Trotter, Zola; Spirko, Blake; Smithline, Howard; Garb, Jane
The aims of the study were to determine the prevalence of variations in the recorded outcomes of clinical evaluations by 2 different physicians during a single patient visit and to comment on observations of physician practices regarding history taking and physical examination. Structured interviews were conducted with both junior and supervising physicians after they had evaluated patients in a pediatric emergency department who presented with complaints of fever (temperature, >100.4°F) in infants younger than 3 months, fever (temperature, >102.2°F) in infants aged 3 to 12 months, headache in patients older than 5 years, abdominal pain in patients older than 5 years, and head injury in patients younger than 18 years. Data were analyzed with descriptive statistics. Most of the data reported by both junior and supervising physicians showed response disagreement. The questions on fever (temperature, >102.2°F) in infants aged 3 to 12 months showed 29% (10/34) disagreement on fever duration and 45% (5/11) on fever height. Questions on abdominal pain in children older than 5 years showed 24% (24/100) disagreement on reporting right lower quadrant pain and 10% (11/106) on right lower quadrant tenderness on examination; however, the discrepancy rates were 56% (56/100) when considering less than complete agreement on all painful sites and 53% (56/106) on all tender sites. Supervising physicians questioned and examined patients presenting with abdominal pain more often than those presenting with other complaints. There are significant variations in the recorded outcome of clinical evaluations by 2 different physicians during a single patient visit. Supervising physicians are more cautious to question and examine patients presenting with abdominal pain compared with other chief complaints.
Trujillo, Adriana; Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Salla, Marta; Medina, Joan Carles; Montesano, Adrián; Soriano, José; Medeiros-Ferreira, Leticia; Cañete, Josep; Corbella, Sergi; Grau, Antoni; Lana, Fernando; Evans, Chris
Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk. Method Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192) from different mental health and primary care centers; and the nonclinical sample (n=452), which included a student and a community sample. Results The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment. Conclusion The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients. PMID:27382288
Barros, Marcio Vinicius Lins; Labropoulos, Nicos
This study was designed to describe the characteristics and clinical outcome of patients diagnosed with plantar vein thrombosis. Patients presenting with sudden pain and/or swelling of the foot were evaluated by duplex scanning of the affected leg. All the main foot veins were imaged with high resolution multi-linear array transducers. The location and extent of thrombosis was recorded in detail. All patients were scheduled for clinical and ultrasound follow-up within a week from the diagnosis and at various intervals thereafter. Acute thrombosis was found in the plantar veins in 11 patients of whom 7 were females. Pain was presented in all patients, swelling in 8 and the left foot was involved in 7. From the risk factors evaluated, the most common were recent surgery 4, use of contraceptive pills 3, followed by malignancy, airplane travel, HIV-AIDS infection, and past history of DVT in one each. Plantar veins were exclusively affected in 8, with lower segment of the posterior tibial veins in 2 and the great saphenous vein in 1. In the follow up, there was evidence of thrombosis extension in 3 patients. At six months partial recanalization was found in 9 and complete in 2. Pain and swelling of the foot can be caused by plantar vein thrombosis. Complete or partial recanalization occurs in these patients by 6 months. Thrombi in the plantar veins can progress more proximally with the possibility of postthrombotic events.
Theoretical models abound within clinical supervision, but these rarely have been applied to supervision evaluation. Instead, it appears that reviewers and researchers have simply transferred to supervision the conceptual frameworks used within medicine, especially the idea that clinical outcomes are the "acid test" of supervisory effectiveness or quality. Following a careful examination of the key literature, in this paper I argue that this has led to an over-emphasis on clinical outcomes, with the net effect of reducing scientific confidence, understanding, and the effectiveness of supervision. To begin to rectify this bias, an augmented fidelity framework is used to reformulate evaluation, drawing on some of the key concepts guiding evaluation within related fields (i.e. service evaluation; staff development; psychotherapy; applied research). The resulting evaluation model is specific to clinical supervision and can help to increase our understanding, enhance our practice, re-prioritise research, and inspire confidence in supervision.
Almeida, J P; De Albuquerque, L A; Dal Fabbro, M; Sampaio, M; Medina, R; Chacon, M; Gondim, J
Endoscopic skull base surgery is one of the most recent fields of neurosurgery. Successive innovations were developed throughout history so that the current concepts that rule this surgical field could be reached. The current paper presents the evolution of endoscopic surgery and its current results on the treatment of skull base tumor, based on a review of meta-analysis and clinical series. A PubMed search for articles published between January 1990 and January 2014 about "endoscopic skull base surgery", "endoscopic transsphenoidal approach", "endoscopic treatment of parasellar tumors" and "suprasellar lesions" was performed. According to the current data, endoscopic surgery seems to be superior to open and transsphenoidal microscopic removal of giant pituitary adenomas. Endoscopy is at least as successful as transsphenoidal microsurgery for the removal of pituitary adenomas and craniopharyngiomas. Transcranial open approaches, in the context of anterior midline skull base meningiomas, present higher rates of gross total resection, fewer complications and better clinical results than endoscopy approaches. The rate of postoperative CSF leakage has been significantly reduced with the introduction of new techniques such as the Hadad- Bassagasteguy flap but still represent one of the most important complications of this technique. Currently, selected tumors located at the anterior, middle and posterior fossa can be adequately assessed using the endoscope with low rates of postoperative CSF leaks. Endoscopic surgery has substantially evolved in the last decades through the collaboration of different teams around the world. The endoscope is now an essential tool in the neurosurgery armamentarium with great potential for new applications in the nearby future.
Barkham, M; Margison, F; Leach, C; Lucock, M; Mellor-Clark, J; Evans, C; Benson, L; Connell, J; Audin, K; McGrath, G
To complement the evidence-based practice paradigm, the authors argued for a core outcome measure to provide practice-based evidence for the psychological therapies. Utility requires instruments that are acceptable scientifically, as well as to service users, and a coordinated implementation of the measure at a national level. The development of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is summarized. Data are presented across 39 secondary-care services (n = 2,710) and within an intensively evaluated single service (n = 1,455). Results suggest that the CORE-OM is a valid and reliable measure for multiple settings and is acceptable to users and clinicians as well as policy makers. Baseline data levels of patient presenting problem severity, including risk, are reported in addition to outcome benchmarks that use the concept of reliable and clinically significant change. Basic quality improvement in outcomes for a single service is considered.
McCormick, Jeremy J; Bray, Christopher C; Davis, W Hodges; Cohen, Bruce E; Jones, Carroll P; Anderson, Robert B
As clinical suspicion increases and radiographic evaluation improves, navicular stress fractures are becoming a more recognized injury. To date, there is a small volume of literature examining these stress fractures, particularly as it pertains to outcomes of surgical management. To evaluate the clinical and computed tomography (CT) outcomes of surgically treated navicular stress fractures. Case series; Level of evidence, 4. Ten navicular stress fractures in 10 patients were available for follow-up at an average of 42.4 months postoperatively (range, 16.8-79.9). These patients underwent a clinical examination and a CT scan of their operatively treated foot. The American Orthopaedic Foot & Ankle Society (AOFAS) and SF-36 scores were completed for each fracture at the time of examination. The CT scans were blindly evaluated for bony union. According to the CT scan evaluation, 8 of 10 navicula (80%) had gone on to union. Clinical outcome scores on all patients were an average AOFAS hindfoot score of 88.5 and an average SF-36 score of 88.3. The feet with united fractures had an average AOFAS score of 92.1 (range, 83-100) and an average SF-36 score of 91.9 (range, 79-98). The 2 patients with nonunions had AOFAS scores of 74 and 74 and SF-36 scores of 70 and 78, respectively. Both nonunions were complete, displaced fractures on preoperative imaging. In our series of operatively treated navicular stress fractures, 80% went on to union, as verified by CT scan. Patients with united fractures had a clinically significant improvement in outcome, with higher AOFAS and SF-36 scores as compared with the 2 patients with nonunions. Patients with complete, displaced navicular stress fractures may be more likely to develop nonunions.
Pinskaya, Yuliya B; Hsieh, Tsung-Ju; Roberts, W Eugene; Hartsfield, James K
To supplement the American Board of Orthodontics (ABO) objective grading system (OGS) for posttreatment dental casts and panoramic radiographs, a comprehensive clinical assessment (CCA) method was developed to assess facial form, dental esthetics, vertical dimension, arch form, periodontium preservation, root resorption, and treatment efficiency. The sum of the CCA and the ABO OGS scores was defined as the clinical outcome. To determine a 3-year baseline for treatment outcomes in a graduate orthodontic program, the posttreatment records of 521 consecutive patients were evaluated. The mean ABO OGS score for the entire sample was 34.4 points: 32.4, 33.1, and 37.8 points for 1998, 1999, and 2000, respectively. The mean CCA score for the entire sample was 4.67 points: 2.96, 5.13, and 6.15 points for 1998, 1999, and 2000, respectively. Corresponding ABO OGS and CCA scores showed a progressive decrease in the quality of finished cases that was associated with a treatment time increase from 28.9 to 39.3 months. Overall, longer active treatment times resulted in a diminished clinical outcome, primarily due to "patient burn-out." Scoring of all finished cases is an effective means for determining clinical outcomes. However, the data suggest that, in initiating a clinical grading program, it is important to establish a multiyear baseline. Patients who are progressing well in treatment tend to be finished by the time the current class graduates, and the problem patients are transferred. Because long treatment times are associated with diminished clinical outcomes, it is often in the best interest of the uncooperative patient to terminate treatment rather than extend active mechanics in an attempt to achieve a better result.
Viliū nienė, Rima; Evans, Chris; Hilbig, Jan; Pakalniškienė, Vilmantė; Danilevičiūtė, Vita; Laurinaitis, Eugenijus; Navickas, Alvydas
There are no standardized tools in Lithuanian feasible for ongoing routine use to measure the effectiveness of psychotherapeutic treatment. The CORE-OM is a widely used 34-item self-report measure for such purpose. To explore the reliability, validity and sensitivity of the Lithuanian translation of CORE-OM questionnaire. A validation study of the CORE-OM was conducted in the psychiatric clinic attached to Vilnius University. A Lithuanian translation of the English original CORE-OM was prepared by a team of translators. Then 39 psychotherapy outpatients and 187 students were asked to complete the Lithuanian version of the CORE-OM; 66 were tested twice to determine test-retest stability. Analysis included both internal and test-retest reliability, acceptability, influence of gender, principal component analysis and criteria for reliable and clinically significant change. Internal and test-retest reliability were good (0.61-0.94), though somewhat lower for the risk domain (α: 0.57-0.79, Spearman's rho 0.25-0.60). Differences between scores of the clinical and non-clinical samples were large and significant (P < 0.001). Some of the Lithuanian criteria for clinically significant change were a bit lower than those of the original UK criteria (e.g. well-being) and others higher (symptoms, functioning, overall score), illustrating the need for local exploration. In spite of small differences in psychometric properties from the original, the Lithuanian version of the CORE-OM was reliable and sensitive in both clinical and non-clinical settings. It has the potential to become a practical, sensitive and reliable tool for psychotherapists in Lithuania.
De Salvo, Simona; Bramanti, Placido; Marino, Silvia
Summary The neurophysiological approach to patients with disorders of consciousness allows recording of both central and peripheral nervous system electrical activities and provides a functional assessment. Data obtained using this approach can supplement information from clinical neurological examination, but also from the use of morphological neuroimaging techniques: computed tomography and magnetic resonance imaging. Neurophysiological techniques, such as electroencephalography (EEG), evoked potentials, transcranial magnetic stimulation, and EEG in association with functional magnetic resonance imaging, allow monitoring of clinical conditions and can help in the formulation of a prognosis. The aim of this review is to describe the main neurophysiological techniques used in disorders of consciousness to evaluate residual cerebral function, to provide information on the neuronal dysfunction for outcome evaluation, and to differentiate clinically between the vegetative and minimally conscious states. PMID:23402676
MacQueen, Kathleen M.; Eley, Natalie T.; Frick, Mike; Mingote, Laia Ruiz; Chou, Alicia; Seidel, Stephanie S.; Hannah, Stacey; Hamilton, Carol
Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials. PMID:27368311
Ryan, Mandy; Major, Kirsten; Skåtun, Diane
This study builds on the results of a randomized controlled trial concerned with examining the effect of reducing waiting times on the health status of patients referred for non-urgent rheumatology opinion. No difference in clinical outcomes was found between a 'fast-track' and 'ordinary' appointment system. This suggests that rationing by waiting times is not detrimental to health. However, such an approach ignores the value patients attach to reducing waiting time. To estimate the monetary value of reducing waiting time, as well as changes in duration of appointment and the introduction of a pain management service, in the provision of rheumatology services. Discrete choice experiment (DCE). The main outpatient clinic of the rheumatology service for the Lothian and Borders region. 262 patients who had received a specialist rheumatology opinion--73 had received fast-track treatment, 65 standard care and 124 were non-trial patients. A response rate of 71% was achieved. Patients valued a 9-week reduction in waiting time at 131 pounds sterling. However, the introduction of a pain management service was valued at 209 pounds sterling. Thus, the latter is of more value to respondents. Evidence was also found of the internal consistency and theoretical validity of the DCE approach. The reduction of waiting times is a central plank of NHS policy. Whilst a reduction in waiting time is of value, a pain management service is of more benefit than a 9-week reduction in waiting time. DCE were shown to be a potentially useful technique for valuing different aspects of health care interventions.
Rogers, Katherine D; Young, Alys; Lovell, Karina; Evans, Chris
This article discusses translation issues arising during the production of a British Sign Language (BSL) version of the psychological outcome measure "Clinical Outcomes in Routine Evaluation-Outcome Measure" (CORE-OM). The process included forward translation, meeting with a team of translators, producing a second draft of the BSL version and back translating into English. Further modifications were made to the BSL version before piloting it with d/Deaf populations. Details of the translation process are addressed, including (a) the implications of translating between modalities (written text to visual language); (b) clarity of frequency anchors: analog versus digital encoding; (c) pronouns and the direction of signing; and (iv) the influence of the on-screen format. The discussion of item-specific issues encountered when producing a BSL version of the CORE-OM includes the expression of precise emotional states in a language that uses visual modifiers, problems associated with iconic signs, and the influence of Deaf world knowledge when interpreting specific statements. Finally, it addresses the extent to which lessons learned through this translation process are generalizable to other signed languages and spoken language translations of standardized instruments. Despite the challenges, a BSL version of the CORE-OM has been produced and found to be reliable.
Zhao, Zhi-qiang; Mao, Jing-yuan; Wang, Xian-liang; Hou, Ya-zhu; Bi, Ying-fei
To evaluate the reliability, validity, and responsiveness of traditional Chinese medicine (TCM) clinical outcomes rating scale for heart failure (HF) based on patients' report. TCM clinical outcomes rating scale for HF (TCM-HF-PRO) were evaluated based on 340 HF patients' report from multiple centers. The completion of the investigation was recorded. Cronbach's α coefficient and split-half reliability were used for reliability analysis, and factor analysis was used to assess the construct validity of the rating scale. Pearson correlation analysis was then used for criterion validity analysis. Discriminant analysis was used to assess the responsiveness of the scale. All 340 HF patients having complete TCM-HF-PRO data were assigned to the treatment group and the control group by central randomization. The total TCM-HF-PRO scores of the two groups were compared using paired t-test to reflect the longitude responsiveness of the scale before treatment and at week 2 after treatment. (1) The recycling rate of the scale was 100.0%. One of them was not filled completely, which was rejected thereby. So the completion rate was 99.7%. The completion time for TCM-HF-PRO scale ranged 15 to 25 min. (2) The Cronbach's α coefficient of rating scale was 0.903, split-half reliability was 0.844 and 0.849. (3) Confirmatory factor analysis showed that 7 factors and items formed according to maximum load factor basically coincided with the construct of the rating scale, 7 factors accumulated contribution rate was 43.8%. TCM clinical outcomes rating scale for HF based on patients' report was relatively better correlated with the Minnesota living with HF questionnaire (r = 0.726, P < 0.01). (4) Discriminant analysis showed that the rating scale correctly classified more than 78.8% of case studies having confirmed initial differential diagnosis by experts. The total scale of the rating scale decreased more in the two group after treatment, with significant difference as compared with
Hummel, Riët; Bruers, Josef; van der Galiën, Onno; van der Sanden, Wil; van der Heijden, Geert
It is well known that treatment variation exists in oral healthcare, but the consequences for oral health are unknown as the development of outcome measures is still in its infancy. The aim of this study was to identify and develop outcome measures for oral health and explore their performance using health insurance claims records and clinical data from general dental practices. The Dutch healthcare insurance company Achmea collaborated with researchers, oral health experts, and general dental practitioners (GDPs) in a proof of practice study to test the feasibility of measures in general dental practices. A literature search identified previously described outcome measures for oral healthcare. Using a structured approach, identified measures were (i) prioritized, adjusted and added to after discussion and then (ii) tested for feasibility of data collection, their face validity and discriminative validity. Data sources were claims records from Achmea, clinical records from dental practices, and prospective, pre-determined clinical assessment data obtained during routine consultations. In total eight measures (four on dental caries, one on tooth wear, two on periodontal health, one on retreatment) were identified, prioritized and tested. The retreatment measure and three measures for dental caries were found promising as data collection was feasible, they had face validity and discriminative validity. Deployment of these measures demonstrated variation in clinical practices of GDPs. Feedback of this data to GDPs led to vivid discussions on best practices and quality of care. The measure 'tooth wear' was not considered sufficiently responsive; 'changes in periodontal health score' was considered a controversial measure. The available data for the measures 'percentage of 18-year-olds with no tooth decay' and 'improvement in gingival bleeding index at reassessment' was too limited to provide accurate estimates per dental practice. The evaluated measures 'time to first
Abdel Ghany, Walid; Amer, Aboubakr; Saeed, Khaled; Emara, Essam; Hamad, Ahmad; Nosseir, Mohamed; Dawood, Osama; Nada, Mohamed A
Lumbar spinal stenosis is a common diagnosis in elderly individuals, and the rates of surgery have risen all over the world. The optimal approach to provide satisfactory decompression and minimize complications for lumbar spinal stenosis remains controversial. The purpose of this study was to evaluate the surgical outcome of interspinous spacers versus decompressive laminectomy in the management of degenerative lumbar canal stenosis. Our prospective, comparative study included 2 groups of patients who were operated on in Ain Shams University Hospitals between January 2010 and December 2014. In the first group, 28 patients underwent decompression and additional implantation of an interspinous spacer (ISP). In the second group, 25 patients underwent decompressive laminectomy (DL). Our statistical results revealed no significant difference in outcome between the 2 groups regarding visual analog scale score for leg pain and Oswestry Low Back Pain Disability Index. However, the improvement (visual analog scale score) for back pain was better in the DL group. Complication and reoperation rates were higher in the ISP group. Although decompression and additional implantation of an ISP are safe procedures, they do not show better improvement in clinical outcome as compared with decompressive laminectomy. Copyright © 2016 Elsevier Inc. All rights reserved.
Friedberg, Mark Kevin; Roche, Susan Lucy; Balasingam, Mervin; Stephenson, Elizabeth; Slorach, Cameron; Fackoury, Cheryl; Kantor, Paul Fraser
We studied mechanical dyssynchrony and its association with clinical status in children with idiopathic dilated cardiomyopathy (IDC). The SD of QRS to peak systolic velocity interval by tissue Doppler was measured in 12 left ventricular segments, as a dyssynchrony index (DI), in each child with IDC during a 12-month period. Results were compared with a control cohort. We used the adult-defined DI cutpoint of 32.6 ms to define patients with IDC as "dyssynchronous" or "synchronous" and compared clinical status and outcomes (transplantation listing/death) between these groups. Patients with IDC (n = 23) and controls (n = 14) had similar age, gender, and QRS duration. Patients with IDC had a higher DI than controls (44.8 +/- 23.7 vs 19.9 +/- 8 ms, p <0.0001). A DI >32.6 ms defined mechanical dyssynchrony in 65% of patients with IDC. Dyssynchronous and synchronous patients had similar QRS durations. Age at diagnosis, at dyssynchrony evaluation, and duration of clinical illness were similar in the 2 groups. New York Heart Association score was better in dyssynchronous than in synchronous patients (2 vs 3.1, p <0.05). Number of synchronous and dyssynchronous patients reaching the end point of death or transplantation was similar, although synchronous patients had poorer actuarial survival from the time of diagnosis (hazard ratio 3.25, p = .04). In conclusion, left ventricular mechanical dyssynchrony is prevalent in pediatric IDC. QRS duration alone is inadequate to define dyssynchrony in pediatric IDC, whereas the adult-derived DI of >32.6 ms seems applicable to the pediatric population. In this cohort, the presence of mechanical dyssynchrony was not associated with more severe clinical status or adverse outcomes.
Marshall, Keith; Willoughby-Booth, Simon
There are few reliable self-report measures suitable for people with a learning disability in reporting psychological distress. This study examines the modification of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), exploring its reliability, using two different presentation styles. One style included a sequencing task then…
Tolls, Dorothy Bazzinotti; Carlson, Nancy; Wilson, Roger; Richman, Jack
Assessed the viability of the Comprehensive Clinical Performance Grid for Student Evaluation, introduced at The New England College of Optometry in 1996 in clinical student assessment. Analyzed faculty and student feedback and consistency with previous evaluations, between evaluators, and between clinical sites and tracts. Found satisfaction with…
Delaney, Conor P; Craver, Christopher; Gibbons, Melinda M; Rachfal, Amy W; VandePol, Christine J; Cook, Suzanne F; Poston, Sara A; Calloway, Michael; Techner, Lee
To evaluate in-hospital clinical outcomes after open and laparoscopic bowel resection (BR) with or without alvimopan treatment. Delayed return of gastrointestinal function after BR may be associated with greater postoperative morbidity and increased hospital length of stay (LOS). In clinical trials, alvimopan--a peripherally acting μ-opioid receptor antagonist--accelerated gastrointestinal recovery after open BR. A retrospective matched-cohort study (NCT01150760) was conducted using a national inpatient database. Each alvimopan patient was exact matched (surgical procedure, surgeon specialty) and propensity score matched (baseline characteristics) to a nonalvimopan BR patient. Outcomes included gastrointestinal and other morbidity (cardiovascular, pulmonary, infection, cerebrovascular, thromboembolic); mortality; readmission rate; and intensive care unit (ICU) stay (intent-to-treat [ITT] population). Postoperative LOS and estimated cost were also compared (modified ITT population). Each cohort included 3525 ITT patients with similar baseline characteristics. Gastrointestinal (29.8% vs 35.7%) and other morbidity (cardiovascular [19.4% vs 24.0%], pulmonary [7.3% vs 10.5%], infectious [9.6% vs 11.8%], thromboembolic [1.2% vs 2.1%]), mortality (0.4% vs 1.0%), and mean ICU stay (0.3 vs 0.6 days) were lower in the alvimopan group (P ≤ 0.003 for each). Postoperative LOS and estimated direct cost were lower for all alvimopan patients and after laparoscopic and open BR (LOS: -1.1, -0.8, and -1.8 days respectively; cost: -$2345, -$1382, and -$3218, respectively; P ≤ 0.0008 for each). On average, alvimopan-treated patients had a lower incidence of mortality and most incidents of morbidities. Length of stay, ICU use, and estimated cost were also lower with comparable readmissions. These results in patients outside the clinical trial setting include laparoscopic colectomy and demonstrate a potential association between acceleration of gastrointestinal recovery and improved
Todorov, Atanas; Schaub, Frederic; Blanke, Fabian; Heisterbach, Patricia; Sachser, Franciska; Gösele, Andreas; Majewski, Martin
cross-sectional study in otherwise healthy athletic adults with a unilateral Achilles tendon rupture. define the relationships of active range of motion, calf circumference or number of heel raises to a full set of isokinetic parameters. Achilles tendon ruptures commonly occur during sports and create a considerable amount of morbidity. The benefits of different treatments are difficult to determine. Complex and expensive isokinetic testing is often required. If a simple force measurement could replace this testing, large clinical trials would be more easily feasible. 74 patients with acute Achilles tendon rupture and surgical treatment were evaluated retrospectively. Active range of motion (ROM), ratio of ROM, number of heel raises, ratio of heel raises, calf circumference and isokintetic measurements were recorded. Regression using a Bayesian elastic net showed the most important correlations. Active range of motion showed a significant correlation to peak torque angle at flexion and extension as well as increased sports activity. There was a negative correlation to percutaneous therapy. Active Heel raise showed a positive correlation to peak torque at dorsal extension and increased sports activity as well as a negative correlation to high postoperative pain, where as calf circumference was positive correlated to peak torque at dorsal extension and body height as well as negative correlated to female gender. device independent measures, like range of Motion, and amount of Heel raise, are an excellent tool providing similar information compared to isokinetic testing and could be used to evaluate clinical outcome after Achilles tendon rupture.
Gajjar, Devarshi U.; Pal, Anuradha K.; Ghodadra, Bharat K.; Vasavada, Abhay R.
Purpose. Fusarium, Aspergillus, and Dematiaceous are the most common fungal species causing keratitis in tropical countries. Herein we report a prospective study on fungal keratitis caused by these three fungal species. Methodology. A prospective investigation was undertaken to evaluate eyes with presumed fungal keratitis. All the fungal isolates (n = 73) obtained from keratitis infections were identified using morphological and microscopic characters. Molecular identification using sequencing of the ITS region and antifungal susceptibility tests using microdilution method were done. The final clinical outcome was evaluated in terms of the time taken for resolution of keratitis and the final visual outcome. The results were analyzed after segregating the cases into three groups, namely, Fusarium, Aspergillus, and Dematiaceous keratitis. Results. Diagnosis of fungal keratitis was established in 73 (35.9%) cases out of 208 cases. The spectra of fungi isolated were Fusarium spp. (26.6%), Aspergillus spp. (21.6%), and Dematiaceous fungi (11.6%). The sequence of the ITS region could identify the Fusarium and Aspergillus species at the species complex level, and the Dematiaceous isolates were accurately identified. Using antifungal agents such as fluconazole, natamycin, amphotericin B, and itraconazole, the minimum inhibitory concentrations (MICs) for Fusarium spp. were >32 μg/mL, 4–8 μg/mL, 0.5–1 μg/mL, and >32 μg/mL, respectively. Antifungal susceptibility data showed that Curvularia spp. was highly resistant to all the antifungal agents. Overall, natamycin and amphotericin B were found to be the most effective antifungal agents. The comparative clinical outcomes in all cases showed that the healing response in terms of visual acuity of the Dematiaceous group was significantly good when compared with the Fusarium and Aspergillus groups (P < 0.05). The time required for healing in the Fusarium group was statistically significantly less when compared with
Klapow, J C; Slater, M A; Patterson, T L; Doctor, J N; Atkinson, J H; Garfin, S R
Individuals with persisting pain often present a constellation of symptoms that includes pain, health-related impairment and dysphoric mood. It is now widely accepted that comprehensive assessment must address each of these dimensions. Despite recognition of the value of multidimensional assessment, no empirical efforts have validated the construct of a multidimensional clinical outcome presentation based on the dimensions of pain, impairment and dysphoric mood. We employed cluster analytic procedures on standard measures of pain, impairment and depression in chronic low back pain (CLBP) patients (n = 96) attending a general orthopedic clinic in order to empirically characterize multidimensional clinical outcomes. Results indicated that 3 groups could be identified reliably: (1) 'Chronic Pain Syndrome' (n = 25; high levels of pain, impairment and depression), (2) 'Positive Adaptation to Pain' (n = 24; high levels of pain with low levels of impairment and depression) and (3) 'Good Pain Control' (n = 47; low levels of pain, impairment and depression). The reliability of this cluster solution was supported by several tests of internal consistency. Discriminability of the clusters was examined across both the outcome measures themselves and several additional independent variables. The cluster solution was then cross-validated in an independent sample of pain clinic CLBP patients (n = 180) to test its generalizability. Finally the stability of the cluster dimensions over time was tested by re-assessing 36 CLBP patients 6 months after they initially were characterized into 1 of the 3 outcome groups on the same measures. MANOVA results indicated that the outcome groups were differentiated statistically across assessments. The multiple outcome measures did not change significantly across time, nor did the outcome groups change differentially across time on these measures. We conclude that the outcome dimensions of pain, impairment and depression are relatively stable
Todorov, Atanas; Schaub, Frederic; Blanke, Fabian; Heisterbach, Patricia; Sachser, Franciska; Gösele, Andreas; Majewski, Martin
Summary Study design cross-sectional study in otherwise healthy athletic adults with a unilateral Achilles tendon rupture. Objectives define the relationships of active range of motion, calf circumference or number of heel raises to a full set of isokinetic parameters. Background Achilles tendon ruptures commonly occur during sports and create a considerable amount of morbidity. The benefits of different treatments are difficult to determine. Complex and expensive isokinetic testing is often required. If a simple force measurement could replace this testing, large clinical trials would be more easily feasible. Methods 74 patients with acute Achilles tendon rupture and surgical treatment were evaluated retrospectively. Active range of motion (ROM), ratio of ROM, number of heel raises, ratio of heel raises, calf circumference and isokintetic measurements were recorded. Regression using a Bayesian elastic net showed the most important correlations. Results Active range of motion showed a significant correlation to peak torque angle at flexion and extension as well as increased sports activity. There was a negative correlation to percutaneous therapy. Active Heel raise showed a positive correlation to peak torque at dorsal extension and increased sports activity as well as a negative correlation to high postoperative pain, where as calf circumference was positive correlated to peak torque at dorsal extension and body height as well as negative correlated to female gender. Conclusion device independent measures, like range of Motion, and amount of Heel raise, are an excellent tool providing similar information compared to isokinetic testing and could be used to evaluate clinical outcome after Achilles tendon rupture. PMID:26261784
Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie
Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully
Habayeb, Osama M H; Konje, Justin C
Couples with recurrent miscarriages make several visits to specialized clinics for investigations before treatment is offered. Consequently, 'the interval' between receipt of referral and advice to try for a pregnancy is often lengthy. The objectives of this study were to examine the effect of a 'one-stop' clinic on 'the interval', throughput and the outcome from this clinic. The processes for investigation, management and outcomes of 189 couples seen in our Recurrent Miscarriage Clinic (RMC) and their records were reviewed. The one-stop clinic reduced the interval and number of visits by 36% (206.6 to 130.4 days, P < 0.001) and by 60% (2.5 to 1, P < 0.002) respectively. The prevalence and frequency of aetiological factors were similar in those with two and three or more miscarriages (41% versus 45%, P > 0.05). The commonest aetiological factors were thrombophilias (14%) and antiphospholipid syndrome (11%). No cause was identified in 54% of cases. The pregnancy and live birth rates were best in the idiopathic group (75%), those with thrombophilias (64%) and autoimmune antibodies (83%). Older couples had the worse pregnancy rates and outcome. A one-stop clinic significantly shortens 'the interval' between referral and initiation of treatment. Investigations should be initiated in women after two consecutive miscarriages.
Ibekwe, Perpetus Chudi; Onu, Fidelis Agwu; Onwe, Ogah Emeka; Ezeonu, Thecla Chinonyelum; Omeje, Innocent
Introduction Fetal distress has been shown to contribute to the increasing caesarean section rate. There has been controversy on the usefulness of clinical diagnosis of fetal distress using only the intermittent counting of the fetal heart rate and/or passage of meconium-stained liquor. Aim To evaluate the clinical diagnosis of fetal distress and the perinatal outcome. Materials and Methods This was a retrospective study in which the case records of the patients, who were diagnosed of fetal distress at Federal Teaching Hospital, Abakaliki, Nigeria, from January 1, 2008 to December 31, 2014, were collated. The statistical analysis was done using the Statistical Package for Social Sciences version 17 software (SPSS Inc., Chicago IL, USA). Results Out of the 15,640 deliveries carried out within the study period, 3,761 (24.05%) deliveries were through caesarean section. A total of 326 (8.9%) of the 3,761 caesarean sections were due to fetal distress within the study period. More so, a total of 227 (70.9%) babies were born with ≥ 7 Apgar score at the 1st minute of delivery. The perinatal mortality rate was 31.25 per 1000 deliveries. Though birth asphyxia was recorded more on babies of mothers that had fresh meconium-stained liquor and whose decision-intervention interval was more than 30 minutes when compared with those without any of the two conditions, there was no statistical significant difference between them. Conclusion The clinical diagnosis of fetal distress is accurate in 29.1% of the cases. However, it has led to an unnecessary caesarean section in the remaining 70.9% of the parturients. In order to reduce this high trend of unnecessary caesarean sections due to clinical diagnosis of fetal distress in this environment, antepartum fetal assessment with non-stress test or biophysical profile and intrapartum use of continuous electronic fetal monitoring should be used to confirm or refute the fetal distress before any surgical intervention. Fetal blood sampling
Ajah, Leonard Ogbonna; Ibekwe, Perpetus Chudi; Onu, Fidelis Agwu; Onwe, Ogah Emeka; Ezeonu, Thecla Chinonyelum; Omeje, Innocent
Fetal distress has been shown to contribute to the increasing caesarean section rate. There has been controversy on the usefulness of clinical diagnosis of fetal distress using only the intermittent counting of the fetal heart rate and/or passage of meconium-stained liquor. To evaluate the clinical diagnosis of fetal distress and the perinatal outcome. This was a retrospective study in which the case records of the patients, who were diagnosed of fetal distress at Federal Teaching Hospital, Abakaliki, Nigeria, from January 1, 2008 to December 31, 2014, were collated. The statistical analysis was done using the Statistical Package for Social Sciences version 17 software (SPSS Inc., Chicago IL, USA). Out of the 15,640 deliveries carried out within the study period, 3,761 (24.05%) deliveries were through caesarean section. A total of 326 (8.9%) of the 3,761 caesarean sections were due to fetal distress within the study period. More so, a total of 227 (70.9%) babies were born with ≥ 7 Apgar score at the 1(st) minute of delivery. The perinatal mortality rate was 31.25 per 1000 deliveries. Though birth asphyxia was recorded more on babies of mothers that had fresh meconium-stained liquor and whose decision-intervention interval was more than 30 minutes when compared with those without any of the two conditions, there was no statistical significant difference between them. The clinical diagnosis of fetal distress is accurate in 29.1% of the cases. However, it has led to an unnecessary caesarean section in the remaining 70.9% of the parturients. In order to reduce this high trend of unnecessary caesarean sections due to clinical diagnosis of fetal distress in this environment, antepartum fetal assessment with non-stress test or biophysical profile and intrapartum use of continuous electronic fetal monitoring should be used to confirm or refute the fetal distress before any surgical intervention. Fetal blood sampling and fetal pulse oximetry should be performed in event
Daley, L L; Wright, L K
Outcome evaluation research is a relatively new paradigm that allows those in nursing to explain the impact of an intervention. The term efficacy is used when an intervention is evaluated as part of a controlled research study, while effectiveness denotes outcome evaluation of uncontrolled interventions in diverse settings. This article describes a graduate nursing student's supervised research experience that contributed to evaluating the efficacy of an intervention consisting of counseling caregivers of elders with dementia via telecommunications. The student's preparation for the role of research evaluator included acquisition of conceptual knowledge about evaluation research, interviewing techniques, and analytical skills to interpret evaluation data. Conceptual knowledge focused on the application of the Donabedian Structure. Process, Outcome Model and issues such as stakeholder, vested interest, and confidentiality. Data collection interviews involved the use of open-ended questions (qualitative) and administration of a structured questionnaire (quantitative). Analysis of qualitative data required identification of positive and negative themes; item responses on the structured questionnaire were compiled as percentages. Findings from the evaluation were used to improve the design of an ongoing intervention study.
Zheng, Bin; Shen, Lijun; Walker, Maria K; Zhang, Zongduan; Zheng, Jingwei; She, Xiangjun; Zhou, Jing; Xu, Zhaoxia; Chen, Yan
To evaluate the clinical value of rigid gas permeable contact lenses (RGPCLs) in patients with traumatic corneal scarring and address implications of primary corneal repair. Eighteen subjects with a history of corneal laceration were fit with RGPCLs. Scar locations were divided into two zones; each patient was examined using Pentacam. Entering data included uncorrected visual acuity (UCVA), spectacle-corrected visual acuity (SVA), time between injury and RGPCL fitting, location and size of scar, and amount of corneal astigmatism. Follow-up data included RGPCL visual acuity (RGPCLVA), RGPCL-related complications, and dropout characteristics. Visual acuity values were converted to logMAR for analysis. No serious complications occurred. The average time between suture removal and RGPCL fitting was 5.7±5.5 months. Average corneal astigmatism was -3.44±2.09 diopters. One subject had developed corneal ectasia. RGPCLVA was more than 0.1 in three subjects: one experienced primary corneal repair complications, and two subjects (<10 years) developed amblyopia. In both zones, the difference in RGPCLVA outcome between zone I and zone II was not statistically significant (F=0.060, P=0.809). The difference between SVA in zones I and II was found to be statistically significant (F=6.131, P=0.026), as were the differences between SVA and RGPCLVA (F=8.598, P=0.010). The scar size had no significant influence on RGPCLVA, SVA, or UCVA. Four participants (22.2%) were successfully fit. Dropout characteristics included ocular discomfort, inconvenience, parental apprehension, and low motivation. Rigid gas permeable contact lens is an ideal method for evaluating visual potential in patients with traumatic corneal astigmatism. Pentacam examinations of those patients with poor RGPCLVA can help an ophthalmologist find and understand existing problems in suture techniques.
Nemeth, Nicole M; Kratz, Gail E; Bates, Rebecca; Scherpelz, Judy A; Bowen, Richard A; Komar, Nicholas
West Nile virus (WNV) infection and associated disease and mortality have been documented in numerous North American raptor species. Information regarding clinical presentations and long-term outcomes of WNV-infected raptors is important in the clinic for the diagnosis, treatment, and assessment of prognosis, as well as for understanding potential population level effects on raptor species. Raptors of 22 species admitted to a rehabilitation clinic were tested, from 2002 to 2005, for previous and acute WNV infection, while comparing clinical syndromes, trauma, and rehabilitation outcomes. Forty-two percent of admitted raptors (132/314) had been infected with WNV, and these presented with a WNV-attributed clinical disease rate of 67.4% (89/132). West Nile virus-infected raptors were less likely to be released (79/132 [59.8%]) than negative raptors (138/182 [75.8%]) and more likely to die or be euthanized (47/132 [35.6%] for WNV-infected vs. 32/182 [17.6%] for WNV-negative). However, WNV-infected raptors with neurologic disease were no less likely to be released (29/53 [54.7%]) than those without neurologic disease (50/79 [63.3%]). Clinical WNV-associated syndromes varied among species. Great horned owls (Bubo virginianus) were more likely to have neurologic signs, whereas American kestrels (Falco sparverius) and Swainson's hawks (Buteo swainsonii) were less likely to have neurologic signs. These results suggest that free-ranging raptors are frequently infected with WNV and that clinical syndromes differ among species. WNV has potentially devastating effects on raptors; however, rehabilitation of WNV-infected raptors can lead to positive outcomes, even for those having had severe neurologic disease.
Lang, Niklaus P; Zitzmann, Nicola U
The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.
The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.
Kanger, Chatrian; Brown, Lisanne; Mukherjee, Snigdha; Xin, Haichang; Diana, Mark L; Khurshid, Anjum
Quality incentive programs, such as Meaningful Use, operate under the assumption that clinical quality measures can be reliably extracted from EHRs. Safety Net providers, particularly Federally Qualified Health Centers and Look-Alikes, tend to be high adopters of EHRs; however, recent reports have shown that only about 9% of FQHCs and Look-Alikes were demonstrating meaningful use as of 2013. Our experience working with the Crescent City Beacon Community (CCBC) found that many health centers relied on chart audits to report quality measures as opposed to electronically generating reports directly from their EHRs due to distrust in the data. This paper describes a step-by-step process for improving the reliability of data extracted from EHRs to increase reliability of quality measure reports, to support quality improvement, and to achieve alignment with national clinical quality reporting requirements. Lack of standardization in data capture and reporting within EHRs drives distrust in EHR-reported data. Practices or communities attempting to achieve standardization may look to CCBC's experience for guidance on where to start and the level of resources required in order to execute a data standardization project. During the time of this data standardization project, CCBC was launching an HIE. Lack of trust in EHR data was a driver for distrust in the HIE data. We present a case study where a five-step process was used to harmonize measures, reduce data errors, and increase trust in EHR clinical outcomes reports among a community of Safety Net providers using a common EHR. Primary outcomes were the incidence of reporting errors and the potential effect of error types on quality measure percentages. The activities and level of resources required to achieve these results were also documented by the CCBC program. Implementation of a community-wide data reporting project resulted in measure harmonization, reduced reporting burden, and error reduction in EHR
Kanger, Chatrian; Brown, Lisanne; Mukherjee, Snigdha; Xin, Haichang; Diana, Mark L.; Khurshid, Anjum
Introduction: Quality incentive programs, such as Meaningful Use, operate under the assumption that clinical quality measures can be reliably extracted from EHRs. Safety Net providers, particularly Federally Qualified Health Centers and Look-Alikes, tend to be high adopters of EHRs; however, recent reports have shown that only about 9% of FQHCs and Look-Alikes were demonstrating meaningful use as of 2013. Our experience working with the Crescent City Beacon Community (CCBC) found that many health centers relied on chart audits to report quality measures as opposed to electronically generating reports directly from their EHRs due to distrust in the data. This paper describes a step-by-step process for improving the reliability of data extracted from EHRs to increase reliability of quality measure reports, to support quality improvement, and to achieve alignment with national clinical quality reporting requirements. Background: Lack of standardization in data capture and reporting within EHRs drives distrust in EHR-reported data. Practices or communities attempting to achieve standardization may look to CCBC’s experience for guidance on where to start and the level of resources required in order to execute a data standardization project. During the time of this data standardization project, CCBC was launching an HIE. Lack of trust in EHR data was a driver for distrust in the HIE data. Methods: We present a case study where a five-step process was used to harmonize measures, reduce data errors, and increase trust in EHR clinical outcomes reports among a community of Safety Net providers using a common EHR. Primary outcomes were the incidence of reporting errors and the potential effect of error types on quality measure percentages. The activities and level of resources required to achieve these results were also documented by the CCBC program. Findings: Implementation of a community-wide data reporting project resulted in measure harmonization, reduced reporting
Ingram, Megan; Choi, Yun Hee; Chiu, Chung-Yi; Haggard, Rob; Dougall, Angela Liegey; Buschang, Peter; Gatchel, Robert J.
Temporomandibular joint and muscle disorder (TMJMD) is one of the most prevalent types of musculoskeletal disorders. The major goal of the study was to more objectively quantify clinically meaningful relief for TMJMD treatment outcomes by using the new metric of minimal clinically important difference (MCID). Pre- to post-treatment changes on a number of self-report measures were evaluated in a cohort of 101 acute TMJMD patients. An anchor-based MCID approach was employed, with an objective chewing performance measure serving as the clinical outcome of interest. Using a Receiver Operating Curve analysis, it was found that the Physical Component Scale (PCS) of the SF-36 was the most robust self-report measure to use as the MCID in a TMJMD patient population. PMID:22919263
Background Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a standardised but flexible outcome evaluation instrument. The aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers’ experiences and perceived importance of outcomes of Moral Case Deliberation. Methods A multi-item instrument for assessing outcomes of Moral Case Deliberation (MCD) was constructed through an iterative process, founded on a literature review and modified through a multistep review by ethicists and health care providers. The instrument measures perceived importance of outcomes before and after MCD, as well as experienced outcomes during MCD and in daily work. A purposeful sample of 86 European participants contributed to a Delphi panel and content validity testing. The Delphi panel (n = 13), consisting of ethicists and ethics researchers, participated in three Delphi-rounds. Health care providers (n = 73) participated in the content validity testing through ‘think-aloud’ interviews and a method using Content Validity Index. Results The development process resulted in the European Moral Case Deliberation Outcomes Instrument (Euro-MCD), which consists of two sections, one to be completed before a participant’s first MCD and the other after completing multiple MCDs. The instrument contains a few open-ended questions and 26 specific items with a corresponding rating/response scale representing various MCD outcomes. The items were categorised into the following six domains: Enhanced
Patty, Willard W.
This 1949 paper considers the evaluation of health education outcomes. It describes the nature of health education, discusses whether it is possible to measure all health education outcomes, then examines how to evaluate student health habits and skills, health attitudes, and health knowledge. It concludes that it is important to evaluate health…
den Hartog, Laurens; Raghoebar, Gerry M; Slater, James J Huddleston; Stellingsma, Kees; Vissink, Arjan; Meijer, Henny J A
To evaluate the aesthetic outcome of single-tooth implants in the aesthetic zone with different neck designs from a professional's and patient's perception. Ninety-three patients with a missing anterior tooth in the maxilla were randomly assigned to be treated with an implant with a smooth neck, a rough neck with grooves or a scalloped rough neck with grooves. Implants were installed in healed sites. One year after definitive crown placement (18 months post-implant placement), photographs were taken and the aesthetic outcome was assessed according to two objective aesthetic indexes: pink esthetic score/white esthetic score (PES/WES) and implant crown aesthetic index (ICAI). A questionnaire was used to assess the aesthetic outcome and general satisfaction from a patient's perception. standardized radiographs were taken to measure marginal bone level changes. One implant was lost. Although there was a significant difference in marginal bone loss between the different implant neck designs (smooth neck 1.19±0.82mm, rough neck 0.90±0.57mm, scalloped neck 2.01±0.77mm), there were no differences in aesthetic outcome. According to the professional's assessments using PES/WES and ICAI, 79.3% and 62% of the cases showed acceptable crown aesthetics, and 59.8% and 56.5% of the cases showed acceptable mucosa aesthetics. Overall, patients were satisfied about the aesthetics of the mucosa (81.5%) and crown (93.3%), and general patient satisfaction was high (9.0±1.0 out of a maximum of 10). According to the professional's assessment, a pre-implant augmentation procedure was associated with less favorable aesthetics of the mucosa. This study shows that the aesthetics of single-tooth implants in the maxillary aesthetic zone appears to be independent of the implant neck designs applied but dependent on the need for pre-implant surgery. © 2011 Wiley Periodicals, Inc.
Cézar, Rodrigo S; Cerqueira, Bruno A V; da Paz, Silvana de Souza; Barbosa, Cynara G; de Moura Neto, José P; Barreto, José H de S; Goncalves, Marilda de S
The aim of this study is to investigate the clinical, hematological, and immunophenotypic characteristics of Brazilian children with B-cell acute lymphoblastic leukemia (B-ALL) to identify prognostic biomarkers of the disease. Thirty-three children newly diagnosed with B-ALL were followed between March 2004 and December 2009. Information about the demographic profile, diagnosis, immunophenotype, clinical manifestations, and disease outcome were gathered from the patients' medical records. Of the 33 patients with B-ALL, 18 were male and 15 female. Eighteen patients were classified as high risk; 13 as low risk, and 2 as true low risk. The frequencies of cluster of differentiation (CD)10, CD19, and CD20 antigens were 69.7%, 81.8%, and 18.2%, respectively. Six patients (18.2%) had aberrant expression of myeloid antigens. At diagnosis, patients immunopositive for CD20 had elevated white blood cell counts (P = 0.018) and lower platelet counts (P = 0.017). The 6-year overall survival was 67.5%± 3.47%. Our results demonstrate the distinct immunophenotypic and prognostic characteristics of patients with B-ALL, which can be related to the Brazilian racial admixture. Consequently, these results will most likely aid in the selection of additional prognostic markers and their use in monitoring the clinical manifestations and treatment response among B-ALL patients.
Harris, Wayne B
The bulk of the literature on kidney cancer in African Americans comes from population-based studies of incidence and survival over varying periods of time using databases from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI). The purpose of this review is to summarize the literature on racial disparities in clinical outcome in patients with renal cell carcinoma (RCC) with the objective of identifying any biomarkers that might point to a biological explanation for these differences. Special attention is given to biomarkers of systemic inflammation and their potential utility for kinetic risk assessment. In addition, arguments are presented as to why the study of ethnic and racial disparities is a promising strategy for accelerating the pace of biomarker development for all patients with RCC.
Mohammed, Noor; Subramanian, Venkataraman
Ulcerative colitis (UC) is a chronic inflammatory bowel condition characterised by a relapsing and remitting course. Symptom control has been the traditional mainstay of medical treatment. It is well known that histological inflammatory activity persists despite adequate symptom control and absence of endoscopic inflammation. Current evidence suggests that presence of histological inflammation poses a greater risk of disease relapse and subsequent colorectal cancer risk. New endoscopic technologies hold promise for developing endoscopic markers of mucosal inflammation. Achieving endoscopic and histological remission appears be the future aim of medical treatments for UC. This review article aims to evaluate the use of endoscopy as a tool in assessment of mucosal inflammation UC and its correlation with disease outcomes. PMID:27895420
Takamori, Shinkichi; Akamine, Takaki; Toyokawa, Gouji; Morodomi, Yosuke; Okamoto, Tatsuro; Maehara, Yoshihiko
Background: Analog chest drainage systems (ACS) are generally used to monitor postoperative alveolar air leakage (PAL) after lung resection. An electronic digital chest drainage system (DCS) has recently been developed that reportedly has several advantages over the traditional ACS. Here, we report a single institution’s experience of PAL management with the DCS. We also sought to establish whether DCS had superior clinical benefits and outcomes compared with ACS. Methods: We enrolled 112 consecutive patients who underwent lung resection and were subsequently managed with DCS. We compared PAL rate, duration of chest drainage, and the incidence of complications with a group of 121 consecutive patients previously managed with ACS after lung resection, using propensity score matching. Results: Mean maximum and minimum PAL rates during DCS chest drainage were 48.9 ml/min (range: 2.0–868.6 ml/min) and 0.1 ml/min (0.0–1.2 ml/min), respectively. Mean PAL rate at DCS removal was 1.3 ml/min (0.0–10.0 ml/min). After propensity score matching, mean duration of chest drainage was significantly shorter with DCS than ACS (2.7 days, range: 1–9 days, compared with 3.7 days, range: 1–21 days, respectively; P = 0.031). Conclusions: Managing PAL with DCS after pulmonary resection appears to reduce the duration of chest drainage. PMID:27885215
Calliess, Tilman; Bocklage, Raphael; Karkosch, Roman; Marschollek, Michael; Windhagen, Henning; Schulze, Mareike
Clinical scores and motion-capturing gait analysis are today's gold standard for outcome measurement after knee arthroplasty, although they are criticized for bias and their ability to reflect patients' actual quality of life has been questioned. In this context, mobile gait analysis systems have been introduced to overcome some of these limitations. This study used a previously developed mobile gait analysis system comprising three inertial sensor units to evaluate daily activities and sports. The sensors were taped to the lumbosacral junction and the thigh and shank of the affected limb. The annotated raw data was evaluated using our validated proprietary software. Six patients undergoing knee arthroplasty were examined the day before and 12 months after surgery. All patients reported a satisfactory outcome, although four patients still had limitations in their desired activities. In this context, feasible running speed demonstrated a good correlation with reported impairments in sports-related activities. Notably, knee flexion angle while descending stairs and the ability to stop abruptly when running exhibited good correlation with the clinical stability and proprioception of the knee. Moreover, fatigue effects were displayed in some patients. The introduced system appears to be suitable for outcome measurement after knee arthroplasty and has the potential to overcome some of the limitations of stationary gait labs while gathering additional meaningful parameters regarding the force limits of the knee.
Esterly, John S.; Wagner, Jamie; McLaughlin, Milena M.; Postelnick, Michael J.; Qi, Chao
Predictive modeling suggests that actual carbapenem MIC results are more predictive of clinical patient outcomes than categorical classification of the MIC as susceptible, intermediate, or resistant. Some have speculated that current CLSI guidelines' suggested thresholds are too high and that clinical success is more likely if the MIC value is ≤1 mg/liter for certain organisms. Patients treated with carbapenems and with positive blood cultures for Pseudomonas aeruginosa, Acinetobacter baumannii, or extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria were considered for evaluation in this clinical retrospective cohort study. Relevant patient demographics and microbiologic variables were collected, including carbapenem MIC. The primary objective was to define a risk-adjusted all-cause hospital mortality breakpoint for carbapenem MICs. Secondarily, we sought to determine if a similar breakpoint existed for indirect outcomes (e.g., time to mortality and length of stay [LOS] postinfection for survivors). Seventy-one patients met the criteria for study inclusion. Overall, 52 patients survived, and 19 died. Classification and regression tree (CART) analysis determined a split of organism MIC between 2 and 4 mg/liter and predicted differences in mortality (16.1% versus 76.9%; P < 0.01). Logistic regression controlling for confounders identified each imipenem MIC doubling dilution as increasing the probability of death 2-fold (adjusted odds ratio [aOR] 2.0; 95% confidence interval [CI], 1.3 to 3.2). Secondary outcomes were similar between groups. This study revealed that patients with organisms that had a MIC of ≥4 mg/liter had worse outcomes than patients whose isolates had a MIC of ≤2 mg/liter, even after adjustment for confounding variables. We recommend additional clinical studies to better understand the susceptibility breakpoint for carbapenems. PMID:22777044
Pransky, G; Benjamin, K; Himmelstein, J; Mundt, K; Morgan, W; Feuerstein, M; Koyamatsu, K; Hill-Fotouhi, C
The purpose of this study was to describe the demographic, vocational, medical, workplace, and psychosocial characteristics of patients treated for work-related upper-extremity disorders, to document treatment patterns in a community-practice setting, and to determine which of these factors predicts subsequent employment and functional status outcomes. A questionnaire was administered by mail or telephone to 112 patients seen at the University of Massachusetts Occupational Upper Extremities Disorders Clinic and included measures of disease-specific functional status, pain, reactions to pain, employer-employee relations, and number and type of interventions used to treat the disorder. Results were compared with baseline data obtained, on average, 16 months prior to follow-up. Of the original cohort (n = 124), 112 participated in the prospective study. Although most patients reported improvement in pain severity, fear of pain, life situation, and functional status, there was little change in employment status. Patients' self-reported intentions of return to work at baseline did not predict work status at follow-up. In general, those who were employed at baseline remained employed, had a greater reduction in symptom severity over time, and were significantly more likely to report improvement in their problem than those who were unemployed. The efficacy of various interventions was examined by type, mix, and intensity (number of different interventions undergone by the patient). No positive relationship was found between these measures and employment status, self-reported change in the problem, or self-reported improvement in functional status. Significant negative relationships were found between surgery, psychotherapeutic interventions, and outcomes. This was likely to have occurred because of a selection bias toward the more chronic and severely disabled patients for these treatments. However, the relative ineffectiveness of such intensive interventions as surgery
Fadiga, Mohamed Siddick; Diouf, Joseph Samba; Diop Ba, Khady; Gueye, Idrissa; Ngom, Papa Ibrahima; Diagne, Falou
In the context of this study, a clinical audit of cases treated by a single orthodontist was carried out to illustrate one practical application of the PAR index. Fifty pairs of dental casts taken from the patient group before and at the end of orthodontic treatment were evaluated by an orthodontist trained in the use of the PAR index. This evaluation shows that the average overall PAR score for the subjects included in the study fell from an initial value of 25.64 ± 11.73 points to 1.78 ± 2.79 points at the end of orthodontic treatment. The average reduction attributable to orthodontic treatment was 23.86 ± 0.95 points, for an average percentage reduction of 93.36 ± 9.02%. When cases were classified according to the degree of improvement suggested by the nomogram of the PAR index, 23 (46%) were in the "Improved" category after treatment, and 27 cases (54%) in the "Greatly improved" category. This adds up to a total of 100% in these two categories, with none in the "No better" or "Worse" categories. It should be recalled that a high standard of orthodontic treatment is considered to be reached when the average percentage reduction of the PAR score exceeds 70% and when the number of cases in the "Worse or no better" category is below 5%. Copyright © 2014. Published by Elsevier Masson SAS.
O'Farrell, S; Smart, K M; Caffrey, A; Daly, O; Doody, C
A number of clinical specialist physiotherapist (CSP)-led musculoskeletal triage clinics have been established in the Republic of Ireland as a means of managing patients referred for an outpatient orthopaedic consultation. The purpose of this study was to evaluate the outcomes of a recently established 'Musculoskeletal Assessment Clinic' (MAC) in St Vincent's University Hospital (SVUH) Dublin. We identified the (a) number of patients independently managed by the CSPs and (b) conversion rate to orthopaedic intervention as a useful measure of this. University College Dublin Research Ethics Committee granted ethical exemption and the Clinical Audit Department of SVUH approved the study. A retrospective service evaluation was carried out on all orthopaedic patients who attended the MAC between January and July 2012. Data were analysed using SPSS v20 using descriptive statistics. Seven-hundred and fourteen patients attended the MAC, 54 % of whom were female; mean age 50 years (range 12-89). The majority of patients were diagnosed with low back pain (35 %) and knee osteoarthritis (16 %). The majority of patients who attended the MAC (76 %) were independently managed by the CSPs without need for orthopaedic consultation; from a valid sample (n = 110), 80 patients required orthopaedic intervention, a conversion rate of 73 %. The most common interventions were arthroplasty (22 %) and arthroscopy (16 %). The findings of this service evaluation indicate that a significant number of patients referred for an orthopaedic consultation may be managed independently by a CSP and that onward referrals for orthopaedic consultation were highly appropriate.
Careta, Mariana Figueiroa; Leite, Claudia da Costa; Cresta, Fernando; Albino, Jose; Tsunami, Mirian; Romiti, Ricardo
Scleroderma featuring rare connective tissue disease that manifests as skin sclerosis and variable systemic involvement. Two categories of scleroderma are known: systemic sclerosis, characterized by cutaneous sclerosis and visceral involvement and localized scleroderma or morphea which classically presents benign evolution and self-limited, confined to the skin and/or underlying tissue. Recent studies show that the localized form may possibly course with involvement of internal organs and variable morbidity. This study aimed to determine the demographic characteristics, the prevalence of systemic manifestations and laboratory findings, as well as the association with autoimmune diseases, and the evolution of neurological findings, both clinical as brain MRI in patients with scleroderma of the face and its relation with the activity skin. Patients with localized scleroderma with facial involvement were evaluated and underwent neurological examination, magnetic resonance imaging and ophthalmology evaluation. After 3years, the patients were subjected again to MRI. We studied 12 patients with localized scleroderma of the face. Of this total, headache being the most frequent complaint found in 66.7% of patients, 33.3% had neurological changes possibly associated with scleroderma. As for ophthalmologic evaluation, 25% of patients showed abnormalities. The most frequent parenchymal finding was the presence of lesions with hyperintense or hypointense signal in 75% of patients, followed by ventricular asymmetry at 16.7%. Of the patients who had neurological deficits, 75% also had a change to MRI. In all patients, imaging findings after 3years were unchanged. During this interval of 3years, 25% of patients showed signs of activity of scleroderma. Patients with localized scleroderma of the face have a high prevalence of neurological and ophthalmological changes. Based on these findings, we suggest that all cases of localized scleroderma of the face should be thoroughly
Noble, Simon; Pease, Nikki; Sui, Jessica; Davies, James; Lewis, Sarah; Malik, Usman; Alikhan, Raza; Prout, Hayley; Nelson, Annmarie
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
Rhodes, Nathaniel J; Liu, Jiajun; McLaughlin, Milena M; Qi, Chao; Scheetz, Marc H
Predicted and observed failures at higher cefepime MICs have prompted the Clinical and Laboratories Standards Institute (CLSI) to lower the susceptible breakpoint for Enterobacteriaceae to ≤2mg/L, with dose-dependent susceptibility at 4-8mg/L, while the susceptibility breakpoint for nonfermentative organisms remain unchanged at ≥8mg/L. The contribution of increasing cefepime MIC to mortality risk in the setting of aggressive cefepime dosing is not well defined. Patients who were treated with cefepime for Gram-negative blood stream infections (GNBSIs), including both Enterobacteriaceae and nonfermentative organisms, were screened for inclusion in this retrospective cohort study. Demographic and microbiologic variables were collected, including pathogen, cefepime MIC, dosage, and interval. The objective was to define a risk-adjusted mortality breakpoint for cefepime MICs. Secondarily, we looked at time to death and length of stay (LOS) postculture. Ninety-one patients were included in the analysis. Overall, 19 patients died and 72 survived. Classification and Regression Tree analysis identified an inhospital mortality breakpoint at a cefepime MIC between 2 and 4mg/L for patients with a modified Acute Physiology and Chronic Health Evaluation II score ≤16.5 (4.2% versus 25%, respectively). Multivariate logistic regression revealed increased odds of mortality at a cefepime MIC of 4mg/L (adjusted odds ratio [aOR] 6.47; 95% confidence interval [CI] 1.25-33.4) and 64mg/L (aOR 6.54, 95% CI 1.03-41.4). Those with cefepime MICs ≥4mg/L experienced a greater median intensive care unit LOS for survivors (16 versus 2days; P=0.026). Increasing cefepime MIC appears to predict inhospital mortality among patients who received aggressive doses of cefepime for GNBSIs, supporting a clinical breakpoint MIC of 2mg/L.
Wesson, Matthew; Whybrow, Dean; Gould, Matthew; Greenberg, Neil
Behavioural Activation (BA) is an evidence-based psychological treatment for depression based on behavioural theory. However, in common with other talking therapies, there is limited evidence about occupational factors related to treatment. This is an important gap in the research given the emphasis placed on employment considerations in recent service initiatives. A service evaluation to investigate the clinical and fitness to work outcomes of a group BA programme for serving military personnel. 46 patients experiencing moderate to severe depression attended a 12-session Military Behavioural Activation and Rehabilitation Course (MBARC). The primary outcomes were the Patient Health Questionnaire-9 (PHQ-9), a self-report measure of depression and the patient's medical employability category. Clinical and statistically significant changes were found on the PHQ-9 between pre-course and 3-month follow-up. Pretreatment 3 patients (6.5%) were psychologically fit to deploy on full operational duties in their primary role; this increased to 25 (56.8%) and 29 (65.9%) at 3 and 6-months respectively. Preliminary findings suggest that MBARC is a clinically and occupationally effective treatment for depression in military personnel. Further research is required to identify if BA delivered in a group setting would be effective in non-military settings and whether treatment benefits are maintained in the longer term.
Sacroiliac joint syndrome (SIJ) is diagnosed in 10% to 25% of cases of lower back pain. The response to traditional radiofrequency (RF) denervation of the SIJ has being inconsistent. The Simplicity III RF probe (Neruotherm. Inc.) offers a novel treatment option. To evaluate the long-term clinical outcome (12 months) refractory SIJ syndrome in terms of pain intensity and functional improvement. A 50% reduction in intensity pain intensity (VAS) at 12 months was deemed clinically significant. A 12-month retrospective observational evaluation all of adults treated with RF for refractory SIJ. Chronic pain management center. The medical records of all adults treated with this technique was retrospectively reviewed. The primary outcome was pain intensity scores (VAS) over a 12 months period; Secondary outcomes included Roland-Morris Functional scores (RMF), Brief Pain Inventory (BPI), general health assessment (Sf12), and patient satisfaction scores (GPI), which were recorded pre and post denervation. Pain Intensity improved by 4.7 points compared to pre-treatment representing a 61% reduction in pain at 12 months (n=11, P < 0.001). Significant improvements in (a) RMF (P < 0.01, W2 = 0.63 (large effect size); (b) BPI (P < 0.001, W2 = 0.72 (strong effect size); and (c) Sf12 (P < 0.01) were noted. Overall patients were satisfied with the outcome (GPI = 77.7%). The retrospective in nature of the study and the small sample size are limitations. As it was our policy to monitor the progress of the individuals since the introduction of this technique a reliable method of recording the baseline and outcome variables at each point of contact was in place. Access to a complete set of variables in all individuals over a 12-month period was therefore possible, which we feel contributes to the quality of the dataset. By creating a consistent radiofrequency lesion between the sacral foramen and the SIJ will reliably capture the innervation to the SIJ with significant long-term clinical
Lawrence, David; Bryant, Tara K; Nobel, Tamar B; Dolansky, Mary A; Singh, Mamta K
As the evidence supporting the value of well-coordinated healthcare teams continues to grow, so to do the calls from medical educators and policy makers for the development of meaningful interprofessional educational experiences for health professions students. The student-run clinic has emerged as a unique venue for such experiential interprofessional learning experiences, with over 100 such clinics now in operation across North America. As the number and variety of these clinics rises, it has become increasingly important to understand the quality of care which they deliver. Here, patient satisfaction data from an interprofessional student-run free clinic are described, and these results are quantitatively compared to similar data obtained from a non-interprofessional, non-student-run clinic in a post-experience only, non-equivalent groups design. Student-run free clinic patients reported high levels of satisfaction with the patient care team and the facility quality, and lower levels of satisfaction with waiting times. When compared to the non-student-run clinic, there was no significant difference in the high levels of patient satisfaction with the patient care teams between the clinics. Student-run free clinic patients did, however, report significantly lower levels of satisfaction with the accessibility of care and with the perceived privacy of protected health information. Overall, this report provides evidence that an interprofessional student-run free clinic is capable of performing at the level of an experienced free clinic across many domains of patient satisfaction, while also identifying notable areas for improvement within the domains of clinic accessibility and the perception of the privacy of protected health information.
Attenberger, Corinna; Amsler, Felix; Gross, Thomas
No sufficiently validated disease-specific instrument is available to assess patient outcome after polytrauma. The aim of this investigation was to test the recently published Trauma Outcome Profile (TOP) in the longer-term outcome of multiply injured patients. Single centre validation study on the TOP in comparison with objective and subjective measures of patient, injury or treatment characteristics and longer-term outcome (e.g. medical outcomes study Short Form-36, SF-36; Nottingham Health Profile, NHP; working capacity), at least 2 years following trauma in 117 survivors of polytrauma (injury severity score, ISS>16), using comparative analysis and correlation testing of prospectively collected data. Patients' mean weighted self-rating with regard to the 10 single TOP dimensions of Health Related Quality of Life (HRQoL, 0-100) ranged from lowest values for mental functioning (52.6+33.5) to highest values for daily activities (79.0+27.5). The rate of persons who indicated an abnormal level of function or pain increased significantly from pre-injury status (2% and 5%, resp.) to 46% for both values at longer-term follow-up (p<0.001). Observed associations between single dimensions or TOP component summary scores with the corresponding values from general HRQol instruments, such as the SF-36, resulted in R (Pearson) up to 0.85. Survivors of polytrauma who presented with a reduced working capacity (RWC) at longer-term follow-up in all TOP dimensions included a significantly higher rate of patients conspicuous for a relevantly reduced outcome compared with those with a non reduced working capacity (NRWC) (posttraumatic stress disease, PTSD: p<0.05; all other dimensions: p<0.001). Patients with a RWC were characterised by an almost fivefold probability of reduced outcome with regard to the TOP dimensions 'social interaction' or 'satisfaction' (odds ratio, OR 12.4 (95% CI 5.1-30.1) and 12.5 (4.0-39.0), resp.). This first clinical and methodological evaluation in a well
Kautz, Donald D; Kuiper, RuthAnne; Pesut, Daniel J; Knight-Brown, Phyllis; Daneker, Darlene
Promoting clinical reasoning in undergraduate nursing students through application of the Outcome Present State Test (OPT) Model of Clinical Reasoning, is a challenge that can be successfully managed through effective teaching-learning strategies. Empirical evidence to support teaching strategies that foster both cognitive and metacognitive skill acquisition is limited. The purpose of this research was to evaluate the development of clinical reasoning skills among nursing students through the application and evaluation of teaching-learning strategies associated with self-regulated learning and the OPT model (Pesut & Herman, 1998; 1999; Pesut, 2004). The model and self-regulated learning prompts were used to structure learning with junior level baccalaureate nursing students during a ten-week, medical-surgical clinical experience in acute care telemetry units. Data analysis revealed students effectively made gains in learning associated with the OPT model. Qualitative analysis of self-regulated learning prompt journal data revealed students made significant gains in self-observation, self-judgment, knowledge work and use of health care personnel resources during clinical experiences. Results indicated the intentional use of guided reflection coupled with structure and learning tools of the OPT model significantly enhanced clinical reasoning skill acquisition, and provided evidence for the effectiveness of structured teaching learning strategies.
Winston, Susanna E.; Montague, Brian T.; Lopez, Michael J.; Delong, Allison; LeMarchand, Chloe; Bedoya, Armando; Gillani, Fizza S.; Beckwith, Curt G.
Background HIV-infected refugees resettled in the United States face many challenges. Longitudinal data regarding HIV-specific outcomes in this population are limited. Methods We reviewed charts of 51 HIV-infected sub-Saharan African refugees matched to 102 nonrefugees. Outcomes analyzed included CD4 counts, viral loads (VLs), antiretroviral treatment (ART) use, appointment adherence, opportunistic infections, and resistance mutations. Results The ART initiation was similar. Appointment adherence was similar in year 1, but refugees were significantly less adherent beyond year 3. Refugees and nonrefugees spent similar amounts of time in care suppressed (83% vs 80%, P = .93). Refugees had higher odds of viremia following undetectable VL (OR 2.3, P < .05). Discussion Initially, sub-Saharan African HIV-infected refugees have comparable appointment adherence, ART use, and VL suppression to nonrefugees. Overtime refugees were less adherent to appointments and more likely to have postsuppression viremia. The support services provided to refugees early in care may be important for retention in care and treatment success. PMID:23024042
Winston, Susanna E; Montague, Brian T; Lopez, Michael J; Delong, Allison; Lemarchand, Chloe; Bedoya, Armando; Gillani, Fizza S; Beckwith, Curt G
HIV-infected refugees resettled in the United States face many challenges. Longitudinal data regarding HIV-specific outcomes in this population are limited. We reviewed charts of 51 HIV-infected sub-Saharan African refugees matched to 102 nonrefugees. Outcomes analyzed included CD4 counts, viral loads (VLs), antiretroviral treatment (ART) use, appointment adherence, opportunistic infections, and resistance mutations. The ART initiation was similar. Appointment adherence was similar in year 1, but refugees were significantly less adherent beyond year 3. Refugees and nonrefugees spent similar amounts of time in care suppressed (83% vs 80%, P = .93). Refugees had higher odds of viremia following undetectable VL (OR 2.3, P < .05). Initially, sub-Saharan African HIV-infected refugees have comparable appointment adherence, ART use, and VL suppression to nonrefugees. Overtime refugees were less adherent to appointments and more likely to have postsuppression viremia. The support services provided to refugees early in care may be important for retention in care and treatment success.
Aghaeepour, Nima; Chattopadhyay, Pratip; Chikina, Maria; Dhaene, Tom; Van Gassen, Sofie; Kursa, Miron; Lambrecht, Bart N.; Malek, Mehrnoush; Qian, Yu; Qiu, Peng; Saeys, Yvan; Stanton, Rick; Tong, Dong; Vens, Celine; Walkowiak, Sławomir; Wang, Kui; Finak, Greg; Gottardo, Raphael; Mosmann, Tim; Nolan, Garry; Scheuermann, Richard H.; Brinkman, Ryan R.
The Flow Cytometry: Critical Assessment of Population Identification Methods (FlowCAP) challenges were established to compare the performance of computational methods for identifying cell populations in multidimensional flow cytometry data. Here we report the results of FlowCAP-IV where algorithms from seven different research groups predicted the time to progression to AIDS among a cohort of 384 HIV+ subjects, using antigen-stimulated peripheral blood mononuclear cell (PBMC) samples analyzed with a 14-color staining panel. Two approaches (FlowReMi.1 and flowDensity-flowType-RchyOptimyx) provided statistically significant predictive value in the blinded test set. Manual validation of submitted results indicated that unbiased analysis of single cell phenotypes could reveal unexpected cell types that correlated with outcomes of interest in high dimensional flow cytometry datasets. PMID:26447924
Hui, Rita L; Yamada, Brian D; Spence, Michele M; Jeong, Erwin W; Chan, James
To assess the impact of a Medicare Medication Therapy Management (MTM) program in a large integrated health plan on patient mortality, hospitalization and emergency department (ED) utilization, and daily prescription costs. Retrospective matched cohort study. Patients who received MTM services between 2006 and 2010 were matched to control patients who were enrolled in Medicare but did not receive MTM services. They were matched in a 1:4 ratio based on age, gender, geographic location, and prospective diagnostic-cost-group (DxCG) risk score. Multivariate regressions were used to analyze the outcomes. Subgroup analyses were conducted for patients enrolled in 2010 because the Centers for Medicare & Medicaid Services lowered the drug-cost threshold for MTM eligibility and changed from opt-in to optout participation. We identified 34,532 members who received MTM services and 138,128 control members. The MTM group was found to have a significantly reduced mortality (hazard ratio 0.86, 95% confidence interval [CI], 0.84-0.88; P <.001), lower odds for hospitalization (odds ratio [OR] = 0.97, 95% CI, 0.94-0.99; P = .018), higher odds for emergency department visits (OR = 1.17, 95% CI, 1.14-1.20; P <.001), and no differences in change in daily medication costs when compared to the matched group. The subgroup analysis of the 2010 cohort found similar results with better outcomes than the overall cohort. Medicare MTM services resulted in lower mortality and odds for hospitalization for enrolled patients compared with matched controls. This study observed an increase in ED visits and no differences in change in daily medication costs in MTM services.
Teich, Sorin T; Roperto, Renato; Alonso, Aurelio A; Lang, Lisa A
A Comprehensive Care Experience Level (CCEL) system that is aligned with Commission on Dental Accreditation (CODA) standards, promotes comprehensive care and prevention, and addresses flaws observed in previous Relative Value Units (RVU)-based programs has been implemented at the School of Dental Medicine, Case Western Reserve University since 2011. The purpose of this article is to report on the design, implementation, and preliminary outcomes of this novel clinical evaluation system. With the development of the CCEL concept, it was decided not to award points for procedures performed on competency exams. The reason behind this decision was that exams are not learning opportunities and are evaluated with summative tools. To determine reasonable alternative requirements, production data from previous classes were gathered and translated into CCEL points. These RVU points had been granted selectively only for restorative procedures completed after the initial preparation stage of the treatment plan, and achievement of the required levels was checked at multiple points during the clinical curriculum. Results of the CCEL system showed that low performing students increased their productivity, overall production at graduation increased significantly, and fluoride utilization to prevent caries rose by an order of magnitude over the RVU system. The CCEL program also allowed early identification and remediation of students having difficulty in the clinic. This successful implementation suggests that the CCEL concept has the potential for widespread adoption by dental schools. This method also can be used as a behavior modification tool to achieve specific patient care or clinical educational goals as illustrated by the way caries prevention was promoted through the program.
Regner, Sean R.; Wilcox, Nicholas; Friedman, Lisa S.; Seyer, Lauren; Schadt, Kim; Brigatti, Karlla W.; Perlman, Susan; Delatycki, Martin; Wilmot, George R.; Gomez, Christopher M.; Bushara, Khalaf O.; Mathews, Katherine D.; Subramony, S.H.; Ashizawa, Tetsuo; Ravina, Bernard; Brocht, Alicia; Farmer, Jennifer M.; Lynch, David R.
Friedreich ataxia is an autosomal recessive neurodegenerative disorder characterized by ataxia, dysarthria, and areflexia. We report the progress of a large international non-interventional cohort (n = 410), tracking the natural history of disease progression using the neurological exam-based Friedreich Ataxia Rating Scale. We analyzed the rate of progression with cross-sectional analysis and longitudinal analysis over a 2-year period. The Friedreich Ataxia Rating Scale captured disease progression when used at 1 and 2 years following initial evaluation, with a lower ratio of standard deviation of change to mean change over 2 years of evaluation. However, modeling of disease progression identified substantial ceiling effects in the Friedreich Ataxia Rating Scale, suggesting this measure is most useful in patients before maximal deficit is approached. PMID:22752494
Jalil, Sakib; Myers, Trina; Atkinson, Ian
A worldwide demographic shift is in progress and the aged population proportion is projected to more than double across the next four decades. Our current healthcare models may not be adequate to handle this shift in demography, which may have serious consequences for the ageing population who are more prone to chronic diseases. One proposed remediation is to provide in-home assisted healthcare with technology-intervened approaches. Telemedicine, telehealth, e-health are paradigms found in scientific literature that provide clinical treatment through a technology intervention. In evidence-based medical science, these technology interventions are evaluated through clinical trials, which are targeted to measure improvements in medical conditions and the treatment's cost effectiveness. However, effectiveness of a technology also depends on the interaction pattern between the technology and its' users, especially the patients. This paper presents (1) a meta-synthesis of clinical trials for technology-intervened treatments of type 2 diabetes and (2) the Clinical User-Experience Evaluation (CUE). CUE is a recommendation for future telemedicine clinical trials that focuses on the patient as the user from Human-Computer Interaction (HCI) perspective and was developed as part of this research. The clinical trials reviewed were interpreted from a technology perspective and the non-medical or non-biological improvements of the users (patients) rather than the medical outcome. Results show that technology-intervened treatments provide positive behavior changes among patients and are potentially highly beneficial for chronic illness management such as type 2 diabetes. The results from the CUE method show how it complements clinical trials to capture patients' interaction with a technology.
Papagno, Costanza; Casarotti, Alessandra; Comi, Alessandro; Gallucci, Marcello; Riva, Marco; Bello, Lorenzo
We describe how a neuropsychological evaluation in patients with brain tumors should be performed, specifically in the case of low-grade gliomas. Neuropsychological examination is crucial before starting any treatment as well as during the follow-up, since it can improve neurosurgery techniques and reveal potential cognitive effects of chemotherapy and radiotherapy, besides planning rehabilitation. We underline that sensitive and wide-ranging tests are required; specific tasks based on the lesion site should be added. Moreover, some tests can provide additional information about the evolution of the tumor. A careful, thorough examination improves quality of life.
Lee, Kun-Yu; Chen, David Yen-Ting; Hsu, Hui-Ling; Chen, Chi-Jen
Background Severe intracranial arterial stenosis results in more than 10% incidence of stroke and transient ischemic attack. Using undersized angioplasty with off-label closed-cell Enterprise stent may be a feasible alternative option for treating patients with intracranial atherosclerotic disease who fail dual-antiplatelet medical therapy. The results of the authors’ study are presented in this paper. Materials and methods Between January 2013 and July 2014, 24 symptomatic patients with a total of 30 intracranial arterial stenotic lesions refractory to medical therapy, who underwent undersized angioplasty and Enterprise stenting, were retrospectively reviewed in the authors’ institution. The results evaluated include technical success rate, clinical outcome measured as modified Rankin Scale at presentation and follow-up, peri-procedural morbidity within 30 days and 1 year, and follow-up vessel patency. Results Stent deployment was successfully achieved in all stenotic lesions (30/30). Mean pre-stent and post-stent diameter residual stenosis was 81% and 18%, respectively. The peri-procedural complication rate during 30 days after stenting was 10% per lesion (3/30), including intracranial hemorrhage, in-stent thrombosis and ischemic stroke. No further thromboembolic event or complication occurred in any patient more than 30 days after stenting. Modified Rankin scale ≤ 2 was observed in 64% and 83% of patients at initial presentation and follow-up (mean 15.8 months), respectively. Imaging follow-up was available in 17 of 24 patients (70.8%) and 20 of 30 treated lesions (66.6%) with a mean follow-up period of 15.4 months. Only one asymptomatic in-stent restenosis occurred in 20 available lesions (5.0%). Conclusion This preliminary study suggests that using undersized angioplasty and Enterprise stenting may effectively treat high-degree symptomatic intracranial arterial stenosis with favorable clinical and angiographic outcome. PMID:26542728
Krasny, Marta; Krasny, Kornel; Zadurska, Małgorzata; Fiedor, Piotr
The use of antibiotic therapy during implantation to reduce the risk of an early implant failure is widely discussed among clinicists. However, half an hour after the procedure a quarter of patients show bacteremia which could decrease the efficacy of the surgery. Implant failure is associated with destruction of bone tissue within the alveolar process and may lead to an alternative but compromised treatment plan. The aim of the study was to evaluate the influence of perioperative antibiotic protection on success of implantation. The retrospective study involved 1915 patients (females: 57.3%, males: 42.7%) with no systemic or local diseases, who required antibiotic therapy during surgical procedures. Group 1 comprised 203 patients with diagnosed vertical or horizontal bone atrophy within the alveolar ridge requiring reconstruction procedure before implantation. Group 2 included 1712 patients who did not need any surgical procedures before implantation. All the subjects took three types of antibiotics twice a day for 7 days. The data were statistically analyzed. A total number of 3309 implants were placed. Implantation efficacy in group 1 amounted to 98.53% and in group 2 it was 99.24%. Complications occurred most commonly after administration of cephalosporin which proved to be statistically significant for the patients who underwent augmentation with a bone block before the implant procedure (p 0.0209). Perioperative use of antibiotic therapy beneficially influences tissue healing, provides safety and success of the surgical procedure, as well as translates into high efficacy of implantation (99.52%). Copyright © 2015 Medical University of Bialystok. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.
Huang, Zhengxing; Dong, Wei; Ji, Lei; Duan, Huilong
Clinical outcome prediction, as strong implications for health service delivery of clinical treatment processes (CTPs), is important for both patients and healthcare providers. Prior studies typically use a priori knowledge, such as demographics or patient physical factors, to estimate clinical outcomes at early stages of CTPs (e.g., admission). They lack the ability to deal with temporal evolution of CTPs. In addition, most of the existing studies employ data mining or machine learning methods to generate a prediction model for a specific type of clinical outcome, however, a mathematical model that predicts multiple clinical outcomes simultaneously, has not yet been established. In this study, a hybrid approach is proposed to provide a continuous predictive monitoring service on multiple clinical outcomes. More specifically, a probabilistic topic model is applied to discover underlying treatment patterns of CTPs from electronic medical records. Then, the learned treatment patterns, as low-dimensional features of CTPs, are exploited for clinical outcome prediction across various stages of CTPs based on multi-label classification. The proposal is evaluated to predict three typical classes of clinical outcomes, i.e., length of stay, readmission time, and the type of discharge, using 3492 pieces of patients' medical records of the unstable angina CTP, extracted from a Chinese hospital. The stable model was characterized by 84.9% accuracy and 6.4% hamming-loss with 3 latent treatment patterns discovered from data, which outperforms the benchmark multi-label classification algorithms for clinical outcome prediction. Our study indicates the proposed approach can potentially improve the quality of clinical outcome prediction, and assist physicians to understand the patient conditions, treatment inventions, and clinical outcomes in an integrated view.
Allen, J; Annells, M; Nunn, R; Petrie, E; Clark, E; Lang, L; Robins, A
The study aimed to explore the effectiveness of a mental health screening and referral clinical pathway for generalist community nursing care of war veterans and war widow(er)s in Australia on outcomes of client self-reported mental health, quality of life, and client and carer satisfaction. The pathway was developed by literature review and consultation, then trialled and evaluated. Validated screening tools were embedded within the pathway to support generalist nurses' mental health decision making. Pre- and post-measures were applied. Clients on whom the pathway was trialled were invited to complete an evaluation survey questionnaire, as were their informal carers. Most clients and carers who responded to these questionnaires were highly satisfied or satisfied with care provided through application of the pathway. This study adds understanding about one way that community nurses might identify people with mental health difficulties. The trialled pathway, which was modified and refined following the study, is now available on the Internet as an evidence-based resource for community nurses in Australia to guide practice and maximize holistic care for war veterans and war widow(er)s where that care is funded by Department of Veterans' Affairs.
Migliore, Alberto; Integlia, Davide; Bizzi, Emanuele; Piaggio, Tomaso
There are plenty of different clinical, organizational and economic parameters to consider in order having a complete assessment of the total impact of a pharmaceutical treatment. In the attempt to follow, a holistic approach aimed to provide an evaluation embracing all clinical parameters in order to choose the best treatments, it is necessary to compare and weight multiple criteria. Therefore, a change is required: we need to move from a decision-making context based on the assessment of one single criteria towards a transparent and systematic framework enabling decision makers to assess all relevant parameters simultaneously in order to choose the best treatment to use. In order to apply the MCDA methodology to clinical decision making the best pharmaceutical treatment (or medical devices) to use to treat a specific pathology, we suggest a specific application of the Multiple Criteria Decision Analysis for the purpose, like a Clinical Multi-criteria Decision Assessment CMDA. In CMDA, results from both meta-analysis and observational studies are used by a clinical consensus after attributing weights to specific domains and related parameters. The decision will result from a related comparison of all consequences (i.e., efficacy, safety, adherence, administration route) existing behind the choice to use a specific pharmacological treatment. The match will yield a score (in absolute value) that link each parameter with a specific intervention, and then a final score for each treatment. The higher is the final score; the most appropriate is the intervention to treat disease considering all criteria (domain an parameters). The results will allow the physician to evaluate the best clinical treatment for his patients considering at the same time all relevant criteria such as clinical effectiveness for all parameters and administration route. The use of CMDA model will yield a clear and complete indication of the best pharmaceutical treatment to use for patients
Diogenes, Anibal; Ruparel, Nikita B
Immature teeth are at risk for pulp necrosis, resulting in arrested root development and poor long-term prognosis. There is growing evidence that regenerative endodontic procedures promote desirable clinical outcomes. Despite significant advances in the field of regenerative endodontics and acceptable clinical outcomes, current evidence suggests that the tissues formed following currently used procedures do not completely recapitulate the former pulp-dentin complex. Further research is needed to identify prognostic factors and predictors of successful outcomes and to develop different treatment strategies to better predictably achieve all identified clinical outcomes, while favoring tissue formation that more closely resembles the pulp-dentin complex. Copyright Â© 2016. Published by Elsevier Inc.
Hakkers, Charlotte S; Kraaijenhof, Jordan M; van Oers-Hazelzet, Esther B; Visser-Meily, Anne J M A; Hoepelman, Andy I M; Arends, Joop E; Barth, Roos E
Neurocognitive impairment (NCI) is an increasingly important comorbidity in an ageing HIV+ population. Despite the lack of available treatment modalities, screening for NCI is recommended. In the UMC Utrecht, yearly NCI screening is done using the Montreal Cognitive Assessment (MoCA) tool and the HIV Dementia Scale (HDS). The aim of this study was to evaluate this screening protocol in relation to clinical outcomes and management. A retrospective cohort study was performed in suppressed adult HIV+ patients. Apart from the MoCa and the HDS, the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) and the Hospital Anxiety and Depression Scale (HADS) were performed. Patients scoring below average on cognitive screening tests or with subjective cognitive complaints were further evaluated using a standardized protocol, including optimizing cART and checking for somatic disorders. In patients with cognitive complaints and participation restrictions, cognitive rehabilitation was proposed. Two hundred eighty-six patients were screened. The vast majority were MSM with an average age of 49 years. One hundred forty-four out of 286 patients (50%) had an abnormal test score and/or had subjective cognitive complaints. Restrictions in participation were present in 23% of patients. Six patients on Efavirenz switched their regimes, as this drug is known for its potential central nervous system (CNS) side effects. A depressive component was present in 58 patients (40%). Five patients had a clinical relevant laboratory abnormality. Moreover, six patients were referred for cognitive rehabilitation, which resulted in a 100% success rate in set goals in the five evaluable patients. Although the protocol was not fully adhered to in all patients, it did result in detectable underlying causes of NCI in 59% of patients, and 21% was referred for further treatment. Moreover, cognitive rehabilitation appears to be a very successful intervention for patients with NCI who
Malavolta, Eduardo A; Assunção, Jorge Henrique; Ramos, Frederico F; Ferreira, Thiago C; Gracitelli, Mauro E C; Bordalo-Rodrigues, Marcelo; Ferreira Neto, Arnaldo A
Sugaya's classification is the most commonly used for postoperative evaluation of rotator cuff repairs. However, the correlation between this classification and clinical outcomes after supraspinatus tendon repair were not performed with serial MRI examinations in standardized time intervals. This prospective case series involved 54 patients undergoing repair of the supraspinatus tendon tear. Magnetic resonance imaging (MRI, 1.5 T) was used to determine the Sugaya's classifications at 3, 6, and 12 months, and these data were correlated with the visual analog scale for pain (VAS), Constant and University of California at Los Angeles (UCLA) assessments. Patients with types I, II, and ≥III of Sugaya's classification experienced pain of 1.27 ± 1.95, 1.00 ± 1.40, and 3.43 ± 3.36, respectively (p = 0.010), according to the VAS. The Constant and UCLA scales did not differ significantly. Type II predominated, though their percentage decreased over time (from 77.8 to 66.7 %), whereas type I became more frequent (from 1.9 to 20.4 %). The pain was more intense in patients classified as types III, IV, or V of Sugaya's classification. The postoperative appearance of the supraspinatus tendon was not correlated with the Constant and UCLA scales. The occurrence of type II, the most prevalent, decreased over time, whereas the occurrence of type I increased; these differences were not significant. Level de evidence: prospective cohort evaluation-level III.
Freehill, Michael T; Mannava, Sandeep; Safran, Marc R
The high-level athletic population poses difficulty when evaluating outcomes in orthopedic surgery, given generally good overall health and high function at baseline. Subtle differences in performance following injury or orthopedic surgery are hard to detect in high-performance athletes using standard outcome metrics; however, attaining these subtle improvements after injury or surgery are key to an athletes' livelihood. Outcome measures serve as the cornerstone for critical evaluation of clinical outcomes following orthopedic surgery or injury. In the age of "evidence-based medicine" and "pay-for-performance" accountability for surgical intervention, understanding clinically relevant outcome measures is essential for careful review of the published literature, as well as one's own critical review of surgical performance. The purpose of this manuscript is to evaluate clinical outcome measures in the context of the athletic elbow. An emphasis will be placed on evaluation of the 5 most clinically relevant outcome measures for sports-related elbow outcomes: (1) American Shoulder and Elbow Committee; (2) Mayo Elbow Performance Index; (3) Andrews-Timmerman [and its precursor the (4) Andrews-Carson]; and (5) Kerlan-Jobe Orthopaedic Clinic overhead athlete score. A final outcome measure that will be analyzed is "return to play" statistics, which has been published in various studies of athletes' recovery from elbow surgery, as well as, the outcomes metric known as the "Conway-Jobe scale." Although there is no perfect outcomes score for the athletic elbow, the Kerlan-Jobe Orthopaedic Clinic score is the only outcomes tool developed and validated for outcomes for elbow injuries in the overhead athlete, as compared with the Andrew-Timmerman and Conway-Jobe metrics, which were not validated outcome measures for the elbow in this patient population. Despite the Disabilities of Arm, Shoulder, Hand (DASH) (and DASH-Sport module) being validated in the general population, this
Nieto Pol, Enrique
Both the initial evaluation and follow-up of patients with osteoarthritis require systematic evaluation of the indicators that provide information on the degree of involvement of the disease and allow its quantification. Reliable measures of disease progression help decision-making by clinicians and provide valid information on treatment response and the effectiveness of the distinct therapeutic interventions. The instruments recommended in research, as outcome measures in osteoarthritis, are pain evaluation, assessment of physical function, and self-reported global evaluation. In studies lasting more than 1 year, structural changes are evaluated through simple X-ray. Self-reported quality of life assessment and physician global assessment are also recommended as options. These indicators should be incorporated into routine clinical practice for adequate evaluation and correct follow-up of patients with osteoarthritis. The recommended pain evaluation method for use in clinical practice is the visual analog scale (VAS). The best instrument to evaluate physical function in patients with hip or knee osteoarthritis is the WOMAC scale (Western Ontario and McMaster Universities Osteoarthritis Index). For patient-reported global assessment in routine practice, the recommended scales are VAS or the SF-12 (12-item short-form health survey). Copyright © 2014 Elsevier España, S.L. All rights reserved.
Efficace, Fabio; Kemmler, Georg; Vignetti, Marco; Mandelli, Franco; Molica, Stefano; Holzner, Bernhard
Health-related quality of life (HRQOL) is increasingly reported as an important outcome in cancer clinical trials. However, very little evidence exists on the impact of such evaluation in randomised controlled trials (RCTs) of leukaemia patients. A systematic search of the literature from 1980 to 2007 was undertaken and studies were identified and evaluated independently, according to a pre-defined coding scheme, by three reviewers. Both HRQOL outcomes and traditional clinical reported outcomes were systematically analysed to evaluate their consistency and their relevance for supporting clinical decision making. Nine RCTs were identified, involving 3838 patients overall. There were four RCTs involving acute myeloid leukaemia patients (AML), three with chronic myeloid leukaemia (CML) and two with chronic lymphocytic leukaemia (CLL). Six studies were published after 2000 and provided fairly robust methodological quality. Imatinib greatly improved HRQOL compared to interferon based treatments in CML patients and fludarabine plus cyclophosphamide does not seem to have a deleterious impact on patient's HRQOL when compared to fludarabine alone or chlorambucil in CLL patients. This study revealed the paucity of HRQOL research in leukaemia patients. Nonetheless, HRQOL assessment is feasible in RCTs and has the great potential of providing valuable outcomes to further support clinical decision making.
Naves, Luciana Ansaneli; Porto, Lara Benigno; Rosa, João Willy Corrêa; Casulari, Luiz Augusto; Rosa, José Wilson Corrêa
Geographical information systems (GIS) have emerged as a group of innovative software components useful for projects in epidemiology and planning in Health Care System. This is an original study to investigate environmental and geographical influences on epidemiology of acromegaly in Brazil. We aimed to validate a method to link an acromegaly registry with a GIS mapping program, to describe the spatial distribution of patients, to identify disease clusters and to evaluate if the access to Health Care could influence the outcome of the disease. Clinical data from 112 consecutive patients were collected and home addresses were plotted in the GIS software for spatial analysis. The buffer spatial distribution of patients living in Brasilia showed that 38.1% lived from 0.33 to 8.66 km, 17.7% from 8.67 to 18.06 km, 22.2% from 18.07 to 25.67 km and 22% from 25.68 to 36.70 km distant to the Reference Medical Center (RMC), and no unexpected clusters were identified. Migration of 26 patients from 11 others cities in different regions of the country was observed. Most of patients (64%) with adenomas bigger than 25 mm lived more than 20 km away from RMC, but no significant correlation between the distance from patient's home to the RMC and tumor diameter (r = 0.45 p = 0.20) nor for delay in diagnosis (r = 0.43 p = 0.30) was found. The geographical distribution of diagnosed cases did not impact in the latency of diagnosis or tumor size but the recognition of significant migration denotes that improvements in the medical assistance network are needed.
Paquette-Warren, Jann; Harris, Stewart B; Naqshbandi Hayward, Mariam; Tompkins, Jordan W
Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real-world evaluation. Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real-world comprehensive evaluations in health care settings. The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub-steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built-in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale-up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. © 2016 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.
Bonifati, C; Berardesca, E
Several tools have been introduced in clinical trials to quantify the severity and the response to a given therapeutic regimen of both psoriasis and psoriatic arthritis. Each method present specific advantages and limitations. Here we will discuss some of the most popular clinical outcome measures of both psoriasis (Psoriasis Severity Index, Physician Global Assessment, National Psoriasis Fundation-Psoriasis Score, Dermatology Life Quality Index) and psoriatic arthritis (American College Rheumatology response criteria, Psoriatic Arthritis Response Criteria).
Smolen, Harry J; Murphy, Daniel R; Gahn, James C; Yu, Xueting; Curtis, Bradley H
The treatment for patients with type 2 diabetes mellitus (T2DM) follows a stepwise progression. As a treatment loses its effectiveness, it is typically replaced with a more complex and frequently more costly treatment. Eventually this progression leads to the use of basal insulin typically with concomitant treatments (e.g., metformin, a GLP-1 RA [glucagon-like peptide-1 receptor agonist], a TZD [thiazolidinedione] or a DPP-4i [dipeptidyl peptidase 4 inhibitor]) and, ultimately, to basal-bolus insulin in some forms. As the cost of oral antidiabetics (OADs) and noninsulin injectables have approached, and in some cases exceeded, the cost of insulin, we reexamined the placement of insulin in T2DM treatment progression. Our hypothesis was that earlier use of insulin produces clinical and cost benefits due to its superior efficacy and treatment scalability at an acceptable cost when considered over a 5-year period. To (a) estimate clinical and payer cost outcomes of initiating insulin treatment for patients with T2DM earlier in their treatment progression and (b) estimate clinical and payer cost outcomes resulting from delays in escalating treatment for T2DM when indicated by patient hemoglobin A1c levels. We developed a Monte Carlo microsimulation model to estimate patients reaching target A1c, diabetes-related complications, mortality, and associated costs under various treatment strategies for newly diagnosed patients with T2DM. Treatment efficacies were modeled from results of randomized clinical trials, including the time and rate of A1c drift. A typical treatment progression was selected based on the American Diabetes Association and the European Association for the Study of Diabetes guidelines as the standard of care (SOC). Two treatment approaches were evaluated: two-stage insulin (basal plus antidiabetics followed by biphasic plus metformin) and single-stage insulin (biphasic plus metformin). For each approach, we analyzed multiple strategies. For each analysis
Rueda, C; Puig-Asensio, M; Guinea, J; Almirante, B; Cuenca-Estrella, M; Zaragoza, O
Paradoxical growth (PG) and trailing effect (TE) are frequently observed during antifungal susceptibility testing (AFST). These two phenomena interfere with the determination of the minimal inhibitory concentration (MIC). The aim of this study was to assess the clinical impact of TE and PG. We analysed the frequency of TE and PG of 690 Candida isolates collected from a population-based study performed in Spain (CANDIPOP) and correlated the results with clinical outcome of the patients. Around 70% (484/690) of the isolates exhibited TE to azoles. Candida tropicalis showed the highest presence of TE (39/53 isolates exhibited residual growth >25% of control). No TE was seen in most of the isolates from the psilosis complex. PG was mainly associated with echinocandins. In patients treated with fluconazole within the first 48 hours after blood sampling (n = 221), the presence of TE to azoles tended to be associated with lower 30-day mortality (odds ratio (OR) 0.55, 95% confidence interval (CI) 0.25-1.00) but not with clinical failure (OR 0.85, 95% CI 0.45-1.54). In the subgroup of 117 patients treated with echinocandins, the presence of PG was not associated with patient's response to antifungal treatment (OR for 30-day mortality 1.63, 95% CI 0.76-4.03; OR for clinical failure 1.17, 95% CI 0.53-2.70). TE or PG are widely expressed among Candida spp., although they do not seem to influence clinical outcome. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Thompson, Amy N; Ragucci, Kelly R; Fermo, Joli D; Whitley, Heather P
Until recently, Prothrombin Time/International Normalized Ratio (PT/INR) measurements have typically been used to monitor patients on warfarin through institutional laboratories via venous puncture. The Point-of-Care Testing (POCT) device has revolutionized the patient care process by allowing for laboratory testing outside of the central laboratory. To analyze humanistic and clinical outcomes in patients currently treated with warfarin and monitored through a pharmacist-managed anticoagulation clinic using point-of-care testing (POCT) device versus venipuncture within ambulatory care clinics at our institution. All patients currently treated with warfarin therapy who were managed by clinical pharmacists for anticoagulation monitoring at the Medical University of South Carolina (MUSC) Family Medicine Center and University Diagnostic Center, were enrolled. Patients were asked to complete a satisfaction survey regarding their anticoagulation monitoring. In addition, data related to emergency department (ED) visits, hospitalizations and percent of time in the INR therapeutic range for 6 months pre- and post-implementation of POCT device was collected. This information was obtained through an electronic patient information database, Oacis. A total of 145 patients were included in the data collection from the two clinics. The majority (41%) of these patients were taking warfarin for atrial fibrillation. Satisfaction surveys were completed by 86 (59 %) of patients. The surveys revealed that POCT device was preferred over venipuncture in 95% of patients. Reasons for the preference included more face-to-face interaction, less wait time, less pain, less blood needed, and quicker results. Of the 145 patients who were included in the objective data analysis, no significant differences were found in the number of hospitalizations, ED visits, or percent of time in the INR therapeutic range pre- and post-implementation of POCT device. The results of this study demonstrate
Hall, Emily A; Docherty, Carrie L
To determine the concurrent validity of standard clinical outcome measures compared to laboratory outcome measure while performing the weight-bearing lunge test (WBLT). Cross-sectional study. Fifty participants performed the WBLT to determine dorsiflexion ROM using four different measurement techniques: dorsiflexion angle with digital inclinometer at 15cm distal to the tibial tuberosity (°), dorsiflexion angle with inclinometer at tibial tuberosity (°), maximum lunge distance (cm), and dorsiflexion angle using a 2D motion capture system (°). Outcome measures were recorded concurrently during each trial. To establish concurrent validity, Pearson product-moment correlation coefficients (r) were conducted, comparing each dependent variable to the 2D motion capture analysis (identified as the reference standard). A higher correlation indicates strong concurrent validity. There was a high correlation between each measurement technique and the reference standard. Specifically the correlation between the inclinometer placement at 15cm below the tibial tuberosity (44.9°±5.5°) and the motion capture angle (27.0°±6.0°) was r=0.76 (p=0.001), between the inclinometer placement at the tibial tuberosity angle (39.0°±4.6°) and the motion capture angle was r=0.71 (p=0.001), and between the distance from the wall clinical measure (10.3±3.0cm) to the motion capture angle was r=0.74 (p=0.001). This study determined that the clinical measures used during the WBLT have a high correlation with the reference standard for assessing dorsiflexion range of motion. Therefore, obtaining maximum lunge distance and inclinometer angles are both valid assessments during the weight-bearing lunge test. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.
Boguniewicz, Mark; Abramovits, William; Paller, Amy; Whitaker-Worth, Diane L; Prendergast, Mary; Cheng, J Wang; Wang, Patrick; Tong, Kuo B
Atopic dermatitis (AD) increases health care utilization, affects patient quality of life, places a burden on caregivers, decreases patient/parent productivity, and adds to health care costs. Few studies have examined the effect of specific treatment modalities across a variety of AD-related outcomes. This prospective, multicenter, open-label longitudinal study of adult and pediatric patients with moderate to severe AD was conducted to evaluate the effect of a specific therapeutic intervention on AD-related outcomes over a period of 6 months. Surveys collected physician clinical assessments and patient- and caregiver-reported data across the following domains: clinical outcome, health care utilization/costs, quality of life, physical appearance, productivity/absenteeism, and medication compliance. This study is intended to help guide future research efforts on the net costs and benefits of different interventions across a diverse set of domains and in larger populations.
Lalor, Joan G; Casey, Dympna; Elliott, Naomi; Coyne, Imelda; Comiskey, Catherine; Higgins, Agnes; Murphy, Kathy; Devane, Declan; Begley, Cecily
The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed 'different', and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Multiple approaches to data collection are needed to evaluate the impact
Topilsky, Yan; Michelena, Hector; Bichara, Valentina; Maalouf, Joseph; Mahoney, Douglas W; Enriquez-Sarano, Maurice
holosystolic MR. However, shorter MR yields lower regurgitant volume, consequences, and benign outcomes. Instantaneous ERO by flow convergence should be interpreted in context, and in mid-late systolic MR, regurgitant volume provides information more reflective of MR severity. Therefore, for clinical management and surgical referral, clinicians should carefully take into account the timing and consequences of MR.
Michiue, Tomomi; Ishikawa, Takaki; Quan, Li; Zhu, Bao-Li; Maeda, Hitoshi
In forensic casework, investigation of injury severity in traffic accidents is important for evaluating the mortality, occasionally in terms of the adequacy of clinical management. The present study evaluated 5 cases of clinically unexpected delayed collapse followed by death using the abbreviated injury scale (AIS), injury severity score (ISS), and a clinical trauma care method (trauma and injury severity score, TRISS). In these cases, major injury (AIS = 3-5) was found in the head, chest and/or abdomen at autopsy, and ISS was estimated to be 11-45 (serious to critical but not incompatible with life). By the TRISS method, the probability of survival (P (s)) was estimated to be >0.5 for all cases (0.60-0.99), suggesting that these were preventable deaths. However, the present cases showed several common features: (a) fatality due to closed injury/-ies to the thoracic and/or abdominal viscera, (b) alert and poor symptoms/clinical signs, and (c) poor positive findings in diagnostic imaging at early times after injury, and (d) complications of other evident injuries, suggesting difficulties in the clinical diagnosis of potentially fatal injuries, but (e) possibly predictable fatal injury when typical patterns of traffic accident injury were considered.
van der Veeken, Frida C A; Lucieer, Jacques; Bogaerts, Stefan
Rehabilitation in forensic psychiatry is achieved gradually with different leave modules, in line with the Risk Need Responsivity model. A forensic routine outcome monitoring tool should measure treatment progress based on the rehabilitation theory, and it should be predictive of important treatment outcomes in order to be usable in decision-making. Therefore, this study assesses the predictive validity for both positive (i.e., leave) and negative (i.e., inpatient incidents) treatment outcomes with the Instrument for Forensic Treatment Evaluation (IFTE). Two-hundred and twenty-four patients were included in this study. ROC analyses were conducted with the IFTE factors and items for three leave modules: guided, unguided and transmural leave for the whole group of patients. Predictive validity of the IFTE for aggression in general, physical aggression specifically, and urine drug screening (UDS) violations was assessed for patients with the main diagnoses in Dutch forensic psychiatry, patients with personality disorders and the most frequently occurring co-morbid disorders: those with combined personality and substance use disorders. Results tentatively imply that the IFTE has a reasonable to good predictive validity for inpatient aggression and a marginal to reasonable predictive value for leave approvals and UDS violations. The IFTE can be used for information purposes in treatment decision-making, but reports should be interpreted with care and acknowledge patients' personal risk factors, strengths and other information sources.
van der Veeken, Frida C. A.
Background Rehabilitation in forensic psychiatry is achieved gradually with different leave modules, in line with the Risk Need Responsivity model. A forensic routine outcome monitoring tool should measure treatment progress based on the rehabilitation theory, and it should be predictive of important treatment outcomes in order to be usable in decision-making. Therefore, this study assesses the predictive validity for both positive (i.e., leave) and negative (i.e., inpatient incidents) treatment outcomes with the Instrument for Forensic Treatment Evaluation (IFTE). Methods Two-hundred and twenty-four patients were included in this study. ROC analyses were conducted with the IFTE factors and items for three leave modules: guided, unguided and transmural leave for the whole group of patients. Predictive validity of the IFTE for aggression in general, physical aggression specifically, and urine drug screening (UDS) violations was assessed for patients with the main diagnoses in Dutch forensic psychiatry, patients with personality disorders and the most frequently occurring co-morbid disorders: those with combined personality and substance use disorders. Results and Conclusions Results tentatively imply that the IFTE has a reasonable to good predictive validity for inpatient aggression and a marginal to reasonable predictive value for leave approvals and UDS violations. The IFTE can be used for information purposes in treatment decision-making, but reports should be interpreted with care and acknowledge patients’ personal risk factors, strengths and other information sources. PMID:27517721
Beneciuk, Jason M; Bishop, Mark D; Fritz, Julie M; Robinson, Michael E; Asal, Nabih R; Nisenzon, Anne N; George, Steven Z
Psychologically informed practice emphasizes routine identification of modifiable psychological risk factors being highlighted. The purpose of this study was to test the predictive validity of the STarT Back Screening Tool (SBT) in comparison with single-construct psychological measures for 6-month clinical outcomes. This was an observational, prospective cohort study. Patients (n=146) receiving physical therapy for low back pain were administered the SBT and a battery of psychological measures (Fear-Avoidance Beliefs Questionnaire physical activity scale and work scale [FABQ-PA and FABQ-W, respectively], Pain Catastrophizing Scale [PCS], 11-item version of the Tampa Scale of Kinesiophobia [TSK-11], and 9-item Patient Health Questionnaire [PHQ-9]) at initial evaluation and 4 weeks later. Treatment was at the physical therapist's discretion. Clinical outcomes consisted of pain intensity and self-reported disability. Prediction of 6-month clinical outcomes was assessed for intake SBT and psychological measure scores using multiple regression models while controlling for other prognostic variables. In addition, the predictive capabilities of intake to 4-week changes in SBT and psychological measure scores for 6-month clinical outcomes were assessed. Intake pain intensity scores (β=.39 to .45) and disability scores (β=.47 to .60) were the strongest predictors in all final regression models, explaining 22% and 24% and 43% and 48% of the variance for the respective clinical outcome at 6 months. Neither SBT nor psychological measure scores improved prediction of 6-month pain intensity. The SBT overall scores (β=.22) and SBT psychosocial scores (β=.25) added to the prediction of disability at 6 months. Four-week changes in TSK-11 scores (β=-.18) were predictive of pain intensity at 6 months. Four-week changes in FABQ-PA scores (β=-.21), TSK-11 scores (β=-.20) and SBT overall scores (β=-.18) were predictive of disability at 6 months. Physical therapy treatment was
Bishop, Mark D.; Fritz, Julie M.; Robinson, Michael E.; Asal, Nabih R.; Nisenzon, Anne N.
Background Psychologically informed practice emphasizes routine identification of modifiable psychological risk factors being highlighted. Objective The purpose of this study was to test the predictive validity of the STarT Back Screening Tool (SBT) in comparison with single-construct psychological measures for 6-month clinical outcomes. Design This was an observational, prospective cohort study. Methods Patients (n=146) receiving physical therapy for low back pain were administered the SBT and a battery of psychological measures (Fear-Avoidance Beliefs Questionnaire physical activity scale and work scale [FABQ-PA and FABQ-W, respectively], Pain Catastrophizing Scale [PCS], 11-item version of the Tampa Scale of Kinesiophobia [TSK-11], and 9-item Patient Health Questionnaire [PHQ-9]) at initial evaluation and 4 weeks later. Treatment was at the physical therapist's discretion. Clinical outcomes consisted of pain intensity and self-reported disability. Prediction of 6-month clinical outcomes was assessed for intake SBT and psychological measure scores using multiple regression models while controlling for other prognostic variables. In addition, the predictive capabilities of intake to 4-week changes in SBT and psychological measure scores for 6-month clinical outcomes were assessed. Results Intake pain intensity scores (β=.39 to .45) and disability scores (β=.47 to .60) were the strongest predictors in all final regression models, explaining 22% and 24% and 43% and 48% of the variance for the respective clinical outcome at 6 months. Neither SBT nor psychological measure scores improved prediction of 6-month pain intensity. The SBT overall scores (β=.22) and SBT psychosocial scores (β=.25) added to the prediction of disability at 6 months. Four-week changes in TSK-11 scores (β=−.18) were predictive of pain intensity at 6 months. Four-week changes in FABQ-PA scores (β=−.21), TSK-11 scores (β=−.20) and SBT overall scores (β=−.18) were predictive of
Zhu, Yi-Ming; Jiang, Chunyan; Song, Guanyang; Lu, Yi; Li, Fenglong
To investigate the clinical and radiographic outcomes of the modified arthroscopic Latarjet procedure at a minimum of 2 years after surgery. Patients who had traumatic unidirectional anterior shoulder instability and treated with a modified arthroscopic Latarjet procedure were included. During surgery, the anterior capsule was preserved and repaired back to the glenoid after the coracoid transfer. The clinical results (range of motion, American Shoulder and Elbow Surgeons [ASES] score, Constant-Murley score, and Rowe score) and computed tomographic results were followed. From February 2013 to September 2014, 52 consecutive patients were included. The average duration of follow-up was 28.4 months (range, 24.0-41.7 months). At final follow-up, no recurrent dislocation had occurred. The ASES score and Rowe score improved significantly (ASES score from 85.6 ± 12.7 before surgery to 93.6 ± 5.4 after surgery, P < .0001; Rowe score from 41.5 ± 7.2 before surgery to 92.2 ± 8.7 after surgery, P < .0001). No significant change was found regarding range of motion and the Constant-Murley score. Bone union was achieved in all cases. The transferred coracoid was at the level of the glenoid in all cases. The transferred coracoid was placed below the equator in 48 of 52 cases (92.3%). The orientation of the screw was 22.6° ± 10.8°. Bone resorption around the proximal screw was significantly more prominent than that around the distal screw (P < .0001). The arthroscopic Latarjet procedure with concomitant anterior capsular reconstruction can achieve satisfactory clinical outcomes for the treatment of anterior shoulder instability with marked glenoid bone loss at a minimum of 2 years' follow-up. A satisfactory coracoid graft position, proper screw orientation, and high healing rate of the transferred coracoid can be expected. Bone resorption around the proximal screw is more severe than that around the distal screw. Level IV, therapeutic case series. Copyright © 2017
Weishaar, K M; Thamm, D H; Worley, D R; Kamstock, D A
Lymph node metastasis in dogs with mast cell tumour has been reported as a negative prognostic indicator; however, no standardized histological criteria exist to define metastatic disease. The primary aim of this study was to determine whether different histological patterns of node-associated mast cells correlate with clinical outcome in dogs with mast cell tumour. A secondary goal was to propose a criteria-defined classification system for histological evaluation of lymph node metastasis. The Colorado State University Diagnostic Medicine Center database was searched for cases of canine mast cell tumours with reported lymph node metastasis or evidence of node-associated mast cells. Additional cases were obtained from a clinical trial involving sentinel lymph node mapping and node extirpation in dogs with mast cell neoplasia. Forty-one cases were identified for inclusion in the study. Demographic data, treatment and clinical outcome were collected for each case. Lymph nodes were classified according to a novel classification system (HN0-HN3) based on the number of, distribution of, and architectural disruption by, nodal mast cells. The findings of this study indicate that characterization of nodal mast cells as proposed by this novel classification system correlates with, and is prognostic for, clinical outcome in dogs with mast cell tumours.
Wang, Ximing; Kim, Bokkyu; Park, Ji Hoon; Wang, Erik; Forsyth, Sydney; Lim, Cody; Ravi, Ragini; Karibyan, Sarkis; Sanchez, Alexander; Liu, Brent
Quantitative imaging biomarkers are used widely in clinical trials for tracking and evaluation of medical interventions. Previously, we have presented a web based informatics system utilizing quantitative imaging features for predicting outcomes in stroke rehabilitation clinical trials. The system integrates imaging features extraction tools and a web-based statistical analysis tool. The tools include a generalized linear mixed model(GLMM) that can investigate potential significance and correlation based on features extracted from clinical data and quantitative biomarkers. The imaging features extraction tools allow the user to collect imaging features and the GLMM module allows the user to select clinical data and imaging features such as stroke lesion characteristics from the database as regressors and regressands. This paper discusses the application scenario and evaluation results of the system in a stroke rehabilitation clinical trial. The system was utilized to manage clinical data and extract imaging biomarkers including stroke lesion volume, location and ventricle/brain ratio. The GLMM module was validated and the efficiency of data analysis was also evaluated.
Although there are limited data available on gender as an outcome variable in the treatment of onychomycosis, differences in disease prevalence and impact in males versus females have been observed. This article provides a gender subgroup analysis based on results from recent studies evaluating the efficacy, safety, and tolerability of efinaconazole topical solution 10% in the treatment of onychomycosis. Data were collected from two 52-week, prospective, multicenter, randomized, double-blind studies of patients (age range, 18-70 years) randomized to receive either efinaconazole topical solution 10% or vehicle for treatment of onychomycosis. Results from this analysis indicated that once-daily application of efinaconazole topical solution 10% may provide a useful topical option for treatment of mild to moderate toenail onychomycosis, especially in female patients.
O. Bachmann, Max; Loke, Yoon Kong; D. Musgrave, Stanley; Price, Gill M.; Hale, Rachel; Metcalf, Anthony Kneale; Turner, David A.; Day, Diana J.; A. Warburton, Elizabeth; Potter, John F.
Abstract Background although variation in stroke service provision and outcomes have been previously investigated, it is less well known what service characteristics are associated with reduced short- and medium-term mortality. Methods data from a prospective multicentre study (2009–12) in eight acute regional NHS trusts with a catchment population of about 2.6 million were used to examine the prognostic value of patient-related factors and service characteristics on stroke mortality outcome at 7, 30 and 365 days post stroke, and time to death within 1 year. Results a total of 2,388 acute stroke patients (mean (standard deviation) 76.9 (12.7) years; 47.3% men, 87% ischaemic stroke) were included in the study. Among patients characteristics examined increasing age, haemorrhagic stroke, total anterior circulation stroke type, higher prestroke frailty, history of hypertension and ischaemic heart disease and admission hyperglycaemia predicted 1-year mortality. Additional inclusion of stroke service characteristics controlling for patient and service level characteristics showed varying prognostic impact of service characteristics on stroke mortality over the disease course during first year after stroke at different time points. The most consistent finding was the benefit of higher nursing levels; an increase in one trained nurses per 10 beds was associated with reductions in 30-day mortality of 11–28% (P < 0.0001) and in 1-year mortality of 8–12% (P < 0.001). Conclusions there appears to be consistent and robust evidence of direct clinical benefit on mortality up to 1 year after acute stroke of higher numbers of trained nursing staff over and above that of other recognised mortality risk factors. PMID:28181626
Nicholson, Karl G.; Lim, Wei Shen; Read, Robert C.; Taylor, Bruce L.; Brett, Stephen J.; Openshaw, Peter J. M.; Enstone, Joanne E.; McMenamin, James; Bannister, Barbara; Nguyen-Van-Tam, Jonathan S.
During severe influenza pandemics healthcare demand can exceed clinical capacity to provide normal standards of care. Community Assessment Tools (CATs) could provide a framework for triage decisions for hospital referral and admission. CATs have been developed based on evidence that supports the recognition of severe influenza and pneumonia in the community (including resource limited settings) for adults, children and infants, and serious feverish illness in children. CATs use six objective criteria and one subjective criterion, any one or more of which should prompt urgent referral and admission to hospital. A retrospective evaluation of the ability of CATs to predict use of hospital-based interventions and patient outcomes in a pandemic was made using the first recorded routine clinical assessment on or shortly after admission from 1520 unselected patients (800 female, 480 children <16 years) admitted with PCR confirmed A(H1N1)pdm09 infection (the FLU-CIN cohort). Outcome measures included: any use of supplemental oxygen; mechanical ventilation; intravenous antibiotics; length of stay; intensive or high dependency care; death; and “severe outcome” (combined: use of intensive or high dependency care or death during admission). Unadjusted and multivariable analyses were conducted for children (age <16 years) and adults. Each CATs criterion independently identified both use of clinical interventions that would in normal circumstances only be provided in hospital and patient outcome measures. “Peripheral oxygen saturation ≤92% breathing air, or being on oxygen” performed well in predicting use of resources and outcomes for both adults and children; supporting routine measurement of peripheral oxygen saturation when assessing severity of disease. In multivariable analyses the single subjective criterion in CATs “other cause for clinical concern” independently predicted death in children and in adults predicted length of stay, mechanical ventilation and
Lahav, Amit; Burks, Robert T; Greis, Patrick E; Chapman, Andrew W; Ford, Gregory M; Fink, Barbara P
This study evaluated the clinical outcome in 21 patients (22 knees) undergoing osteochondral autologous transplantation (OATS) in the knee over a 5-year period. Sixteen knees in 15 patients were available for follow-up at an average of 40 months after the procedure. The clinical outcome was analyzed using the IKDC and Knee and Osteoarthritis Outcome Score (KOOS) evaluation forms, a subjective questionnaire, and a clinical examination. At final follow-up, the average KOOS result for pain was 80.6 (range: 56-94), symptoms 53.6 (range: 25-71), function of activities of daily living 93.4 (range: 79-100), function of sports and recreational activities 65.3 (range: 20-100), and quality of life 51.0 (range: 6-88). The average IKDC score was 68.2. On our subjective questionnaire, the average preoperative grade given was 3.1 (range: 1-7) with an improvement at the most recent follow-up to a grade of 8.0 (range: 5-10) (P < .00001). Thirteen (86%) patients reported that they would have the surgery again if they had to make the decision a second time. Age did not correlate with subjective results on the IKDC evaluation (P = .7048) or score difference on our questionnaire (P = .9175). This procedure provides an option for articular resurfacing of the femoral condyles for focal areas of chondral defects with promising results regarding subjective improvement.
Dharanipragada, Subrahmanyam; Basu, Debdatta; Ananthakrishnan, Ramesh; Surendiran, Deepanjali
Introduction Cerebral Venous Thrombosis (CVT) is a well known disease with diverse clinical presentation and causes. With advances in neuroimaging and changing lifestyles, the clinical profile and causes of CVT are changing. D-dimer has been studied in early diagnosis of CVT with variable results. This prospective study was carried out to assess the clinical profile of CVT and role of D-dimer in diagnosis of CVT. Aim To study various aspects of CVT and role of D-dimer. Materials and Methods The study period was September 2012 to July 2014 and included 80 imaging proven patients of CVT. We also included 39 controls for assessing D-dimer. Data was collected according to a preformed format. D-dimer was assessed by a rapid semi-quantitative latex agglutination assay. Discharged patients were followed up to six months. Results Of the total 44 were women and 36 were men (F: M=1.2:1). The mean age of the patients was 29.5±9.68 years. Most common clinical features were headache 77 (96.25%), papilloedema (67.5%) and seizures 51 (63.75%). Pregnancy was the most common cause of CVT. Superior sagittal and transverse sinuses were the most common sinuses to be affected. The sensitivity and specificity of D-dimer for diagnosing CVT was 84.62% and 80% respectively. The risk factors for poor prognosis were altered sensorium, presence of sepsis, increased sinus involvement and deep sinus thrombosis. Conclusion CVT affects both sexes equally. Puerperium still contributes to majority of the cases. Iron deficiency anaemia needs to be evaluated as a contributing factor for incidence of CVT. D-dimer is not useful in puerperal female with CVT. Positive D-dimer will strengthen the suspicion of CVT in patients with acute headache followed by a neurological deficit. PMID:27504325
Background The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. Methods In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed ‘different’, and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Results Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Conclusions Multiple approaches to data
Swaroopa, Deme; Bhaskar, Kakarla; Mahathi, T.; Katkam, Shivakrishna; Raju, Y. Satyanarayana; Chandra, Naval; Kutala, Vijay Kumar
Background and Aim: Studies on potential biomarkers in experimental models of acute lung injury (ALI) and clinical samples from patients with ALI have provided evidence to the pathophysiology of the mechanisms of lung injury and predictor of clinical outcome. Because of the high mortality and substantial variability in outcomes in patients with acute respiratory distress syndrome (ARDS), identification of biomarkers such as cytokines is important to determine prognosis and guide clinical decision-making. Materials and Methods: In this study, we have included thirty patients admitted to Intensive Care Unit diagnosed with ARDS, and serum samples were collected on day 1 and 7 and were analyzed for serum interleukin-6 (IL-6) and IL-8 by ELISA method, and Acute Physiology and Chronic Health Evaluation II (APACHE II) scoring was done on day 1. Results: The mortality in the patients observed with ARDS was 34%. APACHE II score was significantly higher in nonsurvivors as compared to survivors. There were no significant differences in gender and biochemical and hematological parameters among the survivors and nonsurvivors. Serum IL-6 and IL-8 levels on day 1 were significantly higher in all the ARDS patients as compared to healthy controls and these levels were returned to near-normal basal levels on day 7. The serum IL-6 and IL-8 levels measured on day 7 were of survivors. As compared to survivors, the IL-6 and IL-8 levels were significantly higher in nonsurvivors measured on day 1. Spearman's rank correlation analysis indicated a significant positive correlation of APACHE II with IL-8. By using APACHE II score, IL-6, and IL-8, the receiver operating characteristic curve was plotted and the provided predictable accuracy of mortality (outcome) was 94%. Conclusion: The present study highlighted the importance of measuring the cytokines such as IL-6 and IL-8 in patients with ARDS in predicting the clinical outcome. PMID:27688627
Nascimento, E; Fabreti de Oliveira, R A; Maciel, M D; Pereira, A B; das Mercêz de Lucas, F; Salomão-Filho, A; Pereira, W A; Moreira, J B; Vilaça, S S; de Castro Gontijo, R; Lasmar, M F; Vianna, H R; Magalhâes, A; Calazans, C A C; Simão-Filho, C; Vilela, B
Donor-specific antibodies (DSAs) play a fundamental role in kidney transplantation. The identification of DSAs is an essential rejection parameter. We evaluated a protocol in 237 patients receiving kidneys from living (LDs) and deceased donors (DDs). Recipients were classified as being at low (LR), medium (MR), high (HR), or strong (SR) risk of rejection based on Luminex panel reactive antibody (PRA)-single antigen beads (SABs). Grafts that survived for 1 year were evaluated. Of the 237 transplanted patients, 129 (54.43%) received a kidney from an LD and 108 (45.57%) from a DD. Of 95 LR recipients receiving kidneys from LDs, 2 patients lost the graft due to non-immunological causes. Of 34 MR recipients, 13 had rejection episodes, and 2 lost the graft by AMR and one by cellular rejection (CR). Of 108 recipients receiving a kidney from a DD, 59 (54.63%) were LR, 31 (28.70%) MR, 11 (10.19%) HR, and 7 (6.48%) SR. Twenty of all transplanted recipients lost their grafts; 4 were due to clinical causes, 4 by cellular rejection, and 12 by antibody-mediated rejection (AMR) with PRA-SAB mean fluorescent intensity of 530 to 12,591. One-year graft survival for LD transplanted LR and MR patients was 97.6% and 94.1%, respectively (P = .004). In DD recipients, the LR vs MR SD was P = .011, and for LR vs HR + SR it was P = .001. For MR vs HR+SR no SD was found (P = .323). Rejections were detected in 51 patients (21.52%). Graft failure occurred in 16 patients (6.75%). A total of 218 (91.98%) recipients maintained good kidney function after 1 year. This protocol based on fluxogram risk assessment of AMR provided fast and precise immunological evaluation of recipients and donors and stratification by immunological risk of AMR. Copyright © 2014 Elsevier Inc. All rights reserved.
Harris, Stewart B.; Naqshbandi Hayward, Mariam; Tompkins, Jordan W.
Abstract Rationale, aims and objectives Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real‐world evaluation. Method Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real‐world comprehensive evaluations in health care settings. Results The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub‐steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built‐in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. Conclusions This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale‐up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. PMID:26804339
Smith, Stephanie L; Misago, Claire Nancy; Osrow, Robyn A; Franke, Molly F; Iyamuremye, Jean Damascene; Dusabeyezu, Jeanne D'Arc; Mohand, Achour A; Anatole, Manzi; Kayiteshonga, Yvonne; Raviola, Giuseppe J
Introduction Integrating mental healthcare into primary care can reduce the global burden of mental disorders. Yet data on the effective implementation of real-world task-shared mental health programmes are limited. In 2012, the Rwandan Ministry of Health and the international healthcare organisation Partners in Health collaboratively adapted the Mentoring and Enhanced Supervision at Health Centers (MESH) programme, a successful programme of supported supervision based on task-sharing for HIV/AIDS care, to include care of neuropsychiatric disorders within primary care settings (MESH Mental Health). We propose 1 of the first studies in a rural low-income country to assess the implementation and clinical outcomes of a programme integrating neuropsychiatric care into a public primary care system. Methods and analysis A mixed-methods evaluation will be conducted. First, we will conduct a quantitative outcomes evaluation using a pretest and post-test design at 4 purposively selected MESH MH participating health centres. At least 112 consecutive adults with schizophrenia, bipolar disorder, depression or epilepsy will be enrolled. Primary outcomes are symptoms and functioning measured at baseline, 8 weeks and 6 months using clinician-administered scales: the General Health Questionnaire and the brief WHO Disability Assessment Scale. We hypothesise that service users will experience at least a 25% improvement in symptoms and functioning from baseline after MESH MH programme participation. To understand any outcome improvements under the intervention, we will evaluate programme processes using (1) quantitative analyses of routine service utilisation data and supervision checklist data and (2) qualitative semistructured interviews with primary care nurses, service users and family members. Ethics and dissemination This evaluation was approved by the Rwanda National Ethics Committee (Protocol #736/RNEC/2016) and deemed exempt by the Harvard University Institutional Review
Williams, Bryan; Lacy, Peter S; Thom, Simon M; Cruickshank, Kennedy; Stanton, Alice; Collier, David; Hughes, Alun D; Thurston, H; O'Rourke, Michael
Different blood pressure (BP)-lowering drugs could have different effects on central aortic pressures and thus cardiovascular outcome despite similar effects on brachial BP. The Conduit Artery Function Evaluation (CAFE) study, a substudy of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), examined the impact of 2 different BP lowering-regimens (atenolol+/-thiazide-based versus amlodipine+/-perindopril-based therapy) on derived central aortic pressures and hemodynamics. The CAFE study recruited 2199 patients in 5 ASCOT centers. Radial artery applanation tonometry and pulse wave analysis were used to derive central aortic pressures and hemodynamic indexes on repeated visits for up to 4 years. Most patients received combination therapy throughout the study. Despite similar brachial systolic BPs between treatment groups (Delta0.7 mm Hg; 95% CI, -0.4 to 1.7; P=0.2), there were substantial reductions in central aortic pressures with the amlodipine regimen (central aortic systolic BP, Delta4.3 mm Hg; 95% CI, 3.3 to 5.4; P<0.0001; central aortic pulse pressure, Delta3.0 mm Hg; 95% CI, 2.1 to 3.9; P<0.0001). Cox proportional-hazards modeling showed that central pulse pressure was significantly associated with a post hoc-defined composite outcome of total cardiovascular events/procedures and development of renal impairment in the CAFE cohort (unadjusted, P<0.0001; adjusted for baseline variables, P<0.05). BP-lowering drugs can have substantially different effects on central aortic pressures and hemodynamics despite a similar impact on brachial BP. Moreover, central aortic pulse pressure may be a determinant of clinical outcomes, and differences in central aortic pressures may be a potential mechanism to explain the different clinical outcomes between the 2 BP treatment arms in ASCOT.
Zoccali, Giovanni; Cinque, Benedetta; La Torre, Cristina; Lombardi, Francesca; Palumbo, Paola; Romano, Lucia; Mattei, Antonella; Orsini, Gino; Cifone, Maria Grazia; Giuliani, Maurizio
As known, fractional CO2 resurfacing treatments are more effective than non-ablative ones against aging signs, but post-operative redness and swelling prolong the overall downtime requiring up to steroid administration in order to reduce these local systems. In the last years, an increasing interest has been focused on the possible use of probiotics for treating inflammatory and allergic conditions suggesting that they can exert profound beneficial effects on skin homeostasis. In this work, the Authors report their experience on fractional CO2 laser resurfacing and provide the results of a new post-operative topical treatment with an experimental cream containing probiotic-derived active principles potentially able to modulate the inflammatory reaction associated to laser-treatment. The cream containing DermaACB (CERABEST™) was administered post-operatively to 42 consecutive patients who were treated with fractional CO2 laser. All patients adopted the cream twice a day for 2 weeks. Grades were given according to outcome scale. The efficacy of the cream containing DermaACB was evaluated comparing the rate of post-operative signs vanishing with a control group of 20 patients topically treated with an antibiotic cream and a hyaluronic acid based cream. Results registered with the experimental treatment were good in 22 patients, moderate in 17, and poor in 3 cases. Patients using the study cream took an average time of 14.3 days for erythema resolution and 9.3 days for swelling vanishing. The post-operative administration of the cream containing DermaACB induces a quicker reduction of post-operative erythema and swelling when compared to a standard treatment.
Lin, Carol Alice; Bhandari, Mohit; Guyatt, Gordon; Walter, Stephen D; Schemitsch, Emil H; Swiontkowski, Marc; Sanders, David; Tornetta, Paul
To determine the extent to which knowledge from clinical trial protocols is transferred to nonparticipating patients. Retrospective review of prospectively collected data from a large clinical trial. Six level-1 international trauma centers. We compared rates and timing of reoperation in a subset of patients enrolled in the Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) to concurrent patients who were eligible but not enrolled. This was a retrospective review of prospectively collected trial data. The records of 6 of the original SPRINT centers were searched for non-SPRINT patients who underwent intramedullary nailing of a closed tibial fracture. The rate and timing of reoperation were compared. A P < 0.05 was considered significant. One hundred fourteen non-SPRINT patients were compared with 328 patients enrolled in SPRINT from those same sites. There were 7 reoperations (6.1%) in non-SPRINT patients versus 18 (5.2%) in SPRINT patients [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.41 to 3.13; P = 0.811]. There was no difference in the time to reoperation between the SPRINT and non-SPRINT patients (6.2 vs. 6.8 months, 95% CI of the difference -3.8 to 2.6; P = 0.685) or in the proportion of patients who underwent reoperation before 6 months (29% vs. 43%; OR 1.75; 95% CI 0.18 to 15.41; P = 0.647). Patients not enrolled in SPRINT had similarly low rates of reoperation for nonunion, and the average time to reoperation for both groups was longer than 6 months. A 6-month waiting period may have allowed slow-to-heal fractures adequate time to heal, thereby reducing the rate of diagnosis of nonunion. As such, this waiting period could contribute to lower-than-expected reoperation rates for nonunion. It is possible that clinical trials may beneficially influence the care of nonenrolled patients.
Southern Regional Education Board, Atlanta, GA.
Outcome evaluation assesses the results or benefits of mental health services received by clients or communities by comparing descriptive data on the mental health status of clients at different points in time. It aids clinicians and managers in planning programs and managing clinical services. A mental health center should establish goal-oriented…
Sander, Rebecca; Trible, Karen A
Two years ago, faculty and students at this rural university setting collaborated to implement a virtual clinical evaluation tool. In recognition of the frustrations involved in coordinating instructor and student input to a hard copy tool, a virtual clinical evaluation tool was created in the form of an Excel spreadsheet. Excel documents have the advantage of immediate retrieval and use by instructors or students, ease of narration by word processing, automatic mathematical computation of formative and summative scores, and data storage through computer archives. Using the online Blackboard course, students and instructors are able to collaboratively input a Likert score for each posted evaluation outcome and word process-related comments about students' clinical performance. An overview of the 2-year implementation of this virtual clinical evaluation tool, as well as the evaluation process, is discussed.
Lieber, Sarah B; Fowler, Mary Louise; Zhu, Clara; Moore, Andrew; Shmerling, Robert H; Paz, Ziv
Limited data guide practice in evaluation and treatment of septic bursitis. We aimed to characterize clinical characteristics, microbiology, and outcomes of patients with septic bursitis stratified by bursal involvement, presence of trauma, and management type. We conducted a retrospective cohort study of adult patients admitted to a single center from 1998 to 2015 with culture-proven olecranon and patellar septic bursitis. Baseline characteristics, clinical features, microbial profiles, operative interventions, hospitalization lengths, and 60-day readmission rates were determined. Patients were stratified by bursitis site, presence or absence of trauma, and operative or non-operative management. Of 44 cases of septic bursitis, patients with olecranon and patellar bursitis were similar with respect to age, male predominance, and frequency of bursal trauma; patients managed operatively were younger (p = 0.05). Clinical features at presentation and comorbidities were similar despite bursitis site, history of trauma, or management. The most common organism isolated from bursal fluid was Staphylococcus aureus. Patients managed operatively were discharged to rehabilitation less frequently (p = 0.04). This study of septic bursitis is among the largest reported. We were unable to identify presenting clinical features that differentiated patients treated surgically from those treated conservatively. There was no clear relationship between preceding trauma or bursitis site and clinical course, management, or outcomes. Patients with bursitis treated surgically were younger. Additional study is needed to identify patients who would benefit from early surgical intervention for septic bursitis.
Parikh, Coral; Gutgarts, Victoria; Eisenberg, Elliot; Melamed, Michal L.
Most dialysis patients are vitamin D deficient, including deficiencies in both activated vitamin D (1, 25-dihydroxyvitamin D) and the less active 25-hydroxyvitamin D. These and other abnormalities associated with chronic kidney disease (CKD), if they remain untreated, lead to secondary hyperparathyroidism and bone changes, such as osteitis fibrosa cystica. Activated vitamin D has been proven to decrease parathyroid hormone (PTH) levels in dialysis patients and is currently used for this indication. There are multiple other potential “pleotrophic” effects associated with vitamin D therapy. These include associations with lower all-cause and cardiovascular mortality, lower rates of infections and improved glycemic indexes. Meta-analyses of multiple observational studies have shown activated vitamin D therapy to be associated with improved survival. Observational data also suggest fewer infections and better glucose control. There have been no randomized clinical trials powered to evaluate mortality or other clinical outcomes. Small trials of nutritional vitamin D (ergocalciferol and cholecalciferol) showed increases in 25-hydroxyvitamin D levels without hypercalcemia or hyperphosphatemia, even when given in addition to activated vitamin D therapy. While activated vitamin D therapy is associated with improved outcomes, it also leads to higher fibroblast growth factor 23 (FGF-23) levels, which may be detrimental in dialysis patients. Further research is needed to evaluate whether activated or nutritional vitamin D therapy are beneficial in dialysis patients for outcomes other than secondary hyperparathyroidism. PMID:26424141
Nouri, Aria; Tetreault, Lindsay; Côté, Pierre; Zamorano, Juan J; Dalzell, Kristian; Fehlings, Michael G
Ambispective study. To determine whether MRI parameters improve the predictive performance of a validated clinical prediction rule used to assess functional outcomes in surgical patients with DCM. Degenerative cervical myelopathy (DCM) is the most common cause of spinal cord dysfunction in the elderly worldwide. A clinical prediction rule was developed to discriminate between patients with mild myelopathy postoperatively (mJOA ≥ 16) and those with substantial residual neurological impairment (mJOA < 16). Recently, a separate magnetic resonance imaging (MRI)-based prediction model was created. However, a model exploring the combined predictive value of imaging and clinical variables does not exist. One hundred and fourteen patients with MRIs were examined from a cohort of 278 patients enrolled in the AOSpine CSM-North America Study. Ninety-nine patients had complete preoperative imaging and postoperative outcome data. MRIs were evaluated for the presence/absence of signal change on T2- and T1-weighted images. Quantitative analysis of the T2 signal change was conducted and maximum canal compromise and cord compression were calculated. The added predictive performance of each MRI parameter to the clinical model was evaluated using receiver operator characteristic curves. The model developed on our subsample yielded an area under the receiver operator curve (AUC) of 0.811 (95% CI: 0.726-0.896). The addition of imaging variables did not significantly improve the predictive performance. Small improvements in prediction were obtained when sagittal extent of T2 hyperintensity (AUC: 0.826, 95% CI: 0.743-0.908, 1.35% increase) or Wang ratio (AUC: 0.823, 95% CI: 0.739-0.907, 1.21%) was added. Anatomic characteristics, such as maximum canal compromise and maximum cord compression, did not improve the discriminative ability of the clinical prediction model. In our sample of surgical patients, with clinical and image-evidence of DCM, MRI parameters do not significantly add to
Eastlack, Robert K; Garfin, Steven R; Brown, Christopher R; Meyer, S Craig
Prospective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study. To evaluate and summarize the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure. Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells and osteoprogenitor cells that is intended to mimic the performance of iliac crest autograft without the morbidity associated with its harvest. A total of 182 patients were treated with anterior cervical discectomy and fusion using Osteocel Plus in a polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analogue scale for neck and arm pain, neck disability index, and SF-12 physical and mental component scores. Computed tomography and plain film radiographic measures included assessment of bridging bone, disc height, disc angle, and segmental range of motion. A total of 249 levels were treated in 182 patients. Mean procedure time was 100 minutes, blood loss was less than 50 mL in 93% of patients, and hospital stay was 1 day or less in 84% of patients. Significant (P<0.05) average improvements in clinical outcomes from preoperatively to 24 months included the following: neck disability index: 21.5%; visual analogue scale neck: 34 mm; visual analogue scale arm: 35 mm; SF-12 physical component score: 11.2; SF-12 mental component score: 6.8. At 24 months, 93% of patients were satisfied with their outcome. In patients treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3°. In combined single- and 2-level procedures, 87% (157/180) of levels achieved solid bridging and 92% (148/161) had range of motion of less than 3° at 24 months. No patient required revision for pseudarthrosis. Improvements in clinical results at 2 years, high
Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.
Background: The Combined Quality Care Anterior Cruciate Ligament registry provides data for clinical research regarding primary anterior cruciate ligament (ACL) surgery. Purpose: To explore the data with regard to the clinical outcomes between sexes after ACL reconstruction in a Dutch population. Study Design: Cohort study; Level of evidence, 3. Methods: Data involving patients diagnosed with an ACL tear and eligible for surgery were recorded. Isokinetic muscle strength, functional muscle performance, and anterior-posterior translation of the knee joint were documented preoperatively and at 3, 6, 9, and 12 months postoperatively. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner rating scales during each examination using a web-based questionnaire. Results: Approximately 90% of ACL injuries occurred during sport activities. The mean (SD) age at surgery was 28 (11) years for both men and women, and the majority of patients were treated with hamstring tendon autografts (94%). Four percent received bone–patellar tendon–bone autografts, and 2% of the patients received other grafts. Preoperatively, the KOOS, Lysholm, and Tegner scores were significantly higher in males. Twelve months postoperatively, both sexes showed comparable isokinetic strength (P = .336), knee laxity (P = .680), and hop test for distance (P = .122) when comparing the injured with the uninjured side. Self-reported knee function was comparable between sexes as assessed by the KOOS (P = .202), Lysholm (P = .872), and Tegner (P = .767) questionnaires during the 12-month follow-up. Conclusion: One year after ACL surgery, all patients had improved greatly, showing only minor differences between sexes. The male group showed slightly better results when evaluating self-reported knee questionnaires. Comparable outcomes and knee function between sexes can therefore be presumed with patients who are treated with hamstring tendon autografts in a Dutch
Tsehaie, J; Poot, D H J; Oei, E H G; Verhaar, J A N; de Vos, R J
To evaluate whether baseline MRI parameters provide prognostic value for clinical outcome, and to study correlation between MRI parameters and clinical outcome. Observational prospective cohort study. Patients with chronic midportion Achilles tendinopathy were included and performed a 16-week eccentric calf-muscle exercise program. Outcome measurements were the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire and MRI parameters at baseline and after 24 weeks. The following MRI parameters were assessed: tendon volume (Volume), tendon maximum cross-sectional area (CSA), tendon maximum anterior-posterior diameter (AP), and signal intensity (SI). Intra-class correlation coefficients (ICCs) and minimum detectable changes (MDCs) for each parameter were established in a reliability analysis. Twenty-five patients were included and complete follow-up was achieved in 20 patients. The average VISA-A scores increased significantly with 12.3 points (27.6%). The reliability was fair-good for all MRI-parameters with ICCs>0.50. Average tendon volume and CSA decreased significantly with 0.28cm(3) (5.2%) and 4.52mm(2) (4.6%) respectively. Other MRI parameters did not change significantly. None of the baseline MRI parameters were univariately associated with VISA-A change after 24 weeks. MRI SI increase over 24 weeks was positively correlated with the VISA-A score improvement (B=0.7, R(2)=0.490, p=0.02). Tendon volume and CSA decreased significantly after 24 weeks of conservative treatment. As these differences were within the MDC limits, they could be a result of a measurement error. Furthermore, MRI parameters at baseline did not predict the change in symptoms, and therefore have no added value in providing a prognosis in daily clinical practice. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.
Zellers, Jennifer A.; Cortes, Daniel H.
Introduction Achilles tendon rupture results in significant functional deficits regardless of treatment strategy (surgical versus non-surgical intervention). Recovery post-rupture is highly variable, making comprehensive patient assessment critical. Assessment tools may change along the course of recovery as the patient progresses – for instance, moving from a seated heel-rise to standing heel-rise to jump testing. However, tools that serve as biomarkers for early recovery may be particularly useful in informing clinical decision-making. The purpose of this case report was to describe the progress of a young, athletic individual following Achilles tendon rupture managed non-surgically, using patient reported and functional performance outcome measures and comprehensively evaluating Achilles tendon structure and function incorporating a novel imaging technique (cSWE). Subject Description The subject is a 26 year-old, female basketball coach who sustained an Achilles tendon rupture and was managed non-surgically. Outcome The subject was able to steadily progress using a gradual tendon loading treatment approach well-supported by the literature. Multiple evaluative techniques including the addition of diagnostic ultrasound imaging and continuous shear wave elastography (cSWE) to standard clinical tests and measures were used to assess patient-reported symptoms, tendon structure, and tendon functional performance. Five assessments were performed over the course of 2-14 months post-rupture. By the 14-month follow-up, the subject had achieved full self-reported function. Tendon structural and mechanical properties showed similar shear modulus by 14 months, however, viscosity continued to be lower and tendon length longer on the ruptured side. Functional performance, evidenced by the heel-rise test and jump tests, also showed a positive trajectory, however, deficits of 12-28% remained between ruptured and non-ruptured sides at 14 months. Discussion This case report
Lewkowicz, Deborah; Willermain, François; Relvas, Lia Judice; Makhoul, Dorine; Janssens, Sarah; Janssens, Xavier; Caspers, Laure
Purpose. To review the clinical outcome of patients with hypertensive uveitis. Methods. Retrospective review of uveitis patients with elevated intraocular pressure (IOP) > 25 mmHg and >1-year follow-up. Data are uveitis type, etiology, viral (VU) and nonviral uveitis (NVU), IOP, and medical and/or surgical treatment. Results. In 61 patients, IOP values are first 32.9 mmHg (SD: 9.0), highest 36.6 mmHg (SD: 9.9), 3 months after the first episode 19.54 mmHg (SD: 9.16), and end of follow-up 15.5 mmHg (SD: 6.24). Patients with VU (n = 25) were older (50.6 y/35.7 y, p = 0.014) and had more unilateral disease (100%/72.22% p = 0.004) than those with NVU (n = 36). Thirty patients (49.2%) had an elevated IOP before topical corticosteroid treatment. Patients with viral uveitis might have higher first elevated IOP (36.0/27.5 mmHg, p = 0,008) and maximal IOP (40.28/34.06 mmHg, p = 0.0148) but this was not significant when limited to the measurements before the use of topical corticosteroids (p = 0.260 and 0.160). Glaucoma occurred in 15 patients (24.59%) and was suspected in 11 (18.03%) without difference in viral and nonviral groups (p = 0.774). Conclusion. Patients with VU were older and had more unilateral hypertensive uveitis. Glaucoma frequently complicates hypertensive uveitis. Half of the patients had an elevated IOP before topical corticosteroid treatment. PMID:26504598
Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.
Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design. PMID:27602406
Effect of baseline exercise capacity on outcomes in patients with stable coronary heart disease (a post hoc analysis of the clinical outcomes utilizing revascularization and aggressive drug evaluation trial).
Padala, Santosh K; Sidhu, Mandeep S; Hartigan, Pamela M; Maron, David J; Teo, Koon K; Spertus, John A; Mancini, G B John; Sedlis, Steven P; Chaitman, Bernard R; Heller, Gary V; Weintraub, William S; Boden, William E
The impact of baseline exercise capacity on clinical outcomes in patients with stable ischemic heart disease randomized to an initial strategy of optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI) in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial has not been studied. A post hoc analysis was performed in 1,052 patients of COURAGE (PCI + OMT: n = 527, OMT: n = 525) who underwent exercise treadmill testing at baseline. Patients were categorized into 2 exercise capacity groups based on metabolic equivalents (METs) achieved during baseline exercise treadmill testing (<7 METs: n = 464, ≥7 METs: n = 588) and were followed for a median of 4.6 years. The primary composite end point of death or myocardial infarction was similar in the PCI + OMT group and the OMT group for patients with exercise capacity <7 METs (19.1% vs 16.1%, p = 0.31) and ≥7 METs (13.3% vs 10.3%, p = 0.27). After adjusting for baseline covariates, the hazard ratio (99% confidence interval) for the primary end point for the PCI + OMT group versus the OMT group was 1.42 (0.90 to 2.23, p = 0.05) and for the exercise capacity subgroups of ≥7 METs and <7 METs was 0.75 (0.46 to 1.22, p = 0.13). There was no statistically significant interaction between the original treatment arm allocation (PCI + OMT vs OMT) and baseline exercise capacity. In conclusion, there was no difference in the long-term clinical outcomes in patients with exercise capacity <7 METs compared with ≥7 METs, irrespective of whether they were assigned to initial PCI. Patients with exercise capacity <7 METs did not derive a proportionately greater clinical benefit from PCI + OMT compared with those patients who received OMT alone. Published by Elsevier Inc.
Background Schizophrenia is a chronic mental health disorder associated with increased hospital admissions and excessive utilization of outpatient services and long-term care. This analysis examined health care resource utilization from a 24-month observational study of patients with schizophrenia initiated on risperidone long-acting therapy (RLAT). Methods Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE) was a 24-month observational study designed to examine real-world treatment outcomes by prospectively following patients with schizophrenia initiated on RLAT. At baseline visit, prior hospitalization and ER visit dates were obtained for the previous 12 months and subsequent hospitalization visit dates were obtained at 3-month visits, if available. The health care resource utilization outcomes measures observed in this analysis were hospitalizations for any reason, psychiatric-related hospitalizations, and emergency room (ER) visits. Incidence density analysis was used to assess pre-event and postevent rates per person-year (PY). Results The primary medical resource utilization analysis included 435 patients who had a baseline visit, ≥1 postbaseline visits after RLAT initiation, and valid hospitalization dates. The number of hospitalizations and ER visits per PY declined significantly (p < .0001) after initiation with RLAT. A 41% decrease (difference of -0.29 hospitalizations per PY [95% CI: -0.39 to -0.18] from baseline) in hospitalizations for any reason, a 56% decrease (a difference of -0.35 hospitalizations per PY [95% CI: -0.44 to -0.26] from baseline) in psychiatric-related hospitalizations, and a 40% decrease (-0.26 hospitalizations per PY [95% CI: -0.44 to -0.10] from baseline) in ER visits were observed after the baseline period. The percentage of psychiatric-related hospitalizations decreased significantly after RLAT initiation, and patients had fewer inpatient hospitalizations and ER visits (all p < .0001). Conclusion The
Cantarini, Luca; Fabbroni, Marta; Talarico, Rosaria; Costa, Luisa; Caso, Francesco; Cuneo, Gian Luca; Frediani, Bruno; Faralli, Gabriele; Vitale, Antonio; Brizi, Maria Giuseppina; Sabadini, Luciano; Galeazzi, Mauro
The primary aim of the study was to evaluate the long-term effectiveness of adalimumab (ADA) in a cohort of non-radiographic axial spondyloarthritis (nr-axSpA), and the secondary aims were to identify predictive factors of response and evaluate radiological progression.We evaluated 37 patients (male/female: 12/25; mean age 49 ± 14; mean disease duration: 6.3 ± 5.8) with active nr-axSpA (Assessment of SpondyloArthritis International Society criteria), despite the treatment with ≥1 nonsteroidal anti-inflammatory drug for at least 3 months, initiating the treatment with ADA 40 mg every other week. Patients were treated for 24 months, and evaluated at baseline, 6, 12, and 24 months. Outcome measures included Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index. Radiograph of the spine and sacroiliac joints and magnetic resonance of the sacroiliac joints were performed at baseline and according to the standard of assessment for the disease.The proportion of patients that achieved a BASDAI50 response at 6, 12 and 24 months was 51.3%, 70.3%, and 76.8%, respectively. Treatment was well tolerated with no unexpected adverse events and/or serious adverse events. All patients remained on treatment for 2 years, with a good compliance. We did not identify any predictive factor of response to therapy. Moreover, modified Stoke Ankylosing Spondylitis Spine Score and Spondyloarthritis Research Consortium of Canada scores showed a trend of improvement during the study period.ADA was effective on clinical and radiological outcomes at 2-year follow-up; thus, early treatment with ADA may prevent radiographic damage and be associated with low disease activity or remission. Moreover, data from this cohort study have confirmed safety and tolerability profile of ADA in nr-axSpA in the long term.
Towards empirical identification of a clinically meaningful indicator of treatment outcome: Features of candidate indicators and evaluation of sensitivity to treatment effects and relationship to one year follow up cocaine use outcomes
Carroll, Kathleen M.; Kiluk, Brian D.; Nich, Charla; DeVito, Elise E.; Decker, Suzanne; LaPaglia, Donna; Duffey, Dianne; Babuscio, Theresa A.; Ball, Samuel A.
Background Selection of an appropriate indictor of treatment response in clinical trials is complex, particularly for the various illicit drugs of abuse. Most widely-used indicators have been selected based on expert group recommendation or convention rather than systematic empirical evaluation. Absence of an evidence-based, clinically meaningful index of treatment outcome hinders cross-study evaluations necessary for progress in addiction treatment science. Method Fifteen candidate indicators used in multiple clinical trials as well as some proposed recently are identified and discussed in terms of relative strengths and weaknesses (practicality, cost, verifiability, sensitivity to missing data). Using pooled data from five randomized controlled trials of cocaine dependence (N = 434), the indicators were compared in terms of sensitivity to the effects of treatment and relationship to cocaine use and general functioning during follow-up. Results Commonly used outcome measures (percent negative urine screens; percent days of abstinence) performed relatively well in that they were sensitive to the effects of the therapies evaluated. Others, including complete abstinence and reduction in frequency of use, were less sensitive to effects of specific therapies and were very weakly related to cocaine use or functioning during follow-up. Indicators more strongly related to cocaine use during follow-up were those that reflected achievement of sustained periods of abstinence, particularly at the end of treatment. Conclusions These analyses did not demonstrate overwhelming superiority of any single indicator, but did identify several that performed particularly poorly. Candidates for elimination included retention, complete abstinence, and indicators of reduced frequency of cocaine use. PMID:24556275
Ikemoto, Roberto Yukio; Murachovsky, Joel; Nascimento, Luís Gustavo Prata; Bueno, Rogério Serpone; Almeida, Luis Henrique; Strose, Eric; Castiglia, Marcello Teixeira
Objective: To evaluate the clinical and functional outcomes from arthroscopic repairs on small and medium-sized tears of the supraspinatus muscle tendon. Methods: 129 cases of isolated small and medium tears of the supraspinatus muscle tendon were evaluated retrospectively. The average duration of pain was 29 months. The average joint range of motion comprised active elevation of 136°, lateral rotation of 58° and medial rotation at T12 level; and the preoperative functional UCLA score averaged 17 points. In all the cases, complete repair could be achieved. Results: The average score on the UCLA functional scale in the postoperative period was 32 points. The average length of follow-up was 39 months. Seventy-five cases (58%) had excellent results and 42 (32%) had good results. The average final active elevation was 156° with an average gain of 20°, and the average final lateral rotation was 57° with an average gain of 9°. Both of these were statistically significant (P < 0.05). The patients who underwent tenotomy of the long head of the biceps (LHB), with or without tenodesis, did not present statistically inferior functional outcomes, in comparison with the patients who only underwent decompression and lesion repair (P = 1.00). Fourteen cases (10.8%) presented complications during the postoperative period. Six (4.6%) developed adhesive capsulitis and four (3.1%) presented re-rupture of the tendon, proven by means of magnetic resonance imaging. Conclusions: Arthroscopic repair of small and medium tears of the supraspinatus muscle tendon provided a functional clinical improvement, with good and excellent results in 90% of the cases. PMID:27047846
Liu, Junfen; Wu, Yuanxia; Xu, Suming; Su, Dan; Han, Yingli; Wu, Xueqing
This retrospective study aimed to evaluate pregnancy outcome and newborn health condition for a specific group of infertile patients with unicornuate uterus. A total of 34 patients were confirmed to have unicornuate uterus. These patients received 47 cycles of in vitro fertilisation-embryo transfer (IVF-ET) or intracytoplasmic sperm injection-embryo transfer (ICSI-ET), achieved 21 clinical pregnancies with a clinical pregnancy rate of 60.61%. Full-term delivery rate was 76.47%. Eleven patients gave birth to single neonates, while six patients gave birth to twins. Foetal growth restriction was detected in three foetuses in twins. Obstetric complications were reported in three patients with single foetus (27.27%, 3/11), and four out of six patients with twin pregnancies (66.67%, 4/6). This study demonstrated that Han Chinese women with unicornuate uterus have a good chance to conceive and deliver healthy neonates despite increased risk of complications. Impact statement What is already known on this subject: Unicornuate uterus is a rare form of malformation affecting about 1% of infertile patients. Patients with unicornuate uterus have a lower chance of conceiving. It has been reported that assisted reproduction such as in vitro fertilisation-embryo transfer (IVF-ET) was less likely to be successful in patients with unicornuate uterus. What do the results of this study add: Retrospective study of 34 cases of Han Chinese women with unicornuate uterus offered a new perspective. Half of these 34 patients conceived and delivered 23 neonates (11 singletons and 6 pairs of twins). Complications were more frequent but manageable. What are the implications of these findings for clinical practice and/or further research: Our data will serve as a valuable tool for counselling infertile patients with unicornuate uterus with regard to their expected pregnancy outcomes.
Valentini, Vincenzo; Coco, Claudio; Rizzo, Gianluca; Manno, Alberto; Crucitti, Antonio; Mattana, Claudio; Ratto, Carlo; Verbo, Alessandro; Vecchio, Fabio M; Barbaro, Brunella; Gambacorta, Maria A; Montoro, Caterina; Barba, Maria C; Sofo, Luigi; Papa, Valerio; Menghi, Roberta; D'Ugo, Domenico M; Doglietto, Giovanbattista
Our objective was evaluate the outcome of primary clinical T4M0 extraperitoneal rectal cancer treated by neoadjuvant radiochemotherapy. Prognosis of clinical T4 rectal cancer is poor. Preoperative chemoradiation therapy may be beneficial. The results obtained are unclear due to lack of objective and strictly applied staging methods. Patients with primary, clinical, T4MO, extraperitoneal rectal cancer, defined by transrectal ultrasonography, computed tomography or magnetic resonance imaging, were considered. Intraoperative radiotherapy and adjuvant chemotherapy were employed in some patients after curative resection (R0). Variables influencing the possibility to perform an R0 resection and a sphincter-saving procedure were investigated as predictors of outcome. 100 patients were included. R0 resection was performed in 78 patients. R0 resection rate was greater in females (93% vs 67%) and in responders to neoadjuvant chemoradiation (94% vs 60%). The ability to perform a sphincter-saving procedure was 57%, greater in middle rectal location (85% vs 51%) and in responders to the chemoradiation (70% vs 47%). Median follow-up was 31 months (range, 4-136). Local recurrences were found in 7 patients (10%). Five-year local control in R0 patients was 90% and better in the IORT group (100%). Distant relapse occurred in 24 patients (30%). Five-year overall survival was 59%, and was better after an R0 versus an R1 or R2 resection (68% vs 22%). Overall and disease free survival in R0 patients improved after overall downstaging. Adjuvant chemotherapy given in addition to the neoadjuvant therapy did not appear to offer benefit in improving survival. A multimodal approach enabled us to obtain a 5-year overall survival of about 60%. IORT increased local control. The role of adjuvant chemotherapy needs to be further investigated.
Song, Xiao; Zhou, Xiao-Hua; Ma, Shuangge
SUMMARY For censored survival outcomes, it can be of great interest to evaluate the predictive power of individual markers or their functions. Compared with alternative evaluation approaches, the time-dependent ROC (receiver operating characteristics) based approaches rely on much weaker assumptions, can be more robust, and hence are preferred. In this article, we examine evaluation of markers’ predictive power using the time-dependent ROC curve and a concordance measure which can be viewed as a weighted area under the time-dependent AUC (area under the ROC curve) profile. This study significantly advances from existing time-dependent ROC studies by developing nonparametric estimators of the summary indexes and, more importantly, rigorously establishing their asymptotic properties. It reinforces the statistical foundation of the time-dependent ROC based evaluation approaches for censored survival outcomes. Numerical studies, including simulations and application to an HIV clinical trial, demonstrate the satisfactory finite-sample performance of the proposed approaches. PMID:22987578
Newble, David I.
In Australia the usual evaluation of whether a student will perform adequately as a doctor is a subjective evaluation of his clinical performance, usually at the completion of five or six years at medical school. The evaluation is performed on an inadequate and uncontrolled patient sample and appears to be subject to many errors. Recent work…
Trent, Maria; Bass, Debra; Ness, Roberta B; Haggerty, Catherine
PEACH trial data were used to evaluate the relationship between subsequent sexually transmitted infection and recurrent pelvic inflammatory disease on infertility and chronic pelvic pain (CPP). Recurrent pelvic inflammatory disease was associated with an almost 2-fold increase in infertility and more than 4-fold increase in CPP. Subsequent sexually transmitted infection was associated with CPP, but not infertility.
Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio-J; Canullo, Luigi; Peñarrocha-Diago, Miguel
To evaluate and compare peri-implant health, marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses. The present study was a prospective, randomized, single-blind, clinical preliminary trial. Patients were randomized into two treatment groups. In Group A implants were placed immediately post-extraction and in Group B six months after extraction. The following control time-points were established: one week, six months and twelve months after loading. Measurements were taken of peri-implant crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis. Implant success rates were evaluated for the two groups. The study sample included fifteen patients (nine women and six men) with a mean average age of 63.7 years. One hundred and forty-four implants were placed: 76 placed in healed sites and 68 placed immediately. At the moment of prosthetic loading, keratinized mucosa width and probing depth were higher in immediate implants than delayed implants, with statistically significant differences. However, after six and twelve months, differences between groups had disappeared. Bone loss was 0.54 ± 0.39 mm for immediate implants and 0.66 ± 0.25 mm for delayed implants (p=0.201). No implants failed in either group. The present study with a short follow-up and a small sample yielded no statistically significant differences in implant success and peri-implant marginal bone loss between immediate and delayed implants with fixed full-arch prostheses. Peri-implant health showed no statistically significant differences for any of the studied parameters (crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis) at the twelve-month follow-up.
Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio J.; Canullo, Luigi
Purpose: To evaluate and compare peri-implant health, marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses. Material and Methods: The present study was a prospective, randomized, single-blind, clinical preliminary trial. Patients were randomized into two treatment groups. In Group A implants were placed immediately post-extraction and in Group B six months after extraction. The following control time-points were established: one week, six months and twelve months after loading. Measurements were taken of peri-implant crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis. Implant success rates were evaluated for the two groups. The study sample included fifteen patients (nine women and six men) with a mean average age of 63.7 years. One hundred and forty-four implants were placed: 76 placed in healed sites and 68 placed immediately. Results: At the moment of prosthetic loading, keratinized mucosa width and probing depth were higher in immediate implants than delayed implants, with statistically significant differences. However, after six and twelve months, differences between groups had disappeared. Bone loss was 0.54 ± 0.39 mm for immediate implants and 0.66 ± 0.25 mm for delayed implants (p=0.201). No implants failed in either group. Conclusions: The present study with a short follow-up and a small sample yielded no statistically significant differences in implant success and peri-implant marginal bone loss between immediate and delayed implants with fixed full-arch prostheses. Peri-implant health showed no statistically significant differences for any of the studied parameters (crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis) at the twelve-month follow-up. Key words:Immediate implants, delayed implants
Windisch, Péter; Stavropoulos, Andreas; Molnár, Bálint; Szendröi-Kiss, Dóra; Szilágyi, Emese; Rosta, Péter; Horváth, Attila; Capsius, Björn; Wikesjö, Ulf M E; Sculean, Anton
To present the safety profile, the early healing phase and the clinical outcomes at 24 weeks following treatment of human intrabony defects with open flap debridement (OFD) alone or with OFD and rhGDF-5 adsorbed onto a particulate β-tricalcium phosphate (β-TCP) carrier. Twenty chronic periodontitis patients, each with at least one tooth exhibiting a probing depth ≥6 mm and an associated intrabony defect ≥4 mm entered the study. Ten subjects (one defect/patient) were randomized to receive OFD alone (control) and ten subjects OFD combined with rhGDF-5/β-TCP. Blood samples were collected at screening, and at weeks 2 and 24 to evaluate routine hematology and clinical chemistry, rhGDF-5 plasma levels, and antirhGDF-5 antibody formation. Plaque and gingival indices, bleeding on probing, probing depth, clinical attachment level, and radiographs were recorded pre- and 24 weeks postsurgery. Comparable safety profiles were found in the two treatment groups. Neither antirhGDF-5 antibody formation nor relevant rhGDF-5 plasma levels were detected in any patient. At 6 months, treatment with OFD + rhGDF-5/β-TCP resulted in higher but statistically not significant PD reduction (3.7 ± 1.2 vs. 3.1 ± 1.8 mm; p = 0.26) and CAL gain (3.2 ± 1.7 vs. 1.7 ± 2.2 mm; p = 0.14) compared to OFD alone. In the tested concentration, the use of rhGDF-5/β-TCP appeared to be safe and the material possesses a sound biological rationale. Thus, further adequately powered, randomized controlled clinical trials are warranted to confirm the clinical relevance of this new approach in regenerative periodontal therapy. rhGDF-5/β-TCP may represent a promising new techology in regenerative periodontal therapy.
Yuzbasioglu, Emir; Kurt, Hanefi; Turunc, Rana; Bilir, Halenur
The purpose of this study was to compare two impression techniques from the perspective of patient preferences and treatment comfort. Twenty-four (12 male, 12 female) subjects who had no previous experience with either conventional or digital impression participated in this study. Conventional impressions of maxillary and mandibular dental arches were taken with a polyether impression material (Impregum, 3 M ESPE), and bite registrations were made with polysiloxane bite registration material (Futar D, Kettenbach). Two weeks later, digital impressions and bite scans were performed using an intra-oral scanner (CEREC Omnicam, Sirona). Immediately after the impressions were made, the subjects' attitudes, preferences and perceptions towards impression techniques were evaluated using a standardized questionnaire. The perceived source of stress was evaluated using the State-Trait Anxiety Scale. Processing steps of the impression techniques (tray selection, working time etc.) were recorded in seconds. Statistical analyses were performed with the Wilcoxon Rank test, and p < 0.05 was considered significant. There were significant differences among the groups (p < 0.05) in terms of total working time and processing steps. Patients stated that digital impressions were more comfortable than conventional techniques. Digital impressions resulted in a more time-efficient technique than conventional impressions. Patients preferred the digital impression technique rather than conventional techniques.
Background The purpose of this study was to compare two impression techniques from the perspective of patient preferences and treatment comfort. Methods Twenty-four (12 male, 12 female) subjects who had no previous experience with either conventional or digital impression participated in this study. Conventional impressions of maxillary and mandibular dental arches were taken with a polyether impression material (Impregum, 3 M ESPE), and bite registrations were made with polysiloxane bite registration material (Futar D, Kettenbach). Two weeks later, digital impressions and bite scans were performed using an intra-oral scanner (CEREC Omnicam, Sirona). Immediately after the impressions were made, the subjects’ attitudes, preferences and perceptions towards impression techniques were evaluated using a standardized questionnaire. The perceived source of stress was evaluated using the State-Trait Anxiety Scale. Processing steps of the impression techniques (tray selection, working time etc.) were recorded in seconds. Statistical analyses were performed with the Wilcoxon Rank test, and p < 0.05 was considered significant. Results There were significant differences among the groups (p < 0.05) in terms of total working time and processing steps. Patients stated that digital impressions were more comfortable than conventional techniques. Conclusions Digital impressions resulted in a more time-efficient technique than conventional impressions. Patients preferred the digital impression technique rather than conventional techniques. PMID:24479892
Frank, Rachel M.; Mellano, Chris; Shin, Jason J.; Feldheim, Terrence F.; Mascarenhas, Randhir; Yanke, Adam Blair; Cole, Brian J.; Nicholson, Gregory P.; Romeo, Anthony A.; Verma, Nikhil N.
Objectives: The purpose of this study was to determine the clinical outcomes following revision anterior shoulder stabilization performed either via all-arthroscopic soft tissue repair or via Latarjet coracoid transfer. Methods: A retrospective review of prospectively collected data on 91 shoulders undergoing revision anterior shoulder stabilization was performed. All patients underwent prior soft tissue stabilization; those with prior open bone grafting procedures were excluded. For patients with 25% glenoid bone loss, Latarjet was performed (n=28). Patients were queried regarding recurrent instability (subluxation or dislocation). Clinical outcomes were evaluated using validated patient reported outcome questionnaires including the American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), visual analog scale (VAS) for pain, and Western Ontario Shoulder Instability Index (WOSI). Results: A total of 63 shoulders in 62 patients (46 males, 16 females) with an average age of 23.2 ± 6.9 years were included in the revision arthroscopy group. At an average follow-up of 46.9 ± 16.8 months (range, 15 to 78), the mean WOSI score was 80.1 (range, 15.0 to 100), and there were significant improvements (p<0.001) in ASES (63.7 to 85.1), SST (6.2 to 9.1), and VAS pain scores (2.89 to 0.81). Recurrent instability occurred in 12 of 63 shoulders (19%); the number of prior surgeries and baseline hyperlaxity were significant risk factors for failure (p<0.001 and p=0.04, respectively). No patients developed clinical or radiographic evidence of arthritis. A total of 28 shoulders in 28 patients (21 male, 7 female) with an average age of 27.5 years (range 14 to 45) were included in the Latarjet group. Thirteen (46%) had more than one previous stabilization attempt. ), the average WOSI score was 71.9, and there were significant improvements (p<0.001) in ASES (65.7 to 87.0), SST (7.2 to 10.3), and VAS (3.1 to 1.1). Recurrent instability occurred in 2 of 28 shoulders
Gated myocardial perfusion single photon emission computed tomography in the clinical outcomes utilizing revascularization and aggressive drug evaluation (COURAGE) trial, Veterans Administration Cooperative study no. 424.
Shaw, Leslee J; Heller, Gary V; Casperson, Paul; Miranda-Peats, Romalisa; Slomka, Piotr; Friedman, John; Hayes, Sean W; Schwartz, Ronald; Weintraub, William S; Maron, David J; Dada, Marcin; King, Spencer; Teo, Koon; Hartigan, Pamela; Boden, William E; O'Rourke, Robert A; Berman, Daniel S
Stress gated myocardial perfusion single photon emission computed tomography (gSPECT) is increasingly used before and after intercurrent therapeutic intervention and is the basis for ongoing evaluation in the Department of Veterans Affairs clinical outcomes utilizing revascularization and aggressive drug evaluation (COURAGE) trial. The COURAGE trial is a North American multicenter randomized clinical trial that enrolled 2287 patients to aggressive medical therapy vs percutaneous coronary intervention plus aggressive medical therapy. Three COURAGE nuclear substudies have been designed. The goals of substudy 0 are to examine the diagnostic accuracy of the extent and severity of inducible ischemia at baseline in COURAGE patients compared with patient symptoms and quantitative coronary angiography and to explore the relationship between inducible ischemia and the benefit from revascularization when added to medical therapy. Substudy 1 will correlate the extent and severity of provocative ischemia with the frequency, quality, and instability of recurrent symptoms in postcatheterization patients. Substudy 2 (n = 300) will examine the usefulness of sequential gSPECT monitoring 6 to 18 months after therapeutic intervention. Together, these nuclear substudies will evaluate the role of gSPECT to determine the effectiveness of aggressive risk-factor modifications, lifestyle interventions, and anti-ischemic medical therapies with or without revascularization in reducing patients' ischemic burdens. The unfolding of evidence on the application of gSPECT in trials such as COURAGE defines a new era for nuclear cardiology. We hope the evidence that emerges from the COURAGE trial will further establish the role of nuclear imaging in the evidence-based management of patients with stable coronary disease.
Hertzano, Ronna; Teplitzky, Taylor B; Eisenman, David J
The clinical evaluation of patients with tinnitus differs based on whether the tinnitus is subjective or objective. Subjective tinnitus is usually associated with a hearing loss, and therefore, the clinical evaluation is focused on an otologic and audiologic evaluation with adjunct imaging/tests as necessary. Objective tinnitus is divided into perception of an abnormal somatosound or abnormal perception of a normal somatosound. The distinction between these categories is usually possible based on a history, physical examination, and audiogram, leading to directed imaging to identify the underlying abnormality.
Gregory, J. M.; Harwood, D. P.; Gochanour, E.; Sherman, S. L.; Romeo, A. A.
Purpose: Biceps tenotomy and tenodesis are effective treatment options for biceps pathology, but outcomes of revision surgery are not known. This study examines the clinical outcomes of patients who have undergone a revision biceps tenodesis. Materials and Methods: A retrospective review of all patients since 2004 (N = 21) who had undergone a revision biceps tenodesis with greater than 6-month follow-up was completed. A follow-up survey was carried out, and the visual analog scale (VAS), Single Assessment Numeric Evaluation (SANE), Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES), and University of California – Los Angeles (UCLA) scores were obtained, along with SF-12 Mental (MCS-12) and Physical Component Summaries (PCS-12). Results: Indications for revision surgery were continued pain (14) and ruptured biceps (7). Complete follow-up examinations were performed in 15 of 21 patients (71.4%). Average follow-up was 33.4 ± 23.5 months. The mean postoperative scores were 1.9 out of 10, VAS; 79 out of 100, SANE; 10.2 out of 12, SST; 83 out of 100, ASES; 29 out of 35, UCLA; 44, PCS- 12; and 47.1, MCS- 12. Five patients were considered failures with a UCLA score below 27. Seventeen of twenty-one patient underwent concomitant procedures. Complete preoperative and postoperative data were collected for 14 patients. All scores demonstrated highly significant improvement from preoperative levels (P < 0.005), except for the MCS-12. There was no statistically significant difference in the outcomes of revision due to rupture and revision due to persistent pain. Conclusions: The results suggest that revision subpectoral biceps tenodesis provides significant pain relief and improvement in functional outcomes at a mean follow-up of 33.4 months. Level of Evidence: Case Series, Level 4. PMID:22787333
Banday, Irshad Ahmad; Gattoo, Imran; Khan, Azher Maqbool; Javeed, Jasima; Gupta, Ghanshyam; Latief, Mohmad
Acute Pancreatitis is a very common condition leading to the emergency visits in both developed and developing countries. Computed Tomography plays a pivotal role in the diagnosis and subsequent management of pancreatitis. The modified CT severity index includes a simplified assessment of pancreatic inflammation and necrosis as well as an assessment of extra pancreatic complications. To study role of modified computed tomography severity index in evaluation of acute pancreatitis and its correlation with clinical outcome. This was a hospital based prospective correlative study done on patients of all age groups referred to the Department of Radio diagnosis from the various indoor and outdoor departments of the hospital, with clinical/Laboratory/ultrasonography findings suggestive of acute pancreatitis. The severity of pancreatitis was scored using Modified CT severity index & CT severity index and classified into mild, moderate and severe categories. Total of 50 patients of acute pancreatitis presenting to the emergency department of our hospital were included in the study. Clinical outcome parameters for correlation collected from respective referral departments included, the length of hospital stay (in days), need for surgical intervention, need for percutaneous intervention (aspiration and drainage), evidence of infection in any organ system (combination of a fever > 100°F and elevated WBC >15,000/ mm(3)), evidence of organ failure (PaO2 < 60 mm Hg or need of ventilation, systolic BP of < 90 mm Hg, serum creatinine of >300μmoles/L or urine output of < 500 ml / 24 h) and death. The age of the patients in the study group was in the range of 17 to 80 years. Maximum patients were in the age group 40-50 years (42.0%). The mean age was 42.32 years. Out of 50 cases, 33 (66%) were male and 17 (34%) were females with a male to female ratio of 2:1. Cholelithiasis was found to be most common aetiological factor for acute pancreatitis in 40% cases. Alcoholic pancreatitis
Braswell, H R; Williamson, J W
The application of a protocol for the initial assessment of medical care outcomes of geriatric depression management in four multispecialty group practice clinics is described. The clinical findings of this study are limited, but the protocol for the assessment of depression outcomes was found to be feasible, practical and acceptable in all four clinics. The success of the study has positive implications both for improving management of depressed clinic patients and for adapting this quality assurance approach to other health conditions and care settings. PMID:507262
This study was performed to investigate the clinical outcome of childhood masturbation. For this purpose 50 children (mean age = 48.7 +/- 24.5 months, 34 girls females and 16 boys males) with masturbation symptoms were examined at first visit to the Department of Child Psychiatry and two years thereafter with psychiatric interviews. The mean masturbation frequency at the initial interview was significantly decreased after two years. It was noted that 39 children (78%) were completely recovered and 11 children (22%) continued to masturbate after two years. Children who did not recover were significantly younger, began to masturbate earlier and masturbated more frequently than others at the time of initial evaluation. It was concluded that the findings about the beneficial effect of sedative drugs in combination with parental guidance, education and means for behavior modification were promising.
Jordan, T S; Davies, P D
The global targets for tuberculosis (TB) control set by the World Health Assembly (WHA) in 1991 were detection of at least 70% and cure of at least 85% of new sputum smear-positive TB cases by 2000, later revised to 2005. The DOTS strategy was introduced in the mid-1990s, and later became the cornerstone of the Stop TB Strategy, which was launched along with the Global Plan to Stop TB 2006-2015 in 2006. The Global Plan sets out how and to what extent the Stop TB Strategy should be implemented between 2006 and 2015 to achieve the TB-related Millennium Development Goal (MDG) to halt and reverse the incidence of TB by 2015 and the Stop TB Partnership targets to reduce TB prevalence and death rates to 50% of 1990 levels by 2015, and to eliminate TB as a public health concern by 2050. Treatment success and case detection rates are outcome indicators used to measure the effectiveness of TB control along with the impact indicators incidence, prevalence and death rates. Globally, the rate of treatment success for smear-positive cases treated exceeded the WHA global target of 85% for the first time in 2007. This review focuses on articles related to treatment outcome in TB published in the International Journal of Tuberculosis and Lung Disease in 2009.
Atwater, Brett D; Oujiri, James; Wolff, Matthew R
The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial confirmed that percutaneous coronary intervention is no better than optimal medical therapy for the prevention of major adverse cardiac events in patients with stable angina. The impact of these findings on clinical practice remains unknown. Clinicians may more frequently opt for medical rather than procedural therapy of stable angina in response to the COURAGE trial. Clinical information was collected from patients with stable angina referred to our hospital for cardiac catheterization between January 1, 2007 and June 18, 2007 (n = 332). Catheterization referral volume and the use of medications and coronary revascularization were compared before and after the release of the COURAGE trial. There was a significant increase in anti-ischemia medication use prior to catheterization referral following the COURAGE trial (mean = 1.31 [SD 0.83] medications pre-COURAGE, mean = 1.54 [SD 0.84] medications post-COURAGE, P = 0.012). Among 217 patients with coronary disease on catheterization, treatment with medication rather than percutaneous or surgical revascularization increased after COURAGE (11.1% pre-COURAGE vs 23.0% post-COURAGE, P = 0.03). There was also a significant decrease in referral volume following the COURAGE trial (3.12 referrals/day pre-COURAGE vs 2.51 referrals/day post-COURAGE, P = 0.034). The COURAGE trial immediately impacted the management of stable angina. Catheterization referral volume decreased, medication use increased, and the use of medical therapy rather than revascularization increased among patients with coronary disease.
Williams, Rebecca J; Tse, Tony; DiPiazza, Katelyn; Zarin, Deborah A
Clinical trials that end prematurely (or "terminate") raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study.
Williams, Rebecca J.; Tse, Tony; DiPiazza, Katelyn; Zarin, Deborah A.
Background Clinical trials that end prematurely (or “terminate”) raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. Methods and Findings A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Conclusions Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study
Weimar, Dawn; Gray, Jeffrey; Davies, Bud
As Medicaid expands in scope and influence, it is evolving toward being a “purchaser” of quality health care. This commentary discusses measurement and incentivization of clinical outcomes in Medicaid. Advantages and disadvantages of outcome versus process measures are discussed. Distinctions are drawn between the roles of Medicare and Medicaid, including the implications of the growth in Medicaid managed care. Medicaid's influence is particularly notable for obstetric, pediatric, newborn, and long-term care. We provide data on 3 Medicaid outcomes: potentially preventable hospital admissions, readmissions, and complications. The commentary concludes with suggestions for choosing and implementing outcome-oriented value-based purchasing initiatives in Medicaid. PMID:26945295
Heinemann, Allen W; Connelly, Lauri; Ehrlich-Jones, Linda; Fatone, Stefania
Outcome measurement is crucial to assuring high-quality patient services and improving the quality of services provided by prosthetists. This article summarizes recent evidence on the measurement properties of outcome measures, and updates previously published summaries of outcome instruments. The review focuses on measures of mobility, functional status, quality of life, and patient satisfaction, and includes both performance-based and patient-reported outcomes. Amputation-specific and general measures that are suitable for patients served by prosthetists are discussed. It is encouraging that responsiveness of measures is often reported, as this information is needed to improve clinical utility.
Choi, Keum-Hyeong; Buskey, Wendy; Johnson, Bonita
The main purpose of this study was to investigate how receiving personal counseling at a university counseling center helps students deal with their personal problems and facilitates academic functioning. To that end, this study used both clinical and academic outcome measures that are relevant to the practice of counseling provided at a…
Choi, Keum-Hyeong; Buskey, Wendy; Johnson, Bonita
The main purpose of this study was to investigate how receiving personal counseling at a university counseling center helps students deal with their personal problems and facilitates academic functioning. To that end, this study used both clinical and academic outcome measures that are relevant to the practice of counseling provided at a…
Sacks, Lauren; Yee, Kristen; Huijbregts, Maria; Miller, Patricia A; Aggett, Tanya; Salbach, Nancy M
To evaluate the construct validity of the Activity Inventory of the Chedoke-McMaster Stroke Assessment and the Clinical Outcome Variables Scale (COVS), 2 measures of functional mobility. A retrospective longitudinal study of 24 inpatients (mean age 83 years (standard deviation 7)) on a geriatric rehabilitation unit. The primary reasons for admission were deconditioning (n=9) and hip fracture (n=7). We tested hypotheses that Activity Inventory and COVS scores at admission and discharge, and change scores during hospital stay would correlate. Longitudinal construct validity was also estimated using effect size and standardized response mean. Correlations between scores on each measure ranged from r=0.59-0.93 across subscales and total scales (p<0.01). The effect size of the Activity Inventory and the COVS was 1.53 and 1.43, respectively. The standardized response mean of the Activity Inventory and the COVS was 1.83 and 2.30, respectively. Although findings support the validity of both measures, the COVS appears more efficient and sensitive than the Activity Inventory to change in this population. A larger study is needed to confirm these findings.
Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton
Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome.
Surdea Blaga, Teodora; Dumitrascu, Dan; Galmiche, Jean-Paul; Bruley des Varannes, Stanislas
Patients with heartburn and normal upper gastrointestinal endoscopy, normal oesophageal acid exposure, no symptom-reflux association and who fail to respond to a proton-pump inhibitor are classified as having functional heartburn (FH). This study aimed (i) to characterize the symptoms and functional abnormalities of patients with FH and (ii) to describe their clinical outcome. Among all patients referred for 24 h multichannel intraluminal impedance-pH (MII-pH), patients with FH were identified. The clinical characteristics and high-resolution oesophageal pressure topography recordings of FH patients were analyzed at the time of the 24-h MII-pH test. A symptom-related and health-related quality-of-life questionnaire was then sent to FH patients to assess the long-term outcome. Forty patients fulfilled the criteria for FH, representing 8.5% of the referred population. Twenty-two months after initial testing, 66% of patients still suffered from heartburn. The rate of mixed reflux (liquid/gas) was higher in patients with persisting heartburn at the final evaluation (63 vs. 50%, P=0.04). Sixty-six per cent of patients had one or more manometric abnormalities. Acid clearance time in MII-pH was significantly higher in patients with weak peristalsis than patients with normal peristalsis (60 ± 45 vs. 31 ± 19 s, P=0.03). A high rate of mixed reflux and/or a manometric abnormality were associated with a higher risk of persistent heartburn. FH is a chronic disorder with persisting symptoms in two-thirds of patients. An increased rate of mixed reflux and/or the presence of manometric abnormalities are associated with a higher risk of persisting symptoms and may help to identify the population with unmet therapeutic needs.
Baptista, Sergio Bravo; Raposo, Luís; Santos, Lino; Ramos, Ruben; Calé, Rita; Jorge, Elisabete; Machado, Carina; Costa, Marco; Infante de Oliveira, Eduardo; Costa, João; Pipa, João; Fonseca, Nuno; Guardado, Jorge; Silva, Bruno; Sousa, Maria-João; Silva, João Carlos; Rodrigues, Alberto; Seca, Luís; Fernandes, Renato
Penetration of fractional flow reserve (FFR) in clinical practice varies extensively, and the applicability of results from randomized trials is understudied. We describe the extent to which the information gained from routine FFR affects patient management strategy and clinical outcome. Nonselected patients undergoing coronary angiography, in which at least 1 lesion was interrogated by FFR, were prospectively enrolled in a multicenter registry. FFR-driven change in management strategy (medical therapy, revascularization, or additional stress imaging) was assessed per-lesion and per-patient, and the agreement between final and initial strategies was recorded. Cardiovascular death, myocardial infarction, or unplanned revascularization (MACE) at 1 year was recorded. A total of 1293 lesions were evaluated in 918 patients (mean FFR, 0.81±0.1). Management plan changed in 406 patients (44.2%) and 584 lesions (45.2%). One-year MACE was 6.9%; patients in whom all lesions were deferred had a lower MACE rate (5.3%) than those with at least 1 lesion revascularized (7.3%) or left untreated despite FFR≤0.80 (13.6%; log-rank P=0.014). At the lesion level, deferral of those with an FFR≤0.80 was associated with a 3.1-fold increase in the hazard of cardiovascular death/myocardial infarction/target lesion revascularization (P=0.012). Independent predictors of target lesion revascularization in the deferred lesions were proximal location of the lesion, B2/C type and FFR. Routine FFR assessment of coronary lesions safely changes management strategy in almost half of the cases. Also, it accurately identifies patients and lesions with a low likelihood of events, in which revascularization can be safely deferred, as opposed to those at high risk when ischemic lesions are left untreated, thus confirming results from randomized trials. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01835808. © 2016 American Heart Association, Inc.
Barcelos, Roberta; Tannure, Patricia Nivoloni; Gleiser, Rogerio; Luiz, Ronir Raggio; Primo, Laura Guimarães
The effect of smear layer (SL) removal on primary tooth pulpectomy outcome has not been well elucidated. To determine the effect of SL removal on primary tooth pulpectomy outcome. This is a double-blind, randomized, and controlled clinical trial. Forty-eight patients were randomly divided into SL removal (G1 = 40 teeth) or smear layer nonremoval (G2 = 42 teeth) groups. Following the chemomechanical preparation with K-files and 2.5% sodium hypochlorite (NaOCl), teeth were irrigated with either 6% citric acid and 0.9% physiologic solution (G1) or only 0.9% physiologic solution (G2). Camphorated paramonochlorophenol was used as intracanal medication. At the second appointment, 1 week after, root canals were filled with zinc oxide-eugenol paste. Clinical and radiographical baseline criteria were stipulated equally for both groups. The success rate (G1 = 91.2%; G2 = 70.0%) was statistically different (P = 0.04) between the groups. In G2, the outcome was affected significantly by pulpal necrosis (P = 0.02), pre-operatory symptoms (P = 0.02), and periapical/inter-radicular radiolucency (P = 0.04). The pulpectomy outcome was improved by smear layer removal. The outcome for teeth with pulpal necrosis, pre-operatory symptoms, or periapical/inter-radicular radiolucency was significantly improved by removal of the smear layer. © 2011 The Authors. International Journal of Paediatric Dentistry © 2011 BSPD, IAPD and Blackwell Publishing Ltd.
Psychogios, Marios-Nikos; Schramm, Peter; Frölich, Andreas Maximilian; Kallenberg, Kai; Wasser, Katrin; Reinhardt, Lars; Kreusch, Andreas S; Jung, Klaus; Knauth, Michael
Patient selection is crucial in the endovascular treatment of acute ischemic stroke patients. Baseline computed tomographic (CT) images, evaluated with the Alberta Stroke Program Early CT Scale (ASPECTS), are considered significant predictors of outcome. In this study, we evaluated CT images and perfusion parameters, analyzed with ASPECTS, as final outcome predictors after endovascular stroke treatment. We analyzed a cohort of patients with acute ischemic stroke and endovascular treatment. Patients with an occlusion of the M1 segment and multimodal CT imaging were included. CT perfusion data were reconstructed using commercial software. Two experienced neuroradiologists separately reviewed and scored CT and CT perfusion images with the ASPECTS score. Parameters were compared between patients with poor and with favorable follow-up outcome. Significantly different variables were further analyzed by forward stepwise logistic regression. Fifty-one patients were included in our study. Baseline characteristics did not differ between patients with favorable and poor outcomes. No significant difference in recanalization status, the various times, or CT ASPECTS was demonstrated between these 2 groups. Significant differences were demonstrated for age (P=0.0049), cerebral blood volume ASPECTS (P=0.0007), and between cerebral blood volume and cerebral blood flow ASPECTS (P=0.0045). Cerebral blood volume ASPECTS>7 demonstrated the highest sensitivity and specificity for favorable outcome with 84% and 79%, respectively. CT perfusion parameters, evaluated with ASPECTS, are optimal predictors of outcome and are more sensitive and specific than CT ASPECTS in the prediction of favorable outcome. Use of these parameters in treatment decisions could reduce futile recanalizations.
Coates, Dominiek; Woodford, Patricia; Higgins, Oliver; Grover, Deborah
The present study is a review of a cardiometabolic clinic for consumers taking clozapine. This clinic was recently established and co-located with the clozapine clinic at a regional hospital in New South Wales, Australia, to enhance engagement and improve the physical health outcomes of consumers taking antipsychotic medication. A descriptive analysis of clients' (n = 73) information collected during routine care for the first 6 months of the clinic's operation, from January 2016 to July 2016, was conducted. First-visit data were analysed to establish a client profile, consisting of weight, height, blood pressure, pulse, a range of blood measurements, smoking status, alcohol consumption, and eating and exercise habits. Data collected for clients who had three or more visits with the general practitioner (n = 40) were analysed separately for outcomes. Two case studies are used to depict the service received and client profile. At the first appointment, the majority of clients had metabolic syndrome that was mostly left untreated; many of these clients were commenced on metformin. The outcomes are positive, and show that the majority of clients lost weight (82.5%) and had a reduction in body mass index (84.6%); nearly half (44.4%) had a reduction in waist circumference. The majority of clients self-reported increased physical activity (72.5%, n = 29) and positive dietary changes (77.5%, n = 31) since their first appointment. The model trialled by the cardiometabolic clinic integrated a specialist mental health and primary care service, and demonstrates success in engaging clients with severe mental illness in physical health care. Co-location is conceptualized as critical for positive patient outcomes and high levels of engagement.
Viala-Danten, Muriel; Martin, Susan; Guillemin, Isabelle; Hays, Ron D
Background Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries. Methods Clinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights. Results Cronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with measures of sleep interference and
Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T; Calvert, Melanie
Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account
Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T
Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer
Women are under-represented in landmark clinical trials that form the basis of evidence based management of cardiovascular diseases. Differences among male and female patients emerged in effectiveness and safety of therapeutics in some diseases. Especially in dyslipidemia, ischemic heart diseases and heart failure, trials in which women are better represented and guidelines that evaluate findings in women more detailed are needed. This article evaluates differences among men and women in some landmark trials that are used among main references in management guidelines.
Blesneag, AV; Slăvoacă, DF; Popa, L; Stan, AD; Jemna, N; Isai Moldovan, F; Mureșanu, DF
Rationale: Repetitive transcranial magnetic stimulation (rTMS) is used alone or in combination with physiotherapy for rehabilitation of stroke patients. TMS mapping can also quantify the excitability of the motor area in both the ipsilesional (IL) and contralateral (CL) hemisphere. Objective: This study is the first to measure the dynamics of cortical excitability by TMS mapping before and after treatment with low-frequency (LF) rTMS in the contralesional hemisphere at three different timepoints. Furthermore, the patients were clinically evaluated during the same visit as the mapping to establish both short and long-term outcomes after rTMS treatment. Methods and Results: A total of 16 participants with acute ischemic stroke were assessed 10 days post-stroke by TMS mapping. The patients were randomized into two equal groups: a real rTMS group and a sham group. The rTMS group received LF-rTMS to the contralesional hemisphere for 10 days, starting on the first day after the first mapping. Each subject was also evaluated by mapping on days 45 and 90 after stroke onset. The primary clinical outcome measured was the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) on days 10, 45 and 90 post-stroke. At 10 days after stroke onset, both groups presented low excitability in the lesion side and high excitability in the non-affected side. In the real rTMS group, at 45 days after stroke, a downward trend in the excitability of the contralesional hemisphere and an upward trend in the excitability of the lesioned side were observed. At 90 days after stroke, a tendency toward balanced excitability between both hemispheres was observed. In the sham group, at both 45 and 90 days, we observed increased excitability in the non-affected side compared to the side with the lesioned motor area. At 45 days, the real rTMS group demonstrated a better recovery of the upper limb motor function than the sham group, but at 90 days, there was no significant difference between the two groups
Jia, Pu; Tang, Hai; Chen, Hao; Bao, Li; Feng, Fei; Yang, He; Li, Jinjun
A sandwich vertebra is formed after multiple osteoporotic vertebral fractures treated by percutaneous vertebroplasty, which has a risk of developing new fractures. The purpose of our study was to (i) investigate the occurrence of new fractures in sandwich vertebra after cement augmentation procedures and to (ii) evaluate the clinical outcomes after prophylactic vertebral reinforcement applied with resorbable bone cement. From June 2011 to 2014, we analysed 55 patients with at least one sandwich vertebrae and treated with percutaneous vertebroplasty. Eighteen patients were treated by prophylactic vertebroplasty with a resorbable bone cement to strengthen the sandwich vertebrae as the prevention group. The others were the non-prevention group. All patients were examined by spinal radiographs within 1 day, 6 months, 12 months, 24 months and thereafter. The incidence of sandwich vertebra is 8.25% (55/667) in our study. Most sandwich vertebrae (69.01%, 49/71) are distributed in the thoracic–lumbar junction. There are 24 sandwich vertebrae (18 patients) and 47 sandwich vertebrae (37 patients) in either prevention group or non-prevention group, respectively. No significant difference is found between age, sex, body mass index, bone mineral density, cement disk leakage, sandwich vertebrae distribution or Cobb angle in the two groups. In the follow-up, 8 out of 37 (21.6%) patients (with eight sandwich vertebrae) developed new fractures in non-prevention’ group, whereas no new fractures were detected in the prevention group. Neither Cobb angle nor vertebral compression rate showed significant change in the prevention group during the follow-up. However, in the non-prevention group, we found that Cobb angle increased and vertebral height lost significantly (P < 0.05). Prophylactic vertebroplasty procedure applied with resorbable bone cement could decrease the rate of new fractures of sandwich vertebrae. PMID:28149529
Yakimo, Richard; Kurlowicz, Lenore H; Murray, Ruth Beckmann
This report describes and evaluates the current status of outcome analysis in Psychiatric Consultation-Liaison Nursing (PCLN) and offers suggestions for future development. The status of outcome evaluation generally in psychiatric nursing is described with attention given to the scope of practice of PCLN and outcomes used by psychiatric consultation-liaison nurses (PCLNs) to evaluate their interventions. An evaluation framework based on Donabedian's paradigm of structure, process, and outcome is presented and its applicability shown to PCLN. This framework is further explicated with regard to a review of published studies of PCLN within the outcome domains of cost reduction, satisfaction with services, changes in clinical status, and perceptions of work environment. Finally, recommendations for further development of outcomes in PCLN are offered, based on the strengths and limitations of the extant literature.
Rogers, Katherine; Evans, Chris; Campbell, Malcolm; Young, Alys; Lovell, Karina
Previous research has argued that the mental well-being of d/Deaf people is poorer than that of hearing populations. However, there is a paucity of valid and reliable mental health instruments in sign language that have been normalised with d/Deaf populations. The aim of this study was to determine the reliability of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) with d/Deaf populations. A British Sign Language (BSL) version was produced using a team approach to forward translation, and a back-translation check. The CORE-OM was incorporated into an online survey, to be completed in either BSL or English, as preferred by the participant. From December 2010 to March 2011, data were collected from 136 d/Deaf people. Cronbach's α was used to measure the internal consistency of items in the CORE-OM. Comparisons were made between versions, including comparisons with the non-clinical hearing population (not in receipt of mental health services) in a previous study. The reliability of the overall score, as well as the non-risk items in both the BSL and English versions, was satisfactory. The internal reliability of each domain in the BSL version was good (Cronbach's α > 0.70) and comparable to the English version in the hearing population. This was true for most domains of the CORE-OM in the English version completed by d/Deaf people, although the Functioning domain had a relatively low α of 0.79 and the Risk domain had an α of only 0.66 This raised the question whether it is advisable to use a mental health assessment with d/Deaf populations that has been standardised with hearing populations. Nevertheless, this study has shown that it is possible to collect data from d/Deaf populations in the UK via the web (both in BSL and English), and an online BSL version of the CORE-OM is recommended for use with Deaf populations in the community.
Stonestreet, J S; Prevost, S S
This article describes how organizations devise strategic directions. The process of focused strategic or hoshin planning is introduced and reviewed. This model illustrates how a nursing department planned a focused strategic direction for outcomes evaluation. This discussion includes the dedication of resources, the focusing of research priorities and a summary of the outcomes evaluation program, and the method used for implementation of the priorities. Finally, benefits of both the focused planning process and the outcomes evaluation program are discussed.
Shaikh, Abdul Razak; Sangrasi, Ahmed Khan; Shaikh, Gulshan Ara
Appendectomy, being the most common surgical procedure performed in general surgery, is still being performed by both open and laparoscopic methods due to a lack of consensus as to which is the most appropriate method. Because further trials are necessary and few such studies have been performed in developing countries, we decided to evaluate the outcomes of the 2 procedures to share our experience with the international community. Consecutive patients with suspected acute appendicitis who underwent laparoscopic (LA) (n=48) and open (n=52) appendectomy (OA) over a period of 3 years were studied. Clinical outcomes were compared between the 2 groups in relation to operative time, analgesia used, length of hospital stay, return to work, resumption of a regular diet, and postoperative complications. Mean age of patients was 25.8 years in the laparoscopic and 25.5 years in the open group. Patient demographics were similar in both groups (P>0.05). There was significantly less need for analgesia (1.0+/-0.5 in LA and 1.5+/-0.6 doses in OA), a short hospital stay (1.4+/-0.7 in LA and 3.4+/-1.0 days in OA), early return to work (12.6+/-3.3 in LA and 19.1+/-3.1 days in OA), and less time needed to return to a regular diet (20.1+/-2.9 in LA and 22.0+/-4.7, P<0.05 in OA) in the laparoscopic appendectomy group. Operative time was significantly shorter (54.9+/-14.7 in LA and 13.6+/-12.6 minutes in OA) in the open group. Total number of complications was less in the laparoscopic group; however, there was no statistically significant difference. The laparoscopic technique is a safe and clinically beneficial operative procedure. It provides certain advantages over open appendectomy, including short hospital stay, decreased requirement of postoperative analgesia, early food tolerance, and earlier return to normal activities. Where feasible, laparoscopy should be undertaken as the initial procedure of choice for most cases of suspected appendicitis.
Nursing educators and preceptors often find it difficult to evaluate prelicensure students' clinical judgment development. Clinical judgment is critical to excellent patient care decisions and outcomes. The Lasater Clinical Judgment Rubric, a validated, evidence-based clinical judgment rubric, is described as a tool that offers a common language for students, nurse educators, and preceptors and a trajectory for students' clinical judgment development. The rubric has been used to provide feedback for reflective journals and a means for self-evaluation in addition to a guide for formulating higher level thought questions to shape students' thinking like a nurse.
Lederman, Evan S; Toth, Alison P; Nicholson, Gregory P; Nowinski, Robert J; Bal, George K; Williams, Gerald R; Iannotti, Joseph P
Minimal information is currently available on the outcome of rotator cuff repair reinforced with an extracellular matrix (ECM) graft. Therefore, the purpose of this study was to determine the clinical and radiographic outcome of repair of large rotator cuff tears with ECM graft reinforcement. This was a prospective study of 61 shoulders with large repairable rotator cuff tears (3 to 5 cm). The rotator cuff tears were surgically repaired and reinforced with a xenograft ECM graft. The average patient age was 56 years (range, 40-69 years). The average tear size was 3.8 cm. Follow-up was obtained at 6, 12, and 24 months in 58, 54, and 50 of the 61 patients, respectively. Functional outcome scores, isometric muscle strength, and active range of motion were significantly improved compared with baseline. Magnetic resonance imaging at 12 months showed retorn rotator cuff repairs in 33.9% of shoulders, using the criteria of a tear of at least 1 cm, and tears in 14.5% of the shoulders using the criteria of retear >80% of the original tear size. Three patients underwent surgical revision. Complications included 1 deep infection. Repair of large rotator cuff tears structurally reinforced with xenograft ECM resulted in improved functional outcomes scores and strength. Adverse events were uncommon, and the rate of revision surgery was low. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.
Kinnison, Charles J.
An outcomes orientation is examined as the dominant focus for formulating improvements in a college's planning, management, and evaluation (PME) system. Outcomes are seen as individual (produced by college personnel or students), program related, or institutional. An outcomes orientation to PME has the advantages of relating to the quality of…
Vavken, Patrick; Ganal-Antonio, Anne Kathleen B; Quidde, Julia; Shen, Francis H; Chapman, Jens R; Samartzis, Dino
Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of "personalized spine care."
Vavken, Patrick; Ganal-Antonio, Anne Kathleen B.; Quidde, Julia; Shen, Francis H.; Chapman, Jens R.; Samartzis, Dino
Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of “personalized spine care.” PMID:26225283
Gamper, Eva Maria; Nerich, Virginie; Sztankay, Monika; Martini, Caroline; Giesinger, Johannes M; Scarpa, Lorenza; Buxbaum, Sabine; Jeller, Martin; Holzner, Bernhard; Virgolini, Irene
Currently there is little knowledge on real-life sustainability of routine patient-reported outcome (PRO) measurement and the representativeness of collected data. The investigation of routine PRO with regard to noncompletion bias and long-term adher- ence, considering the potential impact of mode of assessment (MOA) (paper-pencil vs. electronic PRO [ePRO]) and patient characteristics. At our department, routine PRO measurement in oncological patients is being done since 2005 using different MOA (paper-pencil assessment until 2011 and ePRO assessment from 2011 onward). We analyzed two different patient groups: patients eligible in both periods (both-MOA group) and patients eligible in only one period (one-MOA group). The primary outcome was PRO noncompletion (100% missing questionnaires). The secondary outcome was poor PRO adherence (>20% missing questionnaires). Multivariate logistic regression models were developed, testing the impact of MOA and patient characteristics on the outcomes in the different patient groups. Data from 1484 eligible patients were included in the analyses. Most of the patients could be included in PRO assessment at least once. PRO noncompletion rates were clearly higher during paper-pencil assessment (odds ratios between 2.72 and 4.31), as were poor PRO adherence rates (odd ratio 2.23). Analyses of potential bias by patient characteristics showed that male patients had a higher risk of poor adherence. Other factors with significant impact were age, country, and cancer diagnosis, but results were indecisive. ePRO increased the feasibility of our clinical routine PRO data for retrospective analyses by increasing completion rates. In general, potential completion bias regarding certain patient characteristics requires attention before generalizing results to the respective populations. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.
Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R
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.
Rice, Kenneth G.; Suh, Hanna; Ege, Engin
Data from clinical and nonclinical samples ("Ns" = 2,096, 618) were used to evaluate and replicate the measurement structure of the Outcome Questionnaire-45.2. Different measurement models and invariance tests were evaluated and the best psychometric support was found for a shortened measure of two factors: overall maladjustment and…
Rice, Kenneth G.; Suh, Hanna; Ege, Engin
Data from clinical and nonclinical samples ("Ns" = 2,096, 618) were used to evaluate and replicate the measurement structure of the Outcome Questionnaire-45.2. Different measurement models and invariance tests were evaluated and the best psychometric support was found for a shortened measure of two factors: overall maladjustment and…
Iselin, Anne-Marie R.; Gully, Kevin J.
This paper examines the sustainability and outcome of Alternatives for Families: A Cognitive-Behavioral Therapy (AF-CBT) as delivered by practitioners in a community-based child protection program who had received training in the model several years earlier. Formerly described as Abuse-Focused CBT, AF-CBT is an evidence-based treatment (EBT) for child physical abuse and family aggression/conflict that was included in the National Child Traumatic Stress Network’s initial EBT dissemination efforts in 2002. Seven practitioners participated in a year-long Learning Collaborative in AF-CBT and in similar training programs for 4 other EBTs. The agency’s routine data collection system was used to document the clinical and adjustment outcomes of 52 families presenting with a physically abused child who received their services between 2 and 5 years after the AF-CBT training had ended. Measures of the use of all 5 EBTs documented their frequency, internal consistency, and intercorrelations. Controlling for the unique content of the other four EBTs, the amount of AF-CBT Abuse-specific content delivered was related to improvements on standardized parent rating scales (i.e., child externalizing behavior, anger, anxiety, social competence) and both parent and clinician ratings of the child’s adjustment at discharge (i.e., child more safe, less scared/sad, more appropriate with peers). The amount of AF-CBT General content was related to a few discharge ratings (better child prognosis, helpfulness to parents). These novel data provide suggestive evidence for the sustainability and clinical benefits of AF-CBT in an existing community clinic serving physically abused children and their families, and are discussed in the context of key developments in the treatment model and dissemination literature. PMID:21354619
Storrs, Mark J; Alexander, Heather; Sun, Jing; Kroon, Jeroen; Evans, Jane L
Previous research on interprofessional education (IPE) assessment has shown the need to evaluate the influence of team-based processes on the quality of clinical education. This study aimed to develop a valid and reliable instrument to evaluate the effectiveness of interprofessional team-based treatment planning (TBTP) on the quality of clinical education at the Griffith University School of Dentistry and Oral Health, Queensland, Australia. A scale was developed and evaluated to measure interprofessional student team processes and their effect on the quality of clinical education for dental, oral health therapy, and dental technology students (known more frequently as intraprofessional education). A face validity analysis by IPE experts confirmed that items on the scale reflected the meaning of relevant concepts. After piloting, 158 students (61% response rate) involved with TBTP participated in a survey. An exploratory factor analysis using the principal component method retained 23 items with a total variance of 64.6%, suggesting high content validity. Three subscales accounted for 45.7%, 11.4%, and 7.5% of the variance. Internal consistency of the scale (α=0.943) and subscales 1 (α=0.953), 2 (α=0.897), and 3 (α=0.813) was high. A reliability analysis yielded moderate (rs=0.43) to high correlations (0.81) with the remaining scale items. Confirmatory factor analyses verified convergent validity and confirmed that this structure had a good model fit. This study suggests that the instrument might be useful in evaluating interprofessional or intraprofessional team-based processes and their influence on the quality of clinical education in academic dental institutions.
Consolaro, Alessandro; Giancane, Gabriella; Schiappapietra, Benedetta; Davì, Sergio; Calandra, Serena; Lanni, Stefano; Ravelli, Angelo
Juvenile idiopathic arthritis (JIA), as a chronic condition, is associated with significant disease- and treatment-related morbidity, thus impacting children's quality of life. In order to optimize JIA management, the paediatric rheumatologist has begun to regularly use measurements of disease activity developed, validated and endorsed by international paediatric rheumatology professional societies in an effort to monitor the disease course over time and assess the efficacy of therapeutic interventions in JIA patients.A literature review was performed to describe the main outcome measures currently used in JIA patients to determine disease activity status.The Juvenile Disease Activity Score (JADAS), in its different versions (classic JADAS, JADAS-CRP and cJADAS) and the validated definitions of disease activity and response to treatment represent an important tool for the assessment of clinically relevant changes in disease activity, leading more and more to a treat-to-target strategy, based on a tight and thorough control of the patient condition. Moreover, in recent years, increasing attention on the incorporation of patient-reported or parent-reported outcomes (PRCOs), when measuring the health state of patients with paediatric rheumatic diseases has emerged.We think that the care of JIA patients cannot be possible without taking into account clinical outcome measures and, in this regard, further work is required.
DeVito, Elise E.; Babuscio, Theresa A.; Nich, Charla; Ball, Samuel A.; Carroll, Kathleen M.
Background Despite extensive research on gender differences in addiction, there are relatively few published reports comparing treatment outcomes for women versus men based on evidence-based treatments evaluated in randomized clinical trials. Methods An aggregate sample comprised of data from five randomized clinical trials of treatment for cocaine dependence (N = 434) was evaluated for gender differences in clinical outcomes. Secondary analyses compared gender differences in outcome by medication condition (disulfiram versus no medication) and across multiple behavioral treatment conditions. Results Women, compared with men, had poorer treatment outcomes on multiple measures of cocaine use during treatment and at post-treatment follow-up. These results appear to be primarily accounted for by disulfiram being less effective in women compared with men. There was no evidence of meaningful gender differences in outcome as a function of the behavioral therapies evaluated. Conclusions These findings suggest that women and men may benefit to similar degrees from some empirically validated behavioral treatments for addiction. Conversely, some addiction pharmacotherapies, such as disulfiram, may be associated with poorer outcomes among women relative to men and point to the need for careful assessment of pharmacological treatments in both sexes prior to widespread clinical implementation. PMID:25457739
Henggeler, Scott W; Schaeffer, Cindy M
Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes.
Wehbe-Janek, Hania; Markova, Tsveti; Polis, Rachael L.; Peters, Marguerite; Liu, Yang
Background: Driven by changes to improve quality in patient care and population health while reducing costs, evolvement of the health system calls for restructuring health professionals' education and aligning it with the healthcare delivery system. In response to these changes, the Accreditation Council for Graduate Medical Education's Clinical Learning Environment Review (CLER) encourages the integration of health system leadership, faculty, and residents in restructuring graduate medical education (GME). Innovative approaches to achieving this restructuring and the CLER objectives are essential. Methods: The Alliance of Independent Academic Medical Centers National Initiative (NI) IV provided a multiinstitutional learning collaborative focused on supporting GME redesign. From October 2013 through March 2015, participants conducted relevant projects, attended onsite meetings, and participated in teleconferences and webinars addressing the CLER areas. Participants shared best practices, resources, and experiences. We designed a pre/post descriptive study to examine outcomes. Results: Thirty-three institutions completed NI IV, and at its conclusion, the majority reported greater CLER readiness compared with baseline. Twenty-two (88.0%) institutions reported that NI IV had a great impact on advancing their efforts in the CLER area of their project focus, and 15 (62.5%) reported a great impact in other CLER focus areas. Opportunities to share progress with other teams and the national group meetings were reported to contribute to teams' success. Conclusion: The NI IV learning collaborative prepared institutions for CLER, suggesting successful integration of the clinical and educational enterprises. We propose that national learning collaboratives of GME-sponsoring health systems enable advancement of their education mission, leading ultimately to better healthcare outcomes. This learning model may be generalizable to newfound programs for academic medical centers
Smeeding, Sandra J W; Bradshaw, David H; Kumpfer, Karol; Trevithick, Susan; Stoddard, Gregory J
The purpose of this longitudinal outcome research study was to determine the effectiveness of the Integrative Health Clinic and Program (IHCP) and to perform a subgroup analysis investigating patient benefit. The IHCP is an innovative clinical service within the Veterans Affairs Health Care System designed for nonpharmacologic biopsychosocial management of chronic nonmalignant pain and stress-related depression, anxiety, and symptoms of post-traumatic stress disorder (PTSD) utilizing complementary and alternative medicine and mind-body skills. A post-hoc quasi-experimental design was used and combined with subgroup analysis to determine who benefited the most from the program. Data were collected at intake and up to four follow-up visits over a 2-year time period. Hierarchical linear modeling was used for the statistical analysis. The outcome measures included: Health-Related Quality of Life (SF-36), the Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI). Subgroup comparisons included low anxiety (BAI < 19, n = 82), low depression (BDI < 19, n = 93), and absence of PTSD (n = 102) compared to veterans with high anxiety (BAI > or = 19, n = 77), high depression (BDI > 19, n = 67), and presence of PTSD (n = 63). All of the comparison groups demonstrated an improvement in depression and anxiety scores, as well as in some SF-36 categories. The subgroups with the greatest improvement, seen at 6 months, were found in the high anxiety group (Cohen's d = 0.52), the high-depression group (Cohen's d = 0.46), and the PTSD group (Cohen's d = 0.41). The results suggest IHCP is an effective program, improving chronic pain and stress-related depression, anxiety, and health-related quality of life. Of particular interest was a significant improvement in anxiety in the PTSD group. The IHCP model offers innovative treatment options that are low risk, low cost, and acceptable to patients and providers.
Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M.; Reyes, D.; Young, M.
(pre-IMM analysis) and overall mitigation of the mission medical impact (IMM analysis); 2) refine the procedure outcome and clinical outcome metrics themselves; 3) refine or develop innovative medical training products and solutions to maximize CMO performance; and 4) validate the methods and products of this experiment for operational use in the planning, execution, and quality assurance of the CMO training process The team has finalized training protocols and developed a software training/testing tool in collaboration with Butler Graphics (Detroit, MI). In addition to the "hands on" medical procedure modules, the software includes a differential diagnosis exercise (limited clinical decision support tool) to evaluate the diagnostic skills of participants. Human subject testing will occur over the next year.
Staerk, Laila; Sherer, Jason A; Ko, Darae; Benjamin, Emelia J; Helm, Robert H
The past 3 decades have been characterized by an exponential growth in knowledge and advances in the clinical treatment of atrial fibrillation (AF). It is now known that AF genesis requires a vulnerable atrial substrate and that the formation and composition of this substrate may vary depending on comorbid conditions, genetics, sex, and other factors. Population-based studies have identified numerous factors that modify the atrial substrate and increase AF susceptibility. To date, genetic studies have reported 17 independent signals for AF at 14 genomic regions. Studies have established that advanced age, male sex, and European ancestry are prominent AF risk factors. Other modifiable risk factors include sedentary lifestyle, smoking, obesity, diabetes mellitus, obstructive sleep apnea, and elevated blood pressure predispose to AF, and each factor has been shown to induce structural and electric remodeling of the atria. Both heart failure and myocardial infarction increase risk of AF and vice versa creating a feed-forward loop that increases mortality. Other cardiovascular outcomes attributed to AF, including stroke and thromboembolism, are well established, and epidemiology studies have championed therapeutics that mitigate these adverse outcomes. However, the role of anticoagulation for preventing dementia attributed to AF is less established. Our review is a comprehensive examination of the epidemiological data associating unmodifiable and modifiable risk factors for AF and of the pathophysiological evidence supporting the mechanistic link between each risk factor and AF genesis. Our review also critically examines the epidemiological data on clinical outcomes attributed to AF and summarizes current evidence linking each outcome with AF. © 2017 American Heart Association, Inc.
Tangren, Jessica Sheehan; Powe, Camille E; Ankers, Elizabeth; Ecker, Jeffrey; Bramham, Kate; Hladunewich, Michelle A; Karumanchi, S Ananth; Thadhani, Ravi
The effect of clinically recovered AKI (r-AKI) on future pregnancy outcomes is unknown. We retrospectively studied all women who delivered infants between 1998 and 2007 at Massachusetts General Hospital to assess whether a previous episode of r-AKI associated with subsequent adverse maternal and fetal outcomes, including preeclampsia. AKI was defined as rise in serum creatinine concentration to 1.5-fold above baseline. We compared pregnancy outcomes in women with r-AKI without history of CKD (eGFR>90 ml/min per 1.73 m(2) before conception; n=105) with outcomes in women without kidney disease (controls; n=24,640). The r-AKI and control groups had similar prepregnancy serum creatinine measurements (0.70±0.20 versus 0.69±0.10 mg/dl; P=0.36). However, women with r-AKI had increased rates of preeclampsia compared with controls (23% versus 4%; P<0.001). Infants of women with r-AKI were born earlier than infants of controls (37.6±3.6 versus 39.2±2.2 weeks; P<0.001), with increased rates of small for gestational age births (15% versus 8%; P=0.03). After multivariate adjustment, r-AKI associated with increased risk for preeclampsia (adjusted odds ratio [aOR], 5.9; 95% confidence interval [95% CI], 3.6 to 9.7) and adverse fetal outcomes (aOR, 2.4; 95% CI, 1.6 to 3.7). When women with r-AKI and controls were matched 1:2 by age, race, body mass index, diastolic BP, parity, and diabetes status, r-AKI remained associated with preeclampsia (OR, 4.7; 95% CI, 2.1 to 10.1) and adverse fetal outcomes (OR, 2.1; 95% CI, 1.2 to 3.7). Thus, a past episode of AKI, despite return to normal renal function before pregnancy, associated with adverse outcomes in pregnancy. Copyright © 2017 by the American Society of Nephrology.
Avanzo, M; Romanelli, P
The development of computer-based image guidance has allowed stereotactic radiosurgery and radiotherapy to be freed from the constraints imposed by the stereotactic frames once required for intracranial radiosurgery. This freedom has led to the application of radiosurgery to targets outside the brain. In this paper, we briefly review the technologies, treatment parameters, and clinical outcomes of radiosurgical treatment for spinal pathology, including metastatic tumors and rare but challenging lesions such as arteriovenous malformations and benign tumors. A special emphasis is put on the newest development, fiducial-less robotic radiosurgery. Spinal radiosurgery is associated with excellent rates of tumor control and pain relief with a good dose sparing of the highly sensitive spinal cord. Further research is required to optimize treatment strategies and to assess clinical benefits and toxicity in the long term.
Tiddens, Harm AWM; Puderbach, Michael; Venegas, Jose G; Ratjen, Felix; Donaldson, Scott H; Davis, Stephanie D; Rowe, Steven M; Sagel, Scott D; Higgins, Mark; Waltz, David A
Cystic fibrosis (CF) is a common inherited condition caused by mutations in the gene encoding the CF transmembrane regulator protein. With increased understanding of the molecular mechanisms underlying CF and the development of new therapies there comes the need to develop new outcome measures to assess the disease, its progression and response to treatment. As there are limitations to the current endpoints accepted for regulatory purposes, a workshop to discuss novel endpoints for clinical trials in CF was held in Anaheim, California in November 2011. The pros and cons of novel outcome measures with potential utility for evaluation of novel treatments in CF were critically evaluated. The highlights of the 2011 workshop and subsequent advances in technologies and techniques that could be used to inform the development of clinical trial endpoints are summarized in this review. Pediatr Pulmonol. © 2014 The Authors. Pediatric Pulmonology published by Wiley Periodicals, Inc. PMID:25641878
Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina; Group, Outcome Measures Working
Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.
Waldman, Amy; Ness, Jayne; Pohl, Daniela; Simone, Isabella Laura; Anlar, Banu; Amato, Maria Pia; Ghezzi, Angelo
Multiple sclerosis (MS) in children manifests with a relapsing-remitting MS (RRMS) disease course. Acute relapses consist of new neurologic deficits persisting greater than 24 hours, in the absence of intercurrent illness, and occur with a higher frequency early in the disease as compared to adult-onset RRMS. Most pediatric patients with MS recover well from these early relapses, and cumulative physical disability is rare in the first 10 years of disease. Brainstem attacks, poor recovery from a single attack, and a higher frequency of attacks portend a greater likelihood of future disability. Although prospective pediatric-onset MS cohorts have been established in recent years, there remains very limited prospective data detailing the longer-term clinical outcome of pediatric-onset MS into adulthood. Whether the advent of MS therapies, and the largely off-label access to such therapies in pediatric MS, has improved prognosis is unknown. MS onset during the key formative academic years, concurrent with active cognitive maturation, is an important determinant of long-term outcome, and is discussed in detail in another article in this supplement. Finally, increasing recognition of pediatric MS worldwide, recent launch of phase III trials for new agents in the pediatric MS population, and the clear imperative to more fully appreciate health-related quality of life in pediatric MS through adulthood highlight the need for standardized, validated, and robust outcome measures.
Slenker, Nicholas R; Lawson, Kevin; Ciccotti, Michael G; Dodson, Christopher C; Cohen, Steven B
We present a systematic review of the current literature regarding the use of the 2 most common surgical treatments for lesions of the long head of the biceps brachii, tenotomy or tenodesis. Currently, there is no consensus management in the literature because most studies lack high levels of evidence. PubMed was systematically reviewed for eligible articles relating to biceps tenotomy or tenodesis. Level I to IV evidence and English-language studies reporting on the clinical outcomes of these 2 procedures were included. The primary clinical outcome measurements for each study were determined and were normalized and reported as the percentage of "excellent/good" versus "poor" results based on criteria laid out in each study. Sixteen studies met the inclusion criteria. All articles reviewed were of Level IV evidence, except for one Level II prospective cohort study.(10) All studies, a total of 433 tenodesis procedures resulted in an excellent/good outcome in 74% of patients, with an 8% rate of cosmetic deformity. A total of 699 tenotomy procedures resulted in an excellent/good outcome in 77% of patients, with a 43% occurrence of cosmetic deformity. Postoperative bicipital pain was found in 43 of 226 cases (19%) of tenotomy and 18 of 74 cases (24%) of tenodesis. The 4 studies that compared the procedures directly did not show any significant clinical differences between the groups other than a cosmetic deformity being present more frequently after tenotomy. Tenotomy and tenodesis have comparably favorable results in the literature, with the only major difference being a higher incidence of cosmetic deformity with biceps tenotomy. However, there is currently no consensus regarding the use of tenotomy versus tenodesis for the treatment of lesions of the long head of the biceps brachii. The lack of prospective, randomized trials limits our ability to recommend 1 technique over the other. There is a great need for controlled trials to investigate the differences between
Mullins, C. Daniel; Quintana, Alvaro; Eckmann, Christian; Shelbaya, Ahmed; Ernst, Frank R.; Krukas, Michelle R.; Reisman, Arlene
Abstract Background: The utility of tigecycline as compared with other antibiotic therapies in the treatment of patients with complicated intra-abdominal infection (cIAI) and the short- and long-term outcomes of a large cohort of severely ill patients were examined. We provide the first published data on post-discharge events for these patients. Methods: Retrospective data for the cIAI cohort were obtained from a large clinical database. Patients aged ≥18 y were selected for inclusion based on hospitalization with a relevant diagnosis code and procedure code, and guideline-compliant antimicrobial therapy. Propensity scoring was used to reduce treatment-selection bias introduced by the use of observational data. Tigecycline patients were placed into quintiles based on propensity score and were matched 1:3. Results: The final model based on propensity score matching included 2,424 patients: Tigecycline (n = 606) and other antibiotic therapy (n = 1,818). Treatment was successful in 426 (70.3%) tigecycline-treated patients and in 1,294 (71.2%) patients receiving other antibiotics. Similar treatment success occurred across all infection sites. Among survivors, treatment failure was associated with a greater need for all-cause re-hospitalization at 30 d and 180 d. No differences in cIAI-related re-hospitalization and discharge status were observed. Conclusions: Using propensity scores to match populations, similar outcomes were demonstrated between treatment with tigecycline and other antibiotics as expressed by treatment success, the need for re-admission, similar 30-d discharge status, and the need for re-admission at 180 d. PMID:26981640
Amodio-Groton, Maria; Rashid, Mohamad; Lamp, Kenneth C.; Hoffman-Roberts, Holly L.; Sakoulas, George; Yoon, Min J.; Schweitzer, Suzanne; Rastogi, Anjay
Patients with underlying renal disease may be vulnerable to vancomycin-mediated nephrotoxicity and Staphylococcus aureus bacteremia treatment failure. In light of recent data demonstrating the successful use of β-lactam plus daptomycin in very difficult cases of S. aureus bacteremia, we examined safety and clinical outcomes for patients who received daptomycin with or without concomitant β-lactams. We identified 106 patients who received daptomycin for S. aureus bacteremia, had mild or moderate renal insufficiency according to FDA criteria, and enrolled in the Cubicin Outcomes Registry and Experience (CORE), a multicenter registry, from 2005 to 2009. Daptomycin treatment success was 81%. Overall treatment efficacy was slightly enhanced with the addition of a β-lactam (87% versus 78%; P = 0.336), but this trend was most pronounced for bacteremia associated with endocarditis or bone/joint infection or bacteremia from an unknown source (90% versus 57%; P = 0.061). Factors associated with reduced daptomycin efficacy (by logistic regression) were an unknown source of bacteremia (odds ratio [OR] = 7.59; 95% confidence interval [CI] = 1.55 to 37.2), moderate renal impairment (OR = 9.11; 95% CI = 1.46 to 56.8), and prior vancomycin failure (OR = 11.2; 95% CI = 1.95 to 64.5). Two patients experienced an increase in creatine phosphokinase (CPK) that resolved after stopping daptomycin. No patients developed worsening renal insufficiency related to daptomycin. In conclusion, daptomycin appeared to be effective and well tolerated in patients with S. aureus bacteremia and mild to moderate renal insufficiency. Daptomycin treatment efficacy might be enhanced with β-lactam combination therapy in primary endovascular and bone/joint infections. Additional studies will be necessary to confirm these findings. PMID:23254428
Mukherjee, Shiuli; Sharma, Sunita; Chakravarty, B N
OBJECTIVES: A large prospective clinical trial was conducted to compare the efficacy of single dose uFSH and clomiphene citrate combination with clomiphene citrate alone for ovulation induction to improve the pregnancy rate. MATERIALS AND METHODS: The study was a randomized, prospective clinical trial. Totally, 1527 infertile women (4381 cycles) with polycystic ovarian syndrome (PCOS) (n=911/2573 cycles) and unexplained infertility (n=616/1808 cycles) were randomized into two groups. Group A received single dose of uFSH on D3 of menstrual cycle along with clomiphene. Group B received clomiphene only for ovulation induction. We compared the pregnancy rate and miscarriage rate between two groups. RESULTS: Group A had a pregnancy rate of 17% compared to 8.3% of Group B which was significantly higher (P=0.0001). The miscarriage rate was 11% in Group A and 10% in Group B which was not significant (P=0.99). Pregnancy rates in PCOS women were 22% in Group A and 9.3% in Group B which shows significantly higher pregnancy rate (P=0.0001) in anovulatory infertility. But in unexplained infertility, there was no significant difference in pregnancy rate between Group A (11%) and Group B(6.3%). Miscarriage rates were 8.8% and 9.5% in Group A and Group B, respectively, in PCOS women and 14% and 13% in women with unexplained infertility. CONCLUSION: Addition of single dose of uFSH improves pregnancy outcome particularly in anovulatory infertility (WHO II). Correction of unexplained infertility may need more than simple correction of possible subtle ovulatory effect. PMID:21209751
Togsverd-Bo, Katrine; Gluud, Christian; Winkel, Per; Larsen, Helle K; Lomholt, Hans B; Cramers, Marie; Bjerring, Peter; Haedersdal, Merete
Treatment of recalcitrant viral warts remains a therapeutic challenge. Intense pulsed light (IPL) has been suggested effective to clear wart tissue. The objective was in a randomized controlled trial to assess the efficacy of paring followed by IPL versus paring alone for recalcitrant hand and foot warts. Eighty-nine patients with recalcitrant hand and foot warts were included and randomized (1:1) to three treatments at 3-week intervals with either paring of warts followed by IPL or paring of warts alone. IPL was given with the Ellipse Flex IPL system (Danish Dermatologic Development A/S, Hørsholm, Denmark, 400-950 nm, 5.5 millisecond pulse duration in double pulses with a 2 millisecond interval, 26.0-32.5 J/cm(2) repetitive passes). The primary outcome was complete and partial clearance of warts evaluated by blinded photo assessment at 6 weeks after final treatment. Secondary outcomes were treatment related pain and adverse reactions. We found no significant difference in clearance of warts between the two intervention groups (OR 1.64, 95% confidence interval 0.62-4.38). Paring followed by IPL resulted in complete or partial clearance of wart tissue in nine (22%) and five patients (12.2%) versus five (13.5%) and four patients (10.8%) from paring alone. Mostly plantar warts were treated (92.1%). The pain intensity after paring and IPL was moderate and significantly higher than the pain intensity after paring alone (P<0.0005). No adverse reactions were observed from the two interventions. Paring followed by IPL did not differ significantly from paring alone in clearance of recalcitrant hand and foot warts but caused significantly more pain.
The diagnosis of a chronic disease such as diabetes generally evokes strong emotions and often brings with it the need to make changes in lifestyle behaviours, such as diet, exercise, medication management and monitoring clinical and metabolic parameters. The diagnosis thus affects not only the person diagnosed but also the family members. Chronic illnesses are largely self-managed with ∼99% of the care becoming the responsibility of patients and their families or others involved in the daily management of their illnesses. While the responsibility for outcomes, such as metabolic control and chronic complications, are shared with the health care team, the daily decisions and behaviours adopted by patients clearly have a strong influence on their future health and well-being. While diabetes self-management education is essential, it is generally not sufficient for patients to sustain behaviours and cope with a lifetime of diabetes. Peers have been proposed as one method for assisting patients to deal with the behavioural and affective components of diabetes and to provide ongoing self-management support. This paper first describes effective behavioural strategies in diabetes, based on multiple studies and/or meta-analyses, and then provides examples of their use by peers or in peer-based programmes in diabetes. A comprehensive search using the MEDLINE® and Cinahl databases was conducted. Key search terms included peer mentors, peer leaders, peer educators, lay health workers and community health workers. Studies that clearly identified behavioural strategies used by peers were included. PMID:19509083
Chen, Stephen T; Buser, Daniel
The aim of this review was to evaluate the clinical outcomes for the different time points of implant placement following tooth extraction. A PubMed search and a hand search of selected journals were performed to identify clinical studies published in English that reported on outcomes of implants in postextraction sites. Only studies that included 10 or more patients were accepted. For implant success/survival outcomes, only studies with a mean follow-up period of at least 12 months from the time of implant placement were included. The following outcomes were identified: (1) change in peri-implant defect dimension, (2) implant survival and success, and (3) esthetic outcomes. Of 1,107 abstracts and 170 full-text articles considered, 91 studies met the inclusion criteria for this review. Bone augmentation procedures are effective in promoting bone fill and defect resolution at implants in postextraction sites, and are more successful with immediate (type 1) and early placement (type 2 and type 3) than with late placement (type 4). The majority of studies reported survival rates of over 95%. Similar survival rates were observed for immediate (type 1) and early (type 2) placement. Recession of the facial mucosal margin is common with immediate (type 1) placement. Risk indicators included a thin tissue biotype, a facial malposition of the implant, and a thin or damaged facial bone wall. Early implant placement (type 2 and type 3) is associated with a lower frequency of mucosal recession compared to immediate placement (type 1).
Much of diabetes care needs to be carried out by patients between office visits with their health care providers. Yet, many patients face difficulties carrying out these tasks. In addition, many adults with diabetes cannot count on effective support from their families and friends to help them with their self-management. Peer support programmes are a promising approach to enhance social and emotional support, assist patients in daily management and living with diabetes and promote linkages to clinical care. This background paper provides a brief overview of different approaches to mobilize peer support for diabetes self-management support, discusses evidence to date on the effectiveness of each of these models, highlights logistical and evaluation issues for each model and concludes with a discussion of directions for future research in this area. PMID:19293400
Bradshaw, M J
Clinical pathways are a means by which an instructor can objectively and effectively evaluate student learning and progress toward clinical outcomes. An advantage to use of pathways in one-time experiences is that the pathway serves as a criterion-based frame of reference for both student and instructor, since the criteria are the same as for other clinical experiences in that course. The faculty member thus has an objective measure of student learning and performance, and the student always knows the measure on which she or he will be evaluated. Clinical pathways are limited to brief experiences and are not designed to show professional growth and progress in learning over time. A pathway could be designed, however, to appraise critical thinking and professional behaviors associated with spontaneous incidents, such as a problem patient. Nurse educators can use pathways as a creative means to address student responses in a variety of situations.
Mohamad, Ismail Lotfy; Elsayh, Khalid I; Mohammad, Hanaa A; Saad, Khaled; Zahran, Asmaa M; Abdallah, Alameldin M; Tawfeek, M S K; Monazea, Eman M
Scorpion envenomation is a health problem in children in tropical and subtropical regions. The aim of this study was to evaluate demographic and clinical characteristics as well as outcomes in referred children to Assiut University Children Hospital during the year 2012 with a history of scorpion sting. The medical files of these patients were reviewed retrospectively for demographic data, time and site of biting, and clinical manifestations. Laboratory investigations of the patients were reviewed for complete blood count (CBC), liver function tests, creatinine phosphokinase (CPK), lactate dehydrogenase (LDH), arterial blood gases, and serum electrolytes. Results showed 111 children with a history of scorpion sting; 69 males and 42 females with a median age of 5 years. Out of the studied patients, 53.2 % were classified as class III of clinical severity with recorded pulmonary edema in 33.3 %, cardiogenic shock in 46.8 %, and severe neurological manifestations in 22.8 %. Twelve patients (10.8 %) were classified as class II with mild systemic manifestations, and 36 % of the patients were classified as class I with only local reaction. Outcomes of these patients were discharge without sequelae in 55.8 %, discharge with sequelae in 26.1 %, and death in 18.1 %. more than half of stung children had a severe clinical presentation and about one fifth died. Aggressive treatment regimens are recommended for such patients to improve the outcome.
Ardern-Holmes, Simone L.; Barker, Fred G.; Blakeley, Jaishri O.; Evans, D. Gareth; Ferner, Rosalie E.; Hadlock, Tessa A.; Halpin, Chris
Objectives: Vestibular schwannomas are the hallmark of neurofibromatosis 2 (NF2), occurring in >95% of patients. These tumors develop on the vestibulocochlear nerve and are associated with significant morbidity due to hearing loss, tinnitus, imbalance, facial weakness, and risk of early mortality from brainstem compression. Although hearing loss and facial weakness have been identified as important functional outcomes for patients with NF2, there is a lack of consensus regarding appropriate endpoints in clinical trials. Methods: The functional outcomes group reviewed existing endpoints for hearing and facial function and developed consensus recommendations for response evaluation in NF2 clinical trials. Results: For hearing endpoints, the functional group endorsed the use of maximum word recognition score as a primary endpoint, with the 95% critical difference as primary hearing outcomes. The group recommended use of the scaled measurement of improvement in lip excursion (SMILE) system for studies of facial function. Conclusions: These recommendations are intended to provide researchers with a common set of endpoints for use in clinical trials of patients with NF2. The use of common endpoints should improve the quality of clinical trials and foster comparison among studies for hearing loss and facial weakness. PMID:24249803
Sharma, Vishal; Rana, Surinder S; Sharma, Ravi K; Kang, Mandeep; Gupta, Rajesh; Bhasin, Deepak K
A number of scoring systems are available to predict prognosis in acute pancreatitis (AP). The aim of the study was to compare extra-pancreatic inflammation on computed tomography (CT) (EPIC score) and renal rim sign with clinical scores (BISAP, SIRS) and conventional CT severity index (CTSI) and modified CTSI (MCTSI) in predicting persistent organ failure (POF), intervention and mortality. The demographic, clinical and radiographic data from patients with AP were retrospectively evaluated. The scores were evaluated by calculating receiver operator characteristic (ROC) curves and area under the ROC (AUROC). Of the 105 patients (65 males; mean age 40.6±12.9 years) included, 8 died, 71 developed POF, and 16 needed intervention. The mean CTSI, MCTSI and EPIC scores were 5.8±3.0, 7.1±2.6 and 4.0±1.9 respectively. The AUROC for SIRS, BISAP, CTSI, MCTSI, Renal Rim Score and EPIC score in predicting POF were 0.65 (95%CI 0.53-0.78), 0.75 (95%CI 0.65-0.86), 0.66 (95%CI 0.54-0.78), 0.70 (95%CI 0.58-0.81), 0.64 (95%CI 0.52-0.76), 0.71 (95%CI 0.60-0.83), for radiological/endoscopic intervention were 0.50 (95%CI 0.35-0.65), 0.64 (95%CI 0.49-0.78), 0.51 (95%CI 0.36-0.66), 0.55 (95%CI 0.41-0.70), 0.51 (95%CI 0.36-0.67), 0.66 (95%CI 0.52-0.81), and for mortality 0.57 (95%CI 0.38-0.75), 0.90 (95%CI 0.83-0.97), 0.67 (95%CI 0.50-0.83), 0.68 (95%CI 0.51-0.85), 0.73 (95%CI 0.57-0.89) and 0.77 (95%CI 0.64-0.90) respectively. The prognostic performance of various clinical and radiological scoring systems in AP is comparable with BISAP having the highest accuracy for predicting POF and mortality.
Jiang, Li; Dou, Zu-Lin; Wang, Qing; Wang, Qiao-Yuan; Dai, Meng; Wang, Zhen; Wei, Xiao-Mei; Chen, Ying-Bei
Objective: Using ultrasonography (US) to guide botulinum toxin type A (BTX-A) injection in patients with post-stroke wrist and finger flexor muscle spasticity and assessing clinical outcomes after the injection and rehabilitation intervention. Methods: Twenty-three patients with wrist and finger spasticity after stroke were recruited in this study from May 2012 to May 2013. Under US guidance, the proper dose (250 U) of BTX-A was injected into each spastic muscle at two injection sites. Then, conventional rehabilitation training started next day after BTX-A injection. The degree of spasticity was assessed by modified Ashworth scale (MAS) and wrist and finger motor function by active rang of movement (AROM), and Fugl-Meyer assessment (FMA) at the baseline, 1, 2, 4 and 12 weeks after BTX-A injection. Results: Significant decreases (p < 0.02) in the MAS scores of both the finger flexor muscle tone and wrist flexor muscle tone measured at 1, 2, 4, and 12 weeks after the BTX-A injection were found in comparison with the baseline scores. Compared with the baseline, the AROM values of the wrist and finger extensions and the FMA scores of the wrist and hand significantly increased (p < 0.02) at 2, 4 and 12 weeks after the BTX-A injection. Conclusions: US-guided BTX-A injection combined with rehabilitation exercise decrease spasticity of the wrist and finger flexor muscles and improve their motor function in stroke patients up to 12 weeks following BTX-A injection. PMID:26388761
Prajapati, Jayesh; Pai, Umesh; Shetty, Kiran
Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, in de novo coronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups. Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients with de novo coronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure. Results. The mean age of the study population was 58 ± 11 years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of 0.18 ± 0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively. Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent. PMID:27597929
Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P
The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses.
Adinolfi, Barbara; Gava, Nicoletta
Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.
Komaba, Hirotaka; Fukagawa, Masafumi
Secondary hyperparathyroidism (SHPT) is a common complication of end-stage renal disease and is one of the most prominent causes of a markedly increased risk of death and cardiovascular disease in this patient population. Cinacalcet hydrochloride is a new option for the treatment of SHPT, and the efficacy and effectiveness to lower parathyroid hormone levels and to improve control of mineral metabolism, even in patients with severe disease, has been well established in many clinical trials and observational studies. Currently, the focus has moved to the impact of cinacalcet on hard clinical outcomes, and two randomized controlled trials, ADVANCE and EVOLVE, have been performed to assess the effects of cinacalcet on cardiovascular calcification and the risk of cardiovascular events and mortality, respectively. Although the primary analysis of both trials did not find significant effects of cinacalcet, the benefit of cinacalcet was suggested in the subanalyses in which the potential problems of the trials were taken into account. These positive results are consistent with experimental studies showing favorable effects of cinacalcet on bone metabolism and vascular calcification, providing plausibility to support the beneficial effects of cinacalcet. Definitive evidence is, however, still lacking, and further efforts should be made to establish the optimal role of cinacalcet in the treatment of SHPT.
Rigal, J G; Albin, H C; Duchier, A R; D'Aulnay, J M; Fenelon, J H; Vincon, G A; Demotes-Mainard, F M
Fifty-one depressed inpatients, after 1 drug-free week, were treated for 5 weeks with imipramine 4 mg/kg day. Plasma levels of imipramine (IMI) and its active metabolite desmethylimipramine (DMI) were measured weekly, 15 hours after the last drug intake. Steady state blood levels (IMI + DMI) ranged from 60 to 585 ng/ml. The mean value for plasma concentration (IMI + DMI) at day 42 was 271 ng/ml. In the same way, therapeutic effectiveness was assessed every week using the Hamilton Rating Scale for Depression (HDRS). There was a significant correlation between plasma concentration and the decrease of Hamilton scores. The IMI/DMI ratio showed a responder-nonresponder difference; 86% patients with a ratio between 0.4 and 1 were responders. Conversely, most patients with a ratio below 0.4 or above 1 were nonresponders. The ideal ratio for clinical response would be 0.68. The ratio is a subject-specific feature, able to be an early predictor of clinical outcome.
Camara-Lemarroy, Carlos Rodrigo; González-Moreno, Emmanuel Irineo; Rodríguez-Gutiérrez, René; Rendón-Ramírez, Erick Joel; Ayala-Cortés, Ana Sofía; Fraga-Hernández, Martha Lizeth; García-Labastida, Laura; Galarza-Delgado, Dionicio Ángel
Mucormycosis (MCM) is a life-threatening infection that carries high mortality rates despite recent advances in its diagnosis and treatment. The objective was to report 14 cases of mucormycosis infection and review the relevant literature. We retrospectively analyzed the demographic and clinical data of 14 consecutive patients that presented with MCM in a tertiary-care teaching hospital in northern Mexico. The mean age of the patients was 39.9 (range 5–65). Nine of the patients were male. Ten patients had diabetes mellitus as the underlying disease, and 6 patients had a hematological malignancy (acute leukemia). Of the diabetic patients, 3 had chronic renal failure and 4 presented with diabetic ketoacidosis. All patients had rhinocerebral involvement. In-hospital mortality was 50%. All patients received medical therapy with polyene antifungals and 11 patients underwent surgical therapy. Survivors were significantly younger and less likely to have diabetes than nonsurvivors, and had higher levels of serum albumin on admission. The clinical outcome of patients with MCM is poor. Uncontrolled diabetes and age are negative prognostic factors. PMID:25210515
Silva, S.C.; Baggio-Zappia, G.L.; Brunialti, M.K.C.; Assunçao, M.S.C.; Azevedo, L.C.P.; Machado, F.R.; Salomao, R.
Recognition of pathogens is performed by specific receptors in cells of the innate immune system, which may undergo modulation during the continuum of clinical manifestations of sepsis. Monocytes and neutrophils play a key role in host defense by sensing and destroying microorganisms. This study aimed to evaluate the expression of CD14 receptors on monocytes; CD66b and CXCR2 receptors on neutrophils; and TLR2, TLR4, TLR5, TLR9, and CD11b receptors on both cell types of septic patients. Seventy-seven septic patients (SP) and 40 healthy volunteers (HV) were included in the study, and blood samples were collected on day zero (D0) and after 7 days of therapy (D7). Evaluation of the cellular receptors was carried out by flow cytometry. Expression of CD14 on monocytes and of CD11b and CXCR2 on neutrophils from SP was lower than that from HV. Conversely, expression of TLR5 on monocytes and neutrophils was higher in SP compared with HV. Expression of TLR2 on the surface of neutrophils and that of TLR5 on monocytes and neutrophils of SP was lower at D7 than at D0. In addition, SP who survived showed reduced expression of TLR2 and TLR4 on the surface of neutrophils at D7 compared to D0. Expression of CXCR2 for surviving patients was higher at follow-up compared to baseline. We conclude that expression of recognition and cell signaling receptors is differentially regulated between SP and HV depending on the receptor being evaluated. PMID:24728213
Sadeghi-Bojd, Simin; Kajbafzadeh, Abdol-Mohammad; Ansari-Moghadam, Alireza; Rashidi, Somaye
Background: Prenatal hydronephrosis (PNH) is dilation in urinary collecting system and is the most frequent neonatal urinary tract abnormality with an incidence of 1% to 5% of all pregnancies. PNH is defined as anteroposterior diameter (APD) of renal pelvis ≥ 4 mm at gestational age (GA) of < 33 weeks and APD ≥ 7 mm at GA of ≥ 33 weeks to 2 months after birth. All patients need to be evaluated after birth by postnatal renal ultrasonography (US). In the vast majority of cases, watchful waiting is the only thing to do; others need medical or surgical therapy. Objectives: There is a direct relationship between APD of renal pelvis and outcome of PNH. Therefore we were to find the best cutoff point APD of renal pelvis which leads to surgical outcome. Patients and Methods: In this retrospective cohort study we followed 200 patients 1 to 60 days old with diagnosis of PNH based on before or after birth ultrasonography; as a prenatal or postnatal detected, respectively. These patients were referred to the nephrology clinic in Zahedan Iran during 2011 to 2013. The first step of investigation was a postnatal renal US, by the same expert radiologist and classifying the patients into 3 groups; normal, mild/moderate and severe. The second step was to perform voiding cystourethrogram (VCUG) for mild/moderate to severe cases at 4 - 6 weeks of life. Tc-diethylene triamine-pentaacetic acid (DTPA) was the last step and for those with normal VCUG who did not show improvement in follow-up examination, US to evaluate obstruction and renal function. Finally all patients with mild/moderate to severe PNH received conservative therapy and surgery was preserved only for progressive cases, obstruction or renal function ≤35%. All patients’ data and radiologic information was recorded in separate data forms, and then analyzed by SPSS (version 22). Results: 200 screened PNH patients with male to female ratio 3.5:1 underwent first postnatal control US, of whom 65% had normal, 18% mild
Stanzel, Roger D P; Henderson, Mark
Advances in cardiopulmonary bypass equipment have played a critical role in improving outcomes for cardiac surgery patients. Recent advancements include reduced priming volumes, biocompatible coatings and gaseous microemboli handling, as well as the incorporation of an arterial filter into the oxygenator.The purpose of this study was to conduct a comprehensive clinical evaluation of adult oxygenators on the market. Oxygenators assessed included the Sorin Synthesis(®) (n = 30), the Sorin Inspire 6F(®) (n = 10) and Inspire 8F(®) (n = 30), the Terumo FX15(®) (n = 13) and FX25(®) (n = 30), the Maquet Quadrox-i(®) (n = 30) and the Medtronic Fusion(®) (n = 30). Parameters assessed included functional prime volumes, gas exchange, pressure gradients and the effects on patient hematology.The Synthesis had the largest functional prime volume (1426 ml), the FX15 the lowest (956 ml). The Inspire 6F, 8F and Fusion had the greatest O2 transfer. The Sorin oxygenators required the lowest sweep gas flows to obtain a PaCO2 of 40 mmHg. The Sorin oxygenators had the largest pressure gradients. While no differences were observed for hemoglobin and platelet levels post cross-clamp removal, the Sorin Synthesis and Inspire 8F had the largest increases in white blood cell (WBC) counts (122% and 141% of baseline, respectively) and neutrophils (162% and 185% of baseline, respectively).The data demonstrate that no single product is superior in all aspects. The choice of ideal oxygenator depends on the aspect(s) of oxygenator performance the perfusion team believes most clinically acceptable based on available data. © The Author(s) 2015.
Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects. Despite numerous clinical trials of short-term isoflavone supplementation, there is a paucity of data regarding longer-term outcomes and safety. Our aim was to evaluate the clinical outcomes of soy hypocoty...
Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.
Purpose: Arthroscopic transosseous (TO) rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless) rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless) rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM) was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student's t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001). Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES) score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%), good in 8 (7.3%), fair in 3 (2.8%), and poor in 3 (2.8%). There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy) compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of injury preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique leads to
Mathisen, G E; Meyer, R D; Thompson, J M; Finegold, S M
Moxalactam was administered intravenously or intramuscularly or both in doses of 1 to 12 g/day to 45 patients with clinically significant infections (17 soft tissue or bone, 9 pleuropulmonary, 9 septicemic, 6 urinary tract, and 4 intraabdominal infections). Mean 0.5-h postinfusion levels were 105 micrograms/ml for a 4.0-g dose, 44.7 micrograms/ml for a 2.0-g dose, and 18 micrograms/ml for a 1.0-g dose. We identified 28 isolates of Enterobacteriaceae, 10 Pseudomonas aeruginosa isolates, 9 Staphylococcus aureus isolates, and 15 anaerobic bacterial isolates. A total of 15 patients were clinically cured, 8 patients improved, 13 patients improved initially but suffered subsequent relapses or superinfections, and 10 patients failed therapy. Toxicity was generally minimal (reversible eosinophilia, and mild liver function abnormalities, and elevated prothrombin time). The selection or emergence of resistant organisms in 17 patients during treatment (particularly Pseudomonas, enterococci, and Candida) was a disturbing feature of therapy. Our results were generally favorable, considering the complicated underlying medical problems of this group of patients. PMID:6213198
Verim, Ayşegül; Naiboğlu, Bariş; Karaca, Çigdem Tepe; Seneldir, Lütfü; Külekçi, Semra; Oysu, Çağatay
To investigate the duration of time elapsed between the onset of symptoms for necrotizing external otitis (NEO) and admission to hospital that may play a role in patient outcome. Retrospective case review. Tertiary referral center. Fourteen consecutive male patients with NEO with no improvement from the previous course of antibiotherapy and with findings of osteomyelitis on temporal bone CT, MRI, and positive detection of Tc-99m methylene diphosphonate on temporal bone, admitted as inpatients between 2008 and 2012. Medical treatment of NEO and surgical debridement. Patients were divided into 2 groups according to median time elapsed between onset of symptoms and hospitalization (<30 d or >30 d). HbA1c, fasting blood sugar, erythrocyte sedimentation rate, C-reactive protein, pain intensity, radiologic grade, improvement since diagnosis, and total time to cure were compared according to the groups. The relationships between the laboratory data were analyzed to determine the parameters associated with time to recovery. Otalgia was significantly worse in patients who were admitted to hospital greater than 30 days after symptom onset (Mann-Whitney U test, p < 0.002). Blood glucose increased related to delayed admission time (p < 0.001). CRP results were independently elevated from the admission time (p < 0.112). There was a statistically significant difference between groups according to ESR levels and recovery time (Mann-Whitney U test, p < 0.004 and p < 0.01). There was a positive correlation between HbA1c levels and recovery time in Group 1 and between ESR levels and recovery time in Group 2 (r = 0.872, p = 0.044; r = 0.630, p = 0.039). Clinical, laboratory, and outcome data worsen later than 30 days in NEO.
Alikhani, Mohammad Yousef; Arebestani, Mohammad Reza; Sayedin Khorasani, Masood; Majlesi, Amir; Jaefari, Mohammad
Helicobacter pylori is known to be a causative agent of chronic active gastritis, peptic ulcer and gastric cancer in human. Diverse genotypes of H. pylori strains have different virulence potency and geographic distribution. The purpose of this study was to investigate the association between the cytotoxin-associated gene (cagA), and the various vacuolating cytotoxin (vacA) genotypes of H. pylori strains and clinical outcomes in patients referred to Shahid-Beheshti Hospital in Hamadan, Iran. In this cross-sectional study, biopsy samples were collected consecutively from 153 patients with gastric cancer (GC), peptic ulcer dyspepsia (PUD) and non-ulcer dyspepsia (NUD) in the gastroenterology department of Shahid-Beheshti Hospital in Hamadan province, the west of Iran. H. pylori infection was confirmed in 83 patients (3 with GC, 27 with PUD, and 53 with NUD) by histology, rapid urease test (RUT) and culture. Genomic DNA was extracted from the bacterial isolate and was further confirmed with 16S rRNA gene sequencing as H. pylori, and characterized based on cagA and vacA genotyping using the polymerase chain reaction (PCR) method. In this study, vacA genotypes s1/m2, s1/m1, s2/m2 and s2/m1 were determined in 43.4%, 19.3%, 13.2% and 6% of the isolated H. pylori, respectively. The vacAs1 genotype was detected in 52 (62.6%) isolates, of which the vacAs1a genotype was detected in 45.2, 40.7, and 66.6% of the isolates from patients with NUD, PUD, and GC, respectively. The cagA-positive genotype was determined in 73 (87.9%) isolates and 10 (12.1%) were negative. The frequency rates of cagA gene were 84.9, 92.6 and 100% in isolates of patients with NUD, PUD, and GC, respectively. The cagA-positive genotype is strongly associated with s1a/m2 and s1a/m1 vacA genotypes. The most predominant VacA genotypes in our areas were s1/m2 and s1/m1, which regard as the genotypes with more virulence intensity. The H. pylori vacAs1a, cagA genotypes have a significant relationship with the
Cobos-Trigueros, Nazaret; Solé, Mar; Castro, Pedro; Torres, Jorge Luis; Rinaudo, Mariano; De Lazzari, Elisa; Morata, Laura; Hernández, Cristina; Fernández, Sara; Soriano, Alex; Nicolás, José María; Mensa, Josep; Vila, Jordi; Martínez, José Antonio
To compare the effect of two strategies of antibiotic use (mixing vs. cycling) on the acquisition of resistant microorganisms, infections and other clinical outcomes. Prospective cohort study in an 8-bed intensive care unit during 35- months in which a mixing-cycling policy of antipseudomonal beta-lactams (meropenem, ceftazidime/piperacillin-tazobactam) and fluoroquinolones was operative. Nasopharyngeal and rectal swabs and respiratory secretions were obtained within 48h of admission and thrice weekly thereafter. Target microorganisms included methicillin-resistant S. aureus, vancomycin-resistant enterococci, third-generation cephalosporin-resistant Enterobacteriaceae and non-fermenters. A total of 409 (42%) patients were included in mixing and 560 (58%) in cycling. Exposure to ceftazidime/piperacillin-tazobactam and fluoroquinolones was significantly higher in mixing while exposure to meropenem was higher in cycling, although overall use of antipseudomonals was not significantly different (37.5/100 patient-days vs. 38.1/100 patient-days). There was a barely higher acquisition rate of microorganisms during mixing, but this difference lost its significance when the cases due to an exogenous Burkholderia cepacia outbreak were excluded (19.3% vs. 15.4%, OR 0.8, CI 0.5-1.1). Acquisition of Pseudomonas aeruginosa resistant to the intervention antibiotics or with multiple-drug resistance was similar. There were no significant differences between mixing and cycling in the proportion of patients acquiring any infection (16.6% vs. 14.5%, OR 0.9, CI 0.6-1.2), any infection due to target microorganisms (5.9% vs. 5.2%, OR 0.9, CI 0.5-1.5), length of stay (median 5 d for both groups) or mortality (13.9 vs. 14.3%, OR 1.03, CI 0.7-1.3). A cycling strategy of antibiotic use with a 6-week cycle duration is similar to mixing in terms of acquisition of resistant microorganisms, infections, length of stay and mortality.
A review of clinical studies of piperacillin shows that it is valuable for the treatment of respiratory infections due to Enterobacteriaceae, Pseudomonas sp, anaerobes, and mixed flora including anaerobes. Various studies of a total of 420 patients treated with piperacillin for lower respiratory tract infections found that 97% of the patients were cured or markedly improved. Piperacillin has also been found as effective as combination therapy (gentamicin or tobramycin plus carbenicillin or ticarcillin) in the treatment of serious infections, including pneumonia and several caused by gram-negative organisms and anaerobic organisms. A review of the literature on bacteriological responses to piperacillin shows that 126 of 153 (82%) of the susceptible strains could be eradicated. Streptococcus pneumoniae, beta-hemolytic streptococci, Haemophilus influenzae, Peptostreptococcus sp, Bacteroides sp, and Fusobacterium sp have been completely eradicated by treatment with piperacillin. Most of the published studies indicate that therapy with the drug is usually well tolerated.
Principles of the design and administration of clinical stereopsis tests are outlined. Once the presence of the distinct sense of the third dimension by binocular vision alone and without help from monocular cues has been established in a patient, the examination can proceed to the measurement of stereoscopic acuity. Best results are obtained with high-contrast, sharp, well-articulated and uncrowded elements from easily-recognized target sets, displayed with no time constraints. Polarization is the preferred method of right/left eye separation; time-sharing at a minimum of 60 Hz on computer displays with counterphase occluding goggles is a feasible procedure. Random-dot stereograms are problematic because not all observers can disentangle the coherent global disparity on a first view. Copyright © 2012 Elsevier Ltd. All rights reserved.
Yilmaz, Murvet; Unsal, Abdulkadir; Sokmen, Mehmet; Kaptanogullari, Ozlem Harmankaya; Alkim, Canan; Kabukcuoglu, Fevziye; Ozagari, Aysim; Bor, Emire
The natural history of AA amyloidosis is typically progressive, leading to multiple organ failure and death. We analyzed the etiology as well as clinical and laboratory features of patients with biopsy-proven AA amyloidosis and evaluated the ultimate outcome. Seventy-three patients (24 female; mean age 41.85±15.89 years) were analyzed retrospectively. Demographic, clinical and laboratory features were studied and the outcome was assessed. Familial Mediterranean Fever and tuberculosis were the most frequent causes of amyloidosis. Mean serum creatinine and proteinuria at diagnosis were 4.65±4.89 mg/dl and 8.04±6.09 g/day, respectively; and stage I, II, III, IV and V renal disease were present in 19.2%, 13.7%, 16.4%, 11%, and 39.7% of the patients, respectively. ESRD developed in 16 patients during the follow-up period. All of the ESRD patients started a dialysis programme. Thirty patients (41%) died during the follow-up period; median patient survival was 35.9±6.12 months. Old age, tuberculosis etiology, advanced renal disease and low serum albumin levels were associated with a worse prognosis. Serum albumin was a predictor of mortality in logistic regression analysis. The ultimate outcome of the patients with AA amyloidosis is poor, possibly due to the late referral to the nephrology clinics. Early referral may be helpful to improve prognosis. Copyright © 2013 S. Karger AG, Basel.
Lamb, Lauren; Zubrod, Chad; Hague, Brent; Brakenhoff, Jeff; Major, Michael
The significance of collateral ligament desmitis of the tarsocrural joint is often clinically underestimated, because it is an uncommon injury with a guarded prognosis for athletic soundness. The objective of this study was to describe the clinical presentation, treatment, and outcome of 12 horses with collateral ligament desmitis, along with tarsocrural joint synovitis secondary to hemarthrosis. Criteria for inclusion in this study included clinical signs of tarsocrural joint synovitis and sonographic evidence of collateral ligament desmitis. This retrospective study evaluated horses over an 8-year period. Median follow-up after treatment was 5.5 years. Four horses in the study returned to their previous level of performance, 6 horses remained lame due to pain in the tarsus, 1 was euthanized, and 1 is in convalescence. This study highlights the importance of collateral ligament desmitis, and emphasizes the need for early, aggressive treatment to prevent the development of osteoarthritis. PMID:23115364
Khatri, Naresh; Halbesleben, Jonathon R B; Petroski, Gregory F; Meyer, Wilbert
Medical research continues to focus overwhelmingly on biomedical interventions, such as drugs, devices, and procedures. The dysfunctional health care cultures and systems need more attention for quality of care to improve further. The existing health services management research has not used a systematic theoretical framework to predict the effects of organizational variables on clinical outcomes. This study tests the theoretical model proposed by N. Khatri, A. Baveja, S. Boren, and A. Mammo (2006). This study surveyed employees from hospitals in Missouri. The sample consisted of 77 respondents from 16 hospitals. The control-based management approach (Management Control and Silos) was found to be positively associated with Culture of Blame and negatively with Learning From Mistakes. In contrast, the commitment-based approach (Fair Management Practices and Employee Participation) was negatively associated with Culture of Blame and positively with Learning From Mistakes, Camaraderie, and Motivation. Mediating variables of Learning From Mistakes and Camaraderie showed a significant negative relationship with Medical Errors. Learning From Mistakes, Camaraderie, and Motivation all showed a significant positive relationship with Quality of Patient Care. The mediating variables had much stronger relationships with Medical Errors and Quality of Patient Care than did the independent variables, lending support to the proposed mediation. Health care organizations can improve the quality of care and reduce medical errors significantly by enhancing learning from mistakes and boosting camaraderie and morale of their employees. They can do so by breaking down silos in their structures, implementing just and fair management practices, and involving employees in decision making.
Cho, Yeoungjee; Badve, Sunil V.; Hawley, Carmel M.; Wiggins, Kathryn; Johnson, David W.
Peritoneal dialysis (PD) is a preferred home dialysis modality and has a number of added advantages including improved initial patient survival and cost effectiveness over haemodialysis. Despite these benefits, uptake of PD remains relatively low, especially in developed countries. Wider implementation of PD is compromised by higher technique failure from infections (e.g., PD peritonitis) and ultrafiltration failure. These are inevitable consequences of peritoneal injury, which is thought to result primarily from continuous exposure to PD fluids that are characterised by their “unphysiologic” composition. In order to overcome these barriers, a number of more biocompatible PD fluids, with neutral pH, low glucose degradation product content, and bicarbonate buffer have been manufactured over the past two decades. Several preclinical studies have demonstrated their benefit in terms of improvement in host cell defence, peritoneal membrane integrity, and cytokine profile. This paper aims to review randomised controlled trials assessing the use of biocompatible PD fluids and their effect on clinical outcomes. PMID:23251801
Parodis, Ioannis; Zickert, Agneta; Sundelin, Birgitta; Axelsson, Magnus; Gerhardsson, Jakob; Svenungsson, Elisabet; Malmström, Vivianne; Gunnarsson, Iva
Objectives Lupus nephritis (LN) is a major cause of morbidity in patients with systemic lupus erythematosus (SLE). B cells have a central role in the pathogenesis of SLE. B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL) are pivotal in B cell homeostasis. We aimed to investigate a potential role of serum BLyS and APRIL as biomarkers in LN, especially as predictors of treatment response. Methods Sixty-four patients with active LN (52 proliferative lupus nephritis (PLN); 12 membranous LN) were included. Renal biopsies were performed at baseline and after immunosuppressive treatment. Serum levels of BLyS, APRIL and autoantibodies were measured on both biopsy occasions and in 64 individually matched controls. Renal biopsies were evaluated using the International Society of Nephrology/Renal Pathology Society classification, and scored for Activity Index and Chronicity Index. Clinical responders (CR) were required to have ≥50% reduction in proteinuria, normal or improved renal function, and inactive urinary sediment. Histopathological responders (HR) were required to have ≥50% improvement in Activity Index. Results Baseline BLyS levels were significantly higher in LN patients compared with controls (p<0.001) and remained unchanged following induction treatment. APRIL levels were significantly higher in patients compared with controls at baseline (p=0.005) and decreased following treatment (p<0.001). Among PLN patients, APRIL levels decreased significantly only in responders (CR: p=0.009; HR: p=0.01). Baseline BLyS levels <1.5 ng/mL predicted treatment response, attaining a positive predictive value of 92% for CR with PLN at baseline. Conclusions BLyS and APRIL were affected differently by immunosuppression; BLyS levels remained unchanged following therapy while APRIL levels decreased. Despite unchanged BLyS levels following therapy, low baseline levels predicted both clinical and histopathological improvement. Our data support APRIL as a
Agabiti, Nera; Davoli, Marina; Fusco, Danilo; Stafoggia, Massimo; Perucci, Carlo A
This introductory guide represents an operative tool to conduct epidemiological studies in the area of comparative outcomes evaluation. It is based on the experience of epidemiological research in this field conducted in Italy within national (BPAC-Esiti del bypass aortocoronarico, Progetto mattoni outcome, Progetto Progressi) or regional (P.Re.Val.E. Programma Regionale di Valutazione degli Esiti, Lazio) health care outcomes projects and the National outcome programme. This guide is aimed to all those interested in conducting or interpreting health care outcomes studies within different levels of the Italian NHS. It gives an introductory description of the operative steps to build outcome indicators and to perform comparative analyses, with the general objective of measuring and promoting improvement in health care. A specific emphasis is given to the use of routinely collected health care databases that have found widespread use for epidemiological purposes. This guide has two parts: part A includes an introduction and comments on critical methodological points, part B shows three example of epidemiological studies (A. Complications after cholecystectomy: comparison between two surgical techniques, B. 30-day mortality after acute myocardial infarction: comparison among hospitals, C. 30-day mortality after acute myocardial infarction: comparison between time periods). The online version of this guide is organised as a hypertext as practical instrument of appraisal.
Ebert, Jay R; Bucher, Thomas A; Mullan, Conor J; Janes, Gregory C
Hip abductor tendon (HAT) tearing is commonly implicated in greater trochanteric pain syndrome. Surgical studies are often reported in small cohorts and with limited information on functional improvement. This study reports the clinical and functional outcomes after HAT repair. 112 patients with symptomatic HAT tears, diagnosed via magnetic resonance imaging, underwent open bursectomy, V-Y lengthening of the iliotibial band, debridement of the diseased tendon, decortication of the trochanteric foot-plate and reattachment of the tendon with suture anchors, augmented with a LARS ligament through a trans-osseous tunnel. Patients were evaluated pre-surgery and at 3, 6 and 12 months post-surgery using the Harris (HHS) and Oxford (OHS) Hip Scores, SF-12, hip range of motion, 6-minute walk and 30-second single leg stance tests. Maximal isometric hip abduction strength (HAS) was assessed and limb symmetry indices (LSIs) were calculated between the operated and non-operated limbs. Patient satisfaction and perceived global rating of change (GRC) was evaluated. Analysis of variance evaluated improvement over time. There was a significant improvement (p<0.05) in all clinical and functional measures. HAS significantly improved over time (p<0.002) and all LSIs were >85% at 12 months. At 12 months, a mean GRC score of 3.5 (range -1 to 5) was reported, while 96% of patients were satisfied with their surgical outcome. There was a 2.7% (n = 3) failure rate at 12 months. HAT reconstruction, augmented with a synthetic ligament, demonstrated significantly improved clinical and functional outcomes, high levels of patient satisfaction and a low failure rate to 12 months post-surgery.
Sinha, C K; Decoppi, Paolo; Pierro, Agostino; Brain, Caroline; Hindmarsh, Peter; Butler, Gary; Dattani, Mehul; Spoudeas, Helen; Kurzawinski, Tom R
The aim of this study was to review the outcomes of thyroid surgery in children operated for both benign and malignant conditions. Demography, clinical features, and surgical outcomes were noted retrospectively for operations performed during the last 23 years. Results were analyzed using Fisher exact test and Woolf (logit) method with p value < 0.05 considered as significant. In total, 61 children (43 girls and 18 boys) underwent thyroidectomy for benign (70%) and malignant (30%) conditions. Median follow-up period was 1.4 years. In the benign group, 84% children had Graves disease and 16% had other conditions. In this study, 42% children had total, 22% had near-total, 27% had subtotal, and 9% had type 2 hemithyroidectomy. In the malignant group, 50% had multiple endocrine neoplasia, 33% had papillary, 11% had follicular cancer, and 6% had B-cell lymphoma. Fifty percent children had prophylactic thyroidectomy, 44% had total thyroidectomy plus lymphadenectomy, and 6% had hemithyroidectomy. At the time of surgery, children with benign conditions were older than those with malignancy (median, 12 vs. 7.5 years). There were no incidents of postoperative bleeding or infection. Hypocalcemia was significantly more frequent in the malignant group (39 vs. 9%, p value = 0.01). The type of recurrent laryngeal nerve (RLN) injury was more serious in the benign group (one bilateral and one unilateral permanent injury) than in the malignant group (transient hoarseness in three). Overall rate of complications was higher for operations for malignancy (56 vs. 28%, p value = 0.07). In Graves disease, the subtotal thyroidectomies had a recurrence of 30% but no recurrence was seen following total or near-total thyroidectomy group (p value = 0.01). There was no recurrence in the malignant group. Children operated after 2000 were younger than those operated before 2000 (median age, 9 vs. 14 years). Malignant conditions were more common in children operated after 2000 in
Siah, We Fong; Al-Muhaylib, Ahmed A; Rajak, Saul; Ziahosseini, Kimia; Selva, Dinesh; Malhotra, Raman; Alsuhaibani, Adel H
To evaluate the clinical outcomes of ruptured dermoid cysts. A multicenter, retrospective study of all cases of periorbital and orbital dermoid cysts with histopathological evidence of rupture, including those with clinical rupture, was performed over a 10-year period. Demographics and clinical outcomes of ruptured dermoid cysts were recorded. Persistent inflammation was defined as the presence of edema, erythema, and discomfort for at least 28 days. Eighty-six cases of dermoid cysts were identified. Median age was 5.5 (range, 1-63) years. Location of cyst was either periorbital (n = 60, 70%) or orbital (n = 26, 30%). There were 29 cases with clinically apparent rupture: 27 surgically ruptured (93%) and 2 spontaneous rupture (7%). Persistent inflammation was found in 1 spontaneous cyst rupture case (50%) and 1 surgically ruptured cyst (3.7%). Older age (p = 0.01) and bony attachment (p = 0.001) were significant factors for cyst rupture, while there was no influence from cyst location (p = 0.14). Persistent inflammation is uncommon after surgical rupture of dermoid cysts, but likely after spontaneous rupture. Older age and bony attachment are risk factors for cyst rupture.
Kolko, David J.; Iselin, Anne-Marie R.; Gully, Kevin J.
This paper examines the sustainability and outcome of Alternatives for Families: A Cognitive-Behavioral Therapy (AF-CBT) as delivered by practitioners in a community-based child protection program who had received training in the model several years earlier. Formerly described as Abuse-Focused CBT, AF-CBT is an evidence-based treatment (EBT) for…
Kolko, David J.; Iselin, Anne-Marie R.; Gully, Kevin J.
This paper examines the sustainability and outcome of Alternatives for Families: A Cognitive-Behavioral Therapy (AF-CBT) as delivered by practitioners in a community-based child protection program who had received training in the model several years earlier. Formerly described as Abuse-Focused CBT, AF-CBT is an evidence-based treatment (EBT) for…
The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-positive errors resulting from the statistical testing of many outcomes, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study. This article discusses the setting of the primary outcome measure, the need for it, the increased risk of false-positive and false-negative errors in secondary outcome results, how to regard articles that do not state the primary outcome, how to interpret results when secondary outcomes are statistically significant but not the primary outcome, and limitations of the concept of a primary outcome measure in clinical trial research.
Bhansali, A; Upreti, V; Dutta, P; Mukherjee, K K; Nahar, U; Santosh, R; Das, S; Walia, R; Pathak, A
Adolescent acromegaly is a rare disorder and these patients present with tall stature/gigantism, tumor mass effects and menstrual irregularities. 34 consecutive (26 males) patients having onset of disease prior to 21 years of age were included in this retrospective analysis. Their clinical features and treatment outcome were studied. Mean age and lag time at presentation were 21.6 +/- 3.9 years and 5.1 +/- 3.5 years respectively. Common presenting manifestations included acral enlargement, tumor mass effects and menstrual irregularities. Mean height at presentation was 174.6 +/- 13.7 cms (range: 150-210 cm) and one third had gigantism (height > or =97th percentile, WHO growth charts). Hypertension and glucose intolerance were seen in 15% and 23.5% respectively. Mean nadir GH after glucose load was 58.2 +/- 13.7 ng/ml and IGF -1 was 534.8 +/- 132.8 ng/ml. Half of the patients had concomitant hyperprolactinemia. Almost all (97%) had macroadenoma and anterior pituitary hormone deficiencies were frequent (75%). Patients with gigantism were younger (19.6 +/- 4.9 vs. 22.6 +/- 2.9 years; p = 0.001), had higher GH values (66.68 +/- 27.22 vs. 53.98 +/- 15.99 ng/ml; p = 0.04) and hypogonadism was more common (90.9% vs. 56.5%, p = 0.03) than those with normal stature. 32 patients (94.1%) were treated primarily with surgery, 7 (21.9%) received post operative radiotherapy. Mean duration of follow up was 33.1 +/- 10.1 months. Only 30% had nadir GH values of <1 ng/ml. One third of adolescent patients had acrogigantism. These patients were younger, had higher GH levels and concurrent hypogonadism was more common. Cure could be achieved only in about one third of the patients.
du Plessis, Jean-Pierre; Dix-Peek, Stewart; Hoffman, Eduard Bernard; Wieselthaler, Nicky; Dunn, Robert Neil
Study design: Retrospective diagnostic feasibility study and clinical review. Objectives: To evaluate the feasibility of making an initial atlanto-occipital dissociation (AOD) diagnosis from four radiological measurements of the craniocervical relationship on lateral cervical spine x-rays and to assess the AOD patients' clinical outcomes relative to their magnetic resonance imaging (MRI) findings. Methods: The Powers ratio, Wackenheim line, basion-dens distance (BDD), and the C1/2:C2/3 interspinous ratio were measured in 58 pediatric controls and ten MRI-confirmed patients with AOD. The ability to identify the required anatomical landmarks and make the measurements was noted and sensitivity and specificity calculated. The correspondence between the clinical presentation and outcomes for patients with AOD and their MRI features was investigated. Results: Clear landmarks for measuring interspinous ratio and Wackenheim line were confirmed by all x-rays. The BDD was measureable in 90% and the Powers ratio could be calculated in only possible in 59%. The interspinous ratio and BDD offered high sensitivities and specificity. Although the Wackenheim line was consistantly measured, it conferred a low sensitivity but reasonable specificity. The Powers ratio offered high specificity with low sensitivity. On MRI, all patients with AOD had apical ligament disruption, with a high rate of interspinous ligamentous injury (8/9); prevertebral swelling (7/9); retroclival hematoma (6/9); and tectorial membrane injury (4/9). The only MRI feature associated with poor outcome was that of altered cord signal. Both patients who died had cord signal changes on T1- and T2-weighted images. The third patient with cord signal change was limited to T2 changes with a normal T1. He had a C5-L3 sensory deficit that resolved. The degree of tectorial membrane injury did not appear to influence outcome. Conclusions: The BDD and interspinous ratio offer the best measures for initial x
Dall, Timothy M; Askarinam Wagner, Rachel C; Zhang, Yiduo; Yang, Wenya; Arday, David R; Gantt, Cynthia J
To share outcomes and lessons learned from an evaluation of disease management (DM) programs for asthma, congestive heart failure (CHF), and diabetes for TRICARE patients. Multiyear evaluation of participants in voluntary, opt-out DM programs. Patient-centered programs, administered by 3 regional contractors, provide phone-based consultations with a care manager, educational materials, and newsletters. The study sample consisted of 23,793 asthma, 4092 CHF, and 29,604 diabetes patients with at least 6 months' tenure in the program. Medical claims were analyzed to quantify program effect on healthcare utilization, medical costs, and clinical outcomes. Multivariate regression analysis with an historical control group was used to predict patient outcomes in the absence of DM. The difference between actual and predicted DM patient outcomes was attributed to the program. A patient survey collected data on program satisfaction and perceived usefulness of program information and services. Modest improvements in patient outcomes included reduced inpatient days and medical costs, and (with few exceptions) increased percentages of patients receiving appropriate medications and tests. Annual per patient reductions in medical costs were $453, $371, and $783 for asthma, CHF, and diabetes program participants, respectively. The estimated return on investment was $1.26 per $1.00 spent on DM services. Findings suggest that the DM programs more than pay for themselves, in addition to improving patient health and quality of life. Lessons learned in program design, implementation, effectiveness, and evaluation may benefit employers contemplating DM, DM providers, and evaluators of DM programs.
Rosenstein, Alan H; O'Daniel, Michelle
Providing safe, error-free care is the number-one priority of all health care professionals. Excellent outcomes have been associated with procedural efficiency, the implementation of evidence-based standards, and the use of tools designed to reduce the likelihood of medical error (such as computerized medication orders and bar-coded patient identification). But the impact of work relationships on clinical outcomes isn't as well documented. The current survey was designed as a follow-up to a previous VHA West Coast survey that examined the prevalence and impact of physicians' disruptive behavior on the job satisfaction and retention of nurses (see "Nurse-Physician Relationships: Impact on Nurse Satisfaction and Retention," June 2002). Based on the findings of that survey and subsequent comments on it, the follow-up survey examined the disruptive behavior of both physicians and nurses, as well as both groups' and administrators' perceptions of its effects on providers and its impact on clinical outcomes. Surveys were distributed to 50 VHA hospitals across the country, and results from more than 1,500 survey participants were evaluated. Nurses were reported to have behaved disruptively almost as frequently as physicians. Most respondents perceived disruptive behavior as having negative or worsening effects, in both nurses and physicians, on stress, frustration, concentration, communication, collaboration, information transfer, and workplace relationships. Even more disturbing was the respondents' perceptions of negative or worsening effects of disruptive behavior on adverse events, medical errors, patient safety, patient mortality, the quality of care, and patient satisfaction. These findings suggest that the consequences of disruptive behavior go far beyond nurses' job satisfaction and morale, affecting communication and collaboration among clinicians, which may well, in turn, have a negative impact on clinical outcomes. Strategies aimed at reducing the incidence and
Background The use of telemedicine is growing, but its efficacy for achieving comparable or improved clinical outcomes has not been established in many medical specialties. The objective of this systematic review was to evaluate the efficacy of telemedicine interventions for health outcomes in two classes of application: home-based and office/hospital-based. Methods Data sources for the study included deports of studies from the MEDLINE, EMBASE, CINAHL, and HealthSTAR databases; searching of bibliographies of review and other articles; and consultation of printed resources as well as investigators in the field. We included studies that were relevant to at least one of the two classes of telemedicine and addressed the assessment of efficacy for clinical outcomes with data of reported results. We excluded studies where the service did not historically require face-to-face encounters (e.g., radiology or pathology diagnosis). All included articles were abstracted and graded for quality and direction of the evidence. Results A total of 25 articles met inclusion criteria and were assessed. The strongest evidence for the efficacy of telemedicine in clinical outcomes comes from home-based telemedicine in the areas of chronic disease management, hypertension, and AIDS. The value of home glucose monitoring in diabetes mellitus is conflicting. There is also reasonable evidence that telemedicine is comparable to face-to-face care in emergency medicine and is beneficial in surgical and neonatal intensive care units as well as patient transfer in neurosurgery. Conclusions Despite the widespread use of telemedicine in virtually all major areas of health care, evidence concerning the benefits of its use exists in only a small number of them. Further randomized controlled trials must be done to determine where its use is most effective. PMID:11737882
Danza, Matteo; Fromovich, Ophir; Guidi, Riccardo; Carinci, Francesco
Spiral family implants (SFIs) are a new type of implant fixture with a conical internal helix and a variable thread design. The aim of this retrospective study was to evaluate the clinical outcomes of a series of SFIs. A total of 234 SFIs were placed in 86 patients (55 females and 31 males, median age 53 years) during the period between May 2004 and November 2007. The mean follow-up was 13 months. Several host, surgery, and implant-related factors were investigated, and the Kaplan Meier algorithm and the Cox regression were used to detect variables associated with the clinical outcome. Only nine out of 234 implants were lost (i.e., survival rate (SVR) of 96.2%) and no differences were detected among the studied variables. SFIs have a high SVR similar to those reported in previous studies on different implant types. SFIs demonstrated a very high primary stability which offers the potential for use of a specific implant device for immediate loading. However, additional studies are necessary to verify their outcome on the medium/long period.
Nygaard, Birgitte; Saedder, Eva A; Dalhoff, Kim; Wikkelsoe, Mette; Jürgens, Gesche
Levothyroxine (LT), T4, poisoning is rarely associated with a severe outcome. However, cases with significant complications have been reported. The aim of this study was to identify factors associated with symptoms of poisoning including late-onset symptoms. All enquiries to the Danish Poison Information Centre (DPIC) concerning LT poisoning between March 2007 and September 2012 were reviewed and the following parameters were recorded: age, dose, time from ingestion, multiple drug intake and symptoms. To evaluate the frequency of late-onset symptoms, a subgroup of patients without initial symptoms were contacted. A total of 181 patients were registered (112 children). Ingested LT dose ranged from 10 to 9000 mcg (median 275 mcg). A total of 29 of 181 (16%) patients were symptomatic at the time of enquiry, and there was no difference in ingested LT dose between asymptomatic and symptomatic patients, neither in children nor in adults (age 16-92 years) (p < 0.68 and p < 0.47, respectively). In total, 153 of 181 (85%) patients did not have symptoms of poisoning at the time of enquiry; however, in 9 of 21 (43%) patients, we were able to contact, late-onset symptoms existed. In none of the cases, hospital contact was needed and there were no reports of long-term sequelae. Acute LT poisoning often follows a benign course. The occurrence of symptoms appears not to be dose dependent. Late-onset symptoms seem to be common. However, all symptoms resolved spontaneously without need of medical care.
Ray, Wilson Z.; Mackinnon, Susan E.
Purpose In this study the authors evaluate the clinical outcomes in patients with radial nerve palsy who underwent nerve transfers utilizing redundant fascicles of median nerve (innervating the flexor digitorum superficialis and flexor carpi radialis muscles) to the posterior interosseous nerve and the nerve to the extensor carpi radialis brevis. Methods A retrospective review of the clinical records of 19 patients with radial nerve injuries who underwent nerve transfer procedures using the median nerve as a donor nerve were included. All patients were evaluated using the Medical Research Council (MRC) grading system. Results The mean age of patients was 41 years (range 17 – 78 years). All patients received at least 12 months of follow-up (20.3 ± 5.8 months). Surgery was performed at a mean of 5.7 ± 1.9 months post-injury. Post-operative functional evaluation was graded according to the following scale: grades MRC 0/5 - MRC 2/5 were considered poor outcomes, while MRC of 3/5 was a fair result, MRC grade 4/5 was a good result, and grade 4+/5 was considered an excellent outcome. Seventeen patients (89%) had a complete radial nerve palsy while two patients (11%) had intact wrist extension but no finger or thumb extension. Post-operatively all patients except one had good to excellent recovery of wrist extension. Twelve patients recovered good to excellent finger and thumb extension, two patients had fair recovery, five patients had a poor recovery. Conclusions The radial nerve is a commonly injured nerve, causing significant morbidity in affected patients. The median nerve provides a reliable source of donor nerve fascicles for radial nerve reinnervation. This transfer was first performed in 1999 and evolved over the subsequent decade. The important nuances of both surgical technique and motor re-education critical for to the success of this transfer have been identified and are discussed. PMID:21168979
Yamashita, Takanori; Wakata, Yoshifumi; Hamai, Satoshi; Nakashima, Yasuharu; Iwamoto, Yukihide; Franagan, Brendan; Nakashima, Naoki; Hirokawa, Sachio
Recently the clinical pathway has progressed with digitalization and the analysis of activity. There are many previous studies on the clinical pathway but not many feed directly into medical practice. We constructed a mind map system that applies the spanning tree. This system can visualize temporal relations in outcome variances, and indicate outcomes that affect long-term hospitalization.
Patterson, R J; Ellerbee, S; Powell, M J; Thompson, P J; Jackson, E
A random retrospective review of the Teen Obstetrical Parenting Perinatal Services (TOPPS) clinic medical records for 1985 to 1989 was completed on 120 adolescent mothers (30 charts for each year). The purpose of this study was to evaluate maternal and infant outcomes related to the goals of the TOPPS clinic located at University Hospital on the UAMS campus in Little Rock, Arkansas. The clinic was cofounded by Lee Lee Doyle, Ph.D., who is now professor of obstetrics/gynecology at UAMS, and Betty Rouse, R.N., M.N.Sc., who is a clinical associate professor at UAMS, College of Nursing. The outcomes measured were nutritional status as measured by maternal weight gain, infant birth weight, gestational age and Apgar scores. Referrals to appropriate agencies during pregnancy were also reviewed. Analysis of the data revealed that 31% of clients received documented nutritional counseling, 60.2% of the babies were healthy (88% term and 87% appropriate for gestational age), and documented referrals (i.e. WIC, AFDC, Medicaid, etc.) were made in 32% of the cases. Conclusions were that both mothers and infants had positive outcomes. Documentation of referrals needs to be improved or rationale stated for non-referral.
Novo-Matos, José; Hurter, Karin; Bektas, Rima; Grest, Paula; Glaus, Tony
Right-sided congestive heart failure (CHF) developed secondary to severe pulmonary hypertension (PH) in an 8-year-old cat with a left-to-right shunting patent ductus arteriosus (PDA). Vascular reactivity was tested prior to shunt ligation by treatment with oxygen and sildenafil. This treatment was associated with a significant decrease in pulmonary artery pressure as assessed by echocardiography. Subsequently surgical shunt ligation was planned. During thoracotomy, digital occlusion of the PDA was performed for 10 min with simultaneous catheter measurement of right ventricular pressure, which did not increase. Permanent shunt ligation resulted in a complete and sustained clinical recovery. A lung biopsy sample obtained during thoracotomy demonstrated histopathological arterial changes typical of PH. Cats can develop clinically severe PH and right-sided CHF secondary to a left-to-right PDA even at an advanced age. Assuming there is evidence of pulmonary reactivity, PDA occlusion might be tolerated and can potentially produce long-term clinical benefits.
Bark, C M; Dietze, R; Okwera, A; Quelapio, M I; Thiel, B A; Johnson, J L
During a recent Food and Drug Administration workshop on clinical trials to evaluate new TB drugs, questions were raised regarding the use of bacteriologic endpoints such as treatment failure and relapse as measures of improvement in health status and long term outcome after treatment. FDA scientists asked how patients' clinical signs and symptoms changed during therapy, noting that while such information is usually collected during clinical trials, it is not often reported. We analyzed data from an international phase 3 TB treatment trial that included systematic assessments of symptoms. The percentage of subjects with self-reported symptoms at baseline ranged from 30% for dyspnea to 81% for cough, with 51% reporting fever. During therapy, fever, sweats, and dyspnea decreased most rapidly, with near resolution by the end of therapy. Chest pain and cough resolved more slowly; 13% of subjects reported cough at six months. Symptom resolution during treatment did not differ between those who relapsed and those who did not. Among those with microbiological relapse, symptoms returned with significant increases in the proportion with fever, cough, and chest pain. At the time of relapse, cough was the most frequent symptom, occurring in 75% of subjects who relapsed but only 12% of those who did not. Our data support the continued use of bacteriologic endpoints based on sputum culture as surrogate measures of the relief of symptoms, improvement in health status and favorable long term treatment outcome in TB drug trials. Copyright © 2011 Elsevier Ltd. All rights reserved.
Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B
An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to
Rivers, Joynelle L.
Nursing education faces many challenges such as faculty shortages, inadequate clinical site placements, the inability to accept qualified students because of limited resources, and how to effectively educate students who are tech savvy, confident, highly motivated yet have differing needs from previous generations. This study sought to explore how…
Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.
Jammer, Ib; Wickboldt, Nadine; Sander, Michael; Smith, Andrew; Schultz, Marcus J; Pelosi, Paolo; Leva, Brigitte; Rhodes, Andrew; Hoeft, Andreas; Walder, Bernhard; Chew, Michelle S; Pearse, Rupert M
There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.
Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S
This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.
Andresen, Morten; Bartek, Jiri; Cortsen, Marie; Eskesen, Vagn; Wagner, Aase
Intra-arterial nimodipine (IAN) has shown a promising effect on cerebral vasospasm (CV) after aneurysmal subarachnoid haemorrhage. At our institution, Rigshospitalet, IAN treatment has been used since 2009, but the short- and long-term clinical efficacy of IAN has not yet been assessed. The purpose was to evaluate the efficacy and clinical outcome of IAN treatment of symptomatic CV, and to assess the predictors of clinical outcome. Medical records of 25 patients undergoing a total of 41 IAN treatment sessions were retrospectively reviewed. Data on angiographic results, blood-flow velocities and the clinical condition before and after the IAN treatment were recorded. Predictors of the clinical outcome were assessed with a linear regression model. Positive angiographic response was achieved in 95.1% of 41 IAN treatment sessions. Flow-velocity measurements showed no relationship with angiographic responses of IAN. The immediate clinical improvement was observed in three patients (12%). Five patients (20%) had a favourable outcome at discharge and at three-month follow-up; 10 patients (40%) had a moderate to poor outcome; and the rest (40%) died. Increased number of affected vessels and number of procedures carried out per patient, and a trend toward an increased delay time from symptomatic CV to confirming angiographic CV and thus instituting IAN treatment predicted the poor clinical outcome. IAN treatment appears to be effective in reversing angiographic CV. However, it is not always effective in reversing clinical deterioration, as several other factors including treatment delay affect the clinical course. PMID:26825134
McAllister, M; Dearing, A
Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS.
Martin, Staci; Merker, Vanessa L.; Gardner, Kathy L.; Hingtgen, Cynthia M.; Tonsgard, James H.; Schorry, Elizabeth K.; Baldwin, Andrea
Objectives: Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. Methods: The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Results: Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥8 years. Conclusions: The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials. PMID:24249806
Moise, Pamela A; Sakoulas, George; McKinnell, James A; Lamp, Kenneth C; DePestel, Daryl D; Yoon, Min J; Reyes, Katherine; Zervos, Marcus J
In light of recent evidence suggesting enhancement of daptomycin activity against vancomycin-resistant Enterococcus (VRE) by ampicillin and other β-lactam antibiotics, we evaluated the safety profile and clinical efficacy of daptomycin with and without concomitant β-lactam antimicrobials in the treatment of VRE (faecium or faecalis) bacteremia from multiple centers across the United States. Data were collected retrospectively as part of a larger multicenter registry (The Cubicin Outcomes Registry and Experience). Efficacy and clinical outcomes in patients with VRE bacteremia who received at least 3 days of daptomycin with or without concomitant β-lactams were analyzed. Although all the cases involved daptomycin-susceptible VRE, additional analysis was performed to examine whether the adjunctive β-lactam would play a more pivotal role in cases where the daptomycin MIC was in the upper limit of the susceptibility range, indicating that daptomycin monotherapy efficacy may be relatively compromised compared with cases with lower daptomycin MICs. Two hundred sixty-two patients from 33 hospitals were evaluated. Most patients had at least one significant comorbidity, such as solid-organ or bone marrow transplantation (16%), neutropenia (36%), dialysis dependency (20%), or critical illness (36%) requiring care in an intensive care unit. Overall treatment success was 86% (n = 225/262), and treatment success for patients taking concomitant β-lactams was 86% (n = 105/122). Logistic regression identified treatment failure to be associated with sepsis (odds ratio = 3.42; P = 0.009) and an elevated daptomycin MIC (3-4 µg/mL) (odds ratio = 3.23, P = 0.013). No significant increase in clinical failure was seen among patients with elevated daptomycin MIC who received concomitant β-lactam therapy (clinical success, 88% vs 79% for MIC ≤2 vs 3-4 µg/mL, respectively; P = 0.417). Of 262 patients, 33 (13%) experienced ≥1 adverse event possibly related to daptomycin (increased
Mavrogenis, Andreas F; Angelini, Andrea; Panagopoulos, Georgios N; Pala, Elisa; Calabrò, Teresa; Igoumenou, Vasilios G; Katzouraki, Galatia; Megaloikonomos, Panayiotis D; Pneumaticos, Spyros G; Papagelopoulos, Panayiotis J; Ruggieri, Pietro
The authors reviewed the files of all patients with chordomas who were admitted and treated at their institutions from 1975 to 2012. Patients were categorized by early local recurrence and metastasis. Aggressive clinical behavior was defined as local recurrence and metastasis within 24 months of diagnosis and adequate treatment (wide en bloc resection with microscopically negative tumor margins). According to these criteria, 13 patients (14.3%) had aggressive chordomas, including 7 men and 6 women, with mean age of 54 years (range, 37-65 years) at diagnosis and treatment. All patients had preoperative tumor biopsy, followed by resection with partial (7 patients) or total sacrectomy (6 patients). In all cases, biopsy and histologic analysis of resected tumor specimens showed conventional chordomas. Resection margins were wide (grossly negative) in 6 patients and wide contaminated in 7 patients. Mean maximum tumor diameter was 11.8 cm (range, 5-21 cm). Mean follow-up was 43 months (range, 8-131 months). Rates of local recurrence, metastasis, and death were evaluated. At the last follow-up, all patients had local recurrence at a mean of 13 months (range, 5-22 months). Histologic examination of recurrent tumors showed a dedifferentiated chordoma with a fibrosarcoma component in 2 patients and no histologic change in the remaining patients. In addition, 8 patients had metastases at a mean of 13 months (range, 4-24 months) and died of their disease. All histologic findings of metastatic lesions were similar to those of primary tumors. Early diagnosis of aggressive tumors requires close follow-up of patients with chordomas. Metastasis is common, with resultant poor survival. [Orthopedics. 2017; 40(2):e248-e254.].
Papa, Francesco; Cortese, Antonio; Sagliocco, Raffaele; Farella, Mauro; Banzi, Claudio; Maltarello, Maria Cristina; Pellegrini, Camilla; D'Agostino, Elio; Aimola, Pierpaolo; Claudio, Pier Paolo
The reconstruction of the maxillary bone frequently represents a real challenge for maxillofacial surgeons especially regarding the best choice of a suitable material to produce the required bone augmentation. In this study, we summarize our clinical experience on 47 sinus lifts with lateral approach using a mixture of aragonitic calcium carbonate and autologous platelet-rich plasma compared with that of a previous published study in which bovine bone (LADDEC) and autologous bone were used in 50 sinus lift operations (Br J Oral Maxillofac Surg 2005;43:309-313). We subjected 34 patients to sinus lift operation, for a total of 47 sinus lifts, using natural coral as osteoconductive material. This material, combined with autologous platelet-rich plasma, was placed onto the maxillary sinus floor, after carefully lifting the endosteum. Cases were clinically, radiographically, and histologically analyzed. Histomorphometrical analysis, tests of microhardness, and x-ray microanalysis were conducted comparing the various sample to controls obtained from the same patients. Histomorphometrical analysis, microhardness test, and x-ray microanalysis demonstrated that the newly formed bone showed morphologic and structural characteristics that were similar for all the grafting materials compared (bovine bone, autologous bone, and coral). Although all the grafting materials did yield good results of maturation of the newly formed bone, best results were achieved using autologous bone.
Zhang, Li; Zhang, Junhua; Chen, Jing; Xing, Dongmei; Wang, Jiaying
Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards. PMID:24312133
Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M,; Foy, M. H.; Dulchavsky, S. A.; Gibson, C. R.
The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capabilities (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities". Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes.
Li, Chen-long; Chen, Ying; Chen, Yong-zheng; Fu, Yao-yao; Zhang, Tian-yu
The aim of the present study was to comprehensively evaluate the clinical features and long-term outcomes of congenital aural stenosis (CAS). This study presents a retrospective review of patients who underwent meatoplasty for CAS at a tertiary referral hospital from 2008 to 2015. A total of 246 meatoplasty procedures were performed on 232 patients in the present study. We performed multivariate regression analysis. Except in the age < 6 years group, no significant difference was observed among different age groups for cholesteatoma formation, p > 0.05. Except for the stenosis of the external auditory canal (EAC) (>4 mm) group, the other stenosis of EAC groups were not associated with cholesteatoma formation, p > 0.05. Postoperative air-bone gaps (ABG) less than 30 dB occurred in 77.3% (99/128) of the patients, and the Jahrsdoerfer score was associated with postoperative ABG, p < 0.001. The complication rate of CAS was 13.8% (20/144), and males showed a higher risk for postoperative complications (OR, 6.563; 95% CI, 1.268–33.966, p = 0.025). These results indicate that meatoplasty was an effective surgical intervention for CAS, showing a stable hearing outcome with prolonged follow-up. There was no significant difference between the cholesteatoma and no cholesteatoma groups for hearing outcomes, p > 0.05. PMID:27257165
Grigg, Celia P; Tracy, Sally K; Tracy, Mark; Daellenbach, Rea; Kensington, Mary; Monk, Amy; Schmied, Virginia
To compare maternal and neonatal birth outcomes and morbidities associated with the intention to give birth in a freestanding primary level midwife-led maternity unit (PMU) or tertiary level obstetric-led maternity hospital (TMH) in Canterbury, Aotearoa/New Zealand. Prospective cohort study. 407 women who intended to give birth in a PMU and 285 women who intended to give birth at the TMH in 2010-2011. All of the women planning a TMH birth were 'low risk', and 29 of the PMU cohort had identified risk factors. Mode of birth, Apgar score of less than 7 at 5 min and neonatal unit admission. labour onset, analgesia, blood loss, third stage of labour management, perineal trauma, non-pharmacological pain relief, neonatal resuscitation, breastfeeding, gestational age at birth, birth weight, severe morbidity and mortality. Women who planned a PMU birth were significantly more likely to have a spontaneous vaginal birth (77.9%vs62.3%, adjusted OR (AOR) 1.61, 95% CI 1.08 to 2.39), and significantly less likely to have an instrumental assisted vaginal birth (10.3%vs20.4%, AOR 0.59, 95% CI 0.37 to 0.93). The emergency and elective caesarean section rates were not significantly different (emergency: PMU 11.6% vs TMH 17.5%, AOR 0.88, 95% CI 0.55 to 1.40; elective: PMU 0.7% vs TMH 2.1%, AOR 0.34, 95% CI 0.08 to 1.41). There were no significant differences between the cohorts in rates of 5 min Apgar score of <7 (2.0%vs2.1%, AOR 0.82, 95% CI 0.27 to 2.52) and neonatal unit admission (5.9%vs4.9%, AOR 1.44, 95% CI 0.70 to 2.96). Planning to give birth in a primary unit was associated with similar or reduced odds of intrapartum interventions and similar odds of all measured neonatal well-being indicators. The results of this study support freestanding midwife-led primary-level maternity units as physically safe places for well women to plan to give birth, with these women having higher rates of spontaneous vaginal births and lower rates of interventions and their
Śmietanka, Krzysztof; Olszewska, Monika; Domańska-Blicharz, Katarzyna; Bocian, A Lukasz; Minta, Zenon
The virulence of pigeon paramyxovirus type 1 (PPMV-1) for different species of birds was investigated in two independent sets of experiments in which groups of pigeons, chickens, turkeys, quails, and geese (10 birds per group) were inoculated with 10(6) median embryo infectious doses of PPMV-1 isolate: 1) nonpassaged (nPPMV-1, intracerebral pathogenicity [ICPI] value = 1.27) and 2) after six passages in specific-pathogen-free chickens (pPPMV-1, ICPI = 1.46) via the oculonasal route. Naive birds were placed in contact with infected birds (two birds per group) to monitor virus transmission. Clinical observation was performed daily. Additionally, cloacal swabs, oropharyngeal swabs, and selected organ samples were collected on days 2, 4, 7, 10, and 14 postinfection and tested by real-time reverse transcriptase-PCR for estimation of viral shedding and distribution in tissues. Infected pigeons exhibited nervous and digestive tract symptoms, mortality, shedding, and transmission to contact birds. Chickens, turkeys, quails, and geese did not exhibit any clinical signs regardless of the PPMV-1 strain used for inoculation. However, in contrast to quails and geese, chickens and turkeys shed the virus via the oral cavity and cloaca, and transmission to contact birds was also observed. Viral RNA was identified in tissues collected from all pPPMV-1-infected birds, whereas negative results were obtained in the case of tissues taken from nPPMV-1-infected quails and geese. We conclude that the PPMV-1 used in this study was most virulent to pigeons, followed by chickens and turkeys, while quails and geese seem to have the highest level of innate resistance to this strain. However, passaging of PPMV-1 in chickens resulted in the increase of ICPI and noticeable but sometimes contrasting changes in the replication capacities of the virus.
Abhari, Roxanna E; Martins, Joana A; Morris, Hayley L; Mouthuy, Pierre-Alexis; Carr, Andrew
Today's sutures are the result of a 4000-year innovation process with regard to their materials and manufacturing techniques, yet little has been done to enhance the therapeutic value of the suture itself. In this review, we explore the historical development, regulatory database and clinical literature of sutures to gain a fuller picture of suture advances to date. First, we examine historical shifts in suture manufacturing companies and review suture regulatory databases to understand the forces driving suture development. Second, we gather the existing clinical evidence of suture efficacy from reviewing the clinical literature and the Food and Drug Administration database in order to identify to what extent sutures have been clinically evaluated and the key clinical areas that would benefit from improved suture materials. Finally, we apply tissue engineering and regenerative medicine design hypotheses to suture materials to identify routes by which bioactive sutures can be designed and passed through regulatory hurdles, to improve surgical outcomes. Our review of the clinical literature revealed that many of the sutures currently in use have been available for decades, yet have never been clinically evaluated. Since suture design and development is industry driven, incremental modifications have allowed for a steady outflow of products while maintaining a safe regulatory position and limiting costs. Until recently, there has been little academic interest in suture development, however the rise of regenerative medicine strategies is shifting the suture paradigm from an inert material, which mechanically approximates tissue, to a bioactive material, which also actively promotes cell-directed repair and a positive healing response. These materials hold significant therapeutic potential, but could be associated with an increased regulatory burden, cost, and clinical evaluation compared with current devices.
Schmidt, C. Max; Choi, Jennifer; Powell, Emilie S.; Yiannoutsos, Constantin T.; Zyromski, Nicholas J.; Nakeeb, Attila; Pitt, Henry A.; Wiebke, Eric A.; Madura, James A.; Lillemoe, Keith D.
Pancreatic fistula continues to be a common complication following PD. This study seeks to identify clinical factors which may predict pancreatic fistula (PF) and evaluate the effect of PF on outcomes following pancreaticoduodenectomy (PD). We performed a retrospective analysis of a clinical database at an academic tertiary care hospital with a high volume of pancreatic surgery. Five hundred ten consecutive patients underwent PD, and PF occurred in 46 patients (9%). Perioperative mortality of patients with PF was 0%. Forty-five of 46 PF (98%) closed without reoperation with a mean time to closure of 34 days. Patients who developed PF showed a higher incidence of wound infection, intra-abdominal abscess, need for reoperation, and hospital length of stay. Multivariate analysis demonstrated an invaginated pancreatic anastomosis and closed suction intraperitoneal drainage were associated with PF whereas a diagnosis of chronic pancreatitis and endoscopic stenting conferred protection. Development of PF following PD in this series was predicted by gender, preoperative stenting, pancreatic anastomotic technique, and pancreas pathology. Outcomes in patients with PF are remarkable for a higher rate of septic complications, longer hospital stays, but in this study, no increased mortality. PMID:19461951
Martínez-Quintana, Efrén; Rodríguez-González, Fayna
CHD patients, especially those with associated hypoxaemia, usually have some level of renal function impairment, even though they are relatively young. The aim of the study was to evaluate those clinical and analytical factors that may contribute to microalbuminuria and determine the association of 24-hour proteinuria with thrombotic events and mortality. A total of 251 CHD patients were studied and demographic characteristics, blood test, and 24-hour urinalysis were analysed. Of the patients, 221 were non-hypoxaemic, and 30 were hypoxaemic (oxygen saturation of 84.3±5.9%). Of the non-hypoxaemic patients, 30 (13.6%), and of the hypoxaemic patients 9 (30%), showed proteinuria (>0.15 g/24 hours) (p=0.028). Hypoxaemic CHD patients also showed higher haematocrit (%) (50.7 (34.6; 72.1) versus 42.8 (34.6; 48.9), p<0.001), serum creatinine (mg/dl) (1.07±0.2 versus 0.96±1.9, p=0.004), microalbuminuria (mg/dl/24 hours) (1.2 (0.0; 261.5) versus 0.5 (0.0; 4.37), p<0.001), proteinuria (gr/24 hours) (1.0 (0.4; 3.1) versus 0.08 (0.04; 0.52), p=0.043), and N-terminal pro-B-type natriuretic peptide (pg/ml) (417.8 (35.7; 8534.0) versus 44.9 (0.0; 670.5), p<0.001) concentrations than non-hypoxaemic CHD patients. During a median follow-up of 26.0 (16.9; 57.7) months, five patients died - one patient had 24-hour proteinuria and four patients did not (p=0.581) - and three patients had some type of thrombosis - two patients had 24-hour proteinuria and one patient did not (p=0.014). Kaplan-Meier survival analysis showed no significant difference between CHD patients with and without 24-hour proteinuria (p=0.631). CHD patients with proteinuria have significantly more thrombosis and more hypoxaemia than those patients without proteinuria.
Olsson, Nicklas; Petzold, Max; Brorsson, Annelie; Karlsson, Jón; Eriksson, Bengt I; Silbernagel, Karin Grävare
In patients with an acute Achilles tendon rupture, it has not been possible to determine the superiority of a single specific treatment modality over other treatments with respect to symptoms and function. When several pertinent treatment protocols are available for an injury, it is of interest to understand how other variables, such as age, sex, or physical activity level, affect outcome to better individualize the treatment. To investigate predictors of both symptomatic and functional outcomes after an acute Achilles tendon rupture. Cohort study (Prognosis); Level of evidence, 2. Ninety-three patients (79 men and 14 women; mean age, 40 years) were evaluated prospectively at 3, 6, and 12 months. The main outcome measures in this study were the Achilles tendon Total Rupture Score (ATRS) for symptoms and maximum heel-rise height for function. The independent variables evaluated as possible predictors of outcome included treatment, sex, age, body mass index (BMI), physical activity level, symptoms, and quality of life. Treatment, age, BMI, physical activity level, heel-rise height at 6 months, and the ATRS at 3 months were eligible for further analysis. Only male sex was included for the prediction models. The 4 different multiple linear regression models (predicting the ATRS at 6 and 12 months and heel-rise height at 6 and 12 months) were significant (P < .001-.002), and the R (2) values for the models were 0.222 to 0.409. Surgical or nonsurgical treatment is a moderate predictor of symptoms and a weak predictor of heel-rise height after an acute Achilles tendon rupture. At the 6-month follow-up, surgical treatment was associated with a larger heel-rise height, but the opposite was seen at 12 months. Surgical treatment resulted in a lower degree of symptoms. Increasing age was a strong predictor of reduced heel-rise height, and an increase in age of 10 years reduced the expected heel-rise height by approximately 8%. A higher BMI was also a strong predictor of a
Almubarak, Salah; Wong, Peter K H
The aim of the study is to determine how specific EEG findings during neonatal period correlate with clinical outcome on follow-up. This is a retrospective study of 118 term newborns who had EEG in the first month of life and subsequent clinical assessment between 4 and 16 years. Clinical neurologic outcome was classified into "favorable" when patients had no or only mild limitation in assessment, "unfavorable" when patients had moderate to severe abnormalities in assessment, and "epilepsy" when patients had seizures. Of the 118 neonates, 36 (30.5%) had favorable and 82 (69.5%) had unfavorable outcome; 89 (75.4%) had epilepsy and 28 (23.7%) had not. Sixty-seven (57%) had abnormal EEG background of which 56 had both unfavorable outcome and epilepsy; 102 (86%) had sharp transient discharges of which 75 had unfavorable outcome; 20 (17%) had ictal epileptiform discharges of which 18 had unfavorable outcome; 98 (83%) had abnormal overall EEG impression of which 77 had unfavorable outcome and 80 had epilepsy. Abnormal EEG background (particularly suppression) during neonatal period may be predictive of Unfavorable outcome. Overall impression of EEG may be predictive of clinical outcome, even when individual parameters were not predictive. Other findings did not appear to be predictive.
Morrow, Kathleen M; Hendrix, Craig
The clinical evaluation of microbicide formulations presents variable and interacting challenges. Specific domains of acceptability, pharmacokinetics, and toxicity interact with each other to potentially inhibit or enhance a microbicide's efficacy. Each of these is further influenced by application and use parameters in the relative presence (or absence) of vaginal and/or seminal fluids, ultimately impacting effectiveness. Historically, acceptability of formulation and use parameters, and their concomitant behavioral influences, have been considered separately from pharmacokinetics and toxicity. While independent evaluation of these elements is necessary in some respects, we must acknowledge that this approach is not sufficient for the successful development of microbicides. Each needs to be considered in an integrated clinical evaluation strategy. This article presents the rationale for such an approach. This article forms part of a special supplement covering two presentations on clinical evaluation of microbicides from the symposium on "Recent Trends in Microbicide Formulations" held on 25 and 26 January 2010, Arlington, VA. Copyright © 2010 Elsevier B.V. All rights reserved.
Wandling, Michael W; Nathens, Avery B; Shapiro, Michael B; Haut, Elliott R
Rapid transport to definitive care ("scoop and run") versus field stabilization in trauma remains a topic of debate and has resulted in variability in prehospital policy. We aimed to identify trauma systems frequently using a true "scoop and run" police transport approach and to compare mortality rates between police and ground emergency medical services (EMS) transport. Using the National Trauma Databank (NTDB), we identified adult gunshot and stab wound patients presenting to Level 1 or 2 trauma centers from 2010 to 2012. Hospitals were grouped into their respective cities and regional trauma systems. Patients directly transported by police or ground EMS to trauma centers in the 100 most populous US trauma systems were included. Frequency of police transport was evaluated, identifying trauma systems with high utilization. Mortality rates and risk-adjusted odds ratio for mortality for police versus EMS transport were derived. Of 88,564 total patients, 86,097 (97.2%) were transported by EMS and 2,467 (2.8%) by police. Unadjusted mortality was 17.7% for police transport and 11.6% for ground EMS. After risk adjustment, patients transported by police were no more likely to die than those transported by EMS (OR = 1.00, 95% CI: 0.69-1.45). Among all police transports, 87.8% occurred in three locations (Philadelphia, Sacramento, and Detroit). Within these trauma systems, unadjusted mortality was 19.9% for police transport and 13.5% for ground EMS. Risk-adjusted mortality was no different (OR = 1.01, 95% CI: 0.68-1.50). Using trauma system-level analyses, patients with penetrating injuries in urban trauma systems were found to have similar mortality for police and EMS transport. The majority of prehospital police transport in penetrating trauma occurs in three trauma systems. These cities represent ideal sites for additional system-level evaluation of prehospital transport policies. Prognostic/epidemiologic study, level III.
Doolittle, B R; Justice, A C; Fiellin, D A
This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.
Jalowiec, Anne; Grady, Kathleen L; White-Williams, Connie
Few studies have examined the impact of patient weight on heart transplant (HT) outcomes. Nine outcomes were compared in 2 groups of HT recipients (N = 347) based on their mean body mass index (BMI) during the first 3 years post-HT. Group 1 consisted of 108 non-overweight patients (BMI <25; mean age 52; 29.6% females; 16.7% minorities). Group 2 consisted of 239 overweight patients (BMI ≥25; mean age 52; 15.9% females; 13.8% minorities). Outcomes were: survival, re-hospitalization, rejections, infections, cardiac allograft vasculopathy (CAV), stroke, renal dysfunction, diabetes, and lymphoma. Non-overweight patients had shorter survival, were re-hospitalized more days after the HT discharge, and had more lymphoma and severe renal dysfunction. Overweight patients had more CAV, steroid-induced diabetes, and acute rejections. Overweight HT patients had better survival, but more rejections, CAV, and diabetes. Non-overweight HT patients had worse survival, plus more re-hospitalization time, lymphoma, and renal dysfunction. Copyright © 2016 Elsevier Inc. All rights reserved.
Pécora, José Otávio Reggi; Malavolta, Eduardo Angeli; Assunção, Jorge Henrique; Gracitelli, Mauro Emílio Conforto; Martins, João Paulo Sobreiro; Ferreira, Arnaldo Amado
OBJECTIVE: To identify prognostic factors of postoperative functional outcomes. METHODS: Retrospective case series evaluating patients undergoing rotator cuff repair, analyzed by the UCLA score (pre and 12-month postoperative) and Magnetic Resonance Imaging (preoperative). Patients' intrinsic variables related to the injury and intervention were evaluated. Multivariate linear regression analysis was performed to determine variables impact on postoperative functional assessment. RESULTS: 131 patients were included. The mean UCLA score increased from 13.17 ± 3.77 to 28.73 ± 6.09 (p<0,001). We obtained 65.7% of good and excellent results. Age (r= 0.232, p= 0.004) and reparability of posterosuperior injuries (r= 0.151, p= 0.043) correlated with the functional assessment at 12 months. After multivariate linear regression analysis, only age was associated (p = 0.008). CONCLUSIONS: The surgical treatment of rotator cuff tears lead to good and excellent results in 65.6% of patients. Age was an independent predictor factor with better clinical outcomes by UCLA score in older patients. Level of Evidence IV, Case Series. PMID:26207092
Lajoie, Travis; Sonkiss, Joshua; Rich, Anne
Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…
Lajoie, Travis; Sonkiss, Joshua; Rich, Anne
Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…
A prospective two-center study on the associations between microalbuminuria, coronary atherosclerosis and long-term clinical outcome in asymptomatic patients with type 2 diabetes mellitus: evaluation by coronary CT angiography.
Kim, Jin-Jin; Hwang, Byung-Hee; Choi, Ik Jun; Choo, Eun-Ho; Lim, Sungmin; Koh, Yoon-Seok; Lee, Jong Min; Kim, Pum-Joon; Seung, Ki-Bae; Lee, Seung-Hwan; Cho, Jae-Hyung; Jung, Jung Im; Chang, Kiyuk
This study assessed the associations between microalbuminuria in asymptomatic patients with type 2 diabetes and the presence, extent, and severity of coronary atherosclerosis, as measured by coronary computed tomography angiography (CCTA), and the long-term clinical outcomes. In total, the study enrolled 284 consecutive eligible asymptomatic patients with type 2 diabetes and without known coronary artery disease (CAD), who then underwent CCTA and 24 h urine albumin measurements. Microalbuminuria was defined as 30-300 mg/day urinary albumin excretion. Obstructive CAD, as measured by CCTA, was defined as maximum intra-luminal stenosis ≥50 %. Patients with and without microalbuminuria were compared in terms of obstructive CAD prevalence, and the extent and severity of coronary atherosclerosis. They were evaluated using the following data: coronary artery calcium score (CACS), atheroma burden obstructive score (ABOS), segment involvement score (SIS) and segment stenosis score (SSS). All-cause mortality within a follow-up period of 5 years was also compared. Compared to patients without microalbuminuria, patients with microalbuminuria were more likely to have obstructive CAD (p = 0.004). Microalbuminuria was associated with higher ABOS (p = 0.010), SIS (p = 0.029), and SSS (p = 0.011), except for CACS (p = 0.058). Multivariable analyses adjusted for conventional cardiovascular risk factors revealed that microalbuminuria was an independent predictor of obstructive CAD [odds ratio 2.255, confidence intervals (CI) 1.121-4.538, p = 0.023] and all-cause mortality (hazard ratio 3.469, CI 1.319-9.121, p = 0.012). In asymptomatic patients with type 2 diabetes, microalbuminuria was associated with increased risk of CAD and poorer clinical outcomes.
Encouraging Early Clinical Outcomes With Helical Tomotherapy-Based Image-Guided Intensity-Modulated Radiation Therapy for Residual, Recurrent, and/or Progressive Benign/Low-Grade Intracranial Tumors: A Comprehensive Evaluation
Purpose: To report early clinical outcomes of helical tomotherapy (HT)-based image-guided intensity-modulated radiation therapy (IMRT) in brain tumors of varying shape, size, and location. Materials and Methods: Patients with residual, recurrent, and/or progressive low-grade intracranial and skull-base tumors were treated on a prospective protocol of HT-based IMRT and followed clinicoradiologically. Standardized metrics were used for plan evaluation and outcome analysis. Results: Twenty-seven patients with 30 lesions were treated to a median radiotherapy dose of 54 Gy in 30 fractions. All HT plans resulted in excellent target volume coverage with steep dose-gradients. The mean (standard deviation) dose homogeneity index and conformity index was 0.07 (0.05) and 0.71 (0.08) respectively. At first response assessment, 20 of 30 lesions were stable, whereas 9 showed partial regression. One patient with a recurrent clival chordoma though neurologically stable showed imaging-defined progression, whereas another patient with stable disease on serial imaging had sustained neurologic worsening. With a median follow-up of 19 months (interquartile range, 11-26 months), the 2-year clinicoradiological progression-free survival and overall survival was 93.3% and 100% respectively. Conclusions: Careful selection of radiotherapy technique is warranted for benign/low-grade brain tumors to achieve durable local control with minimum long-term morbidity. Large or complex-shaped tumors benefit most from IMRT. Our early clinical experience of HT-based IMRT for brain tumors has been encouraging.
Saito, Shigeru; Maehara, Akiko; Vlachojannis, Georgios J; Parise, Helen; Mehran, Roxana
This study evaluated the safety and efficacy of the RESOLUTE(TM)zotarolimus-eluting stent (R-ZES; Medtronic, Inc, Santa Rosa, CA, USA) in Japanese patients for the treatment of de novo native coronary lesions. Both RESOLUTE Japan (R-Japan) and RESOLUTE Japan Small Vessel Study (R-Japan SVS) were prospective, multicenter, single-arm observational studies. R-Japan enrolled 100 patients (reference vessel diameter, 2.5-3.5 mm) and R-Japan SVS enrolled 65 patients (at least 1 lesion suitable for 2.25-mm stent) treated with R-ZES. In R-Japan, in-stent late lumen loss (LLL; the primary endpoint) at 8 months was 0.12 ± 0.22 mm and volume obstruction on intravascular ultrasound was 2.33 ± 3.51%. At 4 years, there were no cases of clinically driven target lesion revascularization (TLR); the target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, and clinically driven TLR) was 5.6% (5/90). In R-Japan SVS, in-stent LLL at 9 months was 0.27 ± 0.33 mm, TLF (primary endpoint) was 4.6% (3/65), without incidence of TLR. At 3 years, TLF was 7.9% (5/63) and clinically driven TLR, 3.2% (2/63). R-Japan and R-Japan SVS demonstrate substantial suppression of neointimal hyperplasia, low LLL, and excellent and sustained long-term clinical outcome with R-ZES in Japanese patients.
DANTO, J L; STEWART, W D; MADDIN, W S; NELSON, A J
The purpose of this study was to determine under carefully controlled clinical conditions the relative anti-inflammatory and anti-pruritic action of betamethasone as compared with prednisone and a placebo. A total of 130 consecutive patients with atopic dermatitis, primary irritant dermatitis, nummular eczema, allergic eczematous contact dermatitis, sweat retention, seborrheic dermatitis and pruritus were selected for study. Under the conditions of this clinical trial, the samples indicated a difference in anti-inflammatory and anti-pruritic response to the therapeutic agents used. The difference between betamethasone and the placebo was highly significant, and the difference in these measured responses was studied on the basis of a careful evaluation and statistically. The result of this study corroborates statistically our clinical impression regarding the therapeutic effect of betamethasone.
Danto, J. L.; Stewart, W. D.; Maddin, W. S.; Nelson, A. J.
The purpose of this study was to determine under carefully controlled clinical conditions the relative anti-inflammatory and anti-pruritic action of betamethasone as compared with prednisone and a placebo. A total of 130 consecutive patients with atopic dermatitis, primary irritant dermatitis, nummular eczema, allergic eczematous contact dermatitis, sweat retention, seborrheic dermatitis and pruritus were selected for study. Under the conditions of this clinical trial, the samples indicated a difference in anti-inflammatory and anti-pruritic response to the therapeutic agents used. The difference between betamethasone and the placebo was highly significant, and the difference in these measured responses was studied on the basis of a careful evaluation and statistically. The result of this study corroborates statistically our clinical impression regarding the therapeutic effect of betamethasone. PMID:14025047
Juvenile Diabetes Research Foundation and Combat Casualty Care Division United States Army Medical Research and Materiel Command References 1. Van den... Diabetes Does Not Influence Selected Clinical Outcomes in Critically Ill Burn Patients Chaitanya K Dahagam, MD, Alejandra Mora, BS, Steven E Wolf, MD...Charles.Wade@amedd.army.mil Abstract Objective—Evaluate glucose control and clinical outcomes in diabetic burn ICU patients. Methods—We reviewed 462 civilian
Martinschek, A; Evers, B; Lampl, L; Gerngroß, H; Schmidt, R; Sparwasser, C
To determine predisposing or prognostic factors and mortality rates of patients with Fournier's gangrene compared to other necrotizing soft tissue infections (NSTI). Data of 55 intensive care patients (1981-2010) with NSTI were evaluated. Data were collected prospectively. 43.4% of the patients were in septic condition and 27.3% were hemodynamically unstable. Half of the patients showed predisposing factors (52.7%). The lower extremity (63.2%), abdomen (30.9%), and perineum (14.5%) were most affected. Polymicrobial infections were frequent (65.5%, mean 2.8, range: 1-4). The mortality rate was 16.4% (n = 9). An increase was shown for diabetes mellitus (20%), cardiac insufficiency (22.3%), septic condition at presentation (33.3%), abdominal affection (47.1%), and hemodynamic instability (46.7%). Comparing survivors and nonsurvivors, statistical significance was seen with age (p < 0.001), septic condition at admission (p < 0.001), hemodynamic instability (p < 0.001), low blood pressure (p < 0.001), and abdominal affection (p < 0.001). In laboratory findings, an increase of creatine kinase (p < 0.001) and lactate (p < 0.001) and a decrease of antithrombin III (p < 0.007) and the Quick value (p < 0.01) proved to be significant. Patients with Fournier's gangrene do not differ in all aspects from those with other NSTI. Successful treatment consists of immediate surgical debridement, broad-spectrum antibiotic treatment, and critical care management. Supportive hyperbaric oxygen therapy should be considered. Copyright © 2012 S. Karger AG, Basel.
Kelly, Kevin R.
Summarizes important advances in clinical knowledge regarding mental health counseling processes and outcomes of treatment as appeared in four major journals in 1994. Findings are summarized by topic and implications for practice are provided. Delineates current lines of inquiry. (EMK)
Ebert, Doug; Byrne, Vicky; Cole, Richard; Dulchavsky, Scott; Foy, Millennia; Garcia, Kathleen; Gibson, Robert; Ham, David; Hurst, Victor; Kerstman, Eric; McGuire, Kerry; Sargsyan, Ashot
The objective of this research is to develop and use clinical outcome metrics and training tools to quantify the differences in performance of a physician vs non-physician crew medical officer (CMO) analogues during simulations.
Schoolcraft, V; Delaney, C
The use of contracts in grading clinical performance has provided faculty with a solution to two important problems. One has been how to ensure that students are graded consistently among the various faculty who are grading the same clinical component of a course. The second has been to increase the opportunity for individualized attention to student learning needs. We have been pleased to see all the faculty members increase their input and involvement in the continuing modifications of the contract. Although we have taken the major responsibility for the semi-annual revisions of the contract, other faculty members have been increasingly more explicit in their evaluations and suggestions as their experience with the contract has expanded. Their confidence in this method of clinical evaluation has increased with each semester of use. We plan to continue in the refinement of the instrument and will develop materials for the use of other faculty groups who are interested in developing similar contracts. We are also designing a survey to attempt to discover how widespread is the use of contract grading in clinical areas.
Topilsky, Yan; Nkomo, Vuyisile T; Vatury, Ori; Michelena, Hector I; Letourneau, Thierry; Suri, Rakesh M; Pislaru, Sorin; Park, Soon; Mahoney, Douglas W; Biner, Simon; Enriquez-Sarano, Maurice
The aim of this study was to assess the outcome of isolated tricuspid regurgitation (TR) and the added value of quantitative evaluation of its severity. TR is of uncertain clinical outcome due to confounding comorbidities. Isolated TR (without significant comorbidities, structural valve disease, significant pulmonary artery systolic pressure elevation by Doppler, or overt cardiac cause) is of unknown clinical outcome. In patients with isolated TR assessed both qualitatively and quantitatively by a proximal isovelocity surface area method, a long-term outcome analysis was conducted. Patients with severe comorbid diseases were excluded. The study involved 353 patients with isolated TR (age 70 years; 33% male; ejection fraction, 63%; all with right ventricular systolic pressure <50 mm Hg). Severe isolated TR was diagnosed in 76 patients (21.5%) qualitatively and 68 patients (19.3%) by quantitative criteria (effective regurgitant orifice [ERO] ≥40 mm(2)). The 10-year survival and cardiac event rates were 63 ± 5% and 29 ± 5%. Severe isolated TR independently predicted higher mortality (adjusted hazard ratio: 1.78 [95% confidence interval (CI): 1.10 to 2.82], p = 0.02 for qualitative definition and 2.67 [95% CI: 1.66 to 4.23] for an ERO ≥40 mm(2), p < 0.0001). The addition of grading by quantitative criteria in nested models eliminated the significance of the qualitative grading and improved the model prediction (p < 0.001 for survival and p = 0.02 for cardiac events). The 10-year survival rate was lower with an ERO ≥40 mm(2) versus <40 mm(2) (38 ± 7% vs. 70 ± 6%; p < 0.0001), independent of all characteristics, right ventricular size or function, comorbidity, or pulmonary pressure (p < 0.0001 for all), and lower than expected in the general population (p < 0.001). Freedom from cardiac events was lower with an ERO ≥40 mm(2) versus <40 mm(2) independently of all characteristics, right ventricular size or function, comorbidity, or pulmonary
Parker, Richard I.; Hagan-Burke, Shanna
The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, "proportion of variance"…
Sullivan, F M; Hoare, T; Gilmour, H
A cohort of 392 patients referred to six outpatient clinics by general practitioners during 1987 with diagnoses of rheumatoid arthritis, osteoarthritis, peripheral vascular disease, psoriasis or eczema, were studied from the time of their first attendance until up to two years later. Six consultant clinics were studied in the three specialties: rheumatology, vascular surgery and dermatology. For each specialty a clinic in both a teaching hospital and a district general hospital were included. The cohort members were predominantly middle-aged or elderly people, with a greater proportion of women, except at the vascular surgery clinic where 65% of patients were men. The 392 patients made a total of 936 visits (median two, range one-eight) during the study period; 91 patients were still attending up to two years after the first visit. Patients referred by their general practitioner for therapy were less likely to be discharged than those referred for other reasons. The principal reason for continuing attendance as perceived by patients, general practitioners and hospital doctors was the necessity for consultant supervision, although agreement was far from complete in individual cases. Junior staff tended to see a higher proportion of patients at follow-up visits than did consultants, and were found to have lower discharge rates than consultants. Analyses of data showed that at the first visit, diagnosis, disease severity and the grade of doctor seeing the patient in the clinic was significantly associated with patient discharge at the P < 0.05 level of significance. Patients considered that their visits had produced improvement in their condition in 38% of cases.(ABSTRACT TRUNCATED AT 250 WORDS)
Sattin, Davide; Morganti, Laura; De Torres, Laura; Dolce, Giuliano; Arcuri, Francesco; Estraneo, Anna; Cardinale, Viviana; Piperno, Roberto; Zavatta, Elena; Formisano, Rita; D'Ippolito, Mariagrazia; Vassallo, Claudio; Dessi, Barbara; Lamberti, Gianfranco; Antoniono, Elena; Lanzillotti, Crocifissa; Navarro, Jorge; Bramanti, Placido; Corallo, Francesco; Zampolini, Mauro; Scarponi, Federico; Avesani, Renato; Salvi, Luca; Ferro, Salvatore; Mazza, Luigi; Fogar, Paolo; Feller, Sandro; De Nigris, Fulvio; Martinuzzi, Andrea; Buffoni, Mara; Pessina, Adriano; Corsico, Paolo; Leonardi, Matilde
Patients with Disorders of consciousness, are persons with extremely low functioning levels and represent a challenge for health care systems due to their high needs of facilitating environmental factors. Despite a common Italian health care pathway for these patients, no studies have analyzed information on how each region have implemented it in its welfare system correlating data with patients' clinical outcomes. A multicenter observational pilot study was realized. Clinicians collected data on the care pathways of patients with Disorder of consciousness by asking 90 patients' caregivers to complete an ad hoc questionnaire through a structured phone interview. Questionnaire consisted of three sections: sociodemographic data, description of the care pathway done by the patient, and caregiver evaluation of health services and information received. Seventy-three patients were analyzed. Length of hospital stay was different across the health care models and it was associated with improvement in clinical diagnosis. In long-term care units, the diagnosis at admission and the number of caregivers available for each patient (median value = 3) showed an indirect relationship with worsening probability in clinical outcome. Caregivers reported that communication with professionals (42%) and the answer to the need of information were the most critical points in the acute phase, whereas presence of Non-Governmental Organizations (25%) and availability of psychologists for caregivers (21%) were often missing during long-term care. The 65% of caregivers reported they did not know the UN Convention on the Rights of Persons with Disabilities. This study highlights relevant differences in analyzed models, despite a recommended national pathway of care. Future public health considerations and actions are needed to guarantee equity and standardization of the care process in all European countries.
Hoque, Dewan Md Emdadul; Kumari, Varuni; Hoque, Masuma; Ruseckaite, Rasa; Romero, Lorena; Evans, Sue M
Clinical quality registries (CQRs) are playing an increasingly important role in improving health outcomes and reducing health care costs. CQRs are established with the purpose of monitoring quality of care, providing feedback, benchmarking performance, describing pattern of treatment, reducing variation and as a tool for conducting research. To synthesise the impact of clinical quality registries (CQRs) as an 'intervention' on (I) mortality/survival; (II) measures of outcome that reflect a process or outcome of health care; (III) health care utilisation; and (IV) healthcare-related costs. The following electronic databases were searched: MEDLINE, EMBASE, CENTRAL, CINAHL and Google Scholar. In addition, a review of the grey literature and a reference check of citations and reference lists within articles was undertaken to identify relevant studies in English covering the period January 1980 to December 2016. The PRISMA-P methodology, checklist and standard search strategy using pre-defined inclusion and exclusion criteria and structured data extraction tools were used. Data on study design and methods, participant characteristics attributes of included registries and impact of the registry on outcome measures and/or processes of care were extracted. We identified 30102 abstracts from which 75 full text articles were assessed and finally 17 articles were selected for synthesis. Out of 17 studies, six focused on diabetes care, two on cardiac diseases, two on lung diseases and others on organ transplantations, rheumatoid arthritis, ulcer healing, surgical complications and kidney disease. The majority of studies were "before after" design (#11) followed by cohort design (#2), randomised controlled trial (#2), experimental non randomised study and one cross sectional comparison. The measures of impact of registries were multifarious and included change in processes of care, quality of care, treatment outcomes, adherence to guidelines and survival. Sixteen of 17 studies
Ledda, Maria Giuseppina; Fratta, Anna Lisa; Pintor, Manuela; Zuddas, Alessandro; Cianchetti, Carlo
A comparison of clinical features and adult outcome in adolescents with three types of psychotic disorders: schizophrenic (SPh), schizoaffective (SA) and bipolar with psychotic features (BPP). Subjects (n = 41) were finally diagnosed (DSM-IV criteria) with SPh (n = 17), SA (n = 11) or BPP (n = 13). Clinical evaluation took place at onset and at a…
Ayeni, Olufemi R; Sansone, Mikael; de Sa, Darren; Simunovic, Nicole; Bedi, Asheesh; Kelly, Bryan T; Farrokhyar, Forough; Karlsson, Jon
Femoro-acetabular impingement (FAI) is increasingly recognized as an important cause of hip pain in the young adult. However, the methods of evaluating the efficacy of surgical intervention are often not validated and/or inconsistently reported. Important clinical, gait, radiographic and biomarker outcomes are discussed. This article (1) presents the rationale for considering a composite outcome for FAI patients; (2) examines a variety of important end points currently used to evaluate FAI surgery; (3) discusses a strategy to generate a composite outcome by combining these end points; and (4) highlights the challenges and current areas of controversy that such an approach to evaluating symptomatic FAI patients may present.
Redlinger-Grosse, Krista; Veach, Patricia McCarthy; Cohen, Stephanie; LeRoy, Bonnie S; MacFarlane, Ian M; Zierhut, Heather
The need for evidence-based medicine, including comparative effectiveness studies and patient-centered outcomes research, has become a major healthcare focus. To date, a comprehensive list of genetic counseling outcomes, as espoused by genetic counselors, has not been established and thus, identification of outcomes unique to genetic counseling services has become a priority for the National Society of Genetic Counselors (NSGC). The purpose of this study was to take a critical first step at identifying a more comprehensive list of genetic counseling outcomes. This paper describes the results of a focus group study using the Reciprocal-Engagement Model (REM) as a framework to characterize patient-centered outcomes of genetic counseling clinical practice. Five focus groups were conducted with 27 peer nominated participants who were clinical genetic counselors, genetic counseling program directors, and/or outcomes researchers in genetic counseling. Members of each focus group were asked to identify genetic counseling outcomes for four to five of the 17 goals of the REM. A theory-driven, thematic analysis of focus group data yielded 194 genetic counseling outcomes across the 17 goals. Participants noted some concerns about how genetic counseling outcomes will be measured and evaluated given varying stakeholders and the long-term nature of genetic concerns. The present results provide a list of outcomes for use in future genetic counseling outcomes research and for empirically-supported clinical interventions.
The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be measured in high throughput toxicity testing and the organism or population-level events that are commonly relevant in defining risk. Recognizing the importance of this emerging framework, the Organisation for Economic Co-operation and Development (OECD) launched a program to support the development, documentation and consideration of AOPs by the international community in 2012 (http://www.oecd.org/chemicalsafety/testing/adverse-outcome-pathways-molecular-screening-and-toxicogenomics.htm). In 2014, a handbook (https://aopkb.org/common/AOP_Handbook.pdf) was developed to guide users in the documentation and evaluation of AOPs and their entry into an official knowledgebase. The handbook draws on longstanding experience in consideration of mechanistic data (e.g., mode of action analysis) to inform risk assessment. To further assist users, a training program was developed by members of the OECD Extended Advisory Group to teach users the basic principles of AOP development and the best practices as outlined in the OECD AOP handbook. Training sessions began in early 2015, and this course will provide training for interested SOT scientists. Following this course, all participants will be familiar w
The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be measured in high throughput toxicity testing and the organism or population-level events that are commonly relevant in defining risk. Recognizing the importance of this emerging framework, the Organisation for Economic Co-operation and Development (OECD) launched a program to support the development, documentation and consideration of AOPs by the international community in 2012 (http://www.oecd.org/chemicalsafety/testing/adverse-outcome-pathways-molecular-screening-and-toxicogenomics.htm). In 2014, a handbook (https://aopkb.org/common/AOP_Handbook.pdf) was developed to guide users in the documentation and evaluation of AOPs and their entry into an official knowledgebase. The handbook draws on longstanding experience in consideration of mechanistic data (e.g., mode of action analysis) to inform risk assessment. To further assist users, a training program was developed by members of the OECD Extended Advisory Group to teach users the basic principles of AOP development and the best practices as outlined in the OECD AOP handbook. Training sessions began in early 2015, and this course will provide training for interested SOT scientists. Following this course, all participants will be familiar w
Computed tomography workup of patients suspected of acute ischemic stroke: perfusion computed tomography adds value compared with clinical evaluation, noncontrast computed tomography, and computed tomography angiogram in terms of predicting outcome.
Zhu, Guangming; Michel, Patrik; Aghaebrahim, Amin; Patrie, James T; Xin, Wenjun; Eskandari, Ashraf; Zhang, Weiwei; Wintermark, Max
To determine whether perfusion computed tomography (PCT) adds value to noncontrast head CT (NCT), CT angiogram (CTA), and clinical assessment in patients suspected of acute ischemic stroke. We retrospectively reviewed 165 patients with acute ischemic stroke. PCT was used to calculate the volumes of infarct core and ischemic penumbra on admission. Other imaging data included Alberta Score Program Early CT Score, site of occlusion, and collateral flow. Clinical data included age, time, National Institutes of Health Stroke Scale at baseline, treatment type, and modified Rankin score (mRS) at 90 days. Recanalization status was assessed on follow-up imaging. In a first multivariate regression analysis, we assessed whether volumes of PCT penumbra and infarct core could be predicted from clinical variables, NCT, or CTA, or whether they represented independent information. In a second multivariate regression analysis, we used mRS at 90 days as outcome and determined which variables predicted it best. Of 165 patients identified, 76 had a mRS score of 0 to 2 at 90 days, 89 had a mRS score >2. PCT infarct could be predicted by clinical data, NCT, CTA, and combinations of this data (P<0.05). PCT penumbra could not be predicted by clinical data, NCT, and CTA. All of the variables but NCT and CTA were significantly associated with 90-day mRS outcome. The single most important predictor was recanalization status (P<0.001). PCT penumbra volume (P=0.001) was also a predictor of clinical outcome, especially when considered in conjunction with recanalization through an interaction term (P<0.001). PCT penumbra represents independent information, which cannot be predicted by clinical, NCT, and CTA data. PCT penumbra is an important determinant of clinical outcome and adds relevant clinical information compared with a stroke CT workup, including NCT and CTA.
Shin, Minho; Choi, Namkyu; Yoo, Youngsun; Kim, Yooseok; Kim, Sungsoo
Purpose Laparoscopic subtotal cholecystectomy (LSC) can be an alternative surgical technique for difficult cholecystectomies. Surgeons performing LSC sometimes leave the posterior wall of the gallbladder (GB) to shorten the operation time and avoid liver injury. However, leaving the inflamed posterior GB wall is a major concern. In this study, we evaluated the clinical outcomes of standard laparoscopic cholecystectomy (SLC), LSC, and LSC removing only anterior wall of the GB (LSCA). Methods We retrospectively reviewed the medical records of laparoscopic cholecystectomies performed between January 2006 to December 2015 and analyzed the outcomes of SLC, LSC, and LSCA. Results A total of 1,037 patients underwent SLC. 22 patients underwent LSC; and 27 patients underwent LSCA. The mean operating times of SLC, LSC, and LSCA were 41, 74, and 68 minutes, respectively (P < 0.01). Blood loss was 5, 45, and 33 mL (P < 0.05). The mean lengths of postoperative hospitalization were 3.4, 5.4, and 5.8 days. Complications occurred in 24 SLC patients (2.3%), 2 LSC patients (9%), and 1 LSCA patient (3.7%). There was no mortality among the LSC and LSCA patients. Conclusion LSC and LSCA are safe and feasible alternatives for difficult cholecystectomies. These procedures help surgeons avoid bile duct injury and conversion to laparotomy. LSCA has the benefits of shorter operation time and less bleeding compared to LSC. PMID:27847794
Lasater, Kathie; Nielsen, Ann
Reflective journaling is a strategy used often in clinical education to gain insight into students' clinical thinking; however, studies indicate that students may benefit from guided reflections. Numerous tools have been used to structure student reflection with varying results. This article describes the outcomes from using the Guide for Reflection based on Tanner's Clinical Judgment Model. The Lasater Clinical Judgment Rubric, created from the Model, is used to evaluate development of clinical judgment and provides language to communicate about clinical thinking with students. Senior immersion course competencies, also developed with language from Tanner's Clinical Judgment Model,offer a comprehensive package that fosters students' clinical judgment development, faculty-student communication about clinical judgment, and evaluation of students' clinical thinking.
Clinical decisions are often based on the results of third trimester sonograms, particularly with small or large babies and so accuracy of estimating fetal weight (EFW) is essential. There are numerous EFW formula available and yet in Australia no one formula has been recommended for use due to the lack of clinical evidence as to their accuracy. Objectives: 1 To assess inter/intra observer error for fetal parameter measurements with multiple observers. 2 To compare six of the most commonly used EFW formulae and analyse inter/intra formulae variations for different weight range. Method: EFW of 121 pregnancies assessed within 7 days of birth by measuring the BPD, OFD, HC, AC, FL and comparing to actual birth weight. Results: Inter‐observer error: 1.3 to 3.1%. Intra‐observer error: 1.1 to 1.9% depending on fetal parameter. Accuracy of each EFW formula changed with different weight ranges. For all formulae the highest random error occurred in the macrosomic group. The lowest random error in all weight groups was the Hadlock B formula incorporating the HC/AC/FL (7.7%). Conclusion: Considering the possible problems of head moulding this study suggests the use of: Hadlock FP et al (1982) – Formula B – incorporating HC/AC/FL. PMID:28191133
McCarthy, Colin J.; Behravesh, Sasan; Naidu, Sailendra G.; Oklu, Rahmi
Air embolism is a rare but potentially fatal complication of surgical procedures. Rapid recognition and intervention is critical for reducing morbidity and mortality. We retrospectively characterized our experience with air embolism during medical procedures at a tertiary medical center. Electronic medical records were searched for all cases of air embolism over a 25-year period; relevant medical and imaging records were reviewed. Sixty-seven air embolism cases were identified; the mean age was 59 years (range, 3–89 years). Ninety-four percent occurred in-hospital, of which 77.8% were during an operation/invasive procedure. Vascular access-related procedures (33%) were the most commonly associated with air embolism. Clinical signs and symptoms were related to the location the air embolus; 36 cases to the right heart/pulmonary artery, 21 to the cerebrum, and 10 were attributed to patent foramen ovale (PFO). Twenty-one percent of patients underwent hyperbaric oxygen therapy (HBOT), 7.5% aspiration of the air, and 63% had no sequelae. Mortality rate was 21%; 69% died within 48 hours. Thirteen patients had immediate cardiac arrest where mortality rate was 53.8%, compared to 13.5% (p = 0.0035) in those without. Air emboli were mainly iatrogenic, primarily associated with endovascular procedures. High clinical suspicion and early treatment are critical for survival. PMID:28106717
Robey, Randall R.
Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and…
Ghiselli, William B.
Studied predictability of therapeutic outcome of an alcoholism treatment program. Data analyzed by a mathematically oriented linear regression approach and by a clinically oriented retrospective parametric approach showed different predictors. Suggested that the parametric clinical approach be used to explain why therapy succeeded or failed.…
Cuerdon, Timothy; And Others
The teaching of interviewing skills is increasingly incorporated into clinical medicine courses in American medical schools, yet the attempts to evaluate the effectiveness of these efforts have been woefully inadequate. Typical outcome measures have included paper and pencil tests of knowledge, preceptor evaluations of clinical performance, and…
Lang, Nikolaus W; Joestl, Julian B; Platzer, Patrick
The treatment of popliteal artery injury (PAI) caused by blunt or penetrating mechanism is demanding. Concomitant injuries and prolonged ischemia are the major causes of lower extremity morbidity and poor rates of limb salvage. This study assessed the amputation rate and, subsequently, the therapeutic management and clinical outcomes regarding the affect of concomitant injuries among patients with PAI in a setting of central European trauma care. Sixty-four patients (20 female and 44 male), with an average age of 44 years (range, 17-79 years) at the time of injury, were evaluated for clinical characteristics, concomitant injuries, complications, amputation rates, and functional outcome after traumatic PAI. The mechanism of injury was blunt trauma in 35 patients (54.7%) and penetrating trauma in 29 (45.3%). The Mangled Extremity Severity Score and the Injury Severity Score were assessed initially and the modified Functional Independence Measure (FIM) Score at 12 months after the primary surgery. Thirty patients (47%) returned to their normal activity level within 1 year after trauma, and 16 (25%) were limited in their daily activity or suffered from chronic pain symptoms. Within the blunt trauma group 26 of 35 patients (74%) sustained severe concomitant injuries, whereas two of 29 patients (7%) in the penetrating group showed severe concomitant injuries (P < .046). Eleven patients (17%) had to undergo revision surgery due to their associated injuries. The median modified FIM score was 10.3, whereas patients with blunt trauma had significantly lower FIM score (P < .0082). The median Mangled Extremity Severity Score was 6 points (range, 6-16 points). Primary or secondary amputation was required in 18 patients (28%) due to failure of revascularization. Patients who sustained blunt trauma had significantly higher amputation rates than those with penetrating injuries (P < .035). Clinical outcome and limb salvage of patients with PAI were influenced by the mechanism of
Leite, Heitor Pons; Pinheiro Nogueira, Larissa Araújo; Teodosio, Ariane Helena Calassa
The objective of this study is to investigate the factors associated with serum phosphate concentrations in severely burned children and whether hypophosphatemia is associated with outcome. Seventy-eight children with a total body surface area of 24% (6.0-68.5) were retrospectively analyzed for serum phosphate concentrations during the first 10 days of stay in the intensive care unit (ICU). The method of generalized estimating equations was used to evaluate the effect of the exposure variables for serum phosphate concentrations during the study period. Outcome variables were the probability of ICU discharge at 30 days and time on mechanical ventilation. Potential explanatory variables for clinical outcome were hypophosphatemia (serum phosphate <3.8 mg/dL for children <2 years and <3.5 mg/dL for older children), age, sex, percent total body surface area burn, inhalation injury, and severe sepsis and/or septic shock. Competing-risk analysis was applied to calculate the probability of ICU discharge at 30 days, and death was assumed as the competing event. The rate of hypophosphatemia was 79.5%. Serum phosphate concentrations were associated with C-reactive protein (coefficient: -0.63; 95% confidence interval [CI]: -0.96 to -0.30; P = .001). Hypophosphatemia was independently associated with a 68% decrease in the probability of ICU discharge at 30 days (subhazard ratio: -0.32; 95% CI: 0.20, 0.53; P = .001) and an increase of 2.9 days in mechanical ventilation (coefficient: 2.91; 95% CI: 1.16, 4.66; P = .001). Serum phosphate concentrations in pediatric burn patients are associated with the magnitude of inflammatory response. Hypophosphatemia is associated with decreased probability of ICU discharge and increased time on mechanical ventilation.
Pieralli, S; Kohal, R J; Jung, R E; Vach, K; Spies, B C
To determine the survival rate and marginal bone loss (MBL) of zirconia dental implants restored with single crowns or fixed dental prostheses. An electronic search was conducted up to November 2015 (without any restriction regarding the publication time) through the databases MEDLINE (PubMed), Cochrane Library, and EMBASE to identify randomized controlled clinical trials and prospective clinical trials including >15 patients. Primary outcomes were survival rate and MBL. Furthermore, the influence of several covariates on MBL was evaluated. Qualitative assessment and statistical analyses were performed. This review was conducted according to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines for systematic reviews. With the applied search strategy, 4,196 titles could be identified. After a screening procedure, 2 randomized controlled clinical trials and 7 prospective clinical trials remained for analyses. In these trials, a total of 326 patients received 398 implants. The follow-up ranged from 12 to 60 mo. Implant loss was mostly reported within the first year, especially within the healing period. Thereafter, nearly constant survival curves could be observed. Therefore, separate meta-analyses were performed for the first and subsequent years, resulting in an implant survival rate of 95.6% (95% confidence interval: 93.3% to 97.9%) after 12 mo and, thereafter, an expected decrease of 0.05% per year (0.25% after 5 y). Additionally, a meta-analysis was conducted for the mean MBL after 12 mo, resulting in 0.79 mm (95% confidence interval: 0.73 to 0.86 mm). Implant bulk material and design, restoration type, and the application of minor augmentation procedures during surgery, as well as the modes of temporization and loading, had no statistically significant influence on MBL. The short-term cumulative survival rates and the MBL of zirconia implants in the presented systematic review are promising. However, additional data are still
Williamson, Paula R; Altman, Douglas G; Blazeby, Jane M; Clarke, Mike; Devane, Declan; Gargon, Elizabeth; Tugwell, Peter
The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.
Knani, L; Gatfaoui, F; Krifa, F; Mahjoub, H; Daldoul, N; Ben Hadj Hamida, F
Dermoid cysts are benign congenital orbital tumors, they are classified as choristomas. Clinical manifestations vary according to location and size. We retrospectively analyzed 43 cases of dermoid cysts surgically treated between July 1998 and March 2009. Mean patient age was 18.64 years. Among patients, 48.83% were male. Preseptal location was most common (41 cases). One of the two cases of intraorbital location required orbitotomy. We observed no complications or recurrence. Dermoid cysts are most often seen in young patients. The mean age of our patients was relatively high. The majority of dermoid cysts are periorbital in location. Superficial orbital dermoid cysts are more frequent, present earlier in life and are more easily identified than deep dermoid cysts. Imaging plays a major role in the management of deep orbital tumors. Complete surgical excision has remained the mainstay of treatment. Dermoid cysts are benign orbital tumors. Superficial dermoid cysts are the most common type. Deeper cysts require a more challenging diagnostic and therapeutic approach. Copyright © 2015 Elsevier Masson SAS. All rights reserved.
Despas, Noémie; Larock, Anne-Sophie; Jacqmin, Hugues; Douxfils, Jonathan; Chatelain, Bernard; Chatelain, Marc; Mullier, François
Traditional anticoagulant agents such as unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, danaparoid and bivalirudine are used in the prevention and treatment of thromboembolic diseases. However, these agents have limitations: their constraining parenteral route of administration and the need for regular coagulation monitoring for HNF. The LMWHs, with their more predictable anticoagulant response, don't require a systematic monitoring. The usefulness of LMWHs monitoring in several clinical situations such as pregnancy, obesity and renal insufficiency is a matter of debate. Indeed, there is no agreement between French and American recommendations on this question. Others aspects are also controversial: the measure of trough anti-Xa activity during pregnancy and the optimal monitoring of LMWHs for patients with antithrombin deficiency (hepatic disease, new-borns). Different tests are available to ensure the monitoring of these drugs, we will see in this review their principle, their advantages and inconvenients. The management of heparin induced thrombocytopenia also needs parenteral anticoagulants: danaparoïd, bivalirudine or argatroban. The modalities of their monitoring are relatively unknown and are presented. Furthermore, platelet monitoring is capital. This article aims to provide guidance about laboratory testing of classic parenteral anticoagulants.
Roh, HyeRin; Rhee, Byoung Doo; Lee, Jong Tae; Bae, Sang Kyun
The aim of the study was to introduce our experience of establish task-based learning outcomes for core clinical clerkships. We first define our educational goal and objectives of the clinical clerkship curriculum according to knowledge, cognitive function and skill, and attitude. We selected clinical presentations and related diseases with expert panels and allocated them to core clinical departments. We classified doctor's tasks into 6 categories: history taking, physical examination, diagnostic plan, therapeutic plan, acute and emergent management, and prevention and patient education. We described learning outcomes by task using behavioral terms. We established goals and objectives for students to achieve clinical competency on a primary care level. We selected 75 clinical presentations and described 377 learning outcomes. Our process can benefit medical schools that offer outcome-based medical education, especially for clinical clerkships. To drive effective clerkships, a supportive system including assessment and faculty development should be implemented.
Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf
The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
Nahm, Eun-Shim; Vaydia, Vinay; Ho, Danny; Scharf, Barbara; Seagull, Jake
Healthcare information systems (HIS) play a vital role in quality of care and the organization's daily operations. Consequently, increasing numbers of clinicians have been involved in HIS implementation, particularly for clinical information systems (CIS). Implementation of these systems is a major organizational investment, and its outcomes must be assessed. The purpose of this article is to provide clinicians and frontline informaticians with a practical guide to assess these outcomes, focusing on outcome variables, assessment methods, and timing of assessment. Based on in-depth literature reviews and their empirical experiences, the authors identified 3 frequently used outcomes: user satisfaction, clinical outcomes, and financial impact. These outcomes have been assessed employing various methods, including randomized controlled trials, pre- and post-test studies, time and motion studies, surveys, and user testing. The timing for outcomes assessments varied depending on several factors, such as learning curves or patients conditions. In conclusion, outcomes assessment is essential for the success of healthcare information technology, and the CIS implementation team members must be prepared to conduct and/or facilitate these studies.
A novel use of the Spine Tango registry to evaluate selection bias in patient recruitment into clinical studies: an analysis of patients participating in the Lumbar Spinal Stenosis Outcome Study (LSOS).
Becker, H-J; Nauer, S; Porchet, F; Kleinstück, F S; Haschtmann, D; Fekete, T F; Steurer, J; Mannion, A F
Patients enrolled in clinical studies typically represent a sub-set of all who are eligible, and selection bias may compromise the generalizability of the findings. Using Registry data, we evaluated whether surgical patients recruited by one of the referring centres into the Lumbar Spinal Stenosis Outcome Study (LSOS; a large-scale, multicentre prospective observational study to determine the probability of clinical benefit after surgery) differed in any significant way from those who were eligible but not enrolled. Data were extracted for all patients with lumbar spinal stenosis registered in our in-house database (interfaced to Eurospine's Spine Tango Registry) from 2011 to 2013. Patient records and imaging were evaluated in relation to the admission criteria for LSOS to identify those who would have been eligible for participation but were not enrolled (non-LSOS). The Tango surgery data and Core Outcome Measures Index (COMI) data at baseline and 3 and 12 months after surgery were analysed to evaluate the factors associated with LSOS enrolment or not. 514 potentially eligible patients were identified, of which 94 (18%) were enrolled into LSOS (range 2-48% for the 6 spine surgeons involved in recruiting patients) and 420 (82%) were not; the vast majority of the latter were due to non-referral to the study by the surgeon, with only 5% actually refusing participation. There was no significant difference in gender, age, BMI, smoking status, or ASA score between the two groups (p ≥ 0.18). Baseline COMI was significantly (p = 0.002) worse in the non-LSOS group (7.4 ± 1.9) than the LSOS group (6.7 ± 1.9). There were no significant group differences in any Tango surgery parameters (additional spine patholothegies, operation time, blood loss, complications, etc.) although significantly more patients in the non-LSOS group had a fusion procedure (38 vs 18% in LSOS; p = 0.0004). Postoperatively, neither the COMI nor its subdomain scores differed significantly
Diefenbeck, Cynthia; Herrman, Judith; Wade, Gail; Hayes, Evelyn; Voelmeck, Wayne; Cowperthwait, Amy; Norris, Susan
The Clinical Immersion Model is an innovative baccalaureate nursing curriculum that has demonstrated successful outcomes over the past 10 years. For those intending to adopt the model, individual components in isolation may prove ineffective. This article describes three core components of the curriculum that form the foundation of preparation for the senior-year clinical immersion. Detailed student-centered outcomes evaluation of these critical components is shared. Results of a mixed-methods evaluation, including surveys and focus groups, are presented. Implications of this curricular evaluation and future directions are explored.
Tomosynthesis holds the promise of detecting breast cancer earlier, at a smaller size, with fewer false-positive outcomes. Progress toward this goal...automatic motorized tomosynthesis system has been delivered, installed and acceptance tested at MGH. A physics report on the imaging characteristics is...complete. We are now in position to evaluate tomosynthesis in the clinical setting. This will permit an understanding of it’s clinical potential, and if warranted, the design of a clinical trial.
Spineli, Loukia M; Fleming, Padhraig S; Pandis, Nikolaos
Missing outcome data are common in clinical trials and despite a well-designed study protocol, some of the randomized participants may leave the trial early without providing any or all of the data, or may be excluded after randomization. Premature discontinuation causes loss of information, potentially resulting in attrition bias leading to problems during interpretation of trial findings. The causes of information loss in a trial, known as mechanisms of missingness, may influence the credibility of the trial results. Analysis of trials with missing outcome data should ideally be handled with intention to treat (ITT) rather than per protocol (PP) analysis. However, true ITT analysis requires appropriate assumptions and imputation of missing data. Using a worked example from a published dental study, we highlight the key issues associated with missing outcome data in clinical trials, describe the most recognized approaches to handling missing outcome data, and explain the principles of ITT and PP analysis.
de Jong, Kaz; Ariti, Cono; van der Kam, Saskia; Mooren, Trudy; Shanks, Leslie; Pintaldi, Giovanni; Kleber, Rolf
Existing tools for evaluating psychosocial interventions (un-validated self-reporting questionnaires) are not ideal for use in non-Western conflict settings. We implement a generic method of treatment evaluation, using client and counsellor feedback, in 18 projects in non-Western humanitarian settings. We discuss our findings from the perspective of validity and suggestions for future research. A retrospective analysis is executed using data gathered from psychosocial projects. Clients (n = 7,058) complete two (complaints and functioning) rating scales each session and counsellors rate the client’s status at exit. The client-completed pre- and post-intervention rating scales show substantial changes. Counsellor evaluation of the clients’ status shows a similar trend in improvement. All three multivariable models for each separate scale have similar associations between the scales and the investigated variables despite different cultural settings. The validity is good. Limitations are: ratings give only a general impression and clinical risk factors are not measured. Potential ceiling effects may influence change of scales. The intra and inter-rater reliability of the counsellors’ rating is not assessed. The focus on client and counsellor perspectives to evaluate treatment outcome seems a strong alternative for evaluation instruments frequently used in psychosocial programming. The session client rated scales helps client and counsellor to set mutual treatment objectives and reduce drop-out risk. Further research should test the scales against a cross-cultural valid gold standard to obtain insight into their clinical relevance. PMID:27315263
Mook, William R.; Petri, Maximilian; Greenspoon, Joshua A.; Horan, Marilee P.; Millett, Peter J.
Objectives: Although the Latarjet procedure for the treatment of recurrent shoulder instability is highly successful, reasons for failure are often unclear. The purpose of our study was to evaluate clinical and anatomic characteristics that were predictive of continued instability or poor outcomes following the Latarjet procedure. Methods: In this IRB approved study, patients who underwent open coracoid Latarjet procedures for anteroinferior instability with glenoid bone loss (>20%) prior to October of 2012 were included. Anatomic measurements of coracoid size (anteroposterior surface area, maximal coracoid width), conjoint and subscapularis tendon widths, estimated glenoid defect surface area, Hill-Sach's Interval, and projected postoperative glenoid track engagement were obtained from preoperative cross-sectional imaging. When the projected glenoid track was smaller than the Hill-Sach's interval, the lesion was determined to be outside-&-engaged compared to inside-&-non-engaged. Patient reported subjective data that was prospectively collected and retrospectively reviewed included patient satisfaction, instability events, SANE score, ASES score, DASH score, and SF-12 PCS. Patients that progressed to another shoulder surgery not related to instability were considered complications and patients that continued to experience dislocations or who underwent revision instability surgeries were considered failures. Results: Thirty-nine shoulders in 39 patients (34 men, 5 women) with a mean age of 26 (range 16-43) were included at a mean follow-up was 3.3 years (2- 7.9 years). There were 25 out of 39 that had prior stabilization surgery and 6 workman's compensation claims. One patient was revised due to broken hardware at 2 months and one because of coracoid nonunion at 18 months. One patient experienced postsurgical adhesive capsulitis treated surgically at a year. All subjective outcome scores significantly improved (p<.05) and a 9 out of 10 median satisfaction score was
Asch, David A; Nicholson, Sean; Srinivas, Sindhu; Herrin, Jeph; Epstein, Andrew J
Patient outcomes have been used to assess the performance of hospitals and physicians; in contrast, residency programs have been compared based on nonclinical measures. To assess whether obstetrics and gynecology residency programs can be evaluated by the quality of care their alumni deliver. A retrospective analysis of all Florida and New York obstetrical hospital discharges between 1992 and 2007, representing 4 906 169 deliveries performed by 4124 obstetricians from 107 US residency programs. Nine measures of maternal complications from vaginal and cesarean births reflecting laceration, hemorrhage, and all other complications after vaginal delivery; hemorrhage, infection, and all other complications after cesarean delivery; and composites for vaginal and cesarean deliveries and for all deliveries regardless of mode. Obstetricians' residency program was associated with substantial variation in maternal complication rates. Women treated by obstetricians trained in residency programs in the bottom quintile for risk-standardized major maternal complication rates had an adjusted complication rate of 13.6%, approximately one-third higher than the 10.3% adjusted rate for women treated by obstetricians from programs in the top quintile (absolute difference, 3.3%; 95% confidence interval, 2.8%-3.8%). The rankings of residency programs based on each of the 9 measures were similar. Adjustment for medical licensure examination scores did not substantially alter the program ranking. Obstetrics and gynecology training programs can be ranked by the maternal complication rates of their graduates' patients. These rankings are stable across individual types of complications and are not associated with residents' licensing examination scores.
Bechard, Lori J.; Rothpletz-Puglia, Pamela; Touger-Decker, Riva; Duggan, Christopher; Mehta, Nilesh M.
Importance Obesity is prevalent among hospitalized children. Knowledge of the relationship between obesity and outcomes in hospitalized children will enhance nutrition assessment and provide opportunities for interventions. Objective To systematically review the existing literature concerning the impact of obesity on clinical outcomes in hospitalized children. Evidence Acquisition PubMed, Web of Science, and EMBASE databases were searched for studies of hospitalized children aged 2 to 18 years with identified obesity and at least 1 of the following clinical outcomes: all-cause mortality, incidence of infections, and length of hospital stay. Cohort and case-control studies were included. Cross-sectional studies, studies of healthy children, and those without defined criteria for classifying weight status were excluded. The Newcastle-Ottawa Scale was used to assess study quality. Results Twenty-eight studies (26 retrospective; 24 cohort and 4 case-control) were included. Of the 21 studies that included mortality as an outcome, 10 reported a significant positive relationship between obesity and mortality. The incidence of infections was assessed in 8 of the 28 studies; 2 reported significantly more infections in obese compared with nonobese patients. Of the 11 studies that examined length of stay, 5 reported significantly longer lengths of hospital stay for obese children. Fifteen studies (53%) had a high quality score. Larger studies observed significant relationships between obesity and outcomes. Studies of critically ill, oncologic or stem cell transplant, and solid organ transplant patients showed a relationship between obesity and mortality. Conclusions and Relevance The available literature on the relationship between obesity and clinical outcomes is limited by subject heterogeneity, variations in criteria for defining obesity, and outcomes examined. Childhood obesity may be a risk factor for higher mortality in hospitalized children with critical illness
Chadha, M.; Coderre, J.A.; Chanana, A.D.
A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT.
Macdermid, Joy C; Silbernagel, Karin Grävare
Synopsis Clinical measurement studies that address outcome evaluation for patients with tendinopathy should consider conceptual, clinical, practical, and measurement issues to guide the selection of valid measures. Clinical outcomes reported in research studies can provide benchmarks that assist with interpretation of scores during clinical decision making. Given the pathophysiology and functional impacts of tendinopathy, there is a need for outcome measures that assess physical impairments, activity performance, and patient-reported symptoms and function. Tendinopathy-specific patient-reported outcome measures have been shown to be superior to more generic tools for some conditions, such as lateral epicondyle tendinopathy (Patient-Rated Tennis Elbow Evaluation) and Achilles tendinopathy (Victorian Institute of Sport Assessment-Achilles), whereas both generic shoulder outcome measures and disease-specific measures perform similarly in individuals with rotator cuff tendinopathy. A patient-reported outcome measure that captures pain and limitation in function should be fundamental to outcome evaluation in patients with tendinopathy. The current measurement literature does not yet provide comprehensive empirical data to define optimal outcome measures for all types of tendinopathy. This article reviews concepts, instruments, and measurement properties that should provide clinicians with a foundation for assessment of condition severity and treatment outcomes in patients with tendinopathy. J Orthop Sports Phys Ther 2015;45(11):950-964. Epub 15 Oct 2015. doi:10.2519/jospt.2015.6054.
Münch, Andreas; Tysk, Curt; Bohr, Johan; Madisch, Ahmed; Bonderup, Ole K; Mohrbacher, Ralf; Mueller, Ralph; Greinwald, Roland; Ström, Magnus; Miehlke, Stephan
The relationship between clinical and histological parameters in collagenous colitis (CC) is poorly understood. Smoking is a risk factor for CC, whereas its impact on clinical activity and outcome is not well known. In a post hoc analysis of pooled data from two randomized controlled trials we assessed the association between demographic data (gender, age, smoking habits, family history of inflammatory bowel disease), clinical variables (duration of symptoms, mean number of stools/watery stools per day, abdominal pain, clinical remission) and histological data (thickness of the collagen band, inflammation of the lamina propria, total numbers of intraepithelial lymphocytes, degeneration). Moreover, we analysed the predictive value of baseline parameters for clinical outcome in a logistic regression model. Pooled data were available from 202 patients with active CC, of whom 36% were current smokers, 29% former smokers and 35% non-smokers. Smoking status was associated with decreased ability to achieve clinical remission (current smokers vs non-smokers: odds ratio [OR] 0.31, 95% confidence interval [CI] 0.10-0.98, p = 0.045; former smokers vs non-smokers: OR 0.19, 95% CI 0.05-0.73, p = 0.016). Current smokers had an increased mean number of watery stools at baseline compared with non-smokers (p = 0.051) and increased mean number of watery stools per se was associated with decreased likelihood of obtaining clinical remission (OR 0.63, 95% CI 0.47-0.86, p = 0.003). Patient characteristics and histology at baseline had no association with clinical parameters and no predictive value for clinical outcome. Smoking worsens clinical symptoms in CC and is associated with an increased number of watery stools and decreased likelihood of achieving clinical remission. There is no significant association between histology and clinical data. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For
Unsinn, Caroline; Neidert, Marian Christoph; Burkhardt, Jan-Karl; Holzmann, David; Grotzer, Michael; Bozinov, Oliver
To evaluate clinical outcome in a 10-year consecutive series of children operated for sellar and parasellar tumors with special focus on neuropsychology and endocrinology. We analyzed 61 children (30 female) under 18 years of age (mean age 9.9, range 1 month-17 years) operated between 2000 and 2010. Medical records were evaluated retrospectively; postoperative histologic diagnoses included 20 craniopharyngiomas, 17 gliomas, 6 pituitary adenomas and 18 rare tumor entities. Of 61 patients, 58 (95%) were still alive at last follow-up. Three patients died, all due to progression of malignant rhabdoid tumors. Postoperative clinical morbidity consisted of endocrinological (66%), visual (60.7%) and other neurological deficits (55.9%) after a mean follow-up of 44 months. When compared to all other tumor entities in this series, craniopharyngiomas were associated with high rates of gross-total resection (p=0.008), frequent progression of residual tumor (p=0.005) scotomas (p=0.013), persistent diabetes insipidus (p<0.001), and panhypopituitarism (p<0.001). Surgically treated gliomas showed higher rates of motor weakness (p=0.004), double vision (p<0.001), and milder forms of endocrinopathy (single hormone deficits, p=0.02). In general, deterioration in school performance was associated with multiple surgeries (p=0.018) and radiotherapy (p=0.021). Excellent overall survival in these patients is possible, however malignant rhabdoid tumors have a poor prognosis. Aggressive treatment is associated with significant morbidity. Children operated for craniopharyngioma showed an expected high rate of endocrine deterioration, whereas glioma patients had higher incidences of motor weakness and double vision. The treating physicians should be well aware of all these considerable postoperative deficits, especially when facing interdisciplinary management decisions, and for the informed consent discussions with the patient and the parents. Copyright © 2014 Elsevier B.V. All rights
Deckert, S; Sabatowski, R; Schmitt, J; Kaiser, U
Decision making in evidence-based medicine is based on general data on therapy outcomes as well as the effectiveness and safety in specific patient populations. Typically, findings concerning therapy outcomes from different studies are aggregated for a final conclusion. In this context a comparison of results is hampered by studies in which therapy outcomes are heterogeneously measured. Such methodological challenges exist for almost all areas of medical treatment, as well as for multimodal pain therapy (MMPT). Through establishing core outcome sets (COS) the required standardization of measurement of therapy outcomes in clinical research can be achieved. A COS is an evidence-based and consented minimum set consisting of outcome domains (i.e. partial aspects of the medical condition to be investigated, which have to be measured in order to give the best possible demonstration of therapy outcome of an intervention) accomplished by valid, reliable and sensitive measurement instruments which should be applied in each clinical trial. No such COS has so far been found for MMPT. The aim of this article is to give an overview about currently recommended methodological approaches to develop a COS accompanied by a brief introduction about existing COS initiatives focusing on chronic pain. The existing COS recommendations are discussed and conclusions are drawn on whether existing recommendations could also be applied for MMPT. Finally, the impact of healthcare research in Germany on a standardized assessment of therapy outcome in MMPT is outlined.
McInnes, Elizabeth; Middleton, Sandy; Gardner, Glenn; Haines, Mary; Haertsch, Maggie; Paul, Christine L; Castaldi, Peter
Clinical networks have been established to improve health outcomes and processes of care by implementing a range of innovations and undertaking projects based on perceived local need. Limited research exists on the necessary conditions required to bring about successful network outcomes and what characterises network success from the perspective of those involved in network initiatives. This qualitative study identified stakeholder views on i) the conditions for effective clinical networks; and ii) desirable outcomes of successful clinical networks. Twenty-seven participants were interviewed using face-to-face audio-recorded semi-structured interviews. Transcribed data were coded and analysed to generate themes relating to the study aims. Five key factors represented as sub-themes were identified as important conditions for the establishment of successful clinical networks under the main theme of effective network structure, organisation and governance. These were: building relationships; effective leadership; strategic evidence-based workplans; adequate resources; and ability to implement and evaluate network initiatives. Two major themes encapsulated views on desirable outcomes of successful clinical networks: connecting and engaging which represented the outcomes of interdisciplinary and consumer collaboration and, partnerships with state health and local health services, and changing the landscape of care, which represented the importance of outcomes associated with improving services, care and patient health outcomes and implementing evidence-based practice. This study provides new knowledge on the conditions needed to establish successful clinical networks and on desirable outcomes arising from network projects and initiatives that are considered to be valuable by those working in or associated with clinical networks. This provides health services with information on what needs to be in place for successful networks and on the types of outcomes that can be
Kanno, T; Nagata, J; Hoshino, M; Nakagawa, T; Chaudhari, M; Sano, H; Katada, K
A retrospective analysis of our series of 355 cases of putaminal hemorrhage revealed some interesting aspects of its pathogenesis. All the cases were studied in detail with special attention to clinical presentation, diagnostic findings and the long-term clinical outcome. Role of surgery in management of putaminal hemorrhage is still controversial. Inability to form proper useful classification has been one of the reasons responsible for this controversy. A new classification is formulated which divides putaminal hemorrhage into four types. Mild type has hematoma localized to external capsule while moderate type shows hematoma extension to corona radiata from external capsule. In severe type, hematoma extends to internal capsule also while in very severe type it further extends to midbrain. These four types could be very well correlated to long-term clinical outcome. Accessory hematoma is discussed in detail. It is found to be more common in severe and very severe types. Its presence in mild or moderate types results in worse clinical outcome. Hypertension (BP greater than 200 mm of Hg) may play an important role in further extension of hematoma.
Liu, Ann; Sankey, Eric W; Jusué-Torres, Ignacio; Patel, Mira A; Elder, Benjamin D; Goodwin, C Rory; Hoffberger, Jamie; Lu, Jennifer; Rigamonti, Daniele
Idiopathic normal pressure hydrocephalus (iNPH) is a neurological disorder that classically presents with a triad of progressive gait impairment, urinary incontinence, and cognitive deterioration. Treatment predominantly involves ventriculoperitoneal (VP) shunting, but one alternative is ventriculoatrial (VA) shunting. This study sought to describe and evaluate the clinical outcomes of patients with iNPH primarily treated with VA shunting. A retrospective review of patients with iNPH who were treated with VA shunting at a single institution, from 2003 to 2013, was performed. 58 patients with iNPH underwent primary VA shunting at a median age of 74 (IQR: 70-80) years. The most common comorbidities included hypertension (n=39, 67%) and diabetes mellitus (n=11, 19%). Median duration of symptoms prior to VA shunting was 24 (IQR: 12-36) months. All patients had gait impairment, 52 (90%) had cognitive decline, and 43 (74%) had urinary incontinence. Forty-three (74%) patients had all three symptoms. At a median last follow-up of 16 (IQR: 7-26) months, median iNPH score improved from 6 to 3 (p<0.0001), mini mental status exam (MMSE) tended to increase from 26 to 29 (p=0.082), timed up-and-go (TUG) improved from 18 to 13s (p<0.0001), and Tinetti score improved from 19 to 25 (p<0.0001) after VA shunting. 78% of patients had improvement in at least one of their symptoms with 66% of patients having improvement in gait, 53% having improvement in their cognition, and 52% having improved urinary incontinence. A total of 21 patients (36%) had improvement in all 3 symptoms. There were significant improvements in functional outcomes as evaluated via the iNPH score, TUG, and Tinetti score, while improvement in MMSE trended toward significance. Patients also had improvement of clinical symptoms related to gait, urinary function and cognition. These results suggest that VA shunting can be an effective primary treatment alternative to VP shunting for iNPH. Published by Elsevier B.V.
Heneghan, Carl; Goldacre, Ben; Mahtani, Kamal R
Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measure and report outcomes that fall short of this clear requirement. We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy. These complex issues include the use of surrogate, composite and subjective endpoints; a failure to take account of patients' perspectives when designing research outcomes; publication and other outcome reporting biases, including the under-reporting of adverse events; the reporting of relative measures at the expense of more informative absolute outcomes; misleading reporting; multiplicity of outcomes; and a lack of core outcome sets. Trial outcomes can be developed with patients in mind, however, and can be reported completely, transparently and competently. Clinicians, patients, researchers and those who pay for health services are entitled to demand reliable evidence demonstrating whether interventions improve patient-relevant clinical outcomes.
Phoenix Bittner, Nancy; Gravlin, Gayle; MacDonald, Claire; Bourgeois, Darlene
The aim of this project was to evaluate the effectiveness and outcomes of a redesigned newly licensed nurse orientation program. A unique aspect of this program was an end-of-orientation simulated four-patient assignment that was designed to assess five categories of critical thinking: prioritization and delegation, problem recognition, clinical decision making, clinical implementation, and reflection. Newly licensed nurses' critical thinking was measured by the Advisory Board's Critical Thinking Diagnostic tool at 10 weeks, 6 months, and 12 months. Findings showed that in all five categories of critical thinking, a significant increase was found between the 10-week and 6-month evaluation. Two of the categories-prioritization and delegation, and problem recognition-were found to have a significant increase from the 6-month evaluation to the 12-month evaluation. In addition, newly licensed nurses reported improvement in their confidence and in their preparation to work independently. J Contin Educ Nurs. 2017;48(1):22-28. Copyright 2017, SLACK Incorporated.
van Munster, Caspar E P; Uitdehaag, Bernard M J
Due to the heterogeneous nature of the disease, it is a challenge to capture disease activity of multiple sclerosis (MS) in a reliable and valid way. Therefore, it can be difficult to assess the true efficacy of interventions in clinical trials. In phase III trials in MS, the traditionally used primary clinical outcome measures are the Expanded Disability Status Scale and the relapse rate. Secondary outcome measures in these trials are the number or volume of T2 hyperintense lesions and gadolinium-enhancing T1 lesions on magnetic resonance imaging (MRI) of the brain. These secondary outcome measures are often primary outcome measures in phase II trials in MS. Despite several limitations, the traditional clinical measures are still the mainstay for assessing treatment efficacy. Newer and potentially valuable outcome measures increasingly used or explored in MS trials are, clinically, the MS Functional Composite and patient-reported outcome measures, and on MRI, brain atrophy and the formation of persisting black holes. Several limitations of these measures have been addressed and further improvements will probably be proposed. Major improvements are the coverage of additional functional domains such as cognitive functioning and assessment of the ability to carry out activities of daily living. The development of multidimensional measures is promising because these measures have the potential to cover the full extent of MS activity and progression. In this review, we provide an overview of the historical background and recent developments of outcome measures in MS trials. We discuss the advantages and limitations of various measures, including newer assessments such as optical coherence tomography, biomarkers in body fluids and the concept of 'no evidence of disease activity'.
Shek, Daniel T L
Empirical studies investigating the inter-relationships among subjective outcomes and objective outcomes are sparse in the scientific literature. This study examined the relationship between these 2 forms of outcome evaluation data in Chinese adolescents, utilizing longitudinal data. In Wave 3 and Wave 4 of a randomized group trial, 2,784 Chinese secondary school students responded to the Chinese Positive Youth Development Scale (CPYDS) assessing objective outcome at pretest (Wave 3) and posttest (Wave 4). Students in the experimental schools also responded to a measure of client satisfaction assessing the subjective outcome of a positive youth development program at posttest (Wave 4). Subjective outcome evaluation measures (eg, process, program, and effectiveness) at Wave 3 were significantly correlated with CPYDS scores at Wave 4 and difference scores. Subjective outcome evaluation measures also predicted changes in the objective outcome evaluation measures scores across time. The present findings replicated the previous findings that subjective outcome and objective outcome evaluation findings were intimately related, and subjective outcome measures predicted posttest measures and their changes over time. The present study suggests that subjective outcome evaluation findings may yield useful information regarding program effectiveness in youth work settings. Copyright © 2014 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.
Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas
Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase in melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication.
Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh
One of the strategies for a good outcome and pain free childbearing is to design the delivery room. The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants' intervention vs. 66% of control participants had perinea laceration (P = 0.041). According to the findings of the present study, distracting senses in snoezelen room decreases mother's pain intensity, the length of labor, and incidence of episiotomy.
Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh
Background: One of the strategies for a good outcome and pain free childbearing is to design the delivery room. Objectives: The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. Patients and Methods: This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. Results: The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants’ intervention vs. 66% of control participants had perinea laceration (P = 0.041). Conclusions: According to the findings of the present study, distracting senses in snoezelen room decreases mother’s pain intensity, the length of labor, and incidence of episiotomy. PMID:26082849
Low levels of high-density lipoprotein cholesterol and increased risk of cardiovascular events in stable ischemic heart disease patients: A post-hoc analysis from the COURAGE Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation).
Acharjee, Subroto; Boden, William E; Hartigan, Pamela M; Teo, Koon K; Maron, David J; Sedlis, Steven P; Kostuk, William; Spertus, John A; Dada, Marcin; Chaitman, Bernard R; Mancini, G B John; Weintraub, William S
This study sought to assess the independent effect of high-density lipoprotein-cholesterol (HDL-C) level on cardiovascular risk in patients with stable ischemic heart disease (SIHD) who were receiving optimal medical therapy (OMT). Although low HDL-C level is a powerful and independent predictor of cardiovascular risk, recent data suggest that this may not apply when low-density lipoprotein-cholesterol (LDL-C) is reduced to optimal levels using intensive statin therapy. We performed a post-hoc analysis in 2,193 men and women with SIHD from the COURAGE trial. The primary outcome measure was the composite of death from any cause or nonfatal myocardial infarction (MI). The independent association between HDL-C levels measured after 6 months on OMT and the rate of cardiovascular events after 4 years was assessed. Similar analyses were performed separately in subjects with LDL-C levels below 70 mg/dl (1.8 mmol/l). In the overall population, the rate of death/MI was 33% lower in the highest HDL-C quartile as compared with the lowest quartile, with quartile of HDL-C being a significant, independent predictor of death/MI (p = 0.05), but with no interaction for LDL-C category (p = 0.40). Among subjects with LDL-C levels <70 mg/dl, those in the highest quintile of HDL-C had a 65% relative risk reduction in death or MI as compared with the lowest quintile, with HDL-C quintile demonstrating a significant, inverse predictive effect (p = 0.02). In this post-hoc analysis, patients with SIHD continued to experience incremental cardiovascular risk associated with low HDL-C levels despite OMT during long-term follow-up. This relationship persisted and appeared more prominent even when LDL-C was reduced to optimal levels with intensive dyslipidemic therapy. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.
A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation
Background The University of New South Wales (UNSW) Faculty of Medicine replaced its old content-based curriculum with an innovative new 6-year undergraduate entry outcomes-based integrated program in 2004. This paper is an initial evaluation of the perceived and assessed clinical capabilities of recent graduates of the new outcomes-based integrated medical program compared to benchmarks from traditional content-based or process-based programs. Method Self-perceived capability in a range of clinical tasks and assessment of medical education as preparation for hospital practice were evaluated in recent graduates after 3 months working as junior doctors. Responses of the 2009 graduates of the UNSW’s new outcomes-based integrated medical education program were compared to those of the 2007 graduates of UNSW’s previous content-based program, to published data from other Australian medical schools, and to hospital-based supervisor evaluations of their clinical competence. Results Three months into internship, graduates from UNSW’s new outcomes-based integrated program rated themselves to have good clinical and procedural skills, with ratings that indicated significantly greater capability than graduates of the previous UNSW content-based program. New program graduates rated themselves significantly more prepared for hospital practice in the confidence (reflective practice), prevention (social aspects of health), interpersonal skills (communication), and collaboration (teamwork) subscales than old program students, and significantly better or equivalent to published benchmarks of graduates from other Australian medical schools. Clinical supervisors rated new program graduates highly capable for teamwork, reflective practice and communication. Conclusions Medical students from an outcomes-based integrated program graduate with excellent self-rated and supervisor-evaluated capabilities in a range of clinically-relevant outcomes. The program-wide curriculum reform at
First-in-man study evaluating the safety and efficacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary lesions: clinical, Angiographic, and OCT outcomes of CREDIT-1.
Wang, Geng; Sun, Zhongwei; Jin, Quanmin; Xu, Kai; Li, Yi; Wang, Xiaozeng; Ma, Yingyan; Liu, Haiwei; Zhao, Xin; Wang, Bin; Deng, Jie; Guan, Shaoyi; Ge, Meiling; Wang, Xiaoyan; Xu, Bo; Han, Yaling
To evaluate the preliminary safety and efficacy of the EXCEL II stent system. Although the first biodegradable polymer drug-eluting stent (BP-DES), EXCEL, was launched nearly a decade ago, in-stent restenosis and stent thrombosis remain pertinent clinical problems in practice. A new cobalt-chromium BP-DES EXCEL II has been developed with the aim of improving stent safety and efficacy. Forty-five patients with single de novo native coronary lesions were enrolled and randomized to two groups in a 2:1 ratio, the 4-month follow-up group (n = 30) and the 12-month follow-up group (n = 15). All patients underwent percutaneous coronary intervention (PCI) with the EXCEL II stent system. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were used to assess coronary vasculature at the designated 4- or 12-month follow-up. The primary outcome was major adverse cardiac events (MACE) at 30 days post-PCI. No MACE, thrombotic events, or target lesion failure was found in the 45 patients during the 12-month follow-up. There was no significant difference (P > 0.05) between the two groups in terms of in-stent and in-segment late lumen loss (LLL). No in-stent and in-segment restenosis was found in either group. At follow-up, the ratio of >10% uncovered struts per lesion was 26.67% in the 4-month group and 0% in the 12-month group (P < 0.05). Neointimal coverage in the 12-month group was significantly better than in the 4-month group (98.58% vs. 93.51%, P < 0.01). This first-in-man study demonstrates promising feasibility, safety, and efficacy of EXCEL II stents. These stents were found to have rapid endothelialization and low LLL rates at 4 and 12 months after implantation. © 2015 Wiley Periodicals, Inc.
Matucci-Cerinic, Marco; Steen, Virginia D; Furst, Daniel E; Seibold, James R
The pathogenesis of systemic sclerosis (SSc) is complex and largely unclear. The clinical heterogeneity of the disease and its progression over a number of years makes the choice of endpoints in the design of clinical trials difficult. The overwhelming need in this disease is to diagnose it early and identify those patients who will benefit most from early, aggressive treatment that potentially can alter the clinical disease course. To achieve this, innumerable challenges must be overcome. This article reviews data from recent clinical trials and the lessons derived from retrospective observational studies, databases, and patient registries. Taken together, these observations will help to improve our understanding of the diverse clinical course of SSc and permit refinement of existing outcome measures for the design of future clinical trials, in which the likelihood of observing a positive treatment effect with the drugs at our disposal will be maximized. PMID:17767745
Greenberg, Steven M.; Rustam Al-Shahi, Salman; Biessels, Geert Jan; van Buchem, Mark; Cordonnier, Charlotte; Lee, Jin-Moo; Montaner, Joan; Schneider, Julie A.; Smith, Eric E; Vernooij, Meike; Werring, David J.
Efforts are underway for early-phase trials of candidate therapies for cerebral amyloid angiopathy (CAA), an untreatable cause of hemorrhagic stroke and vascular cognitive impairment. A major barrier to these trials is the lack of consensus on measuring treatment effectiveness. We review a range of potential outcome markers for CAA against the ideal criteria of being clinically meaningful, closely reflective of biological progression, efficient for smaller/shorter trials, reliably measurable, and cost effective. In practice, outcomes tend either to have high clinical salience but relatively low statistical efficiency and thus more applicability for later phase studies, or greater statistical efficiency but more limited clinical meaning. The most statistically efficient outcomes are those that are potentially reversible with treatment, though their clinical significance remains unproven. Many of the candidate outcomes for CAA trials are likely to be applicable to other small vessel brain diseases as well. Considerations emerging from this review outline a path towards rapid and efficient testing of emerging candidate therapies for CAA and other small vessel diseases. PMID:24581702
Sakalys, J A; Stember, M L; Magilvy, J K
Meaningful examination of program outcomes is one of the most challenging tasks facing faculty and administrators involved in the design and delivery of educational programs. This article reports the outcomes for one doctoral program in nursing and elucidates salient conceptual and methodologic issues in educational outcomes research for this discipline. Career development, scholarly productivity, and professional leadership were the foci of this outcomes study. Three instruments were used; data were provided by alumni, graduate faculty, and alumni supervisors. Data analysis techniques included content analysis and descriptive and correlational statistics. Results showed that graduates embarked on diverse career paths with the majority employed in academic institutions. Most graduates reported active involvement in research, publications, presentations, and professional leadership. Employment pattern differences were noted between academic year and summer-only program graduates with associated divergence in career emphasis, research productivity, and job satisfaction. A positive correlation of time since degree conferral with scholarly productivity and professional leadership was noted. Recommendations for future research include refining outcomes, linking process to outcome, using longitudinal designs, and attending to unique nursing student and doctoral program characteristics.
Park, Si-Woon; Wolf, Steven L.; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S.
Background and Objective This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. Methods A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Results Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Conclusions Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT. PMID:18780883
Bonomini, V; Coli, L; Scolari, M P; Stefoni, S
The present comparative evaluation aims at establishing whether the basic structure of dialysis membrane is able to predict long-term clinical outcome. From a population of 1,256 patients on renal dialysis treatment, treated by the Institute of Nephrology and Dialysis of the St. Orsola University Hospital of Bologna from 1963 to 1993, 122 patients were retrospectively selected for the present study. Patients were divided into two different groups according to the kind of dialysis membrane used--cellulose-based (64 patients) and synthetic-based (58 patients) membranes. The parameters considered were: intradialytic biology, long-term biocompatibility, survival and morbidity, and cost/benefit. The results obtained demonstrate that cellulosic membranes can be said to cause a greater acute intradialytic biological response than synthetics, though not to a significant degree. There are, however, no significant differences in the biological changes from group to group. Nonsignificant differences were noted in long-term survival general morbidity. In terms of sheer cost, synthetic membrane treatment is anything up to 200% dearer than cellulosic.
Brogan, C; Lawrence, D; Mayhew, L
THE PROBLEM OF MANAGING DEMAND: Most healthcare systems have 'third-party payers' who face the problem of keeping within budgets despite pressures to increase resources due to the ageing population, new technologies and patient demands to lower thresholds for care. This paper uses the UK National Health Service as a case study to suggest techniques for system-based demand management, which aims to control demand and costs whilst maintaining the cost-effectiveness of the system. The technique for managing demand in primary, elective and urgent care consists of managing treatment thresholds for appropriate care, using a whole-systems approach and costing the care elements in the system. It is important to analyse activity in relation to capacity and demand. Examples of using these techniques in practice are given. The practical effects of using such techniques need evaluation. If these techniques are not used, managing demand and limiting healthcare expenditure will be at the expense of clinical outcomes and unmet need, which will perpetuate financial crises.
Stetter, Friedhelm; Kupper, Sirko
Autogenic training (AT) is a self-relaxation procedure by which a psychophysiological determined relaxation response is elicited. A meta-analysis was performed to evaluate the clinical effectiveness of AT. Seventy-three controlled outcome studies were found (published 1952-99). Sixty studies (35 randomized controlled trials [RCT]) qualified for inclusion in the meta-analysis. Medium-to-large effect sizes (ES) occurred for pre-post comparisons of disease-specific AT-effects, with the RCTs showing larger ES. When AT was compared to real control conditions, medium ES were found. Comparisons of AT versus other psychological treatment mostly resulted in no effects or small negative ES. This pattern of results was stable at follow-up. Unspecific AT-effects (i.e., effects on mood, cognitive performance, quality of life, and physiological variables) tended to be even larger than main effects. Separate meta-analyses for different disorders revealed a significant reduction of the heterogeneity of ES. Positive effects (medium range) of AT and of AT versus control in the meta-analysis of at least 3 studies were found for tension headache/migraine, mild-to-moderate essential hypertension, coronary heart disease, asthma bronchiale, somatoform pain disorder (unspecified type), Raynaud's disease, anxiety disorders, mild-to-moderate depression/dysthymia, and functional sleep disorders.
Gómez de Liaño Sánchez, P; Olavarri González, G; Merino Sanz, P; Escribano Villafruela, J C
To describe the clinical characteristics and surgical outcomes of a group of patients with age-related distance esotropia (ARDE). A retrospective study was conducted on a consecutive case series of 16 adult patients diagnosed with ARDE between 2008 and 2015. The clinical features evaluated included mean age and gender, primary position deviations at distance and near, measured in prism dioptres (pd), treatment offered in each case, and post-surgical deviations. Ductions and versions were full, with no evidence of lateral rectus paresis. None of these patients had any obvious underlying neurological disorder, such as, high myopia or thyroid disease. A good result is considered to be the disappearance of diplopia in all positions of gaze. A total of 16 patients (11 females [68.8%]) were identified. The mean age at diagnosis was 78.19±6.77 years. The mean initial esodeviation was 2.25±3.08 pd at near (-4 to +8 pd) and 9.5±4.18 pd at distance (2 to 18 pd). Treatment was not necessary in 5 cases because the symptoms were intermittent or well-tolerated. Of the 11 patients with symptoms, one was corrected with an external base therapeutic prism. Botulinum toxin was administered in another patient, without satisfactory results. Unilateral medial rectus muscle recession was performed on one patient, and unilateral lateral rectus plication on 7 patients, indicating prisms before surgery. One patient refused surgery despite continuous diplopia in far vision. After a mean follow-up of 16.5 months, all operated patients were asymptomatic. Not all patients with ARDE require treatment, as the tolerance to diplopia varies from one subject to another. Both medial rectus weakening and lateral rectus strengthening provides excellent results. Crown Copyright Â© 2016. Publicado por Elsevier España, S.L.U. All rights reserved.
Patel, Twisha S.
The Clinical and Laboratory Standards Institute (CLSI) lowered the MIC breakpoints for meropenem and imipenem from 4 mg/liter to 1 mg/liter for Enterobacteriaceae in 2010. The breakpoint change improves the probability of pharmacodynamic target attainment and eliminates the need for microbiology labs to perform confirmatory testing for Klebsiella pneumoniae carbapenemase (KPC) production or other beta-lactamases that hydrolyze carbapenems. However, there are limited data evaluating clinical outcomes of the affected breakpoints, and it is unknown if patients infected with Enterobacteriaceae with reduced susceptibility are more likely to have poor outcomes when treated with a carbapenem. We conducted a single-center retrospective matched-cohort analysis in adult patients with Enterobacteriaceae infections treated with meropenem, imipenem, or doripenem. Patients with Enterobacteriaceae infection with a carbapenem MIC of 2 to 8 mg/liter were matched based on pathogen, source of infection, comorbidities, and disease severity (1:1 ratio) to those with a carbapenem MIC of ≤1 mg/liter. A total of 36 patients were included in the study. The group with carbapenem MICs of 2 to 8 mg/liter had a significantly higher 30-day mortality than the group with carbapenem MICs of ≤1 mg/liter (38.9% compared to 5.6%, P = 0.04). Total hospital length of stay (LOS) and intensive care unit (ICU) LOS were longer in the group with MICs of 2 to 8 mg/liter than in the group with MICs of ≤1 mg/liter (57.6 days compared to 34.4 days [P = 0.06] and 56.6 days compared to 21.7 days [P < 0.01], respectively). Patients infected with Enterobacteriaceae with a carbapenem MIC of 2, 4, or 8 mg/liter had higher mortality rates and longer ICU LOS than matched cohorts with carbapenem MICs of ≤1 mg/liter, which supports CLSI's recommendation to lower susceptibility breakpoints for carbapenems. PMID:25378572
Williams, Paul D; Owens, Charles R; Dziegielewski, Jaroslaw; Moskaluk, Christopher A; Read, Paul W; Larner, James M; Story, Michael D; Brock, William A; Amundson, Sally A; Lee, Jae K; Theodorescu, Dan
The tools for predicting clinical outcome after radiotherapy are not yet optimal. To improve on this, we applied the COXEN informatics approach to in vitro radiation sensitivity data of transcriptionally profiled human cells and gene expression data from untreated head and neck squamous cell carcinoma (HNSCC) and bladder tumors to generate a multigene predictive model that is independent of histologic findings and reports on tumor radiosensitivity. The predictive ability of this 41-gene model was evaluated in patients with HNSCC and was found to stratify clinical outcome after radiotherapy. In contrast, this model was not useful in stratifying similar patients not treated with radiation. This led us to hypothesize that expression of some of the 41 genes contributes to tumor radioresistance and clinical recurrence. Hence, we evaluated the expression the 41 genes as a function of in vitro radioresistance in the NCI-60 cancer cell line panel and found cyclophilin B (PPIB), a peptidylprolyl isomerase and target of cyclosporine A (CsA), had the strongest direct correlation. Functional inhibition of PPIB by small interfering RNA depletion or CsA treatment leads to radiosensitization in cancer cells and reduced cellular DNA repair. Immunohistochemical evaluation of PPIB expression in patients with HNSCC was found to be associated with outcome after radiotherapy. This work demonstrates that a novel 41-gene expression model of radiation sensitivity developed in bladder cancer cell lines and human skin fibroblasts predicts clinical outcome after radiotherapy in head and neck cancer patients and identifies PPIB as a potential target for clinical radiosensitization.
Tocker, Lotem; Ben-Amitay, Galit; Horesh-Reinman, Netta; Lask, Michal; Toren, Paz
This cross-sectional, case control study examines the association between child sexual abuse and interpersonal and intrapersonal outcomes among 54 adolescents, examining specific clinical measures (depression, anxiety, dissociation, and posttraumatic stress disorder, attachment patterns, self-esteem, self-disclosure, and family environment characteristics). The research results point to a correlation between sexual abuse and higher levels of the clinical measures. In addition, a correlation was found between sexual abuse and level of avoidant attachment, self-esteem, and family environment characteristics. Stepwise hierarchical regressions were conducted to examine how adolescent attributes predicted depression, anxiety, and dissociation beyond the prediction based on sexual abuse. A combination of self-esteem, anxiety attachment, and family cohesiveness made sexual abuse insignificant when predicting levels of depression, anxiety, and dissociation. This study contributes to characterizing the emotional, personal, and family attributes of adolescents who experienced sexual abuse. It also raises questions about the clinical outcomes usually associated with sexual abuse.
Spiegel, Brennan M R
Patient-generated reports, also known as Patient-Reported Outcomes (PROs), capture the patients' illness experience in a structured format and may help bridge the gap between patients and providers. PROs measure any aspect of patient-reported health (e.g., physical, emotional or social symptoms) and can help to direct care and improve clinical outcomes. When clinicians systematically collect patient-reported data in the right place at the right time, PRO measurement can effectively aid in detection and management of conditions, improve satisfaction with care and enhance the patient-provider relationship. This review article summarizes the latest approaches to PRO measuring for clinical trials and clinical practice, with a focus on use of PROs in gastroenterology.
Noseworthy, Tom; Wasylak, Tracy; O'Neill, Blair
In June 2012, Alberta Health Services introduced Strategic Clinical Networks (SCNs) as engines of innovation. The SCNs are collaborative clinical teams, with a provincial strategic mandate and with goals of achieving best outcomes, seeking greatest value for money and engaging clinicians in all aspects of the work. The SCNs are led by clinicians, driven by clinical needs, based on measurement and best evidence, and supported by research expertise, infrastructure, quality improvement, and analytic resources. Eleven SCNs are operational, with five others planned. Early measurable value is demonstrable in each. Examples include improving care and outcomes following stroke, reducing use of anti-psychotics in Long-Term Care (LTC), and improving surgical safety through effective implementation of the Safe Surgery Checklist. © 2015 The Canadian College of Health Leaders.
Barlak, Aysegul; Unsal, Sibel; Kaya, Kurtulus; Sahin-Onat, Sule; Ozel, Sumru
The objective of this study was to assess the possible causes of hemiplegic shoulder pain (HSP) in Turkish patients with stroke, to identify the correlation between HSP and clinical factors, and to review the effects of HSP on functional outcomes. A total of 187 consecutive patients with stroke were evaluated for the presence of HSP and for the…
Barlak, Aysegul; Unsal, Sibel; Kaya, Kurtulus; Sahin-Onat, Sule; Ozel, Sumru
The objective of this study was to assess the possible causes of hemiplegic shoulder pain (HSP) in Turkish patients with stroke, to identify the correlation between HSP and clinical factors, and to review the effects of HSP on functional outcomes. A total of 187 consecutive patients with stroke were evaluated for the presence of HSP and for the…
Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred. PMID:21179614
Marks, Michael P; Lansberg, Maarten G; Mlynash, Michael; Kemp, Stephanie; McTaggart, Ryan A; Zaharchuk, Greg; Bammer, Roland; Albers, Gregory W
DEFUSE 2 demonstrated that patients with magnetic resonance imaging mismatch had a favorable clinical response to tissue reperfusion assessed by magnetic resonance imaging. This study reports the endovascular results and correlates angiographic reperfusion with clinical and imaging outcomes. Prospectively enrolled ischemic stroke patients underwent baseline magnetic resonance imaging and started endovascular therapy within 12 h of onset. Patients were classified as either target mismatch or no target mismatch using magnetic resonance imaging. The pre- and postprocedure angiogram was evaluated to determine thrombolysis in cerebral infarction scores. Favorable clinical response was determined at day 30, and good functional outcome was defined as a modified Rankin Scale 0-2 at day 90. One-hundred patients had attempted endovascular treatment. At procedure end, 23% were thrombolysis in cerebral infarction 0-1, 31% thrombolysis in cerebral infarction 2A, 28% thrombolysis in cerebral infarction 2B, and 18% thrombolysis in cerebral infarction 3. More favorable thrombolysis in cerebral infarction-reperfusion scores were associated with greater magnetic resonance imaging reperfusion (P<0·001). thrombolysis in cerebral infarction scores correlated with 30-day favorable clinical response (P=0·041) and 90-day modified Rankin Scale 0-2 (P=0·008). These correlations were significant for target mismatch patients at 30 days (P=0·034) and 90 days (P=0·003). Infarct growth was strongly associated with poorer thrombolysis in cerebral infarction scores in target mismatch patients (P<0·001). Patients with thrombolysis in cerebral infarctionnfarction 2A reperfusion had less magnetic resonance imaging reperfusion (P=0·004) and poorer clinical outcome at 90 days (P=0·01) compared with thrombolysis in cerebral infarction 2B-3 patients. Thrombolysis in cerebral infarction reperfusion following endovascular therapy for ischemic stroke is highly correlated with magnetic resonance
Dietrich, Martin; Renner, Simone
This study analyzes the impact of subjective quality information in the form of aggregate patient experience outcomes on respondent evaluation and intended choice of hospitals. We compared clinical performance-based quality measures (i.e., wound infection rates) with participant evaluations and choice intentions when they were additionally provided with subjective quality information (i.e., patient experience outcomes in different display formats). Results suggest that patient experience outcomes significantly affected the evaluations and choice intentions. Additionally, we found significant effects of subjective information display formats. Limitations, directions for future research, and implications for publishing subjective quality information in health care markets are discussed.
Qi, Peter; Abdullahi, Abdikarim; Stanojcic, Mile; Patsouris, David; Jeschke, Marc G.
Recent discoveries have highlighted the novel metabolic functions of adipose tissue in enhancing hypermetabolism after trauma. As the exact function and expression profiles of serum lipids and free fatty acids (FFA) are essentially unknown, we determined the lipidomic expression profile after burn in correlation to clinical outcomes to identify important lipid mediators affecting post-burn outcomes. We conducted a prospective cohort study with 46 adult burn patients and 5 healthy controls at the Ross Tilley Burn Center in Toronto, Canada. Patients were stratified based on major demographic and clinical variables, including age, burn severity, mortality, and sepsis. Serum FFAs and inflammatory markers were measured during acute hospital stay. We found that FFAs were acutely elevated post-burn and returned to baseline over time. Greater burn severity and age were associated with an impaired acute response in unsaturated FFAs and pro-inflammatory cytokines. Elevations in saturated and mono-unsaturated FFAs correlated significantly to increased mortality. In summary, persistent elevation of unsaturated lipids was associated with a functionally altered inflammatory-immunological milieu and worse clinical outcomes. The present lipidomic analysis indicates profound alterations in the lipid profile after burn by characterizing key lipids as potential diagnostic and outcome indicators in critically injured patients. PMID:27982130
Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh
This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.
Oliver, Paloma; Buno, Antonio; Alvarez-Sala, Rodolfo; Fernandez-Calle, Pilar; Alcaide, Maria Jose; Casitas, Raquel; Garcia-Quero, Cristina; Madero, Rosario; Gomez-Rioja, Ruben; Iturzaeta, Jose Manuel
Arterial blood gas analysis is relevant in chronic obstructive pulmonary disease (COPD) management. The aim of this study was to evaluate whether the use of a blood gas analyzer in pulmonology departments improves the clinical, operational and economic outcomes when compared with clinical laboratory measurements. It is an observational prospective study. 112 patients were selected. After specimen collection, the measurement was performed both in pulmonology office as point-of-care and in laboratory. We evaluated clinical outcomes (modification of the indication of long-term oxygen therapy (LTOT) according to results, changes in blood gas analysis results, relationship of the partial pressure of oxygen (PaO2) obtained in the medical visit and velocity of change of the PaO2, influence of total haemoglobin concentration and the change in PaO2), operational outcomes (turnaround time (TAT) from specimen collection to receiving the blood gas analysis report) and economic outcomes (overall cost per process of patient care). There were discrepancies in the indication of LTOT in 13.4% of patients. All parameters showed changes. PaO2 levels showed changes in 2 ways, though they frequently increase over time. The correlation was not good in the other two clinical outcomes. The median TATs in pulmonology office were 1 min versus 79 in laboratory, with 52 min for specimen preparation and transport and 17 min for TAT intralaboratory. The overall cost for the 112 patients in pulmonology office and laboratory was 16,769.89€ and 22,260.97€ respectively. The use of a blood gas analyzer in a pulmonology office improves clinical, operational and economic outcomes when compared with clinical laboratory. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
Hojat, Mohammadreza; Louis, Daniel Z; Markham, Fred W; Wender, Richard; Rabinowitz, Carol; Gonnella, Joseph S
To test the hypothesis that physicians' empathy is associated with positive clinical outcomes for diabetic patients. A correlational study design was used in a university-affiliated outpatient setting. Participants were 891 diabetic patients, treated between July 2006 and June 2009, by 29 family physicians. Results of the most recent hemoglobin A1c and LDL-C tests were extracted from the patients' electronic records. The results of hemoglobin A1c tests were categorized into good control (<7.0%) and poor control (>9.0%). Similarly, the results of the LDL-C tests were grouped into good control (<100) and poor control (>130). The physicians, who completed the Jefferson Scale of Empathy in 2009, were grouped into high, moderate, and low empathy scorers. Associations between physicians' level of empathy scores and patient outcomes were examined. Patients of physicians with high empathy scores were significantly more likely to have good control of hemoglobin A1c (56%) than were patients of physicians with low empathy scores (40%, P < .001). Similarly, the proportion of patients with good LDL-C control was significantly higher for physicians with high empathy scores (59%) than physicians with low scores (44%, P < .001). Logistic regression analyses indicated that physicians' empathy had a unique contribution to the prediction of optimal clinical outcomes after controlling for physicians' and patients' gender and age, and patients' health insurance. The hypothesis of a positive relationship between physicians' empathy and patients' clinical outcomes was confirmed, suggesting that physicians' empathy is an important factor associated with clinical competence and patient outcomes.
Oruç, Melike; Ozer, Kadri; Çolak, Özlem; Kankaya, Yüksel; Koçer, Uğur
Digital nerve injuries are the mostly detected nerve injury in the upper extremity. However, since the clinical phenomenon of crossover innervation at some degree from uninjured digital nerve to the injured side occurs after digital nerve injuries is sustained, one could argue that this concept might even result in the overestimation of the outcome of the digital nerve repair. With this knowledge in mind, this study aimed to present novel, pure, focused and valuable clinical data by comparing the outcomes of bilateral and unilateral digital nerve repair. A retrospective review of 28 fingers with unilateral or bilateral digital nerve repair using end-to-end technique in 19 patients within 2 years was performed. Weber's two-point discrimination, sharp/dull discrimination, warm/cold sensation and Visual Analog Scale scoring were measured at final 12-month follow ups in all patients. There was no significant difference in recovery of sensibility after unilateral and bilateral digital nerve repairs. Though there is crossover innervation microscopically, it is not important in the clinical evaluation period. According to clinical findings from this study, crossover innervations appear to be negligible in the estimation of outcomes of digital neurorrhaphy.
Wong, Ming Chao; Cummings, Elizabeth; Turner, Paul
This paper examines the outcomes for clinicians from their involvement in the development of an electronic clinical hand-over tool developed using principles of user-centered design. Conventional e-health post-implementation evaluations tend to emphasize technology-related (mostly positive) outcomes. More recently, unintended (mostly negative) consequences arising from the implementation of e-health technologies have also been reported. There remains limited focus on the post-implementation outcomes for users, particularly those directly involved in e-health design processes. This paper presents detailed analysis and insights into the outcomes experienced post-implementation by a cohort of junior clinicians involved in developing an electronic clinical handover tool in Tasmania, Australia. The qualitative methods used included observations, semi-structured interviews and analysis of clinical handover notes. Significantly, a number of unanticipated flow-on effects were identified that mitigated some of the challenges arising during the design and implementation of the tool. The paper concludes by highlighting the importance of identifying post-implementation user outcomes beyond conventional system adoption and use and also points to the need for more comprehensive evaluative frameworks to encapsulate these broader socio-technical user outcomes.
Deggs, David; Weaver, Sue W.
Student feedback is essential to improving the quality of instruction in higher education. This article chronicles the process by which an end-of-course reflection exercise was used to gather additional feedback from students and to determine learning outcomes in online course for adult learners. Students were given guiding questions for the…
The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be mea...
The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be mea...
Bansal, Neha; Simmons, Kristina D; Epstein, Andrew J; Morris, Jon B; Kelz, Rachel R
To evaluate and financially reward general surgery residency programs based on performance, performance must first be defined and measureable. To assess general surgery residency program performance using the objective clinical outcomes of patients operated on by program graduates. A retrospective cohort study was conducted of discharge records from 349 New York and Florida hospitals between January 1, 2008, and December 31, 2011. The records comprised 230,769 patients undergoing 1 of 24 general surgical procedures performed by 454 surgeons from 73 general surgery residency programs. Analysis was conducted from June 4, 2014, to June 16, 2015. In-hospital death; development of 1 or more postoperative complications before discharge; prolonged length of stay, defined as length of stay greater than the 75th percentile when compared with patients undergoing the same procedure type at the same hospital; and failure to rescue, defined as in-hospital death after the development of 1 or more postoperative complications. Patients operated on by surgeons trained in residency programs that were ranked in the top tertile were significantly less likely to experience an adverse event than were patients operated on by surgeons trained in residency programs that were ranked in the bottom tertile. Adjusted adverse event rates for patients operated on by surgeons trained in programs that were ranked in the top tertile and those who were operated on by surgeons trained in programs that were ranked in the bottom tertile were, respectively, 0.483% vs 0.476% for death, 9.68% vs 10.79% for complications, 16.76% vs 17.60% for prolonged length of stay, and 2.68% vs 2.98% for failure to rescue (all P < .001). The differences remained significant in procedure-specific subset analyses. The rankings were significantly correlated among some but not all outcome measures. The magnitude of the effect of the residency program on the outcomes achieved by the graduates decreased with increasing
Berry-Kravis, Elizabeth; Hessl, David; Abbeduto, Leonard; Reiss, Allan L.; Beckel-Mitchener, Andrea; Urv, Tiina K.
Objective Progress in basic neuroscience has led to identification of molecular targets for treatment in fragile X syndrome (FXS) and other neurodevelopmental disorders, however, there is a gap in translation to targeted therapies in humans. One major obstacle to the demonstration of efficacy in human trials has been the lack of generally accepted endpoints to assess improvement in function in individuals with FXS. To address this problem, the NIH convened a meeting of leading scientists and clinicians with the goal of identifying and standardizing outcome measures for use as potential endpoints in clinical trials in FXS. Methods Participants in the meeting included FXS experts, experts in the design and implementation of clinical trials and measure development, and representatives from advocacy groups, industry, and federal agencies. Results The group generated recommendations for optimal outcome measures in cognitive, behavioral, and biomarker/medical domains, including additional testing and validation of existing measures, and development of new measures in areas of need. Although no one endpoint or set of endpoints could be identified that met all criteria as an optimal measure, recommendations are presented in this report. Conclusion The report is expected to guide the selection of measures in clinical trials and lead to the use of a more consistent battery of measures across trials. Further, this will help to direct research toward gaps in the development of validated FXS-specific outcome measures, and to assist with interpretation of clinical trial data by creating templates for measurement of treatment efficacy. PMID:24042082
Carr, Gemma; Bloeschl, Guenter; Loucks, Daniel Pete
Evaluation of participation programmes, projects and activities is essential to identify whether stakeholder involvement has been successful in achieving its aims. Aims may include an improvement in water resource management such as enhanced ecological functioning, an improvement in human wellbeing and economic conditions, or overcoming a conflict between interest groups. Evaluating against "interest-based" resource management criteria requires that a desirable outcome can be identified, agreed upon and be measured at the time of evaluation. In many water management situations where collaborative approaches are applied, multiple interests and objectives are present, or stakeholders have not yet identified their own positions and priorities. Even if a resource management objective has been identified and strategy agreed upon, resource management changes tend to emerge over longer timescales and evaluation frequently takes place before they can be recognised. Evaluating against resource management criteria may lead evaluators to conclude that a programme has failed because it has not achieved a resource management objective at the time of evaluation. This presents a critical challenge to researchers assessing the effectiveness of stakeholder participation programmes. One strategy to overcome this is to conduct "goal-free" evaluation to identify what the programme is actually achieving. An evaluation framework that includes intermediary outcomes that are both tangible achievements such as innovation, creation of new organisations, and shared information and knowledge, as well as intangible achievements such as trust and network development can be applied to more broadly assess a programme's success. Analysis of case-studies in the published literature for which a resource management outcome has been achieved shows that intermediary outcomes frequently precede resource management outcomes. They seem to emerge over shorter timescales than resource management outcomes
Clinical librarian services have been in existence for over 40 years. Although three systematic reviews have examined clinical librarian roles they continue to pose a challenge to rigorous evaluation. Difficulties can be articulated around their Population, Intervention, Comparator and Outcome (PICO) characteristics as well as within a wider evaluation framework. This feature suggests that developments within health research aimed at evaluating complex interventions may hold the key to assessing the contribution of such a variety of service models. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.
McNeil, Rita C.
Outcomes-based program evaluation is a systematic approach to identifying outcome indicators and measuring results against those indicators. One dimension of program evaluation is assessing the level of learner acquisition to determine if learning objectives were achieved as intended. The purpose of the proposed model is to use Bloom's Taxonomy to…
Valier, Alison R.; Lam, Kenneth C.
The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…
Valier, Alison R.; Lam, Kenneth C.
The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…
Fayed, Nora; de Camargo, Olaf Kraus; Elahi, Inam; Dubey, Ankita; Fernandes, Ricardo M; Houtrow, Amy; Cohen, Eyal
Children with chronic conditions experience medical issues over long-term periods of time which can have lasting emotional and social consequences impacting daily life and functioning. Activities and participation outcomes are needed in order to comprehensively assess child-important health in clinical trials. Our objective was to review the extent to which activity and participation outcomes are included in clinical trials of childhood chronic disease and to determine what trial characteristics are associated with their use. A review of a large clinical trial registration database (clinicaltrials.gov) was conducted over the 2010 calendar year. The measures used to assess primary and secondary endpoints were coded according to the ICF classification system. Trial characteristics that might be associated with activity and participation outcome use such as sponsorship type, intervention type, health condition, whether the trial was focused on pediatric patients, phase of trial and sample size were also extracted and explored with univariable and multivariable regressions. Four hundred and ninety-nine trials met inclusion criteria, 495 of which had complete information about hypothesized predictors. Only 36 out of 495 trials included an activity and participation outcome as part of the trial evaluation process. Both univariable and multivariable regression models showed that non-drug trials and late phase of trial (phase IV) showed the strongest likelihood with whether a trial would include an activity and participation outcome. Most registered clinical trials for children with chronic or ongoing medical conditions do not include a comprehensive approach to health outcomes assessment, especially drug trials and early phase trials. Outcome measures in pediatric clinical trials are lagging relative to World Health Organization standards for comprehensive health evaluation.
Irby, David; Rakestraw, Philip
Medical students have been rating clinical teaching in an obstetrics and gynecology clerkship at the University of Washington using an assessment form designed to reflect six factors of clinical teaching effectiveness. High interrater reliability and the utility of the data for faculty development and advancement are discussed. (Author/JMD)
Turocy, Paula Sammarone; Comfort, Ronald E.; Perrin, David H.; Gieck, Joe H.
Objective: To determine the efficacy of the National Athletic Trainers' Association Board of Certification (NATABOC) clinical experience requirements and individual student characteristics to predict candidate outcomes on the NATABOC certification examination. Design and Setting: For all subjects, we gathered survey information and examination scores. The survey information included age, sex, route to certification, previous athletic training and allied health experience, and clinical education experiences. Subjects: A total of 269 subjects, 22.25% of all first-time candidates for the June and November 1993 NATABOC examinations, were included in this study. Measurements: Data were analyzed for standard descriptive statistics and parametric linear regression and correlational relationships. Results: Total clinical hours, high-risk sport experiences, and previous athletic training experience were not predictive of examination outcomes. Although our results indicated a relationship between previous allied health experience and both outcome on the written section of the examination and age and outcome on the oral/practical section, these characteristics also were not predictive of examination outcomes. Conclusions: Gaining clinical experience hours in excess of 400 hours beyond the 800-or 1500-hour requirement may yield no greater benefit for an entry-level professional than less time. The quality, rather than the quantity, of clinical experiences should be evaluated. More emphasis should be placed on the achievement of an entry level of clinical competency, rather than on total hour collection. Also, because high-risk sport experiences did not predict outcomes on the NATABOC examination, the emphasis of clinical education should be on students' receiving a more structured clinical experience, in which they are progressively required to assume greater responsibilities integrating both cognitive and psychomotor skills, while working under the supervision of a certified
Wostrack, Maria; Shiban, Ehab; Obermueller, Thomas; Gempt, Jens; Meyer, Bernhard; Ringel, Florian
Intradural cauda equina and conus medullaris tumors (CECMTs) are rare. Only a few large clinical series exist to date. Therefore, clinical symptoms, surgical complications, and outcomes are poorly understood. The aim of the present study was to evaluate outcome after surgery of CECMTs and to identify the factors associated with a worse clinical prognosis based on the results of a series with sufficiently high number of cases. All cases of intradural CECMTs treated surgically at the authors' department between March 2006 and May 2012 were retrospectively evaluated. Arachnoid cysts and multifocal tumors were excluded. Sixty-eight adult patients met the inclusion criteria (35 female and 33 male patients; median age 56 years). Follow-up data were available for 72% (n = 49) in a median period of 9 months. Overall, 18 tumors were located intramedullary and 50 extramedullary. The majority were nerve sheath tumors (n = 27), ependymomas (n = 17), and meningiomas (n = 9). The most common preoperative symptom was pain. The rate of new transient postoperative impairment was 18% (n = 12), and new permanent deficits were observed in only 6% (n = 4). Overall neurological improvement was achieved in 62%. The reversibility of preoperative symptoms was related to the interval between the time of symptom onset and the time of surgery and to the presence of preoperative neurological deficits. Surgery of ependymoma and carcinoma metastases was associated with a higher rate of morbidity. Intradural CECMTs present as a group of tumors with varying histological features and clinical symptoms. Symptomatic manifestation is usually unspecific, mimicking degenerative lumbar spine syndromes. Despite a significant risk of transient deterioration, early surgery is advisable because more than 94% of patients maintain at least their preoperative status and more than 60% improve during follow-up. The reversibility of preoperative symptoms is related to the duration between symptom onset and surgery
Avery, Robert A.; Allen, Jeffrey C.; Ardern-Holmes, Simone L.; Bilaniuk, Larissa T.; Ferner, Rosalie E.; Gutmann, David H.; Listernick, Robert; Martin, Staci; Ullrich, Nicole J.; Liu, Grant T.
Objective: The goal of the Response Evaluation in Neurofibromatosis and Schwannomatosis Visual Outcomes Committee is to define the best functional outcome measures for future neurofibromatosis type 1 (NF1)-associated optic pathway glioma (OPG) clinical trials. Methods: The committee considered the components of vision, other ophthalmologic parameters affected by OPG, potential biomarkers of visual function, and quality of life measures to arrive at consensus-based, evidence-driven recommendations for objective and measurable functional endpoints for OPG trials. Results: Visual acuity (VA) assessments using consistent quantitative testing methods are recommended as the main functional outcome measure for NF1-OPG clinical trials. Teller acuity cards are recommended for use as the primary VA endpoint, and HOTV as a secondary endpoint once subjects are old enough to complete it. The optic disc should be assessed for pallor, as this appears to be a contributory variable that may affect the interpretation of VA change over time. Given the importance of capturing patient-reported outcomes in clinical trials, evaluating visual quality of life using the Children's Visual Function Questionnaire as a secondary endpoint is also proposed. Conclusions: The use of these key functional endpoints will be essential for evaluating the efficacy of future OPG clinical trials. PMID:24249802
Maahs, David M; Buckingham, Bruce A; Castle, Jessica R; Cinar, Ali; Damiano, Edward R; Dassau, Eyal; DeVries, J Hans; Doyle, Francis J; Griffen, Steven C; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W; Kollman, Craig; Kovatchev, Boris; Levy, Brian L; Nimri, Revital; O'Neal, David N; Philip, Moshe; Renard, Eric; Russell, Steven J; Weinzimer, Stuart A; Zisser, Howard; Lum, John W
Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.
Maahs, David M.; Buckingham, Bruce A.; Castle, Jessica R.; Cinar, Ali; Damiano, Edward R.; Dassau, Eyal; DeVries, J. Hans; Doyle, Francis J.; Griffen, Steven C.; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W.; Kollman, Craig; Kovatchev, Boris; Levy, Brian L.; Nimri, Revital; O’Neal, David N.; Philip, Moshe; Renard, Eric; Russell, Steven J.; Weinzimer, Stuart A.; Zisser, Howard
Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes. PMID:27330126
Baldwin, Scott A.; Imel, Zac E.; Braithwaite, Scott R.; Atkins, David C.
Objective Multilevel models have become a standard data analysis approach in intervention research. Although the vast majority of intervention studies involve multiple outcome measures, few studies use multivariate analysis methods. The authors discuss multivariate extensions to the multilevel model that can be used by psychotherapy researchers. Method and Results Using simulated longitudinal treatment data, the authors show how multivariate models extend common univariate growth models and how the multivariate model can be used to examine multivariate hypotheses involving fixed effects (e.g., does the size of the treatment effect differ across outcomes?) and random effects (e.g., is change in one outcome related to change in the other?). An online supplemental appendix provides annotated computer code and simulated example data for implementing a multivariate model. Conclusions Multivariate multilevel models are flexible, powerful models that can enhance clinical research. PMID:24491071
Vaughan-Shaw, PG; Saunders, J; Smith, T; King, AT
Introduction Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. Methods A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Results Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24kg/m2 vs 27kg/m2, p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ2=13.1, df=1, p=0.001). Conclusions Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery. PMID:24025285
Vaughan-Shaw, P G; Saunders, J; Smith, T; King, A T; Stroud, M A
Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24 kg/m(2) vs 27 kg/m(2), p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ(2) =13.1, df=1, p=0.001). Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery.
Kwok, Man Leung; Yuen, Hon; Lai, Sik To
Severe acute respiratory syndrome (SARS) poses a major threat to the health of people worldwide. We performed a retrospective case series analysis to assess clinical outcome and identify pretreatment prognostic correlates of SARS, managed under a standardized treatment protocol. We studied 127 male and 196 female patients with a mean age of 41±14 (range 18–83). All patients, except two, received ribavirin and steroid combination therapy. In 115 (36%) patients, the course of disease was limited. Pneumonitis progressed rapidly in the remaining patients. Sixty-seven (21%) patients required intensive care, and 42 (13%) required ventilator support. Advanced age, high admission neutrophil count, and high initial lactate dehydrogenase level were independent correlates of an adverse clinical outcome. SARS-associated coronavirus caused severe illnesses in most patients, despite early treatment with ribavirin and steroid. This study has identified three independent pretreatment prognostic correlates. PMID:14519241
Kear, Mavra E; Bear, Mary
Portfolio evaluation is an efficient and effective strategy to objectively demonstrate the accomplishment of program objectives using students' perceptions of their academic experiences. A portfolio evaluation tool was developed to quantitatively measure students' perceptions of their achievement of the nursing program's goals and objectives. Data were collected from a convenience sample of 26 portfolio evaluations. Reliability testing showed the tool has high interrater reliability, with Cohen's Kappa >0.80 for most items. Individual achievement of program goals and objectives ranged from 53.6% to 100%. These data will be used in the next formative evaluation of the curriculum to revise program objectives and correspondneing course objectives and assignments.ty
The combined evaluation of interim contrast-enhanced computerized tomography (CT) and FDG-PET/CT predicts the clinical outcomes and may impact on the therapeutic plans in patients with aggressive non-Hodgkin's lymphoma.
Yang, Deok-Hwan; Min, Jung-Joon; Jeong, Yong Yeon; Ahn, Jae-Sook; Kim, Yeo-Kyeoung; Cho, Sang-Hee; Chung, Ik-Joo; Bom, Hee-Seung; Kim, Hyeoung-Joon; Lee, Je-Jung
We investigated the concomitant interim response of patients with aggressive non-Hodgkin's lymphoma (NHL) using multi-detector row computerized tomography (CT) and (18)F-fluoro-2-deoxy-D: -glucose-positron emission tomography (PET)/CT for prediction of clinical outcomes. One hundred six newly diagnosed patients with aggressive NHL were enrolled. Both the CT and PET/CT were serially performed at the time of diagnosis and after three to four cycles of chemotherapy (interim). The patients were categorized into four different responsive groups according to the interim PET/CT and CT: (1) complete metabolic response (CMR)-complete response unconfirmed (CRu), (2) CMR-partial response (PR), (3) partial metabolic response (PMR)-Cru, and (4) PMR-PR. Fifty-five patients with CMR-CRu, 20 patients with CMR-PR, seven patients with PMR-Cru, and 23 patients with PMR-PR were distributed. In addition, one patient experienced a disease progression. There was a significant difference in relapse rates between PET/CT-positive (67.3%) and PET/CT-negative patients (17.3%; P < 0.01). Also, there was a significant difference between patients with PMR-PR (32.0% and 26.1%) and CMR-CRu (89.3% and 80.0%) for 3-year overall survival (OS) and event-free survival (EFS), respectively. A multivariate analysis revealed that high international prognostic index (> or =3) at diagnosis, T-cell phenotype, and PMR-PR in interim PET/CT and CT were independent prognostic significances for OS. Moreover, bulky disease (>10 cm), T-cell phenotype, and PMR-PR showed significant associations for EFS. PMR-PR in interim response was the predictive prognostic determinant for both OS and EFS, with a hazard ratio of 3.93 (1.61-9.60) and 3.60 (1.62-7.98), respectively. The combined evaluation of interim PET/CT and CT was found to be a significant predictor of disease progression, OS, and EFS.
A pilot evaluation of the long-term effect of combined therapy with intravenous iron sucrose and erythropoietin in elderly patients with advanced chronic heart failure and cardio-renal anemia syndrome: influence on neurohormonal activation and clinical outcomes.
Comín-Colet, Josep; Ruiz, Sonia; Cladellas, Mercè; Rizzo, Marcelo; Torres, Adriana; Bruguera, Jordi
The prognosis in elderly patients with advanced chronic heart failure (CHF) and cardio-renal anemia syndrome (CRAS) is ominous, and treatment alternatives in this subset of patients are scarce. To assess the long-term influence of combined therapy with intravenous (IV) iron and erythropoietin (rHuEPO) on hemoglobin (Hb), natriuretic peptides (NT-proBNP), and clinical outcomes in elderly patients with advanced CHF and mild-to-moderate renal dysfunction and anemia (CRAS) who are not candidates for other treatment alternatives, 487 consecutive patients were evaluated. Of them, 65 fulfilling criteria for entering the study were divided into 2 groups and treated in an open-label, nonrandomized fashion: intervention group (27, combined anemia therapy) and control group (38, no treatment for anemia). At baseline, mean age was 74 +/- 8 years, left ventricular ejection fraction was 34.5 +/- 14.1, Hb was 10.9 +/- 0.9 g/dL, creatinine was 1.5 +/- 0.5 mg/dL, NT-proBNP was 4256 +/- 4952 pg/mL, and 100% were in persistent New York Heart Association (NYHA) Class III or IV. At follow-up (15.3 +/- 8.6 months), patients in the intervention group had higher levels of hemoglobin (13.5 +/- 1.5 vs. 11.3 +/- 1.1; P < .0001), lower levels of natural log of NT-proBNP (7.3 +/- 0.8 vs. 8.0 +/- 1.3, P = .016), better NYHA functional class (2.0 +/- 0.6 vs. 3.3 +/- 0.5; P < .001), and lower readmission rate (25.9% vs. 76.3%; P < .001). In the multivariate Cox proportional hazards model, combined therapy was associated with a reduction of the combined end point all-cause mortality or cardiovascular hospitalization (HR 95%CI 0.2 [0.1-0.6]; P < .001). Long-term combined therapy with IV iron and rHuEPO may increase Hb, reduce NT-proBNP, and improve functional capacity and cardiovascular hospitalization in elderly patients with advanced CHF and CRAS with mild to moderate renal dysfunction.
Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich
Background Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. Methods and Findings We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically
Castagnini, Luis A; Munoz, Flor M
We describe the features and outcomes of neonatal pertussis and compare these with neonates with non-pertussis acute respiratory illness from July 2000 through December 2007. Patients with pertussis had a more severe course of disease as evidenced by the clinical presentation, length of hospitalization, and oxygen requirement. Clinicians should have a high index of suspicion so that appropriate supportive care can be initiated promptly.
Ha, Sang Woo; Kim, Seok Won; Lee, SeungMyung; Kim, Yong Hyun; Kim, Hyeun Sung
Objective Discal cyst is rare and causes indistinguishable symptoms from lumbar disc herniation. The clinical manifestations and pathological features of discal cyst have not yet been completely known. Discal cyst has been treated with surgery or with direct intervention such as computed tomography (CT) guided aspiration and steroid injection. The purpose of this study is to evaluate the safety and efficacy of the percutaneous endoscopic surgery for lumbar discal cyst over at least 6 months follow-up. Methods All 8 cases of discal cyst with radiculopathy were treated by percutaneous endoscopic surgery by transforaminal approach. The involved levels include L5-S1 in 1 patient, L3-4 in 2, and L4-5 in 5. The preoperative magnetic resonance imaging and 3-dimensional CT with discogram images in all cases showed a connection between the cyst and the involved intervertebral disc. Over a 6-months period, self-reported measures were assessed using an outcome questionaire that incorporated total back-related medical resource utilization and improvement of leg pain [visual analogue scale (VAS) and Macnab's criteria]. Results All 8 patients underwent endoscopic excision of the cyst with additional partial discectomy. Seven patients obtained immediate relief of symptoms after removal of the cyst by endoscopic approach. There were no recurrent lesions during follow-up period. The mean preoperative VAS for leg pain was 8.25±0.5. At the last examination followed longer than 6 month, the mean VAS for leg pain was 2.25±2.21. According to MacNab' criteria, 4 patients (50%) had excellent results, 3 patients (37.5%) had good results; thus, satisfactory results were achieved in 7 patients (87.5%). However, one case had unsatisfactory result with persistent leg pain and another paresthesia. Conclusion The radicular symptoms were remarkably improved in most patients immediately after percutaneous endoscopic cystectomy by transforaminal approach. PMID:22737300
Baena, María Isabel; Fajardo, Paloma C; Pintor-Mármol, Antonio; Faus, M José; Marín, Rosario; Zarzuelo, Antonio; Martínez-Olmos, José; Martínez-Martínez, Fernando
The results of analyses of patients' health problems related to medication use have been highly variable due to various factors, such as different study methodology, diverse variables determined, fields of study. The aim of our study was to determine the prevalence and preventability of negative clinical outcomes of medication (NCOMs). This was a cross-sectional study performed in the emergency departments (EDs) of nine Spanish hospitals during a 3-month period. A two-stage probabilistic sampling method was used , and a systematic appraisal tool was used to identify the NCOMs based on information gathered through patient interview and review of the medical records. Case evaluations were conducted in two phases by pharmacists and physicians. The prevalence and preventability of NCOM were calculated. A homogeneity test was performed to assess potential differences in the prevalence for each hospital. A total of 4,611 patients were included in the study. The overall prevalence of NCOMs was 35.7 % [95 % confidence interval (CI) 33.3-38.1]. These NCOMs could be divided into three categories: ineffectiveness (18.2 %; 95 % CI 16.2-20.1), necessity (14.9 %; 95 % CI 13.4-16.6), and lack of safety (2.4 %; 95 % CI 1.9-2.8). About 81 % (95 % CI 80.1-82.3) of the NCOMs could have been prevented. NCOMs provoked approximately one-third of visits to the EDs, and a high percentage of these were preventable. Implementation of strategies for patient safety and pharmaceutical care could help to prevent these problems and optimize the use of medications.
Larson, Erik W; Peterson, Halloran E; Lamoreaux, Wayne T; MacKay, Alexander R; Fairbanks, Robert K; Call, Jason A; Carlson, Jonathan D; Ling, Benjamin C; Demakas, John J; Cooke, Barton S; Lee, Christopher M
Glioblastoma multiforme (GBM) is the most common malignant primary brain tumor with a survival prognosis of 14-16 mo for the highest functioning patients. Despite aggressive, multimodal upfront therapies, the majority of GBMs will recur in approximately six months. Salvage therapy options for recurrent GBM (rGBM) are an area of intense research. This study compares recent survival and quality of life outcomes following Gamma Knife radiosurgery (GKRS) salvage therapy. Following a PubMed search for studies using GKRS as salvage therapy for malignant gliomas, nine articles from 2005 to July 2013 were identified which evaluated rGBM treatment. In this review, we compare Overall survival following diagnosis, Overall survival following salvage treatment, Progression-free survival, Time to recurrence, Local tumor control, and adverse radiation effects. This report discusses results for rGBM patient populations alone, not for mixed populations with other tumor histology grades. All nine studies reported median overall survival rates (from diagnosis, range: 16.7-33.2 mo; from salvage, range: 9-17.9 mo). Three studies identified median progression-free survival (range: 4.6-14.9 mo). Two showed median time to recurrence of GBM. Two discussed local tumor control. Six studies reported adverse radiation effects (range: 0%-46% of patients). The greatest survival advantages were seen in patients who received GKRS salvage along with other treatments, like resection or bevacizumab, suggesting that appropriately tailored multimodal therapy should be considered with each rGBM patient. However, there needs to be a randomized clinical trial to test GKRS for rGBM before the possibility of selection bias can be dismissed. PMID:24829861
Koter, Ryan; Regan, Sara; Clark, Caitlin; Huang, Vicki; Mosley, Melissa; Wyant, Erin; Cook, Chad; Hoder, Jeffrey
Contraversive Lateropulsion, also referred to as contraversive pushing, pusher behavior, and pusher syndrome, can be associated with increased hospital length of stay, increased health care costs, and delayed outcomes in persons with stroke. The purpose of this updated systematic review was to identify scales used to classify contraversive lateropulsion, investigate literature that addresses their clinimetric properties, and create a resource for clinicians recommending use in clinical practice. Three databases were searched for articles from inception to March 2017. The search strategy followed Cochrane Collaboration guidelines. The Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was applied to evaluate methodological quality. Four hundred three records were screened. Seven studies met inclusion criteria. Four scales were identified: the Scale for Contraversive Pushing (SCP), the Modified Scale for Contraversive Pushing (M-SCP), the Burke Lateropulsion Scale (BLS), and the Swedish Scale for Contraversive Pushing (S-SCP). Psychometric property investigation was most robust for the SCP and the BLS. Cross-cultural validity has not been fully investigated in scales used outside of their country of origin. The BLS is recommended for identifying contraversive lateropulsion. The scale assesses the presence of contraversive lateropulsion across several functional tasks, from rolling to walking, and is the only scale originally written in English. The BLS is the only tool to receive ratings greater than poor for reliability and responsiveness. The BLS should be implemented as soon as contraversive lateropulsion is suspected to guide frontline clinicians' initial plan of care, allow objective identification of change over time, and facilitate easier investigation of interventional efficacy.Video Abstract available for additional insights from the authors (see Video, Supplemental Digital Content 1, http
Clinical problem solving exercises for preclinical medical education that were developed at Michigan State University School of Osteopathic Medicine are described. Two types of outcomes were set as priorities in the design and implementation of the problem solving sessions: small group peer interactions as instructional and evaluative resources;…
Bliss, Joseph M.; Wong, Angela Y.; Bhak, Grace; Laforce-Nesbitt, Sonia S.; Taylor, Sarah; Tan, Sylvia; Stoll, Barbara J.; Higgins, Rosemary D.; Shankaran, Seetha; Benjamin, Daniel K.
Objective To determine if premature infants with invasive Candida infection caused by strains with increased virulence properties have worse clinical outcomes than those infected with less virulent strains. Study design Clinical isolates were studied from 2 populations; premature infants colonized with Candida (commensal, n=27), and those with invasive candidiasis (n=81). Individual isolates of C. albicans and C. parapsilosis were tested for virulence in each of 3 assays: phenotypic switching, adhesion, and cytotoxicity. Invasive isolates were considered to have enhanced virulence if they measured more than 1 SD above the mean for the commensal isolates in at least 1 assay. Outcomes of patients with invasive isolates with enhanced virulence were compared with those with invasive isolates lacking enhanced virulence characteristics. Results 61% of invasive isolates of C. albicans and 42% of invasive isolates of C. parapsilosis had enhanced virulence. All C. albicans cerebrospinal fluid (CSF) isolates (n=6) and 90% of urine isolates (n=10) had enhanced virulence, compared with 48% of blood isolates (n=40). Infants with more virulent isolates were younger at the time of positive culture and had higher serum creatinine. Conclusions Individual isolates of Candida species vary in their virulence properties. Strains with higher virulence are associated with certain clinical outcomes. PMID:22504098
Brinker, Mark R; O'Connor, Daniel P
Modern interest in patient-reported outcomes measures (PROMs) in orthopaedics dates back to the mid-1980s. While gradual growth of activity in this area has occurred over the past 25 years, the extent to which this research methodology is applied in clinical practice to improve patient care is unclear. WHERE ARE WE NOW?: Historically, clinical research in orthopaedics has focused on the technical success of treatment, and objective indicators such as mortality, morbidity, and complications. By contrast, the PROMs framework focuses on effects of treatment described in terms of relief of symptoms, restoring functional ability, and improving quality of life. PROMs can be used to study the relative effects of disease, injury, and treatment across different health conditions. WHERE DO WE NEED TO GO?: All clinical research should begin with identifying clear and meaningful research questions so that the resources and efforts required for data collection result in useful data. Different consumers of research data have different perspectives on what comprises meaningful information. Involving stakeholders such as patients, providers, payers, and policy-makers when defining priorities in the larger research endeavor is one way to inform what type of data should be collected in a particular study. HOW DO WE GET THERE?: Widespread collection of outcomes data would potentially aid these stakeholders by identifying best practices, benefits and costs, and important patient or practice characteristics related to outcomes. Several initiatives currently underway may help systematic collection of PROMs, create efficient systems, and foster collaborations to provide support and resources to minimize costs.
Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L; Cañete, Adela; Castel, Victoria; Font de Mora, Jaime
Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma.
Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L.; Cañete, Adela; Castel, Victoria; de Mora, Jaime Font
Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma. PMID:28423360
Saberi, Parya; Neilands, Torsten B.; Johnson, Mallory O.
Despite numerous potential health outcomes of dog guardianship, their value has not been examined in the HIV-positive population. The study objective was to examine the relationship between dog guardianship and HIV clinical outcomes (antiretroviral adherence [≥95% versus <95%], HIV viral load [≥48copies/mL versus <48copies/mL], and CD4+ cell count) among HIV-positive individuals. We conducted a secondary analysis of baseline data of 370 HIV-positive men on antiretrovirals enrolled in the Duo Project. Generalized estimating equations were used for inferential regression analyses, while controlling for the focal dog guardianship variable and non-focal covariates. Current dog guardianship was reported in 28.7% of participants. Dog guardianship may be associated with higher CD4+ (coefficient=60.6, p=0.052) and adherence ≥95% (OR=1.80, p=0.048); however, having a detectable viral load was not related to dog guardianship (OR=0.94, p=0.85). Further clinical research with detailed dog guardianship data is needed to further examine the association between dog guardianship and HIV clinical outcomes. PMID:25436253
The role of evaluation is to determine whether a project achieves what it sets out to do. Using a strategy often referred to as "backwards planning" or "backwards research design," the evaluation process operationalizes project goals and then, asking the question "What would success look like?" identifies measurable indices of success (Friedman,…
The role of evaluation is to determine whether a project achieves what it sets out to do. Using a strategy often referred to as "backwards planning" or "backwards research design," the evaluation process operationalizes project goals and then, asking the question "What would success look like?" identifies measurable indices of success (Friedman,…
Khan, Zaraq; Zanfagnin, Valentina; El-Nashar, Sherif A; Famuyide, Abimbola O; Daftary, Gaurang S; Hopkins, Matthew R
To evaluate the risk factors, presentation, and outcomes in cases of abdominal wall endometriosis. A case-control study (Canadian Task Force classification II-2). An academic medical center. A total of 102 (34 cases and 68 controls) were included. Surgical resection of abdominal wall endometriosis. Cases underwent surgical excision for abdominal wall endometriosis at Mayo Clinic from January 1, 2000, through December 31, 2013. For each case, 2 controls were randomly selected from a list of women who had surgery in the same year with minimal (American Society for Reproductive Medicine stage I-II) endometriosis. A chart review was completed for variables of interest. Regression models were used to identify independent risk factors associated with abdominal wall endometriosis. In 14 years, 2539 women had surgery for endometriosis at Mayo Clinic. Of these, only 34 (1.34%) had abdominal wall endometriosis. The mean age was 35.2 ± 5.9 years, and the median parity was 2 (range, 0-5). Clinical examination diagnosed abdominal wall endometriosis in 41% of cases, with the cesarean delivery scar being the most common site (59%). There was a strong correlation between the size of the lesion on clinical examination compared with the size of the pathology specimen (r(2) = 0.74, p < .001). When compared with controls, cases had significantly higher parity and body mass index, more cyclic localized abdominal pain, less dysmenorrhea, longer duration from the start of symptoms to surgery, and more gynecologic surgeries for symptoms without cure. In the final multivariable model, cyclic localized abdominal pain, absence of dysmenorrhea, and previous laparotomy were independently associated with abdominal wall endometriosis with adjusted odds ratios of 10.6 (95% CI 1.85-104.4, p < .001), 12.4 (95% CI 1.64-147.1, p < .001), and 70.1 (95% CI 14.8-597.7, p < .001), respectively, with an area under the curve for the receiver operating characteristic of 0.94 (95% CI, 0
Chen, Minghao; Huang, Jun; Zhong, Ying; Quan, Song
To compare the clinical outcomes of embryos selected using time-lapse microscopy and traditional morphological method in IVF/ICSI cycles and evaluate the clinical value of time-lapse microscopy in early embryo monitoring and selection. e retrospectively analyzed the clinical data of 139 IVF/ICSI cycles with embryo selection based on time-lapse monitoring (TLM group, n=68) and traditional morphological method (control group, n=71). The βHCG-positive rate, clinical pregnancy rate and embryo implantation rate were compared between the 2 groups. Subgroup analysis was performed in view of female patients age and the fertilization type. The βHCG-positive rate, clinical pregnancy rate and implantation rate were 66.2%, 61.8% and 47.1% in TLM group, significantly higher than those in the control group (47.9%, 43.7% and 30.3%, respectively; P<0.05). Compared with patients below 30 years of age, patients aged between 31 and 35 years benefited more from time-lapse monitoring with improved clinical outcomes. time-lapse monitoring significantly increased the βHCG-positive rate, clinical pregnancy rate and implantation rate for patients undergoing IVF cycles, but not for those undergoing ICSI or TESA cycles. Compared with those selected using traditional morphological method, the embryos selected with time-lapse microscopy have better clinical outcomes, especially in older patients (31-35 years of age) and in IVF cycles.
Shaw, L J; Miller, D D; Berman, D S; Hachamovitch, R
The future of nuclear medicine procedures, as understood within our current economic climate, depends upon its ability to provide relevant clinical information at similar or lower comparative costs. With an ever-increasing emphasis on cost containment, outcome assessment forms the basis of preserving the quality of patient care. Today, outcomes assessment encompasses a wide array of subjects including clinical, economic, and humanistic (i.e., quality of life) outcomes. For nuclear cardiology, evidence-based medicine would require a threshold level of evidence in order to justify the added cost of any test in a patient's work-up. This evidence would include large multicenter, observational series as well as randomized trial data in sufficiently large and diverse patient populations. The new movement in evidence-based medicine is also being applied to the introduction of new technologies, in particular when comparative modalities exist. In the past 5 years, we have seen a dramatic shift in the quality of outcomes data published in nuclear cardiology. This includes the use of statistically rigorous risk-adjusted techniques as well as large populations (i.e., > 500 patients) representing multiple diverse medical care settings. This has been the direct result of the development of multiple outcomes databases that have now amassed thousands of patients worth of data. One of the benefits of examining outcomes in large patient datasets is the ability to assess individual endpoints (e.g., cardiac death) as compared with smaller datasets that often assess combined endpoints (e.g., death, myocardial infarction, or unstable angina). New technologies for the diagnosis of coronary artery disease have contributed to the rising costs of care. In the United States and in Europe, costs of care have risen dramatically, consuming an ever-increasing amount of available resources. The overuse of diagnostic angiography often leads to unnecessary revascularization that does not lead to
Xiang, Shengjin; Lin, Bin; Pan, Qintuo; Zheng, Meiqin; Qin, Xiaoyi; Wang, Youpei; Zhang, Zongduan
The purpose of our study is to analyze the clinical, ultrasonic, microbiologic, and histopathologic characteristics, management, and outcomes in a series of primary canaliculitis with concretions patients who underwent canaliculotomy with curettage.Thirty-six patients were reviewed for age, sex, location and laterality, duration of symptoms, clinical symptoms, ultrasonic signs, result of microbiologic culture and histopathologic examination, treatment, and outcomes. Main outcomes were the clinical, ultrasonic, and microbiological characteristics of the canalicular concretions; the histopathologic profiles; and the treatment effect.Thirty-six patients were identified with concretions in all 37 cases of the patients with canaliculitis. There were 30 (83.3%) female patients with a mean age of 54.2 years. Twenty-eight (77.8%) patients were misdiagnosed or delayed diagnosed, and the mean duration was 17.1 months. The common most clinical presentations were discharge (100%), epiphora (66.7%), erythema (52.8%), and swelling (47.2%), and concretions were found in 31 of 37 patients by typical clinical manifestations and in 5 of 6 patients by ultrasonic. Actinomyces was found in 8 of 13 histopathologic specimens, and microbiological cultures were positive in 13 of 24 patients. All patients underwent canaliculotomy with curettage to completely remove all concretions and contents; 35 of 36 patients' symptoms improved and 1 recurred after treatment at a median of 21.7 months follow-up according to the telephonic questionnaires.Canalicular concretions play an important role in primary canaliculitis. Canaliculotomy with curettage is a standard therapy with canalicular concretions, and the surgical removal of all possible concretions is essential for cure.
Xiang, Shengjin; Lin, Bin; Pan, Qintuo; Zheng, Meiqin; Qin, Xiaoyi; Wang, Youpei; Zhang, Zongduan
Abstract The purpose of our study is to analyze the clinical, ultrasonic, microbiologic, and histopathologic characteristics, management, and outcomes in a series of primary canaliculitis with concretions patients who underwent canaliculotomy with curettage. Thirty-six patients were reviewed for age, sex, location and laterality, duration of symptoms, clinical symptoms, ultrasonic signs, result of microbiologic culture and histopathologic examination, treatment, and outcomes. Main outcomes were the clinical, ultrasonic, and microbiological characteristics of the canalicular concretions; the histopathologic profiles; and the treatment effect. Thirty-six patients were identified with concretions in all 37 cases of the patients with canaliculitis. There were 30 (83.3%) female patients with a mean age of 54.2 years. Twenty-eight (77.8%) patients were misdiagnosed or delayed diagnosed, and the mean duration was 17.1 months. The common most clinical presentations were discharge (100%), epiphora (66.7%), erythema (52.8%), and swelling (47.2%), and concretions were found in 31 of 37 patients by typical clinical manifestations and in 5 of 6 patients by ultrasonic. Actinomyces was found in 8 of 13 histopathologic specimens, and microbiological cultures were positive in 13 of 24 patients. All patients underwent canaliculotomy with curettage to completely remove all concretions and contents; 35 of 36 patients’ symptoms improved and 1 recurred after treatment at a median of 21.7 months follow-up according to the telephonic questionnaires. Canalicular concretions play an important role in primary canaliculitis. Canaliculotomy with curettage is a standard therapy with canalicular concretions, and the surgical removal of all possible concretions is essential for cure. PMID:28248874
de Beurs, Edwin; Barendregt, Marko; de Heer, Arco; van Duijn, Erik; Goeree, Bob; Kloos, Margot; Kooiman, Kees; Lionarons, Helen; Merks, Andre
Approaches based on continuous indicators (the size of the pre-to-post-test change; effect size or ΔT) and on categorical indicators (Percentage Improvement and the Jacobson-Truax approach to Clinical Significance) are evaluated to determine which has the best methodological and statistical characteristics, and optimal performance, in comparing outcomes of treatment providers. Performance is compared in two datasets from providers using the Brief Symptom Inventory or the Outcome Questionnaire. Concordance of methods and their suitability to rank providers is assessed. Outcome indicators tend to converge and lead to a similar ranking of institutes within each dataset. Statistically and conceptually, continuous outcome indicators are superior to categorical outcomes as change scores have more statistical power and allow for a ranking of providers at first glance. However, the Jacobson-Truax approach can complement the change score approach as it presents outcome information in a clinically meaningful manner. Copyright © 2015 John Wiley & Sons, Ltd. When comparing various indicators or treatment outcome, statistical considerations designate continuous outcomes, such as the effect size of the pre-post change (effect size or ΔT) as the optimal choice. Expressing outcome in proportions of recovered, changed, unchanged or deteriorated patients has supplementary value, as it is more easily interpreted and appreciated by clinicians, managerial staff and, last but not the least, by patients. If categorical outcomes are used with small datasets, true differences in institutional performance may get obscured due to diminished power to detect differences. With sufficient data, outcome according to continuous and categorical indicators converge and lead to similar rankings of institutes' performance. Copyright © 2015 John Wiley & Sons, Ltd.
Gibbs, Deborah A; Hawkins, Stephanie R; Clinton-Sherrod, A Monique; Noonan, Rita K
Although empowerment evaluation has gained widespread currency, few reports have described its outcomes. This article combines perspectives of participants and technical assistance providers to describe the process and outcomes of the Evaluation Assistance for Sexual Violence Programs project. Participating programs reported substantial enhancements in evaluation capacity, resources devoted to evaluation, and the extent and sophistication of their evaluation practice, as well as numerous examples of the application of evaluation findings to program improvement. Experiences from evaluation technical assistance providers identified aspects of the process that were particularly useful in achieving these outcomes, including investing in collaborative relationships, maximizing participation among program staff, tailoring the content and form of technical assistance to program preferences, and combining structured learning with program-specific technical assistance.
Yang, Qiwei; Tang, Ping; Luo, Wenbo; Luo, Yue-jia
Efficient implicit emotion regulation processes, which run without awareness, are important for human well-being. In this study, to investigate the influence of implicit emotion regulation on psychological and electrophysiological responses to gains and losses, participants were required to select between two Chinese four-character idioms to match the meaning of the third one before they performed a monetary gambling task. According to whether their meanings were related to emotion regulation, the idioms fell into two categories. Event-related potentials and self-rating emotional experiences to outcome feedback were recorded during the task. Priming emotion regulation reduced subjective emotional experience to both gains and losses and the amplitudes of the feedback-related negativity, while the P3 component was not influenced. According to these results, we suggest that the application of implicit emotion regulation effectively modulated the subjective emotional experience and the motivational salience of current outcomes without the cost of cognitive resources. This study implicates the potential significance of implicit emotion regulation in decision-making processes. PMID:25332404
Yang, Qiwei; Tang, Ping; Gu, Ruolei; Luo, Wenbo; Luo, Yue-jia
Efficient implicit emotion regulation processes, which run without awareness, are important for human well-being. In this study, to investigate the influence of implicit emotion regulation on psychological and electrophysiological responses to gains and losses, participants were required to select between two Chinese four-character idioms to match the meaning of the third one before they performed a monetary gambling task. According to whether their meanings were related to emotion regulation, the idioms fell into two categories. Event-related potentials and self-rating emotional experiences to outcome feedback were recorded during the task. Priming emotion regulation reduced subjective emotional experience to both gains and losses and the amplitudes of the feedback-related negativity, while the P3 component was not influenced. According to these results, we suggest that the application of implicit emotion regulation effectively modulated the subjective emotional experience and the motivational salience of current outcomes without the cost of cognitive resources. This study implicates the potential significance of implicit emotion regulation in decision-making processes. © The Author (2014). Published by Oxford University Press. For Permissions, please email: firstname.lastname@example.org.
Despite a huge number of published laboratory bonding studies on dental oxide ceramics clinical long-term studies on resin bonded oxide ceramic restorations are rare. The purpose of this review is to present the best available clinical evidence for successful bonding of dental oxide ceramic restorations. Clinical trials with resin-bonded restorations that had no or only limited mechanical retention and were made from alumina or zirconia ceramic were identified using an electronic search in PubMed database. Overall 10 publications with clinical trials could be identified. Their clinical outcome was compared with that laboratory bond strength studies. Clinical data provide strong evidence that air-abrasion at a moderate pressure in combination with using phosphate monomer containing primers and/or luting resins provide long-term durable bonding to glass-infiltrated alumina and zirconia ceramic under the humid and stressful oral conditions. As simple and clinically reliable bonding methods to oxide ceramics exist, the rationale for development of alternative bonding methods might be reconsidered especially when these methods are more time consuming or require rather complicated and/or technique sensitive procedures. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.
Cenzi, Roberto; Farina, Antonio; Zuccarino, Luca; Carinci, Francesco
Porous polyethylene (Medpor) is an alloplastic material worldwide used for craniofacial reconstruction. To evaluate complications and risk factors associated with this synthetic graft, a retrospective study was performed. A series of 285 Medpor grafts were placed in 187 patients. Age, sex, diagnosis at admission, site, type of surgical insertion, type of fixation, and outcome (no complications, anesthesia, exposure, infection, and implant remodeling and removal) are considered. By means of univariate and multivariate analyses, we detect variables most associated with poor outcome. Univariate analysis showed that graft "survival" curves stratified according to (1) diagnosis at admission and (2) site are statistically significant. Subsequently, a Cox analysis was performed: both variables are also predictors of graft outcome. Porous polyethylene is a reliable alloplastic material that can be satisfactory used for craniofacial reconstruction. However, some sites (i.e., nose, maxilla, and ear) and diagnosis at admission (i.e., syndromic patients previously operated) are related to an higher risk of implant failure.
Shek, Daniel T. L.
Objective: As there are few studies examining the relationship between subjective and objective outcome evaluation findings, this study investigated the linkage between these two types of outcomes in the Chinese culture. Method: In an experimental study, 3,298 Chinese secondary school students responded to the Chinese Positive Youth Development…
Plotkin, Scott R; Davis, Stephanie D; Robertson, Kent A; Akshintala, Srivandana; Allen, Julian; Fisher, Michael J; Blakeley, Jaishri O; Widemann, Brigitte C; Ferner, Rosalie E; Marcus, Carole L
Plexiform neurofibromas (PNs) are complex, benign nerve sheath tumors that occur in approximately 25%-50% of individuals with neurofibromatosis type 1 (NF1). PNs that cause airway compromise or pulmonary dysfunction are uncommon but clinically important. Because improvement in sleep quality or airway function represents direct clinical benefit, measures of sleep and pulmonary function may be more meaningful than tumor size as endpoints in therapeutic clinical trials targeting airway PN. The Response Evaluation in Neurofibromatosis and Schwannomatosis functional outcomes group reviewed currently available endpoints for sleep and pulmonary outcomes and developed consensus recommendations for response evaluation in NF clinical trials. For patients with airway PNs, polysomnography, impulse oscillometry, and spirometry should be performed to identify abnormal function that will be targeted by the agent under clinical investigation. The functional group endorsed the use of the apnea hypopnea index (AHI) as the primary sleep endpoint, and pulmonary resistance at 10 Hz (R10) or forced expiratory volume in 1 or 0.75 seconds (FEV1 or FEV0.75) as primary pulmonary endpoints. The group defined minimum changes in AHI, R10, and FEV1 or FEV0.75 for response criteria. Secondary sleep outcomes include desaturation and hypercapnia during sleep and arousal index. Secondary pulmonary outcomes include pulmonary resistance and reactance measurements at 5, 10, and 20 Hz; forced vital capacity; peak expiratory flow; and forced expiratory flows. These recommended sleep and pulmonary evaluations are intended to provide researchers with a standardized set of clinically meaningful endpoints for response evaluation in trials of NF1-related airway PNs. © 2016 American Academy of Neurology.
Iqbal, Nousheen; Irfan, Muhammad; Zubairi, Ali Bin Sarwar; Jabeen, Kauser; Awan, Safia; Khan, Javaid A
Introduction Pulmonary aspergillosis has variable course of illness, severity and outcomes depending on underlying conditions. There is limited data available on the clinical manifestations and outcome of pulmonary aspergillosis from Pakistan. Methods To determine the clinical manifestations and outcome of pulmonary aspergillosis in a tertiary care hospital a retrospective study was conducted from 2004 to 2014 in patients admitted with pulmonary aspergillosis at the Aga Khan University Hospital Karachi, Pakistan. Results Of the 280 cases with provisional diagnosis of aspergillosis 69 met the inclusion criteria. The mean age was 45±15.7 years, 48 (69.6%) were men and 21 (30.4%) had diabetes mellitus (DM). The average length of hospital stay (LOS) was 10.61±9.08 days. Aspergillus fumigatus was the most common (42.0%), followed by Aspergillus flavus (28.9%). More than one-third of patients previously had tuberculosis (TB) (39.13%). The commonest pulmonary manifestation was chronic pulmonary aspergillosis (CPA) 47 (68.1%) followed by invasive pulmonary aspergillosis (IPA) 12 (17.4%) and subacute invasive aspergillosis (SAIA) 8 (11.6%). Surgical excision was performed in 28 patients (40.57%). Intensive care unit admission was required for 18 patients (26.08%). Case fatality rate was 14/69 (20.3%). DM, mean LOS and hypoxic respiratory failure were identified as independent risk factors of mortality on multivariate analysis. Conclusion A. fumigatus was the most frequent species found especially in patients with prior TB. CPA was the commonest pulmonary manifestation seen as post TB sequel. Diabetes, hypoxic respiratory failure and increased LOS were independent predictors of poor outcomes. Overall patients had good outcome with CPA compared with SAIA and IPA. PMID:28074136
Kober, Ralph; Eggleton, Ian R. C.
Evaluating the outcomes achieved by service providers who assist people with intellectual disabilities is extremely important in terms of ascertaining whether service providers achieve their goals. Furthermore, knowledge of the outcomes achieved by service providers better equips those charged with managing them to make strategic decisions to…
Wolf, Kenneth; Goodwin, Laura
Accreditation is a mark of distinction indicating that an institution has met high standards set by the profession, and an increasingly important feature of the accreditation process in higher education is "outcomes assessment." This article presents two rubrics for evaluating the quality of an institution's outcomes assessment system. One rubric…
Clerici, Renata; Castiglioni, Maria; Grion, Valentina; Zago, Giuseppe; Da Re, Lorenza
This work discusses the professional outcomes of University of Padova graduates in academic year 2007/08. Its aim was to carry out an overall assessment of higher education professional outcomes, involving all the main actors of the learning process, students, teachers and tutors, in a perspective of participatory evaluation, to improve teaching…
North Carolina State Dept. of Public Instruction, Raleigh. Div. of Accountability Services/Research.
In 1996, North Carolina began a 5-year evaluation of Alternative Learning Programs (ALPs). This report describes selected outcomes for students who participated in ALPs during 1995-96. These outcomes include performance on North Carolina End-of-Grade tests (elementary school) and performance on the End-of-Course(EOC) tests (high school) for…
Oechsler, Rafael A; Feilmeier, Michael R; Miller, Darlene; Shi, Wei; Hofling-Lima, Ana Luisa; Alfonso, Eduardo C
Purpose To determine differences in the clinical characteristics and antifungal susceptibility patterns among molecularly characterized ocular Fusarium sp isolates. Methods 58 Fusarium isolates obtained from 52 eyes of 52 patients were retrieved from the Bascom Palmer Eye Institute’s (BPEI) ocular microbiology laboratory and grown in pure culture. These isolates were characterized based on DNA sequence analysis of the ITS1/2 and rDNA regions. Antifungal susceptibilities were determined for each isolate using broth microdilution methods and the corresponding medical records were reviewed to determine clinical outcomes. Results Fusarium (F.) solani isolates had significantly higher voriconazole MIC90 values than F. non-solani organisms (16 and 4ug/ml, respectively). F. solani isolates also exhibited a significantly longer time to cure (65 vs 40.5 days), a worse follow up BCVA (20/118 vs 20/36), and increased need for urgent surgical management (7 vs 0 penetrating keratoplasties) when compared to F. non-solani isolates. Conclusions This is the first report to examine the correlation between ocular genotyped Fusarium species and clinical outcomes. It supports the overall worse prognosis for F. solani versus F. non-solani isolates, including higher voriconazole resistance by the former. The clinical implementation of molecular-based diagnostics and antifungal efficacy testing, may yield important prognostic and therapeutic information that could improve the management of fungal ocular infections. PMID:23343947
Mittag, Falk; Leichtle, Carmen Ina; Schlumberger, Michael; Leichtle, Ulf Gunther; Wünschel, Markus
Infection after total hip (THA) and knee arthroplasty (TKA) is a serious complication which typically leads to a long lasting and intensive surgical and medicamentous treatment. The aim of this study was to identify factors that influence outcome after revision surgery caused by prosthetic infection. We retrospectively analyzed 64 patients who had revision surgery between 1989 and 2009 due to periprosthetic infection. We examined a total of 69 joints (TKA: 36%, THA: 64%), follow-up 5.1 years (0.5-21 years) after the initial surgical intervention. The mean patient age at time of surgery was 67 years old (43-79 years old). Clinical data and scores including the Western Ontario and McMaster Universities (WOMAC)-Index, the Harris Hip Score (HHS) and the Hospital for Special Surgery Score (HSS) were surveyed. There was no difference in clinical scores regarding treatment between a single and a multiple stage treatment regime. Infections with multiple microorganisms and Enterococcus spp. lead to a significantly higher number of interventions. Using a modified Tsukayama system we classified 24% as type I, 34% type II and 42% type III- infections, with no differences in clinical outcome. Overweight patients had a significantly lower HHS and WOMAC-score. Immunosuppression leads to a worse WOMAC and HSS-Score. An increased number of procedures was associated to a limping gait. Thorough surgical technique leads to good clinical results independent of infection-type and treatment philosophy. Level of Evidence III, Case Control Study.
Gupta, Aditya K; Korotzer, Andrew
Although a completely normal nail would be the ideal outcome when treating onychomycosis, this is not always achievable and long treatment courses or patient expectations can impact patient adherence. We analyzed cure rates from a number of subpopulations derived from the two pivotal phase III studies with efinaconazole topical solution (10%) to provide some insights into clinically meaningful treatment outcomes and support for effective long-term management programs. Efinaconazole affords greater efficacy in milder disease, female patients, and those patients whose disease is relatively recent and confined to the great toenail, following 48 weeks' treatment. With longer treatment courses, similar results may be achieved in other subpopulations. Clinically meaningful results (a 40% improvement in the involvement of the diseased nail) were achieved with efinaconazole within six months in half the patients treated, and in over 90% of patients by study end. A greater proportion of female patients achieved clinically meaningful results at six months, although treatment success did not seem to be influenced by baseline disease severity. The majority of patients treated with efinaconazole could expect to see clinically meaningful results within six months.
J Drugs Dermatol. 2016;15(10):1260-1266.
Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas
Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase of melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication. PMID:26342156
Finland has performed, as one of the first Bologna countries, a national evaluation of the outcomes of the implementation of the Bologna process. The evaluation was organized by the Finnish Higher Education Evaluation Council and performed by an independent expert group during 2010. In general, the reform was conceived as a significant development…
Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike
Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd.
Stoddard, Douglas R; Sebesta, James A; Welder, Matthew D; Foster, Andrew J; Rush, Robert M
The idea of the preoperative anesthesia clinic as a means of examining and treating the patient so that he will arrive in the operating theater as strong and healthy as possible is well established in practice and literature.However, problems in clinic design and execution often result in high patient waiting times, decreased patient and staff satisfaction, decreased patient capacity, and high clinic costs. Although the details of clinic design, outcomes, and satisfaction have been extensively evaluated at civilian hospitals, we have not found corresponding literature addressing these issues specifically within military preoperative evaluation clinics. We find that changing to an appointment-based (versus walk-in) system and eliminating data collection step redundancies will likely result in lower wait times, higher satisfaction, lower per patient costs, and a more streamlined and resource-efficient structure. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.
Stucken, Emily Z; Brown, Kevin; Selesnick, Samuel H
In the past century, significant advances have been made in understanding the clinical features of acoustic neuromas. Furthermore, rapid technological advances have led to the development of sensitive, rapid, and relatively noninvasive diagnostic modalities, which has allowed for earlier discovery of acoustic neuromas and has reduced the average tumor size at time of diagnosis. The ultimate result has been improved clinical outcomes after surgery and radiotherapy.
Wang, Jinping; Logovinsky, Veronika; Hendrix, Suzanne B; Stanworth, Stephanie H; Perdomo, Carlos; Xu, Lu; Dhadda, Shobha; Do, Ira; Rabe, Martin; Luthman, Johan; Cummings, Jeffrey; Satlin, Andrew
Background Development of new therapies for Alzheimer's disease (AD) is increasingly focused on more mildly affected populations, and requires new assessment and outcome strategies. Patients in early stages of AD have mild cognitive decline and no, or limited, functional impairment. To respond to these assessment challenges, we developed a measurement approach based on established scale items that exhibited change in previous amnestic Mild Cognitive Impairment (aMCI) trials. Methods Partial least squares regression with a longitudinal clinical decline model identified items from commonly used clinical scales with the highest combined sensitivity to change over time in aMCI and weighted these items according to their relative contribution to detecting clinical progression in patients’ early stages of AD. The resultant AD Composite Score (ADCOMS) was assessed for its ability to detect treatment effect in aMCI/prodromal AD (pAD) clinical trial populations. Results ADCOMS consists of 4 Alzheimer's Disease Assessment Scale–cognitive subscale items, 2 Mini-Mental State Examination items, and all 6 Clinical Dementia Rating—Sum of Boxes items. ADCOMS demonstrated improved sensitivity to clinical decline over individual scales in pAD, aMCI and in mild AD dementia. ADCOMS also detected treatment effects associated with the use of cholinesterase inhibitors in these populations. Improved sensitivity predicts smaller sample size requirements when ADCOMS is used in early AD trials. Conclusions ADCOMS is proposed as new standard outcome for pAD and mild AD dementia trials, and is progressing in a CAMD-sponsored qualification process for use in registration trials of pAD. PMID:27010616
Chia, Chih-Chun; Rubinfeld, Ilan; Scirica, Benjamin M; McMillan, Sean; Gurm, Hitinder S; Syed, Zeeshan
Conventional algorithms for modeling clinical events focus on characterizing the differences between patients with varying outcomes in historical data sets used for the model derivation. For many clinical conditions with low prevalence and where small data sets are available, this approach to developing models is challenging due to the limited number of positive (that is, event) examples available for model training. Here, we investigate how the approach of developing clinical models might be improved across three distinct patient populations (patients with acute coronary syndrome enrolled in the DISPERSE2-TIMI33 and MERLIN-TIMI36 trials, patients undergoing inpatient surgery in the National Surgical Quality Improvement Program registry, and patients undergoing percutaneous coronary intervention in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry). For each of these cases, we supplement an incomplete characterization of patient outcomes in the derivation data set (uncensored view of the data) with an additional characterization of the extent to which patients differ from the statistical support of their clinical characteristics (censored view of the data). Our approach exploits the same training data within the derivation cohort in multiple ways to improve the accuracy of prediction. We position this approach within the context of traditional supervised (2-class) and unsupervised (1-class) learning methods and present a 1.5-class approach for clinical decision-making. We describe a 1.5-class support vector machine (SVM) classification algorithm that implements this approach, and report on its performance relative to logistic regression and 2-class SVM classification with cost-sensitive weighting and oversampling. The 1.5-class SVM algorithm improved prediction accuracy relative to other approaches and may have value in predicting clinical events both at the bedside and for risk-adjusted quality of care assessment.
ARI Research Note 88-99 Evaluation of the Job Skills N Education Program: Learning Outcomes Lf Ln Lee M. Hoffman, Clifford P. Hahn, Diane M. Hoffman...IDENTIFICATION NUMBER ORGANIZATION (If applicable) Soldier Education Division DAPC-PDE MDA 903-87-C-0081 Sc. ADDRESS(City, State, and ZIP Code) 10...R.1 11. TITLE (Incluce Security Classification) Evaluation of the Job Skills Education Program: Learning Outcomes 12. PERSONAL AUTHOR(S) Hoffman, Lee
Berent, Dominika; Zboralski, Krzysztof; Orzechowska, Agata; Gałecki, Piotr
The clinical implications of thyroid hormones in depression have been studied extensively and still remains disputable. Supplementation of thyroid hormones is considered to augment and accelerate antidepressant treatment. Studies on the role of thyroid hormones in depression deliver contradictory results. Here we assess theirs impact on depression severity and final clinical outcome in patients with major depression. Thyrotropin, free thyroxine (FT4), and free triiodothyronine (FT3) concentrations were measured with automated quantitative enzyme immunoassay. Depression severity and final clinical outcome were rated with 17-itemic Hamilton Rating Scale for Depression [HDRS(17)] and Clinical Global Impression Scales for severity and for improvement (CGIs, CGIi). FT3 and FT4 concentrations were significantly positively correlated with clinical improvement evaluated with CGIi (R = 0.38, P = 0.012; R = 0.33, P = 0.034, respectively). There was a significant correlation between FT4 concentrations and depression severity assessed in HDRS(17) (R = 0.31, P = 0.047). Male patients presented significantly higher FT3 serum levels (Z = 2.34, P = 0.018) and significantly greater clinical improvement (Z = 2.36, P = 0.018) when compared to female patients. We conclude that free thyroid hormones concentrations are associated with depression severity and have an impact on final clinical outcome. It can be more efficient to augment and accelerate the treatment of major depressive disorder with triiodothyronine instead of levothyroxine because of individual differences in thyroid hormones metabolism.
Karande, Sunil; Murkey, Rajneesh; Ahuja, Sanjeev; Kulkarni, Madhuri
To examine the etiological factors, clinical features, treatment modalities and outcome of acute respiratory failure in children. This hospital-based prospective observational study was conducted over 15 months. Fifty children with acute respiratory failure, diagnosed by serial arterial blood gas analysis, were consecutively enrolled. Ventilation therapy was initiated when the FiO2 requirement went above 0.6. Pulmonary diseases accounted for majority (68%) of cases, followed by nervous system (12%); and cardiovascular and skeletal muscle system diseases (10%, each). Bronchopneumonia was the commonest cause of acute respiratory failure (11 cases). The majority of cases were in the age group 1 month to < 1 year (26 cases). The commonest signs were altered depth and pattern of respiration (100%), chest wall retractions (88%), flaring of alae nasae (88%), tachypnea (84%), tachycardia (82%), and irritability (64%). Cyanosis was noticed in only 26 (52%) cases. Thirty-six (72%) children required ventilation therapy. The overall mortality was 58%. The mortality was high (55.9% to 66.7%), irrespective of the primary system involved. Significantly higher mortality was associated with co-existent malnutrition (p<0.001), Type I failure (p=0.039) and ventilation therapy (p<0.0001). Acute respiratory failure has varied etiology and clinical manifestations, and a high mortality. Its outcome is independent of age of the child and the primary system involved. Malnutrition and Type I failure are factors associated with a poor outcome.
Bland, Adrienne Lynn
The Instant Word Notebook study was a program evaluation completed by two educators who saw a need for an instructional tool to teach and assess Instant Words. In order to address reading deficits of students in first and second grades, teachers were expected to teach Instant Words. Unfortunately, teachers did not have a systematic process to…
Bland, Adrienne Lynn
The Instant Word Notebook study was a program evaluation completed by two educators who saw a need for an instructional tool to teach and assess Instant Words. In order to address reading deficits of students in first and second grades, teachers were expected to teach Instant Words. Unfortunately, teachers did not have a systematic process to…
Case, Annette; Burchfield, Erin; Sommers, Paul
Unemployment wage data were evaluated to assess employment, job retention, and wage progression for graduates of Community Jobs (CJ), a short-term public job creation program for the hard to employ in the state of Washington. The following were among the findings: (1) 66% of all participants were employed after graduating from CJ; (2) 53% were…
Eum, Jin Hee; Park, Jae Kyun; Kim, So Young; Paek, Soo Kyung; Seok, Hyun Ha; Chang, Eun Mi; Lee, Woo Sik
Objective Assisted reproductive technology has been associated with an increase in multiple pregnancies. The most effective strategy for reducing multiple pregnancies is single embryo transfer. Beginning in October 2015, the National Supporting Program for Infertility in South Korea has limited the number of embryos that can be transferred per in vitro fertilization (IVF) cycle depending on the patient's age. However, little is known regarding the effect of age and number of transferred embryos on the clinical outcomes of Korean patients. Thus, this study was performed to evaluate the effect of the number of transferred blastocysts on clinical outcomes. Methods This study was carried out in the Fertility Center of CHA Gangnam Medical Center from January 2013 to December 2014. The clinical outcomes of 514 women who underwent the transfer of one or two blastocysts on day 5 after IVF and of 721 women who underwent the transfer of one or two vitrified-warmed blastocysts were analyzed retrospectively. Results For both fresh and vitrified-warmed cycles, the clinical pregnancy rate and live birth or ongoing pregnancy rate were not significantly different between patients who underwent elective single blastocyst transfer (eSBT) and patients who underwent double blastocyst transfer (DBT), regardless of age. However, the multiple pregnancy rate was significantly lower in the eSBT group than in the DBT group. Conclusion The clinical outcomes of eSBT and DBT were equivalent, but eSBT had a lower risk of multiple pregnancy and is, therefore, the best option. PMID:27689039
Eum, Jin Hee; Park, Jae Kyun; Kim, So Young; Paek, Soo Kyung; Seok, Hyun Ha; Chang, Eun Mi; Lee, Dong Ryul; Lee, Woo Sik
Assisted reproductive technology has been associated with an increase in multiple pregnancies. The most effective strategy for reducing multiple pregnancies is single embryo transfer. Beginning in October 2015, the National Supporting Program for Infertility in South Korea has limited the number of embryos that can be transferred per in vitro fertilization (IVF) cycle depending on the patient's age. However, little is known regarding the effect of age and number of transferred embryos on the clinical outcomes of Korean patients. Thus, this study was performed to evaluate the effect of the number of transferred blastocysts on clinical outcomes. This study was carried out in the Fertility Center of CHA Gangnam Medical Center from January 2013 to December 2014. The clinical outcomes of 514 women who underwent the transfer of one or two blastocysts on day 5 after IVF and of 721 women who underwent the transfer of one or two vitrified-warmed blastocysts were analyzed retrospectively. For both fresh and vitrified-warmed cycles, the clinical pregnancy rate and live birth or ongoing pregnancy rate were not significantly different between patients who underwent elective single blastocyst transfer (eSBT) and patients who underwent double blastocyst transfer (DBT), regardless of age. However, the multiple pregnancy rate was significantly lower in the eSBT group than in the DBT group. The clinical outcomes of eSBT and DBT were equivalent, but eSBT had a lower risk of multiple pregnancy and is, therefore, the best option.
Cyclooxygenase (COX) inhibition is of concern in fish because COX inhibitors (e.g., ibuprofen) are ubiquitous in aquatic systems/fish tissues, and can disrupt synthesis of prostaglandins that modulate a variety of essential biological functions including reproduction. High content (transcriptomic) empirical data and publicly available high throughput toxicity data (actor.epa.gov) were utilized to develop putative adverse outcome pathways (AOPs) for molecular initiating event (MIE) of COX inhibition. Effects of a waterborne, 96h exposure to indomethacin (IN; 100 µg/L), ibuprofen (IB; 200 µg/L) and celecoxib (CX; 20 µg/L) on liver metabolome and ovarian gene expression (using oligonucleotide microarrays) in sexually mature fathead minnows (n=8) were examined. Metabolomic profiles of IN, IB and CX were not significantly different from control or one another. Exposure to IB and CX resulted in differential expression of comparable numbers of genes (IB = 433, CX= 545). In contrast, 2558 genes were differentially expressed in IN-treated fish. Functional analyses (canonical pathway and gene set enrichment) indicated extensive effects of IN on prostaglandin synthesis pathway, oocyte meiosis and several other processes consistent with physiological roles of prostaglandins. Transcriptomic data was congruent with apical endpoint data - IN reduced plasma prostaglandin F2 alpha concentrations, and ovarian COX activity, whereas IB and CX did not. Putative AOPs pathways for
CANO, STEFAN J.; MAYHEW, ANNA; GLANZMAN, ALLAN M.; KROSSCHELL, KRISTIN J.; SWOBODA, KATHRYN J.; MAIN, MARION; STEFFENSEN, BIRGIT F.; BÉRARD, CAROLE; GIRARDOT, FRANÇOISE; PAYAN, CHRISTINE A.M.; MERCURI, EUGENIO; MAZZONE, ELENA; ELSHEIKH, BAKRI; FLORENCE, JULAINE; HYNAN, LINDA S.; IANNACCONE, SUSAN T.; NELSON, LESLIE L.; PANDYA, SHREE; ROSE, MICHAEL; SCOTT, CHARLES; SADJADI, REZA; YORE, MACKENSIE A.; JOYCE, CYNTHIA; KISSEL, JOHN T.
Introduction Trial design for SMA depends on meaningful rating scales to assess outcomes. In this study Rasch methodology was applied to 9 motor scales in spinal muscular atrophy (SMA). Methods Data from all 3 SMA types were provided by research groups for 9 commonly used scales. Rasch methodology assessed the ordering of response option thresholds, tests of fit, spread of item locations, residual correlations, and person separation index. Results Each scale had good reliability. However, several issues impacting scale validity were identified, including the extent that items defined clinically meaningful constructs and how well each scale measured performance across the SMA spectrum. Conclusions The sensitivity and potential utility of each SMA scale as outcome measures for trials could be improved by establishing clear definitions of what is measured, reconsidering items that misfit and items whose response categories have reversed thresholds, and adding new items at the extremes of scale ranges. PMID:23836324
Cano, Stefan J; Mayhew, Anna; Glanzman, Allan M; Krosschell, Kristin J;