.4%) had been referred from operating doctors or operating clinics. 3) There were 1,516 (62.7%) patients with complaints related to the implant therapy. 4) There were 1,367 (56.5%) patients who had ill feelings toward their attending doctors. 5) There were 1,112 (46.0%) patients with biological complications. 6) Regarding patients with or without a referral from the doctor who had performed their dental implant, those patients who had been referred showed significantly higher occurrence of loss of implants, neurological symptoms, doctor's recommendation, prosthetic problems, and surgical problems. Almost implant therapies were treated with other treatments for natural teeth, including surgical treatment, prosthetic treatment, periodontal treatment and maintenance. These were too complex to enable the results to be forecast before treatment, therefore unpredictable symptoms often occur in patients with implant therapy. Informed consent including patient education is important, but the results of this study suggest that it is insufficient at present.

Management of Acute Hypertensive Response in Intracerebral Hemorrhage Patients After ATACH-2 Trial.

PubMed

Majidi, Shahram; Suarez, Jose I; Qureshi, Adnan I

2017-10-01

Acute hypertensive response is elevation of systolic blood pressure (SBP) in the first 24 h after symptom onset which is highly prevalent in patients with intracerebral hemorrhage (ICH). Observational studies suggested association between acute hypertensive response and hematoma expansion, peri-hematoma edema and death and disability, and possible reduction in these adverse outcomes with treatment of acute hypertensive response. Recent clinical trials have focused on determining the clinical efficacy of early intensive SBP reduction in ICH patients. The Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-2) trial was the latest phase 3 randomized controlled multicenter clinical trial aimed to study the efficacy of early intensive reduction of SBP in ICH patients. In this review article, we summarize the results of recent clinical trials, treatment principles based on the latest guidelines, and the anticipated interpretation and incorporation of ATACH-2 trial results in clinical practice.

Patient satisfaction with psychotropic drugs: sensitivity to change and relationship to clinical status, quality-of-life, compliance and effectiveness of treatment. Results from a nation-wide 6-month prospective study.

PubMed

Gasquet, Isabelle; Tcherny-Lessenot, Stéphanie; Lépine, Jean-Pierre; Falissard, Bruno

2006-12-01

To see if patient satisfaction with psychotropics (PSP) could be used as a patient-oriented outcome variable in the evaluation of PSP drugs in clinical epidemiological studies, relationships between PSP, clinical status, QoL, compliance and the type of antipsychotic were analyzed. Elements of validation of PSP were also assessed. In a 6-month prospective study, 933 schizophrenic outpatients with initiation or change to their antipsychotic treatment were enrolled. Psychiatrists completed five CGI-SCH scales (positive, negative, cognitive, depressive and global), hospitalization, compliance, and prescription variables. Patients completed PSP, EuroQoL scales, sexual function and compliance variables. A satisfactory structural equation model was obtained showing significant relationships PSP/compliance (coef.=0.16), QoL/PSP (coef.=0.37), clinical status/QoL (coef.=0.61), clinical status/compliance (coef.=0.09). Patients receiving olanzapine were more satisfied than patients receiving other atypicals (coef.=012) and had better clinical status than patients treated with typicals (coef.=0.08). Evolution of PSP was related to clinical status, QoL, and continuation of treatment (all P<001). Sensitivity to change of PSP was moderate (effect size=0.2). PSP produced consistent results in relation to validated outcome variables. However, a single-item measure was not sufficiently sensitive to change. Multi-item questionnaires evaluating different dimensions are needed.

Transforming primary care in the New Orleans safety-net: the patient experience.

PubMed

Schmidt, Laura A; Rittenhouse, Diane R; Wu, Kevin J; Wiley, James A

2013-02-01

The patient-centered medical home (PCMH) is a key service delivery innovation in health reform. However, there are growing questions about whether the changes in clinics promoted by the PCMH model lead to improvements in the patient experience. To test the hypothesis that PCMH improvements in safety-net primary care clinics are associated with a more positive patient experience. Multilevel cross-sectional analysis of patients nested within the primary care clinics that serve them. Primary care clinic leaders and patients throughout the City of New Orleans health care safety-net. Dependent variables included patient ratings of accessibility, coordination, and confidence in the quality/safety of care. The key independent variable was a score measuring PCMH structural and process improvements at the clinic level. Approximately two thirds of patients in New Orleans gave positive ratings to their clinics on access and quality/safety, but only one third did for care coordination. In all but the largest clinics, patient experiences of care coordination were positively associated with the clinic's use of PCMH structural and process changes. Results for patient ratings of access and quality/safety were mixed. Among primary care clinics in the New Orleans safety-net, use of more PCMH improvements at the clinic level led to more positive patient rating of care coordination, but not of accessibility or confidence in quality/safety. Ongoing efforts to pilot, demonstrate, implement, and evaluate the PCMH should consider how the impact of medical practice transformation could vary across different aspects of the patient experience.

HRV biofeedback for pediatric irritable bowel syndrome and functional abdominal pain: a clinical replication series.

PubMed

Stern, Mark J; Guiles, Robert A F; Gevirtz, Richard

2014-12-01

Irritable bowel syndrome (IBS) and Functional Abdominal Pain (FAP) are among the most commonly reported Functional Gastrointestinal Disorders. Both have been associated with varying autonomic dysregulation. Heart Rate Variability Biofeedback (HRVB) has recently begun to show efficacy in the treatment of both IBS and FAP. The purpose of this multiple clinical replication series was to analyze the clinical outcomes of utilizing HRVB in a clinical setting. Archival data of twenty-seven consecutive pediatric outpatients diagnosed with IBS or FAP who received HRVB were analyzed. Clinical outcomes were self-report and categorized as full or remission with patient satisfaction, or no improvement. Qualitative reports of patient experiences were also noted. Full remission was achieved by 69.2 % and partial remission was achieved by 30.8 % of IBS patients. Full remission was achieved by 63.6 % and partial remission was achieved by 36.4 % of FAP patients. No patients in either group did not improve to a level of patient satisfaction or >50 %. Patient's commonly reported feeling validated in their discomfort as a result of psychophysiological education. Results suggest that HRVB is a promising intervention for pediatric outpatients with IBS or FAP. Randomized controlled trials are necessary to accurately determine clinical efficacy of HRVB in the treatment of IBS and FAP.

Preserving residual renal function in dialysis patients: an update on evidence to assist clinical decision making

PubMed Central

Jensen, Jens Dam; Peters, Christian Daugaard; Jespersen, Bente

2011-01-01

It has been documented that preservation of residual renal function in dialysis patients improves quality of life as well as survival. Clinical trials on strategies to preserve residual renal function are clearly lacking. While waiting for more results from clinical trials, patients will benefit from clinicians being aware of available knowledge. The aim of this review was to offer an update on current evidence assisting doctors in clinical practice. PMID:25949486

Involving American Indians and medically underserved rural populations in cancer clinical trials

PubMed Central

Guadagnolo, B Ashleigh; Petereit, Daniel G; Helbig, Petra; Koop, David; Kussman, Patricia; Dunn, Emily Fox; Patnaik, Asha

2010-01-01

Purpose To assess cancer clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based cancer care center. Methods We prospectively tracked clinical trial enrollment incidence among all new patients presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each patient regarding clinical trial enrollment status and primary reasons for nonenrollment. Patients who identified as American Indian were referred to a program where patients were assisted in navigating the medical system by trained, culturally competent staff. Results Between September 2006 and January 2008, 891 new cancer patients were evaluated. Seventy-eight patients (9%; 95% confidence intervals, 7–11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69–75%) of patients (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4–7%) patients refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3–16%) were American Indian. Three additional American Indian patients were enrolled under a nontreatment cancer control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5–17%). Limitations Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed. Conclusion Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common cancer sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a Patient Navigation program were used to engage AI patients and may have resulted in higher clinical trial enrollment among this racial/ethnic group. PMID:19933720

Combined Percutaneous and Endovascular Treatment of Symptomatic Aneurysmal Bone Cyst of the Spine: Clinical Six Months. Follow-up of Six Cases.

PubMed

Guarnieri, G; Ambrosanio, G; Vassallo, P; Granato, F; Setola, F R; Greco, B; Izzo, R; Muto, M

2010-03-01

We describe the usefulness of endovascular and direct percutaneous treatment as a therapy option for aneurysmal bone cysts (ABCs) of the spine. From January 2007 to December 2008, we treated six consecutive patients with symptomatic ABCs resistant to continuous medical management or with acute clinical onset of paraparesis at cervical, thoracic and lumbar spine level. Two patients were treated after emergency laminectomy. All patients were studied with an MRI protocol and multidetector CT with MPR reconstructions followed by angiographic control before treatment. The procedure was performed under general anaesthesia for all patients. Under CT or fluoroscopy guidance, percutaneous treatment was performed either by direct injection of Glubran(®) diluted at 30% with Lipiodol(®) only, or combined with endovascular treatment by Onyx® injection. Clinical and X-ray follow-up was performed at three and six months. Combined endovascular and percutaneous treatment for ABCs was successful and led to an excellent outcome in five out of six patients with clinical improvement. There were no periprocedural or subsequent clinical complications and the glue resulted in successful selective permanent occlusion with intralesional penetration. Direct sclerotherapy resulted in immediate thrombosis of the malformation with no progression of symptoms. Complete healing was observed in five out of six aggressive lesions. No major complications were noted. At six month follow-up the symptoms had completely resolved and X-ray control showed a partial or total sclerotic reaction of the lesion with stable clinical results (no partial or clinical abnormalities). One patient had a recurrence of the ABC with spinal cord cervical clinical symptomatology. Combined endovascular and percutaneous treatment or direct percutaneous sclerotherapy with glue alone are important, safe, effective therapy options for symptomatic aneurysmal bone cyst. Results are stable and confirmed by clinical and X-ray follow-up six months after treatment.

Development of clinical pharmacy in Belgian hospitals through pilot projects funded by the government.

PubMed

Somers, A; Spinewine, A; Spriet, I; Steurbaut, S; Tulkens, P; Hecq, J D; Willems, L; Robays, H; Dhoore, M; Yaras, H; Vanden Bremt, I; Haelterman, M

2018-04-30

Objectives The goal is to develop clinical pharmacy in the Belgian hospitals to improve drug efficacy and to reduce drug-related problems. Methods From 2007 to 2014, financial support was provided by the Belgian federal government for the development of clinical pharmacy in Belgian hospitals. This project was guided by a national Advisory Working Group. Each funded hospital was obliged to describe yearly its clinical pharmacy activities. Results In 2007, 20 pharmacists were funded in 28 pilot hospitals; this number was doubled in 2009 to 40 pharmacists over 54 institutions, representing more than half of all acute Belgian hospitals. Most projects (72%) considered patient-related activities, whereas some projects (28%) had a hospital-wide approach. The projects targeted patients at admission (30%), during hospital stay (52%) or at discharge (18%). During hospital stay, actions were mainly focused on geriatric patients (20%), surgical patients (15%), and oncology patients (9%). Experiences, methods, and tools were shared during meetings and workshops. Structure, process, and outcome indicators were reported and strengths, weaknesses, opportunities, and threats were described. The yearly reports revealed that the hospital board was engaged in the project in 87% of the cases, and developed a vision on clinical pharmacy in 75% of the hospitals. In 2014, the pilot phase was replaced by structural financing for clinical pharmacy in all acute Belgian hospitals. Conclusion The pilot projects in clinical pharmacy funded by the federal government provided a unique opportunity to launch clinical pharmacy activities on a broad scale in Belgium. The results of the pilot projects showed clear implementation through case reports, time registrations, and indicators. Tools for clinical pharmacy activities were developed to overcome identified barriers. The engagement of hospital boards and the results of clinical pharmacy activities persuaded the government to start structural financing of clinical pharmacy.

Nurse-led Multidisciplinary Heart Failure Group Clinic Appointments: Methods, Materials and Outcomes Used in the Clinical Trial

PubMed Central

Smith, C. E.; Piamjariyakul, U.; Dalton, K. M.; Russell, C.; Wick, J.; Ellerbeck, E.F.

2015-01-01

Background The Self-Management and Care of Heart Failure through Group Clinics Trial (SMAC-HF) evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high risk heart failure (HF) patients. Objective The purpose of this article is to: (1) describe key SMAC-HF group clinic interactive learning strategies; (2) describe resources and materials used in the group clinic appointment; and (3) present results supporting this patient-centered group intervention. Methods This clinical trial included 198 HF patients (randomized to either group clinical appointments or to standard care). Data were collected from 72 group clinic appointments via patients’: (1) group clinic session evaluations; (2) HF Self-Care Behaviors Skills; (3) HF related discouragement and quality of life scores and (4) HF related reshopitalizations during the 12 month follow-up. Also the costs of delivery of the group clinical appointments were tabulated. Results Overall, patients rated group appointments as 4.8 out of 5 on the “helpfulness” in managing HF score. The statistical model showed a 33% decrease in the rate of rehospitalizations (incidence rate ratio (IRR) = 0.67) associated with the intervention over the 12-month follow-up period when compared with control patients (χ2(1) = 3.9, p = 0.04). The total cost for implementing five group appointments was $243.58 per patient. Conclusion The intervention was associated with improvements in HF self-care knowledge and home care behavior skills and managing their for HF care. In turn, better self-care was associated with reductions in HF related hospitalizations. PMID:25774836

Transarterial embolization for massive gastrointestinal hemorrhage following abdominal surgery

PubMed Central

Zhou, Chun-Gao; Shi, Hai-Bin; Liu, Sheng; Yang, Zheng-Qiang; Zhao, Lin-Bo; Xia, Jin-Guo; Zhou, Wei-Zhong; Li, Lin-Sun

2013-01-01

AIM: To evaluate the clinical results of angiography and embolization for massive gastrointestinal hemorrhage after abdominal surgery. METHODS: This retrospective study included 26 patients with postoperative hemorrhage after abdominal surgery. All patients underwent emergency transarterial angiography, and 21 patients underwent emergency embolization. We retrospectively analyzed the angiographic features and the clinical outcomes of transcatheter arterial embolization. RESULTS: Angiography showed that a discrete bleeding focus was detected in 21 (81%) of 26 patients. Positive angiographic findings included extravasations of contrast medium (n = 9), pseudoaneurysms (n = 9), and fusiform aneurysms (n = 3). Transarterial embolization was technically successful in 21 (95%) of 22 patients. Clinical success was achieved in 18 (82%) of 22 patients. No postembolization complications were observed. Three patients died of rebleeding. CONCLUSION: The positive rate of angiographic findings in 26 patients with postoperative gastrointestinal hemorrhage was 81%. Transcatheter arterial embolization seems to be an effective and safe method in the management of postoperative gastrointestinal hemorrhage. PMID:24187463

Improving the quality of palliative care for ambulatory patients with lung cancer

PubMed Central

von Plessen, Christian; Aslaksen, Aslak

2005-01-01

Problem Most patients with advanced lung cancer currently receive much of their health care, including chemotherapy, as outpatients. Patients have to deal with the complex and time consuming logistics of ambulatory cancer care. At the same time, members of staff often waste considerable time and energy in organisational aspects of care that could be better used in direct interaction with patients. Design Quality improvement study using direct observation and run and flow charts, and focus group meetings with patients and families regarding perceptions of the clinic and with staff regarding satisfaction with working conditions. Setting Thoracic oncology outpatient clinic at a Norwegian university hospital where patients receive chemotherapy and complementary palliative care. Key measures for improvement Waiting time and time wasted during consultations; calmer working situation at the clinic; satisfaction among patients. Strategies for change Rescheduled patients' appointments, automated retrieval of blood test results, systematic reporting in patients' files, design of an information leaflet, and refurnishing of the waiting area at the clinic. Effects of change Interventions resulted in increased satisfaction for patients and staff, reduced waiting time, and reduced variability of waiting time. Lessons learnt Direct observation, focus groups, questionnaires on patients' satisfaction, and measurement of process time were useful in systematically improving care in this outpatient clinic. The description of this experience can serve as an example for the improvement of a microsystem, particularly in other settings with similar problems. PMID:15933354

Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

PubMed

Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

2014-10-01

Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

Improved Clinical Outcomes in Patients with Positive Blood Culture by Proactive Intervention of Antimicrobial Use-Impact of Antimicrobial Stewardship Program Implementation on Clinical Practice.

PubMed

Yamada, Takehiro; Kagami, Keisuke; Imai, Shungo; Akizawa, Koji; Iwasaki, Sumio; Fukumoto, Tatsuya; Ishiguro, Nobuhisa; Iseki, Ken

2017-01-01

Bacteremia is one of the most serious infectious illness resulting from nosocomial infection. Therefore, appropriate antimicrobial chemotherapy should be provided as soon as possible to patients exhibiting symptoms of infectious disease and having positive blood culture results. Antimicrobial stewardship (AS) guidelines were recently released by the Infectious Diseases Society of America. The guidelines recommend "proactive intervention and feedback" as one of the core strategies for implementing optimal antimicrobial drug use to improve patient outcomes in clinical settings. We began using the AS program for optimizing antimicrobial chemotherapy in patients with positive blood culture results. The results of blood cultures and antimicrobial prescriptions for the corresponding patients were daily reviewed by a pharmacist and a physician, members of the infection control team (ICT). If the antimicrobial agents selected were inappropriate, ICT made a recommendation to the attending physicians who prescribed the antibiotics. To evaluate the outcomes of this program, we conducted a single-center, retrospective investigation for near a hundred of patients who underwent intervention by infection-control physician and pharmacist. Resolution of bacteremia (determined by blood culture results) was 96.3% in the group that accepted intervention, whereas only 16.7% of the cases resolved in the group that did not accept intervention. These results strongly suggest the importance of the infection disease-specialist team intervention. This program could become an important method for improving clinical outcomes in patients with bacteremia.

[Clinical manifestations of Legionella pneumonia in hematology patients].

PubMed

Galstian, G M; Kostina, I É; Katrysh, S A; Kliasova, G A; Karpova, T I; Tartakovskiĭ, I S

2014-01-01

To detect the most common clinical manifestations of Legionella pneumonia (LP) in immunocompromized patients. Clinical manifestations, the results of investigation of bronchoalveolar lavage fluid (BALF) and urine, and the data of lung computed tomography (CT) were studied in patients with blood system diseases and acute respiratory failure (ARF). The diagnosis of LP was verified in 8 (10.5%) of 76 patients with blood system diseases and ARF. The disease manifested as fever, higher concentrations of inflammatory markers (procalcitonin, fibrinogen), ARF, hypoxemia, and infiltrative lung injury. Six of the 8 patients were switched to mechanical ventilation. Lung CT showed no pathognomonic signs. Five of the 8 patients were observed to have renal dysfunction. The diagnosis of LP was made on the basis of the results of BALF examination in 7 patients and urinary antigen detection in 1. The disease was caused by Legionella pneumophila serogroup 1 in 3 patients and by L. pneumophila of other serogroups in the other patients. Therapy with respiratory fluoroquinolones was performed in 5 patients. Three patients died from progressive ARF and hypoxemia. BALF results were obtained after their death and therapy for legionellosis was not initiated. The incidence of LP is 10.5% in hematology patients. The clinical manifestations of legionellosis are nonspecific; its diagnosis requires bacteriological and/or serological evidence. Due to the high risk of death, it is reasonable to preuse respiratory fluoroquinolones or macrolides in immunocompromized patients with progressive ARF and suspected Legionella pneumonia before diagnosis.

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

PubMed Central

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

2006-01-01

INTRODUCTION Ezetimibe (EZ) is a selective cholesterol absorption inhibitor approved for use in Canada. The effect and tolerability of EZ among patients was evaluated in the clinical setting of a specialty cardiovascular risk reduction clinic at the University of Alberta Hospital, Edmonton, Alberta. PATIENTS AND METHODS All patients 18 years of age or older who were prescribed EZ were included, unless they failed to take EZ for a minimum of two weeks, did not have baseline and on-EZ low-density lipoprotein cholesterol (LDL-C) levels, or had concomitant lipid-lowering drugs or dosages changed within one month of starting EZ. RESULTS Eighty-four patients (mean age 57.9 years) were included. By Framingham risk calculation, 71.4% were found to be high-risk patients, 13.1% moderate-risk patients and 15.5% low-risk patients; 66.7% of patients had prior cardiovascular events. On EZ, the mean reductions were: total cholesterol level 1.11 mmol/L (16.5%); LDL-C level 1.01 mmol/L (22.3%); high-density lipoprotein cholesterol level 0.06 mmol/L (4.6%); and ratio of total cholesterol level to high-density lipoprotein cholesterol level 0.68 mmol/L (12.8%); all were statistically significant (P<0.001). Results were similar when stratified by primary (n=28) versus secondary (n=56) prevention. Patients on EZ monotherapy (n=34) had mean LDL-C reductions of 1.03 mmol/L (20.5%) compared with 1.19 mmol/L (30.1%) or 0.95 mmol/L (22.5%), where EZ was added to low-dose or high-dose statins (P<0.01 for all). On EZ, 30 patients (35.7%) achieved previously unattainable target LDL-C levels. Four patients discontinued the drug due to side effects. CONCLUSIONS EZ is safe and effective in high-risk patients treated in the clinical setting of a cardiovascular risk reduction clinic. A mean LDL-C reduction of 1 mmol/L (20% to 30%) in all patient subgroups is consistent with previous clinical trial results. The significant reduction in LDL-C (mean 22.5%) observed in the EZ plus high-dose statin subgroup provides clinical evidence for use of this medication beyond published studies. PMID:16971979

Impact of three-phase bone scintigraphy on the diagnosis and treatment of complex regional pain syndrome type I or reflex sympathetic dystrophy.

PubMed

Shehab, Dia; Elgazzar, Abdelhamid; Collier, B David; Naddaf, Sleiman; Al-Jarallah, Khalid; Omar, Abdelmoneim; Al-Mutairy, Moudi

2006-01-01

To determine the impact of three-phase bone scintigraphy (TPBS) on the diagnosis and management of complex regional pain syndrome type I (CRPSI) or reflex sympathetic dystrophy (RSD). Twenty consecutive patients with a recent clinical evidence of CRPSI were referred for TPBS as part of their routine management plan. All patients underwent neurological examinations with special attention to the evaluation of clinical features of vasomotor, sudomotor, motor and sensory dysfunction. Patients were followed prospectively. When both the clinical and TPBS results supported the diagnosis of CRPSI, patients were started on treatment. Of the 20 patients, TPBS supported the diagnosis of RSD in 9 who were treated with steroids and physiotherapy. Complete follow-up was available for 7 of them and all had a satisfactory response to treatment. For the remaining 11 patients RSD was diagnosed clinically but not confirmed by TPBS. On follow-up there was no evidence that TPBS failed to identify RSD in these 11 patients. The results indicate that TPBS confirmed the clinical diagnosis of RSD, and, more importantly, had a significant impact on its management.

Walking Clinic in ambulatory surgery--A patient based concept: A Portuguese pioneer project.

PubMed

Vinagreiro, M; Valverde, J N; Alves, D; Costa, M; Gouveia, P; Guerreiro, E

2015-06-01

Walking Clinic is an innovative, efficient and easily reproducible concept adapted to ambulatory surgery. It consists of a preoperative single day work-up, with a surgeon, an anesthetist and a nurse. The aim of this study was to evaluate patient satisfaction and its determinants. A survey was applied to 171 patients (101 of the Walking Clinic group and 70 not engaged in this new concept). Patient satisfaction was assessed evaluating five major questionnaire items: secretariat (quality of the information and support given), physical space (overall comfort and cleanliness), nurses and medical staff (willingness and expertise), and patients (waiting time until pre-operative consults and exams, waiting time until being scheduled for surgery, surgery day waiting time and postoperative pain control). Furthermore, overall assessment of the received treatment, and probability of patient recommending or returning to our ambulatory unit were also analyzed. Walking Clinic group had overall better results in the five major questionnaire items assessed, with statistical significance, except for the physical space. It also showed better results regarding the sub-items postoperative pain control, waiting time until being scheduled for surgery and surgery day waiting time. The results confirm better patient satisfaction with this new concept. The Walking Clinic concept complements all the tenets of ambulatory surgery, in a more efficient manner. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Effect of Humeral Component Version on Outcomes in Reverse Shoulder Arthroplasty.

PubMed

Aleem, Alexander W; Feeley, Brian T; Austin, Luke S; Ma, C Benjamin; Krupp, Ryan J; Ramsey, Matthew L; Getz, Charles L

2017-05-01

Although reverse shoulder arthroplasty provides excellent clinical results in appropriately selected patients, loss of external and internal rotation may occur. Component selection, design, and placement affect postoperative results. Recent studies considered the effect of humeral component version on functional results. The current study investigated whether humeral stem retroversion affects the outcomes of reverse shoulder arthroplasty with a retrospective review of a multisurgeon, industry-sponsored, prospectively gathered database of a single reverse shoulder arthroplasty implant. All patients had at least 2-year follow-up. Clinical outcomes, including American Shoulder and Elbow Surgeons score, visual analog scale pain score, Short Form-12 Mental and Physical Component scores, range of motion, and internal rotation function, were compared between patients with humeral retroversion of 10° or less (group A) and those with humeral retroversion of 20° or greater (group B). Radiographic outcomes were compared. The analysis included 64 patients (group A, 29 patients; group B, 35 patients). No clinical or statistically significant difference was found in American Shoulder and Elbow Surgeons scores. Both groups showed statistical and clinical improvement vs preoperative scores, with group A averaging 77.8 and group B averaging 79.2 at final follow-up. No differences were found between groups in range of motion or ability to perform tasks that require shoulder internal rotation. Patients can expect good clinical improvement after reverse shoulder arthroplasty. No difference was found in clinical or radiologic outcomes based on humeral component retroversion. Despite the theoretical increase in external rotation when the humeral component is placed closer to native retroversion, the results did not show this effect. [Orthopedics. 2017; 40(3):179-186.]. Copyright 2017, SLACK Incorporated.

Radical and sparing surgical treatment of patients with upper urinary tract transitional cell carcinomas (UUT -TCC) - preliminary results.

PubMed

Jabłonowski, Zbigniew; Kędzierski, Robert; Sosnowski, Marek

2011-01-01

Tumors originating from transitional epithelium of the renal pelvis and ureter are infrequent. Their course is asymptomatic at early stages of the disease, and diagnosis and institution of appropriate treatment delayed. The aim of the study is to assess the results of treatment in patients with upper urinary tract transitional cell carcinomas (UUT-TCC). Fifteen patients treated in 2005-2010 for UUT-TCC were qualified for the retrospective study. Clinical symptoms, diagnostic methods, tumor location, clinical stage and histopathological characteristics of the tumors were assessed. Then, the instituted treatment and its results were analyzed. The average follow-up period was 51 month (range 6-65), UUT-TCC accounted for 6.7% of renal tumors treated. Concurrent treated vesical tumors were observed in 4 (26.7%) patients. Primary UUT-TCC was diagnosed in 10 (66.7%) patients. Radical surgery was performed in 10 (66.7%) patients, whereas 5 (33.3%) underwent sparing operations. Macroscopic hematuria was the predominant clinical symptom. In most cases T2-T3 clinical stage (60.0%) and high-grade (66.7%) were observed. Development of an upper urinary tract tumor after treatment of a vesical tumor was noted in 4 (26.7%) patients. During the follow-up period, urinary bladder carcinomas were diagnosed in 5 (33.3%) patients with primary upper urinary tract tumors. Nephroureterectomy remains the standard treatment for UUT-TCC. Organ-sparing surgery is possible in selected patients with low clinical stage and low grade tumors. Patients treated for urinary bladder carcinomas require regular monitoring of the upper urinary tract.

Evaluation of Correlation between Pretest Probability for Clostridium difficile Infection and Clostridium difficile Enzyme Immunoassay Results.

PubMed

Kwon, Jennie H; Reske, Kimberly A; Hink, Tiffany; Burnham, C A; Dubberke, Erik R

2017-02-01

The objective of this study was to evaluate the clinical characteristics and outcomes of hospitalized patients tested for Clostridium difficile and determine the correlation between pretest probability for C. difficile infection (CDI) and assay results. Patients with testing ordered for C. difficile were enrolled and assigned a high, medium, or low pretest probability of CDI based on clinical evaluation, laboratory, and imaging results. Stool was tested for C. difficile by toxin enzyme immunoassay (EIA) and toxigenic culture (TC). Chi-square analyses and the log rank test were utilized. Among the 111 patients enrolled, stool samples from nine were TC positive and four were EIA positive. Sixty-one (55%) patients had clinically significant diarrhea, 19 (17%) patients did not, and clinically significant diarrhea could not be determined for 31 (28%) patients. Seventy-two (65%) patients were assessed as having a low pretest probability of having CDI, 34 (31%) as having a medium probability, and 5 (5%) as having a high probability. None of the patients with low pretest probabilities had a positive EIA, but four were TC positive. None of the seven patients with a positive TC but a negative index EIA developed CDI within 30 days after the index test or died within 90 days after the index toxin EIA date. Pretest probability for CDI should be considered prior to ordering C. difficile testing and must be taken into account when interpreting test results. CDI is a clinical diagnosis supported by laboratory data, and the detection of toxigenic C. difficile in stool does not necessarily confirm the diagnosis of CDI. Copyright © 2017 American Society for Microbiology.

Warfarin Patients With Anemia Show Trend of Out-of-Range International Normalized Ratio Frequency With Point-of-Care Testing in an Anticoagulation Clinic.

PubMed

DeRemer, Christina E; McMichael, Bliss; Young, Henry N

2018-01-01

Many factors influence international normalized ratio (INR); however, few studies have examined the impact of anemia in warfarin patients. The primary objective of this study was to explore the relationship between in-clinic anemia and the control of INR within an anticoagulation clinic. A retrospective chart review was performed on a random sample of patients seen in an academic medical center pharmacy-managed anticoagulation clinic. Hemochron® Signature Elite machine was utilized to monitor point-of-care (POC) INR. In-clinic anemia was defined as hematocrit <32%. Statistical analyses were conducted using STATA MP a webbased platform ( https://www.stata.com/statamp/ ). Of the 300 patients analyzed, 45 (15%) patients had in-clinic anemia. Patients with in-clinic anemia were more likely to be younger ( P < .05), female ( P < .05), and have a diagnosis of sickle cell disease or anemia ( P < .05). In the unadjusted logistic regression model, patients with in-clinic anemia were less likely to have an in-range INR ( OR: 0.52; 95% CI: 0.27-0.98). The adjusted regression model did not show significance. Study results suggest that in-clinic anemia may be more prevalent among younger, female patients prescribed warfarin, and patients diagnosed with in-clinic anemia may be a risk factor for out-of-range INR. Pharmacists practicing in anticoagulation clinics can incorporate this information into patient care practice in efforts to maintain optimal management.

Development and Implementation of a Pharmacist-Managed Clinical Pharmacogenetics Service

PubMed Central

Crews, Kristine R.; Cross, Shane J.; McCormick, John N.; Baker, Donald K.; Molinelli, Alejandro R.; Mullins, Richard; Relling, Mary V.; Hoffman, James M.

2011-01-01

Purpose The development and implementation of a pharmacist-managed Clinical Pharmacogenetics service is described. Summary Therapeutic drug monitoring (TDM) is a well-accepted role of the pharmacist. Pharmacogenetics, the study of genetic factors that influence the variability in drug response among patients, is a rapidly evolving discipline that integrates knowledge of pharmacokinetics and pharmacodynamics with modern advances in genetic testing. There is growing evidence for the clinical utility of pharmacogenetics, and pharmacists can play an essential role in the thoughtful application of pharmacogenetics to patient care. A pharmacist-managed Clinical Pharmacogenetics service was designed and implemented. The goal of the service is to provide clinical pharmacogenetic testing for gene products important to the pharmacodynamics of medications used in our patients. The service is modeled after and integrated with an already established Clinical Pharmacokinetics service. All clinical pharmacogenetic test results are first reported to one of the pharmacists, who reviews the result and provides a written consult. The consult includes an interpretation of the result and recommendations for any indicated changes to therapy. In 2009, 136 clinical pharmacogenetic tests were performed, consisting of 66 TPMT tests, 65 CYP2D6 tests, and 5 UGT1A1 tests. Our service has been met with positive clinician feedback. Conclusion Our experience demonstrates the feasibility of the design and function of a pharmacist-managed Clinical Pharmacogenetics service at an academic specialty hospital. The successful implementation of this service highlights the leadership role that pharmacists can take in moving pharmacogenetics from research to patient care, thereby potentially improving patient outcomes. PMID:21200062

Development and validation of PSPSQ 2.0 measuring patient satisfaction with pharmacist services.

PubMed

Sakharkar, Prashant; Bounthavong, Mark; Hirsch, Jan D; Morello, Candis M; Chen, Timothy C; Law, Anandi V

2015-01-01

The extant literature reveals a lack of psychometrically validated tools measuring patient satisfaction with pharmacist clinical services. The Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) was developed to address this need using a mixed methods approach. To assess the psychometric properties of the PSPSQ 2.0, an instrument developed to measure patient satisfaction with clinical services provided by pharmacists. Validation studies were conducted in two Veterans Affairs (VA)-based and two community-based (diabetes and psychiatric care) disease management/medication therapy management clinics. The PSPSQ 2.0 consisted of 22-items related to three domains identified as quality of care, patient-pharmacist relationship and overall satisfaction using a 4-point, Likert-type scale. It was administered to participants following their session with a pharmacist at the clinics. Collected data were analyzed for descriptive statistics, internal consistency, and validity using exploratory factor analysis. A total of 149 patients completed the survey. Patients from VA clinics were on average 61 years old, mostly white (63%), and predominantly male (95%). Patients from non-VA clinics were on average 47 years old, mostly White (47%) and male (53%). Non-VA patients mostly had Medicaid (42%) and commercial health insurance (31%), whereas VA patients retained benefits with the US Department of Veterans Affairs. Reliability of the scale using internal consistency metrics revealed a Cronbach's alpha of 0.98, 0.98 and 0.95 for VA, diabetes, and psychiatric care clinics, respectively, whereas the Cronbach's alpha for the pooled sample was 0.96. Factor analyses resulted in a three-factor solution accounting for 91% and 69% variance for diabetes and psychiatric care clinics, respectively; however, VA clinics and pooled sample yielded only 2-factor solution with 80% and 66% variance, respectively, with more items loading on patient-pharmacist relationship domain. The results suggest that the PSPSQ 2.0 can serve as a reliable and valid tool for measuring patient satisfaction with pharmacists providing clinical services in VA- and non-VA settings upon further validation. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical Effect of Acute Complete Acromioclavicular Joint Dislocation Treated with Micro-Movable and Anatomical Acromioclavicular Plate

PubMed Central

Liu, Qingjun; Miao, Jianyun; Lin, Bin; Guo, Zhimin

2012-01-01

Objectives: We evaluated the long-term clinical results of acute complete acromioclavicular dislocations treated with micro-movable and anatomical acromioclavicular plate. Methods: Open reduction and internal fixation was performed using the MAAP in 16 patients (10 males, 6 females; mean age 36 years; range16 to 63 years) with acute complete acromioclavicular joint dislocation. Radiographic evaluations were routinely conducted every 3 weeks until 3 months postoperatively. The MAAP were removed under local anesthesia after 3 months postoperatively. We evaluated the functional results by using the constant scoring system and radiological results in the last follow-up time. The mean follow up was 26 months (range 16 to 38 months). Results: The mean Constant score was 94 (range, 78 to 100). The results were excellent in 12 patients (75.0%), good in 3 patients (18.8%) and satisfactory in 1patient (6.2%). Three patients with scores of 80 to 90 had mild pain during activity, but have not affected the shoulder range of motion. One patient has both some pain and limited range of motion of shoulder joint. All patients but one have returned to their preoperative work without any limitations. Compared to the contralateral side, radiography showed anatomical reposition in the vertical plane in 14 cases, slight loss of reduction in 2 older patients. Conclusion: We recommend the MAAP fixation for surgical treatment of acute complete acromioclavicular joint dislocation as it could provide satisfactory shoulder functions and clinical results, with lower complication rate. However, it is necessary to continue to observe the clinical effects of this fixation technique. PMID:23091410

[The clinical and experimental validation of the role of laser-magnetic therapy in the combined treatment of patients following plastic operations on the ureter].

PubMed

Loran, O B; Kaprin, A D; Afanas'ev, M B

1994-01-01

The paper deals with clinical efficacy of laser magnetic therapy performed in patients following ureteroplasty on distal parts of the ureters. The results were estimated by clinical, biochemical and ultrasound monitoring.

Beginning level nursing students' experiences with cancer patients in their first clinical placement: a qualitative appraisal in Turkey.

PubMed

Yildiz, Hicran; Akansel, Neriman

2011-01-01

This study was conducted to evaluate beginning nursing students' point of view related to caring cancer patients in their first clinical placement. Data were collected by evaluating the diaries kept by four beginning level nursing students who were assigned to do their fundamentals of nursing clinical practice in hematology clinic from February to May 2011. A qualitative research method was used and data were analyzed using inductive method. Nursing students experienced anxiety, had difficulties while communicating with cancer patients and observed some negative practices related to patient care and treatment. During their clinical placement nursing students were able to differentiate right and wrong practices in clinical environment, they tried to tailor their theoretical knowledge to the clinical practice and reported decrease in their anxiety by the end of clinical rotation. Being assigned to care for cancer patients was a stressful experience for the first year students. According to these results, it can be said that clinics such as hematology can be used as a clinical placement only in mandatory conditions for beginning level nursing students because of their limited clinical experience and the knowledge requirement related to these patients.

Patients and families

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Continuing Need for Sexually Transmitted Disease Clinics After the Affordable Care Act

PubMed Central

Parsell, Bradley W.; Leichliter, Jami S.; Habel, Melissa A.; Tao, Guoyu; Pearson, William S.; Gift, Thomas L.

2015-01-01

Objectives. We assessed the characteristics of sexually transmitted disease (STD) clinic patients, their reasons for seeking health services in STD clinics, and their access to health care in other venues. Methods. In 2013, we surveyed persons who used publicly funded STD clinics in 21 US cities with the highest STD morbidity. Results. Of the 4364 STD clinic patients we surveyed, 58.5% were younger than 30 years, 72.5% were non-White, and 49.9% were uninsured. They visited the clinic for STD symptoms (18.9%), STD screening (33.8%), and HIV testing (13.6%). Patients chose STD clinics because of walk-in, same-day appointments (49.5%), low cost (23.9%), and expert care (8.3%). Among STD clinic patients, 60.4% had access to another type of venue for sick care, and 58.5% had access to another type of venue for preventive care. Most insured patients (51.6%) were willing to use insurance to pay for care at the STD clinic. Conclusions. Despite access to other health care settings, patients chose STD clinics for sexual health care because of convenient, low-cost, and expert care. Policy Implication. STD clinics play an important role in STD prevention by offering walk-in care to uninsured patients. PMID:26447908

The impacts of a pharmacist-managed outpatient clinic and chemotherapy-directed electronic order sets for monitoring oral chemotherapy.

PubMed

Battis, Brandon; Clifford, Linda; Huq, Mostaqul; Pejoro, Edrick; Mambourg, Scott

2017-12-01

Objectives Patients treated with oral chemotherapy appear to have less contact with the treating providers. As a result, safety, adherence, medication therapy monitoring, and timely follow-up may be compromised. The trend of treating cancer with oral chemotherapy agents is on the rise. However, standard clinical guidance is still lacking for prescribing, monitoring, patient education, and follow-up of patients on oral chemotherapy across the healthcare settings. The purpose of this project is to establish an oral chemotherapy monitoring clinic, to create drug and lab specific provider order sets for prescribing and lab monitoring, and ultimately to ensure safe and effective treatment of the veterans we serve. Methods A collaborative agreement was reached among oncology pharmacists, a pharmacy resident, two oncologists, and a physician assistant to establish a pharmacist-managed oral chemotherapy monitoring clinic at the VA Sierra Nevada Healthcare System. Drug-specific electronic order sets for prescribing and lab monitoring were created for initiating new drug therapy and prescription renewal. The order sets were created to be provider-centric, minimizing clicks needed to order necessary medications and lab monitoring. A standard progress note template was developed for documenting interventions made by the clinic. Patients new to an oral chemotherapy regimen were first counseled by an oncology pharmacist. The patients were then enrolled into the oral chemotherapy monitoring clinic for subsequent follow up and pharmacist interventions. Further, patients lacking monitoring or missing provider appointments were captured through a Clinical Dashboard developed by the US Department of Veterans Affairs (VA) Regional Office (VISN21) using SQL Server Reporting Services. Between September 2014 and April 2015, a total of 68 patients on different oral chemotherapy agents were enrolled into the clinic. Results Out of the 68 patients enrolled into the oral chemotherapy monitoring clinic, 31 patients (45%) were identified as having a therapy-related problem with their oral chemotherapy regimen on a gross measure for safety and appropriateness of medication management during the course of eight months follow-up between September 2014 and April 2015. In addition, the clinic helped to reestablish care for three patients (4.4%) who were lost to follow-up. The clinic identified 12 patients (17.6%) non-adherent to their prescribed regimen in some degree, where patients were suspected to miss doses due to delay in refilling prescriptions at least three days later than the expected date. However, these patients denied non-adherence. Among them, six patients (8.8%) were truly non-adherent. These patients stated that they had missed at least one day of therapy or were not taking the medication as prescribed. Medication regimen errors were discovered for five patients, accounting for a 7.3% medication-related error rate. Finally, seven patients (10.3%) were found to have an adverse reaction attributed to their oral chemotherapy. Two of them (2.9%) developed severe adverse reactions (Grade 3 and 4), which required hospitalization or immediate dose de-escalation. Conclusions The pilot clinic was able to identify current deficiencies and gaps in our practice settings for managing oral chemotherapy in a Veterans population. The oral chemotherapy monitoring clinic played a proactive role to identify preventable medication errors, monitor medication therapy, improve adherence, manage adverse drug reactions and re-establish care for patients who were lost to follow-up. The results suggest that close monitoring and follow-up of patients on oral chemotherapy is crucial to achieve therapeutic goals, improve patient safety and adherence, and to reduce drug adverse events and health care cost.

Clinical outcome of fresh and vitrified-warmed blastocyst and cleavage-stage embryo transfers in ethnic Chinese ART patients

PubMed Central

2012-01-01

Objectives This study sought to evaluate the outcome of fresh and vitrified-warmed cleavage-stage and blastocyst-stage embryo transfers in patients undergoing ART treatment within an ethnic Chinese population. Study design We compared the clinical results of embryo transfer on the 3rd (cleavage stage) or 5th (blastocyst stage) day after oocyte retrieval, including clinical pregnancy rates, implantation rates and multiple pregnancy rates. Results Our data showed that blastocyst transfer on day 5 did not significantly increase clinical pregnancy rate (41.07% vs 47.08%, p>0.05) and implantation rate (31.8% vs 31.2%, p>0.05) in patients under 35 years of age, in comparison with day 3 cleavage stage embryo transfer. In patients older than 35 years of age, the clinical pregnancy rate after blastocyst transfer was slightly decreased compared with cleavage stage embryo transfer (33.33% vs 42.31%, p>0.05). Unexpectedly, It was found that vitrified-warmed blastocyst transfer resulted in significantly higher clinical pregnancy rate (56.8%) and implantation rate (47%) compared with fresh blastocyst transfer in controlled stimulation cycles (41.07% and 31.8%, respectively). For patients under 35 years of age, the cumulative clinical pregnancy rate combining fresh and vitrified-warmed blastocyst transfer cycles were significantly higher compared to just cleavage-stage embryo transfer (70.1% versus 51.8%, p<0.05). However, the cumulative multiple pregnancy rates showed no significant difference between the two groups. Conclusions In an ethnic Chinese patient population, fresh blastocyst transfer does not significantly increase clinical pregnancy rate. However, subsequent vitrified-warmed blastocyst transfer in a non-controlled ovarian hyperstimulation cycle dramatically improves clinical outcomes. Therefore, blastocyst culture in tandem with vitrified-warmed blastocyst transfer is recommended as a favourable and promising protocol in human ART treatment, particularly for ethnic Chinese patients. PMID:23039212

The relationship between diabetes attitudes and treatment among free clinic patients and volunteers.

PubMed

Kamimura, Akiko; Christensen, Nancy; Nourian, Maziar M; Myers, Kyl; Saunders, AnnMarie; Solis, Silvia P; Ashby, Jeanie; Greenwood, Jessica L J; Reel, Justine J

2014-12-01

Free clinics provide free primary care to the under or uninsured and have been playing an important role in serving the socio-economically disadvantaged. Free clinic patients represent a group of people who experience significant barriers to receiving diabetes prevention and intervention. This study examined diabetes attitudes among free clinic patients and volunteers. English or Spanish speaking patients and volunteers (N = 384), aged 18 years or older completed a self-administered survey. Diabetic patients and volunteers shared similar levels of diabetes attitudes compared to non-diabetic patients. Among patients, ethnicity, education level, diabetes education, and family history affected diabetes attitudes. Among volunteers, diabetes education was an important factor associated with positive diabetes attitudes. Whether the volunteer is a healthcare professional or student was related only to one aspect of diabetes attitudes, seriousness of type 2 diabetes. The results, indicating free clinic diabetic patients and volunteers shared similar levels of diabetes attitudes, were positive for maintaining and developing diabetes education programs at a free clinic. Unfortunately, the average length of volunteering at this free clinic was short and student volunteers likely leave the clinic upon graduation. Future research should examine issues of volunteer retention in free clinics. Diabetes education for patients may need to be diversified according to ethnicity, family history of diabetes, and educational level. Finally, non-healthcare professional volunteers could potentially be involved in diabetes education at a free clinic.

Diagnostic criteria and follow-up in neuroendocrine cell hyperplasia of infancy: a case series*

PubMed Central

Gomes, Vivianne Calheiros Chaves; Silva, Mara Cristina Coelho; Maia, José Holanda; Daltro, Pedro; Ramos, Simone Gusmão; Brody, Alan S.; Marchiori, Edson

2013-01-01

OBJECTIVE: Neuroendocrine cell hyperplasia of infancy (NEHI) is a form of childhood interstitial lung disease characterized by tachypnea, retractions, crackles, and hypoxia. The aim of this study was to report and discuss the clinical, imaging, and histopathological findings in a series of NEHI cases at a tertiary pediatric hospital, with an emphasis on diagnostic criteria and clinical outcomes. METHODS: Between 2003 and 2011, 12 full-term infants were diagnosed with NEHI, based on clinical and tomographic findings. Those infants were followed for 1-91 months. Four infants were biopsied, and the histopathological specimens were stained with bombesin antibody. RESULTS: In this case series, symptoms appeared at birth in 6 infants and by 3 months of age in the remaining 6. In all of the cases, NEHI was associated with acute respiratory infection. The most common initial chest HRCT findings were ground-glass opacities that were in the middle lobe/lingula in 12 patients and in other medullary areas in 10. Air trapping was the second most common finding, being observed in 7 patients. Follow-up HRCT scans (performed in 10 patients) revealed normal results in 1 patient and improvement in 9. The biopsy findings were nonspecific, and the staining was positive for bombesin in all samples. Confirmation of NEHI was primarily based on clinical and tomographic findings. Symptoms improved during the follow-up period (mean, 41 months). A clinical cure was achieved in 4 patients. CONCLUSIONS: In this sample of patients, the diagnosis of NEHI was made on the basis of the clinical and tomographic findings, independent of the lung biopsy results. Most of the patients showed clinical improvement and persistent tomographic changes during the follow-up period, regardless of the initial severity of the disease or type of treatment. PMID:24310630

[Personalized cell therapy for early postoperative bullous keratopathy (experimental proof and clinical results)].

PubMed

Kasparov, A A; Kasparova, Evg A; Fadeeva, L L; Subbot, A M; Borodina, N V; Kasparova, E A; Kobzova, M V; Musaeva, G M; Pavliuk, A S

2013-01-01

The article presents the results of a long-term research on development and clinical application of personalized cell therapy (PCT) for treatment of early postoperative (manifesting within the first 3 months after surgery) bullous keratopathy (BK). The method of intracameral PCT implies in vitro incubation of the patient's blood sample with poly(A:U) stimulator, separation of the serum with activated leukocytes, and injection of the final cell preparation into the anterior chamber. The fundamental part of the research was aimed at a detailed description of the cell preparation and investigation of its possible mechanisms of action. Cytokine and growth factor level in the cell preparation suggested that its high clinical efficacy might be due to its ability to improve regeneration of damaged corneal endothelium. The clinical study was conducted on a group of 52 patients with early BK. A significant effect (smoothing of the Descement's membrane folds, complete resorption of corneal edema, improvement of corneal transparency, reduction of corneal thickness and increase of visual acuity by 0.49 +/- 0.27) was achieved in 44.2% of patients, while partial effect was seen in 21.1% of patients. There was no clinical effect in 34.6% of patients. In those patients who developed significant or partial clinical effect after the PCT, many endotheliocytes appeared to have multiple nuclei (2 and more). In some patients polyploid nuclei persisted for 3-5 years after the treatment. Polyploidy results from incomplete mitosis which might be due to regenerative processes in the endothelium stimulated by the PCT. Obviously, high efficacy and relative simplicity of the method should promote its further clinical introduction.

Clinical impact of 2-deoxy-2-[18F]fluoro-D-glucose (FDG)-positron emission tomography (PET) on treatment choice in recurrent cancer of the cervix uteri.

PubMed

Bjurberg, Maria; Brun, Eva

2013-11-01

The superiority of positron emission tomography (PET) with 2-deoxy-2-[18F]fluoro-D-glucose (FDG) over computed tomography and magnetic resonance imaging in detecting recurrent cervical cancer and determining the extent of the disease has been demonstrated in several clinical trials. However, there is a lack of data concerning the clinical impact of the extra findings. We report here a prospective clinical study aimed at investigating the clinical impact of FDG-PET findings on the treatment plans in recurrent cervical cancer. Thirty-six patients with suspected recurrent cervical cancer underwent FDG-PET. Relapses were confirmed in 26 cases, and one case of primary lung cancer was found. The clinical impact of the FDG-PET results was assessed using a systematic scoring system with a 4-grade scale. Median follow-up time after FDG-PET was 33.1 months (range, 5-83 months) for all patients and 22.4 months (range, 5-83 months) for patients with positive PET results. More sites of metastases were detected with FDG-PET in 56% of the patients compared to the findings by conventional imaging. The results of FDG-PET led to a change in treatment modality for 33% of the patients; and for 22%, a change in dose or deliverance of treatment was recorded. Treatment intention was changed in 30%, in all but one patient, from curative to palliative. In 48% of the patients, the initially planned treatment was reduced regarding dose or extent, or was withheld. In recurrent cervical cancer, FDG-PET provides clinically valuable information with a high impact on treatment decisions.

Relationship between red meat allergy and sensitization to gelatin and galactose-α-1,3-galactose.

PubMed

Mullins, Raymond James; James, Hayley; Platts-Mills, Thomas A E; Commins, Scott

2012-05-01

We have observed patients clinically allergic to red meat and meat-derived gelatin. We describe a prospective evaluation of the clinical significance of gelatin sensitization, the predictive value of a positive test result, and an examination of the relationship between allergic reactions to red meat and sensitization to gelatin and galactose-α-1,3-galactose (α-Gal). Adult patients evaluated in the 1997-2011 period for suspected allergy/anaphylaxis to medication, insect venom, or food were skin tested with gelatin colloid. In vitro (ImmunoCAP) testing was undertaken where possible. Positive gelatin test results were observed in 40 of 1335 subjects: 30 of 40 patients with red meat allergy (12 also clinically allergic to gelatin), 2 of 2 patients with gelatin colloid-induced anaphylaxis, 4 of 172 patients with idiopathic anaphylaxis (all responded to intravenous gelatin challenge of 0.02-0.4 g), and 4 of 368 patients with drug allergy. Test results were negative in all patients with venom allergy (n = 241), nonmeat food allergy (n = 222), and miscellaneous disorders (n = 290). ImmunoCAP results were positive to α-Gal in 20 of 24 patients with meat allergy and in 20 of 22 patients with positive gelatin skin test results. The results of gelatin skin testing and anti-α-Gal IgE measurements were strongly correlated (r = 0.46, P < .01). α-Gal was detected in bovine gelatin colloids at concentrations of approximately 0.44 to 0.52 μg/g gelatin by means of inhibition RIA. Most patients allergic to red meat were sensitized to gelatin, and a subset was clinically allergic to both. The detection of α-Gal in gelatin and correlation between the results of α-Gal and gelatin testing raise the possibility that α-Gal IgE might be the target of reactivity to gelatin. The pathogenic relationship between tick bites and sensitization to red meat, α-Gal, and gelatin (with or without clinical reactivity) remains uncertain. Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Features Associated with Successful Recruitment of Diverse Patients onto Cancer Clinical Trials: Report from the American College of Surgeons Oncology Group

PubMed Central

Diehl, Kathleen M.; Green, Erin M.; Weinberg, Armin; Frederick, Wayne A.; Holmes, Dennis R.; Green, Bettye; Morris, Arden; Kuerer, Henry M.; Beltran, Robert A.; Mendez, Jane; Gines, Venus; Ota, David M.; Nelson, Heidi; Newman, Lisa A.

2018-01-01

Background The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design We evaluated the accrual patterns for ten clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999–2009, and analyzed results by race/ethnicity as well as study design. Results Eight of ten protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully-recruiting protocols were: (i) studies designed to recruit patients with regional or advanced-stage disease (2/2 protocols); and (ii) studies that involved some investigational systemic therapy (3/3 protocols). Discussion AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients. PMID:21681382

A snapshot of patients' perceptions of oncology providers' cultural competence.

PubMed

Davey, Maureen P; Waite, Roberta; Nuñez, Ana; Niño, Alba; Kissil, Karni

2014-12-01

In this paper, we describe an anonymous cross-sectional survey with a sample of 100 racially diverse adult oncology patients using a newly developed patient-reported measure of providers' cultural competence, the Physicians' Cultural Competence for Patient Satisfaction Scale (PCCPS) [1, 2], which was developed using a US midwestern sample of primary care patients. Our primary aims were to examine the reliability of the PCCPS in a more racially diverse urban oncology clinical setting and to identify salient domains of oncology provider cultural competence based on patient-reported satisfaction with direct clinical encounters. Results suggest that patient-reported satisfaction was significantly associated with one of the four domains measured by the PCCPS, physician's patient-centered cultural competence (r = 0.40, p = 0.01), and female patients were more satisfied (t (91) = 5.23, p = 0.02). The PCCPS demonstrated good reliability in an urban diverse cancer patient population. Results help to inform the development of clinical tools that can improve oncology providers' cultural competency.

Global clinical response in Cushing’s syndrome patients treated with mifepristone

PubMed Central

Katznelson, Laurence; Loriaux, D Lynn; Feldman, David; Braunstein, Glenn D; Schteingart, David E; Gross, Coleman

2014-01-01

Objective Mifepristone, a glucocorticoid receptor antagonist, improves clinical status in patients with Cushing’s syndrome (CS). We examined the pattern, reliability and correlates of global clinical response (GCR) assessments during a 6-month clinical trial of mifepristone in CS. Design Post hoc analysis of secondary end-point data from a 24-week multicentre, open-label trial of mifepristone (300–1200mg daily) in CS. Intraclass correlation coefficient (ICC) was used to examine rater concordance, and drivers of clinical improvement were determined by multivariate regression analysis. Patients Forty-six adult patients with refractory CS along with diabetes mellitus type 2 or impaired glucose tolerance, and/or a diagnosis of hypertension. Measurements Global clinical assessment made by three independent reviewers using a three-point ordinal scale (+1 = improvement; 0=no change; −1=worsening) based on eight broad clinical categories including glucose control, lipids, blood pressure, body composition, clinical appearance, strength, psychiatric/cognitive symptoms and quality of life at Weeks 6, 10, 16, and 24. Results Positive GCR increased progressively over time with 88% of patients having improved at Week 24 (P<0·001). The full concordance among reviewers occurred in 76·6% of evaluations resulting in an ICC of 0·652 (P<0·001). Changes in body weight (P<0·0001), diastolic blood pressure (P<0·0001), two-hour postoral glucose challenge glucose concentration (P = 0·0003), and Cushingoid appearance (P=0·022) were strong correlates of GCR. Conclusions Mifepristone treatment for CS results in progressive clinical improvement. Overall agreement among clinical reviewers was substantial and determinants of positive GCR included change in weight, blood pressure, glucose levels and appearance. PMID:24102404

Heart rate variability measurement and clinical depression in acute coronary syndrome patients: narrative review of recent literature

PubMed Central

Harris, Patricia RE; Sommargren, Claire E; Stein, Phyllis K; Fung, Gordon L; Drew, Barbara J

2014-01-01

Aim We aimed to explore links between heart rate variability (HRV) and clinical depression in patients with acute coronary syndrome (ACS), through a review of recent clinical research literature. Background Patients with ACS are at risk for both cardiac autonomic dysfunction and clinical depression. Both conditions can negatively impact the ability to recover from an acute physiological insult, such as unstable angina or myocardial infarction, increasing the risk for adverse cardiovascular outcomes. HRV is recognized as a reflection of autonomic function. Methods A narrative review was undertaken to evaluate state-of-the-art clinical research, using the PubMed database, January 2013. The search terms “heart rate variability” and “depression” were used in conjunction with “acute coronary syndrome”, “unstable angina”, or “myocardial infarction” to find clinical studies published within the past 10 years related to HRV and clinical depression, in patients with an ACS episode. Studies were included if HRV measurement and depression screening were undertaken during an ACS hospitalization or within 2 months of hospital discharge. Results Nine clinical studies met the inclusion criteria. The studies’ results indicate that there may be a relationship between abnormal HRV and clinical depression when assessed early after an ACS event, offering the possibility that these risk factors play a modest role in patient outcomes. Conclusion While a definitive conclusion about the relevance of HRV and clinical depression measurement in ACS patients would be premature, the literature suggests that these measures may provide additional information in risk assessment. Potential avenues for further research are proposed. PMID:25071372

Multiple factors contribute to positive results for hepatitis A virus immunoglobulin M antibody.

PubMed

Alatoom, Adnan; Ansari, M Qasim; Cuthbert, Jennifer

2013-01-01

In the United States, a successful vaccination program for hepatitis A virus (HAV) infection has decreased both its incidence and the true positive rate for diagnostic immunoglobulin M (IgM) antibody to HAV in acute hepatitis. To survey positive results of HAV IgM tests and determine the effect of changing ordering options. We reviewed all positive results for IgM antibody to HAV between January 2007 and December 2010. Patient demographics, clinical history, and laboratory data were recorded and the encounter, order, and reason for test reviewed. Each result was categorized as indicating acute, recent, resolved, or indeterminate HAV infection. A total of 10,735 tests were performed; 35 patients had 49 positive results. Most positive test results were associated with outpatient visits and were ordered in the assessment of patients with liver disease, but not clinical acute hepatitis. In the final analysis, 4 patients had acute hepatitis A and 20 individual patients had recent and/or resolved hepatitis. All but 1 of the remaining 11 patients had another established cause of liver disease with a positive IgM HAV antibody test result; data to determine causality were insufficient. The total number of tests requested annually decreased more than 35% with the introduction of computerized physician order entry. Current assays for IgM HAV antibodies are overused in the absence of clinical acute hepatitis; future clinical decision support may improve patterns of order entry. Most patients have findings consistent with HAV exposure but not acute hepatitis; dormant viral infection may be a continuing source of antigen.

Is electromyography a predictive test of patient response to biofeedback in the treatment of fecal incontinence?

PubMed

Lacima, Gloria; Pera, Miguel; González-Argenté, Xavier; Torrents, Abiguei; Valls-Solé, Josep; Espuña-Pons, Montserrat

2016-03-01

Biofeedback is effective in more than 70% of patients with fecal incontinence. However, reliable predictors of successful treatment have not been identified. The aim was to identify clinical variables and diagnostic tests, particularly electromyography, that could predict a successful outcome. We included 135 consecutive women with fecal incontinence treated with biofeedback. Clinical evaluation, manometry, ultrasonography, electromyography, and pudendal nerve terminal motor latency were performed before therapy. Treatment outcome was assessed using a symptoms diary, Wexner incontinence score and the patient's subjective perception. According to the symptoms diaries, 106 (78.5%) women had a good clinical result and 29 (21.5%) had a poor result. There were no differences in age, severity and type of fecal incontinence. Maximum resting pressure (39.3 ± 19.1 mmHg vs. 33.7 ± 20.2 mmHg; P = 0.156) and maximum squeeze pressure (91.8 ± 33.2 mmHg vs. 79.8 ± 31.2 mmHg; P = 0.127) were higher in patients having good clinical outcome although the difference was not significant. There were no differences in the presence of sphincter defects or abnormalities in electromyographic recordings. Logistic regression analysis found no independent predictive factor for good clinical outcome. Biofeedback is effective in more than 75% of patients with fecal incontinence. Clinical characteristics of patients and results of baseline tests have no predictive value of response to therapy. Specifically, we found no association between severity of electromyographic deficit and clinical response. © 2015 Wiley Periodicals, Inc.

Prospective correlative chemosensitivity testing in high-dose intraarterial chemotherapy for liver metastases.

PubMed

Link, K H; Aigner, K R; Kuehn, W; Schwemmle, K; Kern, D H

1986-09-01

Clinical response of liver metastases treated by high-dose intraarterial chemotherapy (HDIAC) delivered via the hepatic artery was predicted by a modification of the human tumor colony-forming assay (HTCFA) originally described by Hamburger and Salmon [Science (Wash. DC), 197:461-463, 1977. In a first set of experiments, the immediate clinical response to HDIAC was determined in 12 patients with colorectal liver metastases. Biopsies were taken immediately before and after HDIAC, and cells were plated in the HTCFA. Three patients received intraoperative 4-epidoxorubicin and another 9 received mitomycin C by 15-min intraarterial infusions. Sensitivity in the HTCFA was defined as 50% inhibition of colony formation in tumors exposed to the chemotherapeutic agent, compared to the untreated controls. Clinical response was accurately predicted by the HTCFA in 11 of 12 cases. Eight patients had a regression of disease following HDIAC treatment with mitomycin C, as evidenced by either greater than 50% reduction in carcinoembryonic antigen serum level (7 patients) or regression of tumor by computed tomography scan (1 patient). Three patients had no evidence of clinical response to epidoxorubicin, and their tumors were resistant to epidoxorubicin in the HTCFA. One tumor was sensitive to mitomycin C in the HTCFA, but serum carcinoembryonic antigen in the patient continued to increase following HDIAC. The HTCFA was also performed on untreated biopsies following incubation in vitro with the drug used for HDIAC. Results correlated with clinical response in all 12 cases. In a second set of experiments, the HTCFA was used to predict the long-term clinical response to HDIAC of 30 patients with liver metastases. One patient had breast cancer metastases, one patient had carcinoid liver metastases, 4 had liver metastases of malignant melanoma, and 24 patients had colorectal liver metastases. All 21 of the patients whose tumors were sensitive in vitro had clinical response, while 6 of 9 patients predicted by the HTCFA to be resistant had no clinical response. Our results demonstrate a high correlation between the HTCFA and clinical response.

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

PubMed

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

2016-01-01

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

Entheseal involvement in asymptomatic human immunodeficiency virus infected patients: preliminary results of a clinical and ultrasonographic study.

PubMed

Ciancio, Giovanni; Sighinolfi, Laura; Furini, Federica; Segala, Daniela; Farina, Ilaria; Galuppi, Elisa; De Stefani, Elena; Simone, Loredana; Boccia, Sergio; Grilli, Anastasio; Pazzi, Paolo; Libanore, Marco; Contini, Carlo; Govoni, Marcello

2018-05-24

As a strong association between human immunodeficiency virus (HIV) infection and spondyloarthritis (SpA) has been hypothesised, our main objective was to explore by power Doppler ultrasonography (PDUS) the presence of subclinical enthesitis in asymptomatic HIV patients. The presence of subclinical synovitis was also evaluated. Consecutive asymptomatic HIV patients were studied and compared with asymptomatic HCV patients and healthy controls (HC). All subjects underwent a clinical and PDUS bilateral examination of the following entheses and joints: epicondyle, quadriceps, patellar, Achilles and plantar fascia; wrists, II and III metacarpo-phalangeal, knee and ankle. Twenty-nine HIV, 32 HCV and 25 HC were recruited; 1.032 entheses and 860 joints were examined. Clinical diagnosis of enthesitis was made in 10.3% HIV patients, 6.2% HCV patients (p=0.66) and none HC (p=0.24). PDUS enthesitis was found in 72.4% HIV, 28.1% HCV (p=0.0008) and 12% HC (p<0.0001). Clinical diagnosis of synovitis was made in 3.4% HIV patients, 9.3% HCV patients (p=0.61) and none HC (p=1). PDUS abnormalities were documented in 24.1% HIV patients, 71.8% HCV patients (p=0.0003) and none HC (p=0.0001). In detecting enthesitis and synovitis, PDUS was more sensitive than clinical examination both in HIV and HCV patients. Our preliminary study shows the high frequency of PDUS enthesitis in asymptomatic HIV patients, which highlights the close link between HIV and SpA. Further studies are desirable on a larger number of HIV patients to confirm these results. PDUS proved to be more sensitive than clinical examination in detecting subclinical involvement of entheses and joints.

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

PubMed

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

2016-04-01

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

Association between cell-derived microparticles and adverse events in patients with nonpulsatile left ventricular assist devices

PubMed Central

Nascimbene, Angelo; Hernandez, Ruben; George, Joggy K.; Parker, Anita; Bergeron, Angela L.; Pradhan, Subhashree; Vijayan, K. Vinod; Civitello, Andrew; Simpson, Leo; Nawrot, Maria; Lee, Vei-Vei; Mallidi, Hari R.; Delgado, Reynolds M.; Dong, Jing Fei; Frazier, O.H.

2014-01-01

BACKGROUND Continuous-flow left ventricular assist devices (LVADs) expose blood cells to high shear stress, potentially resulting in the production of microparticles that express phosphatidylserine (PS+) and promote coagulation and inflammation. In this prospective study, we attempted to determine whether PS+ microparticle levels correlate with clinical outcomes in LVAD-supported patients. METHODS We enrolled 20 patients undergoing implantation of the HeartMate II LVAD and 10 healthy controls who provided reference values for the microparticle assays. Plasma was collected before LVAD implantation, at discharge, at 3-month follow-up, and when an adverse clinical event occurred. We quantified PS+ microparticles in the plasma using flow cytometry. RESULTS During the study period, 8 patients developed adverse clinical events: ventricular tachycardia storm (n=1), non–ST-elevation myocardial infarction (n=2), arterial thrombosis (n=2), gastrointestinal bleeding (n=2), and stroke (n=3). Levels of PS+ microparticles were higher in patients at baseline than in healthy controls (2.11%±1.26 vs 0.69±0.46, P=0.007). After LVAD implantation, patient PS+ microparticle levels increased to 2.39%±1.22 at discharge and then leveled to 1.97%±1.25 at 3-month follow-up. Importantly, patients who developed an adverse event had significantly higher levels of PS+ microparticles than did patients with no events (3.82%±1.17 vs 1.57%±0.59, P<0.001), even though the 2 patient groups did not markedly differ in other clinical and hematologic parameters. CONCLUSIONS Our results suggest that an elevation of PS+ microparticle levels may be associated with adverse clinical events. Thus, measuring PS+ microparticle levels in LVAD-supported patients may help identify patients at increased risk for adverse events. PMID:24656391

Evaluation of flow cytometric HIT assays in relation to an IgG-Specific immunoassay and clinical outcome.

PubMed

Kerényi, Adrienne; Beke Debreceni, Ildikó; Oláh, Zsolt; Ilonczai, Péter; Bereczky, Zsuzsanna; Nagy, Béla; Muszbek, László; Kappelmayer, János

2017-09-01

Heparin-induced thrombocytopenia (HIT) is a severe side effect of heparin treatment caused by platelet activating IgG antibodies generated against the platelet factor 4 (PF4)-heparin complex. Thrombocytopenia and thrombosis are the leading clinical symptoms of HIT. The clinical pretest probability of HIT was evaluated by the 4T score system. Laboratory testing of HIT was performed by immunological detection of antibodies against PF4-heparin complex (EIA) and two functional assays. Heparin-dependent activation of donor platelets by patient plasma was detected by flow cytometry. Increased binding of Annexin-V to platelets and elevated number of platelet-derived microparticles (PMP) were the indicators of platelet activation. EIA for IgG isotype HIT antibodies was performed in 405 suspected HIT patients. Based on negative EIA results, HIT was excluded in 365 (90%) of cases. In 40 patients with positive EIA test result functional tests were performed. Platelet activating antibodies were detected in 17 cases by Annexin V binding. PMP count analysis provided nearly identical results. The probability of a positive flow cytometric assay result was higher in patients with elevated antibody titer. 71% of patients with positive EIA and functional assay had thrombosis. EIA is an important first line laboratory test in the diagnosis of HIT; however, HIT must be confirmed by a functional test. Annexin V binding and PMP assays using flow cytometry are functional HIT tests convenient in a clinical diagnostic laboratory. The positive results of functional assays may predict the onset of thrombosis. © 2016 International Clinical Cytometry Society. © 2016 International Clinical Cytometry Society.

A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder

PubMed Central

Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

2018-01-01

Purpose The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. Patients and methods A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Results Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1–10. Conclusion Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid prescriptions and 2) reduce pain in patients at low risk of developing OUD. PMID:29379313

The Patient Concerns Inventory integrated as part of routine head and neck cancer follow-up consultations: frequency, case-mix, and items initiated by the patient.

PubMed

Rogers, S N; Thomson, F; Lowe, D

2018-03-01

Introduction The National Institute for Health and Care Excellence guidance Improving Supportive and Palliative Care for Adults with Cancer (2004) and the Cancer Reform Strategy (2007) support the premise that assessment and discussion of patients' needs for physical, social, psychological, and spiritual wellbeing should be undertaken during oncology follow-up. We report the use of the Patient Concerns Inventory in a routine head and neck cancer clinic setting over a seven-year period, summarising the number of available clinics, the number of patients completing the inventory within a clinic, the range of clinical characteristics and the concerns they wanted to discuss. Methods The data were analysed from oncology follow-up clinics between 1 August 2007 and 10 December 2014. Audit approval was given by the Clinical Audit Department, University Hospital Aintree. Results There were 386 patients with 1198 inventories completed at 220 clinics, median 6 (range 4-7) per clinic. The most common concerns raised by patients across all the clinic consultations were dry mouth (34%), fear of recurrence (33%), sore mouth (26%), dental health (25%), chewing (22%) and fatigue/tiredness (21%). Conclusions The incorporation of the Patient Concerns Inventory as part of routine oncology clinics allows for a more patient initiated and focused consultation available to the majority of patients throughout their follow-up. The inventory allows for greater opportunity to provide holistic targeted multiprofessional intervention and support.

Delivery of HIV care during the 2007 post-election crisis in Kenya: a case study analyzing the response of the Academic Model Providing Access to Healthcare (AMPATH) program

PubMed Central

2013-01-01

Background Widespread violence followed the 2007 presidential elections in Kenya resulting in the deaths of a reported 1,133 people and the displacement of approximately 660,000 others. At the time of the crisis the United States Agency for International Development-Academic Model Providing Access to Healthcare (USAID-AMPATH) Partnership was operating 17 primary HIV clinics in western Kenya and treating 59,437 HIV positive patients (23,437 on antiretroviral therapy (ART)). Methods This case study examines AMPATH’s provision of care and maintenance of patients on ART throughout the period of disruption. This was accomplished by implementing immediate interventions including rapid information dissemination through the media, emergency hotlines and community liaisons; organization of a Crisis Response leadership team; the prompt assembly of multidisciplinary teams to address patient care, including psychological support staff (in clinics and in camps for internally displaced persons (IDP)); and the use of the AMPATH Medical Records System to identify patients on ART who had missed clinic appointments. Results These interventions resulted in the opening of all AMPATH clinics within five days of their scheduled post-holiday opening dates, 23,949 patient visits in January 2008 (23,259 previously scheduled), uninterrupted availability of antiretrovirals at all clinics, treatment of 1,420 HIV patients in IDP camps, distribution of basic provisions, mobilization of outreach services to locate missing AMPATH patients and delivery of psychosocial support to 300 staff members and 632 patients in IDP camps. Conclusion Key lessons learned in maintaining the delivery of HIV care in a crisis situation include the importance of advance planning to develop programs that can function during a crisis, an emphasis on a rapid programmatic response, the ability of clinics to function autonomously, patient knowledge of their disease, the use of community and patient networks, addressing staff needs and developing effective patient tracking systems. PMID:24289095

Boron neutron capture therapy (BNCT) for newly-diagnosed glioblastoma: comparison of clinical results obtained with BNCT and conventional treatment.

PubMed

Kageji, Teruyoshi; Nagahiro, Shinji; Mizobuchi, Yoshifumi; Matsuzaki, Kazuhito; Nakagawa, Yoshinobu; Kumada, Hiroaki

2014-01-01

The purpose of this study was to evaluate the clinical outcome of boron neutron capture therapy (BNCT) and conventional treatment in patients with newly diagnosed glioblastoma. Since 1998 we treated 23 newly-diagosed GBM patients with BNCT without any additional chemotherapy. Their median survival time was 19.5 months; the 2-, 3-, and 5-year survival rates were 31.8%, 22.7%, and 9.1%, respectively. The clinical results of BNCT in patients with GBM are similar to those of recent conventional treatments based on radiotherapy with concomitant and adjuvant temozolomide.

An economic comparison of hospital-based and community-based glaucoma clinics

PubMed Central

Sharma, A; Jofre-Bonet, M; Panca, M; Lawrenson, J G; Murdoch, I

2012-01-01

Introduction We have established one model for community care of glaucoma clinic patients. Community optometrists received training and accreditation in glaucoma care. Once qualified they alternated between running half day glaucoma clinics in their own High Street practices and assisting in a hospital-based glaucoma clinic session. This paper reports the cost of this model. Methods Micro-costing was undertaken for the hospital clinic. A consensus meeting was held to agree costs for community clinics involving all optometrists in the project along with representatives of the multiple chain optometry practices who had participated. Costs to patients both indirect and direct were calculated following structured interviews of 197 patients attending hospital clinics and 194 attending community clinics. Results The estimated cost per patient attendance to the hospital clinic was £63.91 and the estimated cost per attendance to the community clinic was £145.62. For patients the combined direct and indirect cost to attend the hospital clinic was £6.15 and the cost to attend the community clinic £5.91. Discussion The principal reason for the higher cost in the community clinic was higher overhead costs in the community. Re-referral to the hospital system only occurred for 9% of patients and was not a large contribution to the increased cost. Time requested to next appointment was similar for the two clinics. Sensitivity analysis shows a strong effect of increasing patients seen per clinic. It would, however, require 25 patients to be seen per clinician per day in the community in order to make the costs comparable. PMID:22562188

Integrating Undergraduate Patient Partners into Diabetes self-management education: Evaluating a free clinic pilot program for the Underserved.

PubMed

Lee, Tiffany C; Frangos, Stephanie N; Torres, Marcella; Winckler, Britanny; Ji, Sung G; Dow, Emily

2016-01-01

Diabetes self-management education (DSME) improves glycemic control and health outcomes in patients with diabetes. A process evaluation of a two-year pilot intervention examined the feasibility and acceptability of undergraduate volunteers as Patient Partners to foster DSME participation among the underserved.Design setting, and participants. In the setting of a student-run free clinic, 22 patients enrolled in DSME were paired with 16 undergraduate volunteers. During the DSME courses, Patient Partners assisted patients during classes, called patients weekly, and accompanied patients to clinic appointments.Key process evaluation results. Average attendance at DSME classes was 79.4% and 94.7% for patients and Patient Partners, respectively. Sixty-three percent of phone calls were successful and Patient Partners attended 50% of appointments with their patients. Focus groups demonstrated resounding acceptability of the Patient Partner role. Volunteer undergraduate Patient Partners are a beneficial adjunct to DSME delivery in the resource-constrained environment of a student-run free clinic.

Tenofovir stock shortages have limited impact on clinic- and patient-level HIV treatment outcomes in public sector clinics in South Africa.

PubMed

Brennan, Alana T; Bor, Jacob; Davies, Mary-Ann; Conradie, Francesca; Maskew, Mhairi; Long, Lawrence; Sanne, Ian; Fox, Matthew P

2017-02-01

Using data from four public sector clinics in South Africa, we sought to investigate provider- and patient-level outcomes, to understand how the 2012 tenofovir stock shortage affected the HIV care and monitoring of ART patients. Prospective cohort analysis of ART-naïve, non-pregnant, HIV-infected patients >18 years initiating first-line ART between 1 July 2011-31 March 2013. Linear regression was used for all outcomes (number of ART initiates, days between pharmacy visits, transfers, single-drug substitutions, treatment interruptions, missed pharmacy visits, loss to follow-up and elevated viral load). We fit splines to smooth curves with knots at the beginning (1 February 2012) and end (31 August 2012) of the stock shortage and displayed results graphically by clinic. Difference-in-difference models were used to evaluate the effect of the stock shortage on outcomes. Results suggest a potential shift in the management of patients during the shortage, mainly fewer average days between visits during the shortage vs. before or after at all four clinics, and a significant difference in the proportion of patients missing visits during vs. before (RD: 1.2%; 95% CI: 0.5%, 2.0%). No significant difference was seen in other outcomes. While South Africa has made great strides to extend access to ART and increase the quality of the health services provided, patient care can be affected when stock shortages/outs occur. While our results show little effect on treatment outcomes, this most likely reflects the clinics' ability to mitigate the crisis by continuing to keep patient care and treatment as consistent as possible. © 2016 John Wiley & Sons Ltd.

Is a combination of Tc-SPECT or perfusion weighted magnetic resonance imaging with spinal tap test helpful in the diagnosis of normal pressure hydrocephalus?

PubMed

Hertel, F; Walter, C; Schmitt, M; Mörsdorf, M; Jammers, W; Busch, H P; Bettag, M

2003-04-01

The aim of this study was to evaluate the combination of spinal tap test (STT) with cerebral perfusion measurement assessed either by Tc-bicisate-SPECT (Tc-SPECT) or perfusion weighted MRI (pwMRI), or both, for a better preoperative selection of promising candidates for shunt operations in suspected idiopathic normal pressure hydrocephalus. 27 consecutive patients were examined with a standard clinical protocol (assessed by the Homburg Hydrocephalus Scale (HHS)) as well as with 99m Tc-bicisate-SPECT (n=27) or additionally by pwMRI (n=12) before and after STT. The results of these examinations were compared preoperatively for each patient and correlated with postoperative clinical outcome after shunt surgery. Nine patients showed both, a clinical improvement, and increased cerebral perfusion after STT. They underwent shunt surgery with good to excellent results. In another nine patients increasing cerebral perfusion was detected although they did not show a clear clinical improvement after STT. Six of them also received a shunt operation with good to excellent outcome. Three patients of the last group could have an operation. Nine patients did not show any clinical improvement or any kind of increasing cerebral perfusion after STT. Therefore, they did not undergo surgery. The results of SPECT and pwMRI correlated in 92 % of the patients (11 of 12). It is concluded that a combination of clinical assessment with SPECT or pwMRI is helpful in the preoperative selection of patients for shunting procedures with suspected NPH syndrome. This combination is a minimal invasive and objective test modality that is superior to STT alone. Further studies are necessary for a comparison of the described imaging techniques with different diagnostic tests in this difficult field of cerebral disease.

Microbiology specimens obtained at the time of surgical lung biopsy for interstitial lung disease: clinical yield and cost analysis.

PubMed

Fibla, Juan J; Brunelli, Alessandro; Allen, Mark S; Wigle, Dennis; Shen, Robert; Nichols, Francis; Deschamps, Claude; Cassivi, Stephen D

2012-01-01

In efforts to obtain complete results, current practice in surgical lung biopsy (LB) for interstitial lung disease (ILD) recommends sending lung tissue samples for bacterial, mycobacterial, fungal, and viral cultures. This study assesses the value of this practice by evaluating the microbiology findings obtained from LB for ILD and their associated costs. A total of 296 consecutive patients (140 women, 156 men, median age=61 years) underwent LB for ILD from 2002 to 2009. All had lung tissue sent for microbiology examination. Microbiology results and resultant changes in patient management were analyzed retrospectively. A cost analysis was performed based upon nominal hospital charges adjusted on current inflation rates. Cost data included cultures, stains, smears, direct fluorescent antibody studies, and microbiologist consulting fees. As many as 25 patients (8.4%) underwent open LB and 271 (91.6%) underwent thoracoscopic LB. A total of 592 specimens were assessed (range 1-4 per patient). The most common pathologic diagnoses were idiopathic pulmonary fibrosis in 122 (41.2%), cryptogenic organizing pneumonia in 31 (10.5%), and respiratory bronchiolitis ILD in 16 (5.4%). Microbiology testing was negative in 174 patients (58.8%). A total of 118 of 122 (96.7%) positive results were clinically considered to be contaminants and resulted in no change in clinical management. The most common contaminants were Propionibacterium acnes (38 patients; 31%) and Penicillium fungus (16 patients; 13%). In only four patients (1.4%), the organism cultured (Nocardia one, Histoplasma one, and Aspergillus fumigatus two) resulted in a change in clinical management. The cost of microbiology studies per specimen was $984 (€709), with a total cost for the study cohort being $582,000 (€420,000). The yield and impact on clinical management of microbiology specimens from LB for ILD is very low. Its routine use in LB is questionable. We suggest it should be limited to those cases of ILD with a high suspicion of infection. Substantial cost savings are possible with this change in clinical practice.

A technician-delivered 'virtual clinic' for triaging low-risk glaucoma referrals.

PubMed

Kotecha, A; Brookes, J; Foster, P J

2017-06-01

PurposeThe purpose of this study is to describe the outcomes of a technician-delivered glaucoma referral triaging service with 'virtual review' of resultant data by a consultant ophthalmologist.Patients and methodsThe Glaucoma Screening Clinic reviewed new optometrist or GP-initiated glaucoma suspect referrals into a specialist ophthalmic hospital. Patients underwent testing by three ophthalmic technicians in a dedicated clinical facility. Data were reviewed at a different time and date by a consultant glaucoma ophthalmologist. Approximately 10% of discharged patients were reviewed in a face-to-face consultant-led clinic to examine the false-negative rate of the service.ResultsBetween 1 March 2014 and 31 March 2016, 1380 patients were seen in the clinic. The number of patients discharged following consultant virtual review was 855 (62%). The positive predictive value of onward referrals was 84%. Three of the 82 patients brought back for face-to-face review were deemed to require treatment, equating to negative predictive value of 96%.ConclusionsOur technician-delivered glaucoma referral triaging clinic incorporates consultant 'virtual review' to provide a service model that significantly reduces the number of onward referrals into the glaucoma outpatient department. This model may be an alternative to departments where there are difficulties in implementing optometrist-led community-based referral refinement schemes.

Probing consciousness with event-related potentials in the vegetative state

PubMed Central

Faugeras, F.; Rohaut, B.; Weiss, N.; Bekinschtein, T.A.; Galanaud, D.; Puybasset, L.; Bolgert, F.; Sergent, C.; Cohen, L.; Dehaene, S.

2011-01-01

Objective: Probing consciousness in noncommunicating patients is a major medical and neuroscientific challenge. While standardized and expert behavioral assessment of patients constitutes a mandatory step, this clinical evaluation stage is often difficult and doubtful, and calls for complementary measures which may overcome its inherent limitations. Several functional brain imaging methods are currently being developed within this perspective, including fMRI and cognitive event-related potentials (ERPs). We recently designed an original rule extraction ERP test that is positive only in subjects who are conscious of the long-term regularity of auditory stimuli. Methods: In the present work, we report the results of this test in a population of 22 patients who met clinical criteria for vegetative state. Results: We identified 2 patients showing this neural signature of consciousness. Interestingly, these 2 patients showed unequivocal clinical signs of consciousness within the 3 to 4 days following ERP recording. Conclusions: Taken together, these results strengthen the relevance of bedside neurophysiological tools to improve diagnosis of consciousness in noncommunicating patients. PMID:21593438

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

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

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

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

New design of care: Assessment of an interdisciplinary orthopaedic clinic with a pivot nurse in the province of Quebec.

PubMed

Poder, Thomas G; Bellemare, Christian; Bédard, Suzanne K; He, Jie; Lemieux, Renald

2010-01-01

New designs of care in orthopaedic clinics are needed to cope with the shortage of orthopaedic surgeons and the lengthening of waiting times. To assess the effectiveness of an interdisciplinary orthopaedic clinic with a pivot nurse in the Canadian province of Quebec with regard to accessibility, quality of care, efficacy and efficiency of the clinic, and patient's quality of life. Two strategies were developed: (1) a selected cohort of new patients attending an orthopaedic service from February to September 2008 were entered into a database recording patient details, source of referral, diagnosis, satisfaction, and quality of life (36-Item Short Form Health Survey version 2). In this setting, 2 sets of questionnaires were administered to the patients: the first one during the first visit and the second one, 2 months later. A total of 243 patients from the case control were compared with 89 patients of the case study, where an interdisciplinary orthopaedic clinic with a pivot nurse has been developed; (2) costs per patient were calculated using the staff timesheets provided by the two orthopaedic clinics. The results showed a significant reduction in the waiting-list duration (accessibility) in the case study clinic owing to a strong decrease in the inappropriate consultations with the orthopaedic consultant. The quality of care remained high, and the target surgeries for total hip and knee replacement were reached, despite a strong shortage of orthopaedic doctors. Interdisciplinary orthopaedic clinic with a pivot nurse is a new approach in the province of Quebec and first results are encouraging.

Understanding Study Participants Views on Co-Creation of Data and Use of EHR in Clinical Studies.

PubMed

Scott Duncan, Therese; Hägglund, Maria

2018-01-01

In order to increase clinical trial participation, the reasons for participating need to be observed. Since there is rather inadequate information concerning how individuals such as patients, decides to participate in clinical trials semi-structured interviews have been done. Examining the use of EHR in clinical trials and co-creation of data, the result showed that it is important for the researches to have access to the patients' EHR and for the patients to contribute with their own ideas of research. Important aspects of further participation in clinical trials were that it should be fun and informative. The patients agreed on that the effort of participating could decrease with the use of electronically collection and self-reporting of data, e.g. through a patient portal.

A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials.

PubMed

Rose, Klaus; Kummer, Hans

2015-05-28

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

Clinical utility of FDG PET/CT in acute complicated pyelonephritis-results from an observational study.

PubMed

Wan, Chih-Hsing; Tseng, Jing-Ren; Lee, Ming-Hsun; Yang, Lan-Yan; Yen, Tzu-Chen

2018-03-01

Acute complicated pyelonephritis (ACP) is an upper urinary tract infection associated with coexisting urinary tract abnormalities or medical conditions that could predispose to serious outcomes or treatment failures. Although CT and magnetic resonance imaging (MRI) are frequently used in patients with ACP, the clinical value of 18 F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) has not been systematically investigated. This single-center retrospective study was designed to evaluate the potential usefulness of FDG PET/CT in patients with ACP. Thirty-one adult patients with ACP who underwent FDG PET/CT were examined. FDG PET/CT imaging characteristics, including tracer uptake patterns, kidney volumes, and extrarenal imaging findings, were reviewed in combination with clinical data and conventional imaging results. Of the 31 patients, 19 (61%) showed focal FDG uptake. The remaining 12 study participants showed a diffuse FDG uptake pattern. After volumetric approximation, the affected kidneys were found to be significantly enlarged. Patients who showed a focal uptake pattern had a higher frequency of abscess formation requiring drainage. ACP patients showing diffuse tracer uptake patterns had a more benign clinical course. Seven patients had suspected extrarenal coinfections, and FDG PET/CT successfully confirmed the clinical suspicion in five cases. FDG PET/CT was as sensitive as CT in identifying the six patients (19%) who developed abscesses. Notably, FDG PET/CT findings caused a modification to the initial antibiotic regimen in nine patients (29%). FDG PET/CT may be clinically useful in the assessment of patients with ACP who have a progressive disease course.

Sinonasal involvement in systemic vasculitides and cocaine-induced midline destructive lesions: Diagnostic controversies

PubMed Central

García-Lliberós, A.; Gómez, M. J.; Navarro, A.; Martorell, A.

2013-01-01

Multiple systemic diseases produce various clinical manifestations in the sinonasal area. They usually appear as difficult-to-diagnose disease processes with slow, atypical clinical courses. The aim of this study was to evaluate the sinonasal manifestations of systemic vasculitides, highlighting key points for diagnosis and differential diagnosis with other pathological entities, especially cocaine-induced midline destructive lesions (CIMDL). A retrospective study was performed of 10 patients treated in our hospital during the last 5 years with an initial diagnosis of systemic vasculitides with sinonasal involvement: eight patients with granulomatosis with polyangiitis (GPA; new nomenclature for Wegener granulomatosis) and two patients with Churg-Strauss syndrome (CSS). The study variables were clinical presentation, nasal endoscopy results, maxillofacial scan results, nasal biopsy results, erythrocyte sedimentation rate, and autoimmune antibody levels. The definitive diagnosis was GPA in six (60%) patients, CSS in two (20%) patients, and CIMDL in two (20%) patients. Nasal symptoms were similar in all patients, but nasal polyps were present in only one patient with CSS. Systemic manifestations were absent in patients with CIMDL. Likewise, peripheral eosinophilia was observed only in the two patients with CSS. Specific positive biopsy specimens were obtained in six patients (all six patients with GPA, one with CSS, and one with CIMDL). Antineutrophil cytoplasmic antibodies (ANCA) were positive in all patients with GPA (proteinase 3 antigen in five patients and myeloperoxidase in one patient), and perinuclear ANCA was positive in one patient with CIMDL; however, this patient showed an undefined pattern. Finally, the response to treatment was adequate in all patients excluding those with CIMDL. GPA and CIMDL syndromes pose a difficult differential diagnosis because they have common clinical, serological, and histological presentations. Negative histological results do not exclude the diagnosis of sinonasal vasculitides. The absence of systemic manifestations and the lack of response to treatment will lead to the confirmation of CIMDL syndrome in a cocaine user. Otolaryngologists play an important role in the early and differential diagnosis of these diseases. PMID:24124643

Probabilistic techniques for obtaining accurate patient counts in Clinical Data Warehouses

PubMed Central

Myers, Risa B.; Herskovic, Jorge R.

2011-01-01

Proposal and execution of clinical trials, computation of quality measures and discovery of correlation between medical phenomena are all applications where an accurate count of patients is needed. However, existing sources of this type of patient information, including Clinical Data Warehouses (CDW) may be incomplete or inaccurate. This research explores applying probabilistic techniques, supported by the MayBMS probabilistic database, to obtain accurate patient counts from a clinical data warehouse containing synthetic patient data. We present a synthetic clinical data warehouse (CDW), and populate it with simulated data using a custom patient data generation engine. We then implement, evaluate and compare different techniques for obtaining patients counts. We model billing as a test for the presence of a condition. We compute billing’s sensitivity and specificity both by conducting a “Simulated Expert Review” where a representative sample of records are reviewed and labeled by experts, and by obtaining the ground truth for every record. We compute the posterior probability of a patient having a condition through a “Bayesian Chain”, using Bayes’ Theorem to calculate the probability of a patient having a condition after each visit. The second method is a “one-shot” approach that computes the probability of a patient having a condition based on whether the patient is ever billed for the condition Our results demonstrate the utility of probabilistic approaches, which improve on the accuracy of raw counts. In particular, the simulated review paired with a single application of Bayes’ Theorem produces the best results, with an average error rate of 2.1% compared to 43.7% for the straightforward billing counts. Overall, this research demonstrates that Bayesian probabilistic approaches improve patient counts on simulated patient populations. We believe that total patient counts based on billing data are one of the many possible applications of our Bayesian framework. Use of these probabilistic techniques will enable more accurate patient counts and better results for applications requiring this metric. PMID:21986292

Clinical, Electrophysiological, and Serological Evaluation of Patients with Cramp-Fasciculation Syndrome

PubMed Central

POYRAZ, Mürüvvet; MATUR, Zeliha; AYSAL, Fikret; TÜZÜN, Erdem; HANOĞLU, Lütfü; ÖGE, A. Emre

2017-01-01

Introduction Cramp-fasciculation syndrome (CFS) is a rare peripheral nerve hyperexcitability syndrome. There are only a few reports on clinical and serological profile of a CFS cohort that was followed up by a single outpatient clinic. Methods Clinical, electrophysiological, and serological features of 6 CFS patients (5 men, 1 woman; 27–65 years old) were investigated. Results All patients presented with cramps, fasciculations, muscle pain, and autonomic symptoms, and 2 also reported numbness and burning sensation in limbs, suggestive of neuropathic pain. Antibodies to uncharacterized voltage-gated potassium channel (VGKC)-complex proteins were found in 2 patients and to contactin-associated protein-like 2 (CASPR2) in 1 patient. None of the patients had a tumor. Most of the patients revealed prolonged after-discharges following tibial nerve stimulation. Nerve conduction studies and R-R interval variability tests were normal, whereas sympathetic skin responses were increased in amplitude in 3 seronegative patients. Five patients showed favorable response to carbamazepine or pregabalin treatment, whereas 1 VGKC-antibody-positive patient was resistant to carbamazepine and immunosuppressant treatment. Conclusion Neuropathic pain and VGKC-complex antibodies may be encountered in CFS patients. Although autonomic symptoms are commonly found in CFS, routine autonomic system tests which are done in electrophysiology laboratories might yield normal results. PMID:28680318

Proband-only medical exome sequencing as a cost-effective first-tier genetic diagnostic test for patients without prior molecular tests and clinical diagnosis in a developing country: the China experience.

PubMed

Hu, Xuyun; Li, Niu; Xu, Yufei; Li, Guoqiang; Yu, Tingting; Yao, Ru-En; Fu, Lijun; Wang, Jiwen; Yin, Lei; Yin, Yong; Wang, Ying; Jin, Xingming; Wang, Xiumin; Wang, Jian; Shen, Yiping

2017-11-02

PurposeTo evaluate the performance of proband-only medical exome sequencing (POMES) as a cost-effective first-tier diagnostic test for pediatric patients with unselected conditions.MethodsA total of 1,323 patients were tested by POMES, which targeted 2,742 known disease-causing genes. Clinical relevant variants were Sanger-confirmed in probands and parents. We assessed the diagnostic validity and clinical utility of POMES by means of a survey questionnaire.ResultsPOMES, ordered by 136 physicians, identified 512 pathogenic or likely pathogenic variants associated with over 200 conditions. The overall diagnostic rate was 28.8%, ranging from 10% in neonatal intensive care unit patients to over 35% in pediatric intensive care unit patients. The test results had an impact on the management of the 45.1% of patients for whom there were positive findings. The average turnaround time was 57 days; the cost was $360/case.ConclusionWe adopted a relatively efficient and cost-effective approach in China for the molecular diagnosis of pediatric patients with suspected genetic conditions. While training for clinical geneticists and other specialists is lagging behind in China POMES is serving as a diagnostic equalizer for patients who do not normally receive extensive clinical evaluation and clinical diagnosis prior to testing. This Chinese experience should be applicable to other developing countries that are lacking clinical, financial, and personnel resources.GENETICS in MEDICINE advance online publication, 2 November 2017; doi:10.1038/gim.2017.195.

Fluctuating olfactory sensitivity and distorted odor perception in allergic rhinitis.

PubMed

Apter, A J; Gent, J F; Frank, M E

1999-09-01

To characterize the relationship between allergic rhinitis, the severity and duration of nasal disease, olfactory function, and self-reported olfactory symptoms, including fluctuations or distortions in odor perception. Assessment of olfactory function and symptoms of 90 patients with allergic rhinitis. A clinic of a university teaching hospital and research facility. Sixty patients who presented to the Taste and Smell Clinic who had positive allergy test results and 30 patients who presented to the Allergy-Immunology Clinic. The Taste and Smell Clinic patients were grouped by nasal-sinus disease status (30 without chronic rhinosinusitis or nasal polyps, 14 with chronic rhinosinusitis but without polyps, and 16 with nasal polyps). Subjective olfactory symptom questionnaire and objective olfactory function tests. The Allergy-Immunology Clinic patients were diagnosed as being normosmic and the Taste and Smell Clinic patients as being hyposmic or anosmic with olfactory loss that increased significantly with nasal-sinus disease severity. Comparisons with normative data confirm that olfactory scores observed in all groups were significantly lower than expected because of the aging process alone. The self-reported duration of olfactory loss increased significantly with nasal-sinus disease severity. The Taste and Smell Clinic patients without chronic rhinosinusitis or nasal polyps reported the greatest incidence of olfactory distortions and olfactory loss associated with upper respiratory tract infections. There appears to be a continuum of duration and severity of olfactory loss in allergic rhinitis that parallels increasing severity of nasal-sinus disease. As a result of the increased frequency of respiratory infection associated with allergic rhinitis, these patients are at risk for damage to the olfactory epithelium.

Patient characteristics driving clinical utility in psychiatric pharmacogenetics: a reanalysis from the AB-GEN multicentric trial.

PubMed

Menchón, J M; Espadaler, J; Tuson, M; Saiz-Ruiz, J; Bobes, J; Vieta, E; Álvarez, E; Pérez, V

2018-05-04

Clinical utility of commercial multi-gene pharmacogenetic tests in depression is starting to be studied with some promising results on efficacy and tolerability. Among the next steps is the definition of the patient profile that is most likely to benefit from testing. Here we present a reanalysis of data from the AB-GEN randomized clinical trial showing that clinical utility of pharmacogenetic testing can be markedly influenced by patient characteristics such as age, baseline severity and duration of current depressive episode.Trial registration ClinicalTrials.gov NCT02529462.

Does Previous Hip Surgery Effect the Outcome of Tönnis Triple Periacetabular Osteotomy? Mid-Term Results.

PubMed

Konya, Mehmet Nuri; Aydn, Bahattin Kerem; Yldrm, Timur; Sofu, Hakan; Gürsu, Sarper

2016-03-01

Hip dysplasia (HD) is 1 of the major reasons of coxarthrosis. The goal of the treatment of HD by Tönnis triple pelvic osteotomy (TPAO) is to improve the function of hip joint while relieving pain, delaying and possibly preventing end-stage arthritis. The aim of this study is to compare the clinical and radiological results of TPAO to determine if previous surgery has a negative effect on TPAO.Patients operated with TPAO between 2005 and 2010, included in this study. Patients divided into 2 groups: primary acetabular dysplasia (PAD) and residual acetabular dysplasia (RAD). Prepostoperatively, hip range of motion, Harris hip score (HHS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) hip score, visual analog scores (VAS), impingement tests, and also the presence of Trendelenburg sign (TS) were investigated for clinical evaluation. For radiological analysis pre-postoperative, anterior-posterior (AP) pelvis and faux profile radiographs were used. Acetabular index, lateral center edge (LCE) angle, and Sharp angles were measured by AP pelvis; anterior center edge (ACE) angle were measured by faux profile radiography. All the clinical and radiological data of the groups were analyzed separately for the pre-postoperative scores also the amount of improvement in all parameters were analyzed.SPSS20 (SPSS Inc., Chicago, IL) was used for statistical analysis. Wilcoxon test, McNemar test, paired t tests, and Mann-Whitney U tests were used to compare the groups. P < 0.05 were defined as statistically significant.Study included 27 patients: 17 patients were in PAD and 10 patients were in RAD. The mean follow-up period was 6.2 years (5.2-10.3 years). In all patients, the radiological and the clinical outcomes were better after TPAO except the flexion of the hip parameter. When the patient groups were evaluated as pre-postoperatively, more statistically significant parameters were found in the PAD group when compared with RAD group. Extension, impingement, TS, VAS, HHS, WOMAC score parameters in clinical outcome and LCE, ACE, Sharp angle, coverage ratio in radiological results were significantly better in PAD group postoperatively but in RAD group; only extension, VAS, HHS, and WOMAC parameters were clinically and LCE and Coverage ratio were significantly different compared with the preoperative measurements. The change of the parameters that used for the evaluation of clinical and radiological results did not show a significant difference between groups.Our data suggest that TPAO can be performed on patients with HD for both groups. Although there were fewer parameters which changed significantly after TPAO in RAD patients; the improvement of radiological and clinical results was similar for groups. Further long-term follow-up studies with large number of patients are needed to determine the proper results of TPAO.

Correlation between lumbo-ventricular perfusion and MRI-CSF flow studies in idiopathic normal pressure hydrocephalus.

PubMed

Hakim, R; Black, P M

1998-01-01

After the initial description of normal pressure hydrocephalus (NPH) and its clinical triad, there has been a continuous interest from clinicians and researchers to set different diagnostic criteria that would make the selection of candidates for shunt surgery easier and more precise. A preliminary group of 12 patients was given a diagnosis of idiopathic normal pressure hydrocephalus by clinical and radiologic criteria. Each patient underwent two different tests: a magnetic resonance imaging-cerebrospinal fluid (MRI-CSF) flow study and a lumbo-ventricular perfusion test. The purpose was to compare the correlation of the results obtained with these tests and the clinical results obtained after CSF diversion. Eleven patients were given shunts and one was managed with lumbar punctures. One year after treatment, 10 of the 12 patients had improved with good results. The MRI-CSF flow studies were reliable in six patients; there were five false negatives and one false positive. The lumbo-ventricular perfusion test showed reliability in nine patients; there were two false negatives and one false positive. In only three patients were the results of both of these tests in accordance with the outcome. Even though there are few patients in this study so far, the data suggests that at the present time the most predictive guides for the diagnosis of NPH and its outcome after shunting are the clinical criteria and the radiological findings in computed tomography (CT) and/or MRI rather than lumbo-ventricular perfusion and CSF flow studies.

[Clinical and histopathological features of myositis associated with anti-mitochondrial antibodies].

PubMed

Shimizu, Jun

2013-01-01

Anti-mitochondrial antibodies (AMA) are known to be characteristic markers of primary biliary cirrhosis (PBC). The association of PBC with myositis has been reported mainly as case reports, and comprehensive studies of the clinical and histopathological features of patients with myositis and AMAs or PBC have not been conducted thus far. We retrospectively reviewed 212 patients with inflammatory myopathies in our laboratory and found 24 patients with AMA-positive myositis (11%) (seven patients with PBC and 17 patients without PBC). The analysis of clinical and histopathological features revealed that myositis associated with AMAs frequently include patients with a clinically chronic disease course, muscle atrophy, cardiopulmonary involvement and granulomatous inflammation, regardless of the presence or absence of PBC. We also reviewed and analyzed the clinical features of previously reported patients. The analysis of 75 patients, which have been described in previous case reports including the ones of meeting abstracts, also showed the similar results about clinical features of myositis associated with AMAs and supported our findings. Our study suggests that myositis associated with AMAs form a characteristic subgroup.

Patient characteristics for outpatient acupuncture in Beijing, China.

PubMed

Napadow, Vitaly; Kaptchuk, Ted J

2004-06-01

This study quantifies and compares patient characteristics in outpatient acupuncture. Prospective primary source evidence was gathered at two prominent outpatient acupuncture clinics in Beijing, China (n = 563, n = 233). The most common condition was Bell's palsy, which represented 20.6% and 25.3% of total cases at the two clinics, respectively. The second most common condition was cerebrovascular accident (CVA) rehabilitation. These treatments represented 11.9% and 12.0% of treatments at the two clinics, respectively. Other trends at the clinics included the following: (1) neurologic complaints predominated; (2) doctors see a large number of patients per day; (3) the majority of patients overall were female; while (4) the majority of patients treated for CVAs rehabilitation were male. As cultural and socioeconomic differences in perceptions of acupuncture exist between peoples of different countries, this study also compared patient main complaints in China to available data on acupuncture patients seen in other parts of China, Germany, the United Kingdom, Australia, and the United States. Except for the German clinic data, Western clinic acupuncturists saw more musculoskeletal complaints compared to China, where neurologic complaints predominated. Another significant difference between Asian and Western clinics was the number of patients seen per hour. While acupuncturists were reported to see 1.2 patients per hour in U. S. clinics, acupuncturists at the two Beijing, China, clinics saw 7.0 and 10.4 patients per hour, respectively. The main complaints seen in acupuncture outpatient clinics throughout the world likely result from a combination of inherent disease prevalence as well as patients' attitudes toward what acupuncture can treat successfully. Copyright Mary Ann Liebert, Inc.

Clinical insomnia and associated factors in failed back surgery syndrome: a retrospective cross-sectional study.

PubMed

Yun, Soon Young; Kim, Do Heon; Do, Hae Yoon; Kim, Shin Hyung

2017-01-01

Background Insomnia frequently occurs to patients with persistent back pain. By worsening pain, mood, and physical functioning, insomnia could lead to the negative clinical consequences of patients with failed back surgery syndrome (FBSS). This retrospective and cross-sectional study aims to identify the risk factors associated with clinical insomnia in FBSS patients. Methods A total of 194 patients with FBSS, who met the study inclusion criteria, were included in this analysis. The Insomnia Severity Index (ISI) was utilized to ascertain the presence of clinical insomnia (ISI score ≥ 15). Logistic regression analysis evaluates patient demographic factors, clinical factors including prior surgical factors, and psychological factors to identify the risk factors of clinical insomnia in FBSS patients. Results After the persistent pain following lumbar spine surgery worsened, 63.4% of patients reported a change from mild to severe insomnia. In addition, 26.2% of patients met the criteria for clinically significant insomnia. In a multivariate logistic regression analysis, high pain intensity (odds ratio (OR) =2.742, 95% confidence interval (CI): 1.022 - 7.353, P =0.045), high pain catastrophizing (OR=4.185, 95% CI: 1.697 - 10.324, P =0.002), greater level of depression (OR =3.330, 95% CI: 1.127 - 9.837, P =0.030) were significantly associated with clinical insomnia. However, patient demographic factors and clinical factors including prior surgical factors were not significantly associated with clinical insomnia. Conclusions Insomnia should be addressed as a critical part of pain management in FBSS patients with these risk factors, especially in patients with high pain catastrophizing.

Evaluation of the Use of a Virtual Patient on Student Competence and Confidence in Performing Simulated Clinic Visits.

PubMed

Taglieri, Catherine A; Crosby, Steven J; Zimmerman, Kristin; Schneider, Tulip; Patel, Dhiren K

2017-06-01

Objective. To assess the effect of incorporating virtual patient activities in a pharmacy skills lab on student competence and confidence when conducting real-time comprehensive clinic visits with mock patients. Methods. Students were randomly assigned to a control or intervention group. The control group completed the clinic visit prior to completing virtual patient activities. The intervention group completed the virtual patient activities prior to the clinic visit. Student proficiency was evaluated in the mock lab. All students completed additional exercises with the virtual patient and were subsequently assessed. Student impressions were assessed via a pre- and post-experience survey. Results. Student performance conducting clinic visits was higher in the intervention group compared to the control group. Overall student performance continued to improve in the subsequent module. There was no change in student confidence from pre- to post-experience. Student rating of the ease of use and realistic simulation of the virtual patient increased; however, student rating of the helpfulness of the virtual patient decreased. Despite student rating of the helpfulness of the virtual patient program, student performance improved. Conclusion. Virtual patient activities enhanced student performance during mock clinic visits. Students felt the virtual patient realistically simulated a real patient. Virtual patients may provide additional learning opportunities for students.

Discordance between MTB/RIF and Real-Time Tuberculosis-Specific Polymerase Chain Reaction Assay in Bronchial Washing Specimen and Its Clinical Implications.

PubMed

Jo, Yong Suk; Park, Ju-Hee; Lee, Jung Kyu; Heo, Eun Young; Chung, Hee Soon; Kim, Deog Kyeom

2016-01-01

The prevalence and clinical implications of discordance between Xpert MTB/RIF assays and the AdvanSure TB/NTM real-time polymerase chain reaction (PCR) for bronchial washing specimens have not been studied in pulmonary TB (PTB) patients. The discordant proportion and its clinical impact were evaluated in 320 patients from the bronchoscopy registry whose bronchial washing specimens were tested simultaneously with Xpert MTB/RIF and the TB/NTM PCR assay for three years, and the accuracy of the assays, including the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were studied. The clinical risk factors for discordance and false positivity of assays were also studied. Among 130 patients who were clinically diagnosed with PTB, 64 patients showed positive acid-fast bacilli culture results, 56 patients showed positive results in molecular methods and clinician diagnosed PTB without results of microbiology in 10 patients. The sensitivity, specificity, PPV, and NPV were 80.0%, 98.95%, 98.1%, and 87.9%, respectively, for Xpert MTB/RIF and 81.5%, 92.6%, 88.3%, and 88.0%, respectively, for TB/NTM PCR. The discordant proportion was 16.9% and was higher in culture-negative PTB compared to culture-confirmed PTB (24.3% vs. 9.4%, p = 0.024). However, there were no significant differences in the clinical characteristics, regardless of the discordance. The diagnostic yield increased with an additional assay (7.7% for Xpert MTB/RIF and 9.2% for TB/NTM PCR). False positivity was less common in patients tested with Xpert MTB/RIF (1.05% vs. 7.37%, p = 0.0035). No host-related risk factor for false positivity was identified. The Xpert MTB/RIF and TB/NTM PCR assay in bronchial washing specimens can improve the diagnostic yields for PTB, although there were considerable discordant results without any patient-related risk factors.

[To consider negative viral loads below the limit of quantification can lead to errors in the diagnosis and treatment of hepatitis C virus infection].

PubMed

Acero Fernández, Doroteo; Ferri Iglesias, María José; López Nuñez, Carme; Louvrie Freire, René; Aldeguer Manté, Xavier

2013-01-01

For years many clinical laboratories have routinely classified undetectable and unquantifiable levels of hepatitis C virus RNA (HCV-RNA) determined by RT-PCR as below limit of quantification (BLOQ). This practice might result in erroneous clinical decisions. To assess the frequency and clinical relevance of assuming that samples that are BLOQ are negative. We performed a retrospective analysis of RNA determinations performed between 2009 and 2011 (Cobas/Taqman, lower LOQ: 15 IU/ml). We distinguished between samples classified as «undetectable» and those classified as «<1.50E+01IU/mL» (BLOQ). We analyzed 2.432 HCV-RNA measurements in 1.371 patients. RNA was BLOQ in 26 samples (1.07%) from 23 patients (1.68%). BLOQ results were highly prevalent among patients receiving Peg-Riba: 23 of 216 samples (10.6%) from 20 of 88 patients receiving treatment (22.7%). The clinical impact of BLOQ RNA samples was as follows: a) 2 patients initially considered to have negative results subsequently showed quantifiable RNA; b) 8 of 9 patients (88.9%) with BLOQ RNA at week 4 of treatment later showed sustained viral response; c) 3 patients with BLOQ RNA at weeks 12 and 48 of treatment relapsed; d) 4 patients with BLOQ RNA at week 24 and/or later had partial or breakthrough treatment responses, and e) in 5 patients the impact were null or could not be ascertained. This study suggests that BLOQ HCV-RNA indicates viremia and that equating a BLOQ result with a negative result can lead to treatment errors. BLOQ results are highly prevalent in on-treatment patients. The results of HCV-RNA quantification should be classified clearly, distinguishing between undetectable levels and levels that are BLOQ. Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.

[CLINICAL UTILITY OF T-SPOT.TB ASSAY WITH T-Cell Xtend REAGENT FOR ACTIVE TUBERCULOSIS DIAGNOSIS IN THE FIELD TEST AT OUR HOSPITAL].

PubMed

Nemoto, Kenji; Oh-ishi, Shuji; Taguchi, Masato; Hyodo, Kentaro; Kanazawa, Jun; Miura, Yukiko; Takaku, Takio; Usui, Shingo; Hayashihara, Kenji; Saito, Takefumi

2016-04-01

T-SPOT.TB (T-SPOT), an interferon-gamma release assay, has shown promise as a diagnostic tool for active tuberculosis (TB), and its use is expanding. Addition of the T-Cell Xtend (TCX) reagent may allow delayed processing, and this characteristic is important for using this test in the field. However, limited data is available on the usefulness of T-SPOT with TCX as a field test for diagnosing active TB. To investigate the clinical utility of T-SPOT with TCX and the risk factors for a false-negative result in patients with active TB. A total of 57 patients with active TB who underwent the T-SPOT test with TCX prior to treatment were enrolled between May 2013 and May 2015. One patient with an indeterminate result for T-SPOT was excluded; therefore, the data of 56 patients were eventually included in the final analysis. The basic characteristics and clinical findings were compared between the true-positive and false-negative T-SPOT groups. Of the 56 patients, 40 (71.4%), 13 (23.2%), 3 (5.4%) had true-positive, false-negative, and borderline T-SPOT results, respectively. This study did not reveal any significant risk factors for a false-negative T-SPOT result. In this clinical study, the proportion of patients with a false-negative result for T-SPOT with TCX for active TB was higher than that reported previously. Therefore, careful interpretation of a negative result for T-SPOT with TCX is necessary, regardless of the patient's background.

Granulomatous Mastitis: A Ten-Year Experience at a University Hospital

PubMed Central

Korkut, Ercan; Akcay, Mufide Nuran; Karadeniz, Erdem; Subasi, Irmak Durur; Gursan, Nesrin

2015-01-01

Objective: In this study we aimed to define clinical, radiologic and pathological specialties of patients who applied to General Surgery Department of Atatürk University Medical Faculty with granulomatous mastitis and show medical and surgical treatment results. With the help of this study we will be able to make our own clinical algorithm for diagnosis and treatment. Materials and Methods: We searched retrospectively addresses, phone numbers and clinical files of 93 patients whom diagnosed granulomatous mastitis between a decade of January 2001 – December 2010. We noted demographic specialties, ages, gender, medical family history, main complaints, physical findings, radiological and laboratory findings, medical treatments, postoperative complications and surgical procedures if they were operated; morbidity, recurrence and success ratios, complications after treatment for patients discussed above. Results: In this study we evaluated 93 patients, 91 females and 2 males, with granulomatous mastitis retrospectively who applied to General Surgery Department of Atatürk University Medical Faculty between January 2001 and December 2010. Mean age was 34.4 years. The diagnosis was confirmed by histopathologic examination of the lesions. Seventy three patients had idiopathic granulomatous lobular mastitis and 20 patients had specific granulomatous mastitis IGM (18 tuberculosis mastitis, 1 alveolar echinococcosis and 1 silk reaction). All the patients had surgical debridement or antibiotic, and anti-inflammatory treatment with results bad clinical response before applied our clinic. Conclusion: Empiric antibiotic therapy and drainage of the breast lesions are not enough for complete remission of idiopathic granulomatous mastitis. The lesion must be excised completely. In selected patients, corticosteroid therapy can be useful. In the patients with tuberculous mastitis, abscess drainage and antituberculous therapy can be useful, but wide excision must be chosen for the patients with recurrent disease. PMID:26644764

The development of agoraphobia is associated with the symptoms and location of a patient's first panic attack

PubMed Central

2012-01-01

Background The place where a patient experiences his/her first panic attack (FPA) may be related to their agoraphobia later in life. However, no investigations have been done into the clinical features according to the place where the FPA was experienced. In particular, there is an absence of detailed research examining patients who experienced their FPA at home. In this study, patients were classified by the location of their FPA and the differences in their clinical features were explored (e.g., symptoms of FPA, frequency of agoraphobia, and severity of FPA). Methods The subjects comprised 830 panic disorder patients who were classified into 5 groups based on the place of their FPA (home, school/office, driving a car, in a public transportation vehicle, outside of home), The clinical features of these patients were investigated. Additionally, for panic disorder patients with agoraphobia at their initial clinic visit, the clinical features of patients who experienced their FPA at home were compared to those who experienced their attack elsewhere. Results In comparison of the FPAs of the 5 groups, significant differences were seen among the 7 descriptors (sex ratio, drinking status, smoking status, severity of the panic attack, depression score, ratio of agoraphobia, and degree of avoidance behavior) and 4 symptoms (sweating, chest pain, feeling dizzy, and fear of dying). The driving and public transportation group patients showed a higher incidence of co-morbid agoraphobia than did the other groups. Additionally, for panic disorder patients with co-morbid agoraphobia, the at-home group had a higher frequency of fear of dying compared to the patients in the outside-of-home group and felt more severe distress elicited by their FPA. Conclusion The results of this study suggest that the clinical features of panic disorder patients vary according to the place of their FPA. The at-home group patients experienced "fear of dying" more frequently and felt more distress during their FPA than did the subjects in the other groups. These results indicate that patients experiencing their FPA at home should be treated with a focus on the fear and distress elicited by the attack. PMID:22494552

Medical Paraclinical Standards, Political Economy of Clinic, and Patients’ Clinical Dependency; A Critical Conversation Analysis of Clinical Counseling in South of Iran

PubMed Central

Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

2014-01-01

Background: Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. Methods: The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. Results: Results show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Conclusion: Although we can’t condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can’t reduce it to instrumental and linear methods of body treatment. PMID:25349858

Assessing quality of life in a clinical study on heart rehabilitation patients: how well do value sets based on given or experienced health states reflect patients' valuations?

PubMed

Leidl, Reiner; Schweikert, Bernd; Hahmann, Harry; Steinacker, Juergen M; Reitmeir, Peter

2016-03-22

Quality of life as an endpoint in a clinical study may be sensitive to the value set used to derive a single score. Focusing on patients' actual valuations in a clinical study, we compare different value sets for the EQ-5D-3L and assess how well they reproduce patients' reported results. A clinical study comparing inpatient (n = 98) and outpatient (n = 47) rehabilitation of patients after an acute coronary event is re-analyzed. Value sets include: 1. Given health states and time-trade-off valuation (GHS-TTO) rendering economic utilities; 2. Experienced health states and valuation by visual analog scale (EHS-VAS). Valuations are compared with patient-reported VAS rating. Accuracy is assessed by mean absolute error (MAE) and by Pearson's correlation ρ. External validity is tested by correlation with established MacNew global scores. Drivers of differences between value sets and VAS are analyzed using repeated measures regression. EHS-VAS had smaller MAEs and higher ρ in all patients and in the inpatient group, and correlated best with MacNew global score. Quality-adjusted survival was more accurately reflected by EHS-VAS. Younger, better educated patients reported lower VAS at admission than the EHS-based value set. EHS-based estimates were mostly able to reproduce patient-reported valuation. Economic utility measurement is conceptually different, produced results less strongly related to patients' reports, and resulted in about 20 % longer quality-adjusted survival. Decision makers should take into account the impact of choosing value sets on effectiveness results. For transferring the results of heart rehabilitation patients from another country or from another valuation method, the EHS-based value set offers a promising estimation option for those decision makers who prioritize patient-reported valuation. Yet, EHS-based estimates may not fully reflect patient-reported VAS in all situations.

Presentation of laboratory test results in patient portals: influence of interface design on risk interpretation and visual search behaviour.

PubMed

Fraccaro, Paolo; Vigo, Markel; Balatsoukas, Panagiotis; van der Veer, Sabine N; Hassan, Lamiece; Williams, Richard; Wood, Grahame; Sinha, Smeeta; Buchan, Iain; Peek, Niels

2018-02-12

Patient portals are considered valuable instruments for self-management of long term conditions, however, there are concerns over how patients might interpret and act on the clinical information they access. We hypothesized that visual cues improve patients' abilities to correctly interpret laboratory test results presented through patient portals. We also assessed, by applying eye-tracking methods, the relationship between risk interpretation and visual search behaviour. We conducted a controlled study with 20 kidney transplant patients. Participants viewed three different graphical presentations in each of low, medium, and high risk clinical scenarios composed of results for 28 laboratory tests. After viewing each clinical scenario, patients were asked how they would have acted in real life if the results were their own, as a proxy of their risk interpretation. They could choose between: 1) Calling their doctor immediately (high interpreted risk); 2) Trying to arrange an appointment within the next 4 weeks (medium interpreted risk); 3) Waiting for the next appointment in 3 months (low interpreted risk). For each presentation, we assessed accuracy of patients' risk interpretation, and employed eye tracking to assess and compare visual search behaviour. Misinterpretation of risk was common, with 65% of participants underestimating the need for action across all presentations at least once. Participants found it particularly difficult to interpret medium risk clinical scenarios. Participants who consistently understood when action was needed showed a higher visual search efficiency, suggesting a better strategy to cope with information overload that helped them to focus on the laboratory tests most relevant to their condition. This study confirms patients' difficulties in interpreting laboratories test results, with many patients underestimating the need for action, even when abnormal values were highlighted or grouped together. Our findings raise patient safety concerns and may limit the potential of patient portals to actively involve patients in their own healthcare.

Classification of non-demented patients attending a memory clinic using the new diagnostic criteria for Alzheimer's disease with disease-related biomarkers.

PubMed

Ivanoiu, Adrian; Dricot, Laurence; Gilis, Nathalie; Grandin, Cécile; Lhommel, Renaud; Quenon, Lisa; Hanseeuw, Bernard

2015-01-01

New diagnostic criteria for predemential Alzheimer's disease (AD) advocate the use of biomarkers. However, the benefit of using biomarkers has not been clearly demonstrated in clinical practice. To investigate whether a combination of biomarkers may be helpful in classifying a population of non-demented patients attending a Memory Clinic. Sixty non-demented patients were compared with 31 healthy elderly subjects. All subjects underwent a neuropsychological examination, brain 3T magnetic resonance imaging, [F18]-fluorodeoxyglucose and [F18]-flutemetamol positron emission tomography. According to their performance on memory, language, executive, and visuo-spatial domains, the patients were classified as mild cognitive impairment (amnestic, non-amnestic, single, or multiple domain) or subjective cognitive impairment. Patients were then classified according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria, using the normalized mean hippocampal volume (Freesurfer), [F18]-FDG PALZAD, and [F18]-flutemetamol standard uptake value ratio (SUVr) (cut-off at the 10th percentile of controls). The standard of truth was the clinical status at study entry (patient versus control). The sensitivity/specificity of the clinical classification was 65/84%. The NIA-AA criteria were applicable in 85% of patients and 87% of controls. For biomarkers the best sensitivity (72%) at a fixed specificity of 84% was achieved by a combination of the three biomarkers. The clinical diagnosis was reconsidered in more than one third of the patients (42%) as a result of including the biomarker results. Application of the new NIA-AA AD diagnostic criteria based on biomarkers in an unselected sample of non-demented patients attending a Memory Clinic was useful in allowing for a better classification of the subjects.

Axillary Ultrasound Accurately Excludes Clinically Significant Lymph Node Disease in Patients with Early Stage Breast Cancer

PubMed Central

Tucker, Natalia S.; Cyr, Amy E.; Ademuyiwa, Foluso O.; Tabchy, Adel; George, Krystl; Sharma, Piyush; Jin, Linda X.; Sanati, Souzan; Aft, Rebecca; Gao, Feng; Margenthaler, Julie A.; Gillanders, William E.

2016-01-01

Objective Assess the performance characteristics of axillary ultrasound (AUS) for accurate exclusion of clinically significant axillary lymph node (ALN) disease. Background Sentinel lymph node biopsy (SLNB) is currently the standard of care for staging the axilla in patients with clinical T1–T2, N0 breast cancer. AUS is a noninvasive alternative to SLNB for staging the axilla. Methods Patients were identified using a prospectively maintained database. Sensitivity, specificity, and negative predictive value (NPV) were calculated by comparing AUS findings to pathology results. Multivariate analyses were performed to identify patient and/or tumor characteristics associated with false negative (FN) AUS. A blinded review of FN and matched true negative cases was performed by two independent medical oncologists to compare treatment recommendations and actual treatment received. Recurrence-free survival was described using Kaplan-Meier product limit methods. Results 647 patients with clinical T1–T2, N0 breast cancer underwent AUS between January, 2008 and March, 2013. AUS had a sensitivity of 70%, NPV of 84% and PPV of 56% for the detection of ALN disease. For detection of clinically significant disease (> 2.0 mm), AUS had a sensitivity of 76% and NPV of 89%. FN AUS did not significantly impact adjuvant medical decision making. Patients with FN AUS had recurrence-free survival equivalent to patients with pathologic N0 disease. Conclusions AUS accurately excludes clinically significant ALN disease in patients with clinical T1–T2, N0 breast cancer. AUS may be an alternative to SLNB in these patients where axillary surgery is no longer considered therapeutic, and predictors of tumor biology are increasingly used to make adjuvant therapy decisions. PMID:26779976

SU-F-J-116: Clinical Experience-Based Verification and Improvement of a 4DCT Program

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

Fogg, P; West, M; Aland, T

2016-06-15

Purpose: To demonstrate the role of continuous improvement fulfilled by the Medical Physicist in clinical 4DCT and CBCT scanning. Methods: Lung (SABR and Standard) patients’ 4D respiratory motion and image data were reviewed over a 3, 6 and 12 month period following commissioning testing. By identifying trends of clinically relevant parameters and respiratory motions, variables were tested with a programmable motion phantom and assessed. Patient traces were imported to a motion phantom and 4DCT and CBCT imaging were performed. Cos6 surrogate and sup-inf motion was also programmed into the phantom to simulate the long exhale of patients for image contrastmore » tests. Results: Patient surrogate motion amplitudes were 9.9+5.2mm (3–35) at 18+6bpm (6–30). Expiration/Inspiration time ratios of 1.4+0.5second (0.6–2.9) showed image contrast effects evident in the AveCT and 3DCBCT images. Small differences were found for patients with multiple 4DCT data sets. Patient motion assessments were simulated and verified with the phantom within 2mm. Initial image reviews to check for reconstructed artefacts and data loss identified a small number of patients with irregularities in the automatic placement of inspiration and expiration points. Conclusion: The Physicist’s involvement in the continuous improvements of a clinically commissioned technique, processes and workflows continues beyond the commissioning stage of a project. Our experience with our clinical 4DCT program shows that Physics presence is required at the clinical 4DCT scan to assist with technical aspects of the scan and also for clinical image quality assessment prior to voluming. The results of this work enabled the sharing of information from the Medical Physics group with the Radiation Oncologists and Radiation Therapists. This results in an improved awareness of clinical patient respiration variables and how they may affect 4D simulation images and also may also affect the treatment verification images.« less

Patients' approaches to students' learning at a clinical education ward--an ethnographic study.

PubMed

Manninen, Katri; Henriksson, Elisabet Welin; Scheja, Max; Silén, Charlotte

2014-07-02

It is well known that patients' involvement in health care students' learning is essential and gives students opportunities to experience clinical reasoning and practice clinical skills when interacting with patients. Students encounter patients in different contexts throughout their education. However, looking across the research providing evidence about learning related to patient-student encounters reveals a lack of knowledge about the actual learning process that occurs in encounters between patients and students. The aim of this study was to explore patient-student encounters in relation to students' learning in a patient-centered health-care setting. An ethnographic approach was used to study the encounters between patients and students. The setting was a clinical education ward for nursing students at a university hospital with eight beds. The study included 10 observations with 11 students and 10 patients. The observer followed one or two students taking care of one patient. During the fieldwork observational and reflective notes were taken. After each observation follow-up interviews were conducted with each patient and student separately. Data were analyzed using an ethnographic approach. The most striking results showed that patients took different approaches in the encounters with students. When the students managed to create a good atmosphere and a mutual relationship, the patients were active participants in the students' learning. If the students did not manage to create a good atmosphere, the relationship became one-way and the patients were passive participants, letting the students practice on their bodies but without engaging in a dialogue with the students. Patient-student encounters, at a clinical education ward with a patient-centred pedagogical framework, can develop into either a learning relationship or an attending relationship. A learning relationship is based on a mutual relationship between patients and students resulting in patients actively participating in students' learning and they both experience it as a joint action. An attending relationship is based on a one-way relationship between patients and students resulting in patients passively participating by letting students to practice on their bodies but without engaging in a learning dialogue with the students.

A computerized resolution of scheduling conflicts.

PubMed

Bolinger, R E; McFarlane, M J

1989-01-01

Residency training programs in Internal Medicine require resident attendance in a continuity clinic. This inevitably engenders conflicts between scheduling in the ambulatory clinic and the required teaching activities of the in-patient services. Some of the conflicts can be resolved by allowing the in-patient service directors to indicate preferred plans for their residents to attend in the continuity clinic. With this plan, scheduling becomes quite complicated. A computer program is presented with coordinates these service requests with ambulatory clinic scheduling. As a result, a given resident may have his/her clinic day changed on different rotations. The program automatically arbitrates conflicts and publishes the attendance dates for the entire academic year. This information is supplied to the appointment desk so that patients can be scheduled accordingly. This system has resulted in a 74% continuity rate and improved satisfaction by both residents and staff.

Capsule endoscopy: impact on clinical decision making in patients with suspected small bowel bleeding.

PubMed

Gubler, C; Fox, M; Hengstler, P; Abraham, D; Eigenmann, F; Bauerfeind, P

2007-12-01

Capsule endoscopy is widely used for diagnosis of small-bowel disease; however, the impact of capsule endoscopy on clinical management remains uncertain. We conducted a prospective study of the impact capsule endoscopy on clinical management decisions in 128 patients with suspected small-bowel pathology. Prior to performing each procedure the gastroenterologist predicted the findings of capsule endoscopy and further management based on the clinical history and previous investigations. This prediction was compared with the actual results of capsule endoscopy and the following investigative and therapeutic management. The actual findings of capsule endoscopy and the further management were consistent with clinical prediction in 93/128 patients (73 %) and, irrespective of capsule endoscopy findings, no further procedures were required in 80 % of these patients. In 13 patients (10 %), gastric or colonic pathology was discovered that had not been detected on prior gastroscopy or colonoscopy. Thus, capsule endoscopy findings in the small bowel changed clinical management in 22 patients (17 %). In 4 patients, positive findings on capsule endoscopy that had not been predicted by the examiner prompted referral for abdominal surgery. Conversely, planned surgery was canceled in four other patients. In this series of patients referred for capsule endoscopy, small-bowel findings and appropriate clinical management were predicted on clinical grounds alone in approximately three-quarters of patients. Repetition of standard upper and lower endoscopy may be useful in many patients prior to small-bowel imaging. Referral for capsule endoscopy should take into account whether the findings will impact on clinical management; however, capsule endoscopy is mandatory in patients in whom surgery for small-bowel bleeding is intended.

Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study

PubMed Central

Imperiali, Gianni; Terpin, Maria Maddalena; Beverina, Ivo; Bortoli, Aurora; Devani, Massimo; Viganò, Chiara

2017-01-01

Background Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although it is limited by costs and variability of results. Aim To assess effectiveness of granulocyte-monocyte apheresis in patients with steroid-dependent, azathioprine-intolerant/resistant moderate ulcerative colitis. Methods Consecutive patients fulfilling inclusion criteria were prospectively enrolled, treated by apheresis, and followed up for 12 months. The primary end point of the study was steroid-free clinical remission at 12 months, with no need for biologic therapy or surgery. Results From January to December 2013, 33 patients were enrolled. After one year of follow-up, 12 (36%) patients had clinical remission, were steroid-free, and had no need for biological therapy or surgery; 3 (9%) cases showed a clinical response (but not clinical remission). Moreover, 12 (36%) patients required biologic therapy, 4 (12%) underwent colectomy, and in the other 2 (6%) a reduction, but not withdrawal, of steroid dose was achieved. Conclusions Our study shows that a standard course of granulocyte-monocyte apheresis is associated with a 36% steroid-free clinical remission in patients with steroid-dependent, azathioprine-intolerant or resistant moderate ulcerative colitis. Apheresis might represent an alternative to biologic therapy or surgery in this specific subgroup of patients. This trial is registered with Clinicaltrial.gov NCT03189888. PMID:29403531

Triage for coronary artery bypass graft surgery in Canada: Do patients agree on who should come first?

PubMed Central

Shufelt, Katy; Chong, Alice; Alter, David A

2007-01-01

Background The extent to which clinical and non-clinical factors impact on the waiting-list prioritization preferences of patients in the queue is unknown. Using a series of hypothetical scenarios, the objective of this study was to examine the extent to which clinical and non-clinical factors impacted on how patients would prioritize others relative to themselves in the coronary artery bypass surgical queue. Methods Ninety-one consecutive eligible patients awaiting coronary artery bypass grafting surgery at Sunnybrook Health Sciences Centre (median waiting-time duration prior to survey of 8 weeks) were given a self-administered survey consisting of nine scenarios in which clinical and non-clinical characteristic profiles of hypothetical patients (also awaiting coronary artery bypass surgery) were varied. For each scenario, patients were asked where in the queue such hypothetical patients should be placed relative to themselves. Results The eligible response rate was 65% (59/91). Most respondents put themselves marginally ahead of a hypothetical patient with identical clinical and non-clinical characteristics as themselves. There was a strong tendency for respondents to place patients of higher clinical acuity ahead of themselves in the queue (P < 0.0001). Social independence among young individuals was a positively valued attribute (P < 0.0001), but neither age per se nor financial status, directly impacted on patients waiting-list priority preferences. Conclusion While patient perceptions generally reaffirmed a bypass surgical triage process based on principals of equity and clinical acuity, the valuation of social independence may justify further debate with regard to the inclusion of non-clinical factors in waiting-list prioritization management systems in Canada, as elsewhere. PMID:17651503

[Clinical and empirical findings with the OPD-CA].

PubMed

Winter, Sibylle; Jelen, Anna; Pressel, Christine; Lenz, Klaus; Lehmkuhl, Ulrike

2011-01-01

60 clinical patients (5-17 years) were diagnosed with an interview-manual of OPD-CA (Winter, 2004). For clinical validity a comparison of patients with internal (N=17) and external disorders (N=19) was shown. References for clinical validity resulted from the comparison of the groups, especially for the axes "conflict" and "prerequisites for treatment". Patients with internal disorders showed the conflict desire for care versus autarchy significantly more often than patients with external disorders. On the other hand patients with external disorders displayed the conflict submission versus control significantly more often. Significant differences were also found for the axis "prerequisites for treatment". Patients with internal disorders had better "prerequisites for treatment" in the domains experience of illness and the prerequisites for therapy. For the axes "interpersonal relation", "structure" and "prerequisites for treatment" satisfactory data for validity and reliability were found. The clinical validity points to the usefulness of OPD-CA-manual for psychodynamic diagnostics in childhood and adolescence.

Analysis of Search on Clinical Narrative within the EHR

ERIC Educational Resources Information Center

Natarajan, Karthik

2012-01-01

Electronic Health Records (EHRs) are used increasingly in the hospital and outpatient settings, and patients are amassing digitized clinical information. On one hand, aggregating all the patient's clinical information can greatly assist health care workers in making sound decisions. On the other hand, it can result in information overload,…

A Mixed-Methods Study of Patient-Provider E-mail Content in a Safety-Net Setting

PubMed Central

Mirsky, Jacob B.; Tieu, Lina; Lyles, Courtney; Sarkar, Urmimala

2016-01-01

Objective To explore the content of patient-provider e-mails in a safety-net primary care clinic. Methods We conducted a content analysis using inductive and deductive coding of e-mail exchanges (n=31) collected from January through November of 2013. Participants were English-speaking adult patients with a chronic condition (or their caregivers) cared for at a single publicly-funded general internal medicine clinic and their primary care providers (attending general internist physicians, clinical fellows, internal medicine residents, and nurse practitioners). Results All e-mails were non-urgent. Patients included a medical update in 19% of all e-mails. Patients requested action in 77% of e-mails, and the most common requests overall were for action regarding medications or treatment (29%). Requests for information were less common (45% of e-mails). Patient requests (n=56) were resolved in 84% of e-mail exchanges, resulting in 63 actions. Conclusion Patients in safety-net clinics are capable of safely and effectively using electronic messaging for between-visit communication with providers. Practical Implications Safety-net systems should implement electronic communications tools as soon as possible to increase healthcare access and enhance patient involvement in their care. PMID:26332306

Communication differences when patients and caregivers are seen separately or together.

PubMed

Swetenham, Kate; Tieman, Jennifer; Butow, Phyllis; Currow, David

2015-11-01

Southern Adelaide Palliative Care Services introduced a nurse-led early introduction to a palliative care clinic in 2011. The clinic offers a thorough psychosocial assessment and the provision of information and an introduction to future care planning. The patients and their caregivers are seen together by the nurse practitioner initially for a physical assessment. They are then seen by a social worker to focus on advanced care planning and assessment of social and emotional factors. After the social work visit, the patient and caregiver are separated, and the patient sees the psychosocial nurse for coping and adjustment to illness and the carer sees the caregiver network facilitator to assess their informal supports to assist in the role of community-based caregiving. The pilot study looks at the nature of communication in the clinic where patient and carer are together and compares that to when they are separated. A total of 33 patients and their caregivers agreed for their coversations to be tape recorded between May and November of 2013. All tape recordings were transcribed verbatim. Ten patient transcripts (n=40) have been coded for quantitative analysis. The codes identify content and function of speech, cues for information and emotion and whether they are responded to by clinicians. Pilot results reveal that caregivers contribute little in the combined clinics and dominate the conversation in the private clinic. Patients, when seen alone, predominantly express emotion related cues, opposed to cues for information. The clinicians focus on their area of specialty, which results in little duplication in this clinic setting. An earlier evaluation of this clinic found that patients and their caregivers appreciate being separated in the clinic setting to have time and privacy to reveal fears and feelings related to end-of-life care. This current study quantifies the patient and caregiver experience and confirms those earlier findings.

"This clinic is number one": a qualitative study of factors that contribute toward "successful" care at a South African Pediatric HIV/AIDS clinic.

PubMed

Watermeyer, Jennifer

2012-09-01

HIV/AIDS has significantly affected health care practices. The need for high adherence and regular clinic visits places pressure on health care providers and patients. Poor quality of care has been described in many contexts, but some clinics have achieved excellent treatment results. Using a success case approach, this study aimed to understand factors which contribute to successful care at a South African pediatric HIV/AIDS clinic with documented high patient adherence and follow-up rates. Data included over 50 hours of ethnographic observations and interviews with a total of 35 clinic staff and caregivers. Thematic analysis highlighted strong congruence between caregiver and staff perceptions. Factors which seemed to contribute to successful care included organizational routines, staff-patient relationships, communication, teamwork, leadership, job commitment, caregivers' negative experiences at other clinics, and faith in the "life-saving" care at this clinic. Results suggest the need for all factors to be present in order to promote quality of care. Recommendations for other clinic settings are discussed.

A survey of North Carolina safety-net dental clinics' methods for communicating with patients of limited english proficiency (LEP).

PubMed

Hammersmith, Kimberly J; Lee, Jessica Y

2009-01-01

Dental providers are increasingly challenged in communicating with patients with limited English proficiency (LEP). Accordingly, the purpose of the study was to examine methods of communicating with patients with LEP in North Carolina (NC) safety-net dental clinics as perceived by dental staff. An anonymous, 36-item, cross-sectional survey was distributed to representatives of 68 NC safety-net dental clinics. Question domains included: a) a perceived need for language services; b) methods of language services provided; c) perceptions of dental staff about dental care experiences for patients with LEP; and d) perceived legal and financial roles in providing language services. Of the 68 clinics, 55 responded (81 percent). All clinics reported treating patients with LEP, and 93 percent of clinics reported a need for providing language services. Many clinics used multiple methods to provide language services. Some clinics reported differences in treatment recommendations (13 percent), treatment provided (19 percent), and visit length (61 percent) for patients with LEP. All responded that additional costs are incurred to treat patients with LEP, and only 69 percent of responding clinics recognized legal obligations of treating patients with LEP. There is a reported need for language services in NC safety-net dental clinics. These services often resulted in additional costs to the dental clinic. To maintain the quality of care and to comply with legal requirements related to dental patients with LEP, additional funding sources might be required to recruit multilingual staff, support language services in dental clinics, and provide language skills training for practicing dentists. Additionally, studies are suggested to measure the perception of the effectiveness of communication methods of patients with LEP.

Implementation of a pharmacist-driven immunization program designed to improve overall vaccination rates in indigent and uninsured patients.

PubMed

Stilwell, Allison M; Pavero, Chris; Buxton, Jennifer; Herrington, Glenn

To demonstrate the results of a pharmacist-driven immunization program designed to increase overall vaccination rates among the low-income, uninsured patients in a free clinic. Cape Fear Clinic, a free clinic located in Wilmington, North Carolina. Cape Fear Clinic provides medical, pharmacy, mental health, and dental services to adults in 4 eastern North Carolina counties who are uninsured and have incomes of no more than 200% of Federal Poverty Guidelines. A pharmacist-driven immunization program consisting of a comprehensive chart review of every active clinic patient in order to improve the vaccination status of the clinic's patients at no cost to the patient. Student pharmacists completed a comprehensive chart review of every active clinic patient to identify patients eligible for immunizations according to the Advisory Committee on Immunization Practices guidelines. More than 500 patients eligible for immunizations were notified of their immunization status and educated about indicated vaccinations. Patients willing to receive indicated vaccinations would present to the pharmacy and a pharmacist or student pharmacist administered the necessary doses. The vaccine initiative was introduced January 1, 2015 and has since delivered 1878 doses of vaccines as of June 30, 2016. The immunization program implemented by pharmacists and student pharmacists at Cape Fear Clinic has been successful in increasing awareness of vaccine preventable diseases as well as increasing rates of vaccination among eligible clinic patients. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Correlation of abdominopelvic computed tomography with clinical manifestations in methamphetamine body stuffers.

PubMed

Bahrami-Motlagh, Hooman; Hassanian-Moghaddam, Hossein; Zamini, Hedieh; Zamani, Nasim; Gachkar, Latif

2018-02-01

Little is known about methamphetamine body stuffers and correlation of clinical manifestations with imaging studies. Current study was done to determine abdominopelvic computed tomography findings and clinical manifestations in methamphetamine body stuffers. In an IRB-approved routine data base study, demographic characteristics, clinical findings, and CT results of 70 methamphetamine body stuffers were retrieved. According to the clinical manifestations, the patients were categorized into either benign- or severe-outcome group. Also, they were determined to have positive or negative CT results. In the group with positive results, number and place of the baggies were determined, as well. Results of the CT were compared between the two groups. Almost 43% of the patients had positive abdominopelvic CT results. Mean density of the packs was 176.2 ± 152.7 Hounsfield unit. Based on the clinical grounds, 57% of the patients were in the benign- and 33% were in the severe-outcome group. In the benign group, 45% of the patients had positive CTs while in the severe-risk group, this was 40% (p > 0.05). Except variables defined as severe outcome (seizure, intubation, creatinine level, aspartate aminotransferase level, creatine phosphokinase and troponin level), agitation, on-arrival pulse rate, lactate dehydrogenase, bicarbonate, base excess, loss of consciousness and hospitalization period were correlating factors. But in regression analysis, we could not find a significant variable that prognosticate severe outcome. It seems that there is no relationship between the CT findings and clinical manifestations of the methamphetamine body stuffers. Severe outcomes may be observed even in the face of negative CTs.

Clinical features of atopic keratoconjunctivitis.

PubMed

Tuft, S J; Kemeny, D M; Dart, J K; Buckley, R J

1991-02-01

The clinical spectrum of ocular disease in 37 patients with atopic keratoconjunctivitis (AKC) is described. Patients typically had a severe blepharoconjunctivitis. Associated corneal scarring, suppurative keratitis, or keratoconus were the major causes of visual loss. Serum and tear samples from these patients were analyzed to quantify total and specific IgE antibodies. The results were compared as a case control study with results from samples from 55 patients with other forms of atopic disease and 16 nonatopic volunteers. Although the mean values for total and specific IgEs in the serum of patients with atopic disease were markedly higher than the values from nonatopic controls (P less than 0.00002), a difference between the disease groups could not be demonstrated (P greater than 0.05). There were also differences between both the total IgE (P = 0.0002) and pollen-specific IgE (P = 0.015) in tears from patients with atopic disease and nonatopic controls, but not for house dust mite or cat dander-specific IgEs. These results suggest that clinical differences between groups of patients with chronic allergic external eye disease are not associated with specific patterns of IgE production.

Subtotal resection of vestibular schwannoma: Evaluation with Ki-67 measurement, magnetic resonance imaging, and long-term observation

PubMed Central

Iannella, Giannicola; de Vincentiis, Marco; Di Gioia, Cira; Carletti, Raffaella; Pasquariello, Benedetta; Manno, Alessandra; Angeletti, Diletta; Savastano, Ersilia; Magliulo, Giuseppe

2017-01-01

Purpose The aim of this study was to compare the postoperative clinical and radiological data of patients with vestibular schwannomas who were initially managed by near total resection (NTR) or subtotal resection (STR). The Ki-67 analysis results were compared with tumor regrowth to determine the presence of a correlation between this proliferative index and postoperative tumor regrowth. Study Design Seventeen adult patients (7 male, 10 female) were retrospectively reviewed. Nine (52.9%) and eight (47.1%) patients underwent NTR and STR, respectively. Postoperative clinical and radiological data associated with vestibular schwannoma growth were compared with the Ki-67 immunohistochemical analysis results. Results Evidence of clinically significant regrowth was observed in four (23.5%) patients. Patients who underwent NTR had a lower rate/incidence of tumor regrowth than did patients who underwent STR. Patients with a higher Ki-67 index had the highest tumor regrowth rates. Conclusions Our study indicates that assessment of the Ki-67 index may be useful for determining the probability of regrowth of vestibular schwannomas when only partial removal is accomplished. PMID:28447494

The pathophysiology of chronic noncommunicating hydrocephalus: lessons from continuous intracranial pressure monitoring and ventricular infusion testing.

PubMed

Eide, Per Kristian

2017-08-11

OBJECTIVE The pathophysiology of chronic noncommunicating hydrocephalus (ncHC) is poorly understood. This present study explored whether lessons about the pathophysiology of this clinical entity might be retrieved from results of overnight monitoring of pulsatile and static intracranial pressure (ICP) and ventricular infusion testing. METHODS The study cohort included adult patients (> 20 years of age) with chronic ncHC due to aqueductal stenosis in whom symptoms had lasted a minimum of 6 months. A reference cohort consisted of age- and sex-matched patients managed for communicating HC (cHC). Information about symptoms and clinical improvement following surgery was retrieved from a quality register, and results of overnight ICP recordings and ventricular infusion testing were retrieved from the hospital ICP database. RESULTS The cohort with ncHC consisted of 61 patients of whom 6 (10%) were managed conservatively, 34 (56%) by endoscopic third ventriculostomy (ETV), and 21 (34%) using ETV and subsequent shunt surgery. In patients responding to surgery, pulsatile ICP (mean ICP wave amplitude) was significantly increased to a similar magnitude in patients with ncHC and the reference cohort (cHC). Furthermore, intracranial compliance (ICC) was reduced in clinical responders. The results of ventricular infusion testing provided evidence that patients responding to ETV have impaired ventricular CSF absorption, while those requiring shunt placement after ETV present with impaired CSF absorption both in the intraventricular and extraventricular compartments. CONCLUSIONS The study may provide some lessons about the pathophysiology of chronic ncHC. First, increased pulsatile ICP and impaired ICC characterize patients with chronic ncHC who respond clinically to CSF diversion surgery, even though static ICP is not increased. Second, in patients responding clinically to ETV, impaired ventricular CSF absorption may be a key factor. Patients requiring shunt placement for clinical response appear to have both intraventricular and extraventricular CSF absorption failure. A subgroup of patients with ncHC due to aqueductal stenosis has normal ventricular CSF absorption and normal ICC and may not be in need of surgical CSF diversion.

MRI predictors of clinical success in MR-guided focused ultrasound (MRgFUS) treatments of uterine fibroids: results from a single centre.

PubMed

Mindjuk, Irene; Trumm, Christoph G; Herzog, Peter; Stahl, Robert; Matzko, Matthias

2015-05-01

To assess the technical and clinical results of MRgFUS treatment and factors affecting clinical treatment success. A total of 252 women (mean age, 42.1 ± 6.9 years) with uterine fibroids underwent MRgFUS. All patients underwent MRI before treatment. Results were evaluated with respect to post-treatment nonperfused volume (NPV), symptom severity score (SSS), reintervention rate, pregnancy and safety data. NPV ratio was significantly higher in fibroids characterized by low signal intensity in contrast-enhanced T1-weighted fat saturated MR images and in fibroids distant from the spine (>3 cm). NPV ratio was lower in fibroids with septations, with subserosal component and in skin-distant fibroids (p < 0.001). NPV ratio was highly correlated with clinical success: NPV of more than 80 % resulted in clinical success in more than 80 % of patients. Reintervention rate was 12.7 % (mean follow-up time, 19.4 ± 8 months; range, 3-38). Expulsion of fibroids (21 %) was significantly correlated with a high clinical success rate. No severe adverse events were reported. Adequate patient selection and correct treatment techniques, based on the learning curve of this technology, combined with technical advances of the system, lead to higher clinical success rates with low complications rate, comparable to other uterine-sparing treatment options. • MRgFUS appears to be a valid alternative to other uterus-preserving therapies • Patient selection is a significant factor in achieving high NPV ratios • MRI screening parameters correlate with the amount of fibroid ablation in MRgFUS • NPV results of more than 80 % correlate with higher clinical success rates.

Impact of scribes on patient interaction, productivity, and revenue in a cardiology clinic: a prospective study

PubMed Central

Bank, Alan J; Obetz, Christopher; Konrardy, Ann; Khan, Akbar; Pillai, Kamalesh M; McKinley, Benjamin J; Gage, Ryan M; Turnbull, Mark A; Kenney, William O

2013-01-01

Objective Scribes have been used in the emergency department to improve physician productivity and patient interaction. There are no controlled, prospective studies of scribe use in the clinic setting. Methods A prospective controlled study compared standard visits (20 minute follow-up and 40 minute new patient) to a scribe system (15 minute follow-up and 30 minute new patient) in a cardiology clinic. Physician productivity, patient satisfaction, physician–patient interaction, and revenue were measured. Results Four physicians saw 129 patients using standard care and 210 patients with scribes during 65 clinic hours each. Patients seen per hour increased (P < 0.001) from 2.2 ± 0.3 to 3.5 ± 0.4 (59% increase) and work relative value units (wRVU) per hour increased (P < 0.001) from 3.5 ± 1.3 to 5.5 ± 1.3 (57% increase). Patient satisfaction was high at baseline and unchanged with scribes. In a substudy, direct patient contact time was lower (9.1 ± 2.0 versus 12.9 ± 3.4 minutes; P < 0.01) for scribe visits, but time of patient interaction (without computer) was greater (6.7 ± 2.1 versus 1.5 ± 1.9 minutes; P < 0.01). Subjective assessment of physician–patient interaction (1–10) was higher (P < 0.01) on scribe visits (9.1 ± 0.9 versus 7.9 ± 1.1). Direct and indirect (downstream) revenue per patient seen was $142 and $2,398, with $205,740 additional revenue generated from the 81 additional patients seen with scribes. Conclusion Using scribes in a cardiology clinic is feasible, produces improvements in physician–patient interaction, and results in large increases in physician productivity and system cardiovascular revenue. PMID:23966799

Patients' Perceptions of Dehumanization of Patients in Dental School Settings: Implications for Clinic Management and Curriculum Planning.

PubMed

Raja, Sheela; Shah, Raveena; Hamad, Judy; Van Kanegan, Mona; Kupershmidt, Alexandra; Kruthoff, Mariela

2015-10-01

Although the importance of empathy, rapport, and anxiety/pain awareness in dentist-patient relations has been well documented, these factors continue to be an issue with patients in many dental school clinics. The aim of this study was to develop an in-depth understanding of how patients at an urban, university-affiliated medical center and its dental school's clinic experienced oral health care and to generate ideas for improving the dental school's clinical curriculum and management of the clinic. Although patient satisfaction surveys are common, in-depth patient narratives are an underutilized resource for improving dental education. In-depth qualitative interviews were conducted with 20 uninsured or underinsured dental patients at these sites, and the results were analyzed using content analysis. Major phenomena that participants discussed were the importance of empathy and good rapport with their oral health providers and provider awareness of dental pain and anxiety. Many patients also discussed feeling dehumanized during dental visits. Based on their positive and negative experiences, the participants made suggestions for how oral health professionals can successfully engage patients in treatment.

Clinical characteristics of patients with gender identity disorder at a Japanese gender identity disorder clinic.

PubMed

Okabe, Nobuyuki; Sato, Toshiki; Matsumoto, Yosuke; Ido, Yumiko; Terada, Seishi; Kuroda, Shigetoshi

2008-01-15

The aim of this study was to examine the clinical characteristics of patients with gender identity disorder (GID) at a GID clinic in Japan. A total of 603 consecutive patients were evaluated at the GID clinic using clinical information and results of physical and neurological examinations. Using DSM-IV criteria, 579 patients (96.0%) were diagnosed with GID. Four patients were excluded for transvestic fetishism, eight for homosexuality, five for schizophrenia, three for personality disorders, and four for other psychiatric disorders. Among the GID patients, 349 (60.3%) were the female-to-male (FTM) type, and 230 (39.7%) were the male-to-female (MTF) type. Almost all FTM-type GID patients started to feel discomfort with their sex before puberty and were sexually attracted to females. The proportion of FTM patients who had experienced marriage as a female was very low, and very few had children. Therefore, FTM-type GID patients seem to be highly homogeneous. On the other hand, various patterns of age at onset and sexual attraction existed among MTF patients. Among the MTF-type GID patients, 28.3% had married as males and 18.7% had sired children. Thus, MTF-type GID patients seem to be more heterogeneous.

Updated cost-effectiveness analysis of supplemental glutamine for parenteral nutrition of intensive-care patients

PubMed Central

Pradelli, L; Povero, M; Muscaritoli, M; Eandi, M

2015-01-01

Background/Objectives: Intravenous (i.v.) glutamine supplementation of parenteral nutrition (PN) can improve clinical outcomes, reduce mortality and infection rates and shorten the length of hospital and/or intensive care unit (ICU) stays compared with standard PN. This study is a pharmacoeconomic analysis to determine whether i.v. glutamine supplementation of PN remains both a highly favourable and cost-effective option for Italian ICU patients. Subjects/Methods: A previously published discrete event simulation model was updated by incorporating the most up-to-date and clinically relevant efficacy data (a clinically realistic subgroup analysis from a published meta-analysis), recent cost data from the Italian health-care system and the latest epidemiology data from a large Italian ICU database (covering 230 Italian ICUs and more than 77 000 patients). Sensitivity analyses were performed to test the robustness of the results. Results: Parenteral glutamine supplementation can significantly improve ICU efficiency in Italy, as the additional cost of supplemented treatment is more than completely offset by cost savings in hospital care. Supplementation was more cost-effective (cost-effectiveness ratio (CER)=€35 165 per patient discharged alive) than standard, non-supplemented PN (CER=€40 156 per patient discharged alive), and it resulted in mean cost savings of €4991 per patient discharged alive or €1047 per patient admitted to the hospital. Sensitivity analyses confirmed the robustness of these results. Conclusions: Alanyl-glutamine supplementation of PN is a clinically and economically attractive strategy for ICU patients in Italy and may be applicable to selected ICU patient populations in other countries. PMID:25469466

A model measuring therapeutic inertia and the associated factors among diabetes patients: A nationwide population-based study in Taiwan.

PubMed

Huang, Li-Ying; Shau, Wen-Yi; Yeh, Hseng-Long; Chen, Tsung-Tai; Hsieh, Jun Yi; Su, Syi; Lai, Mei-Shu

2015-01-01

This article presents an analysis conducted on the patterns related to therapeutic inertia with the aim of uncovering how variables at the patient level and the healthcare provider level influence the intensification of therapy when it is clinically indicated. A cohort study was conducted on 899,135 HbA1c results from 168,876 adult diabetes patients with poorly controlled HbA1c levels. HbA1c results were used to identify variations in the prescription of hypoglycemic drugs. Logistic regression and hierarchical linear models (HLMs) were used to determine how differences among healthcare providers and patient characteristics influence therapeutic inertia. We estimated that 38.5% of the patients in this study were subject to therapeutic inertia. The odds ratio of cardiologists choosing to intensify therapy was 0.708 times that of endocrinologists. Furthermore, patients in medical centers were shown to be 1.077 times more likely to be prescribed intensified treatment than patients in primary clinics. The HLMs presented results similar to those of the logistic model. Overall, we determined that 88.92% of the variation in the application of intensified treatment was at the within-physician level. Reducing therapeutic inertia will likely require educational initiatives aimed at ensuring adherence to clinical practice guidelines in the care of diabetes patients. © 2014, The American College of Clinical Pharmacology.

Clinical outcomes and patients' perceptions of nurse-led healthy lifestyle clinics.

PubMed

Marshall, Bob; Floyd, Sue; Forrest, Rachel

2011-03-01

The Nurse-Led Healthy Lifestyle Clinics focussed on lifestyle issues for patients with known health inequalities. Much of the nursing was educative and preventative care. This evaluation assessed patient experiences and opinions, as well as clinical outcomes. Information came from clinical outcome data for 2850 individuals and 424 patient satisfaction surveys. Patients were aged 0-95 years (45% between 40 and 59 years); 60% Pakeha/European, 31.4% Maori, 4.2% Pacific and 4.4% other ethnicities. Only 19% of claimants (approximately 40% were Maori or Pacific) came from quintile 5 addresses, suggesting the target population was not reached effectively. Ninety-four percent of patients had a better understanding of their diagnosis, medication and treatment plan, and were more motivated to self-manage their health needs. This increase in patient empowerment is a significant outcome of the project. Clinical outcome data showed no significant differences between first and last clinic visits for average weight, blood pressure, smoking, glycosylated haemoglobin levels, waist circumference or cardiovascular risk. Significant improvements were shown in the Dartmouth Primary Care Cooperative Information results for social activity, change in health, and overall health (n=89). More effective techniques to access the target population have been implemented, as has an extended period for review of clinical outcomes. More focussed evaluation of clinical outcomes is necessary to provide quantitative data on the clinics. The large percentage of patients who felt more empowered to self-manage their health needs suggests the clinics were effective in this area.

A cluster-analytic profiling of heroin-dependent patients based on level, clinical adequacy, and patient-desired adjustment of buprenorphine dosage during buprenorphine-naloxone maintenance treatment in sixteen Spanish centers.

PubMed

Alcaraz, Saul; González-Saiz, Francisco; Trujols, Joan; Vergara-Moragues, Esperanza; Siñol, Núria; Pérez de Los Cobos, José

2018-06-01

Buprenorphine dosage is a crucial factor influencing outcomes of buprenorphine treatment for heroin use disorders. Therefore, the aim of the present study is to identify naturally occurring profiles of heroin-dependent patients regarding individualized management of buprenorphine dosage in clinical practice of buprenorphine-naloxone maintenance treatment. 316 patients receiving buprenorphine-naloxone maintenance treatment were surveyed at 16 Spanish centers during the stabilization phase of this treatment. Patients were grouped using cluster analysis based on three key indicators of buprenorphine dosage management: dose, adequacy according to physician, and adjustment according to patient. The clusters obtained were compared regarding different facets of patient clinical condition. Four clusters were identified and labeled as follows (buprenorphine average dose and percentage of participants in each cluster are given in brackets): "Clinically Adequate and Adjusted to Patient Desired Low Dosage" (2.60 mg/d, 37.05%); "Clinically Adequate and Adjusted to Patient Desired High Dosage" (10.71 mg/d, 29.18%); "Clinically Adequate and Patient Desired Reduction of Low Dosage" (3.38 mg/d, 20.0%); and "Clinically Inadequate and Adjusted to Patient Desired Moderate Dosage" (7.55 mg/d, 13.77%). Compared to patients from the other three clusters, participants in the latter cluster reported more frequent use of heroin and cocaine during last week, lower satisfaction with buprenorphine-naloxone as a medication, higher prevalence of buprenorphine-naloxone adverse effects and poorer psychological adjustment. Our results show notable differences between clusters of heroin-dependent patients regarding buprenorphine dosage management. We also identified a group of patients receiving clinically inadequate buprenorphine dosage, which was related to poorer clinical condition. Copyright © 2018 Elsevier B.V. All rights reserved.

Clinical impact of migraine for the management of glaucoma patients.

PubMed

Nguyen, Bao N; Lek, Jia Jia; Vingrys, Algis J; McKendrick, Allison M

2016-03-01

Migraine is a common and debilitating primary headache disorder that affects 10-15% of the general population, particularly people of working age. Migraine is relevant to providers of clinical eye-care because migraine attacks are associated with a range of visual sensory symptoms, and because of growing evidence that the results of standard tests of visual function necessary for the diagnosis and monitoring of glaucoma (visual fields, electrophysiology, ocular imaging) can be abnormal due to migraine. These abnormalities are measureable in-between migraine events (the interictal period), despite patients being asymptomatic and otherwise healthy. This picture is further complicated by epidemiological data that suggests an increased prevalence of migraine in patients with glaucoma, particularly in patients with normal tension glaucoma. We discuss how migraine, as a co-morbidity, can confound the results and interpretation of clinical tests that form part of contemporary glaucoma evaluation, and provide practical evidence-based recommendations for the clinical testing and management of patients with migraine who attend eye-care settings. Copyright © 2015 Elsevier Ltd. All rights reserved.

Re-emergent tremor in Parkinson's disease.

PubMed

Belvisi, Daniele; Conte, Antonella; Bologna, Matteo; Bloise, Maria Carmela; Suppa, Antonio; Formica, Alessandra; Costanzo, Matteo; Cardone, Pierluigi; Fabbrini, Giovanni; Berardelli, Alfredo

2017-03-01

Re-emergent tremor (RET) is a postural tremor that appears after a variable delay in patients with Parkinson's disease (PD). The aim of the present study was to evaluate the occurrence and the clinical characteristics of RET in a population of patients with PD. We consecutively assessed 210 patients with PD. We collected the patients' demographic and clinical data. RET was clinically characterized in terms of latency, severity and body side affected. We also investigated a possible relationship with motor and non-motor symptoms and differences in the clinical features in patients with and without RET. RET was present in 42/210 patients. The mean latency of RET was 9.20 ± 6.8 seconds. Mean severity was 2.4 ± 1.9. RET was unilateral in 21 patients. Patients with RET had less severe speech, posture and gait disorders and upper limb and global bradykinesia than patients without RET. Similar findings were observed when we compared patients with RET with patients with tremor at rest associated with action tremor, patients with isolated action tremor and patients with no tremor. By contrast, patients with RET tremor did not clinically differ from those with isolated tremor at rest. Our results suggest that patients with RET and patients with isolated tremor at rest represent the same clinical subtype, whereas patients with action tremor (whether isolated or associated with tremor at rest) might belong to a distinct subtype that is clinically worse. Patients with RET represents a benign subtype of PD, even within the tremor-dominant phenotype. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cost-effective analysis of conventional and nurse-led clinics for common otological procedures.

PubMed

Uppal, S; Jose, J; Banks, P; Mackay, E; Coatesworth, A P

2004-03-01

The need to reduce costs while providing a first-class service has led to the expansion in the role of nurses in recent years. We present results of a comparison of the cost-effectiveness of conventional and nurse-led out-patient ear clinics. Our results indicate that cost-effective health care is a distinct competitive advantage for nurses taking up some roles conventionally performed by doctors. The difference in mean cost of out-patient visit per patient between the two groups is 75.28 pounds. This is equivalent to a reduction in cost to the hospital of more than 47,000 pounds for the 626 patients seen in a nurse-led ear clinic in a year. The nurse-led service is thus more cost-effective and presents an opportunity by freeing up otolaryngologists' time to see more complex patients and has the potential for reducing out-patient access time in the NHS.

Clinical correlation of biopsy results in patients with temporal arteritis.

PubMed

Yuksel, Volkan; Guclu, Orkut; Tastekin, Ebru; Halici, Umit; Huseyin, Serhat; Inal, Volkan; Canbaz, Suat

2017-11-01

Temporal arteritis is systemic vasculitis of medium and large sized vessels. The lowest incidence rates were reported in Turkey, Japan and Israel. We aimed to investigate the results of patients with biopsy-proven temporal arteritis and those classified according to the American College of Rheumatology criteria from a low-incidence region for temporal arteritis. The results of our study are noteworthy, since there is limited data on pathologic diagnosis of temporal arteritis in Turkey. We studied the medical records, laboratory findings such as erythrocyte sedimentation rate and C-reactive protein levels, biopsy results, and postoperative complications of all the patients operated for temporal artery biopsy at our clinic. We used the computerized laboratory registry that keeps all records of 42 consecutive temporal artery biopsy results from January 2011 to December 2016. The mean age was 66±12.5 years. The most common manifestations on admission were temporal headache, optic neuritis and jaw claudication, respectively. Temporal artery biopsy  results confirmed tempoal arteritis in eight out of 42 (19%) patients. There was no statistically significant difference between biopsy-positive and biopsy-negative groups in terms of sex, age, erythrocyte sedimentation rate, C-reactive protein and biopsy length. We were not able to find a correlation between the analysis of biopsy results and clinical evaluation of patients with temporal arteritis. We suggest that diagnosis of temporal arteritis  depends on clinical suspicion. Laboratory examination results may not be helpful in accurate diagnosis of tempoal arteritis.

Bcl-2 antisense therapy in B-cell malignant proliferative disorders.

PubMed

Chanan-Khan, Asher; Czuczman, Myron S

2004-08-01

Overexpression of Bcl-2 oncogene has been clinically associated with an aggressive clinical course, chemotherapy and radiotherapy resistance, and poor survival in patients with malignant B-cell disorders. Patients with relapsed or refractory chronic lymphocytic leukemia, multiple myeloma, or non-Hodgkin's lymphoma have limited therapeutic options. Preclinical and early clinical data have shown that Bcl-2 oncoprotein can be decreased by Bcl-2 antisense therapy. Also, downregulation of Bcl-2 protein can result in reversal of chemotherapy resistance and improved antitumor activity of biologic agents. Various clinical trials are evaluating the role of targeting Bcl-2 as a mechanism to enhance the antitumor potential of chemotherapy and immunotherapy. Early results from these clinical studies are encouraging and confirm the proof of principle for antisense therapy. As current data mature, these trials will hopefully validate preliminary results and establish Bcl-2 antisense as an important addition to the current armamentarium used in the treatment of patients with B-cell neoplasms.

[Clinical features of patients with Becker muscular dystrophy and deletions of the rod domain of dystrophin gene].

PubMed

Wang, Yanyun; Zhu, Yuling; Yang, Juan; Li, Yaqin; Sun, Jiangwen; Zhan, Yixin; Zhang, Cheng

2018-02-10

OBJECTIVE To explore the clinical features of patients carrying deletions of the rod domain of the dystrophin gene. METHODS Clinical data of 12 Chinese patients with Becker muscular dystrophy (BMD) and such deletions was reviewed. RESULTS Most patients complained of muscle weakness of lower limbs. Two patients had muscle cramps, one had increased creatine kinase (CK) level, and one had dilated cardiomyopathy. CONCLUSION Compared with DMD, the clinical features of BMD are much more variable, particularly for those carrying deletions of the rod domain of the dystrophin gene. Muscular weakness may not be the sole complaint of BMD. The diagnosis of BMD cannot be excluded by moderately elevated CK. For male patients with dilated cardiomyopathy, the possibility of BMD should be considered.

Sensitivity of mouse bioassay in clinical wound botulism.

PubMed

Wheeler, Charlotte; Inami, Gregory; Mohle-Boetani, Janet; Vugia, Duc

2009-06-15

California has an ongoing epidemic of wound botulism (WB) among injection drug users (IDUs). We retrospectively studied a cohort of patients with WB and determined the sensitivity of the mouse bioassay-the gold standard laboratory test for confirmation of botulism-in verifying WB. We defined a clinical case of WB as an acute, bilateral, descending, flaccid paralysis starting with 1 cranial nerve palsies in an IDU with no other explainable diagnosis. We calculated the sensitivity of the mouse bioassay as the proportion of clinical WB cases that had positive serum toxin test results by mouse bioassay. We compared serum toxin-positive with serum toxin-negative patients. Of 73 patients with WB, 50 tested serum toxin positive, yielding a sensitivity of 68%. Serum toxin-positive patients did not differ significantly from serum toxin-negative patients with respect to demographic characteristics or injection drug use practices or in days from patient symptom onset to collection of specimens for testing. Patients did not differ significantly by clinical characteristics, except that serum toxin-positive patients were more likely than serum toxin-negative patients to have required mechanical ventilation during their hospital courses (74% vs. 43%; P = .01). In this study, the mouse bioassay failed to detect botulinum toxin in the serum samples of nearly one-third of IDUs with characteristic WB. Such patients should be considered to have probable WB. Physicians should be aware of the test's limitations and base their final diagnosis of suspected WB on clinical criteria when the mouse bioassay produces negative results.

[Asthenic syndrome in patients with burnout syndrome].

PubMed

Chutko, L S; Surushkina, S Iu; Rozhkova, A V; Nikishena, I S; Iakovenko, E A

2013-01-01

The authors present the results of a survey of 103 patients aged 25 to 45 years with burnout syndrom. The results showed that most patients with the syndrome of burnout have clinical manifestations of asthenia, varying degrees of severity. According to psychological and psychophysiological examination in this group of patients were found attention and memory dysfunction. This study evaluated the efficacy of memoplant in the treatment of this pathology. The high efficiency of memoplant (improvement in 69.7% of cases) was detected, confirmed by the data of the clinical, psychological and neuropsychological research.

[Evidence-based medicine and 'The Cochrane Collaboration'].

PubMed

Kawamura, T; Tamakoshi, A; Wakai, K; Ohno, Y

1999-06-01

In Evidence-Based Medicine (EBM), a clinical decision is based neither on pathophysiological theories nor personal experience but on the results derived from scientifically designed clinical epidemiological studies (i.e., evidence). EBM is used in various clinical applications, such as therapy, diagnosis, and prognosis prediction. The process includes (1) asking a clinical question consisting of the three elements of "patient", "exposure", and "outcome"; (2) searching for the best evidence using MEDLINE or Cochrane Library; (3) appraising critically the validity of the method and the magnitude and probability of the result; and finally (4) applying the evidence of the patient. In actual clinical practice, clinical expertise and patient preferences should be as much regarded as research evidence. 'The Cochrane Collaboration' supplies systematic reviews of clinical trials carried out all over the world to its consumers. Its fruit, 'The Cochrane Library (CD-ROM),' is a highly valuable resource. 'The Cochrane Collaboration' serves as the infrastructure for EBM. EBM, which was originally developed for the individual patient care, can also be applicable to community- or workplace-healthcare and policy making by governments. Thus, EBM is both a philosophy and a method to provide people with the most appropriate medical practice.

False-Positive Xpert MTB/RIF Results in Retested Patients with Previous Tuberculosis: Frequency, Profile, and Prospective Clinical Outcomes.

PubMed

Theron, Grant; Venter, Rouxjeane; Smith, Liezel; Esmail, Aliasgar; Randall, Philippa; Sood, Vishesh; Oelfese, Suzette; Calligaro, Greg; Warren, Robin; Dheda, Keertan

2018-03-01

Globally, Xpert MTB/RIF (Xpert) is the most widely used PCR test for the diagnosis of tuberculosis (TB). Positive results in previously treated patients, which are due to old DNA or active disease, are a diagnostic dilemma. We prospectively retested sputum from 238 patients, irrespective of current symptoms, who were previously diagnosed to be Xpert positive and treated successfully. Patients who retested as Xpert positive and culture negative were exhaustively investigated (repeat culture, chest radiography, bronchoscopy with bronchoalveolar lavage, long-term clinical follow-up). We evaluated whether the duration since previous treatment completion, mycobacterial burden (the Xpert cycle threshold [ C T ] value), and reclassification of Xpert-positive results with a very low semiquantitation level to Xpert-negative results reduced the rate of false positivity. A total of 229/238 (96%) of patients were culture negative. Sixteen of 229 (7%) were Xpert positive a median of 11 months (interquartile range, 5 to 19 months) after treatment completion. The specificity was 93% (95% confidence interval [CI], 89 to 96%). Nine of 15 (40%) Xpert-positive, culture-negative patients reverted to Xpert negative after 2 to 3 months (1 patient declined further participation). Patients with false-positive Xpert results had a lower mycobacterial burden than patients with true-positive Xpert results ( C T , 28.7 [95% CI, 27.2 to 30.4] versus 17.6 [95% CI, 16.9 to 18.2]; P < 0.001), an increased likelihood of a chest radiograph not compatible with active TB (5/15 patients versus 0/5 patients; P = 0.026), and less-viscous sputum (15/16 patients versus 2/5 patients whose sputum was graded as mucoid or less; P = 0.038). All patients who initially retested as Xpert positive and culture negative ("Xpert false positive") were clinically well without treatment after follow-up. The duration since the previous treatment poorly predicted false-positive results (a duration of ≤2 years identified only 66% of patients with false-positive results). Reclassifying Xpert-positive results with a very low semiquantitation level to Xpert negative improved the specificity (+3% [95% CI, +2 to +5%]) but reduced the sensitivity (-10% [95% CI, -4 to -15%]). Patients with previous TB retested with Xpert can have false-positive results and thus not require treatment. These data inform clinical practice by highlighting the challenges in interpreting Xpert-positive results, underscore the need for culture, and have implications for next-generation ultrasensitive tests. Copyright © 2018 American Society for Microbiology.

Association Between Medicare Summary Star Ratings for Patient Experience and Clinical Outcomes in US Hospitals.

PubMed

Trzeciak, Stephen; Gaughan, John P; Bosire, Joshua; Mazzarelli, Anthony J

2016-03-01

In 2015, the Centers for Medicare and Medicaid Services (CMS) released new summary star ratings for US hospitals based on patient experience. We aimed to test the association between CMS patient experience star ratings and clinical outcomes. We analyzed risk-adjusted data for more than 3000 US hospitals from CMS Hospital Compare using linear regression. We found that better patient experience was associated with favorable clinical outcomes. Specifically, a higher number of stars for patient experience had a statistically significant association with lower rates of many in-hospital complications. A higher patient experience star rating also had a statistically significant association with lower rates of unplanned readmissions to the hospital within 30 days. Better patient experience according to the CMS star ratings is associated with favorable clinical outcomes. These results support the inclusion of patient experience data in the framework of how hospitals are paid for services.

Sarcoidosis diagnostic score (SDS): a systematic evaluation to enhance the diagnosis of sarcoidosis.

PubMed

Bickett, Alexandra N; Lower, Elyse E; Baughman, Robert P

2018-05-17

The diagnosis of sarcoidosis is made by the combination of clinical features and biopsy results. The clinical features of sarcoidosis can be quite variable. We developed a Sarcoidosis Diagnostic Score (SDS) to summarize the clinical features of possible sarcoidosis patients. Biopsy confirmed sarcoidosis patients seen during a seven-month time period at the University of Cincinnati Sarcoidosis clinic were prospectively identified. Non-sarcoidosis patients seen at the same clinic were used as controls. Using a modified WASOG organ assessment instrument, we scored all patients for presence of biopsy, one or more highly probable symptom, and one or more at least probable symptom for each area. Two sarcoidosis scores were generated: SDS biopsy (with biopsy) and SDS clinical (without biopsy). The 980 evaluable patients were divided into two cohorts: an initial 600 patients (450 biopsy confirmed sarcoidosis, 150 controls) to establish cut-off values for SDS biopsy and SDS clinical and a validation cohort of 380 patients (103 biopsy confirmed sarcoidosis patients and 277 controls). The best cutoff value for SDS biopsy was > 6 (sensitivity =99.3%; specificity=100%). For the total the 980 patients, an SDS clinical > 3 had a sensitivity of 94.2%, specificity of 88.8%, and a likelihood ratio of 7.9. An SDS clinical score > 4 had a lower sensitivity of (76.9%) but higher specificity (98.6%). For sarcoidosis, the presence of specific clinical features, especially multi-organ involvement, can enhance the diagnostic certainty. The SDS scoring system quantitated the clinical features consistent with sarcoidosis. Copyright © 2018. Published by Elsevier Inc.

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

PubMed

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

2000-08-01

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

Patient mobile telephone 'text' reminder: a novel way to reduce non-attendance at the ENT out-patient clinic.

PubMed

Geraghty, M; Glynn, F; Amin, M; Kinsella, J

2008-03-01

Non-attendance at out-patient clinics is a seemingly intractable problem, estimated to cost 65 pounds sterling (97 euros) per incident. This results in under-utilisation of resources and prolonged waiting lists. In an effort to reduce out-patient clinic non-attendance, our ENT department, in conjunction with the information and communication technology department, instigated the use of a mobile telephone short message service ('text') reminder, to be sent out to each patient three days prior to their out-patient clinic appointment. To audit non-attendance rates at ENT out-patient clinics following the introduction of a text reminder system. Retrospective review. Non-attendance at our institution's ENT out-patient clinics was audited, following introduction of a text message reminder system in August 2003. Rates of non-attendance were compared for the text message reminder group and a historical control group. Before the introduction of the text message reminder system, the mean rate of non-attendance was 33.6 per cent. Following the introduction of the system, the mean rate of non-attendance reduced to 22 per cent. Sending text message reminders is a simple and cost-effective way to improve non-attendance at ENT out-patient clinics.

Practical aspects of recruitment and retention in clinical trials of rare genetic diseases: the phenylketonuria (PKU) experience.

PubMed

DeWard, Stephanie J; Wilson, Ashley; Bausell, Heather; Volz, Ashley S; Mooney, Kimberly

2014-02-01

Bringing treatments for rare genetic diseases to patients requires clinical research. Despite increasing activism from patient support and advocacy groups to increase access to clinical research studies, connecting rare disease patients with the clinical research opportunities that may help them has proven challenging. Chief among these challenges are the low incidence of these diseases resulting in a very small pool of known patients with a particular disease, difficulty of diagnosing rare genetic diseases, logistical issues such as long distances to the nearest treatment center, and substantial disease burden leading to loss of independence. Using clinical studies of phenylketonuria as an example, this paper discusses how, based on the authors' collective experience, partnership among clinicians, patients, study coordinators, genetic counselors, dietitians, industry, patient support groups, and families can help overcome the challenges of recruiting and retaining patients in rare disease clinical trials. We discuss specific methods of collaboration, communication, and education as part of a long-term effort to build a community committed to advancing the medical care of patients with rare genetic diseases. By talking to patients and families regularly about research initiatives and taking steps to make study participation as easy as possible, rare disease clinic staff can help ensure adequate study enrollment and successful study completion.

The importance of serological tests implementation in disseminated candidiasis diagnose.

PubMed

Gegić, Merima; Numanović, Fatima; Delibegović, Zineta; Tihić, Nijaz; Nurkić, Mahmut; Hukić, Mirsada

2013-03-01

Candidiasis is defined as an infection or disease caused by a fungus of the genus Candida. Rate of disseminated candidiasis increases with the growth of the number of immunocompromised patients. In the the last few decades the incidence of disseminated candidiasis is in growth as well as the mortality rate. The aim of this survey is to show the importance of serological tests implementation in disseminated candidiasis diagnose. This is a prospective study involving 60 patients with malign diseases with and without clinical signs of disseminated candidiasis and 30 healthy people who represent the control group. Apart from hemoculture, detection of circulating mannan antigen and adequate antibodies of Candida species applying comercial ELISA test was determined in each patient. This survey deals with relevant factors causing disseminated candidiasis. This survey showed that the group of patients with clinical signs of disseminated candidiasis had more patients with positive hemoculture to Candida species, then the group of patients without clinical signs of disseminated candidiasis. The number of patients being examined and positive to antigens and antibodies was higher (p < 0.01) in the group of patients with clinical signs of disseminated candidiasis (7/30; 23.3%), then in the group of patients without clinical signs of disseminated candidiasis (0/30; 0%): Average value of titra antigen was statistically higher (p < 0.001) in patients with Candida spp. positive hemocultures rather then in patients with Candida spp. negative hemocultures. In the group of patients with clinical signs of disseminated candidiasis 6/30 (20%) of patients had Candida spp.positive hemocultures while in the group of patients without clinical signs of disseminated candidiasis 1/30 (3.3%) of patients had Candida spp. positive hemocultures, which was considerably higher (p < 0.05). Correlation of results of hemoculture and mannan antigens and antibodies in patients with disseminated candidiasis were statistically significant, while correlation of results of hemoculture and antibodies was insignificant. Because of low sensitivity of hemoculture and time needed for isolation of Candida spp., introducing serological tests in regular procedures would speed disseminated candidiasis diagnose.

Improving Timely Resident Follow-Up and Communication of Results in Ambulatory Clinics Utilizing a Web-Based Audit and Feedback Module.

PubMed

Boggan, Joel C; Swaminathan, Aparna; Thomas, Samantha; Simel, David L; Zaas, Aimee K; Bae, Jonathan G

2017-04-01

Failure to follow up and communicate test results to patients in outpatient settings may lead to diagnostic and therapeutic delays. Residents are less likely than attending physicians to report results to patients, and may face additional barriers to reporting, given competing clinical responsibilities. This study aimed to improve the rates of communicating test results to patients in resident ambulatory clinics. We performed an internal medicine, residency-wide, pre- and postintervention, quality improvement project using audit and feedback. Residents performed audits of ambulatory patients requiring laboratory or radiologic testing by means of a shared online interface. The intervention consisted of an educational module viewed with initial audits, development of a personalized improvement plan after Phase 1, and repeated real-time feedback of individual relative performance compared at clinic and program levels. Outcomes included results communicated within 14 days and prespecified "significant" results communicated within 72 hours. A total of 76 of 86 eligible residents (88%) reviewed 1713 individual ambulatory patients' charts in Phase 1, and 73 residents (85%) reviewed 1509 charts in Phase 2. Follow-up rates were higher in Phase 2 than Phase 1 for communicating results within 14 days and significant results within 72 hours (85% versus 78%, P  < .001; and 82% versus 70%, P  = .002, respectively). Communication of "significant" results was more likely to occur via telephone, compared with communication of nonsignificant results. Participation in a shared audit and feedback quality improvement project can improve rates of resident follow-up and communication of results, although communication gaps remained.

Patient, staff, and clinician perspectives on implementing electronic communications in an interdisciplinary rural family health practice.

PubMed

Chang, Feng; Paramsothy, Thivaher; Roche, Matthew; Gupta, Nishi S

2017-03-01

Aim To conduct an environmental scan of a rural primary care clinic to assess the feasibility of implementing an e-communications system between patients and clinic staff. Increasing demands on healthcare require greater efficiencies in communications and services, particularly in rural areas. E-communications may improve clinic efficiency and delivery of healthcare but raises concerns about patient privacy and data security. We conducted an environmental scan at one family health team clinic, a high-volume interdisciplinary primary care practice in rural southwestern Ontario, Canada, to determine the feasibility of implementing an e-communications system between its patients and staff. A total of 28 qualitative interviews were conducted (with six physicians, four phone nurses, four physicians' nurses, five receptionists, one business office attendant, five patients, and three pharmacists who provide care to the clinic's patients) along with quantitative surveys of 131 clinic patients. Findings Patients reported using the internet regularly for multiple purposes. Patients indicated they would use email to communicate with their family doctor for prescription refills (65% of respondents), appointment booking (63%), obtaining lab results (60%), and education (50%). Clinic staff expressed concerns about patient confidentiality and data security, the timeliness, complexity and responsibility of responses, and increased workload. Clinic staff members are willing to use an e-communications system but clear guidelines are needed for successful adoption and to maintain privacy of patient health data. E-communications might improve access to and quality of care in rural primary care practices.

Association between the clinical classification of hypothyroidism and reduced TSH in LT4 supplemental replacement treatment for pregnancy in China.

PubMed

Zhang, Lyu; Zhang, Zhaoyun; Ye, Hongying; Zhu, Xiaoming; Li, Yiming

2016-01-01

The study was aimed to evaluate the effects of levothyroxine (LT4) supplemental replacement treatment for pregnancy and analyze the associations between the clinical classification of hypothyroidism and reduced thyroid-stimulating hormone (TSH) in LT4 therapy. Totally, 195 pregnant women with hypothyroidism receiving routine prenatal care were enrolled. They were categorized into three groups: overt hypothyroidism (OH), subclinical hypothyroidism (SCH) with negative thyroperoxidase antibody (TPOAb), and SCH with positive TPOAb. The association between the clinical classification and reduced TSH in LT4 supplemental replacement treatment was assessed. The results indicated that reduced TSH was significantly different among the groups according to the clinical classifications (p = 0.043). The result was also significantly different between patients with OH and patients with SCH and negative TPOAb (p = 0.036). Similar result was reported for the comparison between patients with OH and patients with SCH and positive TPOAb (p = 0.016). Multiple variable analyses showed that LT4 supplementation, gestational age and the variable of clinical classifications were associated with reduced TSH independently. Our data suggested that the therapeutic effect of substitutive treatment with LT4 was significantly associated with different clinical classifications of hypothyroidism in pregnancy and the treatment should begin as soon as possible after diagnosis.

Patient Satisfaction Is Associated With Time With Provider But Not Clinic Wait Time Among Orthopedic Patients.

PubMed

Patterson, Brendan M; Eskildsen, Scott M; Clement, R Carter; Lin, Feng-Chang; Olcott, Christopher W; Del Gaizo, Daniel J; Tennant, Joshua N

2017-01-01

Clinic wait time is considered an important predictor of patient satisfaction. The goal of this study was to determine whether patient satisfaction among orthopedic patients is associated with clinic wait time and time with the provider. The authors prospectively enrolled 182 patients at their outpatient orthopedic clinic. Clinic wait time was defined as the time between patient check-in and being seen by the surgeon. Time spent with the provider was defined as the total time the patient spent in the examination room with the surgeon. The Consumer Assessment of Healthcare Providers and Systems survey was used to measure patient satisfaction. Factors associated with increased patient satisfaction included patient age and increased time with the surgeon (P=.024 and P=.037, respectively), but not clinic wait time (P=.625). Perceived wait time was subject to a high level of error, and most patients did not accurately report whether they had been waiting longer than 15 minutes to see a provider until they had waited at least 60 minutes (P=.007). If the results of the current study are generalizable, time with the surgeon is associated with patient satisfaction in orthopedic clinics, but wait time is not. Further, the study findings showed that patients in this setting did not have an accurate perception of actual wait time, with many patients underestimating the time they waited to see a provider. Thus, a potential strategy for improving patient satisfaction is to spend more time with each patient, even at the expense of increased wait time. [Orthopedics. 2017; 40(1):43-48.]. Copyright 2016, SLACK Incorporated.

PMMA versus titanium cage after anterior cervical discectomy - a prospective randomized trial.

PubMed

Schröder, J; Grosse-Dresselhaus, F; Schul, C; Wassmann, H

2007-02-01

Nonautologous interbody fusion materials are utilised in increasing numbers after anterior cervical disc surgery to overcome the problem of donor site morbidity of autologous bone grafts. This study investigates the performance of two nonautologous materials, the bone cement Polymethylmethacrylate (PMMA) and titanium cages. This prospective randomised trial, with assessment of the results by an independent observer, evaluates whether a Polymethylmethacrylate (PMMA) spacer or a titanium cage provides a better fusion rate around the implant and a better clinical outcome. Between 2000 and 2002, 115 patients with monoradicular cervical nerve root compression syndrome caused by soft cervical disc herniation were eligible for this study. Myelopathy, excessive osteophyte formation, and adjacent level degeneration were exclusion criteria. A block-restricted randomisation was applied. The 2-year clinical outcome served as the primary endpoint of the study. Clinical outcome was assessed according to the Odom scale by an independent observer at the follow-up examination. Preoperative, postoperative, and follow-up radiographs were taken. The study was completed by 107 patients (53 with PMMA and 54 with titanium cage). No significant difference between the two groups could be established with respect to the clinical outcome. In each group, 26 patients scored excellent. Good results were found in 19 PMMA patients and 16 titanium cage patients; satisfactory results were found in 8 PMMA patients and 9 titanium cage patients; bad results were found in 3 titanium cage patients. In 47 titanium cage cases (87%), fusion occurred radiologically as bony bridging around the implant. The fusion rate was significantly lower (p=0.011) in the PMMA group, with 35 cases (66%) united at follow-up. The radiological result of the titanium cage is superior to that of PMMA with respect to the fusion rate. Although the titanium cage achieves a better fusion rate, there is no difference between titanium cages and PMMA with respect to the clinical outcome.

Whole Exome Sequencing in Pediatric Neurology Patients: Clinical Implications and Estimated Cost Analysis.

PubMed

Nolan, Danielle; Carlson, Martha

2016-06-01

Genetic heterogeneity in neurologic disorders has been an obstacle to phenotype-based diagnostic testing. The authors hypothesized that information compiled via whole exome sequencing will improve clinical diagnosis and management of pediatric neurology patients. The authors performed a retrospective chart review of patients evaluated in the University of Michigan Pediatric Neurology clinic between 6/2011 and 6/2015. The authors recorded previous diagnostic testing, indications for whole exome sequencing, and whole exome sequencing results. Whole exome sequencing was recommended for 135 patients and obtained in 53 patients. Insurance barriers often precluded whole exome sequencing. The most common indication for whole exome sequencing was neurodevelopmental disorders. Whole exome sequencing improved the presumptive diagnostic rate in the patient cohort from 25% to 48%. Clinical implications included family planning, medication selection, and systemic investigation. Compared to current second tier testing, whole exome sequencing can result in lower long-term charges and more timely diagnosis. Overcoming barriers related to whole exome sequencing insurance authorization could allow for more efficient and fruitful diagnostic neurological evaluations. © The Author(s) 2016.

Poor Positive Predictive Value of Lyme Disease Serologic Testing in an Area of Low Disease Incidence.

PubMed

Lantos, Paul M; Branda, John A; Boggan, Joel C; Chudgar, Saumil M; Wilson, Elizabeth A; Ruffin, Felicia; Fowler, Vance; Auwaerter, Paul G; Nigrovic, Lise E

2015-11-01

Lyme disease is diagnosed by 2-tiered serologic testing in patients with a compatible clinical illness, but the significance of positive test results in low-prevalence regions has not been investigated. We reviewed the medical records of patients who tested positive for Lyme disease with standardized 2-tiered serologic testing between 2005 and 2010 at a single hospital system in a region with little endemic Lyme disease. Based on clinical findings, we calculated the positive predictive value of Lyme disease serology. Next, we reviewed the outcome of serologic testing in patients with select clinical syndromes compatible with disseminated Lyme disease (arthritis, cranial neuropathy, or meningitis). During the 6-year study period 4723 patients were tested for Lyme disease, but only 76 (1.6%) had positive results by established laboratory criteria. Among 70 seropositive patients whose medical records were available for review, 12 (17%; 95% confidence interval, 9%-28%) were found to have Lyme disease (6 with documented travel to endemic regions). During the same time period, 297 patients with a clinical illness compatible with disseminated Lyme disease underwent 2-tiered serologic testing. Six of them (2%; 95% confidence interval, 0.7%-4.3%) were seropositive, 3 with documented travel and 1 who had an alternative diagnosis that explained the clinical findings. In this low-prevalence cohort, fewer than 20% of positive Lyme disease tests are obtained from patients with clinically likely Lyme disease. Positive Lyme disease test results may have little diagnostic value in this setting. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Clinical Actionability of Comprehensive Genomic Profiling for Management of Rare or Refractory Cancers

PubMed Central

Hirshfield, Kim M.; Tolkunov, Denis; Zhong, Hua; Ali, Siraj M.; Stein, Mark N.; Murphy, Susan; Vig, Hetal; Vazquez, Alexei; Glod, John; Moss, Rebecca A.; Belyi, Vladimir; Chan, Chang S.; Chen, Suzie; Goodell, Lauri; Foran, David; Yelensky, Roman; Palma, Norma A.; Sun, James X.; Miller, Vincent A.; Stephens, Philip J.; Ross, Jeffrey S.; Kaufman, Howard; Poplin, Elizabeth; Mehnert, Janice; Tan, Antoinette R.; Bertino, Joseph R.; Aisner, Joseph; DiPaola, Robert S.

2016-01-01

Background. The frequency with which targeted tumor sequencing results will lead to implemented change in care is unclear. Prospective assessment of the feasibility and limitations of using genomic sequencing is critically important. Methods. A prospective clinical study was conducted on 100 patients with diverse-histology, rare, or poor-prognosis cancers to evaluate the clinical actionability of a Clinical Laboratory Improvement Amendments (CLIA)-certified, comprehensive genomic profiling assay (FoundationOne), using formalin-fixed, paraffin-embedded tumors. The primary objectives were to assess utility, feasibility, and limitations of genomic sequencing for genomically guided therapy or other clinical purpose in the setting of a multidisciplinary molecular tumor board. Results. Of the tumors from the 92 patients with sufficient tissue, 88 (96%) had at least one genomic alteration (average 3.6, range 0–10). Commonly altered pathways included p53 (46%), RAS/RAF/MAPK (rat sarcoma; rapidly accelerated fibrosarcoma; mitogen-activated protein kinase) (45%), receptor tyrosine kinases/ligand (44%), PI3K/AKT/mTOR (phosphatidylinositol-4,5-bisphosphate 3-kinase; protein kinase B; mammalian target of rapamycin) (35%), transcription factors/regulators (31%), and cell cycle regulators (30%). Many low frequency but potentially actionable alterations were identified in diverse histologies. Use of comprehensive profiling led to implementable clinical action in 35% of tumors with genomic alterations, including genomically guided therapy, diagnostic modification, and trigger for germline genetic testing. Conclusion. Use of targeted next-generation sequencing in the setting of an institutional molecular tumor board led to implementable clinical action in more than one third of patients with rare and poor-prognosis cancers. Major barriers to implementation of genomically guided therapy were clinical status of the patient and drug access. Early and serial sequencing in the clinical course and expanded access to genomically guided early-phase clinical trials and targeted agents may increase actionability. Implications for Practice: Identification of key factors that facilitate use of genomic tumor testing results and implementation of genomically guided therapy may lead to enhanced benefit for patients with rare or difficult to treat cancers. Clinical use of a targeted next-generation sequencing assay in the setting of an institutional molecular tumor board led to implementable clinical action in over one third of patients with rare and poor prognosis cancers. The major barriers to implementation of genomically guided therapy were clinical status of the patient and drug access both on trial and off label. Approaches to increase actionability include early and serial sequencing in the clinical course and expanded access to genomically guided early phase clinical trials and targeted agents. PMID:27566247

[Development of electronic medical recording system for clinics using the internet based on patient participation in pursuit of NBM].

PubMed

Omatsu, Masahiko; Tachibana, Hidenobu; Umeda, Tokuo

2004-06-01

The current medical system does not allow sufficient time for medical interviews, a situation that can create problems in patient-doctor relationships and result in a variety of problems. The importance of narrative based medicine (NBM) has been raised as a result of the overemphasis on evidence based medicine (EBM) in recent years. From this point of view, we have developed an electronic medical recording (EMR) system for clinics that uses the Internet and is based on patient participation, in pursuit of NBM. This system enables the patient to report information prior to the face-to-face interview with his or her doctor. In this way, the patient has more time to summarize and explain physical conditions and concerns. These reports from patients are automatically saved to the EMR database, without any additional workload. Therefore, this system will provide more effective communication between patient and doctor. In addition, the doctor is able to receive the results of medical treatment directly, in addition to the patient's other records. These sets of records will contribute to more efficient operation of the clinic. At this time, we have improved this system on the assumption that outsourcing the server will avoid the burden of maintenance. This prototype system uses a personal identification number (PIN) and an encode/decode algorithm for security. The secure PIN enables us to use conventional e-mail. Through experimental clinical testing, the effects on mutual understanding in medical examinations were studied. We are confident that this system based on patient narratives will contribute greatly to the spread of EMR systems for clinics operated by family physicians.

Clinical application of microsampling versus conventional sampling techniques in the quantitative bioanalysis of antibiotics: a systematic review.

PubMed

Guerra Valero, Yarmarly C; Wallis, Steven C; Lipman, Jeffrey; Stove, Christophe; Roberts, Jason A; Parker, Suzanne L

2018-03-01

Conventional sampling techniques for clinical pharmacokinetic studies often require the removal of large blood volumes from patients. This can result in a physiological or emotional burden, particularly for neonates or pediatric patients. Antibiotic pharmacokinetic studies are typically performed on healthy adults or general ward patients. These may not account for alterations to a patient's pathophysiology and can lead to suboptimal treatment. Microsampling offers an important opportunity for clinical pharmacokinetic studies in vulnerable patient populations, where smaller sample volumes can be collected. This systematic review provides a description of currently available microsampling techniques and an overview of studies reporting the quantitation and validation of antibiotics using microsampling. A comparison of microsampling to conventional sampling in clinical studies is included.

Case study: physicians develop results viewer amid Y2K commotion.

PubMed

Wurz, J A; Manis, J L

2000-01-01

Amid a flurry of Y2K preparations, which included converting patient accounting and order processing systems for six of its eight hospitals, Advocate Health Care needed to address physician complaints that the compliant software was awkward. By partnering with physicians, information systems (IS) rapidly developed a solution that met both the need for compliance and the demand for an easy-to-use, patient-centric clinical information system. A robust, browser-based results viewer provides physician access to information from patient accounting, order processing, and several clinical ancillary systems. Advocate anticipates greater challenges as the system is promoted to other sites and clinical communities.

Arthroscopic repair of the rotator cuff: prospective study of tendon healing after 70 years of age in 145 patients.

PubMed

Flurin, P-H; Hardy, P; Abadie, P; Boileau, P; Collin, P; Deranlot, J; Desmoineaux, P; Duport, M; Essig, J; Godenèche, A; Joudet, T; Kany, J; Sommaire, C; Thelu, C-E; Valenti, P

2013-12-01

The level of activity of patients older than 70 years is tending to increase, as are their expectations in terms of joint function recuperation. It has not been proven that rotator cuff repair healing is satisfactory in the elderly. The main hypothesis of this study was: repair of supraspinous lesions in patients older than 70 years is reliable in terms of both clinical results and healing. The secondary hypothesis was: tendon healing is significantly correlated with the Constant, ASES, and SST scores as well as with age, tendon retraction, and fatty infiltration. Multicenter prospective study on 145 patients older than 70 years, with 135 patients reviewed at 1 year (93%). The mean age was 73.9 years. Full-thickness tears of the supraspinatus extended at most to the upper third of the infraspinatus and retraction limited to Patte stages 1 and 2 were included. Clinical assessment was carried out in accordance with the Constant, ASES, and SST scores. Healing was evaluated with ultrasound. A significant improvement was noted in the Constant (44/76)+31.5 (P<0.0001), ASES (35/90)+54.4 (P<0.0001), and SST (3.5/10)+6.6 (P>0.0001) scores at 1 year of follow-up. The healing rate was 89% with 15 re-tears, nine of which were stage 1 and six stage 2. The clinical result was not correlated with patient age (Constant, P=0.24; ASES, P=0.38; SST, P=0.83) nor with the retraction stage (Constant, P=0.71; ASES, P=0.35; SST, P=0.69) or the stage of fatty infiltration (P>0.7). Healing was correlated with the quality of the clinical result (Constant, P=0.02; ASES, P=0.03) and age (P=0.01) but was not correlated with retraction or the fatty infiltration stage (P>0.3). Arthroscopic repair significantly improves the clinical results, even in patients older than 70 years. The clinical results are not correlated with age (but deterioration of the result was not noted after 75 years) or frontal retraction (but the study only included retractions limited to stages 1 and 2). The healing rate is satisfactory, but this study is limited to small ruptures of the supraspinatus, and the postoperative ultrasound analysis probably inferior to CT imaging with contrast agent injection, often used as the reference. Healing proves to be correlated with the quality of the clinical result and patient age. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study.

PubMed

Eckmann, Jason D; Ravi, Karthik; Katzka, David A; Davis, Dawn R; See, Jacalyn A; Geno, Debra R; Kryzer, Lori A; Alexander, Jeffrey A

2018-03-01

Atopy patch testing (APT) has shown potential for predicting dietary food triggers in studies of children and adolescents with eosinophilic esophagitis (EoE). To assess the efficacy of APT in adults with EoE. We conducted a prospective open-label pilot study of patients ≥ 18 years old with diagnosis of EoE at Mayo Clinic in Rochester, Minnesota, from November 2014 to January 2016. All patients underwent patch testing using intact food products, followed by a six food elimination diet and stepwise food reintroduction. Response to elimination diet was assessed with serial endoscopy with biopsies as well as clinical symptoms. APT results were directly compared to elimination diet results for assessment of efficacy. Correlation between clinical symptoms, endoscopic score, and histology was also qualitatively evaluated. Fifty percent of the patients had a positive APT, while only 16% had an APT result confirmed histologically during food reintroduction. Sensitivity of APT was calculated to be 5.9%, with specificity of 92.0%. Furthermore, we found significant qualitative inter-patient heterogeneity in the correlation between clinical symptoms, EREFS score, and histology. APT does not reliably predict food triggers identified by food elimination diet in adult patients with EoE. As a result, APT does not have a clear role in the evaluation of patients with EoE.

Surgery for vertigo: 10-year audit from a contemporary vertigo clinic.

PubMed

Patnaik, U; Srivastava, A; Sikka, K; Thakar, A

2015-12-01

To present the profile of patients undergoing surgical treatment for vertigo at a contemporary institutional vertigo clinic. A retrospective analysis of clinical charts. The charts of 1060 patients, referred to an institutional vertigo clinic from January 2003 to December 2012, were studied. The clinical profile and long-term outcomes of patients who underwent surgery were analysed. Of 1060 patients, 12 (1.13 per cent) were managed surgically. Of these, disease-modifying surgical procedures included perilymphatic fistula repair (n = 7) and microvascular decompression of the vestibular nerve (n = 1). Labyrinth destructive procedures included transmastoid labyrinthectomy (n = 2) and labyrinthectomy with vestibular nerve section (n = 1). One patient with vestibular schwannoma underwent both a disease-modifying and destructive procedure (translabyrinthine excision). All patients achieved excellent vertigo control, classified as per the American Academy of Otolaryngology - Head and Neck Surgery 1995 criteria. With the advent of intratympanic treatments, surgical treatments for vertigo have become further limited. However, surgery with directed intent, in select patients, can give excellent results.

Transient ischaemic attacks clinics provide equivalent and more efficient care than early in-hospital assessment.

PubMed

Martínez-Martínez, M M; Martínez-Sánchez, P; Fuentes, B; Cazorla-García, R; Ruiz-Ares, G; Correas-Callero, E; Lara-Lara, M; Díez-Tejedor, E

2013-02-01

Clinics for early management of transient ischaemic attacks (TIAs) have been developed in some stroke centres, resulting in reduced recurrence rates compared to appointment-based outpatient management, thus saving on hospitalization. We analysed the care process, recurrence rates and economic impact of the first year of work in our early-management TIA clinic and compared these with our previous in-hospital study protocols for low- and moderate-risk TIA patients. This was a prospective evaluation of the management of low- to moderate-risk TIA patients, comparing a new TIA clinic model (2010) with a previous hospitalization model (2009). Demographic data, vascular risk factor profiles, diagnostic test performance, secondary prevention measures, final aetiological diagnoses and cerebrovascular recurrences at 7 and 90 days were compared between in-hospital and TIA clinic assessed patients. We also carried out an economic comparison of the costs of each model's process. Two hundred and eleven low- to moderate-risk TIA patients were included, of whom 40.8% were hospitalized. There were no differences between the TIA clinic assessed and in-hospital assessed patients in terms of risk factor diagnosis and secondary prevention measures. The stroke recurrence rate (2.4% vs. 1.2%; P = 0.65) was low and similar for both groups (CI 95%, 0.214-20.436; P = 0.52). Cost per patient was €393.28 for clinic versus €1931.18 for in-hospital management. Outpatient management resulted in a 77.8% reduction in hospitalizations. Transient ischaemic attacks clinics are efficient for the early management of low- to moderate-risk TIA patients compared to in-hospital assessment, with no higher recurrence rates and at almost one-fifth the cost. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

Poster - Thur Eve - 55: Monte Carlo simulations of variations in planned dose distributions in a prostate patient population.

PubMed

Balderson, M J; Brown, D W; Quirk, S; Ghasroddashti, E; Kirkby, C

2012-07-01

Clinical outcome studies with clear and objective endpoints are necessary to make informed radiotherapy treatment decisions. Commonly, clinical outcomes are established after lengthy and costly clinical trials are performed and the data are analyzed and published. One the challenges with obtaining meaningful data from clinical trials is that by the time the information gets to the medical profession the results may be less clinically relevant than when the trial began, An alternative approach is to estimate clinical outcomes through patient population modeling. We are developing a mathematical tool that uses Monte Carlo techniques to simulate variations in planned and delivered dose distributions of prostate patients receiving radiotherapy. Ultimately, our simulation will calculate a distribution of Tumor Control Probabilities (TCPs) for a population of patients treated under a given protocol. Such distributions can serve as a metric for comparing different treatment modalities, planning and setup approaches, and machine parameter settings or tolerances with respect to outcomes on broad patient populations. It may also help researchers understand differences one might expect to find before actually doing the clinical trial. As a first step and for the focus of this abstract we wanted to see if we could answer the question: "Can a population of dose distributions of prostate patients be accurately modeled by a set of randomly generated Gaussian functions?" Our results have demonstrated that using a set of randomly generated Gaussian functions can simulate a distribution of prostate patients. © 2012 American Association of Physicists in Medicine.

Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study.

PubMed

Chaikovsky, Illya; Hailer, Birgit; Sosnytskyy, Volodymyr; Lutay, Mykhaylo; Mjasnikov, Georgiy; Kazmirchuk, Anatoly; Bydnyk, Mykola; Lomakovskyy, Alexander; Sosnytskaja, Taisia

2014-09-01

The aim of this paper is to investigate the predictive value of the new integrated magnetocardiographic (MCG) index (CI) in the diagnosis of coronary artery disease (CAD) in patients with suspected CAD with intermediate pretest probability of the disease and uninformative results of routine tests. The study was carried out in the Clinic of Cardiology of the Main Military Clinical Hospital of Ukraine, Kiev (clinic 1), and in the Second Medical Clinic of the 'Katholisches Klinikum Essen', Germany (clinic 2).The main group (group 1) included 89 patients without a history of myocardial infarction. Coronary angiography was performed because of chest pain. Depending on the results of coronary angiography, this group was divided into two subgroups: (i) those with at least 70% stenosis in at least one of the main coronary arteries (subgroup 1a) and (ii) those without hemodynamically significant stenosis (subgroup 1b). The control group included 43 healthy volunteers.In all participants, the MCG examination was performed using a seven-channel MCG system located in an unshielded room. An integrated MCG index (CI), consisting of six parameters, was calculated. It can be shown that CI was significantly higher in patients with stenosis 70% or more compared with the patients without stenosis and healthy volunteers. Sensitivity was 93%, specificity was 84%, positive predictive value was 85%, and negative predictive value was 93%. The MCG test at rest has the potential to be useful in the noninvasive diagnosis of CAD in patients with intermediate pretest probability of disease and uninformative results of routine tests.

Appointment Template Redesign in a Women's Health Clinic Using Clinical Constraints to Improve Service Quality and Efficiency.

PubMed

Huang, Y; Verduzco, S

2015-01-01

Patient wait time is a critical element of access to care that has long been recognized as a major problem in modern outpatient health care delivery systems. It impacts patient and medical staff productivity, stress, quality and efficiency of medical care, as well as health-care cost and availability. This study was conducted in a Women's Health Clinic. The objective was to improve clinic service quality by redesigning patient appointment template using the clinical constraints. The proposed scheduling template consisted of two key elements: the redesign of appointment types and the determination of the length of time slots using defined constraints. The re-classification technique was used for the redesign of appointment visit types to capture service variation for scheduling purposes. Then, the appointment length was determined by incorporating clinic constraints or goals, such as patient wait time, physician idle time, overtime, finish time, lunch hours, when the last appointment was scheduled, and the desired number of appointment slots, to converge the optimal length of appointment slots for each visit type. The redesigned template was implemented and the results indicated a 73% reduction in average patient waiting from the reported 40 to 11 minutes. The patient no-show rate was reduced by 4% from 24% to 20%. The morning section on average finished about 11:50 am. The clinic day was finished around 4:45 pm. Provider average idle time was estimated to be about 5 minutes, which can be used for charting/documenting patients. This study provided an alternative method of redesigning appointment scheduling templates using only the clinical constraints rather than the traditional way that required an objective function. This paper also documented the employed methods step by step in a real clinic setting. The implementation results concluded a significant improvement on patient wait time and no-show rate.

A matched-pair comparison of inlay and onlay trochlear designs for patellofemoral arthroplasty: no differences in clinical outcome but less progression of osteoarthritis with inlay designs.

PubMed

Feucht, Matthias J; Cotic, Matthias; Beitzel, Knut; Baldini, Julia F; Meidinger, Gebhart; Schöttle, Philip B; Imhoff, Andreas B

2017-09-01

To compare clinical and radiographic results after isolated patellofemoral arthroplasty (PFA) using either a second-generation inlay or onlay trochlear design. The hypothesis was that an inlay design will produce better clinical results and less progression of tibiofemoral osteoarthritis (OA) compared to an onlay design. Fifteen consecutive patients undergoing isolated PFA with an onlay design trochlear component (Journey™ PFJ, Smith & Nephew) were matched with 15 patients after isolated PFA with an inlay design trochlear component (HemiCAP ® Wave, Arthrosurface). Matching criteria were age, gender, body mass index, and follow-up period. An independent observer evaluated patients prospectively, whereas data were compared retrospectively. Clinical outcome was assessed using WOMAC, Lysholm score, and pain VAS. Kellgren-Lawrence grading was used to assess progression of tibiofemoral OA. Conversion to total knee arthroplasty was necessary in one patient within each group, leaving 14 patients per group for final evaluation. The mean follow-up was 26 months in the inlay group and 25 months in the onlay group (n.s.). Both groups displayed significant improvements of all clinical scores (p < 0.05). No significant differences were found between the two groups with regard to the clinical outcome and reoperation rate. No significant progression of tibiofemoral OA was observed in the inlay group, whereas 53 % of the onlay group showed progression of medial and/or lateral tibiofemoral OA (p = 0.009). Isolated PFA using either a second-generation inlay or onlay trochlear component significantly improves functional outcome scores and pain. The theoretical advantages of an inlay design did not result in better clinical outcome scores; however, progression of tibiofemoral OA was significantly less common in patients with an inlay trochlear component. This implant design may therefore improve long-term results and survival rates after isolated PFA. III.

Clinical Utility of CLIA-Grade AR-V7 Testing in Patients With Metastatic Castration-Resistant Prostate Cancer.

PubMed

Markowski, Mark C; Silberstein, John L; Eshleman, James R; Eisenberger, Mario A; Luo, Jun; Antonarakis, Emmanuel S

2017-01-01

A splice variant of the androgen receptor, AR-V7, confers resistance to AR-targeted therapies (ATTs) but not taxane chemotherapies in patients with metastatic castration-resistant prostate cancer. Since August 2015, a clinical-grade assay to detect AR-V7 messenger RNA expression in circulating tumors cells (CTCs) has been available to providers through a Clinical Laboratory Improvement Amendments-certified laboratory at Johns Hopkins University. We contacted ordering providers of the first 150 consecutive tests by using a questionnaire-based survey to determine how the results of AR-V7 testing were used to influence clinical practice. In all, 142 (95%) of 150 questionnaires were completed by 38 providers from 29 sites across the United States and Canada. AR-V7 test results were reported either as CTC- (28%), CTC+/AR-V7- (30%), or CTC+/AR-V7+ (42%). Prevalence of AR-V7 detection increased with prior exposure to ATTs (abiraterone and enzalutamide naïve, 22%; after abiraterone or enzalutamide, 35%; after abiraterone and enzalutamide, 43%). Overall, management was affected by AR-V7 testing in 53% of the patients and even more often with CTC+/AR-V7+ results. AR-V7+ patients were commonly switched from ATT to taxane chemotherapy (43%) or were offered a clinical trial (43%); management remained unchanged in only 14% of these patients. Overall, patients who had a change in management on the basis of AR-V7 testing were significantly more likely to achieve a physician-reported 50% decline in prostate-specific antigen response on next-line therapy than those who did not change treatment (54% v 31%; P = .015). Providers used AR-V7 testing to influence clinical decision making more often than not. Physicians reported thatmenwithAR-V7+results had the most treatment changes, and such men were preferentially managed with taxane therapy or offered a clinical trial, which may have improved outcomes.

Profiling the clinical presentation of diagnostic characteristics of a sample of symptomatic TMD patients.

PubMed

Pimenta e Silva Machado, Luciana; de Macedo Nery, Marianita Batista; de Góis Nery, Cláudio; Leles, Cláudio Rodrigues

2012-08-02

Temporomandibular disorder (TMD) patients might present a number of concurrent clinical diagnoses that may be clustered according to their similarity. Profiling patients' clinical presentations can be useful for better understanding the behavior of TMD and for providing appropriate treatment planning. The aim of this study was to simultaneously classify symptomatic patients diagnosed with a variety of subtypes of TMD into homogenous groups based on their clinical presentation and occurrence of comorbidities. Clinical records of 357 consecutive TMD patients seeking treatment in a private specialized clinic were included in the study sample. Patients presenting multiple subtypes of TMD diagnosed simultaneously were categorized according to the AAOP criteria. Descriptive statistics and two-step cluster analysis were used to characterize the clinical presentation of these patients based on the primary and secondary clinical diagnoses. The most common diagnoses were localized masticatory muscle pain (n = 125) and disc displacement without reduction (n = 104). Comorbidity was identified in 288 patients. The automatic selection of an optimal number of clusters included 100% of cases, generating an initial 6-cluster solution and a final 4-cluster solution. The interpretation of within-group ranking of the importance of variables in the clustering solutions resulted in the following characterization of clusters: chronic facial pain (n = 36), acute muscle pain (n = 125), acute articular pain (n = 75) and chronic articular impairment (n = 121). Subgroups of acute and chronic TMD patients seeking treatment can be identified using clustering methods to provide a better understanding of the clinical presentation of TMD when multiple diagnosis are present. Classifying patients into identifiable symptomatic profiles would help clinicians to estimate how common a disorder is within a population of TMD patients and understand the probability of certain pattern of clinical complaints.

Clinical history as a predictor of penicillin skin test outcome.

PubMed

Wong, Benjamin B L; Keith, Paul K; Waserman, Susan

2006-08-01

Up to 10% of the population reports an "allergy" to penicillin, whereas approximately 1.1% has positive penicillin skin test results. Where penicillin skin tests are unavailable, some have advocated using history to decide whether to use a penicillin-related antibiotic. To determine if clinical history predicts penicillin skin test results. Retrospective medical record review of 94 consecutive patients who had previously taken penicillin referred for penicillin allergy. Case histories were taken, penicillin skin tests performed, and an oral challenge recommended if skin test results were negative. Of 91 cases studied, the average patient age was 27 years (range, 6 months to 82 years; 36% female). Fifty-two (57%) experienced hives as their main adverse reaction. Sixteen (18%) had at least 1 positive test result. Of this group, 9 had hives as their main symptom, whereas 1 had respiratory problems and 1 had angioedema. Most patients with positive skin test results had experienced their reaction at least 3 years ago. Regression analysis showed that age, sex, and clinical history, including type of reaction, time of reaction after penicillin ingestion, or time since the last reaction, were not associated with skin test positivity. Seventy-two (96%) of the 75 patients who had negative skin test results underwent oral challenge. Seventy had negative challenge results. The negative predictive value of a negative penicillin skin test result was 97%. Clinical history was not predictive of subsequent penicillin skin test results.

Feasibility of computed tomography-guided core needle biopsy in producing state-of-the-art clinical management in Chinese lung cancer.

PubMed

Chen, Hua-Jun; Yang, Jin-Ji; Fang, Liang-Yi; Huang, Min-Min; Yan, Hong-Hong; Zhang, Xu-Chao; Xu, Chong-Rui; Wu, Yi-Long

2014-03-01

A satisfactory biopsy determines the state-of-the-art management of lung cancer in this era of personalized medicine. This study aimed to investigate the suitability and efficacy of computed tomography (CT)-guided core needle biopsy in clinical management. A cohort of 353 patients with clinically suspected lung cancer was enrolled in the study. Patient factors and biopsy variables were recorded. Epidermal growth factor receptor (EGFR) gene mutations and echinoderm microtubule-associated protein-like 4 (EML4)-anaplastic lymphoma kinase (ALK) rearrangement were detected in tumor specimens. Adequacy of biopsic obtainment for clinical trial screening and tissue bank establishment were reviewed. Overall diagnostic accuracy of malignancy achieved 98.5%. The median biopsy time of the cohort was 20 minutes. In patients with non-small cell lung cancer (NSCLC), 99.3% (287/289) were diagnosed as specific histologic subtypes, and two patients (0.7%) were determined as NSCLC not otherwise specified (NOS). EGFR mutations were analyzed in 81.7% (236/289) of patients with NSCLC, and 98.7% (233/236) showed conclusive results. EML4-ALK gene fusion was tested in 43.9% (127/289) of NSCLC patients, and 98.4% (125/127) showed conclusive results: 6.4% (8/125) of those had gene fusion. Ninety-six NSCLC patients participated in clinical trial screening and provided mandatory tumor slides for molecular profiling. Pathological evaluation was fulfilled in 90 patients (93.8%); 99.4% (320/322) of patients with malignancy provided extra tissue for the establishment of a tumor bank. CT-guided core needle biopsy provided optimal clinical management in this era of translational medicine. The biopsic modality should be prioritized in selected lung cancer patients.

[Short-term results of treatment with 131I in patients with multinodular goiter: effect of the associated degree of hyperthyroidism and other variables].

PubMed

Boj Carceller, D; Liévano Segundo, P; Navarro Beltrán, P; Sanz París, A; de Castro Hernández, P; Monreal Villanueva, M; Abós Olivares, D

2011-01-01

To assess the effectiveness of radioactive iodine (RAI) therapy and the incidence of hypothyroidism post RAI in patients with subclinical hyperthyroidism or clinical hyperthyroidism with Multinodular Goiter (MNG). A retrospective study of 69 consecutive patients treated with (131)I for MNG during the year 2008 observed for six months. All patients received a single fixed dose of 16 mCi (592 MBq) weighted by the gland size. They were categorized into two groups: subclinical hyperthyroidism or clinical hyperthyroidism. We compared the success rate and the incidence of hypothyroidism. The thyroid dysfunction was corrected in 82.09% of the patients. Success rate was 100% in the clinical hyperthyroidism group and 78.13% in the subclinical hyperthyroidism group (P=0.105). The overall incidence of hypothyroidism was 16.42%; 25.00% of patients with clinical hyperthyroidism and 14.55% with subclinical hyperthyroidism developed this secondary effect (P=0.400). No statistically significant differences were found in the success rate in the incidence of hypothyroidism when the results were analyzed according to the thyrotropin decrease in patients with subclinical hyperthyroidism. Seven patients had positive anti-thyroid peroxidase antibodies (anti-TPO) before therapy. The incidence of hypothyroidism was significantly higher in them (57.14% vs 11.67%; P=0.011). Cardiac arrhythmias were four times more frequent in patients with clinical hyperthyroidism. Previous treatment with thiamazol positively affected the outcome. A single fixed weighted dose of (131)I is highly effective and safe for the control of clinical and subclinical hyperthyroidism due to MNG. Patients with anti-TPO antibodies may have a high risk of developing post-iodine hypothyroidism. Copyright © 2010 Elsevier España, S.L. y SEMNIM. All rights reserved.

High sensitivity and specificity of a new functional flow cytometry assay for clinically significant heparin-induced thrombocytopenia antibodies.

PubMed

Garritsen, H S; Probst-Kepper, M; Legath, N; Eberl, W; Samaniego, S; Woudenberg, J; Schuitemaker, J H N; Kroll, H; Gurney, D A; Moore, G W; Zehnder, J L

2014-04-01

Heparin-induced thrombocytopenia (HIT) is a life-threatening condition, in which the anticoagulant heparin, platelet factor 4 (PF4), and platelet-activating antibodies form complexes with prothrombotic properties. Laboratory tests to support clinical diagnosis are subdivided into functional, platelet activation assays, which lack standardization, or immunological assays, which have moderate specificity toward HIT. In this study, clinical performance of HITAlert, a novel in vitro diagnostic (IVD) registered platelet activation assay, was tested in a large cohort of HIT-suspected patients and compared with immunological assays. From 346 HIT-suspected patients (single center), clinical data including 4T pretest probability results, citrated platelet-poor plasmas, and sera were collected, allowing direct comparison of clinical observations with HITAlert results. HITAlert performance was compared with PF4 IgG ELISA (246 patients, three centers) and PF4 PaGIA (298 patients, single center). HITAlert showed high sensitivity (88.2%) and specificity (99.1%) when compared with clinical diagnosis. Agreement of HITAlert with PF4 ELISA- and PF4 PaGIA-positive patients is low (52.7 and 23.2%, respectively), while agreement with PF4 IgG ELISA- and PF4 PaGIA-negative patients is very high (98.1 and 99.1%, respectively). HITAlert performance is excellent when compared with clinical HIT diagnosis, making it a suitable assay for rapid testing of platelet activation due to anticoagulant therapy. © 2013 John Wiley & Sons Ltd.

Clinical and immunologic follow-up of patients who stop venom immunotherapy.

PubMed

Keating, M U; Kagey-Sobotka, A; Hamilton, R G; Yunginger, J W

1991-09-01

We prospectively studied 51 self-selected Hymenoptera sting-sensitive patients to determine (1) whether a minimal or optimal duration for venom immunotherapy (VIT) exists and (2) whether clinical or immunologic parameters exist that are predictive of clinical immunity after VIT was stopped. After 2 to 10 years of VIT, all patients had deliberate sting challenges (DSCs) from live insects. If DSCs were tolerated, patients voluntarily stopped VIT and returned annually for repeat venom skin tests (VSTs) and DSCs. In most patients, it was possible to monitor VST and venom-specific antibody (Ab) levels before and after VIT was stopped. One-year after VIT, VST and venom-specific IgE and IgG Ab level results were variable; 49 patients tolerated DSC, whereas two patients exhibited generalized reactions. These two patients had pre-VIT histories of grade IV field-sting reactions and had received VIT for 2 years and 4 years, respectively. The short-term (1 year) risk of recurrence of clinical allergy to stings after VIT was higher in patients who had experienced grade IV field-sting reactions before VIT versus patients experiencing grade I to III reactions before VIT (2/15, 13% versus 0/36, 0%) and higher in patients who had received VIT for less than 5 years versus patients who received VIT for 5 or more years (2/20, 10% versus 0/31, 0%). We suggest that VIT should be continued for 5 years in patients with pre-VIT field-sting reactions of grade IV severity. VST and venom-specific Ab results do not reliably predict the outcome of DSC or the subsequent clinical course in individual patients stopping VIT.

Osteochondral transplantation of the talus: long-term clinical and magnetic resonance imaging evaluation.

PubMed

Imhoff, Andreas B; Paul, Jochen; Ottinger, Benjamin; Wörtler, Klaus; Lämmle, Lena; Spang, Jeffrey; Hinterwimmer, Stefan

2011-07-01

Osteochondral lesions of the ankle are a common injury after ankle sprains, especially in young and active patients. The Osteochondral Autograft Transfer System (OATS) is the only 1-step surgical technique designed to replace the entire osteochondral unit. This study was conducted to evaluate the long-term clinical and radiographic outcomes of the OATS procedure for the talus and compare the results of patients who have had prior surgical interventions with patients for whom OATS represents the primary surgical treatment. Case series; Level of evidence, 4. The authors retrospectively analyzed 26 talus OATS procedures (25 patients) with an average follow-up of 84 months (range, 53-124 months); 9 patients had OATS as a second surgical intervention. The patients completed the American Orthopaedic Foot & Ankle Society (AOFAS) and Tegner scores plus the visual analog scale (VAS) preoperatively and at follow-up. Magnetic resonance imaging examinations were conducted on a 1.5-T whole-body magnet that assessed transplant congruency, adjacent surface of the talus, the corresponding distal tibia, and joint effusion. The authors found significant increases for the AOFAS score (50 to 78 points, P < .01) and the Tegner score (3.1 to 3.7, P < .05) and a significant decrease for the VAS (7.8 to 1.5, P < .01) from preoperative to postoperative. Patients with normal integration or minor incongruity of the transplant on magnetic resonance imaging (81%) had significantly better AOFAS scores (P = .03). Other magnetic resonance imaging criteria did not predict clinical results. Patients for whom OATS represented a second procedure had significantly worse clinical AOFAS and Tegner scores plus a higher VAS. Long-term clinical and magnetic resonance imaging results after osteochondral transplantation are good and patients significantly benefit from this surgery. Magnetic resonance imaging should not be a routine control but appears to be indicated when clinical symptoms persist after osteochondral transplantation.

Clinical outcome of surgical treatment of the symptomatic accessory navicular.

PubMed

Kopp, Franz J; Marcus, Randall E

2004-01-01

When conservative treatment fails to provide relief for a symptomatic accessory navicular, surgical intervention may be necessary. Numerous studies have been published, reporting the results of the traditional Kidner procedure and alternative surgical techniques, all of which produce mostly satisfactory clinical outcomes. The purpose of this study was to report the clinical results, utilizing the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Scale, of surgical management for symptomatic accessory navicular with simple excision and anatomic repair of the tibialis posterior tendon. The authors retrospectively reviewed the results of 13 consecutive patients (14 feet) who underwent surgical treatment for symptomatic accessory navicular. The patients ranged in age from 16 to 64 years (average, 34.1 years; mean, 28.2 years) at the time of surgery. All patients had a type II accessory navicular. The average follow-up of the patients involved in the study was 103.4 months (range, 45-194 months). The AOFAS Midfoot Scale was utilized to determine both preoperative and postoperative clinical status of the 14 feet included in the study. The average preoperative AOFAS score was 48.2 (range, 20-75; mean, 38.8). The average postoperative AOFAS score was 94.5 (range, 83-100; mean, 94.3). At last follow-up, 13 of 14 feet were without any pain, no patients had activity limitations, and only two of 14 feet required shoe insert modification. Postoperatively, no patients had a clinically notable change in their preoperative midfoot longitudinal arch alignment. All of the patients in the study were satisfied with the outcome of their surgery and would undergo the same operation again under similar circumstances. When conservative measures fail to relieve the symptoms of a painful accessory navicular, simple excision of the accessory navicular and anatomic repair of the posterior tibialis tendon is a successful intervention. Overall, the procedure provides reliable pain relief and patient satisfaction. In the current study, the clinical status of each patient improved significantly postoperatively, quantified utilizing the AOFAS Midfoot Scale.

Using discrete-event simulation in strategic capacity planning for an outpatient physical therapy service.

PubMed

Rau, Chi-Lun; Tsai, Pei-Fang Jennifer; Liang, Sheau-Farn Max; Tan, Jhih-Cian; Syu, Hong-Cheng; Jheng, Yue-Ling; Ciou, Ting-Syuan; Jaw, Fu-Shan

2013-12-01

This study uses a simulation model as a tool for strategic capacity planning for an outpatient physical therapy clinic in Taipei, Taiwan. The clinic provides a wide range of physical treatments, with 6 full-time therapists in each session. We constructed a discrete-event simulation model to study the dynamics of patient mixes with realistic treatment plans, and to estimate the practical capacity of the physical therapy room. The changes in time-related and space-related performance measurements were used to evaluate the impact of various strategies on the capacity of the clinic. The simulation results confirmed that the clinic is extremely patient-oriented, with a bottleneck occurring at the traction units for Intermittent Pelvic Traction (IPT), with usage at 58.9 %. Sensitivity analysis showed that attending to more patients would significantly increase the number of patients staying for overtime sessions. We found that pooling the therapists produced beneficial results. The average waiting time per patient could be reduced by 45 % when we pooled 2 therapists. We found that treating up to 12 new patients per session had no significantly negative impact on returning patients. Moreover, we found that the average waiting time for new patients decreased if they were given priority over returning patients when called by the therapists.

Blood pressure control with cilnidipine treatment in Japanese post-stroke hypertensive patients: The CA-ATTEND study.

PubMed

Aoki, Shiro; Hosomi, Naohisa; Nezu, Tomohisa; Teshima, Tsukasa; Sugii, Hitoshi; Nagahama, Shinobu; Kurose, Yoshiki; Maruyama, Hirofumi; Matsumoto, Masayasu

2017-01-01

Blood pressure control is important in post-stroke hypertensive patients and antihypertensive treatment is recommended for such patients. Ca-channel blockers are recommended as the medications of choice for the treatment of post-stroke patients. Here, we report the results of a large-scale prospective post-marketing surveillance study of post-stroke hypertensive patients (n = 2667, male 60.4%, 69.0 ± 10.9 years) treated with cilnidipine, with regard to blood pressure control and adverse reactions. Cilnidipine treatment caused a decrease in both clinic and home blood pressures 2 months after the beginning of treatment, and the decreased blood pressure was maintained until the end of 12 months' observation. The proportion of patients in whom clinic blood pressure was well controlled (<140/90 mmHg) increased from 21.5% to 65.3% in cilnidipine treatment, with no differences in effectiveness among the various clinical subtypes of stroke. In total, 346 adverse events occurred, with an overall incidence of 8.9% (238 of 2667 patients). In the elderly group, specifically, a fall and a hip fracture each occurred in 1 (0.1%) patient. These results indicate that cilnidipine was effective in treating uncontrolled blood pressure and was well tolerated in Japanese post-stroke hypertensive patients in a real-world clinical setting.

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.

Landscape of Familial Isolated and Young-Onset Pituitary Adenomas: Prospective Diagnosis in AIP Mutation Carriers

PubMed Central

Hernández-Ramírez, Laura C.; Gabrovska, Plamena; Dénes, Judit; Stals, Karen; Trivellin, Giampaolo; Tilley, Daniel; Ferraù, Francesco; Evanson, Jane; Ellard, Sian; Grossman, Ashley B.; Roncaroli, Federico; Gadelha, Mônica R.

2015-01-01

Context: Familial isolated pituitary adenoma (FIPA) due to aryl hydrocarbon receptor interacting protein (AIP) gene mutations is an autosomal dominant disease with incomplete penetrance. Clinical screening of apparently unaffected AIP mutation (AIPmut) carriers could identify previously unrecognized disease. Objective: To determine the AIP mutational status of FIPA and young pituitary adenoma patients, analyzing their clinical characteristics, and to perform clinical screening of apparently unaffected AIPmut carrier family members. Design: This was an observational, longitudinal study conducted over 7 years. Setting: International collaborative study conducted at referral centers for pituitary diseases. Participants: FIPA families (n = 216) and sporadic young-onset (≤30 y) pituitary adenoma patients (n = 404) participated in the study. Interventions: We performed genetic screening of patients for AIPmuts, clinical assessment of their family members, and genetic screening for somatic GNAS1 mutations and the germline FGFR4 p.G388R variant. Main Outcome Measure(s): We assessed clinical disease in mutation carriers, comparison of characteristics of AIPmut positive and negative patients, results of GNAS1, and FGFR4 analysis. Results: Thirty-seven FIPA families and 34 sporadic patients had AIPmuts. Patients with truncating AIPmuts had a younger age at disease onset and diagnosis, compared with patients with nontruncating AIPmuts. Somatic GNAS1 mutations were absent in tumors from AIPmut-positive patients, and the studied FGFR4 variant did not modify the disease behavior or penetrance in AIPmut-positive individuals. A total of 164 AIPmut-positive unaffected family members were identified; pituitary disease was detected in 18 of those who underwent clinical screening. Conclusions: A quarter of the AIPmut carriers screened were diagnosed with pituitary disease, justifying this screening and suggesting a variable clinical course for AIPmut-positive pituitary adenomas. PMID:26186299

Automatic Exposure Control Systems Designed to Maintain Constant Image Noise: Effects on Computed Tomography Dose and Noise Relative to Clinically Accepted Technique Charts

PubMed Central

Favazza, Christopher P.; Yu, Lifeng; Leng, Shuai; Kofler, James M.; McCollough, Cynthia H.

2015-01-01

Objective To compare computed tomography dose and noise arising from use of an automatic exposure control (AEC) system designed to maintain constant image noise as patient size varies with clinically accepted technique charts and AEC systems designed to vary image noise. Materials and Methods A model was developed to describe tube current modulation as a function of patient thickness. Relative dose and noise values were calculated as patient width varied for AEC settings designed to yield constant or variable noise levels and were compared to empirically derived values used by our clinical practice. Phantom experiments were performed in which tube current was measured as a function of thickness using a constant-noise-based AEC system and the results were compared with clinical technique charts. Results For 12-, 20-, 28-, 44-, and 50-cm patient widths, the requirement of constant noise across patient size yielded relative doses of 5%, 14%, 38%, 260%, and 549% and relative noises of 435%, 267%, 163%, 61%, and 42%, respectively, as compared with our clinically used technique chart settings at each respective width. Experimental measurements showed that a constant noise–based AEC system yielded 175% relative noise for a 30-cm phantom and 206% relative dose for a 40-cm phantom compared with our clinical technique chart. Conclusions Automatic exposure control systems that prescribe constant noise as patient size varies can yield excessive noise in small patients and excessive dose in obese patients compared with clinically accepted technique charts. Use of noise-level technique charts and tube current limits can mitigate these effects. PMID:25938214

The impact of renal protection clinics on prescription of and adherence to cardioprotective drug therapy in chronic kidney disease patients.

PubMed

Lepeytre, Fanny; Cardinal, Héloise; Fradette, Lorraine; Verhave, Jacobien; Dorais, Marc; LeLorier, Jacques; Pichette, Vincent; Madore, François

2017-06-01

Background: The aim of this study was to assess the impact of follow-up in renal protection clinics on the prescription of and adherence to cardioprotective drugs in patients with chronic kidney disease (CKD). Methods: We studied stage 4 and 5 CKD patients who initiated follow-up in three renal protection clinics. The prescription pattern of antihypertensive agents (AHA) and lipid-lowering agents (LLAs) was measured as the percentage of patients who are prescribed the agents of interest at a given time. Adherence to drug therapy was defined as the percentage of days, during a pre-defined observation period, in which patients have an on-hand supply of their prescribed medications. Results: A total of 259 CKD patients were enrolled and followed for up to 1 year after referral to renal protection clinics. There was a significant increase in the prescription of angiotensin-converting enzyme inhibitors (34-39%), angiotensin II receptor blockers (11-14%), beta-blockers (40-51%), calcium channel blockers (62-74%), diuretics (66-78%) and LLAs (39-47%) during follow-up in the renal protection clinic compared with baseline (P-values <0.01 for all comparisons). The proportions of patients with good (≥ 80%) and poor (< 80%) adherence to AHA (P = 0.41) and LLAs (P = 0.11) were similar in the year preceding and the year following the first visit to the renal protection clinics. Conclusion: Our results suggest that referral and follow-up in a renal protection clinic may increase the prescription of cardioprotective agents in CKD patients, but does not appear to improve adherence to these medications.

Using Text Messaging in Long-Term Arthroplasty Follow-Up: A Pilot Study.

PubMed

Blocker, Oliver; Bullock, Alison; Morgan-Jones, Rhidian; Ghandour, Adel; Richardson, James

2017-05-16

Patient-reported outcome measures (PROMs) and mobile technology have the potential to change the way patients are monitored following joint replacement surgery. The aim of this study was to determine the feasibility of text messaging to record PROMs in long-term follow-up of hip and knee arthroplasty. Our participants were 17 patients 2-years-plus post hip or knee arthroplasty attending clinic with a mobile telephone number on record. A simple PROM (Oswestry Very Short Form) was texted to the patient. Responses were compared to clinical, radiographic, and existing PROM findings. Patients were interviewed to discover their opinions on this use of texting. A total of 11 patients engaged with the text messaging. Reasons for not engaging included wrong numbers, physical barriers, and lack of understanding. A total of 8 patients attending clinic allowed comparison of text messaging with clinical findings. The average age was 70 years. A total of 4 patient text messaging responses matched clinical and radiographic findings; 3 also matched PROM scores collected in clinic. The 3 patients with mixed responses had abnormal clinical, radiographic, or PROM findings. One patient's text responses conflicted with clinical outcome. Analysis of patients' views showed a generally positive opinion: patients were happy to communicate with surgeons by text. Practical problems, PROM limitations, and trustworthiness of texting were highlighted. Engaging with changing technology creates challenges for patients and health care professionals. Despite this, our results suggest text messaging is a promising way to communicate with arthroplasty patients. Earlier integration of text communication in the patient pathway may be important and needs further research. ©Oliver Blocker, Alison Bullock, Rhidian Morgan-Jones, Adel Ghandour, James Richardson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.05.2017.

Foreign exam management in practice: seamless access to foreign images and results in a regional environment.

PubMed

Nagels, Jason; MacDonald, David; Parker, David

2015-04-01

A challenge for many clinical users is that a patient may receive a diagnostic imaging (DI) service at a number of hospitals or private imaging clinics. The DI services that patients receive at other locations could be clinically relevant to current treatments, but typically, there is no seamless method for a clinical user to access longitudinal DI results for their patient. Radiologists, and other specialists that are intensive users of image data, require seamless ingestion of foreign exams into the picture archiving and communication system (PACS) to achieve full clinical value. Most commonly, a clinical user will depend on the patient to bring in a CD that contains imaging from another location. However, a number of issues can arise when using this type of solution. Firstly, a CD will not provide the clinical user with the full longitudinal record of the patient. Secondly, a CD often will not contain the report associated with the images. Finally, a CD is not seamless, due to the need to manually import the contents of the CD into the local PACS. In order to overcome these limitations, and provide clinical users with a greater benefit related to a patient's longitudinal DI history, the implementation of foreign exam management (FEM) at the local site level is required. This paper presents the experiences of FEM in practice. By leveraging industry standards and edge devices to support FEM, multiple sites with disparate PACS and radiology information system (RIS) vendors are able to seamlessly ingest foreign exams within their local PACS as if they are local exams.

Clinical trials of a personal electrocardiograph

NASA Astrophysics Data System (ADS)

Boyakhchyan, A.; Lezhnina, I.; Overchuk, K.; Perchatkin, V.; Lvova, A.; Alexander, U.

2018-05-01

The article describes the results of a clinical trial at the Cardiology Research Institute in Tomsk. Clinical trials were conducted to identify different important information for diagnosis. These tests were also conducted to remotely monitor the treatment of patients who had already been discharged from the hospital.The study involved 15 patients, the most interesting cases are described in this article.

Does ownership matter for the provision of professionalized services? Hip operations at publicly and privately owned clinics in Denmark.

PubMed

Andersen, Lotte Bøgh; Jakobsen, Mads Leth Felsager

2011-01-01

In terms of clinical procedures (to take the example used in this article, hip operations), both public and private organizations provide highly professionalized services. For this service type, our knowledge about ownership differences is sparse. To begin to fill this gap, we investigate how the ownership of hip clinics affects professional behaviour, treatment quality and patient satisfaction. The comparison of private and public hip clinics is based on data from the Danish Hip Arthroplasty Register and the Danish Central Patient Register combined with 20 semi-structured interviews. We find that private clinics employ stronger individual financial incentives and try harder to increase the income/costs ratio than do public clinics. Private clinics optimize non-clinical factors such as waiting time much more than public clinics and have fewer complication-prone patients than public clinics. However, the clinical procedures are very similar in the two types of clinics. Private clinics do not achieve better clinical results, but patient satisfaction is nevertheless higher with private clinics. The implication is that ownership matters for highly professionalized services, but professionalism neutralizes some – but not all – ownership differences.

Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire

PubMed Central

Kocks, JWH; Tuinenga, MG; Uil, SM; van den Berg, JWK; Ståhl, E; van der Molen, T

2006-01-01

Background Patient-reported outcomes (PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ) in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM). Methods Patients were ≥40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1–7 and 42. A Global Rating of Change (GRC) assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis. Results 210 patients were recruited, 168 completed the CCQ questionnaire on Day42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21. Conclusion This investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4. PMID:16603063

Diabetes quality improvement in Department of Veterans Affairs Ambulatory Care Clinics: a group-randomized clinical trial.

PubMed

Reiber, Gayle E; Au, David; McDonell, Mary; Fihn, Stephan D

2004-05-01

To conduct a group-randomized clinical trial to determine whether regular feedback to primary care providers of synthesized information on patients' health, function, and satisfaction would demonstrate improved outcomes for their patients with diabetes. Patients in General Internal Medicine Clinics Department of Veterans Affairs (VA) Medical Centers were randomized into seven intervention or control firms. Patient self-reported information was collected by mail on general health, diabetes, and up to five other chronic conditions. Patients with diabetes received the Seattle Diabetes Questionnaire, the 36-item Medical Outcomes Study short form (SF-36), and a validated patient satisfaction questionnaire at regular intervals. Data from self-report, clinical, pharmacy, and laboratory sources were synthesized into patient-specific feedback reports that intervention providers received before patients' visits. The timely delivery to primary care providers of state-of-the-art patient-feedback reports that identified patient issues and areas for improvement did not result in significant improvements in patient outcomes between the intervention and control firms. Outcomes in diabetic patients whose providers received synthesized patient data before visits were no better than in those receiving care from control firms. Future studies may benefit from substantial involvement in patients discussing, problem solving, and goal setting in addition to use of timely synthesized patient data.

Identification of Clinical Phenotypes in Idiopathic Interstitial Pneumonia with Pulmonary Emphysema.

PubMed

Sato, Suguru; Tanino, Yoshinori; Misa, Kenichi; Fukuhara, Naoko; Nikaido, Takefumi; Uematsu, Manabu; Fukuhara, Atsuro; Wang, Xintao; Ishida, Takashi; Munakata, Mitsuru

2016-01-01

Objective Since the term "combined pulmonary fibrosis and emphysema" (CPFE) was first proposed, the co-existence of pulmonary fibrosis and pulmonary emphysema (PE) has drawn considerable attention. However, conflicting results on the clinical characteristics of patients with both pulmonary fibrosis and PE have been published because of the lack of an exact definition of CPFE. The goal of this study was thus to clarify the clinical characteristics and phenotypes of idiopathic interstitial pneumonia (IIP) with PE. Methods We retrospectively analyzed IIP patients who had been admitted to our hospital. Their chest high-resolution computed tomography images were classified into two groups according to the presence of PE. We then performed a cluster analysis to identify the phenotypes of IIP patients with PE. Results Forty-four (53.7%) out of 82 patients had at least mild emphysema in their bilateral lungs. The cluster analysis separated the IIP patients with PE into three clusters. The overall survival rate of one cluster that consisted of mainly idiopathic pulmonary fibrosis (IPF) patients was significantly worse than those of the other clusters. Conclusion Three different phenotypes can be identified in IIP patients with PE, and IPF with PE is a distinct clinical phenotype with a poor prognosis.

Increasing colonoscopy screening in disparate populations: Results from an evaluation of patient navigation in the New Hampshire Colorectal Cancer Screening Program.

PubMed

Rice, Ketra; Gressard, Lindsay; DeGroff, Amy; Gersten, Joanne; Robie, Janene; Leadbetter, Steven; Glover-Kudon, Rebecca; Butterly, Lynn

2017-09-01

To investigate uniformly successful results from a statewide program of patient navigation (PN) for colonoscopy, this comparison study evaluated the effectiveness of the PN intervention by comparing outcomes for navigated versus non-navigated patients in one of the community health clinics included in the statewide program. Outcomes measured included screening completion, adequacy of bowel preparation, missed appointments and cancellations, communication of test results, and consistency of follow-up recommendations with clinical guidelines. The authors compared a subset of 131 patients who were navigated to a screening or surveillance colonoscopy with a similar subset of 75 non-navigated patients at one endoscopy clinic. The prevalence and prevalence odds ratios were computed to measure the association between PN and each study outcome measure. Patients in the PN intervention group were 11.2 times more likely to complete colonoscopy than control patients (96.2% vs 69.3%; P<.001), and were 5.9 times more likely to have adequate bowel preparation (P =.010). In addition, intervention patients had no missed appointments compared with 15.6% of control patients, and were 24.8 times more likely to not have a cancellation <24 hours before their appointment (P<.001). All navigated patients and their primary care providers received test results, and all follow-up recommendations were consistent with clinical guidelines compared with 82.4% of patients in the control group (P<.001). PN appears to be effective for improving colonoscopy screening completion and quality in the disparate populations most in need of intervention. To the best of our knowledge, the results of the current study demonstrate some of the strongest evidence for the effectiveness of PN to date, and highlight its value for public health. Cancer 2017;123:3356-66. © 2017 American Cancer Society. © 2017 American Cancer Society.

Semi-Automatic Segmentation Software for Quantitative Clinical Brain Glioblastoma Evaluation

PubMed Central

Zhu, Y; Young, G; Xue, Z; Huang, R; You, H; Setayesh, K; Hatabu, H; Cao, F; Wong, S.T.

2012-01-01

Rationale and Objectives Quantitative measurement provides essential information about disease progression and treatment response in patients with Glioblastoma multiforme (GBM). The goal of this paper is to present and validate a software pipeline for semi-automatic GBM segmentation, called AFINITI (Assisted Follow-up in NeuroImaging of Therapeutic Intervention), using clinical data from GBM patients. Materials and Methods Our software adopts the current state-of-the-art tumor segmentation algorithms and combines them into one clinically usable pipeline. Both the advantages of the traditional voxel-based and the deformable shape-based segmentation are embedded into the software pipeline. The former provides an automatic tumor segmentation scheme based on T1- and T2-weighted MR brain data, and the latter refines the segmentation results with minimal manual input. Results Twenty six clinical MR brain images of GBM patients were processed and compared with manual results. The results can be visualized using the embedded graphic user interface (GUI). Conclusion Validation results using clinical GBM data showed high correlation between the AFINITI results and manual annotation. Compared to the voxel-wise segmentation, AFINITI yielded more accurate results in segmenting the enhanced GBM from multimodality MRI data. The proposed pipeline could be used as additional information to interpret MR brain images in neuroradiology. PMID:22591720

Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes

PubMed Central

Stargardt, Tom; Gonder-Frederick, Linda; Krobot, Karl J; Alexander, Charles M

2009-01-01

Background To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia. Methods An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia. Results 112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0). Conclusion We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents. PMID:19849828

Microbial and Antibiotic Susceptibility Profile among Clinical Samples of Patients with Acute Leukemia.

PubMed

Abdollahi, Alireza; Hakimi, Faezeh; Doomanlou, Mahsa; Azadegan, Azadeh

2016-04-01

Preventing and starting early treatment of infections in patients whose immunity system is weak due to malignancies like leukemia can reduce mortality. This study aimed to determine microbial and antibiotic resistance patterns in clinical samples of patients with acute leukemia to start early treatment before the results of clinical tests are known. In this cross-sectional study, the clinical samples of all patients hospitalized with the diagnosis of acute leukemia were cultured and their antibiogram was evaluated. Then, the data were analyzed by SPSS 18 based on the objectives of the study. Of a total of 2,366 samples, 18.95% were reported to be positive blood samples, 22.96% were reported to be urine samples and 36% wound samples. E. coli was the most common bacteria isolated from the blood and urine cultures (34% in blood, 32% in urine culture) while Staphylococcus Aureus was the most common in the wound culture (35%). The highest level of sensitivity in the organisms with positive blood culture was to Ciprofloxacin, while in positive urine and wound culture was to Imipenem. The highest resistance in blood, urine and wound culture was to Cotrimoxazole. According to results obtained from this study, it is necessary to conduct appropriate studies on this issue in specific conditions in our country. The findings of this study can be used in clinics for more accurate diagnosis, more effective treatment before the results of clinical tests are known and also for prevention of infection in cancer patients.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials

PubMed Central

Rose, Klaus; Kummer, Hans

2015-01-01

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients. PMID:27417359

Computerised mirror therapy with Augmented Reflection Technology for early stroke rehabilitation: clinical feasibility and integration as an adjunct therapy.

PubMed

Hoermann, Simon; Ferreira Dos Santos, Luara; Morkisch, Nadine; Jettkowski, Katrin; Sillis, Moran; Devan, Hemakumar; Kanagasabai, Parimala S; Schmidt, Henning; Krüger, Jörg; Dohle, Christian; Regenbrecht, Holger; Hale, Leigh; Cutfield, Nicholas J

2017-07-01

New rehabilitation strategies for post-stroke upper limb rehabilitation employing visual stimulation show promising results, however, cost-efficient and clinically feasible ways to provide these interventions are still lacking. An integral step is to translate recent technological advances, such as in virtual and augmented reality, into therapeutic practice to improve outcomes for patients. This requires research on the adaptation of the technology for clinical use as well as on the appropriate guidelines and protocols for sustainable integration into therapeutic routines. Here, we present and evaluate a novel and affordable augmented reality system (Augmented Reflection Technology, ART) in combination with a validated mirror therapy protocol for upper limb rehabilitation after stroke. We evaluated components of the therapeutic intervention, from the patients' and the therapists' points of view in a clinical feasibility study at a rehabilitation centre. We also assessed the integration of ART as an adjunct therapy for the clinical rehabilitation of subacute patients at two different hospitals. The results showed that the combination and application of the Berlin Protocol for Mirror Therapy together with ART was feasible for clinical use. This combination was integrated into the therapeutic plan of subacute stroke patients at the two clinical locations where the second part of this research was conducted. Our findings pave the way for using technology to provide mirror therapy in clinical settings and show potential for the more effective use of inpatient time and enhanced recoveries for patients. Implications for Rehabilitation Computerised Mirror Therapy is feasible for clinical use Augmented Reflection Technology can be integrated as an adjunctive therapeutic intervention for subacute stroke patients in an inpatient setting Virtual Rehabilitation devices such as Augmented Reflection Technology have considerable potential to enhance stroke rehabilitation.

Facial transplantation: A concise update

PubMed Central

Barrera-Pulido, Fernando; Gomez-Cia, Tomas; Sicilia-Castro, Domingo; Garcia-Perla-Garcia, Alberto; Gacto-Sanchez, Purificacion; Hernandez-Guisado, Jose-Maria; Lagares-Borrego, Araceli; Narros-Gimenez, Rocio; Gonzalez-Padilla, Juan D.

2013-01-01

Objectives: Update on clinical results obtained by the first worldwide facial transplantation teams as well as review of the literature concerning the main surgical, immunological, ethical, and follow-up aspects described on facial transplanted patients. Study design: MEDLINE search of articles published on “face transplantation” until March 2012. Results: Eighteen clinical cases were studied. The mean patient age was 37.5 years, with a higher prevalence of men. Main surgical indication was gunshot injuries (6 patients). All patients had previously undergone multiple conventional surgical reconstructive procedures which had failed. Altogether 8 transplant teams belonging to 4 countries participated. Thirteen partial face transplantations and 5 full face transplantations have been performed. Allografts are varied according to face anatomical components and the amount of skin, muscle, bone, and other tissues included, though all were grafted successfully and remained viable without significant postoperative surgical complications. The patient with the longest follow-up was 5 years. Two patients died 2 and 27 months after transplantation. Conclusions: Clinical experience has demonstrated the feasibility of facial transplantation as a valuable reconstructive option, but it still remains considered as an experimental procedure with unresolved issues to settle down. Results show that from a clinical, technical, and immunological standpoint, facial transplantation has achieved functional, aesthetic, and social rehabilitation in severely facial disfigured patients. Key words:Face transplantation, composite tissue transplantation, face allograft, facial reconstruction, outcomes and complications of face transplantation. PMID:23229268

Paradoxical results of two automated real-time PCR assays in the diagnosis of pleural tuberculosis.

PubMed

Morales-López, Soraya E; Yepes, Jayr A; Anzola, Irina; Aponte, Hernán; Llerena-Polo, Claudia R

2017-01-01

Tuberculosis (TB) is a major cause of worldwide mortality. We report the case of a non-HIV-infected woman with clinical suspicion of pleural tuberculosis and contradictory results between Xpert ® MTB/RIF and Abbott RealTime MTB assays from pleural fluid specimen. Liquid and solid cultures for tuberculosis were performed with negative results. The patient received treatment, and clinical improvement was observed. Both techniques detect Mycobacterium tuberculosis complex, but they have different targets and limits of detection. Abbott RealTime MTB results correlated well with the clinical findings of the patient. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The effect of multidisciplinary heart failure clinic characteristics on 1-year postdischarge health care costs: a population-based study.

PubMed

Wijeysundera, Harindra C; Austin, Peter C; Wang, Xuesong; Bennell, Maria C; Abrahamyan, Lusine; Ko, Dennis T; Tu, Jack V; Krahn, Murray

2014-03-01

Although multidisciplinary heart failure (HF) clinics are efficacious, it is not known how patient factors or HF clinic structural indicators and process measures have an impact on the cumulative health care costs. In this retrospective cohort study using administrative databases in Ontario, Canada, we identified 1216 HF patients discharged alive after an acute care hospitalization in 2006 and treated at a HF clinic. The primary outcome was the cumulative 1-year health care costs. A hierarchical generalized linear model with a logarithmic link and gamma distribution was developed to determine patient-level and clinic-level predictors of cost. The mean 1-year cost was $27,809 (range, $69 to $343,743). There was a 7-fold variation in the mean costs by clinic, from $14,670 to $96,524. Delays in being seen at a HF clinic were a significant patient-level predictor of costs (rate ratio 1.0015 per day; P<0.001). Being treated at a clinic with >3 physicians was associated with lower costs (rate ratio 0.78; P=0.035). Unmeasured patient-level differences accounted for 97.4% of the between-patient variations in cost. The between-clinic variation in costs decreased by 16.3% when patient-level factors were accounted for; it decreased by a further 49.8% when clinic-level factors were added. From a policy perspective, the wide spectrum of HF clinic structure translates to inefficient care. Greater guidance as to the type of patient seen at a HF clinic, the timeliness of the initial visit, and the most appropriate structure of the HF clinics may potentially result in more cost-effective care.

Patient access and clinical efficiency improvement in a resident hospital-based women's medicine center clinic.

PubMed

Bush, Stephen H; Lao, Michael R; Simmons, Kathy L; Goode, Jeff H; Cunningham, Steve A; Calhoun, Byron C

2007-12-01

To apply the Six Sigma tools of Change Acceleration Process and Work-Out and to improve patient access in an outpatient clinic in a hospital-based residency training program. Observational study. Comparison of productivity in an obstetrics and gynecology clinic after implementation of the Six Sigma principles, with a comparable internal medicine clinic as a control group. Productivity from January 1 through December 31, 2005, was assessed in both clinics. After applying the Six Sigma tools to obstetrics and gynecology, outputs from both clinics from January 1 through December 31, 2006, were analyzed. Wait times for new obstetrical visits decreased from 38 to 8 days. The patient time spent in the clinic dropped from 3.2 to 1.5 hours. Initial gynecologic visits increased by 87% (from 453 to 850 per year), return gynecologic visits increased by 66% (from 1392 to 2311 per year), initial obstetrical visits increased by 55% (from 520 to 808 per year), repeat obstetrical visits increased by 45% (from 2239 to 3243 per year), and the mean patient satisfaction scores increased from 5.75 to 8.54 (on a 10-point scale). The gross clinic revenue increased by 73% in the first 6 months of 2006 over that of the previous year. By contrast, internal medicine patient wait times for new patients and for revisits, patient satisfaction scores, total number of clinic visits, and revenues remained unchanged. Application of the Six Sigma principles resulted in a team approach to solving the clinic's productivity issues.

Physicians' Religious Topic Avoidance during Clinical Interactions.

PubMed

Villagran, Melinda M; MacArthur, Brenda L; Lee, Lauren E; Ledford, Christy J W; Canzona, Mollie R

2017-05-08

Religious and spiritual (R/S) conversations at the end-of-life function to help patients and their families find comfort in difficult circumstances. Physicians who feel uncertain about how to discuss topics related to religious beliefs may seek to avoid R/S conversations with their patients. This study utilized a two-group objective structured clinical examination with a standardized patient to explore differences in physicians' use of R/S topic avoidance tactics during a clinical interaction. Results indicated that physicians used more topic avoidance tactics in response to patients' R/S inquiries than patients' R/S disclosures; however, the use of topic avoidance tactics did not eliminate the need to engage in patient-initiated R/S interactions.

Comparation of clinical and paraclinical findings among patient with Kawasaki disease in Bandar abbas Koodakan Hospital in 2011-14

NASA Astrophysics Data System (ADS)

Borjali, Davood

Title: Comparation of clinical and paraclinical findings among patient with Kawasaki disease in Bandar abbas Koodakan Hospital in 2011-14 Kawasaki disease(KD) is a kind of vasculitis diagnosed by clinical manifestation and it caused acquired heart disease in children because of coronary arteries involvement. Method: patient divided to three group of American Japanese and incomplete and also study in two group according to fever days and then clinical features and laboratory data were checked. Result: A total of 150 patients were enrolled during the study period. number of patients with incomplete Kawasaki disease was 128 american group was 28 and Japanese was 4 patients, the most prevalent symptom was scaling of extremities(61 bladder most seen in group with fever more than five days. Keyword: Kawasaki , epidemiology , criteria

Hospital-Based Clinical Pharmacy Services to Improve Ambulatory Management of Chronic Obstructive Pulmonary Disease

PubMed Central

Smith, Amber Lanae; Palmer, Valerie; Farhat, Nada; Kalus, James S.; Thavarajah, Krishna; DiGiovine, Bruno; MacDonald, Nancy C.

2016-01-01

Background: No systematic evaluations of a comprehensive clinical pharmacy process measures currently exist to determine an optimal ambulatory care collaboration model for chronic obstructive pulmonary disease (COPD) patients. Objective: Describe the impact of a pharmacist-provided clinical COPD bundle on the management of COPD in a hospital-based ambulatory care clinic. Methods: This retrospective cohort analysis evaluated patients with COPD managed in an outpatient pulmonary clinic. The primary objective of this study was to assess the completion of 4 metrics known to improve the management of COPD: (1) medication therapy management, (2) quality measures including smoking cessation and vaccines, (3) patient adherence, and (4) patient education. The secondary objective was to evaluate the impact of the clinical COPD bundle on clinical and economic outcomes at 30 and 90 days post–initial visit. Results: A total of 138 patients were included in the study; 70 patients served as controls and 68 patients received the COPD bundle from the clinical pharmacist. No patients from the control group had all 4 metrics completed as documented, compared to 66 of the COPD bundle group (P < .0001). Additionally, a statistically significant difference was found in all 4 metrics when evaluated individually. Clinical pharmacy services reduced the number of phone call consults at 90 days (P = .04) but did not have a statistically significant impact on any additional pre-identified clinical outcomes. Conclusion: A pharmacist-driven clinical COPD bundle was associated with significant increases in the completion and documentation of 4 metrics known to improve the outpatient management of COPD.

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

PubMed Central

Filipetti, Paul; Remacle, Angélique; Kolanowski, Elisabeth

2016-01-01

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

Expenditure and loss of income incurred by tuberculosis patients before reaching effective treatment in Bangladesh.

PubMed

Croft, R A; Croft, R P

1998-03-01

This small study undertook to assess the economic consequences of developing tuberculosis (TB) among patients presenting to the TB clinic run by the Danish Bangladesh Leprosy Mission in NW Bangladesh. The loss of income resulting from the illness, and the actual expenditure incurred by medicines and doctor's fees before registration for treatment, were estimated and totalled for 21 patients serially registered at the clinic. The results showed a mean financial loss to the patient of US$ 245-an exorbitant sum for a village Bangladeshi. Perhaps economic deprivation suffered by TB patients could be used as a measure of success of the programme.

Potential Usefulness of the Kampo Medicine Yokukansan, Containing Uncaria Hook, for Paediatric Emotional and Behavioural Disorders: A Case Series

PubMed Central

2013-01-01

Background. Paediatric emotional and behavioural disorders (EBD) are relatively common diseases. Although nonpharmacologic and pharmacologic treatments are utilized in these cases, it is sometimes difficult to manage the symptoms of EBD. Historically, Uncaria hook has been used for treating nighttime crying and convulsions in children. Recent clinical studies have demonstrated that the Kampo medicine Yokukansan (YKS), which contains Uncaria hook, is efficacious for behaviour disorders in Alzheimer's disease patients. Herein, we investigated the clinical efficacy and safety of YKS in a series of cases with paediatric EBD. Patients and Methods. We retrospectively reviewed all paediatric patients who sought Japanese Kampo therapy at our outpatient clinics between April 1, 2012, and April 30, 2013; we selected patients who were diagnosed with paediatric EBD and were treated with YKS. Results. After screening all candidates, 3 patients were eligible for this analysis. Their average age was 11.6 years (range 10–13 years). All 3 patients responded very well to YKS within 1 month. No drug-related adverse events were observed during the course of YKS treatment. Conclusion. Yokukansan may be efficacious for paediatric EBD. We believe these results warrant further evaluation of the clinical efficacy and safety of Yokukansan for paediatric EBD in a carefully designed, double-blind, randomized clinical study. PMID:24204394

Perspectives on Research Participation and Facilitation Among Dialysis Patients, Clinic Personnel, and Medical Providers: A Focus Group Study.

PubMed

Flythe, Jennifer E; Narendra, Julia H; Dorough, Adeline; Oberlander, Jonathan; Ordish, Antoinette; Wilkie, Caroline; Dember, Laura M

2017-12-19

Most prospective studies involving individuals receiving maintenance dialysis have been small, and many have had poor clinical translatability. Research relevance can be enhanced through stakeholder engagement. However, little is known about dialysis clinic stakeholders' perceptions of research participation and facilitation. The objective of this study was to characterize the perspectives of dialysis clinic stakeholders (patients, clinic personnel, and medical providers) on: (1) research participation by patients and (2) research facilitation by clinic personnel and medical providers. We also sought to elucidate stakeholder preferences for research communication. Qualitative study. 7 focus groups (59 participants: 8 clinic managers, 14 nurses/patient care technicians, 8 social workers/dietitians, 11 nephrologists/advanced practice providers, and 18 patients/care partners) from 7 North Carolina dialysis clinics. Clinics and participants were purposively sampled. Focus groups were recorded and transcribed. Thematic analysis. We identified 11 themes that captured barriers to and facilitators of research participation by patients and research facilitation by clinic personnel and medical providers. We collapsed these themes into 4 categories to create an organizational framework for considering stakeholder (narrow research understanding, competing personal priorities, and low patient literacy and education levels), relationship (trust, buy-in, and altruistic motivations), research design (convenience, follow-up, and patient incentives), and dialysis clinic (professional demands, teamwork, and communication) aspects that may affect stakeholder interest in participating in or facilitating research. These themes appear to shape the degree of research readiness of a dialysis clinic environment. Participants preferred short research communications delivered in multiple formats. Potential selection bias and inclusion of English-speaking participants only. Our findings revealed patient interest in participating in research and clinical personnel and medical provider interest in facilitating research. Overall, our results suggest that dialysis clinic research readiness may be enhanced through increased stakeholder research knowledge and alignment of clinical and research activities. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Clinical experience of PDT in Brazil: a 300 patient overview

NASA Astrophysics Data System (ADS)

Kurachi, Cristina; Ferreira, Juliana; Marcassa, Luis G.; Cestari Filho, Guilherme A.; Souza, Cacilda S.; Bagnato, Vanderlei S.

2005-04-01

Clinical application of Photodynamic Therapy (PDT) in Brazil is a result of a pioneering work in a collaborative program involving the Physics Institute and the Medical School of the University of Sao Paulo and the Amaral Carvalho Cancer Hospital in the city of Jau, Sao Paulo. This work began in 1997 with the first patient treated in 1999. Up to the end of 2003 this program has treated over 300 patients and the ones with correct follow up had their lesions included in this report. The majority of the lesions were of non-melanoma skin cancer located on the head and neck region, but the group has also treated Esophagus, Bladder, Gynecological, chest wall recurrence of breast cancer, among others. The results have shown to be compatible with internationally reported data, and we have modified some application procedures towards to a better benefit for the patient and an optimization of the results. We present the overall results observed after 5 year of experimental clinical treatment.

Clinical Incidence of Sacroiliac Joint Arthritis and Pain after Sacropelvic Fixation for Spinal Deformity

PubMed Central

Sainoh, Takeshi; Takaso, Masashi; Inoue, Gen; Orita, Sumihisa; Eguchi, Yawara; Nakamura, Junichi; Aoki, Yasuchika; Ishikawa, Tetsuhiro; Miyagi, Masayuki; Arai, Gen; Kamoda, Hiroto; Suzuki, Miyako; Kubota, Gou; Sakuma, Yoshihiro; Oikawa, Yasuhiro; Yamazaki, Masashi; Toyone, Tomoaki; Takahashi, Kazuhisa

2012-01-01

Purpose Sacroiliac fixation using iliac screws for highly unstable lumbar spine has been reported with an improved fusion rate and clinical results. On the other hand, there is a potential for clinical problems related to iliac fixation, including late sacroiliac joint arthritis and pain. Materials and Methods Twenty patients were evaluated. Degenerative scoliosis was diagnosed in 7 patients, failed back syndrome in 6 patients, destructive spondyloarthropathy in 4 patients, and Charcot spine in 3 patients. All patients underwent posterolateral fusion surgery incorporating lumbar, S1 and iliac screws. We evaluated the pain scores, bone union, and degeneration of sacroiliac joints by X-ray imaging and computed tomography before and 3 years after surgery. For evaluation of low back and buttock pain from sacroiliac joints 3 years after surgery, lidocaine was administered in order to examine pain relief thereafter. Results Pain scores significantly improved after surgery. All patients showed bone union at final follow-up. Degeneration of sacroiliac joints was not seen in the 20 patients 3 years after surgery. Patients showed slight low back and buttock pain 3 years after surgery. However, not all patients showed relief of the low back and buttock pain after injection of lidocaine into the sacroiliac joint, indicating that their pain did not originate from sacroiliac joints. Conclusion The fusion rate and clinical results were excellent. Also, degeneration and pain from sacroiliac joints were not seen within 3 years after surgery. We recommend sacroiliac fixation using iliac screws for highly unstable lumbar spine. PMID:22318832

Assessment of intrafamilial clinical variability of poikiloderma with neutropenia by a 10-year follow-up of three affected siblings.

PubMed

Concolino, Daniela; Sestito, Simona; Falvo, Francesca; Romano, Giusy; Ceravolo, Miriam; Anastasio, Elisa; Pensabene, Licia; Colombo, Elisa A; Larizza, Lidia

2018-05-23

Clericuzio-type poikiloderma with neutropenia is a well-defined nosological entity, but despite a remarkable number of clinical reports, no long term follow-up data has been presented to date regarding patients with this rare condition. Here we describe the results of clinical follow-up of three siblings, one male (Patient 1) and two females (Patients 2 and 3), subsequent to their first clinical and then molecular diagnosis of Clericuzio-type poikiloderma with neutropenia syndrome due to mutation of USB1gene. Patient 1 always expressed the most severe phenotype, while patients 2 and 3 showed an intermediate and mild phenotype, respectively, as observed since their first clinical evaluation. None of the patients developed skin cancer and/or myelodysplastic disorders considering the peripheral haematological findings. Lens opacity, never reported before, was found in two of the three patients. The long term follow-up observations confirm the stability over time of the pronounced intra-familial heterogeneity of clinical manifestations observed prior to and upon molecular diagnosis. We conclude that prolonged follow-up is an adjunct tool to monitor intra-familial variability of PN clinical spectrum which may favour surveillance of more serious complications of the disease among siblings, when a patient-specific clinical expressivity is present. Copyright © 2018. Published by Elsevier Masson SAS.

[Use of porous titanium nickelide dental implants].

PubMed

Radkevich, A A; Galonskiĭ, V G; Gantimurov, A A

2013-01-01

The paper presents the results of 20 years clinical experience in dental prosthetics with the use of porous titanium nickelide dental implants. Implants were placed in 565 patients aged 15-17 years. Long-term results analysis showed restorations to function properly after mean follow-up period of 8 years in 435 patients (78.2%) proving this material to be clinically successful.

Diagnostic application of clinical exome sequencing in Leber congenital amaurosis.

PubMed

Han, Jinu; Rim, John Hoon; Hwang, In Sik; Kim, Jieun; Shin, Saeam; Lee, Seung-Tae; Choi, Jong Rak

2017-01-01

Leber congenital amaurosis (LCA) is a hereditary retinal dystrophy with wide genetic heterogeneity. Next-generation sequencing (NGS) targeting multiple genes can be a good option for the diagnosis of LCA, and we tested a clinical exome panel in patients with LCA. A total of nine unrelated Korean patients with LCA were sequenced using the Illumina TruSight One panel, which targets 4,813 clinically associated genes, followed by confirmation using Sanger sequencing. Patients' clinical information and familial study results were obtained and used for comprehensive interpretation. In all nine patients, we identified pathogenic variations in LCA-associated genes: NMNAT1 (n=3), GUCY2D (n=2), RPGRIP1 (n=2), CRX (n=1), and CEP290 or SPATA7 . Six patients had one or two mutations in accordance with inheritance patterns, all consistent with clinical phenotypes. Two patients had only one pathogenic mutation in recessive genes ( NMNAT1 and RPGRIP1 ), and the clinical features were specific to disorders associated with those genes. Six patients were solved for genetic causes, and it remains unclear for three patients with the clinical exome panel. With subsequent targeted panel sequencing with 113 genes associated with infantile nystagmus syndrome, a likely pathogenic allele in CEP290 was detected in one patient. Interestingly, one pathogenic variant (p.Arg237Cys) in NMNAT1 was present in three patients, and it had a high allele frequency (0.24%) in the general Korean population, suggesting that NMNAT1 could be a major gene responsible for LCA in Koreans. We confirmed that a commercial clinical exome panel can be effectively used in the diagnosis of LCA. Careful interpretation and clinical correlation could promote the successful implementation of clinical exome panels in routine diagnoses of retinal dystrophies, including LCA.

Clinical Features and Course of Ocular Toxocariasis in Adults

PubMed Central

Ahn, Seong Joon; Woo, Se Joon; Jin, Yan; Chang, Yoon-Seok; Kim, Tae Wan; Ahn, Jeeyun; Heo, Jang Won; Yu, Hyeong Gon; Chung, Hum; Park, Kyu Hyung; Hong, Sung Tae

2014-01-01

Purpose To investigate the clinical features, clinical course of granuloma, serologic findings, treatment outcome, and probable infection sources in adult patients with ocular toxocariasis (OT). Methods In this retrospective cohort study, we examined 101 adult patients diagnosed clinically and serologically with OT. Serial fundus photographs and spectral domain optical coherence tomography images of all the patients were reviewed. A clinic-based case-control study on pet ownership, occupation, and raw meat ingestion history was performed to investigate the possible infection sources. Results Among the patients diagnosed clinically and serologically with OT, 69.6% showed elevated immunoglobulin E (IgE) levels. Granuloma in OT involved all retinal layers and several vitreoretinal comorbidities were noted depending on the location of granuloma: posterior pole granuloma was associated with epiretinal membrane and retinal nerve fiber layer defects, whereas peripheral granuloma was associated with vitreous opacity. Intraocular migration of granuloma was observed in 15 of 93 patients (16.1%). Treatment with albendazole (400 mg twice a day for 2 weeks) and corticosteroids (oral prednisolone; 0.5–1 mg/kg/day) resulted in comparable outcomes to patients on corticosteroid monotherapy; however, the 6-month recurrence rate in patients treated with combined therapy (17.4%) was significantly lower than that in patients treated with corticosteroid monotherapy (54.5%, P = 0.045). Ingestion of raw cow liver (80.8%) or meat (71.2%) was significantly more common in OT patients than healthy controls. Conclusions Our study discusses the diagnosis, treatment, and prevention strategies for OT. Evaluation of total IgE, in addition to anti-toxocara antibody, can assist in the serologic diagnosis of OT. Combined albendazole and corticosteroid therapy may reduce intraocular inflammation and recurrence. Migrating feature of granuloma is clinically important and may further suggest the diagnosis of OT. Clinicians need to carefully examine comorbid conditions for OT. OT may be associated with ingestion of uncooked meat, especially raw cow liver, in adult patients. PMID:24922534

Genetic testing of aetiology of intellectual disability in a dedicated physical healthcare outpatient clinic for adults with intellectual disability.

PubMed

Wallace, R A

2016-02-01

No guidelines exist for assessment of aetiology of intellectual disability in adults with intellectual disability by adult physicians, although robust guidelines exist for paediatric populations. It was speculated that the paediatric guidelines would also be suitable for adults. In rural/regional setting with limited clinical genetics, to perform a quality assurance evaluation on genetics assessment of aetiology of developmental disability in adults attending a dedicated healthcare clinic for adults with intellectual disability, compared results with paediatric standards, speculates if these seem appropriate for adults and speculates on a role for clinical genetics services. Retrospective chart audit of eligible patients looking at genetic clinical assessment, tests selected (molecular karyotype, G banding, metabolics), and yields of positive results. The results were compared with the recommended paediatric guidelines. Of 117 eligible adult patients, ideal genetic history was incomplete for 40% of patients without Down syndrome because of physician cause and lack of information. The number of abnormal genetic results increased from 46% to 66%, mainly from the molecular karyotype, though not all may have been clinically relevant. The improved yield from this test was similar to that in paediatric studies. Use of G banding and metabolic testing could be refined. Improvement can be made in clinical genetic assessment, but results generally support use of molecular karyotyping as first tier testing of cause of unknown intellectual disability in adults, as in the case for paediatric populations. The study highlights a necessary complementary role for clinical geneticists to interpret abnormal results. © 2016 Royal Australasian College of Physicians.

Consolidated clinical microbiology laboratories.

PubMed

Sautter, Robert L; Thomson, Richard B

2015-05-01

The manner in which medical care is reimbursed in the United States has resulted in significant consolidation in the U.S. health care system. One of the consequences of this has been the development of centralized clinical microbiology laboratories that provide services to patients receiving care in multiple off-site, often remote, locations. Microbiology specimens are unique among clinical specimens in that optimal analysis may require the maintenance of viable organisms. Centralized laboratories may be located hours from patient care settings, and transport conditions need to be such that organism viability can be maintained under a variety of transport conditions. Further, since the provision of rapid results has been shown to enhance patient care, effective and timely means for generating and then reporting the results of clinical microbiology analyses must be in place. In addition, today, increasing numbers of patients are found to have infection caused by pathogens that were either very uncommon in the past or even completely unrecognized. As a result, infectious disease specialists, in particular, are more dependent than ever on access to high-quality diagnostic information from clinical microbiology laboratories. In this point-counterpoint discussion, Robert Sautter, who directs a Charlotte, NC, clinical microbiology laboratory that provides services for a 40-hospital system spread over 3 states in the southeastern United States explains how an integrated clinical microbiology laboratory service has been established in a multihospital system. Richard (Tom) Thomson of the NorthShore University HealthSystem in Evanston, IL, discusses some of the problems and pitfalls associated with large-scale laboratory consolidation. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

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

PubMed Central

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

2017-01-01

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

Physician compensation for industry-sponsored clinical trials in multiple sclerosis influences patient trust.

PubMed

Klein, E; Solomon, A J; Corboy, J; Bernat, J

2016-07-01

Perceived physician financial conflicts of interest of can affect patient trust. Payment to physicians for industry sponsored clinical trials in multiple sclerosis is a relatively new potential source of physician conflict of interest. There is limited available data on how physician payment for trial involvement in multiple sclerosis clinical trials may influence patient trust. To understand how patient trust is influenced by information about physician payment for multiple sclerosis clinical trials. An anonymous online instrument was developed. 597 people with multiple sclerosis participated in the study. The study found that 61% of patients who had not previously participated in a clinical trial estimated that they would have lower levels of trust in their physician if the physician was paid for involvement in their clinical trial. Among former clinical trial participants, 38% self-reported a lower level of trust. Other potential physician-industry relationships, such as industry consulting or giving industry-sponsored talks, also adversely affected trust, though to a lesser extent than physician payment for subject participation in clinical trials. Results of this study demonstrate that physician payment for study participation in multiple sclerosis clinical trials is a potential conflict that can adversely affect patient trust. Copyright © 2016 Elsevier B.V. All rights reserved.

A study of patients who go to a psychology clinic seeking treatment.

PubMed

Estupiñá, Francisco José; Labrador, Francisco Javier; García-Vera, María Paz

2012-03-01

In order to characterize a typical clinical context, as opposed to an academic or research context, this article will analyze the sociodemographic and clinical characteristics of patients who turn to a psychology clinic in need of professional help. This study was conducted using an initial sample of 1,305 patients at the Universidad Complutense de Madrid (UCM) Clínica Universitaria de Psicología. Of the sociodemographic characteristics studied, it is noteworthy that the majority of patients were women (65%) and relatively young (the average age is 29.7 years-old). The disorders for which psychological help was most often needed were anxiety and mood disorders and relationship problems, which together made up 50% of cases. In 17.70% of cases, patients had at least one comorbid disorder in addition to the one that brought them to the clinic. The generalizability and implications of the results are discussed.

OVERSEER: An Expert System Monitor for the Psychiatric Hospital

PubMed Central

Bronzino, Joseph D.; Morelli, Ralph A.; Goethe, John W.

1988-01-01

In order to improve patient care, comply with regulatory guidelines and decrease potential liability, psychiatric hospitals and clinics have been searching for computer systems to monitor the management and treatment of patients. This paper describes OVERSEER: a knowledge based system that monitors the treatment of psychiatric patients in real time. Based on procedures and protocols developed in the psychiatric setting, OVERSEER monitors the clinical database and issues alerts when standard clinical practices are not followed or when laboratory results or other clinical indicators are abnormal. Written in PROLOG, OVERSEER is designed to interface directly with the hospital's database, and, thereby utilizes all available pharmacy and laboratory data. Moreover, unlike the interactive expert systems developed for the psychiatric clinic, OVERSEER does not require extensive data entry by the clinician. Consequently, the chief benefit of OVERSEER's monitoring approach is the unobtrusive manner in which it evaluates treatment and patient responses and provides information regarding patient management.

Oral candidiasis as clinical manifestation of HIV/AIDS infection in Airlangga University hospital patients

NASA Astrophysics Data System (ADS)

Putranti, A.; Asmarawati, T. P.; Rachman, B. E.; Hadi, U.; Nasronudin

2018-03-01

The purpose of this study was to determine the characteristics of HIV/AIDS patients with oral candidiasis as its clinical manifestation at Airlangga University Hospital Surabaya. This is a descriptive analytic research with cross-sectional design using Chi-Square statistic test. Samples of this study consist of 34 patients using total sampling methods. Those patients were all HIV/AIDS infected patients with oral candidiasis clinical manifestations, who were admitted to Airlangga University Hospital Surabaya from January 2016 to September 2017. Results showed that mostly HIV/AIDS patients with oral candidiasis are male (79.4%), old age (40-75years) total amounted to 58.8%, heterosexual as main risk factor (70%), clinical stadium mostly in stage IV (61.8%), 26% of patients with chronic diarrhea and 56% with pulmonary TB, clinical stages of patients have a significant relation to the incidence of oral candidiasis infection (p=0.024). The most common oral lesions found in people with HIV are Candidiasis. The best management is through routine dental examination and dental precautions to maintain health and achieve a better quality of life.

Acute Respiratory Distress Syndrome Measurement Error. Potential Effect on Clinical Study Results

PubMed Central

Cooke, Colin R.; Iwashyna, Theodore J.; Hofer, Timothy P.

2016-01-01

Rationale: Identifying patients with acute respiratory distress syndrome (ARDS) is a recognized challenge. Experts often have only moderate agreement when applying the clinical definition of ARDS to patients. However, no study has fully examined the implications of low reliability measurement of ARDS on clinical studies. Objectives: To investigate how the degree of variability in ARDS measurement commonly reported in clinical studies affects study power, the accuracy of treatment effect estimates, and the measured strength of risk factor associations. Methods: We examined the effect of ARDS measurement error in randomized clinical trials (RCTs) of ARDS-specific treatments and cohort studies using simulations. We varied the reliability of ARDS diagnosis, quantified as the interobserver reliability (κ-statistic) between two reviewers. In RCT simulations, patients identified as having ARDS were enrolled, and when measurement error was present, patients without ARDS could be enrolled. In cohort studies, risk factors as potential predictors were analyzed using reviewer-identified ARDS as the outcome variable. Measurements and Main Results: Lower reliability measurement of ARDS during patient enrollment in RCTs seriously degraded study power. Holding effect size constant, the sample size necessary to attain adequate statistical power increased by more than 50% as reliability declined, although the result was sensitive to ARDS prevalence. In a 1,400-patient clinical trial, the sample size necessary to maintain similar statistical power increased to over 1,900 when reliability declined from perfect to substantial (κ = 0.72). Lower reliability measurement diminished the apparent effectiveness of an ARDS-specific treatment from a 15.2% (95% confidence interval, 9.4–20.9%) absolute risk reduction in mortality to 10.9% (95% confidence interval, 4.7–16.2%) when reliability declined to moderate (κ = 0.51). In cohort studies, the effect on risk factor associations was similar. Conclusions: ARDS measurement error can seriously degrade statistical power and effect size estimates of clinical studies. The reliability of ARDS measurement warrants careful attention in future ARDS clinical studies. PMID:27159648

Orthodontic treatment need among young Saudis attending public versus private dental practices in Riyadh

PubMed Central

Al-Jobair, Asma M; Baidas, Laila F; Al-Hamid, Anfal A; Al-Qahtani, Sara G; Al-Najjar, Amani T; Al-Kawari, Huda M

2016-01-01

Objective To assess and compare the severity of malocclusion and orthodontic treatment need among young Saudis receiving free treatment at public dental practices versus those paying for treatment at private practices. Materials and methods This retrospective study evaluated the records of 300 patients (179 females, 121 males; age 13–21 years) treated at orthodontic clinics from 2013 through 2015. The public sample was selected from orthodontic clinics at the College of Dentistry, King Saud University (KSU); the private sample was selected from five private orthodontic clinics in Riyadh, Saudi Arabia. The records were examined for the severity of malocclusion and for orthodontic treatment need using the Dental Health Component of the Index of Orthodontic Treatment Need. The prevalence of each occlusal discrepancy and the Dental Health Component grade were recorded. The severity of malocclusion and orthodontic treatment need were compared between practice types, age groups, and sexes with the chi-square test. Results Displacement, increased overjet, and Class II and III malocclusion were the most common orthodontic problems in this study. Patients attending public clinics at KSU generally had more severe malocclusion than the patients attending private clinics. Seventy-seven percent of orthodontically treated patients at KSU clinics were in great need of treatment, compared with 58.5% of patients treated at private clinics (P=0.003). Among the patients with great treatment need, approximately 62% of male patients and 70% of patients ≤16 years of age were treated at KSU clinics, compared with 38% and 48%, respectively, treated at private clinics (P<0.0001). Conclusion Young Saudis receiving free orthodontic treatment at public clinics at KSU had more severe malocclusion with greater need of orthodontic treatment than the patients paying for treatment at private clinics. PMID:27843351

Effects of a Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients With Cancer Regarding Clinical Trial Participation: A Multicenter Randomized Controlled Trial

PubMed Central

Jacobsen, Paul B.; Wells, Kristen J.; Meade, Cathy D.; Quinn, Gwendolyn P.; Lee, Ji-Hyun; Fulp, William J.; Gray, Jhanelle E.; Baz, Rachid C.; Springett, Gregory M.; Levine, Richard M.; Markham, Merry-Jennifer; Schreiber, Fred J.; Cartwright, Thomas H.; Burke, James M.; Siegel, Robert D.; Malafa, Mokenge P.; Sullivan, Daniel

2012-01-01

Purpose The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials. Patients and Methods A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later. Results Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials. Conclusion A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials. PMID:22614993

Differences in Predictive Factors for Sustained Clinical Remission with Abatacept Between Younger and Elderly Patients with Biologic-naive Rheumatoid Arthritis: Results from the ABROAD Study.

PubMed

Sekiguchi, Masahiro; Fujii, Takao; Matsui, Kiyoshi; Murakami, Kosaku; Morita, Satoshi; Ohmura, Koichiro; Kawahito, Yutaka; Nishimoto, Norihiro; Mimori, Tsuneyo; Sano, Hajime

2016-11-01

To differentiate predictive factors for sustained clinical remission between elderly and younger patients with rheumatoid arthritis (RA) receiving abatacept (ABA) as an initial biological disease-modifying antirheumatic drug. The study involved 277 biologic-naive patients with RA with high or moderate disease activity, who were treated with intravenous ABA and evaluated for 48 weeks in 43 Japanese hospitals and rheumatology clinics (the ABatacept Research Outcomes as a First-line Biological Agent in the Real WorlD study: UMIN000004651). Predictive factors associated with sustained clinical remission defined by the 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP) during the 24-48-week or 36-48-week periods were determined in elderly (≥ 65 yrs, n = 148) and younger patient groups (< 65 yrs, n = 129) using logistic regression analysis. Clinical remission was achieved at 24 and 48 weeks in 35.1% and 36.5% of patients in the elderly group and 34.9% and 43.4% in the younger group, respectively. In elderly patients, anticitrullinated protein antibody (ACPA) positivity and a lower DAS28-CRP score were significantly associated with sustained clinical remission; however, a lower Health Assessment Questionnaire-Disability Index (HAQ-DI) score was not related to sustained clinical remission. In younger patients, lower DAS28-CRP and HAQ-DI scores were predictive factors for sustained clinical remission, whereas ACPA positivity was not a useful predictive factor for sustained clinical remission. Although the effectiveness of ABA in biologic-naive patients with RA was equally recognized in elderly and younger patients, the baseline clinical characteristics associated with sustained clinical remission were substantially different.

Clinical trials attitudes and practices of Latino physicians.

PubMed

Ramirez, Amelie G; Wildes, Kimberly; Talavera, Greg; Nápoles-Springer, Anna; Gallion, Kipling; Pérez-Stable, Eliseo J

2008-07-01

Ethnic differences in physicians' attitudes and behaviors related to clinical trials might partially account for disparities in clinical trial participation among Latino patients. Literature regarding Latino physicians' clinical trials attitudes and practices, in comparison to White physicians, was lacking. Cross-sectional data from randomly selected physicians (N=695), stratified by ethnicity, were analyzed to test associations of ethnicity with physicians' participation in and attitudes toward referral of patients to clinical trials. Chi-square analyses showed significant (p<0.05) associations of physician race/ethnicity and clinical trials involvement, type of trial for which the physician is likely to recommend a patient, belief in scientific value, and factors that would influence recommendation for a patient to participate. Multivariate analyses resulted in several significant (p<0.05) predictors of clinical trials outcomes, including physician race/ethnicity. Latino physicians were significantly less involved in clinical trials than White physicians and found less scientific value in them, highlighting areas for future education and intervention.

Quantitative appraisal of the Amyloid Imaging Taskforce appropriate use criteria for amyloid-PET.

PubMed

Altomare, Daniele; Ferrari, Clarissa; Festari, Cristina; Guerra, Ugo Paolo; Muscio, Cristina; Padovani, Alessandro; Frisoni, Giovanni B; Boccardi, Marina

2018-04-18

We test the hypothesis that amyloid-PET prescriptions, considered appropriate based on the Amyloid Imaging Taskforce (AIT) criteria, lead to greater clinical utility than AIT-inappropriate prescriptions. We compared the clinical utility between patients who underwent amyloid-PET appropriately or inappropriately and among the subgroups of patients defined by the AIT criteria. Finally, we performed logistic regressions to identify variables associated with clinical utility. We identified 171 AIT-appropriate and 67 AIT-inappropriate patients. AIT-appropriate and AIT-inappropriate cases did not differ in any outcomes of clinical utility (P > .05). Subgroup analysis denoted both expected and unexpected results. The logistic regressions outlined the primary role of clinical picture and clinical or neuropsychological profile in identifying patients benefitting from amyloid-PET. Contrary to our hypothesis, also AIT-inappropriate prescriptions were associated with clinical utility. Clinical or neuropsychological variables, not taken into account by the AIT criteria, may help further refine criteria for appropriateness. Copyright © 2018. Published by Elsevier Inc.

Development of job standards for clinical nutrition therapy for dyslipidemia patients.

PubMed

Kang, Min-Jae; Seo, Jung-Sook; Kim, Eun-Mi; Park, Mi-Sun; Woo, Mi-Hye; Ju, Dal-Lae; Wie, Gyung-Ah; Lee, Song-Mi; Cha, Jin-A; Sohn, Cheong-Min

2015-04-01

Dyslipidemia has significantly contributed to the increase of death and morbidity rates related to cardiovascular diseases. Clinical nutrition service provided by dietitians has been reported to have a positive effect on relief of medical symptoms or reducing the further medical costs. However, there is a lack of researches to identify key competencies and job standard for clinical dietitians to care patients with dyslipidemia. Therefore, the purpose of this study was to analyze the job components of clinical dietitian and develop the standard for professional practice to provide effective nutrition management for dyslipidemia patients. The current status of clinical nutrition therapy for dyslipidemia patients in hospitals with 300 or more beds was studied. After duty tasks and task elements of nutrition care process for dyslipidemia clinical dietitians were developed by developing a curriculum (DACUM) analysis method. The developed job standards were pretested in order to evaluate job performance, difficulty, and job standards. As a result, the job standard included four jobs, 18 tasks, and 53 task elements, and specific job description includes 73 basic services and 26 recommended services. When clinical dietitians managing dyslipidemia patients performed their practice according to this job standard for 30 patients the job performance rate was 68.3%. Therefore, the job standards of clinical dietitians for clinical nutrition service for dyslipidemia patients proposed in this study can be effectively used by hospitals.

Tear film aberration dynamics and vision-related quality of life in patients with dry eye disease.

PubMed

Denoyer, Alexandre; Rabut, Ghislaine; Baudouin, Christophe

2012-09-01

Corneal and ocular wavefront aberrations were recorded together with clinical examination results and patient-reported vision-related quality-of-life evaluation results to define the relevance of dynamic optical analysis of the eye in dry eye disease (DED). Prospective and comparative clinical study. Forty DED patients and 40 age- and gender-matched control subjects. Serial measurements of ocular and corneal higher-order aberrations (HOAs) after blink were performed for 10 seconds using the KR-1 aberrometer (Topcon, Clichy, France). Vision-related health-targeted quality of life was evaluated using the Ocular Surface Disease Index (OSDI) questionnaire. The clinical examination included tear film assessment (tear film break-up time and Schirmer I test), ocular surface damage assessment with the Oxford and van Bijsterveld indexes, and Meibomian dysfunction grading. Tear osmolarity also was measured. The time course of HOAs and modulation transfer function (MTF) was compared between groups and was analyzed in comparison with the OSDI and clinical data in DED patients. The root mean square of ocular and corneal total HOAs, particularly third-order aberrations, significantly increased over the 10-second period in DED patients, whereas no change occurred in controls. Analysis of MTF revealed progressive degradation of ocular optical quality resulting from loss of contrast at intermediate and high spatial frequencies in DED patients compared with controls. The progression index for corneal HOAs was correlated with the subjective index of patient-reported visual outcomes and with objective clinical findings of tear film and ocular surface damage. Objective measurement of the time course of HOAs may constitute a new single instrument to evaluate and manage patients with DED because it reliably reflects the completeness of the disease. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Diagnostic importance of contrast enhanced 18F-fluorodeoxyglucose positron emission computed tomography in patients with tumor induced osteomalacia: Our experience

PubMed Central

Jain, Avani S.; Shelley, Simon; Muthukrishnan, Indirani; Kalal, Shilpa; Amalachandran, Jaykanth; Chandran, Sureshkumar

2016-01-01

Aims and Objectives: To assess the diagnostic utility of contrast-enhanced 18F-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET-ceCT) in localization of tumors in patients with clinical diagnosis of tumor-induced osteomalacia (TIO), in correlation with histopathological results. Materials and Methods: Eight patients (five male and three female) aged 24–60 (mean 42) years with a clinical diagnosis of TIO were included in this prospective study. They underwent whole body (head to toe) FDG PET-ceCT following a standard protocol on Philips GEMINI TF PET-CT scanner. The FDG PET-ceCT results were correlated with postoperative histology findings and clinical follow-up. Results: All the patients had an abnormal PET-ceCT study. The sensitivity of PET-ceCT was 87.5%, and positive predictive value was 100%. The tumor was located in the craniofacial region in 6/8 patients and in bone in 2/8 patients. Hemangiopericytoma was the most common reported histology. All patients underwent surgery, following which they demonstrated clinical improvement. However, one patient with atypical findings on histology did not show any clinical improvement, hence, underwent 68Gallium-DOTANOC PET-ceCT scan for relocalization of the site of the tumor. Conclusion: The tumors causing TIO are small in size and usually located in obscure sites in the body. Hence, head to toe protocol should be followed for FDG PET-ceCT scans with the inclusion of upper limbs. Once the tumor is localized, regional magnetic resonance imaging can be performed for better characterization of soft tissue lesion. Imaging with FDG PET-ceCT plays an important role in detecting the site of the tumor and thereby facilitating timely management. PMID:26917888

A qualitative study examining the benefits and challenges of incorporating patient-reported outcome substance use and mental health questionnaires into clinical practice to improve outcomes on the HIV care continuum.

PubMed

Monroe, Anne K; Jabour, Sarah M; Peña, Sebastian; Keruly, Jeanne C; Moore, Richard D; Chander, Geetanjali; Riekert, Kristin A

2018-06-07

Inadequate identification and treatment of substance use (SU) and mental health (MH) disorders hinders retention in HIV care. The objective of this study was to elicit stakeholder input on integration of SU/MH screening using computer-assisted patient-reported outcomes (PROs) into clinical practice. We conducted semi-structured interviews with HIV-positive patients who self-reported SU/MH symptoms on a computer-assisted PROs (n = 19) and HIV primary care providers (n = 11) recruited from an urban academic HIV clinic. Interviews were audio-recorded and transcribed. We iteratively developed codes and organized key themes using editing style analysis. Two themes emerged: (1) Honest Disclosure: Some providers felt PROs might improve SU/MH disclosure; more were concerned that patients would not respond honestly if their provider saw the results. Patients were also divided, stating PROs could help overcome stigma but that it could be harder to disclose SU/MH to a computer versus a live person. (2) Added Value in the Clinical Encounter: Most providers felt PROs would fill a practice gap. Patients had concerns regarding confidentiality but indicated PROs would help providers take better care of them. Both patients and providers indicated that PROs are potentially useful clinical tools to improve detection of SU/MH. However, patients and providers expressed conflicting viewpoints about disclosure of SU/MH using computerized PROs. Future studies implementing PROs screening interventions must assess concerns over confidentiality and honest disclosure of SU/MH to understand the effectiveness of PROs as a clinical tool. More research is also needed on patient-centered integration of the results of PROs in HIV care.

Patient Compliance Is Critical for Equivalent Clinical Outcomes for Breast Cancer Treated by Breast-Conservation Therapy

PubMed Central

Li, Benjamin D. L.; Brown, William A.; Ampil, Frederico L.; Burton, Gary V.; Yu, Herbert; McDonald, John C.

2000-01-01

Objective To determine the compliance with a standard breast-conservation therapy (BCT) program in a predominantly indigent, minority population of patients with early breast cancer (stage I and II) served by a rural state institution in the South; to compare the clinical outcomes of this group with those reported in clinical trials; and to examine the socioeconomic factors that may have contributed to the rate of compliance. Summary Background Data Disease-free survival and overall survival in early breast cancer treated by BCT versus modified radical mastectomy are reported to be equivalent in prospective randomized trials. However, patients enrolled in clinical trials may not be representative of patients living in the various diverse communities that make up the United States. The authors’ hypothesis is that patients enrolled in clinical trials at the national level may not be representative of indigent patients in the rural South and that clinical trial results may not be directly applicable. Methods A retrospective review of 55 women with early-stage breast cancer treated from 1990 to 1995 was performed. Clinical data, compliance with treatment and clinical follow-up, and recurrence rates were examined. Statistical analysis performed include the Fisher exact test, Kaplan-Meier survival analysis, and log-rank test. Results Full compliance (defined as completion of the entire course of radiation therapy and clinical follow-up) with the BCT program was observed in only 36% of patients. Fifteen of the 35 noncompliant patients did not complete radiation therapy. A significantly higher local failure rate was observed: 8 of these 15 patients (53%) have had local failure. In contrast, patients who were either in full compliance with the BCT program or were deficient only in that they missed part of their clinical follow-up had local failure rates of 5% (1/20) and 10% (2/20), respectively. Age, race, stage of cancer, economic status (measured by availability of medical insurance), distance of patient’s residence from the hospital, and education level were evaluated as potential predictors of compliance. None predicted patient compliance, although a trend toward higher compliance was noted in patients with a higher education level, as determined by literacy testing. Conclusions Compliance with the BCT protocol at the authors’ institution was worse than reported in clinical trials, and noncompliance translated into a significant increase in the local failure rate. Factors examined suggest that literacy may play a role in predicting compliance. Although BCT should be discussed with all breast cancer patients, the judicious application of clinical trial data to an institution’s local population is warranted. PMID:10816632

Clinical utility of transthoracic two-dimensional and Doppler echocardiography.

PubMed

Krumholz, H M; Douglas, P S; Goldman, L; Waksmonski, C

1994-07-01

The purpose of this study was to determine the value of contemporary echocardiography for patient diagnosis and management in clinical practice. Although the use of echocardiography is growing rapidly, there is little information about its clinical utility. A prospective observational study was performed at a community-based, tertiary care teaching hospital. Physicians were interviewed before and after learning the result of their patients' echocardiographic examination. Chart reviews were performed to confirm reports of new diagnoses and treatments that resulted from echocardiography. Physician interviews were successfully completed for 244 (49%) of 497 inpatients and 101 (30%) of 336 outpatients. Among patients with moderate or greater mitral regurgitation, the diagnosis of "clinically significant" mitral regurgitation was unsuspected in 5 (31%) of 16 outpatients and 28 (60%) of 47 inpatients. Among the patients with left ventricular wall motion abnormalities, the result was unsuspected in 7 (50%) of 14 outpatients and 18 (22%) of 81 inpatients. As assessed by chart review, echocardiography produced a definite new diagnosis in 25 inpatients (10%) and 5 outpatients (5%) and was responsible for changes in pharmacologic treatment in at least 16 inpatients (7%) and 2 outpatients (2%). The echocardiogram commonly provided information that was unexpected. This information provided a definite new diagnosis or treatment in a smaller proportion of the patients. Further research is necessary to define the appropriate yield that would warrant echocardiography on the basis of both clinical and cost-effectiveness criteria.

Comparison of Survival Outcomes Among Cancer Patients Treated In and Out of Clinical Trials

PubMed Central

2014-01-01

Background Clinical trials test the efficacy of a treatment in a select patient population. We examined whether cancer clinical trial patients were similar to nontrial, “real-world” patients with respect to presenting characteristics and survival. Methods We reviewed the SWOG national clinical trials consortium database to identify candidate trials. Demographic factors, stage, and overall survival for patients in the standard arms were compared with nontrial control subjects selected from the Surveillance, Epidemiology, and End Results program. Multivariable survival analyses using Cox regression were conducted. The survival functions from aggregate data across all studies were compared separately by prognosis (≥50% vs <50% average 2-year survival). All statistical tests were two-sided. Results We analyzed 21 SWOG studies (11 good prognosis and 10 poor prognosis) comprising 5190 patients enrolled from 1987 to 2007. Trial patients were younger than nontrial patients (P < .001). In multivariable analysis, trial participation was not associated with improved overall survival for all 11 good-prognosis studies but was associated with better survival for nine of 10 poor-prognosis studies (P < .001). The impact of trial participation on overall survival endured for only 1 year. Conclusions Trial participation was associated with better survival in the first year after diagnosis, likely because of eligibility criteria that excluded higher comorbidity patients from trials. Similar survival patterns between trial and nontrial patients after the first year suggest that trial standard arm outcomes are generalizable over the long term and may improve confidence that trial treatment effects will translate to the real-world setting. Reducing eligibility criteria would improve access to clinical trials. PMID:24627276

Outcomes Among Chronically Ill Adults in a Medical Home Prototype

PubMed Central

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

2014-01-01

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

Clinical Practices and Outcomes in Elderly Hemodialysis Patients: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS)

PubMed Central

Tong, Lin; Tentori, Francesca; Akiba, Takashi; Karaboyas, Angelo; Gillespie, Brenda; Akizawa, Tadao; Pisoni, Ronald L.; Bommer, Juergen; Port, Friedrich K.

2011-01-01

Summary Background and objectives Demand for hemodialysis among elderly patients is increasing worldwide. Although clinical care of this high-risk group is complex and challenging, no guidelines exist to inform hemodialysis practices. The Dialysis Outcomes and Practice Patterns Study (DOPPS) provides a unique opportunity to assess dialysis practices and associated outcomes among elderly versus younger patients on chronic in-center hemodialysis in 12 countries. Design, setting, participants, & measurements Clinical characteristics, dialysis practices, and outcomes of elderly versus younger patients were compared among participants in four DOPPS regions in 2005 through 2007. Results Although participant mean age increased over time in all DOPPS countries, the percentage of elderly varied widely. Overall, comorbidities and malnutrition were more common in the elderly. Fistulae were used less frequently among elderly versus younger patients in Europe and North America but not in Australia, New Zealand, and Japan. No difference in treatment time was observed between elderly and younger patients after normalizing for body weight. In all regions, ultrafiltration rates were lower among elderly patients. Elderly patients reported poorer quality of life with respect to the physical but not mental component scores. Mortality risk was three- to sixfold higher in the elderly group, whereas causes of death overall were similar for elderly and younger patients. Conclusions Elderly patients represent a different proportion of DOPPS participants across countries, possibly reflecting differences in policies and clinical practices. In general, hemodialysis practices in the elderly reflected each region's clinical patterns, with some variation by age group depending upon the practice. PMID:21734085

Antitumor activity of nivolumab on hemodialysis after renal allograft rejection.

PubMed

Ong, Michael; Ibrahim, Andrea Marie; Bourassa-Blanchette, Samuel; Canil, Christina; Fairhead, Todd; Knoll, Greg

2016-01-01

Nivolumab (Opdivo™) is a novel IgG4 subclass programmed death-1 (PD-1) inhibiting antibody that has demonstrated breakthrough-designation anti-tumor activity. To date, clinical trials of nivolumab and other checkpoint inhibitors have generally excluded patients with solid organ transplantation and patients with concurrent immunosuppression. However, organ transplant recipients are at high-risk of development of malignancy as a result of suppressed immune surveillance of cancer. We illustrate the outcomes of a 63 year-old type I diabetic female patient who developed pulmonary metastatic, BRAF wild-type cutaneous melanoma 10 years after renal transplantation. After downward titration of the patient's immunosuppressive medications and extensive multidisciplinary review, she was treated with nivolumab in the first-line setting. Within 1 week of administration, the patient experienced acute renal allograft rejection, renal failure and concurrent diabetic ketoacidosis due to steroid therapy. Allograft function did not return, but patient made a full clinical recovery after being placed on hemodialysis. Subsequently, the patient had clinical disease progression off therapy and required re-challenge with nivolumab on hemodialysis, resulting in ongoing clinical and radiographic response. This case illustrates multiple practical challenges and dangers of administering anti-PD1 immune checkpoint inhibitors to patients with solid-organ transplantation including need for titration of immunosuppressive medications, risks of allograft rejection, and treatment during hemodialysis.

Clinical presentation and outcome of avoidant/restrictive food intake disorder in a Japanese sample.

PubMed

Nakai, Yoshikatsu; Nin, Kazuko; Noma, Shun'ichi; Hamagaki, Seiji; Takagi, Ryuro; Teramukai, Satoshi; Wonderlich, Stephen A

2017-01-01

We conducted a study of the clinical presentation and outcome in patients with avoidant/restrictive food intake disorder (ARFID), aged 15-40years, and compared this group to an anorexia nervosa (AN) group in a Japanese sample. A retrospective chart review was completed on 245 patients with feeding and eating disorders (FEDs), analyzing prevalence, clinical presentation, psychopathological properties, and outcomes. Using the DSM-5 criteria, 27 (11.0%) out of the 245 patients with a FED met the criteria for ARFID at entry. All patients with ARFID were women. In terms of eating disorder symptoms, all patients with ARFID had restrictive eating related to emotional problems and/or gastrointestinal symptoms. However, none of the ARFID patients reported food avoidance related to sensory characteristics or functional dysphagia. Additionally, none of them exhibited binge eating or purging behaviors, and none of them reported excessive exercise. The ARFID group had a significantly shorter duration of illness, lower rates of admission history, and less severe psychopathology than the AN group. The ARFID group reported significantly better outcome results than the AN group. These results suggest that patients with ARFID in this study were clinically distinct from those with AN and somewhat different from pediatric patients with ARFID in previous studies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cost-effectiveness analysis of a postoperative clinical care pathway in head and neck surgery with microvascular reconstruction.

PubMed

Dautremont, Jonathan F; Rudmik, Luke R; Yeung, Justin; Asante, Tiffany; Nakoneshny, Steve C; Hoy, Monica; Lui, Amanda; Chandarana, Shamir P; Matthews, Thomas W; Schrag, Christiaan; Dort, Joseph C

2013-12-19

The objective of this study is to evaluate the cost-effectiveness of a postoperative clinical care pathway for patients undergoing major head and neck oncologic surgery with microvascular reconstruction. This is a comparative trial of a prospective treatment group managed on a postoperative clinical care pathway and a historical group managed prior to pathway implementation. Effectiveness outcomes evaluated were total hospital days, return to OR, readmission to ICU and rate of pulmonary complications. Costing perspective was from the government payer. 118 patients were included in the study. All outcomes demonstrated that the postoperative pathway group was both more effective and less costly, and is therefore a dominant clinical intervention. The overall mean pre- and post-pathway costs are $22,733 and $16,564 per patient, respectively. The incremental cost reduction associated with the postoperative pathway was $6,169 per patient. Implementing the postoperative clinical care pathway in patients undergoing head and neck oncologic surgery with reconstruction resulted in improved clinical outcomes and reduced costs.

A systematic review of evidence on the links between patient experience and clinical safety and effectiveness

PubMed Central

Doyle, Cathal; Lennox, Laura; Bell, Derek

2013-01-01

Objective To explore evidence on the links between patient experience and clinical safety and effectiveness outcomes. Design Systematic review. Setting A wide range of settings within primary and secondary care including hospitals and primary care centres. Participants A wide range of demographic groups and age groups. Primary and secondary outcome measures A broad range of patient safety and clinical effectiveness outcomes including mortality, physical symptoms, length of stay and adherence to treatment. Results This study, summarising evidence from 55 studies, indicates consistent positive associations between patient experience, patient safety and clinical effectiveness for a wide range of disease areas, settings, outcome measures and study designs. It demonstrates positive associations between patient experience and self-rated and objectively measured health outcomes; adherence to recommended clinical practice and medication; preventive care (such as health-promoting behaviour, use of screening services and immunisation); and resource use (such as hospitalisation, length of stay and primary-care visits). There is some evidence of positive associations between patient experience and measures of the technical quality of care and adverse events. Overall, it was more common to find positive associations between patient experience and patient safety and clinical effectiveness than no associations. Conclusions The data presented display that patient experience is positively associated with clinical effectiveness and patient safety, and support the case for the inclusion of patient experience as one of the central pillars of quality in healthcare. It supports the argument that the three dimensions of quality should be looked at as a group and not in isolation. Clinicians should resist sidelining patient experience as too subjective or mood-oriented, divorced from the ‘real’ clinical work of measuring safety and effectiveness. PMID:23293244

Snapshot of Teleretinal Screening for Diabetic Retinopathy at the West Los Angeles Medical Center.

PubMed

Tsui, Irena; Havunjian, Margaret A; Davis, John A; Giaconi, JoAnn A

2016-10-01

The West Los Angeles Veterans Affairs Medical Center is a large urban facility with a robust teleretinal screening program in primary care clinic, established in 2006. The purpose of this article is to provide a snapshot of teleretinal screening at this site. Diabetic patients from 2012 were analyzed with a prospective cohort study. Demographic information, results of teleretinal screening, referral to eye clinic, and loss to follow-up (defined as no eye care within 2 years) were collected. Of 516 patients with diabetes screened with teleretinal imaging, 120 patient charts were reviewed for data analysis. Teleretinal imaging diagnosed 15% (18/120) of patients with varying stages of nonproliferative diabetic retinopathy (DR). Of patients screened, 55.8% (67/120) of the patients were referred to an eye clinic for further ophthalmic evaluation. Nondiabetic retinopathy reasons for eye clinic referral included glaucoma suspect (13.3%, 16/120) and age-related macular degeneration (10.0%, 12/120). Of all patients screened, 37.5% (45/120) of them were lost to follow-up, defined as no teleretinal screening or eye clinic appointment within 2 years. Patients who lived farther away from clinic had a higher risk of loss to follow-up (p = 0.04). We found, although only 15% of patients were diagnosed with DR from teleretinal screening, more than 50% of patients were referred to eye clinic. In addition, of all screened patients, there was a high rate of not returning to the Veterans Affairs (VA) for eye care.

Number of sputum specimens during treatment follow-up of tuberculosis patients: two or one?

PubMed Central

Kumar, A. M. V.; Claassens, M.; Banurekha, V. V.; Gomathi, N. S.; Venkatesan, P.; Swaminathan, S.

2013-01-01

Setting: National Institute for Research in Tuberculosis clinics in Chennai and Madurai, India. Objective: To examine the pattern of serial smears (negative-negative [NN], negative-positive [NP], positive-negative [PN], positive-positive [PP]) during treatment follow-up of culture-confirmed new smear-positive tuberculosis (TB) patients, and the proportion of culture-negatives in each category. Design: We reviewed the records and extracted follow-up smear (fluorescent microscopy) and culture (Löwenstein-Jensen) results of patients enrolled in clinical trials from January 2000 to August 2012 and treated with the Category I regimen (2EHRZ3/4HR3). Data entry and analysis were performed using EpiData. Results: Among 520 patients (176 infected with the human immunodeficiency virus), the proportions of culture-negative patients with NN, discordant (PN or NP) and PP patterns were approximately 98%, 80% and 40%, respectively. The smear-positive culture-negative phenomenon was more frequent in follow-up smear results graded 1+, followed by 2+ and 3+. Conclusion: There is justification for discontinuing the examination of second specimens during treatment follow-up among TB patients. However, a positive result on the first smear needs to be confirmed by a second positive result before making clinical management decisions. The World Health Organization may need to reconsider its recommendation on this issue. PMID:26393051

A clinical trial of pefloxacin and ofloxacin in lepromatous leprosy.

PubMed

Fajardo, Tranquilino T; Villahermosa, Laarni G; Cruz, Eduardo C Dela; Cellona, Roland V; Balagon, Ma Victoria F; Abalos, Rodolfo M; Gelber, Robert H

2004-12-01

A 2-month clinical trial of pefloxacin and ofloxacin in previously untreated multibacillary patients was conducted at the Leonard Wood Memorial Leprosy Research Center, Cebu, the Philippines. Treatment with either pefloxacin or ofloxacin resulted in rapid clinical improvement, in this regard pefloxacin appearing somewhat superior. Reactions and side effects were minimal. Single doses of either agent did not result in significant killing of Mycobacterium leprae, but significant bactericidal activity was observed for all fluoroquinolone-treated patients by one week of daily therapy (n = 21), and either agent independently by 3 weeks of daily therapy. At the completion of therapy only two of 10 pefloxacin-treated patients and 0 of 11 ofloxacin-treated patients harboured any detectable viable M. leprae from active lesions, confirming previous work that these fluoroquinolones exhibit bactericidal activity in leprosy patients and more than that found previously for dapsone and clofazimine.

[The detection of antibodies against HIV-1 24-kd protein. A clinico-serological correlation].

PubMed

Díaz Torres, H; Silva Cabrera, E; Rodríguez García, O; Bárcenas Moses, J; Lubián Caballero, A L

1996-01-01

The presence of antibodies against the HIV protein of 24 kd was studies by the parallel use of the DAVIH BLOT western blot and of the DAVIH AC P24 ELISA in serum samples from 176 patients at different HIV-1 infection stages. The results were correlated with the clinical classification of the patient at the moment of taking the sample and with the further evolution during 6 months. 57% of the patients with opportunistic minor infections and 96% of AIDS patients had low antibodies titres. Dead patients showed no reactivity or presented very low titres in samples taken before dying. Different titrations were observed in serum groups with an apparently uniform reactivity in the western blot. The results show and adequate clinical and serological correlation. Therefore, the DAVIH AC P24 ELISA could be useful in the clinical follow-up of HIV-1 infected persons.

Patient-Centered Research

PubMed Central

Wicki, J; Perneger, TV; Junod, AF; Bounameaux, H; Perrier, A

2000-01-01

PURPOSE We aimed to develop a simple standardized clinical score to stratify emergency ward patients with clinically suspected PE into groups with a high, intermediate, or low probability of PE, in order to improve and simplify the diagnostic approach. METHODS Analysis of a database of 1090 consecutive patients admitted to the emergency ward for suspected PE, in whom diagnosis of PE was ruled in or out by a standard diagnostic algorithm. Logistic regression was used to predict clinical parameters associated with PE. RESULTS 296 out of 1090 patients (27%) were found to have PE. The optimal estimate of clinical probability was based on eight variables: recent surgery, previous thromboembolic event, older age, hypocapnia, hypoxemia, tachycardia, band atelectasis or elevation of a hemidiaphragm on chest X-ray. A probability score was calculated by adding points assigned to these variables. A cut-off score of 4 best identified patients with low probability of PE. 486 patients (49%) had a low clinical probability of PE (score < 4), of which 50 (10.3%) had a proven PE. The prevalence of PE was 38% in the 437 patients with an intermediate probability (score 5–8, n = 437) and 81% in the 63 patients with a high probability (score>9). CONCLUSION This clinical score, based on easily available and objective variables, provides a standardized assessment of the clinical probability of PE. Applying this score to emergency ward patients suspected of PE could allow a more efficient diagnostic process.

Blood cultures for women hospitalized with acute pelvic inflammatory disease. Are they necessary?

PubMed

Apuzzio, J J; Hessami, S; Rodriguez, P

2001-09-01

To determine the incidence of positive blood cultures and if the results affect the clinical management or the duration of hospital stay in patients with acute pelvic inflammatory disease (PID). Retrospective study of all patients hospitalized with a diagnosis of acute PID from January 1, 1996, to December 31, 1997. Of 93 patients in the study, 3 had significant bacterial growth from blood culture specimens. The results of blood culture specimens did not affect clinical management. Routine specimens for blood culture may not be needed from patients hospitalized with acute PID.

[Clinical effects of surgical vs manual reduction of ankle fractures].

PubMed

Zhou, Yi-Fei; Yu, Yang; Zhang, Xiao-Lei; Chen, Hua

2012-05-01

To investigate the clinical effects of surgical vs manual reduction of ankle fractures. From March 2006 to April 2010,301 patients with ankle fractures were analyzed retrospectively, of whom 134 patients were treated by manual reduction and plaster fixation, and the other 167 patients underwent surgical treatment. In manual reduction group, there were 86 males and 48 females with a mean age of (38.2 +/- 15.7) years, involving Weber-Denis A in 55 cases,Weber-Denis B in 60 cases, and Weber-Denis C in 19 cases. In surgical reduction group, there were 115 males and 52 females with a mean age of (39.6 +/- 11.9) years, involving Weber-Denis A in 59 cases, Weber-Denis B in 52 cases and Weber-Denis C in 56 cases. The score of the ankle's symptoms and function was calculated according to Mazur,and the difference was analyzed by Chi-squire test. Of the 114 patients with Weber-Denis A, 55 patients were in manual reduction group, with excellent, good, acceptable and poor results in 18, 20, 11 and 6 patients respectively vs 26, 25, 6 and 2 in surgical reduction group of 59 patients. In patients with Weber-Denis B, there were 60 patients in manual reduction group, with excellent, good, acceptable and poor results in 20 , 26, 8 and 6 patients vs 25, 21, 5, and 1 in surgical reduction group of 52 patients. There was no significant difference in clinical effects between the two group of Weber-Denis A and B. The remaining 75 patients belonged to Weber-Denis C, of whom 19 patients were in manual reduction group,with excellent, good, acceptable and poor results in 2, 3, 7 and 7 patients vs 21, 18, 11 and 6 in surgical reduction group of 56 patients. There was no significant difference in clinical effects between the two groups of Weber-Denis C (P=0.007). The clinical effect of surgical reduction group was obviously better than that of manual reduction group for Weber-Denis C, and therefore surgical intervention is recommended for this type of fracture.

Dose versus diagnosis: iatrogenic radiation exposure by multidetector computerised tomography in an academic emergency department with measurement of clinically actionable results and emergently treatable findings.

PubMed

Baskerville, J R; Chang, J H; Viator, M; Rutledge, W; Miryala, R; Duval, K E; Nishino, T K

2009-01-01

To determine the iatrogenic absorbed dosage of radiation of the patient in milligray (mGy) computerised tomography dose index volume (CTDIvol) when tested with multidetector computerised tomography (MDCT) in the emergency department (ED) setting and calculate the absorbed dosage of radiation per clinically actionable result and emergently treatable finding (ETF). The University of Texas Medical Branch (UTMB) ED located in Galveston, Texas, USA, is a level 1 trauma and tertiary referral centre treating 70,000 patients per annum. A retrospective cross-sectional data analysis of 770 emergency patients investigated by MDCT in July 2007. The presence of actionable results and ETF were determined by chart review. A total of 5320 emergency patients was treated in the UTMB ED in July 2007. This included 4508 medical and 812 trauma patients. A total of 1094 MDCT studies was performed, of which complete data were available on 1046. A total of 770 patients was investigated by MDCT, representing 14.47% of all emergency patients. This included 33.99% of trauma patients and 10.96% of medical patients. Actionable results were found in 341 studies and ETF in 105 studies. The mean radiation was 163.27 and 530.23 mGy CTDIvol for actionable results and ETF, respectively, for all studies. The mean radiation was 53.27 and 106.36 mGy CTDIvol for medical and trauma patients, respectively. The absorbed dosage of radiation of patients investigated by MDCT is clinically significant. The actionable results and ETF in our study demonstrate considerable opportunity for improvement in the utilisation of this technology by physicians.

Clinical Significance of Human Herpesvirus 6 Positivity on the FilmArray Meningitis/Encephalitis Multiplex PCR Panel.

PubMed

Green, Daniel A; Pereira, Marcus; Miko, Benjamin; Radmard, Sara; Whittier, Susan; Thakur, Kiran

2018-04-09

A review of 15 patients who tested positive for HHV-6 on the FilmArray Meningitis/Encephalitis (M/E) panel revealed that the majority were unlikely to have HHV-6 encephalitis. Interpreting HHV-6 positive results on the M/E panel requires careful clinical judgment, as this finding may be clinically insignificant for many patients.

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

PubMed

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

2016-03-30

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

Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study

PubMed Central

Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

2017-01-01

Introduction Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. Methods This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. Ethics and dissemination This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. PMID:28132001

Comparing the effectiveness of ultrasound-guided versus blind steroid injection in the treatment of severe carpal tunnel syndrome

PubMed

Karaahmet, Özgür Zeliha; Gürçay, Eda; Kara, Murat; Serçe, Azize; Kıraç Ünal, Zeynep; Çakcı, Aytül

2017-12-19

Background/aim: This study aimed to compare the effectiveness of ultrasound (US)-guided injection versus blind injection of corticosteroids in the treatment of carpal tunnel syndrome (CTS). Materials and methods: This prospective, randomized clinical trial included patients with severe CTS based on clinical and electrophysiological criteria. The patients were evaluated for clinical and electrophysiological parameters at baseline and 4 weeks after treatment. Symptom severity and hand function were assessed by the Boston questionnaire. The patients underwent blind injection or US-guided injection. Results: When compared with baseline, both groups showed significant improvement in Boston questionnaire scores and all electrophysiological parameters. Significant differences were observed between the groups for clinical parameters (Boston Symptom Severity Scale: P = 0.007; Functional Status Scale: P < 0.001) in favor of the US-guided group. Conclusion: This study demonstrated that both US-guided and blind injections were effective in reducing symptoms and improving hand function. US-guided injections may yield more effective clinical results in the short-term than blind injections in the treatment of patients with severe CTS.

ProDisc-L total disc replacement: a comparison of 1-level versus 2-level arthroplasty patients with a minimum 2-year follow-up.

PubMed

Hannibal, Matthew; Thomas, Derek J; Low, Jeffrey; Hsu, Ken Y; Zucherman, James

2007-10-01

This is a retrospective analysis of data that was collected prospectively from 2 concurrent FDA IDE lumbar arthroplasty clinical trials performed at a single center. To determine if there is a clinical difference between the 1-level ProDisc patients versus the 2-level ProDisc patients at a minimum of 2 years of follow-up. Marnay's work with ProDisc I prompted the U.S. Clinical Trials of the ProDisc II under the direction of the FDA. Disc replacement surgery in the United States has shown promising results for all types of prostheses up to 6 months. Marnay and colleagues showed that their results at 10 years were still promising, and they saw no significant difference between 1-level and multilevel disc replacements. The findings of Ipsen and colleagues suggest that multilevel arthroplasty cases may be less successful than disc replacement at a single level. Patients were part of the FDA clinical trial for the Prodisc II versus circumferential fusion study at a single institution. We identified 27 patients who received ProDisc at 1 level and 32 who received it at 2 levels with at least a 2-year follow-up, for a total of 59 patients. Unpaired t tests were performed on the mean results of Visual Analog Scale, Oswestry Disability Index, SF-36 Healthy Survey Physical Component Summary, and satisfaction using 10-cm line visual scale scores to determine a clinical difference if any between the 2 populations. While patients receiving ProDisc at 2 levels scored marginally lower in all evaluation indexes, score differences in each category were also found to hold no statistical significance. This study was unable to identify a statistically significant difference in outcome between 1- and 2-level ProDisc arthroplasty patients in a cohort from a single center. The equality of clinical effectiveness between 1- and 2-level ProDisc has yet to be determined.

How to influence patient oral hygiene behavior effectively.

PubMed

Clarkson, J E; Young, L; Ramsay, C R; Bonner, B C; Bonetti, D

2009-10-01

Considerable resources are expended in dealing with dental disease easily prevented with better oral hygiene. The study hypothesis was that an evidence-based intervention, framed with psychological theory, would improve patients' oral hygiene behavior. The impact of trial methodology on trial outcomes was also explored by the conducting of two independent trials, one randomized by patient and one by dentist. The study included 87 dental practices and 778 patients (Patient RCT = 37 dentists/300 patients; Cluster RCT = 50 dentists/478 patients). Controlled for baseline differences, pooled results showed that patients who experienced the intervention had better behavioral (timing, duration, method), cognitive (confidence, planning), and clinical (plaque, gingival bleeding) outcomes. However, clinical outcomes were significantly better only in the Cluster RCT, suggesting that the impact of trial design on results needs to be further explored.

Nurse-Led Multidisciplinary Heart Failure Group Clinic Appointments: Methods, Materials, and Outcomes Used in the Clinical Trial.

PubMed

Smith, Carol E; Piamjariyakul, Ubolrat; Dalton, Kathleen M; Russell, Christy; Wick, Jo; Ellerbeck, Edward F

2015-01-01

The Self-management and Care of Heart Failure through Group Clinics Trial evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high-risk heart failure (HF) patients. The purpose of this article is to (1) describe key Self-management and Care of Heart Failure through Group Clinics Trial group clinic interactive learning strategies, (2) describe resources and materials used in the group clinic appointment, and (3) present results supporting this patient-centered group intervention. This clinical trial included 198 HF patients (randomized to either group clinical appointments or to standard care). Data were collected from 72 group clinic appointments via patients' (1) group clinic session evaluations, (2) HF self-care behaviors skills, (3) HF-related discouragement and quality of life scores, and (4) HF-related reshopitalizations during the 12-month follow-up. Also, the costs of delivery of the group clinical appointments were tabulated. Overall, patients rated group appointments as 4.8 of 5 on the "helpfulness" in managing HF score. The statistical model showed a 33% decrease in the rate of rehospitalizations (incidence rate ratio, 0.67) associated with the intervention over the 12-month follow-up period when compared with control patients (χ(2)1=3.9, P=.04). The total cost for implementing 5 group appointments was $243.58 per patient. The intervention was associated with improvements in HF self-care knowledge and home care behavior skills and managing their for HF care. In turn, better self-care was associated with reductions in HF-related hospitalizations.

Patients' satisfaction after ear reconstruction with autologous rib cartilage.

PubMed

Kristiansen, Martina; Öberg, Martin; Wikström, Sven Olof

2013-04-01

Patients' satisfaction is an important outcome measure in reconstructive surgery and quality assurance is today central in the clinical practice. The aim of this study was to evaluate the patients' satisfaction with the process and final result after reconstruction for congenital microtia. A questionnaire was designed and sent to 78 patients who had undergone unilateral ear reconstruction with autologous rib cartilage during the period 2000-2010. For a multidimensional view the patients answered 42 questions about aesthetic, functional, psychosocial, and clinic-related outcomes. The response rate was 76% (59/78 patients). The patients were generally satisfied with the aesthetic result of the ear and had function gain in being able to wear glasses; however, some patients did report new different functional problems after the operation. Still, almost all patients felt that the ear was a part of them and would have chosen the same operative procedure if they could do it again. The patients were overall highly satisfied with the care process. This surgery-specific questionnaire is an important tool for quality assurance in this clinical practice. These findings can help to improve the preoperative information to meet the patients' notions, expectations, and fears.

The pitfalls of hair analysis for toxicants in clinical practice: three case reports.

PubMed Central

Frisch, Melissa; Schwartz, Brian S

2002-01-01

Hair analysis is used to assess exposure to heavy metals in patients presenting with nonspecific symptoms and is a commonly used procedure in patients referred to our clinic. We are frequently called on to evaluate patients who have health-related concerns as a result of hair analysis. Three patients first presented to outside physicians with nonspecific, multisystemic symptoms. A panel of analytes was measured in hair, and one or more values were interpreted as elevated. As a result of the hair analysis and other unconventional diagnostic tests, the patients presented to us believing they suffered from metal toxicity. In this paper we review the clinical efficacy of this procedure within the context of a patient population with somatic disorders and no clear risk factors for metal intoxication. We also review limitations of hair analysis in this setting; these limitations include patient factors such as low pretest probability of disease and test factors such as the lack of validation of analytic techniques, the inability to discern between exogenous contaminants and endogenous toxicants in hair, the variability of analytic procedures, low interlaboratory reliability, and the increased likelihood of false positive test results in the measurement of panels of analytes. PMID:11940463

Antihyperglycemic agent therapy for adult patients with type 2 diabetes mellitus 2017: a position statement of the Korean Diabetes Association.

PubMed

Ko, Seung-Hyun; Hur, Kyu Yeon; Rhee, Sang Youl; Kim, Nan-Hee; Moon, Min Kyong; Park, Seok-O; Lee, Byung-Wan; Kim, Hyun Jin; Choi, Kyung Mook; Kim, Jin Hwa

2017-11-01

In 2017, the Korean Diabetes Association (KDA) published a position statement on the use of antihyperglycemic agents for patients with type 2 diabetes mellitus (T2DM). The KDA regularly updates its Clinical Practice Guidelines, but since the last update in 2015, many results from clinical trials have been introduced, and domestic data from studies performed in Korean patients with T2DM have been published. Recently, evidence from large clinical studies assessing cardiovascular outcomes following the use of sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists in patients with T2DM were incorporated into the recommendations. Additionally, new data from clinical trials using dipeptidyl peptidase 4 inhibitors and thiazolidinediones in Korean patients with T2DM were added. Following a systematic review and assessment of recent evidence, the KDA updated and modified its clinical practice recommendations regarding the use of antihyperglycemic agents and revised the treatment algorithm for Korean adult patients with T2DM.

Clinical and genetic features of the patients with X-Linked agammaglobulinemia from Turkey: Single-centre experience.

PubMed

Esenboga, S; Cagdas, D; Ozgur, T T; Gur Cetinkaya, P; Turkdemir, L M; Sanal, O; VanDerBurg, M; Tezcan, I

2018-03-01

X-linked agammaglobulinemia is a primary immunodeficiency disorder resulting from BTK gene mutations. There are many studies in the literature suggesting contradictory ideas about phenotype-genotype correlation. The aim of this study was to identify the mutations and clinical findings of patients with XLA in Turkey, to determine long-term complications related to the disease and to analyse the phenotype-genotype correlation. Thirty-two patients with XLA diagnosed between 1985 and 2016 in Pediatric Immunology Department of Hacettepe University Ihsan Dogramaci Children's Hospital were investigated. A clinical survey including clinical features of the patients was completed, and thirty-two patients from 26 different families were included in the study. Getting early diagnosis and regular assessment with imaging techniques seem to be the most important issues for improving the health status of the patients with XLA. Early molecular analysis gives chance for definitive diagnosis and genetic counselling, but not for predicting the clinical severity and prognosis. © 2018 The Foundation for the Scandinavian Journal of Immunology.

Finite element strategies to satisfy clinical and engineering requirements in the field of percutaneous valves.

PubMed

Capelli, Claudio; Biglino, Giovanni; Petrini, Lorenza; Migliavacca, Francesco; Cosentino, Daria; Bonhoeffer, Philipp; Taylor, Andrew M; Schievano, Silvia

2012-12-01

Finite element (FE) modelling can be a very resourceful tool in the field of cardiovascular devices. To ensure result reliability, FE models must be validated experimentally against physical data. Their clinical application (e.g., patients' suitability, morphological evaluation) also requires fast simulation process and access to results, while engineering applications need highly accurate results. This study shows how FE models with different mesh discretisations can suit clinical and engineering requirements for studying a novel device designed for percutaneous valve implantation. Following sensitivity analysis and experimental characterisation of the materials, the stent-graft was first studied in a simplified geometry (i.e., compliant cylinder) and validated against in vitro data, and then in a patient-specific implantation site (i.e., distensible right ventricular outflow tract). Different meshing strategies using solid, beam and shell elements were tested. Results showed excellent agreement between computational and experimental data in the simplified implantation site. Beam elements were found to be convenient for clinical applications, providing reliable results in less than one hour in a patient-specific anatomical model. Solid elements remain the FE choice for engineering applications, albeit more computationally expensive (>100 times). This work also showed how information on device mechanical behaviour differs when acquired in a simplified model as opposed to a patient-specific model.

Privacy-preserving genomic testing in the clinic: a model using HIV treatment.

PubMed

McLaren, Paul J; Raisaro, Jean Louis; Aouri, Manel; Rotger, Margalida; Ayday, Erman; Bartha, István; Delgado, Maria B; Vallet, Yannick; Günthard, Huldrych F; Cavassini, Matthias; Furrer, Hansjakob; Doco-Lecompte, Thanh; Marzolini, Catia; Schmid, Patrick; Di Benedetto, Caroline; Decosterd, Laurent A; Fellay, Jacques; Hubaux, Jean-Pierre; Telenti, Amalio

2016-08-01

The implementation of genomic-based medicine is hindered by unresolved questions regarding data privacy and delivery of interpreted results to health-care practitioners. We used DNA-based prediction of HIV-related outcomes as a model to explore critical issues in clinical genomics. We genotyped 4,149 markers in HIV-positive individuals. Variants allowed for prediction of 17 traits relevant to HIV medical care, inference of patient ancestry, and imputation of human leukocyte antigen (HLA) types. Genetic data were processed under a privacy-preserving framework using homomorphic encryption, and clinical reports describing potentially actionable results were delivered to health-care providers. A total of 230 patients were included in the study. We demonstrated the feasibility of encrypting a large number of genetic markers, inferring patient ancestry, computing monogenic and polygenic trait risks, and reporting results under privacy-preserving conditions. The average execution time of a multimarker test on encrypted data was 865 ms on a standard computer. The proportion of tests returning potentially actionable genetic results ranged from 0 to 54%. The model of implementation presented herein informs on strategies to deliver genomic test results for clinical care. Data encryption to ensure privacy helps to build patient trust, a key requirement on the road to genomic-based medicine.Genet Med 18 8, 814-822.

Clinical characteristics and initial management of patients with tuberculous pericarditis in the HIV era: the Investigation of the Management of Pericarditis in Africa (IMPI Africa) registry

PubMed Central

Mayosi, Bongani M; Wiysonge, Charles Shey; Ntsekhe, Mpiko; Volmink, Jimmy A; Gumedze, Freedom; Maartens, Gary; Aje, Akinyemi; Thomas, Baby M; Thomas, Kandathil M; Awotedu, Abolade A; Thembela, Bongani; Mntla, Phindile; Maritz, Frans; Blackett, Kathleen Ngu; Nkouonlack, Duquesne C; Burch, Vanessa C; Rebe, Kevin; Parish, Andy; Sliwa, Karen; Vezi, Brian Z; Alam, Nowshad; Brown, Basil G; Gould, Trevor; Visser, Tim; Shey, Muki S; Magula, Nombulelo P; Commerford, Patrick J

2006-01-01

Background The incidence of tuberculous pericarditis has increased in Africa as a result of the human immunodeficiency virus (HIV) epidemic. However, the effect of HIV co-infection on clinical features and prognosis in tuberculous pericarditis is not well characterised. We have used baseline data of the Investigation of the Management of Pericarditis in Africa (IMPI Africa) registry to assess the impact of HIV co-infection on clinical presentation, diagnostic evaluation, and treatment of patients with suspected tuberculous pericarditis in sub-Saharan Africa. Methods Consecutive adult patients in 15 hospitals in three countries in sub-Saharan Africa were recruited on commencement of treatment for tuberculous pericarditis, following informed consent. We recorded demographic, clinical, diagnostic and therapeutic information at baseline, and have used the chi-square test and analysis of variance to assess probabilities of significant differences (in these variables) between groups defined by HIV status. Results A total of 185 patients were enrolled from 01 March 2004 to 31 October 2004, 147 (79.5%) of whom had effusive, 28 (15.1%) effusive-constrictive, and 10 (5.4%) constrictive or acute dry pericarditis. Seventy-four (40%) had clinical features of HIV infection. Patients with clinical HIV disease were more likely to present with dyspnoea (odds ratio [OR] 3.2, 95% confidence interval [CI] 1.4 to 7.4, P = 0.005) and electrocardiographic features of myopericarditis (OR 2.8, 95% CI 1.1 to 6.9, P = 0.03). In addition to electrocardiographic features of myopericarditis, a positive HIV serological status was associated with greater cardiomegaly (OR 3.89, 95% CI 1.34 to 11.32, P = 0.01) and haemodynamic instability (OR 9.68, 95% CI 2.09 to 44.80, P = 0.0008). However, stage of pericardial disease at diagnosis and use of diagnostic tests were not related to clinical HIV status. Similar results were obtained for serological HIV status. Most patients were treated on clinical grounds, with microbiological evidence of tuberculosis obtained in only 13 (7.0%) patients. Adjunctive corticosteroids were used in 109 (58.9%) patients, with patients having clinical HIV disease less likely to be put on them (OR 0.37, 95% CI 0.20 to 0.68). Seven patients were on antiretroviral drugs. Conclusion Patients with suspected tuberculous pericarditis and HIV infection in Africa have greater evidence of myopericarditis, dyspnoea, and haemodynamic instability. These findings, if confirmed in other studies, may suggest more intensive management of the cardiac disease is warranted in patients with HIV-associated pericardial disease. PMID:16396690

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

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

Genotype- phenotype correlation in trisomy X: a retrospective study of a selected group of 36 patients and review of literature.

PubMed

Butnariu, Lăcrămioara; Rusu, Cristina; Caba, Lavinia; Pânzaru, Monica; Braha, Elena; Grămescu, Mihaela; Popescu, Roxana; Bujoranu, C; Gorduza, E V

2013-01-01

Trisomy X (47,XXX) is a gonosomal aneuploidy characterized by the presence of an extra X chromosome in a female person. Usually the diagnosis is established made postnatally by chromosome analysis in patients with suggestive clinical signs. Clinical signs vary by age. In prepubertal patients have a growth retardation associated with uncharacteristic facial dysmorphism, mild mental retardation with behavioral disorders, plus clinical signs of ovarian dysgenesis, postpubertal. We analyzed retrospectively the genotype - phenotype correlations for a selected group of 36 patients diagnosed with trisomy X (homogeneous or mosaic) by cytogenetic methods (X chromatin and karyotype). Analysis of the clinical data of 36 patients diagnosed with trisomy X and correlation with the results of X chromatin and karyotype. Clinical signs detected in patients with homogeneous trisomy X 47,XXX (22.22%), mosaic 46,XX/47,XXX (16.66%) or 47,XXX/48,XXXX (5.55%) were prepubertal, growth retardation associated with dysmorphic facial (upslanted palpebral fissure, epichantus, thin lips) and postpubertal, signs of ovarian dysgenesis (secondary amenorrhea, early menopause). The phenotype of patients with different gonosomal mosaic corresponding to Turner syndrome, incorporating a cell line with trisomy X (55.55%) was variable, correlated with the type of chromosomal abnormalities detected. The results of our study are similar to those obtained in other studies and emphasizes that phenotypic variability of patients with trisomy X feature makes it difficult to genotype - phenotype correlations.

Influence of patients' socioeconomic status on clinical management decisions: a qualitative study.

PubMed

Bernheim, Susannah M; Ross, Joseph S; Krumholz, Harlan M; Bradley, Elizabeth H

2008-01-01

Little is known about how patients' socioeconomic status (SES) influences physicians' clinical management decisions, although this information may have important implications for understanding inequities in health care quality. We investigated physician perspectives on how patients' SES influences care. The study consisted of in-depth semistructured interviews with primary care physicians in Connecticut. Investigators coded interviews line by line and refined the coding structure and interview guide based on successive interviews. Recurrent themes emerged through iterative analysis of codes and tagged quotations. We interviewed 18 physicians from varied practice settings, 6 female, 9 from minority racial backgrounds, and 3 of Hispanic ethnicity. Four themes emerged from our interviews: (1) physicians held conflicting views about the effect of patient SES on clinical management, (2) physicians believed that changes in clinical management based on the patient's SES were made in the patient's interest, (3) physicians varied in the degree to which they thought changes in clinical management influenced patient outcomes, and (4) physicians faced personal and financial strains when caring for patients of low SES. Physicians indicated that patient SES did affect their clinical management decisions. As a result, physicians commonly undertook changes to their management plan in an effort to enhance patient outcomes, but they experienced numerous strains when trying to balance what they believed was feasible for the patient with what they perceived as established standards of care.

Medical Student Bias and Care Recommendations for an Obese versus Non-Obese Virtual Patient

PubMed Central

Persky, Susan; Eccleston, Collette P.

2010-01-01

Objective This study examined the independent effect of a patient's weight on medical students' attitudes, beliefs, and interpersonal behavior toward the patient, in addition to the clinical recommendations they make for her care. Design Seventy-six clinical-level medical students were randomly assigned to interact with a digital, virtual female patient who was visibly either obese or non-obese. Methods Interactions with the patient took place in an immersive virtual clinical environment (i.e., virtual reality) which allowed standardization of all patient behaviors and characteristics except for weight. Visual contact behavior was automatically recorded during the interaction. Afterward, participants filled out a battery of self-report questionnaires. Results Analyses revealed more negative stereotyping, less anticipated patient adherence, worse perceived health, more responsibility attributed for potentially weight-related presenting complaints, and less visual contact directed toward the obese version of a virtual patient than the non-obese version of the patient. In contrast, there was no clear evidence of bias in clinical recommendations made for the patient's care. Conclusion Biases in attitudes, beliefs, and interpersonal behavior have important implications because they can influence the tone of clinical encounters and rapport in the patient-provider relationship, which can have important downstream consequences. Gaining a clear understanding of the nature and source of weight bias in the clinical encounter is an important first step toward development of strategies to address it. PMID:20820169

Does Improving Patient-Practitioner Communication Improve Clinical Outcomes in Patients with Cardiovascular Diseases? A Systematic Review of the Evidence

PubMed Central

Schoenthaler, Antoinette; Kalet, Adina; Nicholson, Joseph; Lipkin, Mack

2014-01-01

Objective To conduct a systematic literature review appraising the effects of interventions to improve patient-practitioner communication on cardiovascular-related clinical outcomes. Methods Databases were searched up to March 27, 2013 to identify eligible studies that included interventions to improve patient and/or practitioner communication skills and assessment of a cardiovascular-related clinical outcome in adults ≥ 18 years of age. Results Fifteen papers were reviewed: The primary focus in seven studies was the patient; seven included a practitioner-focused intervention and one targeted both. Two patient-focused and two practitioner-focused studies demonstrated a beneficial effect of the intervention compared to a control group. Patient-focused studies were designed to improve patients’ information-seeking and question-asking skills with their practitioner. Practitioner-focused studies were designed to either improve practitioner’s general patient-centered communication or risk communication skills. Conclusions Few interventions targeting patient-practitioner communication have assessed the impact on cardiovascular-related clinical outcomes, limiting the ability to determine effectiveness. Additional rigorous research supported by theoretical frameworks and validated measurement is needed to understand the potential of patient-practitioner communication to improve cardiovascular-related clinical outcomes. Practice Implications Investments in communication skills trainings in medical education and practice are needed in order to attain the full potential of patient-centered care on cardiovascular-related clinical outcomes. Systematic Review Protocol Registration CRD42013006302 PMID:24795073

Interpreting the Clinical Significance of Capacity Scores for Informed Consent in Alzheimer Disease Clinical Trials

PubMed Central

Karlawish, Jason; Kim, Scott Y. H.; Knopman, David; van Dyck, Christopher H.; James, Bryan D.; Bioethics, M.; Marson, Daniel

2014-01-01

Objective Among Alzheimer disease (AD) patients enrolled in a clinical trial, the authors assessed the ability of a standardized capacity assessment procedure to identify persons who are capable of giving their own informed consent. Design Cross-sectional interview. Setting Thirteen sites participating in a randomized and placebo controlled study of simvastatin for the treatment of mild to moderate AD. Participants Persons with mild to moderate AD and their study partners enrolled in the simvastatin clinical trial. Measurements Interviews to assess decision-making capacity using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR). Results Judges blinded to the subject’s clinical status had a high rate of agreement on patients capable of giving their own informed consent (κ = 0.73). The understanding subscale had the best receiver operator characteristic and an analysis of positive and negative predictive values over a range of hypothetical prevalences of incapacity to consent demonstrated the value of a range of understanding cut-points. Conclusion Among mild to moderate AD patients, enrolled in an actual clinical trial, these results suggest evidence based guidelines for using the MacCAT-CR understanding subscale to help guide judgments about whether a patient has the capacity to consent. PMID:18556397

Patient-centered Medical Home Capability and Clinical Performance in HRSA-supported Health Centers

PubMed Central

Shi, Leiyu; Lock, Diana C.; Lee, De-Chih; Lebrun-Harris, Lydie A.; Chin, Marshall H.; Chidambaran, Preeta; Nocon, Robert S.; Zhu, Jinsheng; Sripipatana, Alek

2015-01-01

Objectives To evaluate the relationship between Patient-centered Medical Home (PCMH) model adoption in health centers (HCs) and clinical performance measures and to determine if adoption of PCMH characteristics is associated with better clinical performance. Research Design Data came from the Health Resources and Services Administration’s 2009 Uniform Data System and the 2009 Commonwealth Fund National Survey of Federally Qualified Health Centers. Clinical performance measures included 2 process measures (childhood immunization and cervical cancer screening) and 2 outcome measures (hypertension control and diabetes control). Total and subscale PCMH scores were regressed on the clinical performance measures, adjusting for patient, provider, financial, and institutional characteristics. Results The findings showed different directional relationships, with some PCMH domains (care management, test/referral tracking, quality improvement, and external coordination) showing little or no effect on outcome measures of interest, 1 domain (access/communication) associated with improved outcomes, and 1 domain (patient tracking/registry) associated with worse outcomes. Conclusions This study is among the first to examine the association between PCMH transformation and clinical performance in HCs, providing an understanding of the impact of PCMH adoption within safety-net settings. The mixed results highlight the importance of examining relationships between specific PCMH domains and specific clinical quality measures, in addition to analyzing overall PCMH scores which could yield distorted findings. PMID:25793267

Clinical outcome of fresh and vitrified-warmed blastocyst and cleavage-stage embryo transfers in ethnic Chinese ART patients.

PubMed

Tong, Guo Qing; Cao, Shan Ren; Wu, Xun; Zhang, Jun Qiang; Cui, Ji; Heng, Boon Chin; Ling, Xiu Feng

2012-10-05

This study sought to evaluate the outcome of fresh and vitrified-warmed cleavage-stage and blastocyst-stage embryo transfers in patients undergoing ART treatment within an ethnic Chinese population. We compared the clinical results of embryo transfer on the 3rd (cleavage stage) or 5th (blastocyst stage) day after oocyte retrieval, including clinical pregnancy rates, implantation rates and multiple pregnancy rates. Our data showed that blastocyst transfer on day 5 did not significantly increase clinical pregnancy rate (41.07% vs 47.08%, p>0.05) and implantation rate (31.8% vs 31.2%, p>0.05) in patients under 35 years of age, in comparison with day 3 cleavage stage embryo transfer. In patients older than 35 years of age, the clinical pregnancy rate after blastocyst transfer was slightly decreased compared with cleavage stage embryo transfer (33.33% vs 42.31%, p>0.05). Unexpectedly, It was found that vitrified-warmed blastocyst transfer resulted in significantly higher clinical pregnancy rate (56.8%) and implantation rate (47%) compared with fresh blastocyst transfer in controlled stimulation cycles (41.07% and 31.8%, respectively). For patients under 35 years of age, the cumulative clinical pregnancy rate combining fresh and vitrified-warmed blastocyst transfer cycles were significantly higher compared to just cleavage-stage embryo transfer (70.1% versus 51.8%, p<0.05). However, the cumulative multiple pregnancy rates showed no significant difference between the two groups. In an ethnic Chinese patient population, fresh blastocyst transfer does not significantly increase clinical pregnancy rate. However, subsequent vitrified-warmed blastocyst transfer in a non-controlled ovarian hyperstimulation cycle dramatically improves clinical outcomes. Therefore, blastocyst culture in tandem with vitrified-warmed blastocyst transfer is recommended as a favourable and promising protocol in human ART treatment, particularly for ethnic Chinese patients.

Expanding Local Cancer Clinical Trial Options: Analysis of the Economic Impact of the Midwest Cancer Alliance in Kansas

PubMed Central

Gafford, J. Atlee; Krebill, Hope; Lai, Sue Min; Christiadi; Doolittle, Gary C.

2017-01-01

Purpose Patients benefit from receiving cancer treatment closer to home when possible and at high-volume regional centers when specialized care is required. The purpose of this analysis was to estimate the economic impact of retaining more patients in-state for cancer clinical trials and care, which might offset some of the costs of establishing broader cancer trial and treatment networks. Method Kansas Cancer Registry data were used to estimate the number of patients retained in-state for cancer care following the expansion of local cancer clinical trial options through the Midwest Cancer Alliance based at the University of Kansas Medical Center. The 2014 economic impact of this enhanced local clinical trial network was estimated in four parts: Medical spending was estimated on the basis of National Cancer Institute cost-of-care estimates. Household travel cost savings were estimated as the difference between in-state and out-of-state travel costs. Trial-related grant income was calculated from administrative records. Indirect and induced economic benefits to the state were estimated using an economic impact model. Results The authors estimated that the enhanced local cancer clinical trial network resulted in approximately $6.9 million in additional economic activity in the state in 2014, or $362,000 per patient retained in-state. This estimate includes $3.6 million in direct spending and $3.3 million in indirect economic activity. The enhanced trial network also resulted in 45 additional jobs. Conclusions Retaining patients in-state for cancer care and clinical trial participation allows patients to remain closer to home for care and enhances the state economy. PMID:28253204

Impact of Prior Cancer on Eligibility for Lung Cancer Clinical Trials

PubMed Central

Laccetti, Andrew L.; Xuan, Lei; Halm, Ethan A.; Pruitt, Sandi L.

2014-01-01

Background In oncology clinical trials, the assumption that a prior cancer diagnosis could interfere with study conduct or outcomes results in frequent exclusion of such patients. We determined the prevalence and characteristics of this practice in lung cancer clinical trials and estimated impact on trial accrual. Methods We reviewed lung cancer clinical trials sponsored or endorsed by the Eastern Oncology Cooperative Group for exclusion criteria related to a prior cancer diagnosis. We estimated prevalence of prior primary cancer diagnoses among lung cancer patients using Surveillance Epidemiology and End Results (SEER)-Medicare linked data. We assessed the association between trial characteristics and prior cancer exclusion using chi-square analysis. All statistical tests were two-sided. Results Fifty-one clinical trials (target enrollment 13072 patients) were included. Forty-one (80%) excluded patients with a prior cancer diagnosis as follows: any prior (14%), within five years (43%), within two or three years (7%), or active cancer (16%). In SEER-Medicare data (n = 210509), 56% of prior cancers were diagnosed within five years before the lung cancer diagnosis. Across trials, the estimated number and proportion of patients excluded because of prior cancer ranged from 0–207 and 0%-18%. Prior cancer was excluded in 94% of trials with survival primary endpoints and 73% of trials with nonsurvival primary endpoints (P = .06). Conclusions A substantial proportion of patients are reflexively excluded from lung cancer clinical trials because of prior cancer. This inclusion criterion is applied widely across studies, including more than two-thirds of trials with nonsurvival endpoints. More research is needed to understand the basis and ramifications of this exclusion policy. PMID:25253615

Evaluation of clinical pharmacy services in a hematology/oncology outpatient setting.

PubMed

Shah, Sachin; Dowell, Jonathan; Greene, Shane

2006-09-01

The Veterans Affairs North Texas Health Care System in Dallas, TX, provides a unique opportunity for clinical pharmacists to work as providers. Even though clinical pharmacists are actively involved in patient care, many of their efforts remain undocumented, resulting in an underestimation of the importance of their services and missed opportunities for improvements and new directions. To document and evaluate the services of a hematology/oncology clinical pharmacy in the outpatient setting. Pendragon Forms 3.2 software was used to design the documentation template. The template was designed to collect diagnoses, supportive care issues, drug-specific interventions, and prescriptions written. This template was uploaded to the personal digital assistant (PDA) for documentation. Patient-specific information was documented in a password-protected PDA. Data collected from November 1, 2002, to October 31, 2003, were retrospectively analyzed. Clinical pharmacists were involved in 423 patient visits for chemotherapy follow-up or disease management. Cancer diagnoses included colorectal (n = 99), multiple myeloma (59), non-small cell lung (56), chronic lymphocytic leukemia (44), myelodysplastic syndromes (22), and chronic myelogenous leukemia (19). During the 423 patient visits, 342 supportive care issues were addressed including anemia (34%), pain management (22%), constipation/diarrhea (15%), and nausea/vomiting (8%). Major drug-specific interventions included drug addition (41%), discontinuation (23%), and adjustment (21%). Four hundred forty-five prescriptions were filled, of which 181 were new and 150 were refilled. This is the first study, as of July 25, 2006, to document considerable contribution of an outpatient clinical pharmacist in direct cancer patient care. Although the disease management and supportive care issues addressed here may differ based on institution and patient population, the results of our study show that clinical pharmacists have ever-growing roles in the management of these patients.

An economic model of haemophilia in Mexico.

PubMed

Martínez-Murillo, C; Quintana, S; Ambriz, R; Benitez, H; Berges, A; Collazo, J; Esparza, A; Pompa, T; Taboada, C; Zavala, S; Larochelle, M R; Bentkover, J D

2004-01-01

A model was developed to assess the lifetime costs and outcomes associated with haemophilia in Mexico. A retrospective chart review of 182 type A haemophiliacs was conducted for patients aged 0-34 years receiving one of three treatments: (i) cryoprecipitate at clinic; (ii) concentrate at home; or (iii) concentrate at clinic. Patients treated at home experienced 30% less joint damage, used 13-54% less factor VIII, had four times fewer clinic visits, and utilized half as many hospital days than those treated at a clinic. For cryoprecipitate at clinic patients, the annual incidence rates of HCV and HIV were calculated to be 3.6% and 1.4% respectively. The life expectancy for patients receiving cryoprecipitate and those receiving concentrate was estimated to be 49 years and 69 years respectively, with 58% of cryoprecipitate patients predicted to die of AIDS before age 69. Across the lifespan, the average annual cost of care was US$11,677 (MN$110,464) for cryoprecipitate at clinic patients, US$10,104 (M$95,580) for concentrate at home patients and US$18,819 (MN$178,027) for concentrate at clinic patients. Using a 5% discount rate, the incremental lifetime cost per year of life added for treatment with concentrate at home compared with cryoprecipitate at a clinic was US$738 (MN$6981). Rank order stability analysis demonstrated that the model was most sensitive to the cost of fVIII. These results indicate that treatment with concentrate at home compared with cryoprecipitate at a clinic substantially improves clinical outcomes at reduced annual cost levels.

Cost Drivers of a Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase 3 Clinical Trial

PubMed Central

Stergiopoulos, Stella; Calvert, Sara B; Brown, Carrie A; Awatin, Josephine; Tenaerts, Pamela; Holland, Thomas L; DiMasi, Joseph A; Getz, Kenneth A

2018-01-01

Abstract Background Studies indicate that the prevalence of multidrug-resistant infections, including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these disease conditions and the ability to develop new treatments. Additionally, HABP/VABP clinical trials are very costly to conduct given their complex protocol designs and the difficulty in recruiting and retaining patients. Methods With input from clinicians, representatives from industry, and the US Food and Drug Administration, we conducted a study to (1) evaluate the drivers of HABP/VABP phase 3 direct and indirect clinical trial costs; (2) to identify opportunities to lower these costs; and (3) to compare (1) and (2) to endocrine and oncology clinical trials. Benchmark data were gathered from proprietary and commercial databases and used to create a model that calculates the fully loaded (direct and indirect) cost of typical phase 3 HABP/VABP endocrine and oncology clinical trials. Results Results indicate that the cost per patient for a 200-site, 1000-patient phase 3 HABP/VABP study is $89600 per patient. The cost of screen failures and screen failure rates are the main cost drivers. Conclusions Results indicate that biopharmaceutical companies and regulatory agencies should consider strategies to improve screening and recruitment to decrease HABP/VABP clinical trial costs. PMID:29020279

Advancing cognitive engineering methods to support user interface design for electronic health records.

PubMed

Thyvalikakath, Thankam P; Dziabiak, Michael P; Johnson, Raymond; Torres-Urquidy, Miguel Humberto; Acharya, Amit; Yabes, Jonathan; Schleyer, Titus K

2014-04-01

Despite many decades of research on the effective development of clinical systems in medicine, the adoption of health information technology to improve patient care continues to be slow, especially in ambulatory settings. This applies to dentistry as well, a primary care discipline with approximately 137,000 practitioners in the United States. A critical reason for slow adoption is the poor usability of clinical systems, which makes it difficult for providers to navigate through the information and obtain an integrated view of patient data. In this study, we documented the cognitive processes and information management strategies used by dentists during a typical patient examination. The results will inform the design of a novel electronic dental record interface. We conducted a cognitive task analysis (CTA) study to observe ten general dentists (five general dentists and five general dental faculty members, each with more than two years of clinical experience) examining three simulated patient cases using a think-aloud protocol. Dentists first reviewed the patient's demographics, chief complaint, medical history and dental history to determine the general status of the patient. Subsequently, they proceeded to examine the patient's intraoral status using radiographs, intraoral images, hard tissue and periodontal tissue information. The results also identified dentists' patterns of navigation through patient's information and additional information needs during a typical clinician-patient encounter. This study reinforced the significance of applying cognitive engineering methods to inform the design of a clinical system. Second, applying CTA to a scenario closely simulating an actual patient encounter helped with capturing participants' knowledge states and decision-making when diagnosing and treating a patient. The resultant knowledge of dentists' patterns of information retrieval and review will significantly contribute to designing flexible and task-appropriate information presentation in electronic dental records. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Mortality in two recent reports of clinical trials on patients with congestive heart failure compared with mortality in three previous clinical trials.

PubMed

Singer, R B

2000-01-01

Several clinical trials of drug treatment of patients with congestive heart failure (CHF) have previously been reported as Mortality Abstracts in the Journal of Insurance Medicine. Results are presented here for two similar clinical trials reported in September 1999 and compared with the previous results. In a recent international multicenter clinical trial, excess mortality in terms of excess death rates (EDRs) was reduced from 195 per 1000 per year in the placebo group to 139 in the group treated with Spironolactone. There was no significant reduction in the Danish multicenter study of Dofetilide to convert the atrial fibrillation (AF) to a normal rhythm in the 25% of the CHF patients who had AF (EDR was 224 in the placebo group and 216 in the Dofetilide group). In both of these studies, there were more patients with severe CHF than in the previous studies and the EDR values were higher. Results from the Danish study by severity according to the New York Heart Association (NYHA) classification show a progressive increase in EDR from 173 in class 2 to 237 in class 3 to 392 in class 4. Excess mortality in symptomatic CHF is far outside the issue limits for individual life insurance, but these results are of potential utility for the underwriting of such cases for structured settlement annuities.

Treatment of femoro-popliteal lesions with scoring and drug-coated balloon angioplasty: 12-month results of the DCB-Trak registry.

PubMed

Baumhäkel, Magnus; Chkhetia, Shalva; Kindermann, Michael

2018-01-01

Debulking strategies prior to drug-coated balloon (DCB) angioplasty were suggested to improve clinical results in femoro-popliteal lesions. Currently, there are no data regarding plaque modification with a scoring balloon with subsequent DCB-angioplasty. Recently published 6-month results of the DCB-Trak registry in patients treated with scoring-balloon angioplasty and DCB-angioplasty were promising without any safety concerns. Herein, we report the 12-month follow-up data. In a single center registry, 29 consecutive patients with 32 femoro-popliteal lesions were treated with a scoring-balloon (VascuTrak®) and a DCB subsequently. The primary endpoint was the clinically driven target lesion revascularization (TLR). Secondary endpoints were clinically driven target vessel revascularization (TVR), binary restenosis (peak systolic velocity ratio > 2.4), change in Rutherford classification and ankle-brachial-index (ABI). Safety endpoints were major cardiovascular events (cardiovascular death, myocardial infarction, stroke, death) and need for amputation. The procedure was successful in 29 lesions. There were no clinically driven TLRs after 12 months. Two patients required clinically driven TVR and one patient had a binary restenosis. ABI significantly increased after the procedure (0.87±0.24 to 1.04±0.18, P < 0.01) without a relevant change after 6 months (1.01±0.15, P < 0.05) or 12 months (1.01±0.20, P < 0.05). Rutherford classification improved in more than 90% of patients after 6 and 12 months. There was one major cardiovascular event at 6-month follow-up, but no amputations at 6- or 12-month follow-up. Vessel preparation with a scoring-balloon and subsequent DCB-angioplasty was safe and effective in patients with femoro-popliteal lesions. Further multicenter trials have to validate these results.

Clinical use of multifocal visual-evoked potentials in a glaucoma practice: a prospective study

PubMed Central

Liebmann, Jeffrey M.; Ritch, Robert; Hood, Donald C.

2012-01-01

Purpose To test a framework that describes how the multifocal visual-evoked potential (mfVEP) technique is used in a particular glaucoma practice. Methods In this prospective, descriptive study, glaucoma suspects, ocular hypertensives and glaucoma patients were referred for mfVEP testing by a single glaucoma specialist over a 2-year period. All patients underwent standard automated perimetry (SAP) and mfVEP testing within 3 months. Two hundred and ten patients (420 eyes) were referred for mfVEP testing for the following reasons: (1) normal SAP tests suspected of early functional loss (ocular hypertensives, n = 43; and glaucoma suspects on the basis of suspicious optic disks, n = 52); (2) normal-tension glaucoma patients with suspected central SAP defects (n = 33); and (3) SAP abnormalities needing confirmation (n = 82). Results All the glaucoma suspects with normal SAP and mfVEP results remained untreated. Of those with abnormal mfVEP results, 68 % (15/22) were treated because the abnormal regions on the mfVEP were consistent with the abnormal regions seen during clinical examination of the optic disk. The mfVEP was abnormal in 86 % (69/80) of eyes with glaucomatous optic neuropathy and SAP damage, even though it did not result in an altered treatment regimen. In NTG patients, the mfVEP showed central defects in 44 % (12 of 27) of the eyes with apparently normal central fields and confirmed central scotomata in 92 % (36 of 39), leading to more rigorous surveillance of these patients. Conclusions In a clinical practice, the mfVEP was used when clinical examination and subjective visual fields provided insufficient or conflicting information. This information influenced clinical management. PMID:22476612

Using micropower impulse radar technology to screen for pneumothorax: an international bi-institutional study.

PubMed

van der Wilden, Gwendolyn M; Van der Wilden, Gwen; Albers, Christoph E; Albers, Christof; Haefeli, Pascal C; Haefeli, Peter; Zimmermann, Heinz; Zimmerman, Heinz; Exadaktylos, Aristomenis; Exadaktylos, Aris; Levy, Phillip; Birkhan, Oscar; Birkham, Oscar; Michaildou, Maria; Michailidou, Maria; Sideris, Antonios; Velmahos, George C; Velmahos, George; Alam, Hasan B; Alam, Hasan; King, David R; King, David; Fagenholz, Peter J; Fagenholz, Peter; Yeh, D Dante; Yeh, Dante; de Moya, Marc A

2012-12-01

Pneumothoraces (PTXs) are a common entity in thoracic trauma. Micropower impulse radar (MIR) has been able to detect PTXs in surgical patients. However, this technology has not been tested previously on trauma patients. The purpose of this study was to determine the sensitivity and specificity of MIR to detect clinically significant PTXs. We hypothesized that MIR technology can effectively screen trauma patients for clinically significant PTXs. This was a prospective observational study in Level I trauma centers in Boston, Massachusetts, and Bern, Switzerland. All trauma patients undergoing a chest computed tomographic (CT) scan were eligible for the study. Consent was obtained, and readings were performed within 30 minutes before or after the CT scan. The patients had eight lung fields tested (four on each side). The qualitative and quantitative MIR results were blinded and stored on the device. We then compared the results of the MIR to the CT scan and the need for chest tube drainage. We defined PTXs as clinically significant if they required a chest tube. Seventy-five patients were enrolled, with a mean age of 46 ± 16 years. Eighty-four percent were male. The screening test took approximately 1 minute. All but two patients had blunt chest trauma. Six true-positives, 6 false-positives, 63 true-negatives, and 0 false-negatives resulted in an overall sensitivity of 100%. MIR is an easy to use handheld technology that effectively screened patients for clinically significant PTXs, with a sensitivity and negative predictive value of 100%. MIR may be used for rapid, repeatable, and ongoing surveillance of trauma patients. Diagnostic study, level III.

Acute Stroke and Obstruction of the Extracranial Carotid Artery Combined with Intracranial Tandem Occlusion: Results of Interventional Revascularization

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

Lescher, Stephanie, E-mail: stephanie.lescher@kgu.de; Czeppan, Katja; Porto, Luciana

PurposeDue to high thrombus load, acute stroke patients with tandem obstructions of the extra- and intracranial carotid arteries or the middle cerebral artery show a very limited response to systemic thrombolysis. Interventional treatment with mechanical thrombectomy—often in combination with acute stenting of underlying atherosclerotic stenosis or dissection—is increasingly used. It has been shown that such complex interventions are technically feasible. The lack of optimal management strategies and clinical data encouraged us to review our acute stroke interventions in patient with anterior circulation tandem lesions to determine lesion patterns, interventional approaches, and angiographic or clinical outcomes.Patients and MethodsWe retrospectively analyzed amore » series of 39 consecutive patients with intracranial vessel occlusion of the anterior circulation simultaneously presenting with high-grade cervical internal carotid artery (ICA) stenosis or occlusion.ResultsEmergency ICA stent implantation was technically feasible in all patients, and intracranial recanalization with TICI ≥ 2b was reached in a large number of patients (64 %). Good clinical outcomes (mRS ≤ 2 at 3 months) were achieved in one third of the patients (36 %). Symptomatic hemorrhages occurred in four patients (10 %). Mortality was 10 %.ConclusionEndovascular recanalization of acute cervical carotid artery occlusion was technically feasible in all patients, and resulted in high extra- and intracranial revascularization rates. A trend for favorable clinical outcome was seen in a higher TICI score, younger age, good collateral status, and combined IV rTPA and endovascular therapy.« less

Updated cost-effectiveness analysis of supplemental glutamine for parenteral nutrition of intensive-care patients.

PubMed

Pradelli, L; Povero, M; Muscaritoli, M; Eandi, M

2015-05-01

Intravenous (i.v.) glutamine supplementation of parenteral nutrition (PN) can improve clinical outcomes, reduce mortality and infection rates and shorten the length of hospital and/or intensive care unit (ICU) stays compared with standard PN. This study is a pharmacoeconomic analysis to determine whether i.v. glutamine supplementation of PN remains both a highly favourable and cost-effective option for Italian ICU patients. A previously published discrete event simulation model was updated by incorporating the most up-to-date and clinically relevant efficacy data (a clinically realistic subgroup analysis from a published meta-analysis), recent cost data from the Italian health-care system and the latest epidemiology data from a large Italian ICU database (covering 230 Italian ICUs and more than 77,000 patients). Sensitivity analyses were performed to test the robustness of the results. Parenteral glutamine supplementation can significantly improve ICU efficiency in Italy, as the additional cost of supplemented treatment is more than completely offset by cost savings in hospital care. Supplementation was more cost-effective (cost-effectiveness ratio (CER)=[euro ]35,165 per patient discharged alive) than standard, non-supplemented PN (CER=[euro ]40,156 per patient discharged alive), and it resulted in mean cost savings of [euro ]4991 per patient discharged alive or [euro ]1047 per patient admitted to the hospital. Sensitivity analyses confirmed the robustness of these results. Alanyl-glutamine supplementation of PN is a clinically and economically attractive strategy for ICU patients in Italy and may be applicable to selected ICU patient populations in other countries.

From First Line to Sequential Treatment in the Management of Metastatic Pancreatic Cancer

PubMed Central

Martín, Andrés Muñoz; Hidalgo, Manuel; Alvarez, Rafael; Arrazubi, Virginia; Martínez-Galán, Joaquina; Salgado, Mercedes; Macarulla, Teresa; Carrato, Alfredo

2018-01-01

The current management of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) is based on systemic chemotherapy. The results of the MPACT and PRODIGE clinical trials have demonstrated that the combination of nab-paclitaxel and gemcitabine (GEM) as well as FOLFIRINOX regimen result in improvement in overall survival when compared to GEM alone. Treatment guidelines now recommend either one of these two regimens as first line treatment for fit patients with mPDAC. Because no head-to-head comparison between the two regimens exists, the selection of one versus the other is based on clinical criteria. The design and eligibility criteria of these two clinical trials are dissimilar, making the results of the MPACT trial more applicable to the general population of patients with mPDAC. In addition, the combination of nab-paclitaxel and GEM is better tolerated and easier to administer in clinical practice than FOLFIRINOX. Furthermore, when the regimens are studied in comparable patient populations the efficacy results are very similar. Nanoliposomal irinotecan plus 5FU has recently demonstrated a significant increase in efficacy rates after a GEM-based treatment. Importantly, treatment of mPDAC should now be considered as a continuum care for patients who are fit, with second and even third line treatments. Different sequential treatment algorithms are proposed based on available data. In retrospective studies, patients who were managed with GEM-based regimens followed by fluoropyrimidine-based regimens appear to have the most favorable outcome. PMID:29896283

An HL7-CDA wrapper for facilitating semantic interoperability to rule-based Clinical Decision Support Systems.

PubMed

Sáez, Carlos; Bresó, Adrián; Vicente, Javier; Robles, Montserrat; García-Gómez, Juan Miguel

2013-03-01

The success of Clinical Decision Support Systems (CDSS) greatly depends on its capability of being integrated in Health Information Systems (HIS). Several proposals have been published up to date to permit CDSS gathering patient data from HIS. Some base the CDSS data input on the HL7 reference model, however, they are tailored to specific CDSS or clinical guidelines technologies, or do not focus on standardizing the CDSS resultant knowledge. We propose a solution for facilitating semantic interoperability to rule-based CDSS focusing on standardized input and output documents conforming an HL7-CDA wrapper. We define the HL7-CDA restrictions in a HL7-CDA implementation guide. Patient data and rule inference results are mapped respectively to and from the CDSS by means of a binding method based on an XML binding file. As an independent clinical document, the results of a CDSS can present clinical and legal validity. The proposed solution is being applied in a CDSS for providing patient-specific recommendations for the care management of outpatients with diabetes mellitus. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Personalized Oncology Through Integrative High-Throughput Sequencing: A Pilot Study

PubMed Central

Roychowdhury, Sameek; Iyer, Matthew K.; Robinson, Dan R.; Lonigro, Robert J.; Wu, Yi-Mi; Cao, Xuhong; Kalyana-Sundaram, Shanker; Sam, Lee; Balbin, O. Alejandro; Quist, Michael J.; Barrette, Terrence; Everett, Jessica; Siddiqui, Javed; Kunju, Lakshmi P.; Navone, Nora; Araujo, John C.; Troncoso, Patricia; Logothetis, Christopher J.; Innis, Jeffrey W.; Smith, David C.; Lao, Christopher D.; Kim, Scott Y.; Roberts, J. Scott; Gruber, Stephen B.; Pienta, Kenneth J.; Talpaz, Moshe; Chinnaiyan, Arul M.

2012-01-01

Individual cancers harbor a set of genetic aberrations that can be informative for identifying rational therapies currently available or in clinical trials. We implemented a pilot study to explore the practical challenges of applying high-throughput sequencing in clinical oncology. We enrolled patients with advanced or refractory cancer who were eligible for clinical trials. For each patient, we performed whole-genome sequencing of the tumor, targeted whole-exome sequencing of tumor and normal DNA, and transcriptome sequencing (RNA-Seq) of the tumor to identify potentially informative mutations in a clinically relevant time frame of 3 to 4 weeks. With this approach, we detected several classes of cancer mutations including structural rearrangements, copy number alterations, point mutations, and gene expression alterations. A multidisciplinary Sequencing Tumor Board (STB) deliberated on the clinical interpretation of the sequencing results obtained. We tested our sequencing strategy on human prostate cancer xenografts. Next, we enrolled two patients into the clinical protocol and were able to review the results at our STB within 24 days of biopsy. The first patient had metastatic colorectal cancer in which we identified somatic point mutations in NRAS, TP53, AURKA, FAS, and MYH11, plus amplification and overexpression of cyclin-dependent kinase 8 (CDK8). The second patient had malignant melanoma, in which we identified a somatic point mutation in HRAS and a structural rearrangement affecting CDKN2C. The STB identified the CDK8 amplification and Ras mutation as providing a rationale for clinical trials with CDK inhibitors or MEK (mitogenactivated or extracellular signal–regulated protein kinase kinase) and PI3K (phosphatidylinositol 3-kinase) inhibitors, respectively. Integrative high-throughput sequencing of patients with advanced cancer generates a comprehensive, individual mutational landscape to facilitate biomarker-driven clinical trials in oncology. PMID:22133722

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

PubMed

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

2018-06-16

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

Identifying Unmet Treatment Needs for Patients With Osteoporotic Fracture: Feasibility Study for an Electronic Clinical Surveillance System

PubMed Central

Shang, Rung Ji; Hsiao, Fei-Yuan; Lin, Mei-Shu; Hung, Kuan-Yu; Wang, Jui; Lin, Zhen-Fang; Lai, Feipei; Shen, Li-Jiuan

2018-01-01

Background Traditional clinical surveillance relied on the results from clinical trials and observational studies of administrative databases. However, these studies not only required many valuable resources but also faced a very long time lag. Objective This study aimed to illustrate a practical application of the National Taiwan University Hospital Clinical Surveillance System (NCSS) in the identification of patients with an osteoporotic fracture and to provide a high reusability infrastructure for longitudinal clinical data. Methods The NCSS integrates electronic medical records in the National Taiwan University Hospital (NTUH) with a data warehouse and is equipped with a user-friendly interface. The NCSS was developed using professional insight from multidisciplinary experts, including clinical practitioners, epidemiologists, and biomedical engineers. The practical example identifying the unmet treatment needs for patients encountering major osteoporotic fractures described herein was mainly achieved by adopting the computerized workflow in the NCSS. Results We developed the infrastructure of the NCSS, including an integrated data warehouse and an automatic surveillance workflow. By applying the NCSS, we efficiently identified 2193 patients who were newly diagnosed with a hip or vertebral fracture between 2010 and 2014 at NTUH. By adopting the filter function, we identified 1808 (1808/2193, 82.44%) patients who continued their follow-up at NTUH, and 464 (464/2193, 21.16%) patients who were prescribed anti-osteoporosis medications, within 3 and 12 months post the index date of their fracture, respectively. Conclusions The NCSS systems can integrate the workflow of cohort identification to accelerate the survey process of clinically relevant problems and provide decision support in the daily practice of clinical physicians, thereby making the benefit of evidence-based medicine a reality. PMID:29691201

Clinical profile of patients with type 2 diabetes mellitus treated with sodium- glucose cotransporter-2 inhibitors and experience in real-world clinical practice in Spain.

PubMed

Cuatrecasas, Gabriel; Goñi-Goicoechea, Fernando

2016-11-01

The main aim of the treatment of type 2 diabetes is overall control of cardiovascular risk factors. Almost 50% of patients with type 2 diabetes do not achieve glycaemic targets, and a much higher percentage do not achieve weight and blood pressure targets, despite the therapeutic arsenal that has appeared in the last decade for the treatment of this disease. In addition, antidiabetic secretatogues and insulin are associated with weight gain and an increased risk of hyperglycaemic episodes. Clinical practice guidelines recommend sodium-glucose cotransporter-2 inhibitors (SGLT2i) as an alternative in the same therapeutic step as the other options after initiation of metformin therapy. The present study reviews the most appropriate patient profile for SGLT2i therapy, based on their safety and efficacy demonstrated in controlled clinical trials. The article discusses which patients are at risk of experiencing the possible secondary effects due to the mechanism of action of this new therapeutic class, in whom SGLT2i should be used with caution. These considerations on the profile of patients suitable for SGLT2i therapy are contrasted with the results obtained in daily clinical practice, both in retrospective studies from other countries and from real-world experiences in Spain. This article presents a selection of studies performed in distinct centres with a minimum follow-up of 6 months and compares their results with those from clinical trials. SGLT2i are used in clinical practice in any therapeutic step and the efficacy results are very similar to those reported by controlled clinical trials, with a slightly higher proportion of genitourinary infections and a low dropout rate. Half the reported patients are diabetics receiving insulin therapy plus a gliflozin, showing the wide uptake of this therapeutic strategy by clinicians. SGLT2i are especially attractive due to their additional effectiveness in weight and blood pressure control and the possibility of using them in association with other antidiabetic agents or in monotherapy in patients at any stage of type 2 diabetes. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Implementations of clinical functional magnetic resonance imaging using character-based paradigms for the prediction of Chinese language dominance.

PubMed

Liu, Ho-Ling; Wu, Chien-Te; Chen, Jian-Chuan; Hsu, Yuan-Yu; Wai, Yau-Yau; Wan, Yung-Liang

2003-01-01

Recently, functional MRI (fMRI) using word generation (WG) tasks has been shown to be effective for mapping the Chinese language-related brain areas. In clinical applications, however, patients' performance cannot be easily monitored during WG tasks. In this study, we evaluated the feasibility of a word choice (WC) paradigm in the clinical setting and compared the results with those from WG tasks. Intrasubject comparisons of fMRI with both WG and WC paradigms were performed on six normal human subjects and two tumor patients. Subject responses in the WC paradigm, based on semantic judgments, were recorded. Activation strength, extent, and laterality were evaluated and compared. Our results showed that fMRI with the WC paradigm evoked weaker neuronal activation than that with the WG paradigm in Chinese language-related brain areas. It was sufficient to reveal language laterality for clinical use, however. In addition, it resulted in less nonlanguage-specific brain activation. Results from the patient data demonstrated strong evidence for the necessity of incorporating response monitoring during fMRI studies, which suggested that fMRI with the WC paradigm is more appropriate to be implemented for the prediction of Chinese language dominance in clinical environments.

Technical and Clinical Results After Percutaneous Angioplasty in Nonmedial Fibromuscular Dysplasia: Outcome After Endovascular Management of Unifocal Renal Artery Stenoses in 30 Patients

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

Barrier, Pierre, E-mail: p.barrier@gmail.com; Julien, Auriol; Guillaume, Canevet

2010-04-15

Although percutaneous transluminal renal angioplasty (PTRA) is associated with excellent results in medial fibromuscular dysplasia (FMD), the clinical and technical outcome in the less common nonmedial subtype of FMD is not clearly known. Angiographic PTRA results and clinical follow-up were documented, to report technical and clinical results in 30 patients with unifocal, nonmedial dysplastic stenoses. Balloon angioplasty was technically successful in only 65% of the lesions. Additional stenting, performed after PTRA failure in six patients, increased the initial technical success rate to 82%. Stenting was used in another lesion after restenosis, and long-term patency was achieved in only three ofmore » the seven stented lesions. Frequent restenoses and unusual complications were observed during follow-up. Stent fracture occurred in two cases. Overall, long-term clinical and technical successes were sustained in 70 and 76%, respectively. We conclude that nonmedial, unifocal renal artery dysplastic stenoses do not share the excellent prognosis of the medial type and that stenting should be avoided. Therefore, surgery should be considered in lesions remaining unresponsive to balloon dilatation, after a second PTRA attempt.« less

Effects of a digital clinical pathway for elective electrocardioversion for atrial fibrillation on quality of care.

PubMed

Valente, Mattia; Zwaan, Esther; Wit, Mirjam; Kimman, Geert P; Umans, Victor

2010-12-01

Clinical pathways attempt to increase efficiency by organizing the care-delivery process into individual analyzable steps. However, full advantage may only be taken if the process is governed by a "process care taker." Currently, new opportunities are emerging for nurses to become involved as health care experts and may become an intermediate between patient and clinical team. We evaluate a digital clinical pathway for electrocardioversion in atrial fibrillation with a nurse-coordinator in the ongoing consecutive experience in clinical practice. The introduction of a digital pathway into the hospital information system allows continuous surveillance of clinical outcome indicators as well as variance indicators. This article describes a service evaluation and the implementation and effects of introducing a clinical pathway. However, when comparing the 2 eras, the primary goals were improved guideline-adherence and reduced walk-through times in the 600 consecutive pathway patients versus 100 consecutive control patients. The pathway was launched in January 2008. Up to January 2009, 600 all-comer, elective patients were treated using this integrated digital clinical pathway, without exception. Treatment and outpatient check-up appointments are made immediately for all patients. The pathway enabled the cardiologist to complete the risk calculator and drug therapy recommendations significantly better when compared with control patients and also reduced walk-through times significantly. Patient satisfaction rose from 8.7 to 9.1 (P < 0.01) using the pathway. A nurse-led clinical pathway for cardioversion patients is safely and efficaciously introduced in a teaching hospital. The pathway improved guideline-adherence. These results emphasize the importance of a nurse-coordinator who is an intermediary between atrial fibrillation patients and the clinical care team.

Patient, physician and presentational influences on clinical decision making for breast cancer: results from a factorial experiment.

PubMed

McKinlay, J B; Burns, R B; Durante, R; Feldman, H A; Freund, K M; Harrow, B S; Irish, J T; Kasten, L E; Moskowitz, M A

1997-02-01

This study examines the influence of six patient characteristics (age, race, socioeconomic status, comorbidities, mobility and presentational style) and two physician characteristics (medical specialty and years of clinical experience) on physicians' clinical decision making behaviour in the evaluation treatment of an unknown and known breast cancer. Physicians' variability and certainty associated with diagnostic and treatment behaviour were also examined. Separate analyses explored the influence of these non-medical factors on physicians' cognitive processes. Using a fractional factorial design, 128 practising physicians were shown two videotaped scenarios and asked about possible diagnoses and medical recommendations. Results showed that physicians displayed considerable variability in response to several patient-based factors. Physician characteristics also emerged as important predictors of clinical behaviour, thus confirming the complexity of the medical decision-making process.

Prospective evaluation of the clinical utility of laryngeal electromyography.

PubMed

Ingle, John W; Young, VyVy N; Smith, Libby J; Munin, Micheal C; Rosen, Clark A

2014-12-01

To prospectively evaluate the clinical utility of laryngeal electromyography (LEMG) STUDY DESIGN: Prospective observational study. The study involved 50 consecutive patients referred for LEMG. Laryngologists initially indicated diagnoses and treatment plans under the assumption of no access to LEMG. Patients then underwent LEMG by blinded examiners. LEMG results were reviewed by each patient's laryngologist. Diagnoses and treatment plans were either maintained or altered based on the LEMG results. The diagnosis changed 10% (5/50) of the time and treatment plans were altered 36% (18/50) of the time based on information provided by LEMG. Observational periods were eliminated in 13/50 patients based on LEMG, moving them to permanent treatment. LEMG allowed the differentiation between joint fixation and bilateral paralysis in three patients. Previously unrecognized superior laryngeal neuropathies were identified in three patients. Laryngeal electromyography often provides clinically useful information that typically leads to a more accurate diagnosis and a more appropriate, expedited treatment plan. 2b. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Context-Sensitive Clinical Alert Packages Written in Arden Syntax.

PubMed

Zeckl, Julia; Adlassnig, Katharina; Fossler, Renate; Blacky, Alexander; de Bruin, Jeroen S; Koller, Walter; Rappelsberger, Andrea; Adlassnig, Klaus-Peter

2017-01-01

An increasing body of raw patient data is generated on each day of a patient's stay at a hospital. It is of paramount importance that critical patient information be extracted from these large data volumes and presented to the patient's clinical caregivers as early as possible. Contemporary clinical alert systems attempt to provide this service with moderate success. The efficacy of the systems is limited by the fact that they are too general to fit specific patient populations or healthcare institutions. In this study we present an extendable alerting framework implemented in Arden Syntax, which can be configured to the needs and preferences of healthcare institutions and individual patient caregivers. We illustrate the potential of this alerting framework via an alert package that analyzes hematological laboratory results with data from intensive care units at the Vienna General Hospital, Austria. The results show the effectiveness of this alert package and its ability to generate key alerts while avoiding over-alerting.

Six Years of Comprehensive, Clinical, Performance-Based Assessment Using Standardized Patients at the Southern Illinois University School of Medicine.

ERIC Educational Resources Information Center

Vu, Nu Viet; And Others

1992-01-01

The use of a performance-based assessment of senior medical students' clinical skills utilizing standardized patients was evaluated, with 6,804 student-patient encounters involving 405 students over 6 years. Results provide evidence for test security, content validity, construct validity, reliability, and test ability to discriminate a wide range…

Are comparisons of patient experiences across hospitals fair? A study in Veterans Health Administration hospitals.

PubMed

Cleary, Paul D; Meterko, Mark; Wright, Steven M; Zaslavsky, Alan M

2014-07-01

Surveys are increasingly used to assess patient experiences with health care. Comparisons of hospital scores based on patient experience surveys should be adjusted for patient characteristics that might affect survey results. Such characteristics are commonly drawn from patient surveys that collect little, if any, clinical information. Consequently some hospitals, especially those treating particularly complex patients, have been concerned that standard adjustment methods do not adequately reflect the challenges of treating their patients. To compare scores for different types of hospitals after making adjustments using only survey-reported patient characteristics and using more complete clinical and hospital information. We used clinical and survey data from a national sample of 1858 veterans hospitalized for an initial acute myocardial infarction (AMI) in a Department of Veterans Affairs (VA) medical center during fiscal years 2003 and 2004. We used VA administrative data to characterize hospitals. The survey asked patients about their experiences with hospital care. The clinical data included 14 measures abstracted from medical records that are predictive of survival after an AMI. Comparisons of scores across hospitals adjusted only for patient-reported health status and sociodemographic characteristics were similar to those that also adjusted for patient clinical characteristics; the Spearman rank-order correlations between the 2 sets of adjusted scores were >0.97 across 9 dimensions of inpatient experience. This study did not support concerns that measures of patient care experiences are unfair because commonly used models do not adjust adequately for potentially confounding patient clinical characteristics.

Chlamydia and gonorrhoea contamination of clinic surfaces.

PubMed

Lewis, Natasha; Dube, Gail; Carter, Christine; Pitt, Rachel; Alexander, Sarah; Ison, Catherine A; Harding, Jan; Brown, Louise; Fryer, John; Hodson, James; Ross, Jonathan

2012-10-01

Nucleic acid amplification tests, with their ability to detect very small amounts of nucleic acid, have become the principle diagnostic tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in many sexual health clinics. The aim of this study was to investigate the extent of surface contamination with CT and GC within a city centre sexual health clinic and to evaluate the potential for contamination of containers used for the collection of self-taken swabs. Surface contamination with CT and GC was assessed by systematically sampling 154 different sites within one clinic using transcription-mediated amplification (TMA), quantitative PCR and culture. The caps of containers used by patients to collect self-taken samples were also tested for CT and GC using TMA. Of the 154 sites sampled, 20 (13.0%) tested positive on TMA. Of these, five (3.2%) were positive for CT alone, 11 (7.1%) for GC alone and four (2.6%) for both CT and GC. The proportion of GC TMA-positive test results differed by gender, with 11 (18.3%) positive results from the male patient clinic area compared with one (1.6%) from the female area (p=0.002). Positive samples were obtained from a variety of locations in the clinic, but the patient toilets were more likely to be contaminated than examination rooms (p=0.015). Quantitative PCR and culture assays were negative for all samples. 46 caps of the containers used for self-taken swabs were negative for both CT and GC on TMA testing. Surface contamination with chlamydial and gonococcal rRNA can occur within sexual health clinics, but the quantity of nucleic acid detected is low and infection risk to patients and staff is small. There remains a potential risk of contamination of patient samples leading to false-positive results.

Elderly patients and inflammatory bowel disease

PubMed Central

Nimmons, Danielle; Limdi, Jimmy K

2016-01-01

The incidence and prevalence of inflammatory bowel disease (IBD) is increasing globally. Coupled with an ageing population, the number of older patients with IBD is set to increase. The clinical features and therapeutic options in young and elderly patients are comparable but there are some significant differences. The wide differential diagnosis of IBD in elderly patients may result in a delay in diagnosis. The relative dearth of data specific to elderly IBD patients often resulting from their exclusion from pivotal clinical trials and the lack of consensus guidelines have made clinical decisions somewhat challenging. In addition, age specific concerns such as co-morbidity; loco-motor and cognitive function, poly-pharmacy and its consequences need to be taken into account. In applying modern treatment paradigms to the elderly, the clinician must consider the potential for more pronounced adverse effects in this vulnerable group and set appropriate boundaries maximising benefit and minimising harm. Meanwhile, clinicians need to make personalised decisions but as evidence based as possible in the holistic, considered and optimal management of IBD in elderly patients. In this review we will cover the clinical features and therapeutic options of IBD in the elderly; as well as addressing common questions and challenges posed by its management. PMID:26855812

Management of advanced pancreatic cancer with gemcitabine plus erlotinib: efficacy and safety results in clinical practice.

PubMed

Diaz Beveridge, Robert; Alcolea, Vicent; Aparicio, Jorge; Segura, Ángel; García, Jose; Corbellas, Miguel; Fonfría, María; Giménez, Alejandra; Montalar, Joaquin

2014-01-10

The combination of gemcitabine and erlotinib is a standard first-line treatment for unresectable, locally advanced or metastatic pancreatic cancer. We reviewed our single centre experience to assess its efficacy and toxicity in clinical practice. Clinical records of patients with unresectable, locally advanced or metastatic pancreatic cancer who were treated with the combination of gemcitabine and erlotinib were reviewed. Univariate survival analysis and multivariate analysis were carried out to indentify independent predictors factors of overall survival. Our series included 55 patients. Overall disease control rate was 47%: 5% of patients presented complete response, 20% partial response and 22% stable disease. Median overall survival was 8.3 months). Cox regression analysis indicated that performance status and locally advanced versus metastatic disease were independent factors of overall survival. Patients who developed acne-like rash toxicity, related to erlotinib administration, presented a higher survival than those patients who did not develop this toxicity. Gemcitabine plus erlotinib doublet is active in our series of patients with advanced pancreatic cancer. This study provides efficacy and safety results similar to those of the pivotal phase III clinical trial that tested the same combination.

Clinical patterns of cutaneous nontuberculous mycobacterial infections.

PubMed

Bartralot, R; García-Patos, V; Sitjas, D; Rodríguez-Cano, L; Mollet, J; Martín-Casabona, N; Coll, P; Castells, A; Pujol, R M

2005-04-01

Cutaneous nontuberculous mycobacterial infections result from external inoculation, spread of a deeper infection, or haematogenous spread of a disseminated infection. There are two species-specific infections (fish-tank or swimming-pool granuloma, due to Mycobacterium marinum, and Buruli ulcer, caused by M. ulcerans). Most infections, however, produce a nonspecific clinical picture. To define clinical patterns of cutaneous disease in nontuberculous mycobacterial infections. Fifty-one patients with cutaneous nontuberculous mycobacterial infections were reviewed. Clinical and histopathological features of normal hosts and immunosuppressed patients were compared. Two subgroups of immunosuppressed patients were distinguished: patients with cutaneous infection and patients with a disseminated infection and cutaneous involvement. In immunosuppressed patients the number of lesions was significantly higher. Abscesses and ulceration were also more frequently observed. Different species were found in normal hosts and immunosuppressed patients. Several clinical patterns of cutaneous infection were defined: lymphocutaneous or sporotrichoid lesions; nonlymphocutaneous lesions at the site of trauma; folliculitis and furunculosis involving the lower extremities; disseminated lesions on the extremities in immunosuppressed patients. Two patterns were observed in patients with a disseminated infection: localized cutaneous lesions and disseminated cutaneous and mucosal lesions. Cutaneous manifestations of nontuberculous mycobacterial infections may be classified according to criteria such as cutaneous lesions and immune status.

Outcome methods used in clinical studies of Chiari malformation Type I: a systematic review.

PubMed

Greenberg, Jacob K; Milner, Eric; Yarbrough, Chester K; Lipsey, Kim; Piccirillo, Jay F; Smyth, Matthew D; Park, Tae Sung; Limbrick, David D

2015-02-01

Chiari malformation Type I (CM-I) is a common and often debilitating neurological disease. Efforts to improve treatment of CM-I are impeded by inconsistent and limited methods of evaluating clinical outcomes. To understand current approaches and lay a foundation for future research, the authors conducted a systematic review of the methods used in original published research articles to evaluate clinical outcomes in patients treated for CM-I. The authors searched PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov , and Cochrane databases to identify publications between January 2003 and August 2013 that met the following criteria: 1) reported clinical outcomes in patients treated for CM-I; 2) were original research articles; 3) included at least 10 patients or, if a comparative study, at least 5 patients per group; and 4) were restricted to patients with CM-I. Among the 74 papers meeting inclusion criteria, there was wide variation in the outcome methods used. However, all approaches were broadly grouped into 3 categories: 1) "gestalt" impression of overall symptomatic improvement (n=45 papers); 2) postoperative change in specific signs or symptoms (n=20); or 3) results of various standardized assessment scales (n=22). Among standardized scales, 11 general function measures were used, compared with 6 disease-specific tools. Only 3 papers used scales validated in patients with CM-I. To facilitate a uniform comparison of these heterogeneous approaches, the authors appraised articles in multiple domains defined a priori as integral to reporting clinical outcomes in CM-I. Notably, only 7 articles incorporated patient-response instruments when reporting outcome, and only 22 articles explicitly assessed quality of life. The methods used to evaluate clinical outcomes in CM-I are inconsistent and frequently not comparable, complicating efforts to analyze results across studies. Development, validation, and incorporation of a small number of disease-specific patient-based instruments will improve the quality of research and care of CM-I patients.

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.

Developing an advanced practice nurse-led liver clinic.

PubMed

McAfee, Jean L

2012-01-01

End-stage liver disease (ESLD) is a leading cause of digestive disease deaths in the United States and continues to increase exponentially every year. Best practice does not currently recognize or utilize a clinic practice model for ESLD management. Advanced practice registered nurses (APRNs) can impact ESLD disease management by implementing an outpatient clinic care model to focus on treatment compliance, patient education, improvement of patient outcomes, and reduction in hospital admission rates for ESLD patients. A review of 15 research articles was completed to determine the impact APRNs can make on chronic care of ESLD patients. Results from the review support APRN analysis, assessment, diagnosis, treatment, intervention, and evaluation of ESLD patients. The literature reviewed also demonstrates that ESLD patients have improved symptom management when maintained in an outpatient setting, allowing for decreased hospital and insurance expenditures. Following evaluation of the evidence, it was concluded that an APRN-led ESLD clinic merits further study.

Results of a voter registration project at 2 family medicine residency clinics in the Bronx, New York.

PubMed

Liggett, Alisha; Sharma, Manisha; Nakamura, Yumiko; Villar, Ryna; Selwyn, Peter

2014-01-01

Federally qualified health centers provide care to medically underserved populations, the same individuals often underrepresented in the electoral process. These centers are unique venues to access patients for voter registration services. We undertook a clinician-led, nonpartisan voter registration drive within 2 university-affiliated federally qualified health centers in the Bronx, New York. Patients were approached by voter registration volunteers in clinic waiting areas during a 12-week period. Volunteers directly engaged with 304 patients. Of the 128 patients who were eligible and not currently registered, 114 (89%) registered to vote through this project. This number corresponded to 38% of all patients engaged. Sixty-five percent of new registrants were aged younger than 40 years. This project was successful in registering clinic patients to vote. Clinics are not only health centers, but also powerful vehicles for bringing a voice to civically disenfranchised communities. © 2014 Annals of Family Medicine, Inc.

Clinical and mycological study of occult tinea pedis and tinea unguium in dermatological patients from Tokyo.

PubMed

Ogasawara, Y; Hiruma, M; Muto, M; Ogawa, H

2003-04-01

An epidemiological investigation was conducted to determine the prevalence and circumstances of untreated, unsuspected tinea pedis and tinea unguium, morbid conditions that could be termed occult athlete's foot, in patients visiting a dermatology clinic in Tokyo, Japan, for the first time, for other complaints. All subjects completed a questionnaire covering comprehensive anamnestic details, and were examined for disposition of toes, presence of signs suggestive of tinea pedis, other diseases of the foot, score of clinical signs and symptoms, potassium hydroxide (KOH) test, severity score, and mycological culture. The results showed that the prevalence of occult athlete's foot was 25%, and that 59% of those cases were complicated by tinea unguium. The characteristics of patients with occult athlete's foot included a higher proportion of men and a tendency toward a low clinical score together with a high severity score. In the patient background, a strong correlation was observed between a positive KOH test result and characteristics such as age, disposition of toes, and predisposing disease.

Feasibility, acceptability and clinical utility of the Cultural Formulation Interview: mixed-methods results from the DSM-5 international field trial.

PubMed

Lewis-Fernández, Roberto; Aggarwal, Neil Krishan; Lam, Peter C; Galfalvy, Hanga; Weiss, Mitchell G; Kirmayer, Laurence J; Paralikar, Vasudeo; Deshpande, Smita N; Díaz, Esperanza; Nicasio, Andel V; Boiler, Marit; Alarcón, Renato D; Rohlof, Hans; Groen, Simon; van Dijk, Rob C J; Jadhav, Sushrut; Sarmukaddam, Sanjeev; Ndetei, David; Scalco, Monica Z; Bassiri, Kavoos; Aguilar-Gaxiola, Sergio; Ton, Hendry; Westermeyer, Joseph; Vega-Dienstmaier, Johann M

2017-04-01

Background There is a need for clinical tools to identify cultural issues in diagnostic assessment. Aims To assess the feasibility, acceptability and clinical utility of the DSM-5 Cultural Formulation Interview (CFI) in routine clinical practice. Method Mixed-methods evaluation of field trial data from six countries. The CFI was administered to diagnostically diverse psychiatric out-patients during a diagnostic interview. In post-evaluation sessions, patients and clinicians completed debriefing qualitative interviews and Likert-scale questionnaires. The duration of CFI administration and the full diagnostic session were monitored. Results Mixed-methods data from 318 patients and 75 clinicians found the CFI feasible, acceptable and useful. Clinician feasibility ratings were significantly lower than patient ratings and other clinician-assessed outcomes. After administering one CFI, however, clinician feasibility ratings improved significantly and subsequent interviews required less time. Conclusions The CFI was included in DSM-5 as a feasible, acceptable and useful cultural assessment tool. © The Royal College of Psychiatrists 2017.

Wernicke encephalopathy without delirium that appeared as agitation in a patient with lung cancer.

PubMed

Onishi, Hideki; Ishida, Mayumi; Takahashi, Takao; Taji, Yoshitada; Ikebuchi, Kenji; Furuya, Daisuke; Uchida, Nozomu; Akechi, Tatsuo

2018-05-11

Wernicke encephalopathy (WE) is a neuropsychiatric disorder caused by thiamine deficiency, and is sometimes overlooked because of the diversity of clinical symptoms. From a series of WE patients with cancer, we report a lung cancer patient who developed WE, the main symptom of which was agitation.ResultA 50-year-old woman with lung cancer was referred to our psycho-oncology clinic because of agitation lasting for three days. No laboratory findings or drugs explaining her agitation were identified. Although the patient did not develop delirium, ophthalmoplegia, or ataxia, WE was suspected because she experienced a loss of appetite loss lasting 5 weeks. This diagnosis was supported by abnormal serum thiamine and disappearance of agitation one hour after intravenous thiamine administration.Significance of resultsThis report emphasizes the clinical diversity of WE and indicates the limits of the ability to diagnose WE from typical clinical symptoms. The presence of a loss of appetite for more than two weeks may be the key to the accurate diagnosis of WE.

Privacy-preserving clinical decision support system using Gaussian kernel-based classification.

PubMed

Rahulamathavan, Yogachandran; Veluru, Suresh; Phan, Raphael C-W; Chambers, Jonathon A; Rajarajan, Muttukrishnan

2014-01-01

A clinical decision support system forms a critical capability to link health observations with health knowledge to influence choices by clinicians for improved healthcare. Recent trends toward remote outsourcing can be exploited to provide efficient and accurate clinical decision support in healthcare. In this scenario, clinicians can use the health knowledge located in remote servers via the Internet to diagnose their patients. However, the fact that these servers are third party and therefore potentially not fully trusted raises possible privacy concerns. In this paper, we propose a novel privacy-preserving protocol for a clinical decision support system where the patients' data always remain in an encrypted form during the diagnosis process. Hence, the server involved in the diagnosis process is not able to learn any extra knowledge about the patient's data and results. Our experimental results on popular medical datasets from UCI-database demonstrate that the accuracy of the proposed protocol is up to 97.21% and the privacy of patient data is not compromised.

Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

PubMed

McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

2017-10-01

The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.

Sticky eyelid syndrome.

PubMed

Kortvelesy, J Scott; Buerger, George F

2004-11-01

To report on patients seen with an unusual condition affecting the eyelids. The syndrome manifests as a temporary adhesion which forms between the upper and lower eyelid associated with laxity of the lower lid retractors. This results in a peculiar closure of the lids. Retrospective case reports. Charts of affected patients were reviewed for their clinical histories, examination findings, external photographs, and the results of treatment. Ten consecutive patients with the associated findings were reviewed. All cases were unilateral. Seven patients were Asian and three were Caucasian. Nine patients were symptomatic; of these, all were treated conservatively except for one who requested surgery. Two cases are described and photographs are shown. Lower eyelid retractor laxity combined with a temporary adhesion between the upper and lower lid results in the clinical findings of Sticky Eyelid Syndrome.

Improving patient-centered communication: Results of a randomized controlled trial.

PubMed

Maatouk-Bürmann, Barbara; Ringel, Nadja; Spang, Jochen; Weiss, Carmen; Möltner, Andreas; Riemann, Urs; Langewitz, Wolf; Schultz, Jobst-Hendrik; Jünger, Jana

2016-01-01

Patient-centered communication is a key element for improving the quality of care in terms of therapeutic relationship, patient participation, and treatment process. Postgraduate trainings provide an essential way of promoting patient centeredness on the job where learning opportunities are often limited by time, patient volume, and economic pressure. In the present study, changes in patient centeredness during clinical routines of postgraduate physicians (internal medicine) after a three-day communication training were assessed. A randomized controlled trial was conducted in a primary care clinic. The intervention consisted of a communication training that aimed to enhance patient centeredness in postgraduate physicians. The training was based on a need assessment and the principles of deliberate practice. Workplace-based assessment of physicians' communication behavior was obtained using the Roter Interaction Analysis System. Three months after the intervention, trained physicians showed significantly increased patient centeredness (F=5.36, p=.04; d=0.42). The communication training significantly improved patient centeredness during routine clinical practice. Thus, this training provides a structured and theory-based concept to foster patient centeredness. The results support the implementation of communication trainings as a part of faculty development and medical specialization training. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Heart rate prediction for coronary artery disease patients (CAD): Results of a clinical pilot study.

PubMed

Müller-von Aschwege, Frerk; Workowski, Anke; Willemsen, Detlev; Müller, Sebastian M; Hein, Andreas

2015-01-01

This paper describes the results of a pilot study with cardiac patients based on information that can be derived from a smartphone. The idea behind the study is to design a model for estimating the heart rate of a patient before an outdoor walking session for track planning, as well as using the model for guidance during an outdoor session. The model allows estimation of the heart rate several minutes in advance to guide the patient and avoid overstrain before its occurrence. This paper describes the first results of the clinical pilot study with cardiac patients taking β-blockers. 9 patients have been tested on a treadmill and during three outdoor sessions each. The results have been derived and three levels of improvement have been tested by cross validation. The overall result is an average Median Absolute Deviation (MAD) of 4.26 BPM between measured heart rate and smartphone sensor based model estimation.

Satisfaction with Healthcare Received at an Interprofessional Student-run Free Clinic: Invested in Training the Next Generation of Healthcare Professionals.

PubMed

Lu, Karen B; Thiel, Bryan; Atkins, Christopher A; Desai, Anand; Botwin, Ariel; Povlow, Michael R; Simms-Cendan, Judith; Pasarica, Magdalena

2018-03-07

Most medical schools in the United States have an associated student-run free clinic (SRFC) providing medical care to the underserved population around the campus. SRFCs provide students with opportunities to practice history-taking and diagnosis skills. There have been a few studies that have evaluated patient satisfaction within SRFCs; however, these studies report limited aspects of care within these clinics. This study hopes to determine the levels of satisfaction with clinical staff and operations and to ensure that the medical needs of patients are being met. Results showed that 91% of the patients were satisfied or very satisfied with their overall clinic experience. The highest scoring parameters were "courtesy/respect of staff", "availability of free or affordable medications", and "doctor's knowledge". Overall, the patients are satisfied with the staff, care, and availability of medicine provided by the Keeping Neighbors in Good Health Through Service (KNIGHTS) clinic. Most patients enjoy participating in the training and education of future physicians and would recommend this clinic to a friend or family member. The lowest satisfaction rates were associated with length of visit and wait time. In the future, SRFCs should work together to assess patient satisfaction in the clinics, identify problem areas, and develop generalizable interventions for improvement.

Cushing Syndrome in Carney Complex: Clinical, Pathologic, and Molecular Genetic Findings in the 17 Affected Mayo Clinic Patients.

PubMed

Lowe, Kathleen M; Young, William F; Lyssikatos, Charalampos; Stratakis, Constantine A; Carney, J Aidan

2017-02-01

Carney complex (CNC) is a rare dominantly inherited multiorgan tumoral disorder that includes Cushing syndrome (CS). To establish the Mayo Clinic experience with the CS component, including its clinical, laboratory, and pathologic findings, we performed a retrospective search of the patient and pathologic databases of Mayo Clinic in Rochester, MN, for patients with CNC and clinical or laboratory findings of CS. Thirty-seven patients with CNC were identified. Twenty-nine had clinical, pathologic, or laboratory evidence of an adrenocortical disorder. Seventeen had classic CS; 15 underwent bilateral, subtotal, or partial unilateral adrenalectomy, and 2 had no treatment. Pathologically, the glands were normal sized or slightly enlarged with multiple small (1 to 4 mm), brown, black, and yellow micronodules (primary pigmented nodular adrenocortical disease; PPNAD). Three glands each had a mass: a 2 cm adenoma, a 1.5 cm macronodule, and an unencapsulated 1.8 cm myelolipoma. Fourteen of the patients were alive at follow-up, and 3 were deceased; 2 of the latter had PPNAD at autopsy, and the third had PPNAD at surgery. Twelve patients without clinical features of classic CS had abnormal adrenocortical testing results; none developed classic CS during follow-up (mean, 10 y). Autopsy findings in 1 showed bilateral vacuolated cell cortical hyperplasia.

Alternative diagnosis in the putative ventilator-associated pneumonia patient not meeting lavage-based diagnostic criteria.

PubMed

Schoemakers, Rik J; Schnabel, Ronny; Oudhuis, Guy J; Linssen, Catharina F M; van Mook, Walther N K A; Verbon, Annelies; Bergmans, Dennis C J J

2014-12-01

The clinical picture of ventilator-associated pneumonia (VAP) can be mimicked by other infectious and non-infectious diseases. The aim of this study was to determine the alternative diagnoses and to develop a diagnostic flow chart for patients suspected of having VAP not meeting the diagnostic broncho-alveolar lavage (BAL) criteria. Adult intensive care patients with a clinical suspicion of VAP and negative BAL results were included. The clinical suspicion of VAP was based on the combination of clinical, radiological, and microbiological criteria. BAL was considered positive if cell differentiation revealed ≥ 2% cells with intracellular organisms and/or quantitative culture results of ≥ 10(4) cfu/ml. The most likely alternative diagnosis of fever and pulmonary densities was retrospectively determined by two authors independently. In all, 110 of 207 patients with suspected VAP did not meet the diagnostic BAL criteria and required further diagnostic evaluation. In 67 patients an alternative diagnosis for fever could be found. In 51 patients an alternative diagnosis of both fever and pulmonary densities could be established. In almost 40% of patients no alternative diagnosis could be provided. Non-bacterial pneumonia was diagnosed in 10 patients with Herpes simplex virus 1 (HSV-1) as the most common pathogen. In eight patients non-infectious pneumonitis was diagnosed. Due to the wide range of alternative diagnoses and applied tests the diagnostic work-up proved to be necessarily individualized and guided by repeated clinical assessment. The most frequently found alternative diagnoses were viral pneumonia and non-infectious pneumonitis.

A clinical decision-making algorithm for penicillin allergy.

PubMed

Soria, Angèle; Autegarden, Elodie; Amsler, Emmanuelle; Gaouar, Hafida; Vial, Amandine; Francès, Camille; Autegarden, Jean-Eric

2017-12-01

About 10% of subjects report suspected penicillin allergy, but 85-90% of these patients are not truly allergic and could safely receive beta-lactam antibiotics Objective: To design and validate a clinical decision-making algorithm, based on anamnesis (chronology, severity, and duration of the suspected allergic reactions) and reaching a 100% sensitivity and negative predictive value, to assess allergy risk related to a penicillin prescription in general practise. All patients were included prospectively and explorated based on ENDA/EAACI recommendations. Results of penicillin allergy work-up (gold standard) were compared with results of the algorithm. Allergological work-up diagnosed penicillin hypersensitivity in 41/259 patients (15.8%) [95% CI: 11.5-20.3]. Three of these patients were diagnosed as having immediate-type hypersensitivity to penicillin, but had been misdiagnosed as low risk patients using the clinical algorithm. Thus, the sensitivity and negative predictive value of the algorithm were 92.7% [95% CI: 80.1-98.5] and 96.3% [95% CI: 89.6-99.2], respectively, and the probability that a patient with true penicillin allergy had been misclassified was 3.7% [95% CI: 0.8-10.4]. Although the risk of misclassification is low, we cannot recommend the use of this algorithm in general practice. However, the algorithm can be useful in emergency situations in hospital settings. Key messages True penicillin allergy is considerably lower than alleged penicillin allergy (15.8%; 41 of the 259 patients with suspected penicillin allergy). A clinical algorithm based on the patient's clinical history of the supposed allergic event to penicillin misclassified 3/41 (3.7%) truly allergic patients.

Effectiveness of cross polarized light and fluorescence diagnosis for detection of sub-clinical and clinical actinic keratosis during imiquimod treatment.

PubMed

Ortonne, Jean-Paul; Gupta, Girish; Ortonne, Nicolas; Duteil, Luc; Queille, Catherine; Mallefet, Pascal

2010-07-01

During treatment of actinic keratosis (AK) lesions with imiquimod sub-clinical lesions often become visible. It is, however, unclear whether these sub-clinical lesions would be detectable beforehand. The aim of this pilot study was to compare two techniques, cross polarized light photography (CPL) and fluorescence diagnosis (FD) using methyllevulinic acid and illumination with Wood's lamp for their ability to detect sub-clinical lesions. These findings were also compared with biopsy results taken before and after treatment with imiquimod 5% cream or vehicle. Twelve patients with at least five clinically visible AK lesions in a single contiguous 20 cm(2) area on the head were recruited. Patient eligibility was determined at the screening visit, when they were randomized to treatment. The randomization was 3:1, active to vehicle (nine treated with imiquimod, three with vehicle cream) for a total duration of 24 weeks (six clinic visits). Patients were assessed for baseline AK lesion counts (clinical and sub-clinical) at the screening visit and final counts at week 20. The number of clinically observed AK lesions was significantly lower at week 12 and week 20 compared with baseline following imiquimod treatment versus vehicle. The number of counted lesions were significantly higher using the CPL method compared with clinical counting with imiquimod treatment at baseline (8.3 +/- 3.4 vs 5.8 +/- 1.3; P = 0.027) and week 20 (4.8 +/- 2.4 vs 3.0 +/- 1.7; P = 0.02) but not in the vehicle group. The FD lesion counting method did not show a significant increase in the number of detected lesions compared with clinical analysis in the imiquimod and placebo groups but when comparisons were performed using pooled data (treatments and visits combined) the results were significant. The number of sub-clinical and clinical AK lesions detected during treatment with imiquimod can be better demonstrated using the methods of CPL and FD, but statistical significance was reached only using the CPL method. This is only a preliminary study with a small number of patients and as a result it is difficult to conclude both statistical and clinical significance. However, results were encouraging and indicate that larger studies are needed to demonstrate the relevance of these two new methods for improved detection of clinical and especially sub-clinical AK lesions.

Polycystic echinococcosis in the state of Acre, Brazil: contribution to patient diagnosis, treatment and prognosis

PubMed Central

de Siqueira, Nilton Ghiotti; de Siqueira, Cláudia Maria Villar Maziero; Rodrigues-Silva, Rosângela; Soares, Manoel do Carmo P; Póvoa, Marinete Marins

2013-01-01

The lack of knowledge regarding polycystic hydatid disease results in delayed or even incorrect diagnosis. The lack of systematic information regarding treatment also makes it difficult to assess the results and prognosis in patients with peritoneal and hepatic lesions caused by Echinococcus vogeli. Here we describe the clinical features of patients, propose a radiological classification protocol and describe a therapeutic option for the treatment of hydatid disease that previously had only been used for cases of cystic echinococcosis (Echinococcus granulosus). A prospective cohort study was initiated in 1999 and by 2009 the study included 60 patients. These patients were classified according to the PNM classification (parasite lesion, neighbouring organ invasion and metastases) and placed in one of three therapeutic modalities: (i) chemotherapy with albendazole at a dose of 10 mg/kg/day, (ii) surgical removal of cysts or (iii) percutaneous puncture of the cysts via puncture, aspiration, injection and re-aspiration (PAIR). The results were stratified according to therapeutic outcome: "cure", "clinical improvement", "no improvement", "death" or "no information". The PNM classification was useful in indicating the appropriate therapy in cases of polycystic hydatid disease. In conclusion, surgical therapy produced the best clinical results of all the therapies studied based on "cure" and "clinical improvement" outcomes. The use of PAIR for treatment requires additional study. PMID:23903966

Laboratory Diagnosis of Infections in Cancer Patients: Challenges and Opportunities

PubMed Central

2016-01-01

Infections remain a significant cause of morbidity and mortality in cancer patients. The differential diagnosis for these patients is often wide, and the timely selection of the right clinical tests can have a significant impact on their survival. However, laboratory findings with current methodologies are often negative, challenging clinicians and laboratorians to continue the search for the responsible pathogen. Novel methodologies are providing increased sensitivity and rapid turnaround time to results but also challenging our interpretation of what is a clinically significant pathogen in cancer patients. This minireview provides an overview of the most common infections in cancer patients and discusses some of the challenges and opportunities for the clinical microbiologist supporting the care of cancer patients. PMID:27280421

Arterial phase CT for the detection of splenic injuries in blunt trauma: would it improve clinical outcomes?

PubMed

Corwin, Michael T; Fananapazir, Ghaneh; Lamba, Ramit; Salcedo, Edgardo S; Holmes, James F

2016-01-01

To determine if the addition of an arterial phase abdominal computed tomography (CT) improves clinical outcomes in patients with blunt splenic injuries. Retrospective review of patients who underwent CT of the abdomen revealing splenic injuries. Clinical management in these patients was determined. Fifty-one of three thousand five hundred twenty-five patients had splenic injuries. Twenty-five patients underwent nonsurgical management, and 3 failed. The theoretical additional arterial phase resulted in a 62% increase in mean effective dose compared to the portal venous phase alone. Routine use of arterial phase CT in blunt trauma patients may not be warranted as there is minimal improvement in outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

Use of Flutemetamol F 18-Labeled Positron Emission Tomography and Other Biomarkers to Assess Risk of Clinical Progression in Patients With Amnestic Mild Cognitive Impairment.

PubMed

Wolk, David A; Sadowsky, Carl; Safirstein, Beth; Rinne, Juha O; Duara, Ranjan; Perry, Richard; Agronin, Marc; Gamez, Jose; Shi, Jiong; Ivanoiu, Adrian; Minthon, Lennart; Walker, Zuzana; Hasselbalch, Steen; Holmes, Clive; Sabbagh, Marwan; Albert, Marilyn; Fleisher, Adam; Loughlin, Paul; Triau, Eric; Frey, Kirk; Høgh, Peter; Bozoki, Andrea; Bullock, Roger; Salmon, Eric; Farrar, Gillian; Buckley, Christopher J; Zanette, Michelle; Sherwin, Paul F; Cherubini, Andrea; Inglis, Fraser

2018-05-14

Patients with amnestic mild cognitive impairment (aMCI) may progress to clinical Alzheimer disease (AD), remain stable, or revert to normal. Earlier progression to AD among patients who were β-amyloid positive vs those who were β-amyloid negative has been previously observed. Current research now accepts that a combination of biomarkers could provide greater refinement in the assessment of risk for clinical progression. To evaluate the ability of flutemetamol F 18 and other biomarkers to assess the risk of progression from aMCI to probable AD. In this multicenter cohort study, from November 11, 2009, to January 16, 2014, patients with aMCI underwent positron emission tomography (PET) at baseline followed by local clinical assessments every 6 months for up to 3 years. Patients with aMCI (365 screened; 232 were eligible) were recruited from 28 clinical centers in Europe and the United States. Physicians remained strictly blinded to the results of PET, and the standard of truth was an independent clinical adjudication committee that confirmed or refuted local assessments. Flutemetamol F 18-labeled PET scans were read centrally as either negative or positive by 5 blinded readers with no knowledge of clinical status. Statistical analysis was conducted from February 19, 2014, to January 26, 2018. Flutemetamol F 18-labeled PET at baseline followed by up to 6 clinical visits every 6 months, as well as magnetic resonance imaging and multiple cognitive measures. Time from PET to probable AD or last follow-up was plotted as a Kaplan-Meier survival curve; PET scan results, age, hippocampal volume, and aMCI stage were entered into Cox proportional hazards logistic regression analyses to identify variables associated with progression to probable AD. Of 232 patients with aMCI (118 women and 114 men; mean [SD] age, 71.1 [8.6] years), 98 (42.2%) had positive results detected on PET scan. By 36 months, the rates of progression to probable AD were 36.2% overall (81 of 224 patients), 53.6% (52 of 97) for patients with positive results detected on PET scan, and 22.8% (29 of 127) for patients with negative results detected on PET scan. Hazard ratios for association with progression were 2.51 (95% CI, 1.57-3.99; P < .001) for a positive β-amyloid scan alone (primary outcome measure), 5.60 (95% CI, 3.14-9.98; P < .001) with additional low hippocampal volume, and 8.45 (95% CI, 4.40-16.24; P < .001) when poorer cognitive status was added to the model. A combination of positive results of flutemetamol F 18-labeled PET, low hippocampal volume, and cognitive status corresponded with a high probability of risk of progression from aMCI to probable AD within 36 months.

[Clinical studies of flomoxef in the field of pediatrics].

PubMed

Ito, S; Mayumi, M; Mikawa, H

1987-08-01

Flomoxef (FMOX, 6315-S), a newly synthesized antibiotic which belongs to the oxacephem group, was clinically evaluated for its efficacy and safety in 17 patients with ages ranging from 1 month to 9 year-8-month who had bacterial infections. The results obtained were summarized as follows. 1. A pharmacokinetic study following 20 mg/kg FMOX administration by intravenous bolus injection showed that the half-life of FMOX (beta phase) was 39.8 minutes and the urinary excretion of FMOX in the first 6 hours was 76.5%. 2. FMOX was administered to 3 patients with pneumonia, 8 patients with bronchopneumonia, 2 patients with tonsillitis, 2 patients with pyelonephritis, one patient each with cervical lymphadenitis, and pustulosis associated with severe varicella at daily dosage levels of 61.9 approximately 87.2 mg/kg, divided into 3 or 4 administrations by intravenous bolus injection or by 30 minutes drip infusion. The clinical results of these 17 patients were as follows; excellent: 14 patients, good: 2 patients, poor: 1 patient. The efficacy rate was 94.1%. 3. No clinical adverse reaction was observed in any of the 17 patients. Neutropenia, eosinophilia, a slight elevation of GPT and slight elevations of GOT & GPT were observed in 1, 1, 1, and 2 patients, respectively. No abnormality in coagulation system was observed in any of 10 evaluable patients. 4. MICs of FMOX against 13 strains isolated from patients were as follows. MIC against 2 out of 3 strains of Streptococcus pneumoniae was 0.20 micrograms/ml and that of the remaining 1 strain was 0.39 micrograms/ml.(ABSTRACT TRUNCATED AT 250 WORDS)

Treatment Considerations and the Role of the Clinical Pharmacist Throughout Transitions of Care for Patients With Acute Heart Failure.

PubMed

McNeely, Elizabeth B

2017-08-01

Heart failure is associated with increased risk of morbidity and mortality, resulting in substantial health-care costs. Clinical pharmacists have an opportunity to reduce health-care costs and improve disease management as patients transition from inpatient to outpatient care by leading interventions to develop patient care plans, educate patients and clinicians, prevent adverse drug reactions, reconcile medications, monitor drug levels, and improve medication access and adherence. Through these methods, clinical pharmacists are able to reduce rates of hospitalization, readmission, and mortality. In addition, care by clinical pharmacists can improve dosing levels and adherence to guideline-directed therapies. A greater benefit in patient management occurs when clinical pharmacists collaborate with other members of the health-care team, emphasizing the importance of heart failure treatment by a multidisciplinary health-care team. Education is a key area in which clinical pharmacists can improve care of patients with heart failure and should not be limited to patients. Clinical pharmacists should provide education to all members of the health-care team and introduce them to new therapies that may further improve the management of heart failure. The objective of this review is to detail the numerous opportunities that clinical pharmacists have to improve the management of heart failure and reduce health-care costs as part of a multidisciplinary health-care team.

Insulin therapy for adult patients with type 2 diabetes mellitus: a position statement of the Korean Diabetes Association, 2017.

PubMed

Lee, Byung-Wan; Kim, Jin Hwa; Ko, Seung-Hyun; Hur, Kyu Yeon; Kim, Nan-Hee; Rhee, Sang Youl; Kim, Hyun Jin; Moon, Min Kyong; Park, Seok-O; Choi, Kyung Mook

2017-11-01

The Korean Diabetes Association (KDA) has regularly updated its Clinical Practice Guidelines. In 2017, the KDA published a position statement on the use of antihyperglycemic agents for patients with type 2 diabetes mellitus (T2DM). Growing evidence from new multinational clinical trials using novel and traditional insulin analogues has also been accumulated. Following global trends, many results of clinical trials, especially concerning the clinical efficacy and safety of insulin therapy, have been published about Korean patients with T2DM. After a systematic search of recent evidence, the KDA updated and modified its clinical practice recommendations regarding the initiation, choice, and intensification of insulin and created an insulin treatment algorithm for the first time to guide physicians caring for adult Korean patients with T2DM.

[Surgical treatment of ishemic mitral regurgitation: repair, replacement or revascularization alone?].

PubMed

Vrenes, Mile; Velinović, Milos; Kocica, Mladen; Mikić, Aleksandar; Putnik, Svetozar; Djukić, Petar; Djordjević, Aleksandar

2010-01-01

Treatment of ischemic mitral regurgitation in patients that require revascularization of myocardium is still debatable. The aim of this study was to compare three surgical approaches: valve repair and revascularization; valve replacement and revascularization, and revascularization alone. In 2006 and 2007 at the Institute for Cardiovascular Diseases, Clinical Centre of Serbia, Belgrade, 1,040 patients with coronary disease underwent surgery. Forty-three patients (4.3%) had also mitral insufficiency 3-4+. The patients were examined clinically, echocardiographically and haemodynamically. In group I there were 14 (32.3%) patients, in group II 16 (37.2%) patients and in group III 3 (30.5%) patients. Ninety-three per cent of patients were classified as New York Heart Association (NYHA) class III and IV, and three (7%) patients had congestive heart weakness with ejection fraction < or =30%. The decision as to surgical procedure was made by the surgeon. Postoperatively, patients were checked clinically and echocardiographically after 3, 6 and 12 months. The follow-up period was approximately 15 months (8-20). Hospital mortality for the whole group was 6.9% (3 patients). In group I mortality was 14.2% (2 patients), in group II 6.25% and in group III there was no mortality. Long term results, up to 15 months, showed 100% survival in groups I and II, and in group III one patient died (7.7%). Short term results upto 30 days were best in group III, but longer term results were better in groups I and II.

The Case for Laboratory Developed Procedures

PubMed Central

Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.

2017-01-01

An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, and the ability of laboratories to adjust assays as needed to improve results, utilize new sample types, or incorporate new mutations, information, or technologies are positive aspects of Clinical Laboratory Improvement Amendments oversight of laboratory-developed procedures. Laboratories have a long history of successful service to patients operating under Clinical Laboratory Improvement Amendments. A series of detailed clinical examples illustrating the quality and positive impact of laboratory-developed procedures on patient care is provided. These examples also demonstrate how Clinical Laboratory Improvement Amendments oversight ensures accurate, reliable, and reproducible testing in clinical laboratories. PMID:28815200

The Effect of Message Content and Clinical Outcome on Patients' Perception of Physician Compassion: A Randomized Controlled Trial.

PubMed

Tanco, Kimberson; Azhar, Ahsan; Rhondali, Wadih; Rodriguez-Nunez, Alfredo; Liu, Diane; Wu, Jimin; Baile, Walter; Bruera, Eduardo

2018-03-01

In a previous randomized crossover study, patients perceived a physician delivering a more optimistic message (MO) as more compassionate and professional. However, the impact of the clinical outcome of the patient on patient's perception of physician's level of compassion and professionalism has not been previously studied. Our aim was to determine if the reported clinical outcome modified the patient's perception of physician compassion, professionalism, impression, and preference for physician. One hundred twenty-eight advanced cancer patients in an outpatient Supportive Care Center were randomized to complete validated questionnaires about patients' perception of physician's level of compassion, professionalism, impression, and preference of physician for themselves and their family after watching scripted videos depicting a physician delivering an MO versus a less optimistic (LO) message followed by a clinical vignette depicting a worse outcome. Median age was 61 years and 55% were female. There was no difference in compassion score after the vignette in the MO and LO groups. However, there were significantly worse overall impression and professionalism scores in both the MO and LO groups after the vignette. In the MO group, preference for the physician for themselves and their family significantly decreased after the vignette. Seeing a worse clinical outcome did not change the patients' appraisal of an inappropriately optimistic physician. However, it reduced the overall impression of both physicians that conveyed an MO or an LO message and it also resulted in less likelihood of choosing the MO physician for themselves and their family. The study found that a patient's perception of a physician's compassion did not change after reading a vignette describing a negative clinical outcome, regardless of whether the physician had given a more or a less optimistic message to the patient. However, the results suggested that patients perceived worse professionalism and overall physician impression scores for both more and less optimistic physicians and lower likelihood to choose the more optimistic physician for themselves and their family. © AlphaMed Press 2017.

Clinical and microbiological characteristics of spontaneous acute prostatitis and transrectal prostate biopsy-related acute prostatitis: Is transrectal prostate biopsy-related acute prostatitis a distinct acute prostatitis category?

PubMed

Kim, Jong Wook; Oh, Mi Mi; Bae, Jae Hyun; Kang, Seok Ho; Park, Hong Seok; Moon, Du Geon

2015-06-01

This study aimed to compare the clinical and microbiological characteristics between acute bacterial prostatitis and transrectal biopsy-related acute prostatitis. We retrospectively reviewed the records of 135 patients hospitalized for acute prostatitis in three urological centers between 2004 and 2013. Acute bacterial prostatitis was diagnosed according to typical symptoms, findings of physical examination, and laboratory test results. Clinical variables, laboratory test results, and anti-microbial susceptibility results were reviewed. Patients were classified into the spontaneous acute prostatitis group (S-ABP) or biopsy-related acute prostatitis (Bx-ABP) for comparison of their clinical, laboratory, and microbiological findings. The mean age of all patients was 61.7 ± 12.9 years. Compared with S-ABP patients, Bx-ABP patients were significantly older, had larger prostate volumes, higher PSA values, higher peak fever temperatures, and higher incidence of septicemia and antibiotic-resistant bacteria. Overall, of the 135 patients, 57.8% had positive bacterial urine and/or blood cultures. Bx-ABP patients had a higher incidence of bacterial (urine and/or blood) positive cultures compared to S-ABP patients (66.7% versus 55.6%). Escherichia coli was the predominant organism in both groups, but it was more common in Bx-ABP (88.9%) than in S-ABP (66.7%). Extended spectrum beta-lactamase -producing bacteria accounted for 64.7% of culture-positive patients in the Bx-ABP group compared to 13.3% in the S-ABP group. Bx-ABP patients showed a higher incidence of septicemia and antibiotic-resistant bacteria than S-ABP patients. These results have important implications for the management and antimicrobial treatment of Bx-ABP, which may well deserve to be considered a distinct prostatitis category. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Implementation of a chest pain management service improves patient care and reduces length of stay.

PubMed

Scott, Adam C; O'Dwyer, Kristina M; Cullen, Louise; Brown, Anthony; Denaro, Charles; Parsonage, William

2014-03-01

Chest pain is one of the most common complaints in patients presenting to an emergency department. Delays in management due to a lack of readily available objective tests to risk stratify patients with possible acute coronary syndromes can lead to an unnecessarily lengthy admission placing pressure on hospital beds or inappropriate discharge. The need for a co-ordinated system of clinical management based on enhanced communication between departments, timely and appropriate triage, clinical investigation, diagnosis, and treatment was identified. An evidence-based Chest Pain Management Service and clinical pathway were developed and implemented, including the introduction of after-hours exercise stress testing. Between November 2005 and March 2013, 5662 patients were managed according to a Chest Pain Management pathway resulting in a reduction of 5181 admission nights by more timely identification of patients at low risk who could then be discharged. In addition, 1360 days were avoided in high-risk patients who received earlier diagnosis and treatment. The creation of a Chest Pain Management pathway and the extended exercise stress testing service resulted in earlier discharge for low-risk patients; and timely treatment for patients with positive and equivocal exercise stress test results. This service demonstrated a significant saving in overnight admissions.

Mid-Term Clinical Outcome and Reconstruction of Posterior Tibial Slope after UKA.

PubMed

Franz, Alois; Boese, Christoph Kolja; Matthies, Andrej; Leffler, Jörg; Ries, Christian

2018-05-21

Unicompartmental knee arthroplasty (UKA) has gained growing popularity over the last decades. The posterior tibial slope (PTS) has been shown to play a significant role for knee biomechanics and is thought to be crucial for clinical function of the UKA. We evaluated the clinical outcome at mid-term follow-up after UKA. Furthermore, the reconstruction of the individual PTS was analyzed. A total of 91 consecutive patients undergoing medial UKA for osteoarthritis were included. Patients were contacted by telephone for a survival analysis at a minimum of 30 months after surgery. Patient-oriented questionnaires and Knee Osteoarthritis Outcome Score (KOOS) were obtained. A retrospective chart review and radiological analysis of component alignment were performed for all patients before and at 6 weeks after surgery. Of 91 patients (93 knees) undergoing UKA, 69 patients (70 knees) were available for clinical follow-up after a mean of 56.0 (range 31-81) months post-surgery. The clinical results of the examined patients in the present study showed mean subscale scores of the KOOS and Western Ontario and McMaster Universities Osteoarthritis Index between 71 and 91%. Overall 7 of 91 patients were revised during the course of follow-up period and underwent total knee arthroplasty. A Kaplan-Meier analysis showed a survival rate for UKA of 90.5% after 48 months. Calculated implant survival was 75.9 months (95% confidence interval 72.3-79.6) at the mean. The radiographic analysis of pre- and postoperative PTS showed no differences ( p  = 0.113).UKA for osteoarthritis of the medial knee compartment shows encouraging clinical results at mid-term follow-up. The individual PTS could be reconstructed within acceptable ranges. This is a retrospective therapeutic study with Level IV. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Hashimoto thyroiditis is more frequent than expected when diagnosed by cytology which uncovers a pre-clinical state

PubMed Central

2010-01-01

Background Our Thyroid-Multidisciplinary Clinic is a large referral site for thyroid diseases. Thyroid biopsies are mainly performed for thyroid cancer screening. Yet, Hashimoto thyroiditis (HT) is being too frequently diagnosed. The prevalence of HT is reported as 0.3-1.2% or twice the prevalence of type 1 diabetes. However, the prevalence of HT confirmed by cytology is still uncertain. To evaluate different aspects of thyroid physiopathology including prevalence of Hashimoto's, a database of clinical features, ultrasound images and cytology results of patients referred for FNA of thyroid nodules was prospectively developed. Methods We retrospectively studied 811 consecutive patients for whom ultrasound guided thyroid FNA biopsies were performed at our clinic over 2.5 year period (Mar/2006-Sep/2008). Results The analysis of our database revealed that from 761 patients, 102 (13.4%) had HT, from whom 56 (7.4%) were euthyroid or had sub-clinical (non-hypothyroid) disease, and 46 (6%) were clinically hypothyroid. Conclusions This is the first study to show such a high prevalence of HT diagnosed by ultrasound-guided FNA. More strikingly, the prevalence of euthyroid HT, appears to be >5% similar to that of type 2 diabetes. Based on our results, there might be a need to follow up on cytological Hashimoto's to monitor for thyroid failure, especially in high risk states, like pregnancy. The potential risk for thyroid cancer in patients with biopsy-proven inflammation of thyroid epithelium remains to be established prospectively. However, it may explain the increased risk for thyroid cancer observed in patients with elevated but within normal TSH. PMID:21172028

A report on an acute, in-hours, outpatient review clinic with ultrasonography facilities for the early evaluation of general surgical patients.

PubMed

Pidgeon, T E; Shariff, U; Devine, F; Menon, V

2016-09-01

Introduction In 2013 our hospital introduced an in-hours, consultant-led, outpatient acute surgical clinic (ASC) for emergency general surgical patients. In 2014 this clinic was equipped with a dedicated ultrasonography service. This prospective cohort study evaluated this service before and after the introduction of ultrasonography facilities. Methods Data were recorded prospectively for all patients attending the clinic during 2013 and 2014. The primary outcome was patient destination (whether there was follow-up/admission) after clinic attendance. Results The ASC reviewed patients with a wide age range and array of general surgical complaints. In 2013, 186 patients attended the ASC. After the introduction of the ultrasonography service in 2014, 304 patients attended. In 2014, there was a reduction in the proportion of patients admitted to hospital from the clinic (18.3% vs 8.9%, p=0.002). However, the proportion of patients discharged after ASC review remained comparable with 2013 (30.1% in 2013 vs 38.8% in 2014, p=0.051). The proportion of patients undergoing computed tomography (CT) scans also fell (14.0% vs 4.9%, p<0.001). Conclusions The ASC assessed a wide array of general surgical complaints. Only a small proportion required hospital admission. The introduction of an ultrasonography service was associated with a further reduction in admission rates and computed tomography.

Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

PubMed Central

Le, Jimmy T.; Viswanathan, Shilpa; Tarver, Michelle E.; Eydelman, Malvina; Li, Tianjing

2017-01-01

IMPORTANCE Minimally invasive glaucoma surgical (MIGS) devices are one option for lowering intraocular pressure in patients with glaucoma. OBJECTIVE To examine how often existing clinical studies of MIGS devices registered on ClinicalTrials.gov measure patient-centric outcomes that patients value directly. DESIGN, SETTING, AND PARTICIPANTS We searched ClinicalTrials.gov, a registry of publicly and privately supported clinical studies, on February 20, 2015, for records of MIGS device studies involving patients with glaucoma. Two investigators independently abstracted study design and outcome details from eligible records. We classified outcomes as patient-centric or not patient-centric using a prespecified definition. MAIN OUTCOMES AND MEASURES Proportion of patient-centric and nonpatient-centric outcomes registered on ClinicalTrials.gov. RESULTS We identified 51 eligible studies specifying 127 outcomes. Reduction in intraocular pressure was the most frequent outcome specified (78/127; 61%) and a primary outcome in 41 studies. Patient-centric outcomes—such as adverse events (n = 19; 15%), topical medication use (n = 16; 13%), visual acuity (n = 4; 3%), and health-related quality of life (n = 1; 1%)—were less frequently specified (n = 40; 32%) and a primary outcome in only 12 studies. CONCLUSION AND RELEVANCE Patient-centric outcomes that provide insight into the relative desirability and acceptability of the benefits and risks of MIGS devices are not well represented in current clinical studies. PMID:27389667

Clinical and cognitive implications of cerebrospinal fluid oligoclonal bands in multiple sclerosis patients.

PubMed

Anagnostouli, Maria; Christidi, Foteini; Zalonis, Ioannis; Nikolaou, Chryssoula; Lyrakos, Dimitrios; Triantafyllou, Nikolaos; Evdokimidis, Ioannis; Kilidireas, Constantinos

2015-11-01

The presence of cerebrospinal fluid oligoclonal bands (CSF-OCB) in Caucasian patients with multiple sclerosis (MS) is supportive of diagnosis, though the relation with patients' clinical and specifically cognitive features has never been established or thoroughly examined. Thus, we investigated the clinical and for the first time the cognitive profile of MS patients in relation to CSF-OCB. We studied 108 patients with and without OCB and recorded demographic characteristics and detailed clinical data. A comprehensive neuropsychological battery covering different cognitive domains (attention/processing speed, memory, perception/constructions, reasoning, executive functions) was administered to MS patients and 142 demographically related healthy controls (HC). We did not find any significant differences between patients with and without OCB on demographic and clinical parameters (p > 0.05), including subtype and brain neuroimaging findings. Results revealed significantly higher cognitive scores in HC compared to both OCB subgroups, with more widespread cognitive changes in patients with OCB. Analysis between OCB subgroups showed significantly worse performance in patients with OCB on visual memory (Rey's complex figure test-recall; p = 0.006). Concluding, the presence of CSF-OCB in our MS patients tends to be related to more widespread cognitive changes, specifically worse visual memory. Future longitudinal studies in different populations are warranted to better clarify the clinical and cognitive characteristics related to CSF-OCB which could serve as early biomarker in disease monitoring.

[Effect of doctor-patient communication education on oral clinical practice].

PubMed

Wang, Yi; Tang, Yu; He, Yan; Zhu, Ya-qin

2012-08-01

To evaluate the effect of doctor-patient communication education on dental clinical practice. The process of 61 dental interns' clinical practice was divided into two stages. The dental interns were taught with traditional teaching method in the first stage. Doctor-patient communication and communication skill training were added to the second stage. Scale of medical student's doctor-patient communication behavior was used to evaluate the dental interns' behavior by themselves after two stages. The SEGUE frame work was used to evaluate the dental interns' behavior by teachers after two stages. All statistical analysis was performed using SPSS 13.0 software package. The result of scale of medical student's doctor-patient communication behavior was analyzed using Fisher exact test or Chi-square test. The score of the SEGUE frame work was analyzed using Student's t test. The result of Scale of medical student's doctor-patient communication behavior showed only 37.71% of dental interns could establish good doctor-patient relationship in the first stage. After doctor-patient communication and communication skill training, the percentage became 75.4%. The result of the SEGUE frame work showed the score was raised from 16.066±3.308 to 21.867±2.456, and a significant difference was found between the two stages. Doctor-Patient communication education can improve dental interns' communication skills and help to establish a good doctor-patient relationship.

Magnetic resonance imaging of cervical carcinoma using an endorectal surface coil.

PubMed

Brocker, Kerstin A; Alt, Céline D; Gebauer, Gerhard; Sohn, Christof; Hallscheidt, Peter

2014-07-01

The objective of this trial is to investigate the diagnostic value of magnetic resonance imaging (MRI) with an endorectal surface coil for precise local staging of patients with histologically proven cervical cancer by comparing the radiological, clinical, and histological results. Women with cervical cancer were recruited for this trial between February 2007, and September 2010. All the patients were clinically staged according to the FIGO classification and underwent radiological staging by MRI that employed an endorectal surface coil. The staging results after surgery were compared to histopathology in all the operable patients. A total of 74 consecutive patients were included in the trial. Forty-four (59.5%) patients underwent primary surgery, whereas 30 (40.5%) patients were inoperable according to FIGO and underwent primary radiochemotherapy. The mean age of the patients was 50.6 years. In 11 out of the 44 patients concordant staging results were obtained by all three staging modalities. Thirty-two of the 44 patients were concordantly staged by FIGO and histopathological examination, while only 16 were concordantly staged by eMRI and histopathological examination. eMRI overstaged tumors in 14 cases and understaged them in 7 cases. eMRI is applicable in patients with cervical cancer, yet of no benefit than staging with FIGO or standard pelvic MRI. The most precise preoperative staging procedure still appears to be the clinical examination. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Patient perspectives on whole-genome sequencing for undiagnosed diseases.

PubMed

Boeldt, Debra L; Cheung, Cynthia; Ariniello, Lauren; Darst, Burcu F; Topol, Sarah; Schork, Nicholas J; Philis-Tsimikas, Athena; Torkamani, Ali; Fortmann, Addie L; Bloss, Cinnamon S

2017-01-01

This study assessed perspectives on whole-genome sequencing (WGS) for rare disease diagnosis and the process of receiving genetic results. Semistructured interviews were conducted with adult patients and parents of minor patients affected by idiopathic diseases (n = 10 cases). Three main themes were identified through qualitative data analysis and interpretation: perceived benefits of WGS; perceived drawbacks of WGS; and perceptions of the return of results from WGS. Findings suggest that patients and their families have important perspectives on the use of WGS in diagnostic odyssey cases. These perspectives could inform clinical sequencing research study designs as well as the appropriate deployment of patient and family support services in the context of clinical genome sequencing.

Clinical application of pharmacogenetics: focusing on practical issues.

PubMed

Chang, Matthew T; McCarthy, Jeanette J; Shin, Jaekyu

2015-01-01

Recent large-scale genetic-based studies have transformed the field of pharmacogenetics to identify, characterize and leverage genetic information to inform patient care. Genetic testing can be used to alter drug selection, optimize drug dosing and prevent unnecessary adverse events. As precision medicine becomes the mainstay in the clinic, it becomes critical for clinicians to utilize pharmacogenetics to guide patient care. One primary challenge is identifying patients where genetic tests that can potentially impact patient care. To address this challenge, our review highlights many practical issues clinicians may encounter: identifying candidate patients and clinical laboratories for pharmacogenetic testing, selecting highly curated resources to help asses test validity, reimbursing costs of pharmacogenetic tests, and interpreting of pharmacogenetic test results.

The eSexual Health Clinic system for management, prevention, and control of sexually transmitted infections: exploratory studies in people testing for Chlamydia trachomatis.

PubMed

Estcourt, Claudia S; Gibbs, Jo; Sutcliffe, Lorna J; Gkatzidou, Voula; Tickle, Laura; Hone, Kate; Aicken, Catherine; Lowndes, Catherine M; Harding-Esch, Emma M; Eaton, Sue; Oakeshott, Pippa; Szczepura, Ala; Ashcroft, Richard E; Copas, Andrew; Nettleship, Anthony; Sadiq, S Tariq; Sonnenberg, Pam

2017-04-01

Self-directed and internet-based care are key elements of eHealth agendas. We developed a complex online clinical and public health intervention, the eSexual Health Clinic (eSHC), in which patients with genital chlamydia are diagnosed and medically managed via an automated online clinical consultation, leading to antibiotic collection from a pharmacy. Partner notification, health promotion, and capture of surveillance data are integral aspects of the eSHC. We aimed to assess the safety and feasibility of the eSHC as an alternative to routine care in non-randomised, exploratory proof-of-concept studies. Participants were untreated patients with chlamydia from genitourinary medicine clinics, untreated patients with chlamydia from six areas in England in the National Chlamydia Screening Programme's (NCSP) online postal testing service, or patients without chlamydia tested in the same six NCSP areas. All participants were aged 16 years or older. The primary outcome was the proportion of patients with chlamydia who consented to the online chlamydia pathway who then received appropriate clinical management either exclusively through online treatment or via a combination of online management and face-to-face care. We captured adverse treatment outcomes. Between July 21, 2014, and March 13, 2015, 2340 people used the eSHC. Of 197 eligible patients from genitourinary medicine clinics, 161 accessed results online. Of the 116 who consented to be included in the study, 112 (97%, 95% CI 91-99) received treatment, and 74 of those were treated exclusively online. Of the 146 eligible NCSP patients, 134 accessed their results online, and 105 consented to be included. 93 (89%, 95% CI 81-94) received treatment, and 60 were treated exclusively online. In both groups, median time to collection of treatment was within 1 day of receiving their diagnosis. 1776 (89%) of 1936 NCSP patients without chlamydia accessed results online. No adverse events were recorded. The eSHC is safe and feasible for management of patients with chlamydia, with preliminary evidence of similar treatment outcomes to those in traditional services. This innovative model could help to address growing clinical and public health needs. A definitive trial is needed to assess the efficacy, cost-effectiveness, and public health impact of this intervention. UK Clinical Research Collaboration. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

The role of Nesbit's procedure in surgical reconstruction of penile deviation

PubMed Central

Martenstein, Christian; Peruth, Julia; Hamza, Amir

2012-01-01

Objective: We review our results after surgical reconstruction with the Nesbit’s procedure for congenital or acquired penile deviation. Patients and methods: Etiology of penile deviation, surgical outcome for straightening the penis, postoperative patient satisfaction and clinical findings were evaluated for 5 patients undergoing Nesbit’s procedure followed by a Medline review of contemporary literature regarding alternative surgical techniques. Follow-up included clinical examination, self-photography on erection and a standardized interview with erectile dysfunction assessment using IIEF-5 questionnaire. Results: Overall patient satisfaction was 100% in two patients, 2 patients were partly satisfied and 1 patient reported no satisfaction because of severe penile shortening with insufficiency for sexual intercourse postoperatively. Preoperative mean angulation of the penis was 42°. Four patients had Peyronie’s disease and 1 patient’s curvature resulted from an untreated penile fracture during sexual intercourse. Conclusion: The Nesbit technique can give satisfactory results for mild and moderate penile curvature. However, each technique for the reconstruction of penile deviation has its own advantages and disadvantages. Therefore proper patient selection has a major impact on further outcome. PMID:26504690

Impact of cerebro-spinal fluid biomarkers of Alzheimer's disease in clinical practice: a multicentric study.

PubMed

Mouton-Liger, François; Wallon, David; Troussière, Anne-Cécile; Yatimi, Rachida; Dumurgier, Julien; Magnin, Eloi; de la Sayette, Vincent; Duron, Emannuelle; Philippi, Nathalie; Beaufils, Emilie; Gabelle, Audrey; Croisile, Bernard; Robert, Philippe; Pasquier, Florence; Hannequin, Didier; Hugon, Jacques; Paquet, Claire

2014-01-01

CSF biomarkers of Alzheimer's disease are well validated in clinical research; however, their pragmatic utility in daily practice is still unappreciated. These biomarkers are used in routine practice according to Health Authority Recommendations. In 604 consecutive patients explored for cognitive disorders, questionnaires were prospectively proposed and filled. Before and after CSF biomarker results, clinicians provided a diagnosis and an estimate of their diagnostic confidence. Analysis has compared the frequency of diagnosis before and after CSF biomarker results using the net reclassification improvement (NRI) method. We have evaluated external validity comparing with data of French Bank National of AD (BNA). A total of 561 patients [Alzheimer's disease (AD), n = 253; non-AD, n = 308] were included (mean age, 68.6 years; women, 52 %). Clinically suspected diagnosis and CSF results were concordant in 65.2 % of cases. When clinical hypothesis and biological results were discordant, a reclassification occurred in favour of CSF biomarkers results in 76.9 %. The NRI was 39.5 %. In addition, the results show a statistically significant improvement in clinician confidence for their diagnosis. In comparison with BNA data, patients were younger and more frequently diagnosed with AD. Clinicians tend to heavily rely on the CSF AD biomarkers results and are more confident in their diagnoses using CSF AD biomarkers. Thus, these biomarkers appear as a key tool in clinical practice.

Clinical characteristics of patients with tinnitus evaluated with the Tinnitus Sample Case History Questionnaire in Japan: A case series

PubMed Central

Kojima, Takashi; Kanzaki, Sho; Oishi, Naoki; Ogawa, Kaoru

2017-01-01

Background The Tinnitus Sample Case History Questionnaire was determined as a standardized questionnaire for obtaining patient case histories and for characterizing patients into subgroups at the Tinnitus Research Initiative in 2006. In this study, we developed a Japanese version of this questionnaire for evaluating the clinical characteristics of patients with tinnitus. The Japanese version of the questionnaire will be available for evaluating treatments for tinnitus and for comparing data on tinnitus in research centers. Aims/Objectives To evaluate the clinical characteristics of patients with tinnitus in Japan using a newly developed Japanese version of Tinnitus Sample Case History Questionnaire. Study design This was a prospective study based on patient records. Setting University hospitals, general hospitals, and clinics. Subjects and methods We collected patient data using a Japanese translated version of the Tinnitus Sample Case History Questionnaire. In total, 584 patients who visited our institutions in Japan between August 2012 and March 2014 were included (280 males and 304 females; age 13–92 years; mean age, 60.8). We examined patients after dividing them into two groups according to the presence or absence of hyperacusis. The collected results were compared with those from the Tinnitus Research Initiative database. Results Compared with the TRI database, there were significantly more elderly female patients and fewer patients with trauma-associated tinnitus. There was a statistically lower ratio of patients with hyperacusis. We found that patients with tinnitus in addition to hyperacusis had greater tinnitus severity and exhibited higher rates of various complications. Conclusion The Japanese version of the Tinnitus Sample Case History Questionnaire developed in this study can be a useful tool for evaluating patients with tinnitus in Japan. The results of this multicenter study reflect the characteristics of patients with tinnitus who require medical care in Japan. Our data provides a preliminary basis for an international comparison of tinnitus epidemiology. PMID:28841656

Medical costs in the US of clinical events associated with oral anticoagulant (OAC) use compared to warfarin among non-valvular atrial fibrillation patients ≥75 and <75 years of age, based on the ARISTOTLE, RE-LY, and ROCKET-AF trials.

PubMed

Deitelzweig, Steve; Amin, Alpesh; Jing, Yonghua; Makenbaeva, Dinara; Wiederkehr, Daniel; Lin, Jay; Graham, John

2013-09-01

Based on clinical trials the oral anticoagulants (OACs) apixaban, dabigatran, and rivaroxaban are efficacious for reducing stroke risk for non-valvular atrial fibrillation (NVAF) patients. Based on the clinical trials, this study evaluated the medical costs for clinical events among NVAF patients ≥75 and <75 years of age treated with individual OACs vs warfarin. Rates for primary and secondary efficacy and safety outcomes (i.e., clinical events) among NVAF patients receiving warfarin or each of the OACs were determined for NVAF populations aged ≥75 years and <75 years of age from the OAC vs warfarin trials. One-year incremental costs among patients with clinical events were obtained from published literature and inflation adjusted to 2010 costs. Medical costs, excluding medication costs, for clinical events associated with each OAC and warfarin were then estimated and compared. Among NVAF patients aged ≥75, compared to warfarin, use of either apixaban or rivaroxaban was associated with a reduction in medical costs per patient year (apixaban = -$825, rivaroxaban =-$23), while dabigatran use was associated with increased medical costs of $180 per patient year. Among NVAF patients <75 years of age medical costs per patient year were estimated to be reduced -$254, -$367, and -$88, for apixaban, dabigatran, and rivaroxaban, respectively, in comparison to warfarin. This economic analysis was based on clinical trial data and, therefore, the direct application of the results to routine clinical practice will require further assessment. Difference in medical costs between OAC and warfarin treated NVAF patients vary by age group and individual OACs. Although reductions in medical costs for NVAF patients aged ≥75 and <75 were observed for those using either apixaban or rivaroxaban vs warfarin, the reductions were greater per patient year for both the older and younger NVAF populations using apixaban.

Benchmarking by HbA1c in a national diabetes quality register--does measurement bias matter?

PubMed

Carlsen, Siri; Thue, Geir; Cooper, John Graham; Røraas, Thomas; Gøransson, Lasse Gunnar; Løvaas, Karianne; Sandberg, Sverre

2015-08-01

Bias in HbA1c measurement could give a wrong impression of the standard of care when benchmarking diabetes care. The aim of this study was to evaluate how measurement bias in HbA1c results may influence the benchmarking process performed by a national diabetes register. Using data from 2012 from the Norwegian Diabetes Register for Adults, we included HbA1c results from 3584 patients with type 1 diabetes attending 13 hospital clinics, and 1366 patients with type 2 diabetes attending 18 GP offices. Correction factors for HbA1c were obtained by comparing the results of the hospital laboratories'/GP offices' external quality assurance scheme with the target value from a reference method. Compared with the uncorrected yearly median HbA1c values for hospital clinics and GP offices, EQA corrected HbA1c values were within ±0.2% (2 mmol/mol) for all but one hospital clinic whose value was reduced by 0.4% (4 mmol/mol). Three hospital clinics reduced the proportion of patients with poor glycemic control, one by 9% and two by 4%. For most participants in our study, correcting for measurement bias had little effect on the yearly median HbA1c value or the percentage of patients achieving glycemic goals. However, at three hospital clinics correcting for measurement bias had an important effect on HbA1c benchmarking results especially with regard to percentages of patients achieving glycemic targets. The analytical quality of HbA1c should be taken into account when comparing benchmarking results.

Perceived Barriers to Clinic Appointments for Adolescents with Sickle Cell Disease

PubMed Central

Crosby, Lori E.; Modi, Avani C.; Lemanek, Kathleen L.; Guilfoyle, Shanna M.; Kalinyak, Karen A.; Mitchell, Monica J.

2009-01-01

Purpose The purpose of the study was to examine perceived barriers to clinic attendance and strategies to overcome these barriers for adolescents with sickle cell disease (SCD). Materials and Methods This was a two-phased study which utilized focus groups (n = 13) and individual semi-structured interviews (n = 32) with adolescent patients (aged 13–21 years) from three pediatric sickle cell clinics in the Mid-west. Results Adolescents identified competing activities, health status, patient-provider relationships, adverse clinic experiences, and forgetting as barriers to clinic attendance. Calendars/reminders and parent reminders were the most commonly reported strategies to facilitate clinic attendance. Adolescents also reported the need for flexible scheduling and improved patient-provider communication. Discussion Adolescents with SCD and their families may benefit from on-going education about the importance of attending routine clinic visits. Adherence to clinic appointments for adolescents may be enhanced by developing interventions to decrease forgetting (e.g., phone call reminders, text-messaging) and increase patient satisfaction with clinic visits. Scheduling appointments to accommodate busy schedules/scheduling conflicts (e.g., late clinic hours), providing teen-friendly clinic environments and utilizing technology may also facilitate attendance. PMID:19636266

CAR T-cell therapy for glioblastoma: ready for the next round of clinical testing?

PubMed

Prinzing, Brooke L; Gottschalk, Stephen M; Krenciute, Giedre

2018-05-01

The outcome for patients with glioblastoma (GBM) remains poor, and there is an urgent need to develop novel therapeutic approaches. T cells genetically modified with chimeric antigen receptors (CARs) hold the promise to improve outcomes since they recognize and kill cells through different mechanisms than conventional therapeutics. Areas covered: This article reviews CAR design, tumor associated antigens expressed by GBMs that can be targeted with CAR T cells, preclinical and clinical studies conducted with CAR T cells, and genetic approaches to enhance their effector function. Expert commentary: While preclinical studies have highlighted the potent anti-GBM activity of CAR T cells, the initial foray of CAR T-cell therapies into the clinic resulted only in limited benefits for GBM patients. Additional genetic modification of CAR T cells has resulted in a significant increase in their anti-GBM activity in preclinical models. We are optimistic that clinical testing of these enhanced CAR T cells will be safe and result in improved anti-glioma activity in GBM patients.

Clinical and histologic evaluation of calcium-phosphate bone cement in interproximal osseous defects in humans: a report in four patients.

PubMed

Mellonig, James T; Valderrama, Pilar; Cochran, David L

2010-04-01

This study evaluated the clinical and histologic results of a calcium phosphate bone cement in the treatment of human periodontal intraosseous defects. Four patients with chronic advanced periodontitis in whom treatment with complete dentures was planned were recruited. The cement was implanted in one defect per subject with a presurgical probing depth of at least 7 mm and a radiographic bone defect of 4 mm or more. Patients were seen every 2 weeks for periodontal maintenance. At 6 months, clinical measurements were repeated and the tooth was removed en bloc for histologic processing. Results demonstrated that all defects resulted in probing depth reduction and, at three of the four defects, in clinical attachment level gain. However, no site showed periodontal regeneration. There was no new bone formation. New cementum and connective tissue were limited to 0.2 mm or less. Large deposits of the bone cement were noted encapsulated in connective tissue.

Hantavirus pulmonary syndrome clinical findings: evaluating a surveillance case definition.

PubMed

Knust, Barbara; Macneil, Adam; Rollin, Pierre E

2012-05-01

Clinical cases of hantavirus pulmonary syndrome (HPS) can be challenging to differentiate from other acute respiratory diseases, which can lead to delays in diagnosis, treatment, and disease reporting. Rapid onset of severe disease occurs, at times before diagnostic test results are available. This study's objective was to examine the clinical characteristics of patients that would indicate HPS to aid in detection and reporting. Test results of blood samples from U.S. patients suspected of having HPS submitted to the Centers for Disease Control and Prevention from 1998-2010 were reviewed. Patient information collected by case report forms was compared between HPS-confirmed and test-negative patients. Diagnostic sensitivity, specificity, predictive values, and likelihood ratios were calculated for individual clinical findings and combinations of variables. Of 567 patients included, 36% were HPS-confirmed. Thrombocytopenia, chest x-rays with suggestive signs, and receiving supplemental oxygenation were highly sensitive (>95%), while elevated hematocrit was highly specific (83%) in detecting HPS. Combinations that maximized sensitivity required the presence of thrombocytopenia. Using a national sample of suspect patients, we found that thrombocytopenia was a highly sensitive indicator of HPS and should be included in surveillance definitions for suspected HPS. Using a sensitive suspect case definition to identify potential HPS patients that are confirmed by highly specific diagnostic testing will ensure accurate reporting of this disease.

A simple algorithm for the identification of clinical COPD phenotypes.

PubMed

Burgel, Pierre-Régis; Paillasseur, Jean-Louis; Janssens, Wim; Piquet, Jacques; Ter Riet, Gerben; Garcia-Aymerich, Judith; Cosio, Borja; Bakke, Per; Puhan, Milo A; Langhammer, Arnulf; Alfageme, Inmaculada; Almagro, Pere; Ancochea, Julio; Celli, Bartolome R; Casanova, Ciro; de-Torres, Juan P; Decramer, Marc; Echazarreta, Andrés; Esteban, Cristobal; Gomez Punter, Rosa Mar; Han, MeiLan K; Johannessen, Ane; Kaiser, Bernhard; Lamprecht, Bernd; Lange, Peter; Leivseth, Linda; Marin, Jose M; Martin, Francis; Martinez-Camblor, Pablo; Miravitlles, Marc; Oga, Toru; Sofia Ramírez, Ana; Sin, Don D; Sobradillo, Patricia; Soler-Cataluña, Juan J; Turner, Alice M; Verdu Rivera, Francisco Javier; Soriano, Joan B; Roche, Nicolas

2017-11-01

This study aimed to identify simple rules for allocating chronic obstructive pulmonary disease (COPD) patients to clinical phenotypes identified by cluster analyses.Data from 2409 COPD patients of French/Belgian COPD cohorts were analysed using cluster analysis resulting in the identification of subgroups, for which clinical relevance was determined by comparing 3-year all-cause mortality. Classification and regression trees (CARTs) were used to develop an algorithm for allocating patients to these subgroups. This algorithm was tested in 3651 patients from the COPD Cohorts Collaborative International Assessment (3CIA) initiative.Cluster analysis identified five subgroups of COPD patients with different clinical characteristics (especially regarding severity of respiratory disease and the presence of cardiovascular comorbidities and diabetes). The CART-based algorithm indicated that the variables relevant for patient grouping differed markedly between patients with isolated respiratory disease (FEV 1 , dyspnoea grade) and those with multi-morbidity (dyspnoea grade, age, FEV 1 and body mass index). Application of this algorithm to the 3CIA cohorts confirmed that it identified subgroups of patients with different clinical characteristics, mortality rates (median, from 4% to 27%) and age at death (median, from 68 to 76 years).A simple algorithm, integrating respiratory characteristics and comorbidities, allowed the identification of clinically relevant COPD phenotypes. Copyright ©ERS 2017.

Telemedicine in a pediatric headache clinic: A prospective survey.

PubMed

Qubty, William; Patniyot, Irene; Gelfand, Amy

2018-05-08

The aim of this prospective study was to survey our patients about their experience with our clinic's telemedicine program to better understand telemedicine's utility for families, and to improve patient satisfaction and ultimately patient care. This was a prospective survey study of patients and their families who had a routine telemedicine follow-up visit with the University of California San Francisco Pediatric Headache Program. The survey was administered to patients and a parent(s) following their telemedicine visit. Fifty-one of 69 surveys (74%) were completed. All (51/51) patients and families thought that (1) telemedicine was more convenient compared to a clinic visit, (2) telemedicine caused less disruption of their daily routine, and (3) they would choose to do telemedicine again. The mean round-trip travel time from home to clinic was 6.8 hours (SD ± 8.6 hours). All participants thought telemedicine was more cost-effective than a clinic visit. Parents estimated that participating in a telemedicine visit instead of a clinic appointment saved them on average $486. This prospective, pediatric headache telemedicine study shows that telemedicine is convenient, perceived to be cost-effective, and patient-centered. Providing the option of telemedicine for routine pediatric headache follow-up visits results in high patient and family satisfaction. © 2018 American Academy of Neurology.

Posterior reversible encephalopathy syndrome in Korean patients with systemic lupus erythematosus: risk factors and clinical outcome.

PubMed

Jung, S M; Moon, S-J; Kwok, S-K; Ju, J H; Park, K-S; Park, S-H; Kim, H-Y

2013-08-01

Posterior reversible encephalopathy syndrome (PRES) is an uncommon neurologic condition associated with systemic lupus erythematosus (SLE). This study aimed to demonstrate the risk factors and clinical outcome of PRES in patients with SLE. Fifteen patients with SLE were diagnosed with PRES by characteristic clinical manifestations and magnetic resonance imaging (MRI) features from 2000 to 2012. Clinical profiles and outcomes were assessed for this study population. Additionally, 48 SLE patients with neurologic symptoms who underwent brain MRI were included for comparative analyses. The median age and duration of SLE in patients with PRES was 27 and 6.1 years, respectively. Comparison between patients with and without PRES revealed significant differences in the presentation of hypertension and seizure, lupus nephritis with renal insufficiency, treatment with high-dose steroid and cyclophosphamide, recent transfusion, and lupus activity measured by SLE disease activity index. Renal failure was the single independent factor with a high odds ratio of 129.250 by multivariate analysis. Of 15 patients, four experienced relapse and two died of sepsis during hospitalization. Our results suggest that lupus nephritis with renal dysfunction and other related clinical conditions can precede the occurrence of PRES in patients with SLE. It is important to perform early brain imaging for a timely diagnosis of PRES when clinically suspected.

Estimated Cost-Effectiveness, Cost Benefit, and Risk Reduction Associated with an Endocrinologist-Pharmacist Diabetes Intense Medical Management "Tune-Up" Clinic.

PubMed

Hirsch, Jan D; Bounthavong, Mark; Arjmand, Anisa; Ha, David R; Cadiz, Christine L; Zimmerman, Andrew; Ourth, Heather; Morreale, Anthony P; Edelman, Steven V; Morello, Candis M

2017-03-01

In 2012 U.S. diabetes costs were estimated to be $245 billion, with $176 billion related to direct diabetes treatment and associated complications. Although a few studies have reported positive glycemic and economic benefits for diabetes patients treated under primary care physician (PCP)-pharmacist collaborative practice models, no studies have evaluated the cost-effectiveness of an endocrinologist-pharmacist collaborative practice model treating complex diabetes patients versus usual PCP care for similar patients. To estimate the cost-effectiveness and cost benefit of a collaborative endocrinologist-pharmacist Diabetes Intense Medical Management (DIMM) "Tune-Up" clinic for complex diabetes patients versus usual PCP care from 3 perspectives (clinic, health system, payer) and time frames. Data from a retrospective cohort study of adult patients with type 2 diabetes mellitus (T2DM) and glycosylated hemoglobin A1c (A1c) ≥ 8% who were referred to the DIMM clinic at the Veterans Affairs San Diego Health System were used for cost analyses against a comparator group of PCP patients meeting the same criteria. The DIMM clinic took more time with patients, compared with usual PCP visits. It provided personalized care in three 60-minute visits over 6 months, combining medication therapy management with patient-specific diabetes education, to achieve A1c treatment goals before discharge back to the PCP. Data for DIMM versus PCP patients were used to evaluate cost-effectiveness and cost benefit. Analyses included incremental cost-effectiveness ratios (ICERs) at 6 months, 3-year estimated total medical costs avoided and return on investment (ROI), absolute risk reduction of complications, resultant medical costs, and quality-adjusted life-years (QALYs) over 10 years. Base case ICER results indicated that from the clinic perspective, the DIMM clinic costs $21 per additional percentage point of A1c improvement and $115-$164 per additional patient at target A1c goal level compared with the PCP group. From the health system perspective, medical cost avoidance due to improved A1c was $8,793 per DIMM patient versus $3,506 per PCP patient (P = 0.009), resulting in an ROI of $9.01 per dollar spent. From the payer perspective, DIMM patients had estimated lower total medical costs, a greater number of QALYs gained, and appreciable risk reductions for diabetes-related complications over 2-, 5- and 10-year time frames, indicating that the DIMM clinic was dominant. Sensitivity analyses indicated results were robust, and overall conclusions did not change appreciably when key parameters (including DIMM clinic effectiveness and cost) were varied within plausible ranges. The DIMM clinic endocrinologist-pharmacist collaborative practice model, in which the pharmacist spent more time providing personalized care, improved glycemic control at a minimal cost per additional A1c benefit gained and produced greater cost avoidance, appreciable ROI, reduction in long-term complication risk, and lower cost for a greater gain in QALYs. Overall, the DIMM clinic represents an advanced pharmacy practice model with proven clinical and economic benefits from multiple perspectives for patients with T2DM and high medication and comorbidity complexity. No outside funding supported this study. The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Preliminary versions of the study data were presented in abstract form at the American Pharmacists Association Annual Meeting & Exposition; March 27, 2015; San Diego, California, and the Academy of Managed Care Pharmacy Annual Meeting; April 21, 2016; San Francisco, California. Study concept and design were contributed by Hirsch, Bounthavong, and Edelman, along with Morello and Morreale. Arjmand, Ourth, Ha, Cadiz, and Zimmerman collected the data. Data interpretation was performed by Ha, Morreale, and Morello, along with Cadiz, Ourth, and Hirsch. The manuscript was written primarily by Hirsch and Zimmerman, along with Arjamand, Ourth, and Morello, and was revised by Hirsch and Cadiz, along with Bounthavong, Ha, Morreale, and Morello.

Yield of the RYR2 Genetic Test in Suspected Catecholaminergic Polymorphic Ventricular Tachycardia and Implications for Test Interpretation.

PubMed

Kapplinger, Jamie D; Pundi, Krishna N; Larson, Nicholas B; Callis, Thomas E; Tester, David J; Bikker, Hennie; Wilde, Arthur A M; Ackerman, Michael J

2018-02-01

Pathogenic RYR2 variants account for ≈60% of clinically definite cases of catecholaminergic polymorphic ventricular tachycardia. However, the rate of rare benign RYR2 variants identified in the general population remains a challenge for genetic test interpretation. Therefore, we examined the results of the RYR2 genetic test among patients referred for commercial genetic testing and examined factors impacting variant interpretability. Frequency and location comparisons were made for RYR2 variants identified among 1355 total patients of varying clinical certainty and 60 706 Exome Aggregation Consortium controls. The impact of the clinical phenotype on the yield of RYR2 variants was examined. Six in silico tools were assessed using patient- and control-derived variants. A total of 18.2% (218/1200) of patients referred for commercial testing hosted rare RYR2 variants, statistically less than the 59% (46/78) yield among clinically definite cases, resulting in a much higher potential genetic false discovery rate among referrals considering the 3.2% background rate of rare, benign RYR2 variants. Exclusion of clearly putative pathogenic variants further complicates the interpretation of the next novel RYR2 variant. Exonic/topologic analyses revealed overrepresentation of patient variants in exons covering only one third of the protein. In silico tools largely failed to show evidence toward enhancement of variant interpretation. Current expert recommendations have resulted in increased use of RYR2 genetic testing in patients with questionable clinical phenotypes. Using the largest to date catecholaminergic polymorphic ventricular tachycardia patient versus control comparison, this study highlights important variables in the interpretation of variants to overcome the 3.2% background rate that confounds RYR2 variant interpretation. © 2018 American Heart Association, Inc.

[Benefits of using rapid HIV testing at the PMU-FLON walk-in clinic in Lausanne].

PubMed

Gilgien, W; Aubert, J; Bischoff, T; Herzig, L; Perdrix, J

2012-05-16

Lab tests are frequently used in primary care to guide patient care. This is particularly the case when a severe disorder, or one that will affect patients' initial care, needs to be excluded rapidly. At the PMU-FLON walk-in clinic the use of HIV testing as recommended by the Swiss Office of Public Health was hampered by the delay in obtaining test results. This led us to introduce rapid HIV testing which provides results within 30 minutes. Following the first 250 tests the authors discuss the results as well as the benefits of rapid HIV testing in an urban walk-in clinic.

Is there a correlation between physicians' clinical impressions and patients' perceptions of change? Use of the Perceived Change Scale with inpatients with mental disorders.

PubMed

Pavan, Gabriela; Godoy, Julia Almeida; Monteiro, Ricardo Tavares; Moreschi, Hugo Karling; Nogueira, Eduardo Lopes; Spanemberg, Lucas

2016-01-01

Assessment of the results of treatment for mental disorders becomes more complete when the patient's perspective is incorporated. Here, we aimed to evaluate the psychometric properties and application of the Perceived Change Scale - Patient version (PCS-P) in a sample of inpatients with mental disorders. One hundred and ninety-one psychiatric inpatients answered the PCS-P and the Patients' Satisfaction with Mental Health Services Scale (SATIS) and were evaluated in terms of clinical and sociodemographic data. An exploratory factor analysis (EFA) was performed and internal consistency was calculated. The clinical impressions of the patient, family, and physician were correlated with the patient's perception of change. The EFA indicated a psychometrically suitable four-factor solution. The PCS-P exhibited a coherent relationship with SATIS and had a Cronbach's alpha value of 0.856. No correlations were found between the physician's clinical global impression of improvement and the patient's perception of change, although a moderate positive correlation was found between the patients' clinical global impression of improvement and the change perceived by the patient. The PCS-P exhibited adequate psychometric proprieties in a sample of inpatients with mental disorders. The patient's perception of change is an important dimension for evaluation of outcomes in the treatment of mental disorders and differs from the physician's clinical impression of improvement. Evaluation of positive and negative perceptions of the various dimensions of the patient's life enables more precise consideration of the patient's priorities and interests.

Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials

PubMed Central

Mitchell, Sandra A.; Dueck, Amylou C.; Basch, Ethan; Cella, David; Reilly, Carolyn Miller; Minasian, Lori M.; Denicoff, Andrea M.; O’Mara, Ann M.; Fisch, Michael J.; Chauhan, Cynthia; Aaronson, Neil K.; Coens, Corneel; Bruner, Deborah Watkins

2014-01-01

Background The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). Methods We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001–2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. Results We recommend that a core set of 12 symptoms—specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea—be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. Conclusions This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies. PMID:25006191

Vocal fold pseudocyst: results of 46 cases undergoing a uniform treatment algorithm.

PubMed

Estes, Christine; Sulica, Lucian

2014-05-01

To describe treatment results and identify predictors of the need for surgical intervention in patients with vocal fold pseudocyst. Retrospective cohort study with longitudinal followup via survey. Clinical records were reviewed for demographic information, VHI-10 score, and degree of severity of dysphonia. Videostroboscopic examinations were evaluated for presence of vocal fold pseudocyst, along with additional clinical variables, including laterality, reactive lesion, paresis, varix, and hemorrhage. Follow-up surveys were sent to all participants to evaluate current VHI-10 score and degree of vocal limitation. Results were analyzed to determine predictors of surgery and recurrence of pathology. Forty-six patients (41F:5M) with pseudocyst (40 unilateral: 6 bilateral) were reviewed. Twenty-three (50%) had reactive lesions, nineteen (41%) had paresis by clinical criteria, 10 (22%) had varices, and 6 (13%) had hemorrhage on examination. All underwent initial behavioral management (2-12 sessions of voice therapy; mean of 8 sessions). Seventeen (37%) eventually required surgical intervention. No demographic or clinical variables proved predictive of surgical intervention. Follow-up surveys were completed by 63% of patients, and 79% agreed with the statement that they were not professionally limited by their voices. This experience supports behavioral management as an initial intervention in patients with pseudocyst, sufficient by itself to restore vocal function in approximately two out of three patients. Neither initial severity nor any of the studied clinical findings predicted the need for surgery. The large majority of patients with pseudocyst are able to be treated effectively without impact in their professional function. © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

QIN. Early experiences in establishing a regional quantitative imaging network for PET/CT clinical trials

PubMed Central

Doot, Robert K.; Thompson, Tove; Greer, Benjamin E.; Allberg, Keith C.; Linden, Hannah M.; Mankoff, David A.; Kinahan, Paul E.

2012-01-01

The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging is a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients. PMID:22795929

[Freiburg keratoconus registry : Example of application of smart data for clinical research and inititial results].

PubMed

Lang, S J; Böhringer, D; Reinhard, T

2016-06-01

Keratoconus is a progressive corneal disease with thinning and scarring of the cornea. Diagnostic and treatment options are usually evaluated in large prospective or retrospective trials. Big data and smart data provide the possibility to analyze routine data for clinical research. In this article we report the generation of a monocentric keratoconus registry by means of computerized data analysis of routine data. This demonstrates the potential of clinical research by means of routine data. A "clinical data warehouse" was created from all available routine electronic data. At the time of first presentation, each eye was classified into one out of four categories: suspected, early disease, late disease and status postkeratoplasty. Through integration of multiple data sources the clinical course for each patient was documented in the registry. A total of 3681 eyes from 1841 patients were included. The median follow-up time was 0.54 years. Patient age was higher in the groups with more severe stages of keratoconus, the proportion of female patients was higher in the group of suspected keratoconus and patient age and male to female ratios showed statistically significant differences between the groups (p < 0.001). We were able to create a "clinical data warehouse" by linking multiple data sources and normalizing the data. With this tool we established a novel, monocentric keratoconus registry. Only the grading of disease severity and the exclusion of false positive results were carried out manually. In our opinion establishing a structured clinical data warehouse has a huge potential for clinical and retrospective studies and proves the value of the Smart Data concept.

Early experiences in establishing a regional quantitative imaging network for PET/CT clinical trials.

PubMed

Doot, Robert K; Thompson, Tove; Greer, Benjamin E; Allberg, Keith C; Linden, Hannah M; Mankoff, David A; Kinahan, Paul E

2012-11-01

The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging are a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing the feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed, and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients. Copyright © 2012 Elsevier Inc. All rights reserved.

Sjögren's syndrome patients presenting with hypergammaglobulinemia are relatively unresponsive to cevimeline treatment.

PubMed

Komai, Koichiro; Shiozawa, Kazuko; Tanaka, Yasushi; Yoshihara, Ryosuke; Tanaka, Chihiro; Sakai, Hideo; Yamane, Takashi; Murata, Miki; Tsumiyama, Ken; Hashiramoto, Akira; Shiozawa, Shunichi

2009-01-01

Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by sicca symptoms, including dry eyes and dry mouth. Cevimeline is used for the treatment of dry mouth in patients with SS. Here we prospectively tested the clinical effectiveness of cevimeline at increasing saliva secretion in patients with SS, and the results were compared with the clinical parameters of the patients. Saliva secretion was increased >160% in 17 of 30 (56.7%) patients (P < 0.005). When the clinical parameters were compared between the patients who responded to cevimeline treatment and those who did not respond to the treatment, the frequency of patients presenting with hypergammaglobulinemia was significantly higher in the nonresponder group (P < 0.05). It thus appears that cevimeline is effective in SS patients with milder disease activity.

Medical paraclinical standards, political economy of clinic, and patients' clinical dependency; a critical conversation analysis of clinical counseling in South of iran.

PubMed

Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

2014-07-01

Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. RESULTS show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Although we can't condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can't reduce it to instrumental and linear methods of body treatment.

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey

PubMed Central

Smith, Sophia K.; Selig, Wendy; Harker, Matthew; Roberts, Jamie N.; Hesterlee, Sharon; Leventhal, David; Klein, Richard; Patrick-Lake, Bray; Abernethy, Amy P.

2015-01-01

Objective Patient-centered clinical trial design and execution is becoming increasingly important. No best practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed. Methods Individuals from industry, academic institutions, and patient groups were identified through Clinical Trials Transformation Initiative and Drug Information Association rosters and mailing lists. Objectives, practices, and perceived barriers related to engaging patient groups in the planning, conduct, and interpretation of clinical trials were reported in an online survey. Descriptive and inferential statistical analysis of survey data followed a literature review to inform survey questions. Results Survey respondents (n = 179) valued the importance of involving patient groups in research; however, patient group respondents valued their contributions to research protocol development, funding acquisition, and interpretation of study results more highly than those contributions were valued by industry and academic respondents (all p < .001). Patient group respondents placed higher value in open communications, clear expectations, and detailed contract execution than did non–patient group respondents (all p < .05). Industry and academic respondents more often cited internal bureaucratic processes and reluctance to share information as engagement barriers than did patient group respondents (all p < .01). Patient groups reported that a lack of transparency and understanding of the benefits of collaboration on the part of industry and academia were greater barriers than did non–patient group respondents (all p< .01). Conclusions Despite reported similarities among approaches to engagement by the three stakeholder groups, key differences exist in perceived barriers and benefits to partnering with patient groups among the sectors studied. This recognition could inform the development of best practices for patient-centered clinical trial design and execution. Additional research is needed to define and optimize key success factors. PMID:26465328

Simulating clinical trial visits yields patient insights into study design and recruitment.

PubMed

Lim, S Sam; Kivitz, Alan J; McKinnell, Doug; Pierson, M Edward; O'Brien, Faye S

2017-01-01

We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention. Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE)/lupus nephritis (LN) were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits. The Atlanta study involved 6 African-American patients (5 female) aged 27-60 years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32-75 years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1) information, communication, and education; 2) responsiveness to needs; 3) access to care; and 4) coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in discussing SLE, emphasis on transportation and child care help during the visits, and concerns related to financial matters; and they placed greater importance on time commitment, understanding of potential personal benefit, trust, and confidentiality of patient data as factors for participation. Using these results, we present recommendations to improve study procedures to increase retention, recruitment, and compliance for clinical trials. Insights from these two studies can be applied to the development and implementation of future clinical trials to improve patient recruitment, retention, compliance, and advocacy.

Outcome-centered antiepileptic therapy: Rate, rhythm and relief.: Implementing AAN Epilepsy Quality Measures in clinical practice.

PubMed

D'Cruz, O'Neill

2015-12-01

Clinicians who manage patients with epilepsy are expected to assess the relevance of clinical trial results to their practice, integrate new treatments into the care algorithm, and implement epilepsy quality measures, with the overall goal of improving patient outcomes. A disease-based clinical framework that helps with choice and combinations of interventions facilitates provision of efficient, cost-effective, and high-quality care. This article addresses the current conceptual framework that informs clinical evaluation of epilepsy, explores gaps between development of treatment options, quality measures and clinical goals, and proposes an outcome-centered approach that bridges these gaps with the aim of improving patient and population-level clinical outcomes in epilepsy. Copyright © 2015 The Author. Published by Elsevier Inc. All rights reserved.

How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials.

PubMed

Bonnetain, F; Borg, C; Adams, R R; Ajani, J A; Benson, A; Bleiberg, H; Chibaudel, B; Diaz-Rubio, E; Douillard, J Y; Fuchs, C S; Giantonio, B J; Goldberg, R; Heinemann, V; Koopman, M; Labianca, R; Larsen, A K; Maughan, T; Mitchell, E; Peeters, M; Punt, C J A; Schmoll, H J; Tournigand, C; de Gramont, A

2017-09-01

Traditionally, the efficacy of cancer treatment in patients with advance or metastatic disease in clinical studies has been studied using overall survival and more recently tumor-based end points such as progression-free survival, measurements of response to treatment. However, these seem not to be the relevant clinical end points in current situation if such end points were no validated as surrogate of overall survival to demonstrate the clinical efficacy. Appropriate, meaningful, primary patient-oriented and patient-reported end points that adequately measure the effects of new therapeutic interventions are then crucial for the advancement of clinical research in metastatic colorectal cancer to complement the results of tumor-based end points. Health-related quality of life (HRQoL) is effectively an evaluation of quality of life and its relationship with health over time. HRQoL includes the patient report at least of the way a disease or its treatment affects its physical, emotional and social well-being. Over the past few years, several phase III trials in a variety of solid cancers have assessed the incremental value of HRQoL in addition to the traditional end points of tumor response and survival results. HRQoL could provide not only complementary clinical data to the primary outcomes, but also more precise predictive and prognostic value. This end point is useful for both clinicians and patients in order to achieve the dogma of precision medicine. The present article examines the use of HRQoL in phase III metastatic colorectal cancer clinical trials, outlines the importance of HRQoL assessment methods, analysis, and results presentation. Moreover, it discusses the relevance of including HRQoL as a primary/co-primary end point to support the progression-free survival results and to assess efficacy of treatment in the advanced disease setting. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Concurrent Alzheimer's pathology in patients with clinical normal pressure hydrocephalus: correlation of high-volume lumbar puncture results, cortical brain biopsies, and outcomes.

PubMed

Pomeraniec, I Jonathan; Bond, Aaron E; Lopes, M Beatriz; Jane, John A

2016-02-01

Normal pressure hydrocephalus (NPH) remains most often a clinical diagnosis and has been widely considered responsive to the placement of a cerebrospinal fluid (CSF) shunt. The high incidence of patients with Alzheimer's disease (AD) with NPH symptoms leads to poorer outcomes than would be expected in patients with NPH alone. This article reviews a series of patients operated on for presumed NPH in whom preoperative high-volume lumbar puncture (HVLP) and intraoperative cortical brain biopsies were performed. The data derived from these procedures were then used to understand the incidence of AD in patients presenting with NPH symptoms and to analyze the efficacy of HVLP in patients with NPH and patients with concurrent AD (NPH+AD). A review of the outcomes of shunt surgery is provided. The cases of all patients who underwent placement of a CSF shunt for NPH from 1998 to 2013 at the University of Virginia by the senior author were retrospectively reviewed. Patients who underwent HVLP and patients who underwent cortical brain biopsies were stratified based on the biopsy results into an NPH-only group and an NPH+AD group. The HVLP results and outcomes were then compared in these 2 groups. From 1998 to 2013, 142 patients underwent shunt operations because of a preoperative clinical diagnosis of NPH. Of the patients with a shunt who had a diagnosis of NPH, 105 (74%) received HVLPs. Of 142 shunt-treated patients with NPH, 27 (19%) were determined to have concomitant Alzheimer's pathology based on histopathological findings at the time of shunting. Patients who underwent repeat biopsies had an initial positive outcome. After they clinically deteriorated, they underwent repeat biopsies during shunt interrogation, and 13% of the repeat biopsies demonstrated Alzheimer's pathology. Improvements in gait and cognition did not reach significance between the NPH and NPH+AD groups. In total, 105 patients underwent HVLP before shunt placement. In the NPH cohort, 44.6% of patients experienced improvement in symptoms with HVLP and went on to experience resolution or improvement. In the NPH+AD cohort, this proportion was lower (18.2%), and the majority of patients who experienced symptomatic relief with HVLP actually went on to experience either no change or worsening of symptoms (p = 0.0136). A high prevalence of AD histopathological findings (19%) occurred in patients treated with shunts for NPH based on cortical brain biopsies performed during placement of CSF shunts. HVLP results alone were not predictive of clinical outcome. However, cortical brain biopsy results and the presence of Alzheimer's pathology had a strong correlation with success after CSF shunting. Thirteen percent of patients who initially had a normal cortical brain biopsy result had evidence of AD pathology on repeat biopsy, demonstrating the progressive nature of the disease.

Association Between Nursing Diagnoses and Socioeconomic/Clinical Characteristics of Patients on Hemodialysis.

PubMed

Frazão, Cecília Maria Farias de Queiroz; de Sá, Jéssica Dantas; de Paiva, Maria das Graças Mariano Nunes; Lira, Ana Luisa Brandão de Carvalho; Lopes, Marcos Venícios de Oliveira; Enders, Bertha Cruz

2015-07-01

To analyze the association between nursing diagnoses and socioeconomic/clinical characteristics of patients on hemodialysis. Cross-sectional study conducted by means of interview and physical examination of 178 patients consecutively selected. Nursing diagnoses within the NANDA-I domains of health promotion, nutrition, activity/rest, perception/cognition, sexuality, safety/protection, and comfort presented statistically significant association with the socioeconomic/clinical data of age, education, sex, marital status, and duration of the chronic renal disease and hemodialysis. The nursing diagnoses in this population may be influenced by the socioeconomic/clinical data. The results suggest an opportunity for improved nursing intervention in this community. © 2014 NANDA International, Inc.

The cost of implementing rapid HIV testing in sexually transmitted disease clinics in the United States.

PubMed

Eggman, Ashley A; Feaster, Daniel J; Leff, Jared A; Golden, Matthew R; Castellon, Pedro C; Gooden, Lauren; Matheson, Tim; Colfax, Grant N; Metsch, Lisa R; Schackman, Bruce R

2014-09-01

Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected. We determined the cost to sexually transmitted disease (STD) clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in 2010. Costs included counselor and trainer time, supplies, and clinic overhead. We applied national labor rates and test costs. We calculated median clinic start-up costs and mean cost per patient tested, and projected incremental annual costs of implementing universal rapid HIV testing compared with current testing practices. Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial. Rapid HIV testing cost an average of US $22/patient without brief risk reduction counseling and US $46/patient with counseling in these 7 clinics. Median start-up costs per clinic were US $1100 and US $16,100 without and with counseling, respectively. Estimated incremental annual costs per clinic of implementing universal rapid HIV testing varied by whether or not brief counseling is conducted and by current clinic testing practices, ranging from a savings of US $19,500 to a cost of US $40,700 without counseling and a cost of US $98,000 to US $153,900 with counseling. Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics, if brief risk reduction counseling is not offered.

Automated matching software for clinical trials eligibility: measuring efficiency and flexibility.

PubMed

Penberthy, Lynne; Brown, Richard; Puma, Federico; Dahman, Bassam

2010-05-01

Clinical trials (CT) serve as the media that translates clinical research into standards of care. Low or slow recruitment leads to delays in delivery of new therapies to the public. Determination of eligibility in all patients is one of the most important factors to assure unbiased results from the clinical trials process and represents the first step in addressing the issue of under representation and equal access to clinical trials. This is a pilot project evaluating the efficiency, flexibility, and generalizibility of an automated clinical trials eligibility screening tool across 5 different clinical trials and clinical trial scenarios. There was a substantial total savings during the study period in research staff time spent in evaluating patients for eligibility ranging from 165h to 1329h. There was a marked enhancement in efficiency with the automated system for all but one study in the pilot. The ratio of mean staff time required per eligible patient identified ranged from 0.8 to 19.4 for the manual versus the automated process. The results of this study demonstrate that automation offers an opportunity to reduce the burden of the manual processes required for CT eligibility screening and to assure that all patients have an opportunity to be evaluated for participation in clinical trials as appropriate. The automated process greatly reduces the time spent on eligibility screening compared with the traditional manual process by effectively transferring the load of the eligibility assessment process to the computer. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Clinical magnification and residual refraction after implantation of a double intraocular lens system in patients with macular degeneration.

PubMed

Amselem, Luis; Diaz-Llopis, Manuel; Felipe, Adelina; Artigas, Jose M; Navea, Amparo; García-Delpech, Salvador

2008-09-01

To evaluate the efficacy of a standard double intraocular lens (IOL) system (IOL-Vip) in patients with low vision and central scotoma due to macular degeneration and assess the predictability of the residual refraction and magnification. Ophthalmology Department, Hospital General Universitario, Valencia, Spain. This interventional prospective noncomparative case series comprised 13 consecutive surgical procedures in 10 patients with central scotoma. Follow-up was 12 months. Evaluation included the difference between preoperative and postoperative best corrected visual acuity (BCVA), refraction, position of the IOLs, endothelial cell density, and occurrence of postoperative complications. Residual refraction and eye magnification were calculated using a theory developed in a previous study, and the values were compared with the clinical results. The mean BCVA was 1.37 logMAR preoperatively and 0.68 logMAR 1 year postoperatively. The mean best corrected clinical gain was 44%. There was no statistically significant difference between the clinically evaluated and theoretically calculated residual refractions (P = .17). No intraoperative or postoperative complications occurred. Implantation of the double IOL system improved BCVA in patients with low vision due to advanced maculopathy. The results were best in myopic patients (long eyes); patients with hyperopia (short eyes) had high residual refraction. The postoperative clinical gain and residual refraction were predictable, showing the feasibility of implanting a customized double IOL.

Decision making by patients with breast cancer: the role of information in treatment selection.

PubMed

Hughes, K K

1993-05-01

In recent years, patients have become more involved in the clinical decision-making process, yet the nature of this process, including the role of information, is poorly understood. The purpose of this exploratory study was to examine the relationship between information about breast cancer treatment alternatives and patients' choices of treatments. The target population was all patients with breast cancer in the process of deciding between breast conservation (lumpectomy plus irradiation) and more traditional management (modified radical mastectomy, with or without reconstruction). A convenience sample of 71 female patients with stage I or II breast cancer was drawn from a breast clinic affiliated with a 1,000-bed tertiary medical center. The amount of information provided to each subject and the nature of its presentation were recorded using an observer checklist. Recall of information and final treatment selection were ascertained during telephone interviews conducted six to eight weeks after surgery. The results indicate that subjects' choice of treatment was unrelated to the amount of information they received during the clinic visit. Manner of presentation also did not influence treatment selection. However, treatment selection was related to the amount of information subjects received prior to their clinic visit (p < 0.01). The results also indicate that patients' recall of information about treatments and associated risks is exceedingly poor. Clinical and legal implications are discussed and recommendations for further research are offered in this article.

Ablation effects of noninvasive radiofrequency field-induced hyperthermia on liver cancer cells.

PubMed

Chen, Kaiyun; Zhu, Shuguang; Xiang, Guoan; Duan, Xiaopeng; He, Jiwen; Chen, Guihua

2016-05-01

To have in-depth analysis of clinical ablation effect of noninvasive radiofrequency field-induced hyperthermia on liver cancer cells, this paper collected liver cancer patients' treatment information from 10 hospitals during January 2010 and December 2011, from which 1050 cases of patients were randomly selected as study object of observation group who underwent noninvasive radiofrequency field-induced hyperthermia treatment; in addition, 500 cases of liver cancer patients were randomly selected as study object of control group who underwent clinical surgical treatment. After treatment was completed, three years of return visit were done, survival rates of the two groups of patients after 1 year, 2 years, and 3 years were compared, and clinical effects of radiofrequency ablation of liver cancer were evaluated. Zoom results show that the two groups are similar in terms of survival rate, and the difference is without statistical significance. 125 patients in observation group had varying degrees of adverse reactions, while 253 patients in control group had adverse reactions. There was difference between groups P < 0.05, with significant statistical significance. It can be concluded that radiofrequency ablation of liver cancer is more secure. Therefore, the results of this study fully demonstrate that liver cancer treatment with noninvasive radiofrequency field-induced hyperthermia is with safety effect and satisfactory survival rate, thus with relatively high clinical value in clinical practice.

Use of the Ion PGM and the GeneReader NGS Systems in Daily Routine Practice for Advanced Lung Adenocarcinoma Patients: A Practical Point of View Reporting a Comparative Study and Assessment of 90 Patients.

PubMed

Heeke, Simon; Hofman, Véronique; Long-Mira, Elodie; Lespinet, Virginie; Lalvée, Salomé; Bordone, Olivier; Ribeyre, Camille; Tanga, Virginie; Benzaquen, Jonathan; Leroy, Sylvie; Cohen, Charlotte; Mouroux, Jérôme; Marquette, Charles Hugo; Ilié, Marius; Hofman, Paul

2018-03-21

Background : With the integration of various targeted therapies into the clinical management of patients with advanced lung adenocarcinoma, next-generation sequencing (NGS) has become the technology of choice and has led to an increase in simultaneously interrogated genes. However, the broader adoption of NGS for routine clinical practice is still hampered by sophisticated workflows, complex bioinformatics analysis and medical interpretation. Therefore, the performance of the novel QIAGEN GeneReader NGS system was compared to an in-house ISO-15189 certified Ion PGM NGS platform. Methods : Clinical samples from 90 patients (60 Retrospectively and 30 Prospectively) with lung adenocarcinoma were sequenced with both systems. Mutations were analyzed and EGFR , KRAS , BRAF , NRAS , ALK , PIK3CA and ERBB2 genes were compared and sampling time and suitability for clinical testing were assessed. Results : Both sequencing systems showed perfect concordance for the overlapping genes. Correlation of allele frequency was r ² = 0.93 for the retrospective patients and r ² = 0.81 for the prospective patients. Hands-on time and total run time were shorter using the PGM system, while the GeneReader platform provided good traceability and up-to-date interpretation of the results. Conclusion : We demonstrated the suitability of the GeneReader NGS system in routine practice in a clinical pathology laboratory setting.

Clinical manifestations of Clostridium difficile infection in a medical center in Taiwan.

PubMed

Lai, Chih-Cheng; Lin, Sheng-Hsiang; Tan, Che-Kim; Liao, Chun-Hsing; Huang, Yu-Tsung; Hsueh, Po-Ren

2014-12-01

To investigate the clinical characteristics of Clostridium difficile infection (CDI) at a medical center in Taiwan. Patients with CDI were identified from medical records at the National Taiwan University Hospital (Taipei, Taiwan). The following information was gathered and analyzed to better understand the clinical manifestations of CDI: age; sex; underlying immunocompromised conditions; laboratory data; in-hospital mortality; and previous use of drugs such as antimicrobial agents, steroids, and antipeptic ulcer agents. During the years 2000-2010, 122 patients were identified as having CDI. This included 92 patients with nontoxigenic CDI (i.e., positive stool culture for C. difficile but negative results for toxins A and B) and 30 patients with toxigenic CDI (i.e., positive stool culture cultures for C. difficile and positive results for toxins A and B). Of the 122 patients, 48 (39%) patients were older than 65 years and most patients acquired the CDI while in the hospital. Active cancer was the most common reason for hospitalization, followed by diabetes mellitus, and end-stage renal disease. More than 90% of the patients had received antibiotics before acquiring CDI. The results of fecal leukocyte examinations were positive in 33 (27%) patients. The overall in-hospital mortality rate was 26.2%. There were no significant differences between patients with nontoxigenic CDI and patients with toxigenic CDI. Clostridium difficile infection can develop in healthcare facilities and in community settings, especially in immunocompromised patients. Copyright © 2013. Published by Elsevier B.V.

Developing a Tool for Increasing the Awareness about Gendered and Intersectional Processes in the Clinical Assessment of Patients – A Study of Pain Rehabilitation

PubMed Central

Hammarström, Anne; Wiklund, Maria; Stålnacke, Britt-Marie; Lehti, Arja; Haukenes, Inger; Fjellman-Wiklund, Anncristine

2016-01-01

Objective There is a need for tools addressing gender inequality in the everyday clinical work in health care. The aim of our paper was to develop a tool for increasing the awareness of gendered and intersectional processes in clinical assessment of patients, based on a study of pain rehabilitation. Methods In the overarching project named “Equal care in rehabilitation” we used multiple methods (both quantitative and qualitative) in five sub studies. With a novel approach we used Grounded Theory in order to synthesize the results from our sub studies, in order to develop the gender equality tool. The gender equality tool described and developed in this article is thus based on results from sub studies about the processes of assessment and selection of patients in pain rehabilitation. Inspired by some questions in earlier tools, we posed open ended questions and inductively searched for findings and concepts relating to gendered and social selection processes in pain rehabilitation, in each of our sub studies. Through this process, the actual gender equality tool was developed as 15 questions about the process of assessing and selecting patients to pain rehabilitation. As a more comprehensive way of understanding the tool, we performed a final step of the GT analyses. Here we synthesized the results of the tool into a comprehensive model with two dimensions in relation to several possible discrimination axes. Results The process of assessing and selecting patients was visualized as a funnel, a top down process governed by gendered attitudes, rules and structures. We found that the clinicians judged inner and outer characteristics and status of patients in a gendered and intersectional way in the process of clinical decision-making which thus can be regarded as (potentially) biased with regard to gender, socio-economic status, ethnicity and age. Implications The clinical implications of our tool are that the tool can be included in the systematic routine of clinical assessment of patients for both awareness raising and as a base for avoiding gender bias in clinical decision-making. The tool could also be used in team education for health professionals as an instrument for critical reflection on gender bias. Conclusions Thus, tools for clinical assessment can be developed from empirical studies in various clinical settings. However, such a micro-level approach must be understood from a broader societal perspective including gender relations on both the macro- and the meso-level. PMID:27055029

Granulomatous Mastitis: A Ten-Year Experience at a University Hospital.

PubMed

Korkut, Ercan; Akcay, Mufide Nuran; Karadeniz, Erdem; Subasi, Irmak Durur; Gursan, Nesrin

2015-10-01

In this study we aimed to define clinical, radiologic and pathological specialties of patients who applied to General Surgery Department of Atatürk University Medical Faculty with granulomatous mastitis and show medical and surgical treatment results. With the help of this study we will be able to make our own clinical algorithm for diagnosis and treatment. We searched retrospectively addresses, phone numbers and clinical files of 93 patients whom diagnosed granulomatous mastitis between a decade of January 2001 - December 2010. We noted demographic specialties, ages, gender, medical family history, main complaints, physical findings, radiological and laboratory findings, medical treatments, postoperative complications and surgical procedures if they were operated; morbidity, recurrence and success ratios, complications after treatment for patients discussed above. In this study we evaluated 93 patients, 91 females and 2 males, with granulomatous mastitis retrospectively who applied to General Surgery Department of Atatürk University Medical Faculty between January 2001 and December 2010. Mean age was 34.4 years. The diagnosis was confirmed by histopathologic examination of the lesions. Seventy three patients had idiopathic granulomatous lobular mastitis and 20 patients had specific granulomatous mastitis IGM (18 tuberculosis mastitis, 1 alveolar echinococcosis and 1 silk reaction). All the patients had surgical debridement or antibiotic, and anti-inflammatory treatment with results bad clinical response before applied our clinic. Empiric antibiotic therapy and drainage of the breast lesions are not enough for complete remission of idiopathic granulomatous mastitis. The lesion must be excised completely. In selected patients, corticosteroid therapy can be useful. In the patients with tuberculous mastitis, abscess drainage and antituberculous therapy can be useful, but wide excision must be chosen for the patients with recurrent disease.

The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial.

PubMed

Morso, Lars; Schiøttz-Christensen, Berit; Søndergaard, Jens; Andersen, Nils-Bo de Vos; Pedersen, Flemming; Olsen, Kim Rose; Jensen, Morten Sall; Hill, Jonathan; Christiansen, David Høyrup

2018-06-08

Prior studies indicate that stratified care for low back pain results in better clinical outcome and reduced costs in healthcare compared to current practice. Stratified care may be associated with clinical benefits for patients with low back pain at a lower cost, but evidence is sparse. Hence this study aims to evaluate the clinical effects and cost-effectiveness of stratified care in patients with non-specific low back pain compared to current practice. The study is a two-armed randomised controlled trial in primary care in the Regions of Southern and Central Denmark (2.5 million citizens). Patients with non-specific low back will be recruited by paticpating GPs. Patients are randomised to either (1) stratified care or (2) current practice at participating physiotherapy clinics. In the stratified care arm, the intervention is based on the patient's STarT Back Tool classification and trained accordingly, whereas physiotherapists in the current pratice arm are blinded to the STarT score. Primary outcomes in the trial will be group differences in time off work, improvement in LBP disability measured by the Roland Morris Disability Questionnaire (RMDQ) and patient-reported global change. Secondary measures will be pain intensity, patient satisfaction, data on patient healthcare resource utilisation and quality-adjusted life year based on the EQ-5D-5L. Stratified care that effectively targets treatment to relevant sub-groups of patients has potentially great impact on the treatment pathways of low back pain. Thus, if effective, this could result in better patient outcomes and at the same time reduce the costs for treatment of low back pain. ClinicalTrials.gov , NCT02612467 . Registered on 16 November 2015.

Strengthening Health Systems at Facility-Level: Feasibility of Integrating Antiretroviral Therapy into Primary Health Care Services in Lusaka, Zambia

PubMed Central

Topp, Stephanie M.; Chipukuma, Julien M.; Giganti, Mark; Mwango, Linah K.; Chiko, Like M.; Tambatamba-Chapula, Bushimbwa; Wamulume, Chibesa S.; Reid, Stewart

2010-01-01

Introduction HIV care and treatment services are primarily delivered in vertical antiretroviral (ART) clinics in sub-Saharan Africa but there have been concerns over the impact on existing primary health care services. This paper presents results from a feasibility study of a fully integrated model of HIV and non-HIV outpatient services in two urban Lusaka clinics. Methods Integration involved three key modifications: i) amalgamation of space and patient flow; ii) standardization of medical records and iii) introduction of routine provider initiated testing and counseling (PITC). Assessment of feasibility included monitoring rates of HIV case-finding and referral to care, measuring median waiting and consultation times and assessing adherence to clinical care protocols for HIV and non-HIV outpatients. Qualitative data on patient/provider perceptions was also collected. Findings Provider and patient interviews at both sites indicated broad acceptability of the model and highlighted a perceived reduction in stigma associated with integrated HIV services. Over six months in Clinic 1, PITC was provided to 2760 patients; 1485 (53%) accepted testing, 192 (13%) were HIV positive and 80 (42%) enrolled. Median OPD patient-provider contact time increased 55% (6.9 vs. 10.7 minutes; p<0.001) and decreased 1% for ART patients (27.9 vs. 27.7 minutes; p = 0.94). Median waiting times increased by 36 (p<0.001) and 23 minutes (p<0.001) for ART and OPD patients respectively. In Clinic 2, PITC was offered to 1510 patients, with 882 (58%) accepting testing, 208 (24%) HIV positive and 121 (58%) enrolled. Median OPD patient-provider contact time increased 110% (6.1 vs. 12.8 minutes; p<0.001) and decreased for ART patients by 23% (23 vs. 17.7 minutes; p<0.001). Median waiting times increased by 47 (p<0.001) and 34 minutes (p<0.001) for ART and OPD patients, respectively. Conclusions Integrating vertical ART and OPD services is feasible in the low-resource and high HIV-prevalence setting of Lusaka, Zambia. Integration enabled shared use of space and staffing that resulted in increased HIV case finding, a reduction in stigma associated with vertical ART services but resulted in an overall increase in patient waiting times. Further research is urgently required to assess long-term clinical outcomes and cost effectiveness in order to evaluate scalability and generalizability. PMID:20644629

[Study on flomoxef in the perinatal period].

PubMed

Tamate, K; Sengoku, K; Ishikawa, M; Shimizu, T; Haga, H; Hasegawa, T; Takada, H; Mure, K; Kawamura, M; Torii, Y

1991-06-01

The placental passage and the the therapeutic efficacy of flomoxef (FMOX, 6315-S) were studied in patients in the perinatal period. A summary of the obtained results is as follows: 1. Concentrations of FMOX in maternal serum, umbilical cord serum and amniotic fluid obtained upon one-shot intravenous injections to 12 patients were compared with those obtained upon 1 hour drip infusions to 9 patients. It was found that the former means of administration gave higher concentrations that the latter. 2. Concentrations of FMOX in maternal serum, umbilical cord serum and amniotic fluid at 1 to 6 hours after administration through either method were all higher than MIC80's of recognized bacteria. 3. Clinical efficacies were evaluated in 10 patients with puerperal intrauterine infection, 7 patients with endometritis, 2 patients with pyelonephritis and 1 patient each with endo-cervicitis, amniotic fluid infection, mastitis and perineal wound infection. Clinical efficacies were excellent in 5 patients (21.7%), good in 17 patients (73.9%) and poor in 1 patient (4.4%), thus the overall efficacy rate was 95.7%. 4. Eradication of causative bacteria were obtained in all 8 cases tested, hence the eradication rate was 100%. 5. Mild diarrhea in 1 patient was the only side effect observed. No abnormal clinical laboratory test results were found in any patients.

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.

Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study.

PubMed

Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

2017-01-27

Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Implementation issues relevant to outpatient neurology palliative care.

PubMed

Kluger, Benzi M; Persenaire, Michael J; Holden, Samantha K; Palmer, Laura T; Redwine, Hannah; Berk, Julie; Anderson, C Alan; Filley, Christopher M; Kutner, Jean; Miyasaki, Janis; Carter, Julie

2017-11-29

There is growing interest in the application of palliative care principles to improve care for patients and families affected by neurologic diseases. We developed an interdisciplinary outpatient clinic for patients and families affected by neurologic disorders to better address the problems faced by our highest need patients. We have developed and improved this program over the past three years and share several of our most important lessons as well as ongoing challenges and areas where we see our clinic evolving in the future. We provide a description of our clinic logistics, including key steps in the initiation of the clinic, and provide descriptions from similar clinics at other institutions to demonstrate some of the variability in this growing field. We also provide results from a formal one-year quality improvement project and a one-year retrospective study of patients attending this clinic. Our clinic has grown steadily since its inception and maintains high satisfaction ratings from patients, caregivers, and referring providers. To maintain standardized and efficient care we have developed materials for patients and referring physicians as well as checklists and other processes used by our interdisciplinary team. Feedback from our quality improvement project helped define optimal visit duration and refine communication among team members and with patients and families. Results from our chart review suggest our clinic influences advance care planning and place of death. Common referral reasons include psychosocial support, complex symptom management, and advance care planning. Current challenges for our clinic include developing a strategy for continued growth, creating a sustainable financial model for interdisciplinary care, integrating our services with disease-specific sections, improving primary palliative care knowledge and skills within our referral base, and building effective alliances with community neurologists, geriatrics, primary care, nursing homes, and hospices. Specialized outpatient palliative care for neurologic disorders fills several important gaps in care for this patient population, provides important educational opportunities for trainees, and creates opportunities for patient and caregiver-centered research. Educational initiatives are needed to train general neurologists in primary palliative care, to train neurologists in specialist palliative care, and to train palliative medicine specialists in neurology. Research is needed to build an evidence base to identify patient and caregiver needs, support specific interventions, and to build more efficient models of care in both academic and community settings.

Comprehensive molecular diagnosis of 179 Leber congenital amaurosis and juvenile retinitis pigmentosa patients by targeted next generation sequencing

PubMed Central

Wang, Xia; Wang, Hui; Sun, Vincent; Tuan, Han-Fang; Keser, Vafa; Wang, Keqing; Ren, Huanan; Lopez, Irma; Zaneveld, Jacques E; Siddiqui, Sorath; Bowles, Stephanie; Khan, Ayesha; Salvo, Jason; Jacobson, Samuel G; Iannaccone, Alessandro; Wang, Feng; Birch, David; Heckenlively, John R; Fishman, Gerald A; Traboulsi, Elias I; Li, Yumei; Wheaton, Dianna; Koenekoop, Robert K; Chen, Rui

2014-01-01

Background Leber congenital amaurosis (LCA) and juvenile retinitis pigmentosa (RP) are inherited retinal diseases that cause early onset severe visual impairment. An accurate molecular diagnosis can refine the clinical diagnosis and allow gene specific treatments. Methods We developed a capture panel that enriches the exonic DNA of 163 known retinal disease genes. Using this panel, we performed targeted next generation sequencing (NGS) for a large cohort of 179 unrelated and prescreened patients with the clinical diagnosis of LCA or juvenile RP. Systematic NGS data analysis, Sanger sequencing validation, and segregation analysis were utilised to identify the pathogenic mutations. Patients were revisited to examine the potential phenotypic ambiguity at the time of initial diagnosis. Results Pathogenic mutations for 72 patients (40%) were identified, including 45 novel mutations. Of these 72 patients, 58 carried mutations in known LCA or juvenile RP genes and exhibited corresponding phenotypes, while 14 carried mutations in retinal disease genes that were not consistent with their initial clinical diagnosis. We revisited patients in the latter case and found that homozygous mutations in PRPH2 can cause LCA/juvenile RP. Guided by the molecular diagnosis, we reclassified the clinical diagnosis in two patients. Conclusions We have identified a novel gene and a large number of novel mutations that are associated with LCA/juvenile RP. Our results highlight the importance of molecular diagnosis as an integral part of clinical diagnosis. PMID:23847139

Impact of a dedicated cancer-associated thrombosis service on clinical outcomes: a mixed-methods evaluation of a clinical improvement exercise

PubMed Central

Noble, Simon; Pease, Nikki; Sui, Jessica; Davies, James; Lewis, Sarah; Malik, Usman; Alikhan, Raza; Prout, Hayley; Nelson, Annmarie

2016-01-01

Objectives Cancer-associated thrombosis (CAT) complex condition, which may present to any healthcare professional and at any point during the cancer journey. As such, patients may be managed by a number of specialties, resulting in inconsistent practice and suboptimal care. We describe the development of a dedicated CAT service and its evaluation. Setting Specialist cancer centre, district general hospital and primary care. Participants Patients with CAT and their referring clinicians. Intervention A cross specialty team developed a dedicated CAT service , including clear referral pathways, consistent access to medicines, patient's information and a specialist clinic. Primary and secondary outcome measures The service was evaluated using a mixed-methods evaluation , including audits of clinical practice, clinical outcomes, staff surveys and qualitative interviewing of patients and healthcare professionals. Results Data from 457 consecutive referrals over an 18-month period were evaluated. The CAT service has led to an 88% increase in safe and consistent community prescribing of low-molecular-weight heparin, with improved access to specialist advice and information. Patients reported improved understanding of their condition, enabling better self-management as well as better access to support and information. Referring clinicians reported better care standards for their patients with improved access to expertise and appropriate management. Conclusions A dedicated CAT service improves overall standards of care and is viewed positively by patients and clinicians alike. Further health economic evaluation would enhance the case for establishing this as the standard model of care. PMID:27895068

The External Validity of Prediction Models for the Diagnosis of Obstructive Coronary Artery Disease in Patients With Stable Chest Pain: Insights From the PROMISE Trial.

PubMed

Genders, Tessa S S; Coles, Adrian; Hoffmann, Udo; Patel, Manesh R; Mark, Daniel B; Lee, Kerry L; Steyerberg, Ewout W; Hunink, M G Myriam; Douglas, Pamela S

2018-03-01

This study sought to externally validate prediction models for the presence of obstructive coronary artery disease (CAD). A better assessment of the probability of CAD may improve the identification of patients who benefit from noninvasive testing. Stable chest pain patients from the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) trial with computed tomography angiography (CTA) or invasive coronary angiography (ICA) were included. The authors assumed that patients with CTA showing 0% stenosis and a coronary artery calcium (CAC) score of 0 were free of obstructive CAD (≥50% stenosis) on ICA, and they multiply imputed missing ICA results based on clinical variables and CTA results. Predicted CAD probabilities were calculated using published coefficients for 3 models: basic model (age, sex, chest pain type), clinical model (basic model + diabetes, hypertension, dyslipidemia, and smoking), and clinical + CAC score model. The authors assessed discrimination and calibration, and compared published effects with observed predictor effects. In 3,468 patients (1,805 women; mean 60 years of age; 779 [23%] with obstructive CAD on CTA), the models demonstrated moderate-good discrimination, with C-statistics of 0.69 (95% confidence interval [CI]: 0.67 to 0.72), 0.72 (95% CI: 0.69 to 0.74), and 0.86 (95% CI: 0.85 to 0.88) for the basic, clinical, and clinical + CAC score models, respectively. Calibration was satisfactory although typical chest pain and diabetes were less predictive and CAC score was more predictive than was suggested by the models. Among the 31% of patients for whom the clinical model predicted a low (≤10%) probability of CAD, actual prevalence was 7%; among the 48% for whom the clinical + CAC score model predicted a low probability the observed prevalence was 2%. In 2 sensitivity analyses excluding imputed data, similar results were obtained using CTA as the outcome, whereas in those who underwent ICA the models significantly underestimated CAD probability. Existing clinical prediction models can identify patients with a low probability of obstructive CAD. Obstructive CAD on ICA was imputed for 61% of patients; hence, further validation is necessary. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Patients' attitudes and preferences about participation and recruitment strategies in clinical trials.

PubMed

Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S; Loehrer, Laura L; Wahner-Roedler, Dietlind L

2009-03-01

To assess attitudes of patients about participation in clinical trials. This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results.

Does a Physician's Attitude toward a Patient with Mental Illness Affect Clinical Management of Diabetes? Results from a Mixed-Method Study.

PubMed

Welch, Lisa C; Litman, Heather J; Borba, Christina P C; Vincenzi, Brenda; Henderson, David C

2015-08-01

To determine whether physician's attitudes toward patients with comorbid mental illness affect management of a chronic disease. A total of 256 primary care physicians interviewed in 2010. This randomized factorial experiment entailed physicians observing video vignettes of patient-actors with poorly controlled diabetes. Patients were balanced across age, gender, race, and comorbidity (schizophrenia with bizarre or normal affect, depression, eczema). Physicians completed structured and semistructured interviews plus chart notes about clinical management and attitudes. Physicians reported more negative attitudes for patients with schizophrenia with bizarre affect (SBA). There were few differences in clinical decisions measured quantitatively or in charting, but qualitative data revealed less trust of patients with SBA as reporters, with more reliance on sources other than engaging the patient in care. Physicians often alerted colleagues about SBA, thereby shaping expectations before interactions occurred. Results are consistent with common stereotypes about people with serious mental illness. Vignettes did not include intentional indication of unreliable reporting or danger. Reducing health care disparities requires attention to subtle aspects of managing patients--particularly those with atypical affect--as seemingly slight differences could engender disparate patient experiences over time. © Health Research and Educational Trust.

A Telephone-based Physiotherapy Intervention for Patients with Osteoarthritis of the Knee

PubMed Central

Odole, Adesola C.; Ojo, Oluwatobi D.

2013-01-01

This study assessed the effects of a 6-week telephone based intervention on the pain intensity and physical function of patients with knee osteoarthritis (OA), and compared the results to physiotherapy conducted in the clinic. Fifty randomly selected patients with knee OA were assigned to one of two treatment groups: a clinic group (CG) and a tele-physiotherapy group (TG). The CG received thrice-weekly physiotherapist administered osteoarthritis-specific exercises in the clinic for six weeks. The TG received structured telephone calls thrice-weekly at home, to monitor self-administered osteoarthritis-specific exercises. Participants’ pain intensity and physical function were assessed at baseline, two, four, and six weeks, in the clinic environment. Within group comparison showed significant improvements across baseline, and at weeks two, four, and six for both TG and CG’s pain intensity and physical function. Between-group comparison of CG and TG’s pain intensity and physical function at baseline and weeks two, four, and six showed no significant differences. This study demonstrated that a six-week course of structured telephone calls thrice-weekly to patients at their home, to monitor self-administered osteoarthritis-specific exercises for patients with knee OA (i.e., tele-physiotherapy) achieved comparable results to physiotherapy conducted in the clinic. PMID:25945214

Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you?

PubMed

Wells, Kristen J; Quinn, Gwendolyn P; Meade, Cathy D; Fletcher, Michelle; Tyson, Dinorah Martinez; Jim, Heather; Jacobsen, Paul B

2012-08-01

To describe processes used to develop a multi-media psycho-educational intervention to prepare patients for a discussion about cancer clinical trials (CTs). Guided by a Steering Committee, formative research was conducted to develop an informative and engaging tool about cancer CTs. Twenty-three patients and caregivers participated in formative in-depth interviews to elicit information about perceptions of cancer CTs to inform production of a new media product. Formative research revealed participants had concerns about experimentation, held beliefs that cancer CTs were for patients who had no other treatment options, and wanted a balance of information about pros and cons of CT participation. The value of physicians as credible spokespersons and the use of patients as role-models were supported. Using iterative processes, the production team infused the results into creation of a multimedia psycho-educational intervention titled Clinical Trials: Are they Right for You? An intervention, developed through an iterative consumer-focused process involving multiple stakeholders and formative research, may result in an engaging informative product. If found to be efficacious, Clinical Trials: Are they Right for You? is a low-cost and easily disseminated multimedia psycho-educational intervention to assist cancer patients with making an informed decision about cancer CTs. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

[The effectiveness of magnetic therapy of grade I-II radiation pneumofibrosis].

PubMed

Grushina, T I

2014-01-01

Radiation therapy of malignant tumours of the chest organs may result in radiation damage of the lungs. To prevent and reduce radiation-induced lung injuries, new types of radiation therapy have been developed, a number of various modifiers investigated, the methods of pharmacotherapy and physiotherapy proposed. The present study involved 37 patients presenting with radiation pneumofibrosis, including 7 ones with lung cancer and 30 patients with breast cancer. Based on the results of clinical, radiographic, and functional investigations, grade 1 and II pneumofibrosis was diagnosed in 20 and 17 patients respectively. After the application of an alternating magnetic field during 15 days, all the patients experience the overall regression of clinical symptoms and disorders of respiratory biomechanics. However, it seems premature to draw a definitive conclusion about the effectiveness of magnetic therapy of grade 1 and II radiation pneumofibrosis before the extensive in-depth investigations are carried out based on a large clinical material including the results of long-term follow-up studies and continuous monitoring.

Clinical characteristics of lung abscess in children: 15-year experience at two university hospitals

PubMed Central

Choi, Mi Suk; Chun, Ji Hye; Lee, Kyung Suk; Rha, Yeong Ho

2015-01-01

Purpose Information on the clinical features of lung abscess, which is uncommon in children, at hospitalizationis helpful to anticipate the disease course and management. There is no report concerning lung abscess in Korean children. We aimed to identify the clinical characteristics of pediatric lung abscess and compare the difference between primary and secondary abscess groups. Methods The medical records of 11 lung abscess patients (7 males and 4 females) from March 1998 to August 2011 at two university hospitals were retrospectively reviewed. The clinical characteristics, symptoms, underlying disease, laboratory and radiologic findings, microbiological results, and treatments were examined. Results Six patients had underlying structural-related problems (e.g., skeletal anomalies). No immunologic or hematologic problem was recorded. The mean ages of the primary and secondary groups were 2.4 and 5.3 years, respectively, but the difference was not statistically significant. The mean length of hospital stay was similar in both groups (22.8 days vs. 21.4 days). Immunologic studies were performed in 3 patients; the results were within the normal range. Most patients had prominent leukocytosis. Seven and 4 patients had right and left lung abscess, respectively. Staphylococcus aureus, Streptococcus pneumoniae, and antimycoplasma antibodies were detected in both groups. Two patients with primary lung abscess were administered antibiotics in the absence of other procedures, while 8 underwent interventional procedures, including 5 with secondary abscess. Conclusion The most common symptoms were fever and cough. All patients in the primary group were younger than 3 years. Structural problems were dominant. Most patients required interventional procedures and antibiotics. PMID:26770223

The development of agoraphobia is associated with the symptoms and location of a patient's first panic attack.

PubMed

Hara, Naomi; Nishimura, Yukika; Yokoyama, Chika; Inoue, Ken; Nishida, Atsushi; Tanii, Hisashi; Okada, Motohiro; Kaiya, Hisanobu; Okazaki, Yuji

2012-04-11

The place where a patient experiences his/her first panic attack (FPA) may be related to their agoraphobia later in life. However, no investigations have been done into the clinical features according to the place where the FPA was experienced. In particular, there is an absence of detailed research examining patients who experienced their FPA at home. In this study, patients were classified by the location of their FPA and the differences in their clinical features were explored (e.g., symptoms of FPA, frequency of agoraphobia, and severity of FPA). The subjects comprised 830 panic disorder patients who were classified into 5 groups based on the place of their FPA (home, school/office, driving a car, in a public transportation vehicle, outside of home), The clinical features of these patients were investigated. Additionally, for panic disorder patients with agoraphobia at their initial clinic visit, the clinical features of patients who experienced their FPA at home were compared to those who experienced their attack elsewhere. In comparison of the FPAs of the 5 groups, significant differences were seen among the 7 descriptors (sex ratio, drinking status, smoking status, severity of the panic attack, depression score, ratio of agoraphobia, and degree of avoidance behavior) and 4 symptoms (sweating, chest pain, feeling dizzy, and fear of dying). The driving and public transportation group patients showed a higher incidence of co-morbid agoraphobia than did the other groups. Additionally, for panic disorder patients with co-morbid agoraphobia, the at-home group had a higher frequency of fear of dying compared to the patients in the outside-of-home group and felt more severe distress elicited by their FPA. The results of this study suggest that the clinical features of panic disorder patients vary according to the place of their FPA. The at-home group patients experienced "fear of dying" more frequently and felt more distress during their FPA than did the subjects in the other groups. These results indicate that patients experiencing their FPA at home should be treated with a focus on the fear and distress elicited by the attack.

Cardiovascular Magnetic Resonance Imaging—Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study

PubMed Central

Hegde, Vinayak A; Biederman, Robert WW; Mikolich, J Ronald

2017-01-01

BACKGROUND This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. METHODS AND RESULTS Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. CONCLUSIONS Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner. PMID:28579858

Clinical outcomes of arthroscopic single and double row repair in full thickness rotator cuff tears

PubMed Central

Ji, Jong-Hun; Shafi, Mohamed; Kim, Weon-Yoo; Kim, Young-Yul

2010-01-01

Background: There has been a recent interest in the double row repair method for arthroscopic rotator cuff repair following favourable biomechanical results reported by some studies. The purpose of this study was to compare the clinical results of arthroscopic single row and double row repair methods in the full-thickness rotator cuff tears. Materials and Methods: 22 patients of arthroscopic single row repair (group I) and 25 patients who underwent double row repair (group II) from March 2003 to March 2005 were retrospectively evaluated and compared for the clinical outcomes. The mean age was 58 years and 56 years respectively for group I and II. The average follow-up in the two groups was 24 months. The evaluation was done by using the University of California Los Angeles (UCLA) rating scale and the shoulder index of the American Shoulder and Elbow Surgeons (ASES). Results: In Group I, the mean ASES score increased from 30.48 to 87.40 and the mean ASES score increased from 32.00 to 91.45 in the Group II. The mean UCLA score increased from the preoperative 12.23 to 30.82 in Group I and from 12.20 to 32.40 in Group II. Each method has shown no statistical clinical differences between two methods, but based on the sub scores of UCLA score, the double row repair method yields better results for the strength, and it gives more satisfaction to the patients than the single row repair method. Conclusions: Comparing the two methods, double row repair group showed better clinical results in recovering strength and gave more satisfaction to the patients but no statistical clinical difference was found between 2 methods. PMID:20697485

Absolute number of new lesions on 18F-FDG PET/CT is more predictive of clinical response than SUV changes in metastatic melanoma patients receiving ipilimumab.

PubMed

Anwar, Hoda; Sachpekidis, Christos; Winkler, Julia; Kopp-Schneider, Annette; Haberkorn, Uwe; Hassel, Jessica C; Dimitrakopoulou-Strauss, Antonia

2018-03-01

Evaluation of response to immunotherapy is a matter of debate. The aim of the present study was to evaluate the response of metastatic melanoma to treatment with ipilimumab by means of 18 F-FDG PET/CT, using the patients' clinical response as reference. The final cohort included in the analyses consisted of 41 patients with metastatic melanoma who underwent 18 F-FDG PET/CT before and after administration of ipilimumab. After determination of the best clinical response, the PET/CT scans were reviewed and a separate independent analysis was performed, based on the number and functional size of newly emerged 18 F-FDG-avid lesions, as well as on the SUV changes after therapy. The median observation time of the patients after therapy was 21.4 months (range 6.3-41.9 months). Based on their clinical response, patients were dichotomized into those with clinical benefit (CB) and those without CB (No-CB). The CB group (31 patients) included those with stable disease, partial remission and complete remission, and the No-CB group (10 patients) included those with progressive disease. The application of a threshold of four newly emerged 18 F-FDG-avid lesions on the posttherapy PET/CT scan led to a sensitivity (correctly predicting CB) of 84% and a specificity (correctly predicting No-CB) of 100%. This cut-off was lower for lesions with larger functional diameters (three new lesions larger than 1.0 cm and two new lesions larger than 1.5 cm). SUV changes after therapy did not correlate with clinical response. Based on these findings, we developed criteria for predicting clinical response to immunotherapy by means of 18 F-FDG PET/CT (PET Response Evaluation Criteria for Immunotherapy, PERCIMT). Our results show that a cut-off of four newly emerged 18 F-FDG-avid lesions on posttherapy PET/CT gives a reliable indication of treatment failure in patients under ipilimumab treatment. Moreover, the functional size of the new lesions plays an important role in predicting the clinical response. Validation of these results in larger cohorts of patients is warranted.

Impact of the implementation of telemanagement on a disease management program in an elderly heart failure cohort.

PubMed

Gambetta, Miguel; Dunn, Patrick; Nelson, Dawn; Herron, Bobbi; Arena, Ross

2007-01-01

The purpose of the present investigation is to examine the impact of a telemanagement component on an outpatient disease management program in patients with heart failure (HF). A total of 282 patients in whom HF was diagnosed and who were enrolled in an outpatient HF program were included in this analysis. One hundred fifty-eight patients additionally participated in a self-directed telemanagement component. The remaining 124 patients received care at an HF clinic but declined telemanagement. During the 7-month tracking period, 19 patients in the HF clinic plus telemanagement group and 53 patients in the HF clinic only group were hospitalized for cardiac reasons (log rank, 36.0; P<.001). The HF clinic only group had a significantly higher risk for hospitalization (hazard ratio, 4.0; 95% confidence interval, 2.4-6.7; P<.001). The results of the present study indicate that telemanagement is an important component of a disease management program in patients with HF.

Atopy patch tests in young adult patients with atopic dermatitis and controls: dose-response relationship, objective reading, reproducibility and clinical interpretation.

PubMed

Bygum, Anette; Mortz, Charlotte Gotthard; Andersen, Klaus Ejner

2003-01-01

The clinical interpretation and reproducibility of atopy patch tests was studied in 23 selected young adult patients with atopic dermatitis and 25 healthy controls using standard inhalant allergens. Non-invasive measurements were used for objective assessment of test reactions and the participants were retested after 6 weeks. Ten of 19 (53%) evaluable patients with atopic dermatitis had at least one positive atopy patch test. However, there was no clear clinical relevance of the atopy patch test results when related to patient history and distribution of dermatitis. Reproducible and dose-dependent results were obtained with Dermatophagoides pteronyssinus, grass and cat with a reproducibility rate of 0.69 to 0.81 in patients and 0.60-0.96 in controls. A unique finding was a significant positive correlation between a positive atopy patch test, allergen dose and increase in transepidermal water loss and erythema, while measurement of capacitance did not distinguish between positive and negative reactions. The results of the present study do not support the routine use of atopy patch tests in the evaluation of adult patients with atopic dermatitis.

Clinical scoring system in the evaluation of adult pharyngitis.

PubMed

Seppälä, H; Lahtonen, R; Ziegler, T; Meurman, O; Hakkarainen, K; Miettinen, A; Arstila, P; Eskola, J; Saikku, P; Huovinen, P

1993-03-01

To compare results of a clinical scoring system for diagnosis of group A streptococcal pharyngitis with microbiologic results, when several different pharyngeal pathogens were tested simultaneously. Evaluation of clinical manifestations of 106 adult patients with pharyngitis of different microbial origin. General private practice; Health Center Pulssi, Turku, Finland. Adult patients whose chief complaints were sore throats. A symptom score that was assigned to each patient according to the total number of certain signs and symptoms that are postulated to increase the probability of group A streptococcal pharyngitis and blood measurements for infection. The highest symptom scores, 3 and 4, were found in 21 patients. These patients had pharyngitis due to group A streptococcus (four patients), group C streptococcus (four patients), group G streptococcus (two patients), group F streptococcus, Mycoplasma pneumoniae, Chlamydia pneumoniae, influenza A virus, influenza B virus, herpes simplex type 1 virus (two patients), and coxsackie B4 virus. No pathogen could be identified from three of the 21 patients. The C-reactive protein values and the leukocyte counts were raised significantly more often in streptococcal infections than in infections of other origin; the P values were .00016 and .028, respectively. Use of a clinical scoring system alone for diagnosis of pharyngitis may lead to improper use of anti-microbial agents. There is a need for accurate microbiologic diagnostic procedures in general practice to determine proper treatment of pharyngitis as well as to test the effect of antibacterial and, in the future, antiviral treatment in respiratory tract infections.

Delayed-onset post-traumatic headache after a motor vehicle collision: a case report

PubMed Central

Stupar, Maja; Kim, Peter SY

2007-01-01

Introduction Headaches are common after a motor vehicle accident (MVA). Post-traumatic headaches share many clinical symptoms including the clinical course of primary headaches. Secondary headaches (including those resulting from a subdural hematoma) are not as common, but should be considered in cases of post-traumatic events particularly if clinical symptoms progress. Clinical Features A case of a patient with a post-traumatic subdural hematoma demonstrates the importance of carefully examining, properly diagnosing and managing patients that experience headaches after MVAs. This patient presented with uncomplicated low back pain, neck pain and headache which progressed at one month to include focal neurological deficits. Since clinical examination alone may not be sufficient to diagnose secondary headaches, immediate referral to the emergency department may be required. Conclusion Primary contact practitioners should be aware of the various causes of headaches that result after a MVA. Headaches, which do not respond or progress, should be followed aggressively to determine their source. PMID:17657301

Usability Assessment of Secure Messaging for Clinical Document Sharing between Health Care Providers and Patients.

PubMed

Jahn, Michelle A; Porter, Brian W; Patel, Himalaya; Zillich, Alan J; Simon, Steven R; Russ, Alissa L

2018-04-01

 Web-based patient portals feature secure messaging systems that enable health care providers and patients to communicate information. However, little is known about the usability of these systems for clinical document sharing.  This article evaluates the usability of a secure messaging system for providers and patients in terms of its ability to support sharing of electronic clinical documents.  We conducted usability testing with providers and patients in a human-computer interaction laboratory at a Midwestern U.S. hospital. Providers sent a medication list document to a fictitious patient via secure messaging. Separately, patients retrieved the clinical document from a secure message and returned it to a fictitious provider. We collected use errors, task completion, task time, and satisfaction.  Twenty-nine individuals participated: 19 providers (6 physicians, 6 registered nurses, and 7 pharmacists) and 10 patients. Among providers, 11 (58%) attached and sent the clinical document via secure messaging without requiring assistance, in a median (range) of 4.5 (1.8-12.7) minutes. No patients completed tasks without moderator assistance. Patients accessed the secure messaging system within 3.6 (1.2-15.0) minutes; retrieved the clinical document within 0.8 (0.5-5.7) minutes; and sent the attached clinical document in 6.3 (1.5-18.1) minutes. Although median satisfaction ratings were high, with 5.8 for providers and 6.0 for patients (scale, 0-7), we identified 36 different use errors. Physicians and pharmacists requested additional features to support care coordination via health information technology, while nurses requested features to support efficiency for their tasks.  This study examined the usability of clinical document sharing, a key feature of many secure messaging systems. Our results highlight similarities and differences between provider and patient end-user groups, which can inform secure messaging design to improve learnability and efficiency. The observations suggest recommendations for improving the technical aspects of secure messaging for clinical document sharing. Schattauer GmbH Stuttgart.