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Sample records for evaluate clinical outcome

  1. Evaluation of nonlinear frequency compression: Clinical outcomes

    PubMed Central

    Glista, Danielle; Scollie, Susan; Bagatto, Marlene; Seewald, Richard; Parsa, Vijay; Johnson, Andrew

    2009-01-01

    This study evaluated prototype multichannel nonlinear frequency compression (NFC) signal processing on listeners with high-frequency hearing loss. This signal processor applies NFC above a cut-off frequency. The participants were hearing-impaired adults (13) and children (11) with sloping, high-frequency hearing loss. Multiple outcome measures were repeated using a modified withdrawal design. These included speech sound detection, speech recognition, and self-reported preference measures. Group level results provide evidence of significant improvement of consonant and plural recognition when NFC was enabled. Vowel recognition did not change significantly. Analysis of individual results allowed for exploration of individual factors contributing to benefit received from NFC processing. Findings suggest that NFC processing can improve high frequency speech detection and speech recognition ability for adult and child listeners. Variability in individual outcomes related to factors such as degree and configuration of hearing loss, age of participant, and type of outcome measure. PMID:19504379

  2. Functional outcomes for clinical evaluation of implant restorations.

    PubMed

    Bassi, Francesco; Carr, Alan B; Chang, Ting-Ling; Estafanous, Emad W; Garrett, Neal R; Happonen, Risto-Pekka; Koka, Sreenivas; Laine, Juhani; Osswald, Martin; Reintsema, Harry; Rieger, Jana; Roumanas, Eleni; Salinas, Thomas J; Stanford, Clark M; Wolfaardt, Johan

    2013-01-01

    The functional outcomes related to treating patients afflicted with tooth loss are an important hallmark in substantiating prosthodontic intervention. The Oral Rehabilitation Outcomes Network (ORONet) conducted two international workshops to develop a core set of outcome measures, including a functional domain. The process followed the general format used in the Outcome Measures in Rheumatology (OMERACT) workshops to develop consensus for clinical outcome measures in arthritis research, which included: developing a comprehensive list of potential outcomes in the literature; submitting them to a filter for validity, clinical discrimination, and feasibility; and ranking those measures meeting all the filter criteria for relative value. The search was conducted to include functional assessments of speech, swallowing, mastication, nutrition, sensation, and motor function as they relate to dental implant therapies. This literature review surveyed 173 papers that produced some result of these descriptors in the functional domain. Of these, 67 papers reported on functional assessments and further defined objective and subjective outcomes. Many of these results were patient-perceived improvements in function, while others were objective assessments based on established methodologies and instruments. Objective evaluations of masticatory function and speech may meet criteria for validity and discriminability for selected interventions, but are generally not feasible for routine use in clinical care settings. The current recommendation is to employ a well-validated survey instrument that covers mastication and speech, such as the Oral Health Impact Profile (OHIP-14, short form), recognizing that patient perceptions of function may differ from objective ability. PMID:23998137

  3. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine EvaluationOutcome Measure

    PubMed Central

    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

    2016-01-01

    Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine EvaluationOutcome 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 EvaluationOutcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients. PMID:27382288

  4. Beyond the "acid test": a conceptual review and reformulation of outcome evaluation in clinical supervision.

    PubMed

    Milne, Derek

    2014-01-01

    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. PMID:25122986

  5. Evaluation of NOC standardized outcome of "health seeking behavior" in nurse-managed clinics.

    PubMed

    Macnee, Carol L; Edwards, Joellen; Kaplan, Amy; Reed, Sue; Bradford, Susanne; Walls, Jennie; Schaller-Ayers, Jennifer M

    2006-01-01

    This study evaluated the accomplishment of the Nursing Outcomes Classification (NOC) outcome "Health Seeking Behavior" in 5 nurse-managed clinics. Nurse practitioners and registered nurses rated patients on 11 indicators of health seeking behaviors, and recorded their level of knowledge of the patient. A total of 556 evaluations were collected. Health seeking behavior scores were lowest in a rural county school-based clinic and highest in a federally qualified health center. Ratings increased with nurses' knowledge of patients and for older patients. PMID:16816605

  6. Evaluation of the Outcome-Present State Test Model as a way to teach clinical reasoning.

    PubMed

    Bartlett, Robin; Bland, Ann; Rossen, Eileen; Kautz, Donald; Benfield, Susan; Carnevale, Teresa

    2008-08-01

    The Outcome-Present State Test (OPT) Model of Clinical Reasoning is a nursing process model designed to help students develop clinical reasoning skills. Although many nurse educators are using the OPT model as a teaching strategy, few are formally evaluating its use as a method. We used the OPT model as a teaching tool in an undergraduate psychiatric and mental health clinical nursing course and evaluated how quickly students became adept at using it. Most students mastered the use of the model; 29 of 43 students achieved the criterion score (a score greater than 65 on 3 or more models completed over 4 weeks). Not only did the students gain clinical reasoning skills, but they also used and learned more about the North American Nursing Diagnosis Association, Nursing Interventions Classification, and Nursing Outcomes Classification languages. Recommendations for future use of the model include adding client strengths and increasing focus on the quality of students' responses. PMID:18751647

  7. The 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) Scale: Portuguese Validation Studies.

    PubMed

    Vilaça, Margarida; de Sousa, Bruno; Stratton, Peter; Relvas, Ana Paula

    2015-01-01

    This study reports on the validity of the 15-item Portuguese version of the Systemic Clinical Outcome Routine Evaluation (SCORE-15; Vilaça, Silva, & Relvas, 2014), a brief and comprehensive measure of family functioning. Previous studies with SCORE-15 show that this version replicates the three-factor solution found for the original English version: Family strengths, Family communication and Family difficulties. In addition to reviewing previous studies, this article analyses the discriminant, convergent and predictive validity of the Portuguese SCORE-15. To do so, the SCORE-15 was administered to family members attending systemic family or couple's therapy at the start of the first and fourth sessions and also to a group of non-clinical individuals. Overall, data are reported from 618 participants, including 136 from families attending systemic therapy and 482 community family members. Comparisons of community and clinical samples (discriminant validity) showed statistically significant differences for the total scale and subscales (p < .001), with the community participants presenting healthier family functioning than the clinical ones. Analyses using SCORE-15 and the Quality of Life - adult version, another family measure applied simultaneously (convergent validity), indicate that both scales are significantly (p < .01) and moderately (r = -.47) correlated. Mean score analysis of SCORE-15's therapeutic sensitivity to change (predictive validity) showed that only the Family communication subscale was sensitive to statistically significant improvement (p < .05) from session 1 to session 4, whereas the SCORE-15's reliability change index points to its ability to detect clinical improvements (RCI = 14%). PMID:26585316

  8. Modifying the Clinical Outcomes in Routine Evaluation Measure for Use with People Who Have a Learning Disability

    ERIC Educational Resources Information Center

    Marshall, Keith; Willoughby-Booth, Simon

    2007-01-01

    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…

  9. Prognostic Scoring Indicator in Evaluation of Clinical Outcome In Intestinal Perforations

    PubMed Central

    Ahuja, Ashish; Pal, Ravinder

    2013-01-01

    Introduction: Acute generalised peritonitis coming forth due to underlying intestinal perforation is a critical & life-threatening medical condition. It is a common surgical emergency most of the times across the world. Misleading data on crude morbidity and mortality due to the condition usually contaminates substantially the very purpose of medical audit. Thus, early prognostic evaluation is not only desirable but mandate to much extent. High-risk patients require timely & aggressive treatment especially in severe peritonitis & to select them reasonably well, evaluation through prognostic scoring is an approach of choice. Well sought after & reasonably reliable APACHE II scoring system is used for the purpose & scores are correlated well to accentuate & measure the various factors needed for better management of condition. Material and Methods: The study was conducted over the period of 18 months (Jan 2010 to June 2011) on 50 patients with confirmed diagnosis of intestinal perforation. APACHE II score was calculated and correlated with their symptoms & clinical outcomes regarding morbidity and mortality. Results: APACHE II score correlated well with the outcome of the study, showing score affects of two major aspects in the treatment outcome & management.1.) APACHE II score of less than 10 included 30 low risk group patients discharged in a satisfactory gratifying manner. Three out of four in high risk group with APACHE II score >20, shown adverse outcomes. 2.)Mean ICU stay of 9.75 days was found in patients with APACHE II score 20 or more compared to those with mean ICU stay of 0.13 days in patients with APACHE II score 10 or less. Conclusion: Acute generalized peritonitis being life–threatening medical emergency requires careful consideration in its management that needs to be economically viable, acceptably feasible and outcome oriented with better allocation & utilization of ICU resources that needs meticulous case analysis & prioritization. This present

  10. Interim Outcomes Assessment of the Comprehensive Clinical Performance Grid for Student Evaluation.

    ERIC Educational Resources Information Center

    Tolls, Dorothy Bazzinotti; Carlson, Nancy; Wilson, Roger; Richman, Jack

    2001-01-01

    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…

  11. Calculating Clinically Significant Change: Applications of the Clinical Global Impressions (CGI) Scale to Evaluate Client Outcomes in Private Practice

    ERIC Educational Resources Information Center

    Kelly, Peter James

    2010-01-01

    The Clinical Global Impressions (CGI) scale is a therapist-rated measure of client outcome that has been widely used within the research literature. The current study aimed to develop reliable and clinically significant change indices for the CGI, and to demonstrate its application in private psychological practice. Following the guidelines…

  12. An empirical evaluation of multidimensional clinical outcome in chronic low back pain patients.

    PubMed

    Klapow, J C; Slater, M A; Patterson, T L; Doctor, J N; Atkinson, J H; Garfin, S R

    1993-10-01

    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

  13. Clinical assessment is sufficient to allow outcome evaluation following surgical management of Achilles tendon ruptures

    PubMed Central

    Todorov, Atanas; Schaub, Frederic; Blanke, Fabian; Heisterbach, Patricia; Sachser, Franciska; Gösele, Andreas; Majewski, Martin

    2015-01-01

    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

  14. Live Birth is the Correct Outcome for Clinical Trials Evaluating Therapy for the Infertile Couple

    PubMed Central

    Barnhart, Kurt T.

    2014-01-01

    Well-designed and conducted clinical trials are needed to further advance the field for reproductive medicine. However current reporting of outcomes of trials is ambiguous and disparate. In this manuscript it is offed that the preferred outcome for clinical trials in reproductive medicine should be live birth. Multiple births should be listed and it should be specified whether this is multiple births per couple or multiple births per conception. The unit of measure should be women (or couples) and not cycles. The duration of exposure should also be clearly identified (i.e., treatment was one cycle, a pre-specified number of cycles, or a period of time). Pregnancy loss should be specified and the denominator should be those who conceived. While live birth is the primary outcome, complications should be defined and reported including multiple births and other objective markers such as preterm delivery, small-for-gestational age, or stillbirth. PMID:24786740

  15. Randomized noninferiority clinical trial evaluating 3 commercial dry cow mastitis preparations: I. Quarter-level outcomes.

    PubMed

    Arruda, A G; Godden, S; Rapnicki, P; Gorden, P; Timms, L; Aly, S S; Lehenbauer, T W; Champagne, J

    2013-07-01

    The study objective was to compare the efficacy of 3 commercial dry cow mastitis formulations regarding quarter-level prevalence of intramammary infections (IMI) postcalving, cure of preexisting infections over the dry period, prevention of new infections during the dry period, and risk for a clinical mastitis case between calving and 100d in milk (DIM). A total of 1,091 cows (4,364 quarters) from 6 commercial dairy herds in 4 different states (California, Iowa, Minnesota, and Wisconsin) were enrolled and randomized to 1 of the 3 treatments at dry-off: Quartermaster (QT; 1,000,000 IU of procaine penicillin G and 1 g of dihydrostreptomycin; Pfizer Animal Health, New York, NY), Spectramast DC (SP; 500 mg of ceftiofur hydrochloride; Pfizer Animal Health), or ToMorrow Dry Cow (TM; 300mg of cephapirin benzathine; Boehringer Ingelheim Vetmedica Inc., St. Joseph, MO). Quarter milk samples were collected for routine bacteriological culture before dry cow therapy treatment at dry-off, 0 to 6 DIM, and 7 to 13 DIM and an on-farm record-keeping system was used to retrieve data on clinical mastitis cases. Noninferiority analysis was used to evaluate the effect of treatment on the primary outcome, risk for a bacteriological cure during the dry period. Multivariable logistic regression techniques were used to describe the effect of treatment on risk for presence of IMI postcalving and risk of a new IMI during the dry period. Cox proportional hazards regression was used to describe the effect of treatment on the risk and time for quarters to experience an episode of clinical mastitis between calving and 100 DIM. The overall crude quarter-level prevalence of infection at dry-off was 19.2%. The most common pathogen isolated from milk samples at dry-off was coagulase-negative Staphylococcus, followed by Aerococcus spp. and other Streptococcus spp. Noninferiority analysis showed no effect of treatment on risk for a cure between dry-off and calving [least squares means (LSM): QT=93

  16. Evaluation of Clinical Diagnosis of Fetal Distress and Perinatal Outcome in a Low Resource Nigerian Setting

    PubMed Central

    Ibekwe, Perpetus Chudi; Onu, Fidelis Agwu; Onwe, Ogah Emeka; Ezeonu, Thecla Chinonyelum; Omeje, Innocent

    2016-01-01

    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

  17. Clinical evaluation and outcomes of naturally acquired West Nile virus infection in raptors.

    PubMed

    Nemeth, Nicole M; Kratz, Gail E; Bates, Rebecca; Scherpelz, Judy A; Bowen, Richard A; Komar, Nicholas

    2009-03-01

    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. PMID:19368240

  18. HIP FRACTURE: POST-OPERATIVE EVALUATION OF CLINICAL AND FUNCTIONAL OUTCOMES

    PubMed Central

    Guerra, Marcelo Teodoro Ezequiel; Thober, Thomas Alexandre; Bigolin, André Vicente; de Souza, Marcos Paulo; Echeveste, Simone

    2015-01-01

    Objective: To evaluate the clinical and functional outcomes from patients undergoing surgery to treat hip fractures, with regard to the ASA score and time spent waiting for definitive surgical treatment. Method: Over a one-year period, 154 patients with hip fractures, aged 65 years and over, underwent operations. Data on the preoperative ASA score and the time spent waiting for the operation were obtained. Two years after the operation, Zuckerman‘s Functional Recovery Score (FRS) questionnaire was used to assess the patients' current functional capacity. Results: Mortality during the first postoperative year differed between patients with ASA 3 or 4 and those classified as ASA 1 or 2 (significant data; p < 0.05). Mortality up to the end of the second postoperative year was significantly higher (p < 0.05) in the ASA 3 or 4 group. The preoperative ASA score did not demonstrate any significant relationship with the patients' current functional capacity (p > 0.05). There was no significant difference between the group operated within 48 hours of admission and the group operated after 48 hours, in relation to mortality or current functional capacity (p > 0.05). The group aged 80 years and over showed significantly higher mortality (p < 0.05) than the group aged 65 to 79 years up to the end of the second postoperative year. Conclusion: The preoperative ASA score and an age of 80 years or over may be considered to be factors associated with higher mortality two years after hip fracture surgery. In isolation, time spent waiting for surgery was not significant. PMID:27026967

  19. Evaluation of Clinical Outcomes and Renal Vascular Pathology among Patients with Lupus

    PubMed Central

    Barber, Claire; Herzenberg, Andrew; Aghdassi, Ellie; Su, Jiandong; Lou, Wendy; Qian, Gan; Yip, Jonathan; Nasr, Samih H.; Thomas, David; Scholey, James W.; Wither, Joan; Urowitz, Murray; Gladman, Dafna; Reich, Heather

    2012-01-01

    Summary Background and objectives The objective of this study was to determine the clinical significance of renal vascular lesions in lupus nephritis. Design, setting, participants, & measurements Renal vascular lesions defined as thrombotic microangiopathy, lupus vasculopathy, uncomplicated vascular immune deposits, and arterial sclerosis were evaluated in relation to renal and vascular morbidity and overall mortality. Results Biopsies from 161 patients revealed thrombotic microangiopathy (13), lupus vasculopathy (5), and arterial sclerosis (93). No renal vascular lesions were found in 24.8% of patients. At the time of biopsy, arterial sclerosis or lupus vasculopathy patients were older (arterial sclerosis=37.9±13.0 and lupus vasculopathy=44.4±8.9 versus controls=33.1±8.9 years, P<0.05), and the mean arterial pressure was higher in all groups compared with controls. Nephritis subtype, activity indices, and proteinuria were similar between groups, estimated GFR was lower in arterial sclerosis (70.5±33.3 versus 84.5±26.6 ml/min per 1.73 m2, P=0.03), and chronicity index (thrombotic microangiopathy=3.5, lupus vasculopathy=4.5, and arterial sclerosis=2.5) was higher in all renal vascular lesions subgroups versus controls (1.0, P<0.05). In 133 patients with similar follow-up, the association between renal vascular lesions and vascular events was significant (Fisher exact test, P=0.002) and remained so after multivariate analysis (exact conditional scores test, P=0.04), where the difference between arterial sclerosis and uncomplicated vascular immune deposits was most noticeable (odds ratio [95% confidence interval]=8.35[0.98, 83.12], P=0.05). The associations between renal vascular lesions, renal outcomes, and death were not significant, likely because of insufficient power. Conclusions Renal vascular lesions are common in SLE patients with nephritis and may be associated with arterial vascular events. PMID:22442181

  20. Outcomes of Moral Case Deliberation - the development of an evaluation instrument for clinical ethics support (the Euro-MCD)

    PubMed Central

    2014-01-01

    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

  1. Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy

    PubMed Central

    Orange, J S; Belohradsky, B H; Berger, M; Borte, M; Hagan, J; Jolles, S; Wasserman, R L; Baggish, J S; Saunders, R; Grimbacher, B

    2012-01-01

    The importance of serum immunoglobulin (Ig)G concentration in IgG replacement therapy for primary immunodeficiency diseases is established in certain settings. Generally, IgG is infused via the intravenous (IVIG) or subcutaneous (SCIG) route. For IVIG infusion, published data demonstrate that higher IgG doses and trough levels provide patients with improved protection from infection. The same conclusions are not yet accepted for SCIG; data from two recent Phase III studies and a recent post-hoc analysis, however, suggest the same correlation between higher SCIG dose and serum IgG concentration and decreased incidence of infection seen with IVIG. Other measures of clinical efficacy have not been considered similarly. Thus, combined analyses of these and other published SCIG studies were performed; a full comparison of the 13 studies was, however, limited by non-standardized definitions and reporting. Despite these limitations, our analyses indicate that certain clinical outcomes improve at higher SCIG doses and associated higher serum IgG concentrations, and suggest that there might be opportunity to improve patient outcomes via SCIG dose adjustment. PMID:22774992

  2. Clinicopathologic Features and Clinical Outcomes of Esophageal Gastrointestinal Stromal Tumor: Evaluation of a Pooled Case Series.

    PubMed

    Feng, Fan; Tian, Yangzi; Liu, Zhen; Xu, Guanghui; Liu, Shushang; Guo, Man; Lian, Xiao; Fan, Daiming; Zhang, Hongwei

    2016-01-01

    Clinicopathologic features and clinical outcomes of gastrointestinal stromal tumors (GISTs) in esophagus are limited, because of the relatively rare incidence of esophageal GISTs. Therefore, the aim of the current study was to investigate the clinicopathologic features and clinical outcomes of esophageal GISTs, and to investigate the potential factors that may predict prognosis.Esophageal GIST cases were obtained from our center and from case reports and clinical studies extracted from MEDLINE. Clinicopathologic features and survivals were analyzed and compared with gastric GISTs from our center.The most common location was lower esophagus (86.84%), followed by middle and upper esophagus (11.40% and 1.76%). The majority of esophageal GISTs were classified as high-risk category (70.83%). Mitotic index was correlated with histologic type, mutational status, and tumor size. The 5-year disease-free survival and disease-specific survival were 65.1% and 65.9%, respectively. Tumor size, mitotic index, and National Institutes of Health risk classification were associated with prognosis of esophageal GISTs. Only tumor size, however, was the independent risk factor for the prognosis of esophageal GISTs. In comparison to gastric GISTs, the distribution of tumor size, histologic type, and National Institutes of Health risk classification were significantly different between esophageal GISTs and gastric GISTs. The disease-free survival and disease-specific survival of esophageal GISTs were significantly lower than that of gastric GISTs.The most common location for esophageal GISTs was lower esophagus, and most of the esophageal GISTs are high-risk category. Tumor size was the independent risk factor for the prognosis of esophageal GISTs. Esophageal GISTs differ significantly from gastric GISTs in respect to clinicopathologic features. The prognosis of esophageal GISTs was worse than that of gastric GISTs. PMID:26765432

  3. Factor analysis of treatment outcomes from a UK specialist addiction service: Relationship between the Leeds Dependence Questionnaire, Social Satisfaction Questionnaire and 10-item Clinical Outcomes in Routine Evaluation

    PubMed Central

    Fairhurst, Caroline; Böhnke, Jan R; Gabe, Rhian; Croudace, Tim J; Tober, Gillian; Raistrick, Duncan

    2014-01-01

    Introduction and Aims To examine the relationship between three outcome measures used by a specialist addiction service (UK): the Leeds Dependence Questionnaire (LDQ), the Social Satisfaction Questionnaire (SSQ) and the 10-item Clinical Outcomes in Routine Evaluation (CORE-10). Design and Method A clinical sample of 715 service user records was extracted from a specialist addiction service (2011) database. The LDQ (dependence), SSQ (social satisfaction) and CORE-10 (psychological distress) were routinely administered at the start of treatment and again between 3 and 12 months post-treatment. A mixed pre/post-treatment dataset of 526 service users was subjected to exploratory factor analysis. Parallel Analysis and the Hull method were used to suggest the most parsimonious factor solution. Results Exploratory factor analysis with three factors accounted for 66.2% of the total variance but Parallel Analysis supported two factors as sufficient to account for observed correlations among items. In the two-factor solution, LDQ items and nine of the 10 CORE-10 items loaded on the first factor >0.41, and the SSQ items on factor 2 with loadings >0.63. A two dimensional summary appears sufficient and clinically meaningful. Discussion and Conclusions Among specialist addiction service users, social satisfaction appears to be a unique construct of addiction and is not the same as variation due to psychological distress or dependence. Our interpretation of the findings is that dependence is best thought of as a specific psychological condition subsumed under the construct psychological distress. [Fairhurst C, Böhnke JR, Gabe R, Croudace TJ, Tober G, Raistrick D. Factor analysis of treatment outcomes from a UK specialist addiction service: Relationship between the Leeds Dependence Questionnaire, Social Satisfaction Questionnaire and 10-item Clinical Outcomes in Routine Evaluation. Drug Alcohol Rev 2014;33:643–650] PMID:24802233

  4. Clinical Evaluation of a Mobile Sensor-Based Gait Analysis Method for Outcome Measurement after Knee Arthroplasty

    PubMed Central

    Calliess, Tilman; Bocklage, Raphael; Karkosch, Roman; Marschollek, Michael; Windhagen, Henning; Schulze, Mareike

    2014-01-01

    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. PMID:25171119

  5. Evaluation of a Telehealth Service for COPD and HF patients: Clinical outcome and patients' perceptions.

    PubMed

    Odeh, Bassel; Kayyali, Reem; Nabhani-Gebara, Shereen; Philip, Nada; Robinson, Patricia; Wallace, Catherine Russell

    2015-07-01

    NHS Croydon Health Services and NHS Croydon Clinical Commissioning Group have been providing telehealth services for the past 36 months. The aim of this study was to measure the impact of telehealth when implemented as a service within a standard patient care pathway. To measure the clinical outcomes, the number of A&E visits and hospital admissions, recorded on the NHS Secondary Uses Service database, were compared before and after the implementation of the telehealth service. The number of all events despite its cause and the number of events related to the patients' diagnosed condition were collected. To elicit patients' perceptions about the telehealth service, a cross sectional survey of patients registered on the triage manager database was used to explore their perceptions, concerns and general satisfaction with the telehealth service via a 4 point likert scale questionnaire. The data of 48 patients were collected and telehealth reduced the number of both A&E and hospital admission due to all causes by 13% (P = 0.42) and 22% (P = 0.048), respectively. When only the events directly related to the patient's diagnosed condition were considered, a reduction by 36% (P = 0.03) and 28% (P = 0.02) was recorded for A&E visits and hospital admission respectively. 27 patients consented to participate in the survey. Overall, patients were very satisfied with telehealth services. Patients agreed that telehealth had improved their health, it was a convenient form of health care delivery for them and they were more involved in the decisions about their care or treatment. In addition, since being on telehealth, patients' confidence in managing their health increased from somewhat confident to confident. Telehealth, when provided as a service within a standard care pathway, seems to decrease hospital admissions and A&E visits. Good patient satisfaction suggests that the current service is accepted and it could be further expanded to include a larger number of

  6. Clinical performance of porcelain laminate veneers: outcomes of the aesthetic pre-evaluative temporary (APT) technique.

    PubMed

    Gurel, Galip; Morimoto, Susana; Calamita, Marcelo A; Coachman, Christian; Sesma, Newton

    2012-12-01

    This article evaluates the long-term clinical performance of porcelain laminate veneers bonded to teeth prepared with the use of an additive mock-up and aesthetic pre-evaluative temporary (APT) technique over a 12-year period. Sixty-six patients were restored with 580 porcelain laminate veneers. The technique, used for diagnosis, esthetic design, tooth preparation, and provisional restoration fabrication, was based on the APT protocol. The influence of several factors on the durability of veneers was analyzed according to pre- and postoperative parameters. With utilization of the APT restoration, over 80% of tooth preparations were confined to the dental enamel. Over 12 years, 42 laminate veneers failed, but when the preparations were limited to the enamel, the failure rate resulting from debonding and microleakage decreased to 0%. Porcelain laminate veneers presented a successful clinical performance in terms of marginal adaptation, discoloration, gingival recession, secondary caries, postoperative sensitivity, and satisfaction with restoration shade at the end of 12 years. The APT technique facilitated diagnosis, communication, and preparation, providing predictability for the restorative treatment. Limiting the preparation depth to the enamel surface significantly increases the performance of porcelain laminate veneers. PMID:23057051

  7. Evaluating Counseling Outcomes.

    ERIC Educational Resources Information Center

    Smyer, Michael A.; Intrieri, Robert C.

    1990-01-01

    Defines the range of interventions considered under the rubric of counseling for the elderly. Uses evaluation of treatments for depression among the elderly to exemplify the current state of outcome-evaluation research. (Author)

  8. Clinical Characteristics and Outcomes for Patients with Thymic Carcinoma: Evaluation of Masaoka Staging

    PubMed Central

    Litvak, Anya M.; Woo, Kaitlin; Hayes, Sara; Huang, James; Rimner, Andreas; Sima, Camelia S.; Moreira, Andre L.; Tsukazan, Maria; Riely, Gregory J.

    2015-01-01

    Background Thymic carcinomas are rare cancers with limited data regarding outcomes, particularly for those patients with advanced disease. Methods We identified patients with thymic carcinomas diagnosed between 1993 and 2012. Patient characteristics, recurrence free survival (RFS), and overall survival (OS) were analyzed. Results One hundred twenty-one patients with thymic carcinomas were identified. Higher Masaoka stage was associated with worse OS and RFS (5-yr OS of 100%, 81%, 51%, 24%, and 17% for stage I, II, III, IVa and IVb respectively, p<0.001 and 5-yr RFS of 80%, 28%, and 7% for stage I/II, III, and IV respectively, p<0.001). Patients with stage IVb lymph node (LN) only disease had a better 5-year OS as compared to patients with distant metastasis (24% vs. 7%, p=0.025). Of the 61 patients with stage IVb disease, 22/29 patients (76%) with LN-only disease underwent curative intent resection vs. 3/32 patients (9%) with distant metastasis. Twenty-two patients with LN involvement were treated with multi-modality therapy. Three (14%) remain free of disease with long-term follow-up (range: 3.4+ years to 6.8+ years). Conclusions We describe the clinical features of a large series of patients with thymic carcinoma in North America. The Masaoka staging system effectively prognosticated OS and RFS. Patients with stage IVb LN-only disease had significantly better OS as compared to patients with distant metastasis with a subset of patients sustaining long term RFS with multi-modality therapy. If validated, these data would support a revised staging system with sub-classification of stage IVb disease into two groups. PMID:25393794

  9. Outcome Prediction in Clinical Treatment Processes.

    PubMed

    Huang, Zhengxing; Dong, Wei; Ji, Lei; Duan, Huilong

    2016-01-01

    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. PMID:26573645

  10. A 4-year prospective evaluation of protocols to improve clinical outcomes for patients with lymphangioleiomyomatosis in a national clinical centre.

    PubMed

    Bee, Janet; Bhatt, Rupesh; McCafferty, Ian; Johnson, Simon R

    2015-12-01

    Lymphangioleiomyomatosis (LAM) is a rare multisystem disease. Progressive airflow limitation, pneumothorax and angiomyolipoma-related bleeding are major morbidities. As treatments are available for these complications, we prospectively audited loss of FEV1 (ΔFEV1), pneumothorax and angiomyolipoma bleeding against clinical standards over 4 years at the UK Clinical Centre. ΔFEV1 for these patients is lower than previously reported and rates of pneumothorax and angiomyolipoma haemorrhage are low. This suggests that real-time analysis of clinical data with targeted interventions can reduce morbidity in LAM. These measures could be applied as quality standards to compare the emerging LAM clinical networks worldwide. PMID:26123659

  11. Design and Outcomes of a Comprehensive Care Experience Level System to Evaluate and Monitor Dental Students' Clinical Progress.

    PubMed

    Teich, Sorin T; Roperto, Renato; Alonso, Aurelio A; Lang, Lisa A

    2016-06-01

    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. PMID:27251347

  12. A benchmark for evaluation of algorithms for identification of cellular correlates of clinical outcomes.

    PubMed

    Aghaeepour, Nima; Chattopadhyay, Pratip; Chikina, Maria; Dhaene, Tom; Van Gassen, Sofie; Kursa, Miron; Lambrecht, Bart N; Malek, Mehrnoush; McLachlan, G J; Qian, Yu; Qiu, Peng; Saeys, Yvan; Stanton, Rick; Tong, Dong; Vens, Celine; Walkowiak, Sławomir; Wang, Kui; Finak, Greg; Gottardo, Raphael; Mosmann, Tim; Nolan, Garry P; Scheuermann, Richard H; Brinkman, Ryan R

    2016-01-01

    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

  13. Is it the time to rethink clinical decision-making strategies? From a single clinical outcome evaluation to a Clinical Multi-criteria Decision Assessment (CMDA).

    PubMed

    Migliore, Alberto; Integlia, Davide; Bizzi, Emanuele; Piaggio, Tomaso

    2015-10-01

    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

  14. Radiological and clinical outcome of screw placement in adolescent idiopathic scoliosis: evaluation with low-dose computed tomography

    PubMed Central

    Ohlin, Acke; Strömbeck, Anita; Maly, Pavel; Sundgren, Pia C.

    2009-01-01

    Posterior corrective surgery using “all pedicle screw construct” carries risk of neurovascular complications. The study aims were to assess the screw placement in patients with adolescent idiopathic scoliosis using CT with low-radiation dose, and to evaluate the clinical outcome in patients with misplaced pedicle screws. CTs of 49 consecutive patients (873 screws, 79% thoracic) were retrospectively evaluated by two independent radiologists. A new grading system was developed to distinguish between lateral, medial and anterior cortical perforations, endplate perforation and foraminal perforation. The grading system is based on whether the cortical violation is partial or total rather than on mm-basis. The overall rate of screw misplacement was 17% (n = 149): 8% were laterally placed and 6.1% were medially placed. The rates of anterior cortical, endplate and foraminal perforation were 1.5, 0.9, and 0.5%, respectively. Lateral cortical perforation was more frequent in the thoracic spine (P = 0.005), whereas other types of misplacement including medial cortical perforation were more frequent on the left and the concave side of scoliotic curves (P = 0.002 and 0.003). No neurovascular complications were reported. The association between the occurrence of screw misplacement and the Cobb angle was statistically significant (P = 0.037). Misplacements exceeding half screw diameter should be classified as unacceptable. Low-dose CT implies exposing these young individuals to a significantly lower radiation dose than do other protocols used in daily clinical practice. We recommend using low-dose CT and the grading system proposed here in the postoperative assessment of screw placement. PMID:19888607

  15. Clinical and fiscal outcomes of utilization review.

    PubMed

    Murray, Mary Ellen; Darmody, Julie V

    2004-01-01

    Concurrent utilization review (UR) is both a quality improvement tool and a cost containment strategy used by managed care organizations. The UR process requires that providers (hospital staff) communicate clinical information about hospitalized patients to payers who evaluate the appropriateness and medical necessity of the planned care. Payers then make a decision whether to certify the care for reimbursement. This study provides data to indicate that denials of certification have little impact on clinical and fiscal outcomes of patient care. PMID:14740580

  16. Can a management pathway for chronic cough in children improve clinical outcomes: protocol for a multicentre evaluation

    PubMed Central

    2010-01-01

    Background Chronic cough is common and is associated with significant economic and human costs. While cough can be a problematic symptom without serious consequences, it could also reflect a serious underlying illness. Evidence shows that the management of chronic cough in children needs to be improved. Our study tests the hypothesis that the management of chronic cough in children with an evidence-based management pathway is feasible and reliable, and improves clinical outcomes. Methods/Design We are conducting a multicentre randomised controlled trial based in respiratory clinics in 5 major Australian cities. Children (n = 250) fulfilling inclusion criteria (new patients with chronic cough) are randomised (allocation concealed) to the standardised clinical management pathway (specialist starts clinical pathway within 2 weeks) or usual care (existing care until review by specialist at 6 weeks). Cough diary, cough-specific quality of life (QOL) and generic QOL are collected at baseline and at 6, 10, 14, 26, and 52 weeks. Children are followed-up for 6 months after diagnosis and cough resolution (with at least monthly contact from study nurses). A random sample from each site will be independently examined to determine adherence to the pathway. Primary outcomes are group differences in QOL and proportion of children that are cough free at week 6. Discussion The clinical management pathway is based on data from Cochrane Reviews combined with collective clinical experience (250 doctor years). This study will provide additional evidence on the optimal management of chronic cough in children. Trial registration ACTRN12607000526471 PMID:21054884

  17. Outcomes evaluation of the athletic elbow.

    PubMed

    Freehill, Michael T; Mannava, Sandeep; Safran, Marc R

    2014-09-01

    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

  18. [Patient evaluation and outcome measures].

    PubMed

    Nieto Pol, Enrique

    2014-01-01

    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). PMID:24467959

  19. Evaluation of Kidney Disease Education on Clinical Outcomes and Knowledge of Self-Management Behaviors of Patients with Chronic Kidney Disease.

    PubMed

    Enworom, Chinyere D; Tabi, Marian

    2015-01-01

    Chronic kidney disease (CKD) is a public health problem in United States. Providing kidney disease education (KDE) is an effective and integral part of CKD management. This two-part non-experimental study retrospectively evaluated clinical outcomes of participants of a Medicare Kidney Disease Education (KDE) program and prospectively evaluated kidney disease knowledge of survey participants from the general population of patients with CKD. Results showed that participants of a KDE program demonstrated slower decline in GFR compared to non-participants (M = 18.3 mL/min/1.73m2, SD = 8.3 mL/min/1.73m2 vs. M = 15.0 mL/min/1.73m2, SD = 6.1 mL/min/1.73m2). Providing KDE to individuals with CKD Stage 4 was associated with improved clinical outcomes. PMID:26462309

  20. Does Vertebral Endplate Morphology Influence Outcomes in Lumbar Total Disc Arthroplasty? Part II: Clinical and Radiographic Results as Evaluated Utilizing the Vertebral Endplate Yue-Bertagnoli (VEYBR) Classification

    PubMed Central

    Oetgen, Matthew E.; la Torre, Jorge J. Jaramillo-de; Bertagnoli, Rudolf

    2008-01-01

    Study Design This study was a prospective study with a minimum patient follow-up of 2 years. Objective The purpose of this study was to evaluate the clinical usefulness of a vertebral endplate classification system (VEYBR) in predicting outcomes following lumbar arthroplasty. Background In the present study, our previously described endplate classification system was evaluated to determine its clinical usefulness in patients undergoing lumbar arthroplasty. Methods The patient cohort in this study consisted of 80 patients who had been enrolled in the US FDA ProDisc clinical trial. Radiographs were classified using the VEYBR classification. The preoperative categories (Types I to V) were then correlated with the patients’ visual analogue scores (VAS) and Oswestry Disability Index (ODI) scores and radiographic outcomes at an average follow-up point of 28 months. Results The rank order of total change in VAS based on preoperative VEYBR classification was Type IV, III, I II, and V, with Type IV having the greatest improvement in VAS and Type V having the least improvement. The rank order of total change in ODI was Type IV, II, III, I, and V. We found no differences in clinical outcomes among the 5 vertebral endplate types. Type II endplates had least optimal sagittal positioning. Conclusions Although not statistically significant, there was a strong trend for Type V endplates to have the least improvements in VAS and Oswestry clinical outcome scores. Knowledge and use of the endplate classification system did lead to consistent implant placement across endplate classes which may indicate the usefulness of this classification system in preoperative planning, especially for physicians in the “learning curve” phase of this procedure. Level of Evidence Case series (Level IV). PMID:25802609

  1. Routine Outcome Monitoring and Clinical Decision-Making in Forensic Psychiatry Based on the Instrument for Forensic Treatment Evaluation

    PubMed Central

    van der Veeken, Frida C. A.

    2016-01-01

    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

  2. An Evaluation of Community Assessment Tools (CATs) in Predicting Use of Clinical Interventions and Severe Outcomes during the A(H1N1)pdm09 Pandemic

    PubMed Central

    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.

    2013-01-01

    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

  3. Evaluating the effect of a haemoglobin spray on size reduction in chronic DFUs: clinical outcomes at 12 weeks.

    PubMed

    Dawn Hunt, Sharon; Haycocks, Samantha; McCardle, Joanne; Guttormsen, Karl

    2016-06-23

    A recent multi-centre observational evaluation investigated the effect of a topical haemoglobin spray (Granulox, Infirst), used as an adjunct to standard care, on wound size reduction in 17 patients (4 females/13 males) with 20 chronic diabetic foot ulcers (DFUs) over a 4-week period. In 14 of the 18 wounds that completed the evaluation (one patient dropped out due to an infection) there was a mean reduction of 53.8% (range: 11.9-100%). The product was acceptable to both patients and clinicians, who all found it easy to use. This article describes the outcomes for the remaining 13 patients (with 15 wounds) who continued using the spray after the 4-week evaluation ended. (Data are not available for two patients and the one patient who healed during the 4-week evaluation.) By 12 weeks, three wounds (20%) had healed, eight (53%) were progressing towards healing, three (20%) increased in size and one (7%) was slow healing. PMID:27345086

  4. Skull base chordomas: clinical outcome in a consecutive series of 45 patients with long-term follow-up and evaluation of clinical and biological prognostic factors.

    PubMed

    Boari, Nicola; Gagliardi, Filippo; Cavalli, Andrea; Gemma, Marco; Ferrari, Luca; Riva, Paola; Mortini, Pietro

    2016-08-01

    OBJECTIVE Skull base chordomas (SBCs) are rare dysembryogenetic invasive tumors with a variable tendency for recurrence. According to previous studies, the recurrence rate seems to be affected by both clinical variables and tumor biological features. The authors present the results of treatment of SBCs in a large series of patients and investigate the role of 1p36 chromosomal region loss of heterozygosity (LOH) as a prognostic factor. METHODS Between 1990 and 2011, 45 patients were treated for SBCs. The mean follow-up was 76 months (range 1-240 months). An LOH analysis was performed in 27 cases. Survival analysis was performed to determine clinical and biological parameters correlating with clinical outcome. RESULTS The 5- and 10-year overall survival rates were 67% and 57%, respectively. Five- and 10-year progression-free survival rates were 58% and 44%, respectively. Multivariate analysis showed that extent of resection, adjuvant radiation therapy, and absence of rhinopharynx invasion were positive independent predictors of overall survival. The latter 2 variables and a younger patient age were positive independent predictors of progression-free survival. Twenty-one patients showed 1p36 LOH. All events of recurrence and death clustered in the group of patients with 1p36 LOH; however, this biological marker was not statistically significant on multivariate analysis. CONCLUSIONS Resection is the treatment of choice in primary and recurrent SBC. Patient age, rhinopharynx invasion at diagnosis, extent of tumor removal, and postoperative radiation therapy influence SBC prognosis. Genetic analysis, even while showing interesting results, did not reveal 1p36 LOH as an independent predictor of clinical outcome. PMID:26745472

  5. Impact of Patient Sex on Clinical Outcomes

    PubMed Central

    Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.

    2014-01-01

    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

  6. Clinical implications of the Women's Ischemia Syndrome Evaluation: inter-relationships between symptoms, psychosocial factors and cardiovascular outcomes.

    PubMed

    Handberg, Eileen M; Eastwood, Jo-Ann; Eteiba, Wafia; Johnson, B Delia; Krantz, David S; Thompson, Diane V; Vaccarino, Viola; Bittner, Vera; Sopko, George; Pepine, Carl J; Merz, Noel Bairey; Rutledge, Thomas R

    2013-09-01

    Cardiovascular disease remains the leading cause of death in the USA and is associated with several modifiable (hypertension, diabetes, high cholesterol, tobacco use, physical inactivity, obesity and unhealthy diet) and nonmodifiable (age, gender and family history) risk factors. The role of psychosocial risk factors in the development of cardiovascular disease has a growing body of literature, and differences in men and women have been identified. The Women's Ischemia Syndrome Evaluation provides insight into psychosocial risk factors in a cohort of women presenting with chest pain who had a comprehensive battery of psychosocial assessments and long-term follow-up. This review focuses on symptom presentation for chest pain and its relationship to cardiovascular disease morbidity and mortality, quality of life, healthcare costs and psychosocial predictor variables, including anxiety, depression, hostility and social networks. In the Women's Ischemia Syndrome Evaluation, persistent chest pain was associated with an increased rate of adverse events and relatively high rates of depression and anxiety, with reduced functional capacity and impaired quality of life, over a median of 6 years of follow-up. More research is needed to better understand the relationships between symptoms and negative emotions and to determine whether psychological (pharmacologic and/or cognitive) interventions might impact both psychological and cardiovascular outcomes. PMID:24007253

  7. A Prospective Study of the Clinical Profile, Outcome and Evaluation of D-dimer in Cerebral Venous Thrombosis

    PubMed Central

    Dharanipragada, Subrahmanyam; Basu, Debdatta; Ananthakrishnan, Ramesh; Surendiran, Deepanjali

    2016-01-01

    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

  8. Oral pristinamycin for the treatment of resistant Gram-positive infections in patients with cancer: Evaluation of clinical outcomes.

    PubMed

    Teng, J C; Lingaratnam, S M; Trubiano, J A; Thursky, K A; Slavin, M A; Worth, L J

    2016-05-01

    Pristinamycin has been used to treat a range of Gram-positive infections, but reported experience in patients with malignancy is limited. This study aimed to evaluate the use of pristinamycin in patients with cancer at an Australian centre. All patients commenced on oral pristinamycin therapy at the Peter MacCallum Cancer Centre between January 2005 and December 2014 were identified using the hospital pharmacy dispensing system. Information on demographics, co-morbidities, cancer diagnosis, infection characteristics, pristinamycin regimen, pristinamycin tolerability and outcomes was collected. The median duration of follow-up was 398 days. In total, 26 patients received pristinamycin, with median age of 61 years and a male predominance (65%). Underlying diagnoses were haematological malignancies (50%) and solid tumours (50%). Pathogens included 13 meticillin-resistant Staphylococcus aureus, 6 vancomycin-resistant Enterococcus faecium, 4 meticillin-resistant Staphylococcus epidermidis, 2 meticillin-susceptible S. aureus and 1 vancomycin-susceptible E. faecium. Infection sites were osteomyelitis (6), skin and soft-tissue (4), intra-abdominal/pelvic abscess (4), bloodstream (3), empyema (3), endocarditis/endovascular (3), prosthesis-related infection (2) and epididymo-orchitis (1). One patient ceased pristinamycin due to nausea. Regarding outcome, 13 patients (50%) were cured of infection, 8 (31%) had suppression and 5 (19%) had relapse. Relapses included 1 endovascular infection, 2 episodes of osteomyelitis, 1 pelvic abscess and 1 skin and soft-tissue infection. Overall, 81% of patients achieved cure or suppression of antibiotic-resistant or complex Gram-positive infections, consistent with published experience in non-cancer populations. A favourable tolerability profile makes oral pristinamycin a viable treatment option, particularly in settings where outpatient management of cancer is the objective. PMID:27089829

  9. National Cancer Patient Registry--a patient registry/clinical database to evaluate the health outcomes of patients undergoing treatment for cancers in Malaysia.

    PubMed

    Lim, G C C; Azura, D

    2008-09-01

    Cancer burden in Malaysia is increasing. Although there have been improvements in cancer treatment, these new therapies may potentially cause an exponential increase in the cost of cancer treatment. Therefore, justification for the use of these treatments is mandated. Availability of local data will enable us to evaluate and compare the outcome of our patients. This will help to support our clinical decision making and local policy, improve access to treatment and improve the provision and delivery of oncology services in Malaysia. The National Cancer Patient Registry was proposed as a database for cancer patients who seek treatment in Malaysia. It will be a valuable tool to provide timely and robust data on the actual setting in oncology practice, safety and cost effectiveness of treatment and most importantly the outcome of these patients. PMID:19230247

  10. Clinical Outcome of Hypertensive Uveitis

    PubMed Central

    Lewkowicz, Deborah; Willermain, François; Relvas, Lia Judice; Makhoul, Dorine; Janssens, Sarah; Janssens, Xavier; Caspers, Laure

    2015-01-01

    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

  11. Clinical outcome of daily dialysis.

    PubMed

    Vos, P F; Zilch, O; Kooistra, M P

    2001-01-01

    Dialysis patients are prone to malnutrition, which may be counteracted by daily home hemodialysis (DHHD, 6 times a week) due to improved clinical outcome and quality of life. Eleven patients were treated with DHHD during 18 months, after a run-in period with three dialysis sessions a week. The total weekly dialysis dose was kept constant during the first 6 months of DHHD, whereupon it was allowed to increase. KT/V was 3.1 +/- 0.5 at baseline, 3.2 +/- 0.5 after 6 months and 4.0 +/- 0.8 at 18 months. Blood pressure decreased from 142 +/- 19/83 +/- 8 to 130 +/- 25/79 +/- 9 mmHg with a more than 50% reduction in antihypertensive medication. Potassium did not change, but potassium binding resins could be stopped almost completely. Bicarbonate increased from 20.6 +/- 3.3 to 23.1 +/- 2.6 mEq/L after 18 months. Patients with a protein intake of less than 1.0 g/kg/d showed a greater increase in body weight (62.3 +/- 6.0 to 65.5 +/- 3.7, P: < 0.05) and normalized protein catabolic rate (nPCR) (0.87 +/- 0.08 to 1.25 +/- 0.36, ns) than patients with acceptable protein intake (>/=1.0 g/kg/d). Phosphate decreased, though not significantly, especially in the latter group. Erythropoietin dose could be reduced from 6400 +/- 5400 U/L at baseline to 5100 +/- 4000 U/L at 18 months. Quality of life improved significantly, especially with to respect to physical condition and mental health. The DHHD markedly improves hemodynamic control and quality of life. Overall nutritional parameters did not change, except cholesterol. Patients with a low protein intake, however, showed a significant increase in body weight, and a greater rise in nPCR. PMID:11158871

  12. The Clinical Outcome Study for dysferlinopathy

    PubMed Central

    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.

    2016-01-01

    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

  13. Do we evaluate outcome appropriately?

    PubMed

    Beristain, X; Gaviria, M; Dujovny, M; Stark, J L; Ausman, J I

    1996-06-01

    We discuss two different ways of measuring outcome in a sample of 20 patients who had intracranial aneurysm surgery. Patients were evaluated at discharge using the Karnofsky Scale and the Glasgow Outcome Scale. Six months after discharge we conducted a neuropsychiatric evaluation including cognitive, behavioral, and mood status assessment. Although 13 of our patients had a "good recovery', 18 had some neuropsychiatric impairment. We did not find statistical relationships between the discharge evaluation and the neuropsychiatric assessment at follow-up. We discuss the need for developing new outcome measures to pick-up neuropsychiatric deficits, beyond the traditional neurologic semiology. PMID:8837062

  14. Client Outcome Evaluation in Mental Health Centers.

    ERIC Educational Resources Information Center

    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…

  15. AlphaCor artificial cornea: clinical outcome

    PubMed Central

    Jirásková, N; Rozsival, P; Burova, M; Kalfertova, M

    2011-01-01

    Purpose The purpose of this study was to describe the long-term results of AlphaCor implantations, and to evaluate the main complications and risk factors. Methods Retrospective analysis of preoperative and follow-up data from 15 AlphaCor implantations. Analysis of outcomes, trends, and associations was performed and compared with data from published clinical trials and a literature review. Results The survival rate of the device at 1, 2, and 3 years was 87%, 58%, and 42%, respectively. Postoperative visual acuity ranged from hand movement to 0.8. The most significant complications were stromal melt (nine cases), optic deposition (three eyes), and retroprosthetic membrane formation (three eyes). The most common device-unrelated complication was trauma (three patients). All complications were managed without loss of the eye. Conclusion AlphaCor provides a treatment option for patients with corneal blindness in which a donor tissue graft would not succeed. PMID:21681219

  16. Thinking About Clinical Outcomes in Medicaid

    PubMed Central

    Weimar, Dawn; Gray, Jeffrey; Davies, Bud

    2016-01-01

    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

  17. Outcome instruments for prosthetics: clinical applications.

    PubMed

    Heinemann, Allen W; Connelly, Lauri; Ehrlich-Jones, Linda; Fatone, Stefania

    2014-02-01

    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. PMID:24287247

  18. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose

    PubMed Central

    Cohen, Stephen; Martin, Anna; Sall, Kenneth

    2014-01-01

    Background The purpose of this study was to compare changes in corneal staining in patients with dry eye after 6 weeks of treatment with Systane® Gel Drops or Refresh Liquigel® lubricant eye drops. Methods Patients aged ≥18 years with a sodium fluorescein corneal staining sum score of ≥3 in either eye and best-corrected visual acuity of 0.6 logarithm of the minimum angle of resolution or better in each eye who were using a lubricant eye gel or ointment for dry eye were included in this randomized, parallel-group, multicenter, double-blind trial. Patients were randomized to four times daily Systane® Gel Drops (polyethylene glycol 400 0.4% and propylene glycol 0.3%) or Refresh LiquiGel® Drops (carboxymethylcellulose sodium 1%) for 6 weeks. The primary efficacy outcome was mean change from baseline to week 6 in sodium fluorescein corneal staining. Supportive efficacy outcomes included conjunctival staining, tear film break-up time, Patient Global Assessment of Improvement, Impact of Dry Eye on Everyday Life (IDEEL) Treatment Satisfaction/Treatment Bother Questionnaire, Single Symptom Comfort Scale, and Ocular Symptoms Questionnaire. The safety analysis comprised recording of adverse events. Results In total, 147 patients (Systane group, n=73; Refresh group, n=74; mean ± standard deviation age, 57±16 years) were enrolled and included in the safety and efficacy analyses. Corneal staining was significantly reduced from baseline to week 6 for Systane and Refresh (−3.4±2.5 and −2.5±2.6 units, respectively; P<0.0001, t-test), with a significantly greater improvement with Systane versus Refresh (P=0.0294). Results for conjunctival staining, tear film break-up time, and patient-reported outcome questionnaires were not statistically different between groups. No safety issues were identified; adverse events were reported by 19% of patients with Systane and 30% of patients with Refresh eye drops. Conclusion Systane Gel Drops were associated with significantly

  19. ARTHROSCOPIC REPAIR OF SMALL AND MEDIUM TEARS OF THE SUPRASPINATUS MUSCLE TENDON: EVALUATION OF THE CLINICAL AND FUNCTIONAL OUTCOMES AFTER TWO YEARS OF FOLLOW-UP

    PubMed Central

    Ikemoto, Roberto Yukio; Murachovsky, Joel; Nascimento, Luís Gustavo Prata; Bueno, Rogério Serpone; Almeida, Luis Henrique; Strose, Eric; Castiglia, Marcello Teixeira

    2015-01-01

    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

  20. Effectiveness of Adalimumab in Non-radiographic Axial Spondyloarthritis: Evaluation of Clinical and Magnetic Resonance Imaging Outcomes in a Monocentric Cohort.

    PubMed

    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

    2015-07-01

    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. PMID:26222847

  1. A phase IIa randomized controlled pilot study evaluating the safety and clinical outcomes following the use of rhGDF-5/β-TCP in regenerative periodontal therapy.

    PubMed

    Windisch, Péter; Stavropoulos, Andreas; Molnár, Bálint; Szendröi-Kiss, Dóra; Szilágyi, Emese; Rosta, Péter; Horváth, Attila; Capsius, Björn; Wikesjö, Ulf M E; Sculean, Anton

    2012-08-01

    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. PMID:21887500

  2. Meniscal allograft transplantation: preoperative assessment, surgical considerations, and clinical outcomes.

    PubMed

    Mascarenhas, Randy; Yanke, Adam B; Frank, Rachel M; Butty, Davietta C; Cole, Brian J

    2014-12-01

    The purpose of this review is to characterize the preoperative assessment of meniscal allograft transplantation (MAT) candidates, to detail MAT surgical techniques, and to evaluate current clinical outcome data on MAT. The MAT candidate is typically less than 50 years old and has a history of knee injury, previous meniscus surgery, and persistent pain. Physical exam generally reveals knee pain with joint line tenderness with normal radiographs and magnetic resonance imaging demonstrating the postmeniscectomized state. There are several common surgical techniques used for transplantation, with fixation achieved through sutures, bony fixation, or a combination of the two. Concomitant procedures such as anterior cruciate ligament reconstruction, osteotomy, and other cartilage procedures are commonly performed. The available short- and long-term studies of clinical outcomes of MAT are variable and difficult to effectively compare due to heterogeneity of the study population and available treatment techniques. In addition, there are no published randomized controlled trials. However, recent reviews and cohort studies of clinical outcomes following MAT have shown that whether performed in isolation or performed with concomitant articular cartilage, realignment, or soft tissue reconstruction procedures MAT outcomes have been acceptable with the majority of studies reporting improved clinical outcomes regardless of the scoring system employed. MAT has proven to be a safe and effective technique in reducing knee pain and improving function in the symptomatic meniscal deficient knee. Evaluation of long-term clinical outcomes is necessary as is evaluation of meniscal replacement alternatives. PMID:24951950

  3. Single-blind randomized clinical trial to evaluate clinical and radiological outcomes after one year of immediate versus delayed implant placement supporting full-arch prostheses

    PubMed Central

    Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio J.; Canullo, Luigi

    2014-01-01

    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

  4. Early Radiographic and Clinical Outcomes Study Evaluating an Integrated Screw and Interbody Spacer for One- and Two-Level ACDF

    PubMed Central

    Lane, Paul D.; Cox, Jacob L.; Gaskins, Roger B.; Billys, James B.; Castellvi, Antonio E.

    2015-01-01

    Background Multiple techniques and implants can be used in ACDF, the newest of which are integrated cage and screw constructs. These devices may be beneficial over anterior plate constructs due to a negligible anterior profile that may reduce dysphagia. The goal of this study is to review the early radiographical and clinical results associated with a low profile integrated intervertebral cage in one- and two-level anterior column fusions. Methods Fusion rates, incidence of hardware failure and deformity correction were assessed through 1 year. Patientreported scores, including VAS for neck pain, and improvements in axial neck pain and neurologic deficit from the preoperative baseline were quantified at 3, 6 and 12 months post-operatively. The incidence of dysphagia was recorded. Results Lordosis and disc space height at the operated levels increased an average of 4.5° and 3.3mm after device placement (p<0.001). Sagittal plane correction was maintained at 1 year. VAS improved from an average of 5.1 preoperatively to 3.1 immediately postoperatively and was maintained at 12 months. At 3 months, patient-reported improvements in axial neck pain and neurologic deficit were 85% and 93%, respectively. Reported improvements were sustained for both parameters at 12 months (77% and 86%, respectively). Fusion was noted in 93% of the operated levels. There were two documented cases of dysphagia that lasted more than 5 weeks, both following two level ACDFs with the test device (3.5% rate of chronic dysphagia). Conclusions The low profile integrated device improved lordosis at the operated level that was maintained at 1 year. Fusion rates with the new device are consistent with ACDF using anterior plating. In combination with improvements in pain and a minimal rate of dysphagia, study findings support the use of integrated interbody spacers for use in one- and two-level ACDF procedures. Level of Evidence Level IV, Case Series. PMID:26273557

  5. Predicting Clinical Outcomes Using Molecular Biomarkers

    PubMed Central

    Burke, Harry B.

    2016-01-01

    Over the past 20 years, there has been an exponential increase in the number of biomarkers. At the last count, there were 768,259 papers indexed in PubMed.gov directly related to biomarkers. Although many of these papers claim to report clinically useful molecular biomarkers, embarrassingly few are currently in clinical use. It is suggested that a failure to properly understand, clinically assess, and utilize molecular biomarkers has prevented their widespread adoption in treatment, in comparative benefit analyses, and their integration into individualized patient outcome predictions for clinical decision-making and therapy. A straightforward, general approach to understanding how to predict clinical outcomes using risk, diagnostic, and prognostic molecular biomarkers is presented. In the future, molecular biomarkers will drive advances in risk, diagnosis, and prognosis, they will be the targets of powerful molecular therapies, and they will individualize and optimize therapy. Furthermore, clinical predictions based on molecular biomarkers will be displayed on the clinician’s screen during the physician–patient interaction, they will be an integral part of physician–patient-shared decision-making, and they will improve clinical care and patient outcomes. PMID:27279751

  6. Cross-site evaluation of the Alliance to Reduce Disparities in Diabetes: clinical and patient-reported outcomes.

    PubMed

    Lewis, Megan A; Bann, Carla M; Karns, Shawn A; Hobbs, Connie L; Holt, Sidney; Brenner, Jeff; Fleming, Neil; Johnson, Patria; Langwell, Kathryn; Peek, Monica E; Burton, Joseph A; Hoerger, Thomas J; Clark, Noreen M; Kamerow, Douglas B

    2014-11-01

    Alliance programs implemented multilevel, multicomponent programs inspired by the chronic care model and aimed at reducing health and health care disparities for program participants. A unique characteristic of the Alliance programs is that they did not use a fixed implementation strategy common to programs using the chronic care model but instead focused on strategies that met local community needs. Using data provided by the five programs involved in the Alliance, this evaluation shows that of the 1,827 participants for which baseline and follow-up data were available, the program participants experienced significant decreases in hemoglobin A1c and blood pressure compared with a comparison group. A significant time by study group interaction was observed for hemoglobin A1c as well. Over time, more program participants met quality indicators for hemoglobin A1c and blood pressure. Those participants who attended self-management classes and experienced more resources and support for self-management attained more benefit. In addition, program participants experienced more diabetes competence, increased quality of life, and improvements in diabetes self-care behaviors. The cost-effectiveness of programs ranged from $23,161 to $61,011 per quality-adjusted life year. In sum, the Alliance programs reduced disparities and health care disparities for program participants. PMID:25359255

  7. Cross-Site Evaluation of the Alliance to Reduce Disparities in Diabetes: Clinical and Patient-Reported Outcomes

    PubMed Central

    Lewis, Megan A.; Bann, Carla M.; Karns, Shawn A.; Hobbs, Connie L.; Holt, Sidney; Brenner, Jeff; Fleming, Neil; Johnson, Patria; Langwell, Kathryn; Peek, Monica E.; Burton, Joseph A.; Hoerger, Thomas J.; Clark, Noreen M.; Kamerow, Douglas B.

    2015-01-01

    Alliance programs implemented multilevel, multicomponent programs inspired by the chronic care model and aimed at reducing health and health care disparities for program participants. A unique characteristic of the Alliance programs is that they did not use a fixed implementation strategy common to programs using the chronic care model but instead focused on strategies that met local community needs. Using data provided by the five programs involved in the Alliance, this evaluation shows that of the 1,827 participants for which baseline and follow-up data were available, the program participants experienced significant decreases in hemoglobin A1c and blood pressure compared with a comparison group. A significant time by study group interaction was observed for hemoglobin A1c as well. Over time, more program participants met quality indicators for hemoglobin A1c and blood pressure. Those participants who attended self-management classes and experienced more resources and support for self-management attained more benefit. In addition, program participants experienced more diabetes competence, increased quality of life, and improvements in diabetes self-care behaviors. The cost-effectiveness of programs ranged from $23,161 to $61,011 per quality-adjusted life year. In sum, the Alliance programs reduced disparities and health care disparities for program participants. PMID:25359255

  8. Computational Algorithm-Driven Evaluation of Monocytic Myeloid-Derived Suppressor Cell Frequency For Prediction of Clinical Outcomes

    PubMed Central

    Kitano, Shigehisa; Postow, Michael A.; Ziegler, Carly G.K.; Kuk, Deborah; Panageas, Katherine S.; Cortez, Czrina; Rasalan, Teresa; Adamow, Mathew; Yuan, Jianda; Wong, Philip; Altan-Bonnet, Gregoire; Wolchok, Jedd D.; Lesokhin, Alexander M.

    2014-01-01

    Evaluation of myeloid-derived suppressor cells (MDSC), a cell type implicated in T-cell suppression, may inform immune status. However, a uniform methodology is necessary for prospective testing as a biomarker. We report the use of a computational algorithm-driven analysis of whole blood and cryopreserved samples for monocytic MDSC (m-MDSC) quantity that removes variables related to blood processing and user definitions. Applying these methods to samples from melanoma patients identifies differing frequency distribution of m-MDSC relative to that in healthy donors (HD). Patients with a pre-treatment m-MDSC frequency outside a preliminary definition of HD range (<14.9%) were significantly more likely to achieve prolonged overall survival following treatment with ipilimumab, an antibody that promotes T-cell activation and proliferation. m-MDSC frequencies inversely correlated with peripheral CD8+ T-cell expansion following ipilimumab. Algorithm-driven analysis may enable not only development of a novel pre-treatment biomarker for ipilimumab therapy, but also prospective validation of peripheral blood m-MDSC as a biomarker in multiple disease settings. PMID:24844912

  9. Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination

    PubMed Central

    Williams, Rebecca J.; Tse, Tony; DiPiazza, Katelyn; Zarin, Deborah A.

    2015-01-01

    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

  10. Evaluation of Counseling Outcomes at a University Counseling Center: The Impact of Clinically Significant Change on Problem Resolution and Academic Functioning

    ERIC Educational Resources Information Center

    Choi, Keum-Hyeong; Buskey, Wendy; Johnson, Bonita

    2010-01-01

    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…

  11. Outpatient preanaesthesia evaluation clinics.

    PubMed

    Lew, E; Pavlin, D J; Amundsen, L

    2004-11-01

    In recent years, there has been a paradigm shift from an inpatient to outpatient preanaesthesia evaluation. This has been driven by rising healthcare costs and the increasing popularity of ambulatory and same-day admission surgery. These outpatient preanaesthesia clinics play an important role in enhancing the cost-effectiveness of the perioperative process. This review describes the structure of modern outpatient preanaesthesia evaluation clinics, and the associated benefits, limitations and controversies. PMID:15510321

  12. A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.

    PubMed

    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

    2015-01-01

    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. PMID:25924999

  13. Urgent discectomy: Clinical features and neurological outcome

    PubMed Central

    Albert, Ruth; Lange, Max; Brawanski, Alexander; Schebesch, Karl-Michael

    2016-01-01

    Background: To evaluate the clinical features and outcome of patients with progressive neurological deficits due to disc herniation who were treated surgically within 24 h. Methods: We conducted a retrospective analysis of consecutive patients who were admitted between 2004 and 2013 via the Emergency Department. Records were screened for presenting symptoms, neurological status at admission, discharge, and 6-week follow-up. Results: About 72 of 526 patients underwent surgery within 24 h. Magnetic resonance imaging showed lumbar disc herniation in 72 patients. The most common presenting symptoms included radiculopathy (n = 69), the Lasègue sign (n = 60), sensory deficits (n = 57), or motor deficits (n = 47). In addition, 11 patients experienced perineal numbness and 12 had bowel and bladder dysfunction. At discharge, motor and sensory deficits and bowel and bladder dysfunction had improved significantly (P < 0.001, P = 0.029, and P = 0.015, respectively). Conclusion: Motor deficits, sensory deficits, and cauda equina dysfunction were significantly improved immediately after urgent surgery. After 6 weeks, motor and sensory deficits were also significantly improved compared to the neurological status at discharge. Thus, we advocate immediate surgery of disc herniation in patients with acute onset of motor deficits, perineal numbness, or bladder or bowel dysfunction indicative of cauda equina syndrome. PMID:26958423

  14. Clinical outcome measures for Cutaneous Lupus Erythematosus

    PubMed Central

    Albrecht, Joerg; Werth, Victoria P.

    2011-01-01

    Cutaneous lupus erythematosus is a clinically heterogeneous group of rare skin diseases that only rarely have been subjected to controlled clinical trials. This may be have been partly due to a lack of suitable validated outcome instruments. Recently the FDA mandated that organ specific trials for lupus erythematosus need to use a combination of different outcome measures. The patient’s condition needs to be assessed in terms of quality of life, the patient’s global response and organ specific instruments that measure activity of the disease as well as damage due to the disease. For the skin the only formally validated and published instrument is currently the Cutaneous Lupus Erythematosis Disease Area and Severity Index (CLASI). This paper discusses the background of the development of the CLASI as well as issues related to its use and interpretation in the context of clinical research of CLE. PMID:20693208

  15. Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications.

    PubMed

    Vavken, Patrick; Ganal-Antonio, Anne Kathleen B; Quidde, Julia; Shen, Francis H; Chapman, Jens R; Samartzis, Dino

    2015-08-01

    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

  16. Clinical outcomes for Conduits and Scaffolds in peripheral nerve repair

    PubMed Central

    Gerth, David J; Tashiro, Jun; Thaller, Seth R

    2015-01-01

    The gold standard of peripheral nerve repair is nerve autograft when tensionless repair is not possible. Use of nerve autograft has several shortcomings, however. These include limited availability of donor tissue, sacrifice of a functional nerve, and possible neuroma formation. In order to address these deficiencies, researchers have developed a variety of biomaterials available for repair of peripheral nerve gaps. We review the clinical studies published in the English literature detailing outcomes and reconstructive options. Regardless of the material used or the type of nerve repaired, outcomes are generally similar to nerve autograft in gaps less than 3 cm. New biomaterials currently under preclinical evaluation may provide improvements in outcomes. PMID:25685760

  17. Cervical Scoliosis: Clinical and Radiographic Outcomes.

    PubMed

    Mesfin, Addisu; Bakhsh, Wajeeh R; Chuntarapas, Tapanut; Riew, K Daniel

    2016-02-01

    Study Design Retrospective study. Objective Cervical scoliosis is a rare condition that can arise from various etiologies. Few reports on the surgical management of cervical scoliosis exist. Our objective was to evaluate clinical and radiographic outcomes following surgical management of cervical scoliosis. Methods We evaluated our cervical spine surgical database for patients with cervical scoliosis (Cobb angle > 10 degrees) from 2005 to 2010. Demographic data including age, gender, diagnoses, and primary versus revision surgery was collected. Surgical data including procedure (anterior versus posterior), estimated blood loss (EBL), length of surgery, length of hospitalization, and complications was recorded. Preoperative and postoperative Cobb angle measurements and Neck Disability Index (NDI) scores were recorded. Results Cervical scoliosis was identified in 18 patients. We excluded 5, leaving 5 men and 8 women with an average age of 50.7 (median 52, range 25 to 65). The average follow-up was 40 months (median 36.5, range 5 to 87). An anterior-only approach was used in 6 cases (average 4 levels fused), 5 cases were posterior-only approach (average 8.7 levels fused), and 2 cases were combined anterior-posterior approach. The EBL was an average of 286 mL (median 150, range 50 to 900), the average surgical time was 266 minutes (median 239, range 136 to 508), and the average hospital stay was 2.7 days (median 2, range 1 to 7). Complications occurred in 7 patients, and 2 developed adjacent segment pathology. The average coronal Cobb angle preoperatively was 35.1 degrees (median 31, range 13 to 63) and corrected was 15.7 degrees (median 10.5, range 2 to 59) postoperatively (p < 0.005). The average NDI preoperatively was 24.9 (median 26, range 6 to 37) and was reduced to 17.8 (median 18, range 7 to 30) postoperatively (p < 0.02). Conclusion Surgical management of cervical scoliosis can result in deformity correction and improvement in patient

  18. Cervical Scoliosis: Clinical and Radiographic Outcomes

    PubMed Central

    Mesfin, Addisu; Bakhsh, Wajeeh R.; Chuntarapas, Tapanut; Riew, K. Daniel

    2015-01-01

    Study Design Retrospective study. Objective Cervical scoliosis is a rare condition that can arise from various etiologies. Few reports on the surgical management of cervical scoliosis exist. Our objective was to evaluate clinical and radiographic outcomes following surgical management of cervical scoliosis. Methods We evaluated our cervical spine surgical database for patients with cervical scoliosis (Cobb angle > 10 degrees) from 2005 to 2010. Demographic data including age, gender, diagnoses, and primary versus revision surgery was collected. Surgical data including procedure (anterior versus posterior), estimated blood loss (EBL), length of surgery, length of hospitalization, and complications was recorded. Preoperative and postoperative Cobb angle measurements and Neck Disability Index (NDI) scores were recorded. Results Cervical scoliosis was identified in 18 patients. We excluded 5, leaving 5 men and 8 women with an average age of 50.7 (median 52, range 25 to 65). The average follow-up was 40 months (median 36.5, range 5 to 87). An anterior-only approach was used in 6 cases (average 4 levels fused), 5 cases were posterior-only approach (average 8.7 levels fused), and 2 cases were combined anterior-posterior approach. The EBL was an average of 286 mL (median 150, range 50 to 900), the average surgical time was 266 minutes (median 239, range 136 to 508), and the average hospital stay was 2.7 days (median 2, range 1 to 7). Complications occurred in 7 patients, and 2 developed adjacent segment pathology. The average coronal Cobb angle preoperatively was 35.1 degrees (median 31, range 13 to 63) and corrected was 15.7 degrees (median 10.5, range 2 to 59) postoperatively (p < 0.005). The average NDI preoperatively was 24.9 (median 26, range 6 to 37) and was reduced to 17.8 (median 18, range 7 to 30) postoperatively (p < 0.02). Conclusion Surgical management of cervical scoliosis can result in deformity correction and improvement in patient

  19. Clinical predictors of outcome in encephalitis.

    PubMed Central

    Kennedy, C R; Duffy, S W; Smith, R; Robinson, R O

    1987-01-01

    Twenty five patients with encephalitis were studied prospectively, and their clinical and virological features compared with outcome. Among 22 patients with laboratory confirmation of virus infection, evidence of direct effect on the central nervous system by the virus occurred significantly more often both in those with a monophasic illness compared with those with a biphasic illness, and in those with focal neurological signs localising in the cerebral hemispheres compared with those without such signs. Young age at presentation, low score on the Glasgow coma scale, disruption of oculocephalic responses, and laboratory evidence of virus infection within the central nervous system were significantly associated with poor outcome. Computed tomography results, concentrations of creatine phosphokinase BB isoenzyme in cerebrospinal fluid, and procoagulant activity in cerebrospinal fluid were not predictive of outcome. PMID:3688920

  20. Clinical Outcomes after Traumatic Brain Injury.

    PubMed

    Sandsmark, Danielle K

    2016-06-01

    Traumatic brain injury (TBI) is a major cause of death and disability that often affects young people. After injury, the degree of recovery can be highly variable, with some people regaining near complete function while others remain severely disabled. Understanding what factors influence recovery is important for counseling patients and families in the acute period after injury and can help guide therapeutic decisions in the acute period following injury. In this review, prognostic algorithms useful for clinicians are discussed. Tools for grading patient outcomes, their role in clinical care and research studies, and their limitations are reviewed. Ongoing work focusing on the development of biomarkers to track TBI recovery and the refinement of clinical outcome metrics is summarized. PMID:27072952

  1. Clinical Outcomes After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Tibor, Lisa M.; Long, Joy L.; Schilling, Peter L.; Lilly, Ryan J.; Carpenter, James E.; Miller, Bruce S.

    2010-01-01

    Background: Clinical outcomes of autograft and allograft anterior cruciate ligament (ACL) reconstructions are mixed, with some reports of excellent to good outcomes and other reports of early graft failure or significant donor site morbidity. Objective: To determine if there is a difference in functional outcomes, failure rates, and stability between autograft and allograft ACL reconstructions. Data Sources: Medline, Cochrane Central Register of Controlled Trials (Evidence Based Medicine Reviews Collection), Cochrane Database of Systematic Reviews, Web of Science, CINAHL, and SPORTDiscus were searched for articles on ACL reconstruction. Abstracts from annual meetings of the American Academy of Orthopaedic Surgeons, American Orthopaedic Society for Sports Medicine, and Arthroscopy Association of North America were searched for relevant studies. Study Selection: Inclusion criteria for studies were as follows: primary unilateral ACL injuries, mean patient age less than 41 years, and follow-up for at least 24 months postreconstruction. Exclusion criteria for studies included the following: skeletally immature patients, multiligament injuries, and publication dates before 1990. Data Extraction: Joint stability measures included Lachman test, pivot-shift test, KT-1000 arthrometer assessment, and frequency of graft failures. Functional outcome measures included Tegner activity scores, Cincinnati knee scores, Lysholm scores, and IKDC (International Knee Documentation Committee) total scores. Results: More than 5000 studies were identified. After full text review of 576 studies, 56 were included, of which only 1 directly compared autograft and allograft reconstruction. Allograft ACL reconstructions were more lax when assessed by the KT-1000 arthrometer. For all other outcome measures, there was no statistically significant difference between autograft and allograft ACL reconstruction. For all outcome measures, there was strong evidence of statistical heterogeneity between

  2. An Integral Approach to Evaluating Outcome Evaluation Training.

    ERIC Educational Resources Information Center

    Brown, Robert E.; Reed, Celeste Sturdevant

    2002-01-01

    Presents an integral, developmental approach to evaluating outcome evaluation training that links individual and collective attributes. Illustrates this framework with examples from Check Points, an outcome evaluation training program of Michigan State University and the United Way of Michigan. (SLD)

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

    PubMed

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

    2016-04-01

    The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). PMID:26677937

  4. Low-frequency rTMS in patients with subacute ischemic stroke: clinical evaluation of short and long-term outcomes and neurophysiological assessment of cortical excitability

    PubMed Central

    Blesneag, AV; Slăvoacă, DF; Popa, L; Stan, AD; Jemna, N; Isai Moldovan, F; Mureșanu, DF

    2015-01-01

    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

  5. Early clinical outcomes following laparoscopic inguinal hernia repair.

    PubMed

    Tolver, Mette Astrup

    2013-07-01

    Laparoscopic inguinal hernia repair (TAPP) has gained increasing popularity because of less post-operative pain and a shorter duration of convalescence compared with open hernia repair technique (Lichtenstein). However, investigation of duration of convalescence with non-restrictive recommendations, and a procedure-specific characterization of the early clinical outcomes after TAPP was lacking. Furthermore, optimization of the post-operative period with fibrin sealant versus tacks for fixation of mesh, and the glucocorticoid dexamethasone versus placebo needed to be investigated in randomized clinical trials. The objective of this PhD thesis was to characterize the early clinical outcomes after TAPP and optimize the post-operative period. The four studies included in this thesis have investigated duration of convalescence and procedure-specific post-operative pain and other early clinical outcomes after TAPP. Furthermore, it has been shown that fibrin sealant can improve the early post-operative period compared with tacks, while dexamethasone showed no advantages apart from reduced use of antiemetics compared with placebo. Based on these findings, and the existing knowledge, 3-5 days of convalescence should be expected when 1 day of convalescence is recommended and future studies should focus on reducing intraabdominal pain after TAPP. Fibrin sealant can optimize the early clinical outcomes but the risk of hernia recurrence and chronic pain needs to be evaluated. Dexamethasone should be investigated in higher doses. PMID:23809977

  6. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    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.

    2016-01-01

    (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.

  7. Multisystemic Therapy(®) : Clinical Overview, Outcomes, and Implementation Research.

    PubMed

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

    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. PMID:27370172

  8. The role of computed tomography in evaluating body composition and the influence of reduced muscle mass on clinical outcome in abdominal malignancy: a systematic review.

    PubMed

    Gibson, D J; Burden, S T; Strauss, B J; Todd, C; Lal, S

    2015-10-01

    It is estimated that there were 3.45 million new cases and 1.75 million deaths from cancer in Europe in 2012. Colorectal cancer was one of the most common cancers, accounting for 13% of new cases and 12.2% of all deaths. Conditions causing reduced muscle mass, such as sarcopenia, can increase the morbidity and mortality of people with cancer. Computed tomography (CT) scans can provide accurate, high-quality information on body composition, including muscle mass. To date, there has been no systematic review on the role of CT scans in identifying sarcopenia in abdominal cancer. This review aimed to examine the role of CT scans in determining the influence of reduced muscle mass on clinical outcome in abdominal cancer. A systematic review of English-language articles published in 2000 or later was conducted. Articles included cohort, randomised controlled trials and validation studies. Participants were people diagnosed with abdominal cancer who had undergone a CT scan. Data extraction and critical appraisal were undertaken. Ten cohort studies met the inclusion criteria. Seven studies demonstrated that low muscle mass was significantly associated with poor clinical outcome, with six specifically demonstrating reduced survival rates. Eight studies demonstrated that a greater number of patients (27.3-66.7%) were identified as sarcopenic using CT scans compared with numbers identified as malnourished using body mass index. CT scans can identify reduced muscle mass and predict negative cancer outcomes in people with abdominal malignancies, where traditional methods of assessment are less effective. PMID:25782424

  9. Creating clinical trial designs that incorporate clinical outcome assessments.

    PubMed

    Gilbert, Mark R; Rubinstein, Lawrence; Lesser, Glenn

    2016-03-01

    Clinical outcome assessments (COAs) are increasingly being used in determining the efficacy of new treatment regimens. This was typified in the recent use of a symptom-based instrument combined with an organ-based measure of response for the approval of ruxolitinib in myelofibrosis. There are challenges in incorporating these COAs into clinical trials, including designating the level of priority, incorporating these measures into a combined or composite endpoint, and dealing with issues related to compliance and interpretation of results accounting for missing data. This article describes the results of a recent panel discussion that attempted to address these issues and provide guidance to the incorporation of COAs into clinical trials, including novel statistical designs, so that the testing of new treatments in patients with cancers of the central nervous system can incorporate these important clinical endpoints. PMID:26989129

  10. Impact of Remote Monitoring on Clinical Outcomes.

    PubMed

    Varma, Niraj; Ricci, Renato Pietro

    2015-12-01

    Follow-up of patients with cardiac implantable electronic devices is challenging due to both their increasing volume and technical complexity coupled to increasing clinical complexity of recipient patients. Remote monitoring (RM) offers an opportunity to resolve some of these difficulties by improving clinic efficiencies and providing a mechanism for device monitoring and patient management. Several recent randomized clinical trials and registries have demonstrated that RM may reduce in-hospital visit numbers, time required for patient follow-up, physician and nurse time, and hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events, such as atrial fibrillation, ventricular arrhythmias, and heart failure suitable for clinical intervention. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. New organizational models promote significant efficiencies regarding physician and nursing time. Data management techniques are under development. Despite these demonstrable advantages of RM, adoption still remains modest, even in health care systems incentivized to use this follow-up method. PMID:26337400

  11. Correlation of Reconstructed Scaphoid Morphology with Clinical Outcomes

    PubMed Central

    Afshar, Ahmadreza; Mohammadi, Afshin; Zohrabi, Kian; Navaeifar, Nasrin; Sami, Sam H.; Taleb, Hassan

    2015-01-01

    Background: Scaphoid malunion alters the carpal kinematics and impairs clinical outcome because of pain, weakness, restricted range of motion and predisposing the wrist joint to early osteoarthritis. The aim of this study was to evaluate the influence of the scaphoid morphological angles on clinical outcomes in patients with reconstructed scaphoid by non-vascularized bone graft. Methods: Seventeen male patients with the mean age of 31.7±3.7 years and mean non-union time of 31.5±14.7 months were enrolled in this retrospective study. Average follow up was 48.8±9.4 months. At the last follow-up, the patients were evaluated clinically for pain, wrist range of motion, grip strength, and wrist functional status. They were also evaluated radiologically by wrist radiographs and computerized tomography (CT). The overall clinical outcomes were evaluated by the Cooney wrist function score. The morphology of the reconstructed scaphoids was evaluated by the lateral intrascaphoid angle, antroposterior intrascaphoid angle, dorsal cortical angle, measuring the length (mm), and height-to-length ratio on CT scan. The radiological measurements were compared against the overall clinical outcomes. Results: There were 7 excellent, 7 good, 3 fair clinical results. The mean Cooney wrist function score was 83±4. The mean lateral intrascaphoid angle was 34.8±1.4 degrees, mean antroposterior intrascaphoid angle was 33.4±2.2 degrees, mean dorsal cortical angle was 158.3±4.8 degrees, mean scaphoid length was 22.1± 0.7 mm, and mean scaphoid height-to-length ratio was 0.74±0.04. There were no significant statistical correlations between the lateral intrascaphoid angles, antroposterior intrascaphoid angles, dorsal cortical angles, scaphoid lengths and scaphoid height-to-length ratios and Cooney wrist scores in the patients. Conclusion: In the current study, all the patients had some degree of scaphoid malunion; however, the radiological measurements of the reconstructed scaphoids did not

  12. Novel Outcome Measures for Clinical Trials in Cystic Fibrosis

    PubMed Central

    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

    2015-01-01

    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

  13. Correlation of Clinical Outcomes with β-Glucan Levels in Patients with Invasive Candidiasis

    PubMed Central

    Sims, Charles R.; Mohr, John; Rodriguez, Jose; Finkelman, Malcolm; Ostrosky-Zeichner, Luis

    2012-01-01

    The correlation of β-glucan (BG) levels with clinical outcomes in invasive candidiasis (IC) remains unknown. Patients with proven IC were followed prospectively from diagnosis to outcome with twice-weekly serum BG sampling. Correlation of BG with clinical outcome was assessed in each patient. BG levels tend to decrease in successfully treated patients and increase in treatment failures. BG levels may be useful as surrogates for outcome evaluation of IC. PMID:22461680

  14. Pediatric multiple sclerosis: Clinical features and outcome.

    PubMed

    Waldman, Amy; Ness, Jayne; Pohl, Daniela; Simone, Isabella Laura; Anlar, Banu; Amato, Maria Pia; Ghezzi, Angelo

    2016-08-30

    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. PMID:27572865

  15. The Evaluation of Outcome in Schizophrenia.

    ERIC Educational Resources Information Center

    Strauss, John S.; Carpenter, William T., Jr.

    Understanding outcome in schizophrenia is important for choosing among the competing concepts of this disorder and for evaluation of treatment methods. Nevertheless, there is much disagreement and confusion about the nature of outcome in schizophrenia. This report describes features of diagnosis and outcome that contribute to this confusion and…

  16. Clinical outcomes of acute myocarditis in childhood

    PubMed Central

    Lee, K; McCrindle, B; Bohn, D; Wilson, G; Taylor, G; Freedom, R; Smallhorn, J; Benson, L

    1999-01-01

    OBJECTIVE—To describe clinical outcomes of a paediatric population with histologically confirmed lymphocytic myocarditis.
DESIGN—A retrospective review between November 1984 and February 1998.
SETTING—A major paediatric tertiary care hospital.
PATIENTS—36 patients with histologically confirmed lymphocytic myocarditis.
MAIN OUTCOME MEASURES—Survival, cardiac transplantation, recovery of ventricular function, and persistence of dysrhythmias.
RESULTS—Freedom from death or cardiac transplantation was 86% at one month and 79% after two years. Five deaths occurred within 72 hours of admission, and one late death at 1.9 years. Extracorporeal membrane oxygenation support was used in four patients, and three patients underwent heart replacement. 34 patients were treated with intravenous corticosteroids. In the survivor/non-cardiac transplantation group (n = 29), the median follow up was 19 months (range 1.2-131.6 months), and the median period for recovery of a left ventricular ejection fraction to > 55% was 2.8 months (range 0-28 months). The mean (SD) final left ventricular ejection and shortening fractions were 66 (9)% and 34 (8)%, respectively. Two patients had residual ventricular dysfunction. No patient required antiarrhythmic treatment. All survivors reported no cardiac symptoms or restrictions in physical activity.
CONCLUSIONS—Our experience documents good outcomes in paediatric patients presenting with acute heart failure secondary to acute lymphocytic myocarditis treated with immunosuppression. Excellent survival and recovery of ventricular function, with the absence of significant arrhythmias, continued cardiac medications, or restrictions in physical activity were the normal outcomes.


Keywords: myocarditis; paediatric cardiology; immunosuppression PMID:10409542

  17. Outcome Evaluation in Supervision Research.

    ERIC Educational Resources Information Center

    Holloway, Elizabeth L.

    1984-01-01

    Presents a framework of different sources of outcome data in supervision, and classifies research according to this framework. Challenges assumptions of previous research in supervision. Emphasizes influences of trainee and client in supervision and counseling contexts, respectively. Supports broader definition and expanded view of outcome in…

  18. [Cardiovascular outcome clinical trials in type 2 diabetes mellitus: what are the epidemiological and methodological evidence and the first evaluations to date?].

    PubMed

    Fiorentino, Teresa Vanessa; Sesti, Giorgio

    2016-03-01

    Clinical trials of glucose-lowering strategies in patients with type 2 diabetes mellitus (T2DM) have shown a favorable effect of intensive glycemic control on microvascular complications but failed to show a clear benefit on cardiovascular events. In 2008, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have required stringent criteria to approve new glucose-lowering drugs, demanding proof of cardiovascular safety. As a result of these regulatory requirements, a number of cardiovascular outcome trials in T2DM have been conducted examining the cardiovascular safety of novel glucose-lowering drugs. Dipeptidyl peptidase 4 (DPP4) inhibitors, analogs of glucagon-like peptide 1 (GLP-1), and inhibitors of the renal sodium-glucose linked transporter-2 (SGLT2) are new classes of glucose-lowering drugs for subjects with T2DM. The results of the cardiovascular outcome trials comparing the DPP4 inhibitors saxagliptin, alogliptin, and sitagliptin or the GLP-1 analog lixisenatide to placebo have demonstrated that these drugs are safe. The results of a cardiovascular outcome trial comparing the SGLT2 inhibitor empagliflozin to placebo have been published. Notably, empagliflozin treatment has been associated with a significant reduction in the primary composite cardiovascular outcome. Although the question regarding the positive effect of glycemic control on cardiovascular risk is still unanswered, current evidence suggests that a multifactorial approach aimed at treating not only hyperglycemia but also classical cardiovascular risk factors is necessary in order to reduce the risk of cardiovascular events in patients with T2DM. PMID:27030121

  19. Outcomes Evaluation: A Model for the Future.

    ERIC Educational Resources Information Center

    Blasi, John F.; Davis, Barbara S.

    1986-01-01

    Examines issues and problems related to the measurement of community college outcomes in relation to mission and goals. Presents a model for outcomes evaluation at the community college which derives from the mission statement and provides evaluative comment and comparison with institutional and national norms. (DMM)

  20. Further Evaluation of the Outcome Questionnaire-45.2

    ERIC Educational Resources Information Center

    Rice, Kenneth G.; Suh, Hanna; Ege, Engin

    2014-01-01

    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…

  1. Endoscopic ultrasonic dacryocystorhinostomy: clinical profile and outcomes.

    PubMed

    Ali, Mohammad Javed; Singh, Manpreet; Chisty, Naja; Kamal, Saurabh; Naik, Milind N

    2016-07-01

    Ultrasonic endoscopic dacryocystorhinostomy (UEnDCR) is emerging alternative modality of managing nasolacrimal duct obstructions. The aim of this study was to report the clinical profile and outcomes with a UEnDCR with mitomycin C and silicone intubation. Prospective interventional case series performed on all consecutive patients undergoing an ultrasonic endoscopic dacryocystorhinostomy over a 1-year period from September 2013 to October 2014. All surgeries were performed by a single surgeon (MJA). Data collected include demographics, presentation, indications for surgery, past interventions, intraoperative and post-operative complications and outcomes. The main outcome measures were anatomical and functional success of the surgery. 44 procedures were performed in 41 patients. The mean age was 31.6 years. Children with complex congenital nasolacrimal duct obstructions refractory to probing and intubation accounted for 17 % (7/41) of the cohort. Past history of acute dacryocystitis was noted in 35.6 % (15/41). Two patients (4.9 %, 2/41) had failed external DCR. A minimal follow-up of 6 months following surgery was taken for final analysis. Complications included intraoperative focal epithelial burn in one patient that healed spontaneously and post-operative ostium granulomas in 15.9 % (7/44) of the ostia. At the 6-month follow-up, anatomical and functional successes were noted in 93.1 % (41/44) and 88.6 % (39/44), respectively. Ultrasonic dacryocystorhinostomy is a safe and effective alternative modality in the management of nasolacrimal duct obstructions in pediatric and adult age groups. Setup was easy and no additional technical difficulties were observed. PMID:26530294

  2. Clinical characteristics and outcomes in biclonal gammopathies.

    PubMed

    Mullikin, Trey C; Rajkumar, S Vincent; Dispenzieri, Angela; Buadi, Francis K; Lacy, Martha Q; Lin, Yi; Dingli, David; Go, Ronald S; Hayman, Suzanne R; Zeldenrust, Steven R; Russell, Stephen J; Lust, John A; Leung, Nelson; Kapoor, Prashant; Kyle, Robert A; Gertz, Morie A; Kumar, Shaji K

    2016-05-01

    A single monoclonal protein typically characterizes monoclonal gammopathies, but a small proportion may have more than one M protein identifiable. In the setting of symptomatic multiple myeloma (MM), the development of a new monoclonal protein following therapy is associated with better outcomes. As for the precursor conditions, monoclonal gammopathy undetermined significance (MGUS) and smoldering multiple myeloma (SMM), there is limited information on the impact of a second monoclonal protein on the disease course, including progression and response to treatment. The outcomes of patients with MGUS and SMM with more than one monoclonal protein, after identifying 539 patients with biclonal proteins on electrophoresis and/or immunofixation, were reported. About 22 of 393 patients with MGUS/biclonal gammopathy of undetermined significance (BGUS) progressed to SMM (6), MM (11), AL (3), or WM (2), and 5 of 16 patients with biclonal SMM progressed to MM. The rate of progression for BGUS was approximately 1% per year, which is similar to MGUS with one monoclonal protein. The median estimated time of progression of biclonal SMM was 2.6 years; similar to monoclonal SMM. For patients with biclonal MM, both M spikes responded to treatment and, upon relapse, the original dominant M protein remained dominant as the disease progressed. In conclusion, the presence of a second monoclonal protein does not appear to affect the progression of precursor states and suggests multiple monoclonal proteins do not clinically impact one another in the course of the disease. PMID:26840395

  3. The clinical outcome of scaphoid fracture malunion at 1 year.

    PubMed

    Forward, D P; Singh, H P; Dawson, S; Davis, T R C

    2009-02-01

    The aim of this study was to assess the effect of malunion of scaphoid fractures on the clinical outcome at 1 year. Forty-two consecutive patients with united scaphoid waist fractures which had been treated non-operatively underwent longitudinal CT scans to confirm union and assess malunion at 12 to 18 weeks after injury. A blind clinical assessment was made and the Patient Evaluation Measure (PEM) and DASH questionnaires were completed by all the patients 1 year after injury. The group consisted of 38 men and four women with a mean age of 31 years at the time of injury. Correlation analysis revealed no significant relationships between any of the outcome measures (range of motion, grip strength and PEM and DASH scores) and any of the three measures of malunion (height-to-length ratio, the dorsal cortical angle and the lateral intra-scaphoid angle). PMID:19129358

  4. Preparing Academic Medical Centers for the Clinical Learning Environment Review: Alliance of Independent Academic Medical Centers National Initiative IV Outcomes and Evaluation

    PubMed Central

    Wehbe-Janek, Hania; Markova, Tsveti; Polis, Rachael L.; Peters, Marguerite; Liu, Yang

    2016-01-01

    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

  5. Measuring team-based interprofessional education outcomes in clinical dentistry: psychometric evaluation of a new scale at an Australian dental school.

    PubMed

    Storrs, Mark J; Alexander, Heather; Sun, Jing; Kroon, Jeroen; Evans, Jane L

    2015-03-01

    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. PMID:25729018

  6. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

  7. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    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. PMID:24165457

  8. The National Anesthesia Clinical Outcomes Registry.

    PubMed

    Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P

    2015-12-01

    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. PMID:26579661

  9. Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

    PubMed Central

    Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.

    2016-01-01

    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

  10. Multicenter evaluation of the clinical outcomes of daptomycin with and without concomitant β-lactams in patients with Staphylococcus aureus bacteremia and mild to moderate renal impairment.

    PubMed

    Moise, Pamela A; Amodio-Groton, Maria; Rashid, Mohamad; Lamp, Kenneth C; Hoffman-Roberts, Holly L; Sakoulas, George; Yoon, Min J; Schweitzer, Suzanne; Rastogi, Anjay

    2013-03-01

    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

  11. Evaluation of Tigecycline Efficacy and Post-Discharge Outcomes in a Clinical Practice Population with Complicated Intra-Abdominal Infection: A Propensity Score–Matched Analysis

    PubMed Central

    Mullins, C. Daniel; Quintana, Alvaro; Eckmann, Christian; Shelbaya, Ahmed; Ernst, Frank R.; Krukas, Michelle R.; Reisman, Arlene

    2016-01-01

    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

  12. Multicenter Evaluation of the Clinical Outcomes of Daptomycin with and without Concomitant β-Lactams in Patients with Staphylococcus aureus Bacteremia and Mild to Moderate Renal Impairment

    PubMed Central

    Amodio-Groton, Maria; Rashid, Mohamad; Lamp, Kenneth C.; Hoffman-Roberts, Holly L.; Sakoulas, George; Yoon, Min J.; Schweitzer, Suzanne; Rastogi, Anjay

    2013-01-01

    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

  13. Do clinical outcome measures assess consumer-defined recovery?

    PubMed

    Andresen, Retta; Caputi, Peter; Oades, Lindsay G

    2010-05-30

    There is an international call for mental health services to become recovery-oriented, and also to use evidence-based practices. Addressing this call requires recovery-oriented measurement of outcomes and service evaluation. Mental health consumers view recovery as leading as meaningful life, and have criticised traditional clinical measures for being too disability-oriented. This study compares three measures of consumer-defined recovery from enduring mental illness: the Recovery Assessment Scale, the Mental Health Recovery Measure and the Self-Identified Stage of Recovery, with four conventional clinical measures. Correlational analyses supported the convergent validity of the recovery measures, although certain subscales were unrelated to each other. More importantly, little relationship was found between consumer-defined recovery and the clinical measures. Analyses of variance revealed that scores on the recovery measures increased across self-identified stage of recovery, but scores on most clinical measures did not improve consistently across stage of recovery. The findings demonstrate the qualitative difference between the two types of measures, supporting the claim by consumers that clinical measures do not assess important aspects of recovery. There is a need for further research and refinement of recovery measurement, including assessment of stages of recovery, with the aim of including such measures as an adjunct in routine clinical assessment, service evaluation and research. PMID:20227768

  14. Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain

    PubMed Central

    Harrington, Shana; Gilchrist, Laura; Sander, Antoinette

    2014-01-01

    Background Pain is one of the most commonly reported impairments after breast cancer treatment affecting anywhere from 16-73% of breast cancer survivors Despite the high reported incidence of pain from cancer and its treatments, the ability to evaluate cancer pain continues to be difficult due to the complexity of the disease and the subjective experience of pain. The Oncology Section Breast Cancer EDGE Task Force was created to evaluate the evidence behind clinical outcome measures of pain in women diagnosed with breast cancer. Methods The authors systematically reviewed the literature for pain outcome measures published in the research involving women diagnosed with breast cancer. The goal was to examine the reported psychometric properties that are reported in the literature in order to determine clinical utility. Results Visual Analog Scale, Numeric Rating Scale, Pressure Pain Threshold, McGill Pain Questionnaire, McGill Pain Questionnaire – Short Form, Brief Pain Inventory and Brief Pain Inventory – Short Form were highly recommended by the Task Force. The Task Force was unable to recommend two measures for use in the breast cancer population at the present time. Conclusions A variety of outcome measures were used to measure pain in women diagnosed with breast cancer. When assessing pain in women with breast cancer, researchers and clinicians need to determine whether a unidimensional or multidimensional tool is most appropriate as well as whether the tool has strong psychometric properties. PMID:25346950

  15. Clinical outcome of collateral ligament injuries of the tarsus

    PubMed Central

    Lamb, Lauren; Zubrod, Chad; Hague, Brent; Brakenhoff, Jeff; Major, Michael

    2012-01-01

    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

  16. Patient-reported outcomes in lupus clinical trials with biologics.

    PubMed

    Annapureddy, N; Devilliers, H; Jolly, M

    2016-09-01

    Therapeutic advances in systemic lupus erythematosus (SLE) are greatly needed. Despite advances in our knowledge of pathogenesis of the disease and targets, treatment remains a significant challenge. Finding effective and relatively safe medications remains one of the top priorities. SLE significantly impairs quality of life (QoL), and patient-reported outcomes (PROs) measure a unique aspect of the disease not captured by disease activity. Inclusion of PRO measurements is encouraged in SLE clinical trials, as they allow capturing benefits of a proposed intervention in language patients can relate to and in areas deemed pertinent and important to and by patients. Availability of patient-reported and patient-centric clinical trials data may facilitate patients in informed and shared decision making, and allow for comparative cost-effectiveness evaluation for future resource allocation and reimbursements. Herein we review clinical trials with biologic therapies wherein PRO tools were included in the study design. PMID:27497256

  17. Nutrition and Chronic Wounds: Improving Clinical Outcomes.

    PubMed

    Molnar, Joseph A; Vlad, Lucian G; Gumus, Tuna

    2016-09-01

    There is increasing awareness that chronic wound healing is very dependent on the patient's nutritional status, but there are no clearly established and accepted assessment protocols or interventions in clinical practice. Much of the data used as guidelines for chronic wound patients are extrapolated from acutely wounded trauma patients, but the 2 groups are very different patient populations. While most trauma patients are young, healthy, and well-nourished before injury, the chronic wound patient is usually old, with comorbidities and frequently malnourished. We suggest the assumption that all geriatric wound patients are malnourished until proved otherwise. Evaluation should include complete history and physical and a formal nutritional evaluation should be obtained. Laboratory studies can be used in conjunction with this clinical information to confirm the assessment. While extensive studies are available in relation to prevention and treatment of pressure ulcers and perioperative nutrition, less is known of the effect of nutritional deficits and supplementation of the diabetic foot ulcer and venous stasis ulcer patient. This does not necessarily mean that nutritional support of these patients is not helpful. In the pursuit of wound healing, we provide systemic support of cardiac and pulmonary function and cessation of smoking, improve vascular inflow, improve venous outflow, decrease edema, and treat with hyperbaric oxygen. If we address all of these other conditions, why would we not wish to support the most basic of organismal needs in the form of nutrition? PMID:27556777

  18. Evaluating more naturalistic outcome measures

    PubMed Central

    Bove, Riley; White, Charles C.; Giovannoni, Gavin; Glanz, Bonnie; Golubchikov, Victor; Hujol, Johnny; Jennings, Charles; Langdon, Dawn; Lee, Michelle; Legedza, Anna; Paskavitz, James; Prasad, Sashank; Richert, John; Robbins, Allison; Roberts, Susan; Weiner, Howard; Ramachandran, Ravi; Botfield, Martyn

    2015-01-01

    Objective: In this cohort of individuals with and without multiple sclerosis (MS), we illustrate some of the novel approaches that smartphones provide to monitor patients with chronic neurologic disorders in their natural setting. Methods: Thirty-eight participant pairs (MS and cohabitant) aged 18–55 years participated in the study. Each participant received an Android HTC Sensation 4G smartphone containing a custom application suite of 19 tests capturing participant performance and patient-reported outcomes (PROs). Over 1 year, participants were prompted daily to complete one assigned test. Results: A total of 22 patients with MS and 17 cohabitants completed the entire study. Among patients with MS, low scores on PROs relating to mental and visual function were associated with dropout (p < 0.05). We illustrate several novel features of a smartphone platform. First, fluctuations in MS outcomes (e.g., fatigue) were assessed against an individual's ambient environment by linking responses to meteorological data. Second, both response accuracy and speed for the Ishihara color vision test were captured, highlighting the benefits of both active and passive data collection. Third, a new trait, a person-specific learning curve in neuropsychological testing, was identified using spline analysis. Finally, averaging repeated measures over the study yielded the most robust correlation matrix of the different outcome measures. Conclusions: We report the feasibility of, and barriers to, deploying a smartphone platform to gather useful passive and active performance data at high frequency in an unstructured manner in the field. A smartphone platform may therefore enable large-scale naturalistic studies of patients with MS or other neurologic diseases. PMID:26516627

  19. Clinical Outcomes of Characterized Chondrocyte Implantation

    PubMed Central

    Huylebroek, José; Van Der Bauwhede, Jan; Saris, Daniël; Veeckman, Geert; Bobic, Vladimir; Victor, Jan; Almqvist, Karl Fredrik; Verdonk, Peter; Fortems, Yves; Van Lommel, Nel; Haazen, Ludo

    2012-01-01

    Objective: To assess the clinical outcome of patients treated with autologous chondrocyte implantation using ChondroCelect in daily practice. Methods: The study is a cross-sectional analysis of an open-label, noninterventional cohort. The setting was a compassionate use program, involving 43 orthopaedic centers in 7 European countries. The participants were patients treated with ChondroCelect between October 13, 2004 and July 2, 2008. The measurements used were Clinical Global Impression–Improvement and –Efficacy and solicited adverse event reports. Results: Safety data were collected from 334 patients (90.3%), and effectiveness data were from 282 (76.2%) of the 370 patients treated. Mean age at baseline was 33.6 years (range, 12-57 years), 57% were male, and mean body mass index was 25 kg/m2. Mean follow-up was 2.2 years (range, 0.4-4.1 years). A femoral condyle lesion was reported in 66% (288/379) and a patellar lesion in 19% (84/379). Mean lesion size was 3.5 cm2; a collagen membrane was used in 92.4% (328/355). A therapeutic effect was reported in 89% (234/264) of patients overall and in 87% (40/46) of patellar lesion patients. Rates of much or very much improved patients were similar in patients with short- (<18 months: 71% [115/163]) and long-term follow-up (>18 months: 68% [70/103]) (P = 0.68) and were independent of lesion size (>4 cm2: 75.5% [37/49]; ≤4 cm2: 67.7% [111/164]) (P = 0.38). Adverse events were similar to those reported in the randomized trial with the same product, with more arthrofibrosis, more reduced joint mobility, and more crepitations reported in patellar lesions. Overall, less cartilage hypertrophy was noted, probably due to the use of a biological membrane cover. Conclusions: Implantation of ChondroCelect appeared to result in a positive benefit/risk ratio when used in an unselected heterogenous population, irrespective of the follow-up period, lesion size, and type of lesion treated. PMID:26069630

  20. Temporal Relation Extraction in Outcome Variances of Clinical Pathways.

    PubMed

    Yamashita, Takanori; Wakata, Yoshifumi; Hamai, Satoshi; Nakashima, Yasuharu; Iwamoto, Yukihide; Franagan, Brendan; Nakashima, Naoki; Hirokawa, Sachio

    2015-01-01

    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. PMID:26262376

  1. Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility 1

    PubMed Central

    da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

    2015-01-01

    AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility METHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context. PMID:25806631

  2. Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study.

    PubMed

    Shetty, Ranjan; Prajapati, Jayesh; Pai, Umesh; Shetty, Kiran

    2016-01-01

    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

  3. Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study

    PubMed Central

    Prajapati, Jayesh; Pai, Umesh; Shetty, Kiran

    2016-01-01

    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

  4. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    PubMed

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    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

  5. Clinical Outcomes following median to radial nerve transfers

    PubMed Central

    Ray, Wilson Z.; Mackinnon, Susan E.

    2010-01-01

    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

  6. Clinical Outcomes Associated with Home Mechanical Ventilation: A Systematic Review

    PubMed Central

    MacIntyre, Erika J.; Asadi, Leyla; Mckim, Doug A.; Bagshaw, Sean M.

    2016-01-01

    Background. The prevalence of patients supported with home mechanical ventilation (HMV) for chronic respiratory failure has increased. However, the clinical outcomes associated with HMV are largely unknown. Methods. We performed a systematic review of studies evaluating patients receiving HMV for indications other than obstructive lung disease, reporting at least one clinically relevant outcome including health-related quality of life (HRQL) measured by validated tools; hospitalization requirements; caregiver burden; and health service utilization. We searched MEDLINE, EMBASE, CINAHL, the Cochrane library, clinical trial registries, proceedings from selected scientific meetings, and bibliographies of retrieved citations. Results. We included 1 randomized control trial (RCT) and 25 observational studies of mixed methodological quality involving 4425 patients; neuromuscular disorders (NMD) (n = 1687); restrictive thoracic diseases (RTD) (n = 481); obesity hypoventilation syndrome (OHS) (n = 293); and others (n = 748). HRQL was generally described as good for HMV users. Mental rather than physical HRQL domains were rated higher, particularly where physical assessment was limited. Hospitalization rates and days in hospital appear to decrease with implementation of HMV. Caregiver burden associated with HMV was generally high; however, it is poorly described. Conclusion. HRQL and need for hospitalization may improve after establishment of HMV. These inferences are based on relatively few studies of marked heterogeneity and variable quality. PMID:27445559

  7. Clinical Outcomes Associated with Home Mechanical Ventilation: A Systematic Review.

    PubMed

    MacIntyre, Erika J; Asadi, Leyla; Mckim, Doug A; Bagshaw, Sean M

    2016-01-01

    Background. The prevalence of patients supported with home mechanical ventilation (HMV) for chronic respiratory failure has increased. However, the clinical outcomes associated with HMV are largely unknown. Methods. We performed a systematic review of studies evaluating patients receiving HMV for indications other than obstructive lung disease, reporting at least one clinically relevant outcome including health-related quality of life (HRQL) measured by validated tools; hospitalization requirements; caregiver burden; and health service utilization. We searched MEDLINE, EMBASE, CINAHL, the Cochrane library, clinical trial registries, proceedings from selected scientific meetings, and bibliographies of retrieved citations. Results. We included 1 randomized control trial (RCT) and 25 observational studies of mixed methodological quality involving 4425 patients; neuromuscular disorders (NMD) (n = 1687); restrictive thoracic diseases (RTD) (n = 481); obesity hypoventilation syndrome (OHS) (n = 293); and others (n = 748). HRQL was generally described as good for HMV users. Mental rather than physical HRQL domains were rated higher, particularly where physical assessment was limited. Hospitalization rates and days in hospital appear to decrease with implementation of HMV. Caregiver burden associated with HMV was generally high; however, it is poorly described. Conclusion. HRQL and need for hospitalization may improve after establishment of HMV. These inferences are based on relatively few studies of marked heterogeneity and variable quality. PMID:27445559

  8. Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes.

    PubMed

    Sakamoto, Shinji; Takaki, Manabu; Okahisa, Yuko; Mizuki, Yutaka; Inagaki, Masatoshi; Ujike, Hiroshi; Mitsuhashi, Toshiharu; Takao, Soshi; Ikeda, Masashi; Uchitomi, Yosuke; Iwata, Nakao; Yamada, Norihito

    2016-04-01

    Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study. PMID:26674612

  9. The distribution of outcomes research papers across clinical journals.

    PubMed

    Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

    2011-06-01

    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. PMID:21411472

  10. Evaluation of a Mixing versus a Cycling Strategy of Antibiotic Use in Critically-Ill Medical Patients: Impact on Acquisition of Resistant Microorganisms and Clinical Outcomes

    PubMed Central

    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

    2016-01-01

    Objective To compare the effect of two strategies of antibiotic use (mixing vs. cycling) on the acquisition of resistant microorganisms, infections and other clinical outcomes. Methods 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. Results 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). Conclusions 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. PMID:26982807

  11. Clinical Research of Traditional Chinese Medicine Needs to Develop Its Own System of Core Outcome Sets

    PubMed Central

    Zhang, Li; Zhang, Junhua; Chen, Jing; Xing, Dongmei; Wang, Jiaying

    2013-01-01

    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

  12. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    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.

    2015-01-01

    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.

  13. Postnatal Evaluation and Outcome of Prenatal Hydronephrosis

    PubMed Central

    Sadeghi-Bojd, Simin; Kajbafzadeh, Abdol-Mohammad; Ansari-Moghadam, Alireza; Rashidi, Somaye

    2016-01-01

    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

  14. Clinical evaluation of contemporary oxygenators.

    PubMed

    Stanzel, Roger D P; Henderson, Mark

    2016-01-01

    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. PMID:26407816

  15. Clinical outcomes of endovascularly managed iatrogenic renal hemorrhages

    PubMed Central

    Chiramel, George Koshy; Keshava, Shyamkumar Nidugala; Moses, Vinu; Kekre, Nitin; Tamilarasi, V; Devasia, Anthony

    2015-01-01

    Objective: To evaluate the effectiveness of endovascular management in iatrogenic renal injuries with regard to clinical status on follow-up and requirements for repeat angiography and embolization. Materials and Methods: This retrospective study included patients who were referred for endovascular management of significant hemorrhage following an iatrogenic injury. Data was recorded from the Picture Archiving and Communication system (PACS) and electronic medical records. The site and type of iatrogenic injury, imaging findings, treatment, angiography findings, embolization performed, clinical status on follow-up, and requirement for repeat embolization were recorded. The outcomes were clinical resolution, nephrectomy, or death. Clinical findings were recorded on follow-up visits to the clinic. Statistical analysis was performed using descriptive statistics. Results: Seventy patients were included in this study between January 2000 and June 2012. A bleeding lesion (a pseudoaneurysm or arteriovenous fistula) was detected during the first angiogram in 55 patients (78.6%) and was selectively embolized. Fifteen required a second angiography as there was no clinical improvement and five required a third angiography. Overall, 66 patients (94.3%) showed complete resolution and 4 patients (5.7%) died. Three patients (4.3%) underwent nephrectomy for clinical stabilization even after embolization. There were no major complications. The two minor complications resolved spontaneously. Conclusions: Angiography and embolization is the treatment of choice in iatrogenic renal hemorrhage. Upto 20% of initial angiograms may not reveal the bleed and repeat angiography is required to identify a recurrent or unidentified bleed. The presence of multiple punctate bleeders on angiography suggests an enlarging subcapsular hematoma and requires preoperative embolization and nephrectomy. PMID:26752819

  16. Congenital Aural Stenosis: Clinical Features and Long-term Outcomes.

    PubMed

    Li, Chen-Long; Chen, Ying; Chen, Yong-Zheng; Fu, Yao-Yao; Zhang, Tian-Yu

    2016-01-01

    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

  17. Congenital Aural Stenosis: Clinical Features and Long-term Outcomes

    PubMed Central

    Li, Chen-long; Chen, Ying; Chen, Yong-zheng; Fu, Yao-yao; Zhang, Tian-yu

    2016-01-01

    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

  18. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    PubMed

    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

    2016-07-01

    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. PMID:27089522

  19. Repair Integrity and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

    PubMed Central

    Williams, Ariel A.; Mark, P.; DiVenere, Jessica Megan; Klinge, Stephen Austin; Arciero, Robert A.; Mazzocca, Augustus D.

    2016-01-01

    Objectives: To prospectively evaluate the effect of early versus delayed motion on repair integrity on 6-month postoperative magnetic resonance imaging (MRI) scans following rotator cuff repair, and to correlate repair integrity with clinical and functional outcomes. We hypothesized that repair integrity would differ between the early and delayed groups and that patients with repair failures would have worse clinical and functional outcomes. Methods: This was a prospective, randomized, single blinded clinical trial comparing an early motion (post-op day 2-3) to a delayed motion (post-op day 28) rehabilitation protocol following arthroscopic repair of isolated supraspinatus tears. All patients underwent MRI at 6 months post-operatively as part of the study protocol. A blinded board-certified and fellowship-trained orthopaedic surgeon (not part of the surgical team) reviewed operative photos and video to confirm the presence of a full thickness supraspinatus tear and to ensure an adequate and consistent repair. The same surgeon along with a blinded sports medicine fellowship-trained musculoskeletal radiologist independently reviewed all MRIs to determine whether the repair was intact at 6 months. Outcome measures were collected by independent evaluators who were also blinded to group assignment. These included the Western Ontario Rotator Cuff (WORC) index, Single Assessment Numeric Evaluation (SANE) ratings, pain scores, sling use, and physical exam data. Enrolled patients were followed at 6 weeks, 6 months, and 1 year. Results: From October 2008 to April 2012, 73 patients met all inclusion criteria and were willing to participate. 36 patients were randomized to delayed motion and 37 were randomized to early motion. The final study group at 6 months consisted of 58 study participants. Postoperative MRIs were obtained on all of these patients at 6 months regardless of whether or not they were progressing as expected. These MRIs demonstrated an overall failure rate of

  20. Classification and clinical evaluation.

    PubMed

    Pierro, Agostino; Kiely, Edward M; Spitz, Lewis

    2015-10-01

    Conjoined twins represent a great challenge for most pediatric specialists including pediatric surgeons, anesthetists, neonatologists, urologists, neurosurgeons, and orthopedic surgeons. This anomaly can be classified according to the type of twins׳ fusion. Various organs can be fused making the separation difficult. Conjoined twins are usually diagnosed antenatally by ultrasound. Detailed fetal echocardiography is necessary to counsel the parents during pregnancy. Postnatally, the majority of the conjoined twins can be thoroughly investigated using various imaging techniques. This allows careful planning of the operation. However, in approximately one-third of the patients an urgent operation is required at birth without a complete assessment of the joining. This is associated with a poorer outcome. PMID:26382257

  1. Evaluating treatment outcomes for adults who stutter.

    PubMed

    Yaruss, J S

    2001-01-01

    The evaluation of stuttering treatment outcomes has traditionally focused primarily on changes in the production of speech disfluencies, even though many treatment approaches also address other aspects of the stuttering disorder, such as the speaker's reactions to stuttering and the overall effect of stuttering on the speaker's ability to communicate. One reason for the relative lack of outcomes data for many commonly recommended treatment programs is the fact that clinicians and researchers have not previously had access to a reliable means of assessing changes in the broader consequences of stuttering on a speaker's life. This paper describes an ongoing effort to develop a series of measurement instruments that can be used to evaluate the outcomes of a wide variety of stuttering treatment approaches by measuring changes in speakers' affective, behavioral, and cognitive reactions to stuttering; the effect of stuttering on speakers' functional communication abilities; and the impact of stuttering on speakers' overall quality of life. PMID:11322566

  2. Evaluation of the Sustainability and Clinical Outcome of Alternatives for Families: A Cognitive-Behavioral Therapy (AF-CBT) in a Child Protection Center

    ERIC Educational Resources Information Center

    Kolko, David J.; Iselin, Anne-Marie R.; Gully, Kevin J.

    2011-01-01

    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…

  3. Evaluating Practice: Does It Improve Treatment Outcome?

    ERIC Educational Resources Information Center

    Slonim-Nevo, Vered; Anson, Yonatan

    1998-01-01

    Single-case design methodology is evaluated for its effect on treatment outcomes. Participants were juvenile delinquents treated by probation officers with social work degrees in Israel. A quasi-experimental design used measures of the functioning of participants in several settings as dependent variables. Results are presented and discussed. (EMK)

  4. Evaluating Treatment Outcomes for Adults Who Stutter.

    ERIC Educational Resources Information Center

    Yaruss, J. Scott

    2001-01-01

    This article describes efforts to develop measurement instruments that can be used to evaluate outcomes of a variety of stuttering treatment approaches by measuring changes in speakers' affective, behavioral, and cognitive reactions to stuttering, effects of stuttering on functional communication abilities, and the impact of stuttering on quality…

  5. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, Doug; Byrne, Vicky; Cole, Richard; Dulchavsky, Scott; Foy, Millennia; Garcia, Kathleen; Gibson, Robert; Ham, David; Hurst, Victor; Kerstman, Eric; McGuire, Kerry; Sargsyan, Ashot

    2015-01-01

    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.

  6. Development and Clinical Outcomes of a Dialectical Behavior Therapy Clinic

    ERIC Educational Resources Information Center

    Lajoie, Travis; Sonkiss, Joshua; Rich, Anne

    2011-01-01

    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…

  7. Prognostic factors for clinical outcomes after rotator cuff repair

    PubMed Central

    Pécora, José Otávio Reggi; Malavolta, Eduardo Angeli; Assunção, Jorge Henrique; Gracitelli, Mauro Emílio Conforto; Martins, João Paulo Sobreiro; Ferreira, Arnaldo Amado

    2015-01-01

    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

  8. Clinical neurological evaluation.

    PubMed

    Weiss, A H

    1995-06-01

    The importance of the neurological evaluation for PLDD procedures is discussed. Elements of the basic examination are outlined and the reason for specific methods of testing are offered. The physician should pay attention to patient complaints, mechanical signs, and patient capabilities. PMID:10150642

  9. Evaluating Nursing Students' Clinical Performance.

    PubMed

    Koharchik, Linda; Weideman, Yvonne L; Walters, Cynthia A; Hardy, Elaine

    2015-10-01

    This article is one in a series on the roles of adjunct clinical faculty and preceptors, who teach nursing students to apply knowledge in clinical settings. This article describes aspects of the student evaluation process, which should involve regular feedback and clearly stated performance expectations. PMID:26402292

  10. [Clinical autopsy evaluation].

    PubMed

    Sakugawa, H; Saito, A

    1999-01-01

    The hospital autopsy rate in Japan dropped from 63.5 per cent in 1972 to 20.9 per cent in 1995. This reduction is attributable to declining interest by clinicians, surgeons and pathologists. The decline is a very serious problem, because the autopsy contributes to what has been called "quality control" of medical care. However, the method of autopsy should change along with advances in diagnostic technology or various changes in the circumstances surrounding medical practice. The most important problem at present is that autopsies require both time and effort. Delayed autopsy reports by pathologists may result in declined interest by clinicians and thus limit the benefits. To shorten the time delay for autopsy reports, clinicians must clarify their clinical questions concerning the deceased patient so that pathologists can readily identify the patients' problems and determine the causes more promptly, clearly and diplomatically. Other suggestions for improvement include the following: the reports should be simpler; the concept that all autopsies must be complete should be eliminated; a hospital accreditor must emphasize that clinicians intend to gain more precise diagnoses by obtaining post-mortem tissues of various organs using biopsy instruments. In addition, communication between pathologists and clinicians must be active to determine the pathogenesis of disease. PMID:10067363

  11. Single Case Research Results as Clinical Outcomes

    ERIC Educational Resources Information Center

    Parker, Richard I.; Hagan-Burke, Shanna

    2007-01-01

    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" ("R"[superscript 2],…

  12. A model to begin to use clinical outcomes in medical education.

    PubMed

    Haan, Constance K; Edwards, Fred H; Poole, Betty; Godley, Melissa; Genuardi, Frank J; Zenni, Elisa A

    2008-06-01

    The latest phase of the Accreditation Council for Graduate Medical Education (ACGME) Outcome Project challenges graduate medical education (GME) programs to select meaningful clinical quality indicators by which to measure trainee performance and progress, as well as to assess and improve educational effectiveness of programs. The authors describe efforts to measure educational quality, incorporating measurable patient-care outcomes to guide improvement. University of Florida College of Medicine-Jacksonville education leaders developed a tiered framework for selecting clinical indicators whose outcomes would illustrate integration of the ACGME competencies and their assessment with learning and clinical care. In order of preference, indicators selected should align with a specialty's (1) national benchmarked consensus standards, (2) national specialty society standards, (3) standards of local, institutional, or regional quality initiatives, or (4) top-priority diagnostic and/or therapeutic categories for the specialty, based on areas of high frequency, impact, or cost. All programs successfully applied the tiered process to clinical indicator selection and then identified data sources to track clinical outcomes. Using clinical outcomes in resident evaluation assesses the resident's performance as reflective of his or her participation in the health care delivery team. Programmatic improvements are driven by clinical outcomes that are shown to be below benchmark across the residents. Selecting appropriate clinical indicators-representative of quality of care and of graduate medical education-is the first step toward tracking educational outcomes using clinical data as the basis for evaluation and improvement. This effort is an important aspect of orienting trainees to using data for monitoring and improving care processes and outcomes throughout their careers. PMID:18520464

  13. Clinical outcomes of symptomatic arterioportal fistulas after transcatheter arterial embolization

    PubMed Central

    Hirakawa, Masakazu; Nishie, Akihiro; Asayama, Yoshiki; Ishigami, Kousei; Ushijima, Yasuhiro; Fujita, Nobuhiro; Honda, Hiroshi

    2013-01-01

    AIM: To evaluate the complications and clinical outcomes of transcatheter arterial embolization (TAE) for symptoms related to severe arterioportal fistulas (APFs). METHODS: Six patients (3 males, 3 females; mean age, 63.8 years; age range, 60-71 years) with chronic liver disease and severe APFs due to percutaneous intrahepatic treatment (n = 5) and portal vein (PV) tumor thrombosis of hepatocellular carcinoma (n = 1) underwent TAE for symptoms related to severe APFs [refractory ascites (n = 4), hemorrhoidal hemorrhage (n = 1), and hepatic encephalopathy (n = 1)]. Control of symptoms related to APFs and complications were evaluated during the follow-up period (range, 4-57 mo). RESULTS: In all patients, celiac angiography revealed immediate retrograde visualization of the main PV before TAE, indicating severe APF. Selective TAE for the hepatic arteries was performed using metallic coils (MC, n = 4) and both MCs and n-butyl cyanoacrylate (n = 2). Three patients underwent repeated TAEs for residual APFs and ascites. Four patients developed PV thrombosis after TAE. During the follow-up period after TAE, APF obliteration and symptomatic improvement were obtained in all patients. CONCLUSION: Although TAE for severe APFs may sometimes be complicated by PV thrombosis, TAE can be an effective treatment to improve clinical symptoms related to severe APFs. PMID:23494252

  14. Traditional vs. Simulated Guided Methodology in Teaching Vital Sign Assessment of the Normal Newborn to the Nursing Student: A Clinical Outcome Evaluation

    ERIC Educational Resources Information Center

    Rivers, Joynelle L.

    2012-01-01

    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…

  15. Outcome-driven Evaluation Metrics for Treatment Recommendation Systems.

    PubMed

    Mei, Jing; Liu, Haifeng; Li, Xiang; Yu, Yiqin; Xie, Guotong

    2015-01-01

    Treatment recommendation systems aim to providing clinical decision supports, e.g. with integration of Computerized Physician Order Entry (CPOE). One of the most significant issue is the quality of recommendations which needs to be quantified, before getting the acceptance from physicians. In computer science, such evaluations are typically performed by applying appropriate metrics that provides a comparison of different systems. However, a big challenge for evaluating treatment recommendation systems is that ground truth is only partially observed. In this paper, we propose an outcome-driven evaluation methodology, and present five metrics (i.e. precision, recall, accuracy, relative risk and odds ratio) with highlight of their statistic meanings in clinical context. The experimental results are based on the comparison of two well-developed treatment recommendation systems (one is knowledge-driven and based on clinical practice guidelines, while the other is data-driven and based on patient similarity analysis), using our proposed evaluation metrics. As a conclusion, physicians are less prone to comply with clinical guidelines, but once following guideline recommendations, it is much more likely to get good outcomes than not following. PMID:25991128

  16. A Five-Phase Model for Clinical-Outcome Research

    ERIC Educational Resources Information Center

    Robey, Randall R.

    2004-01-01

    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…

  17. Clinical Approach to Teacher Evaluation.

    ERIC Educational Resources Information Center

    Tipton, William

    This manual, prepared for the state of Washington, provides tools and strategies aimed at assisting building administrators in clinical approaches to teacher evaluation. The first section provides preliminary thoughts on the evaluation process and discusses the two major problems: acceptance and time. The second section discusses the sources and…

  18. Clinical Outcome after Colonic Resection in Women with Endometriosis

    PubMed Central

    Klugsberger, Bettina; Shamiyeh, Andreas; Oppelt, Peter; Jabkowski, Christina; Schimetta, Wolfgang; Haas, Dietmar

    2015-01-01

    Background. In severe forms of endometriosis, the colon or rectum may be involved. This study evaluated the functional results and long-term outcome after laparoscopic colonic resection for endometriosis. Patients and Methods. Questionnaire survey with 24 women who had experienced typical symptoms, including pelvic pain, infertility, and endometriotic lesions in the bowel and undergone laparoscopic surgery, including low anterior resection, from 2009 to 2012, was conducted. Results. Information about the postoperative outcome was obtained from 22 women and was analyzed statistically. Twenty-one had undergone low anterior resection; one patient required a primary Hartmann procedure due to a rectovaginal fistula. The conversion rate was 4.5%. Major complications occurred in one patient, including an anastomotic leakage, and a Hartmann procedure was carried out subsequently in this patient. The symptoms of pain during defecation, pelvic pain, dyspareunia, dysmenorrhea, and hematochezia showed clear improvement one year after the operation and at the time of the questionnaire. Conclusion. Laparoscopic low anterior resection for deeply infiltrative endometriosis is technically demanding but feasible and safe, and it improves the clinical symptoms of endometriosis in the bowel. PMID:26258139

  19. Atrial Fibrillation Ablation in Systolic Dysfunction: Clinical and Echocardiographic Outcomes

    PubMed Central

    Lobo, Tasso Julio; Pachon, Carlos Thiene; Pachon, Jose Carlos; Pachon, Enrique Indalecio; Pachon, Maria Zelia; Pachon, Juan Carlos; Santillana, Tomas Guillermo; Zerpa, Juan Carlos; Albornoz, Remy Nelson; Jatene, Adib Domingos

    2015-01-01

    Background Heart failure and atrial fibrillation (AF) often coexist in a deleterious cycle. Objective To evaluate the clinical and echocardiographic outcomes of patients with ventricular systolic dysfunction and AF treated with radiofrequency (RF) ablation. Methods Patients with ventricular systolic dysfunction [ejection fraction (EF) <50%] and AF refractory to drug therapy underwent stepwise RF ablation in the same session with pulmonary vein isolation, ablation of AF nests and of residual atrial tachycardia, named "background tachycardia". Clinical (NYHA functional class) and echocardiographic (EF, left atrial diameter) data were compared (McNemar test and t test) before and after ablation. Results 31 patients (6 women, 25 men), aged 37 to 77 years (mean, 59.8±10.6), underwent RF ablation. The etiology was mainly idiopathic (19 p, 61%). During a mean follow-up of 20.3±17 months, 24 patients (77%) were in sinus rhythm, 11 (35%) being on amiodarone. Eight patients (26%) underwent more than one procedure (6 underwent 2 procedures, and 2 underwent 3 procedures). Significant NYHA functional class improvement was observed (pre-ablation: 2.23±0.56; postablation: 1.13±0.35; p<0.0001). The echocardiographic outcome also showed significant ventricular function improvement (EF pre: 44.68%±6.02%, post: 59%±13.2%, p=0.0005) and a significant left atrial diameter reduction (pre: 46.61±7.3 mm; post: 43.59±6.6 mm; p=0.026). No major complications occurred. Conclusion Our findings suggest that AF ablation in patients with ventricular systolic dysfunction is a safe and highly effective procedure. Arrhythmia control has a great impact on ventricular function recovery and functional class improvement. PMID:25387404

  20. 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

    SciTech Connect

    Gupta, Tejpal

    2012-02-01

    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.

  1. Evaluating health care quality: the moderating role of outcomes.

    PubMed

    Lytle, R S; Mokwa, M P

    1992-03-01

    An integrative model of health care quality is presented. "Health care quality" is defined as provider conformance to patient requirements at three benefit levels: core, intangible, and tangible. The model is operationalized and tested in a clinical setting, a large center for fertility studies with more than 5000 patients. Health care "process variables" such as physician and patient interactions were not as important in patients' evaluations of health care quality when successful outcomes occurred (pregnancy). However, when patients experienced unsuccessful outcomes (no pregnancy), health care "process variables" were important and had a significant influence on patient perceptions of health care quality. Hence, service outcomes can significantly affect the measurement and interpretation of health care quality. Implications for health care management and research are discussed. PMID:10116754

  2. Bioplastique at 6 years: clinical outcome studies.

    PubMed

    Ersek, R A; Gregory, S R; Salisbury, A V

    1997-11-01

    Bioplastique is a biphasic polymer for the permanent augmentation of some soft tissues. It was developed in 1987, and clinical studies at this institution were begun in 1990. The combination of low molecular weight polyvinylpyrrolidone and solid polymer particles allows the implantation of permanent polymer spheres through a small needle under local anesthesia. In this study 127 cases are reviewed of consecutive patients who have received Bioplastique for scar revision, wrinkles, and augmentation for soft-tissue defects at 6 years after application. All patients who had not been in for follow-up recently were contacted by mail and questioned on the permanence of augmentation and migration of particles. About 30 percent of the patients were unreachable and had their charts reviewed for permanence and migration of particles. In eight of these cases, Bioplastique was removed because of overcorrection, two of them may have had infection. Bioplastique has gained wide use throughout the world and although some complications have been reported, in general, it functions quite well when used in selected cases. PMID:9385974

  3. Correlation of clinical outcome to the estimated radiation dose from Boron Neutron Capture Therapy (BNCT)

    SciTech Connect

    Chadha, M.; Coderre, J.A.; Chanana, A.D.

    1996-12-31

    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.

  4. AB129. Osteogenesis imperfecta: clinical features and bisphosphonate treatment outcome

    PubMed Central

    Can, Ngoc Thi Bich; Vu, Dung Chi; Bui, Thao Phuong; Nguyen, Khanh Ngoc

    2015-01-01

    Background and objective Osteogenesis imperfecta (OI) comprises a group of disorders principally affecting type I collagen which result in increased bone fragility. Children with severe OI suffer recurrent fractures, resulting in severe deformity and growth stunting in many cases, with loss of independent ambulation by the teenage years in over 50% of cases. Recently, cyclical intravenous treatment with pamidronate has proven of benefit to children with severe forms of OI. This article aims to describle clinical features and laboratory manifestations of patient with OI and evaluate outcome of bisphosphonate management. Methods Clinical features, biochemical finding, and management outcome of 104 cases were study. The patients were classified into four major subtypes of Sillience et al. 1979. Patients with severe types were treatment with pamidronate (Aredia) used Rauch protocol 2003. Results Now we have 196 patients (87 females and 109 males) but we studied focus on 104 patients from 98 families (60 males, 44 females) onset at 2.1±3.0 years (median 0.35) with the average fracture bone of 5.9±4.4 times. In there, 17% type I, 8% type II, 63% type III, and 12% type IV. Clinical features include of intrauterine fracture visible on ultrasound 35%, bone deformation after birth 68%, triangle face 76%, long bone deformation 91%, chest deformation 46%, scoliosis 27%, short status 90%, blue sclera 83%, dentinogenesis imperfecta 20%, hearing loss 6%. Thirty patients have been treated with pamidronate at 3.2±3.7 years (4 months to 8 years) during 13±0.8 months (6-30 months). Fourteen patients had fracture bone after 6 months of treatment but no patients had fracture bone after 12 months. Seven patients had been treatment after 1.6±0.5 years, BMD increase from 0.39±0.311 to 0.79±0.105 g/cm2 (P<0.05). One patient had fever reaction after first pamidronate infusion but controlled with standard antipyretic therapy, and do not recur in later treatments. Conclusions OI has

  5. Effectiveness of structured hourly nurse rounding on patient satisfaction and clinical outcomes.

    PubMed

    Brosey, Lisa A; March, Karen S

    2015-01-01

    Structured hourly nurse rounding is an effective method to improve patient satisfaction and clinical outcomes. This program evaluation describes outcomes related to the implementation of hourly nurse rounding in one medical-surgical unit in a large community hospital. Overall Hospital Consumer Assessment of Healthcare Providers and Systems domain scores increased with the exception of responsiveness of staff. Patient falls and hospital-acquired pressure ulcers decreased during the project period. PMID:25237791

  6. Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example.

    PubMed

    Armijo-Olivo, Susan; Warren, Sharon; Fuentes, Jorge; Magee, David J

    2011-12-01

    Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. PMID:21658987

  7. Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial

    PubMed Central

    Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

    2015-01-01

    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

  8. Clinical effectiveness and safety outcomes associated with prothrombin complex concentrates.

    PubMed

    Hedges, Ashley; Coons, James C; Saul, Melissa; Smith, Roy E

    2016-07-01

    Prothrombin complex concentrates (PCCs) are indicated for urgent reversal of warfarin and used for reversal of novel oral anticoagulants, in patients with acute major bleeding or need for an urgent procedure. The research goal was to evaluate effectiveness and safety outcomes with PCC usage at our institution. A retrospective review of electronic medical records identified patients that received a PCC commercially available in the United States (KCentra(®) or Profilnine(®)) at twelve hospitals in a tertiary care health system from July 1, 2013 to April 30, 2014. A total of 193 patients received PCC, of which 184 patients received four-factor PCC. The patient population was 48 % male and 75 % Caucasian, with a mean age of 73 years old. Clinical outcomes of interest included time to achieve a target INR ≤1.3, time to Hgb >7 g/dL, and incidence of thromboembolism. A total of 143 patients were on warfarin (74.1 %) at baseline, whereas 18 patients (9.3 %) were taking a novel anticoagulant. Target INR of ≤1.3 was achieved in 125 patients (65.8 %), within a median time of 8.03 h (IQR 3.38-34.07). Among patients with a baseline Hgb <7 g/L (n = 13), the median time to Hgb >7 g/dL was 8.48 h (IQR 6.95-13.00). Eight patients (4.1 %) developed an acute venous thromboembolism following PCC administration. INR reversal was achieved in approximately two-thirds of patients, with a low incidence of venous thromboembolism. Four-factor PCC is a viable alternative to plasma. PMID:26685667

  9. Outcome Markers for Clinical Trials in Cerebral Amyloid Angiopathy

    PubMed Central

    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.

    2014-01-01

    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

  10. A Comparison of Several Outcome Measures Used to Evaluate a Psychiatric Clerkship.

    ERIC Educational Resources Information Center

    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…

  11. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    PubMed Central

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    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

  12. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    PubMed Central

    Shikiar, Richard; Bresnahan, Brian W; Stone, Stephen P; Thompson, Christine; Koo, John; Revicki, Dennis A

    2003-01-01

    Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI), the Psoriasis Symptom Assessment (PSA) Scale, and two itch measures, a Visual Analog Scale (VAS) and the National Psoriasis Foundation (NPF) itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095). Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change) assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology-related limitations of functional

  13. Surgical Predictors of Clinical Outcome following Revision ACL Reconstruction

    PubMed Central

    Wright, Rick W.

    2016-01-01

    Objectives: Revision ACL reconstruction has been documented to have worse outcomes compared with primary ACL reconstructions. The reasons why remain unknown. The purpose of this study was to determine either previous or current surgical factors noted at the time of ACL revision reconstruction predicts activity level, sports function, and OA symptoms at two year follow-up. Methods: Revision ACL reconstruction patients were identified and prospectively enrolled between 2006 and 2011. Data collected included baseline demographics, surgical technique and pathology, and a series of validated patient reported outcome instruments (IKDC, KOOS, WOMAC, and Marx activity rating score). Patients were followed up for 2 years, and asked to complete the identical set of outcome instruments. Regression analysis was used to control for age, gender, BMI, activity level, baseline outcome scores, revision number, time since last ACLR, and a variety of previous and current surgical variables, in order to assess the surgical risk factors for clinical outcomes 2 years after revision ACL reconstruction. Results: 1205 patients met the inclusion criteria and were successfully enrolled. 697 (58%) were males, with a median cohort age of 26 years. The median time since their last ACL reconstruction was 3.4 years. Baseline characteristics of the cohort are summarized in Table 1. At 2 years, follow-up was obtained on 82% (989/1205). Both previous as well as current surgical factors were found to be significant drivers of poorer outcomes at 2 years (Table 2). The most consistent surgical factors driving outcome in revision patients were prior surgical technique, prior tibial tunnel position, current femoral fixation and having a notchplasty. Having a previous arthrotomy compared to the one incision technique resulted in significantly poorer outcomes on the IKDC (odds ratio=0.41; 95% CI=0.17-0.95; p=0.037) and KOOS pain, sports/rec, and QOL subscales (OR range=0.23-0.42; 95% CI=0.10-0.97; p<0

  14. A prospective evaluation of outcomes of two tapered implant systems.

    PubMed

    Andreasi Bassi, M; Lopez, M A; Confalone, L; Gaudio, R M; Lombardo, L; Lauritano, D

    2016-01-01

    The purpose of this prospective clinical study was to evaluate survival rate (SVR - i.e. fixtures still in place at the end of the observation period) and success rate (SCR - i.e. bone resorption around the implant neck) of two tapered implant systems. Both systems were equipped with a tapered connection, one requiring bone-level (BL) placement, while the other required soft-tissue-level (STL) placement. In the period between January 1996 and October 2011, 133 fixtures were inserted, 90 in females and 43 in males, with a mean age of 60±11 years. The mean post-surgical follow-up was 64±38 months. Several clinical parameters were evaluated as potential outcome conditioners. An SPSS program was used for statistical analysis and a Cox analysis was performed. The SVR was 100% since no fixtures were lost. SCR, expressed through the mean marginal bone loss, was 88%. No significant differences were found, for most of the variables investigated with the exception of bone grafting and implant type: STL implants showed a better clinical outcome than BL implants when bone grafting was performed simultaneously with implant placement. Tapered implants are reliable devices for oral rehabilitation of jaws. PMID:27469541

  15. Clinical spectrum and outcome of pulmonary nocardiosis: 5-year experience

    PubMed Central

    Singh, Akashdeep; Chhina, Deepinder; Soni, RK; Kakkar, Chandan; Sidhu, US

    2016-01-01

    Background: Pulmonary nocardiosis is a rare but a life-threatening infection caused by Nocardia spp. The diagnosis is often missed and delayed resulting in delay in appropriate treatment and thus higher mortality. Aim: In this study, we aim to evaluate the clinical spectrum and outcome of patients with pulmonary nocardiosis. Methods: A retrospective, 5-year (2009–2014) review of demographic profile, risk factors, clinical manifestations, imaging findings, treatment, and outcome of patients with pulmonary nocardiosis admitted to a tertiary care hospital. Results: The median age of the study subjects was 54 years (range, 16–76) and majority of them (75%) were males. The risk factors for pulmonary nocardiosis identified in our study were long-term steroid use (55.6%), chronic lung disease (52.8%), diabetes (27.8%), and solid-organ transplantation (22.2%). All the patients were symptomatic, and the most common symptoms were cough (91.7%), fever (78%), and expectoration (72%). Almost two-third of the patients were initially misdiagnosed and the alternative diagnosis included pulmonary tuberculosis (n = 7), community-acquired pneumonia (n = 5), lung abscess (n = 4), invasive fungal infection (n = 3), lung cancer (n = 2), and Wegener's granulomatosis (n = 2). The most common radiographic features were consolidation (77.8%) and nodules (56%). The mortality rate for indoor patients was 33% despite treatment. Higher mortality rate was observed among those who had brain abscess (100.0%), HIV positivity (100%), need for mechanical ventilation (87.5%), solid-organ transplantation (50%), and elderly (age > 60 years) patients (43%). Conclusion: The diagnosis of pulmonary nocardiosis is often missed and delayed resulting in delay in appropriate treatment and thus high mortality. A lower threshold for diagnosing pulmonary nocardiosis needs to be exercised, in chest symptomatic patients with underlying chronic lung diseases or systemic immunosuppression, for the early diagnosis

  16. Angiographic outcome of endovascular stroke therapy correlated with MR findings, infarct growth, and clinical outcome in the DEFUSE 2 trial

    PubMed Central

    Marks, Michael P.; Lansberg, Maarten G.; Mlynash, Michael; Kemp, Stephanie; McTaggart, Ryan A.; Zaharchuk, Greg; Bammer, Roland; Albers, Gregory W.

    2015-01-01

    Background 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. Methods 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. Results 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. Conclusion Thrombolysis in cerebral infarction reperfusion following endovascular therapy for

  17. Nursing home-acquired pneumonia: outcomes from a clinical process improvement program.

    PubMed

    Dempsey, C L

    1995-01-01

    At EHS Christ Hospital and Medical Center, an eight-step process improvement model was developed that incorporates continuous quality improvement concepts for monitoring, evaluating and improving patient care. Nursing home residents admitted with pneumonia were identified as the group having the most influence on mortality and costs associated with treatment of pneumonia at our hospital. A multidisciplinary team evaluated clinical resource use and patient care processes, and identified root causes of various influencing treatment. Clinical guidelines were created and outcomes were defined, resulting in significant improvement in the clinical management of these patients. Average length of stay decreased from 8.6 days in 1992 to 7.6 days in 1993, with a charge reduction of $1830 per patient. The methodologic framework of a process improvement program combines epidemiologic, clinical, and quality improvement sciences. This mix is essential in improving patient care and quantifying outcomes. PMID:7753691

  18. Preoperative indicators of clinical outcome following stereotaxic pallidotomy.

    PubMed

    Kazumata, K; Antonini, A; Dhawan, V; Moeller, J R; Alterman, R L; Kelly, P; Sterio, D; Fazzini, E; Beric, A; Eidelberg, D

    1997-10-01

    We assessed the utility of preoperative clinical assessment and functional brain imaging with 18F-fluorodeoxyglucose (FDG) and positron emission tomography (PET) in predicting the clinical outcome of stereotaxic pallidotomy for the treatment of advanced Parkinson's disease (PD). Twenty-two PD patients undergoing posteroventral pallidotomy were assessed preoperatively with the Core Assessment Program for Intracerebral Transplantation (CAPIT) ratings measured on and off levodopa; quantitative FDG/PET was also performed before surgery. Preoperative clinical and metabolic measurements were correlated with changes in off-state CAPIT ratings determined 3 months after surgery. Clinical outcome following pallidotomy was also correlated with intraoperative measures of spontaneous pallidal single-unit activity as well as postoperative MRI measurements of lesion volume and location. We found that unilateral pallidotomy resulted in variable clinical improvement in off-state CAPIT scores for the contralateral limbs (mean change 30.9 +/- 15.5%). Postoperative MRI revealed that pallidotomy lesions were comparable in location and volume across the patients. Clinical outcome following surgery correlated significantly with preoperative measures of CAPIT score change with levodopa administration (r = 0.60, p < 0.005) and with preoperative FDG/PET measurements of lentiform glucose metabolism (r = 0.71, p < 0.0005). Operative outcome did not correlate with intraoperative measures of spontaneous pallidal neuronal firing rate. We conclude that preoperative measurements of lentiform glucose metabolism and levodopa responsiveness may be useful indicators of motor improvement following pallidotomy. Both preoperative quantitative measures, either singly or in combination, may be helpful in selecting optimal candidates for surgery. PMID:9339694

  19. Poststroke Shoulder Pain in Turkish Stroke Patients: Relationship with Clinical Factors and Functional Outcomes

    ERIC Educational Resources Information Center

    Barlak, Aysegul; Unsal, Sibel; Kaya, Kurtulus; Sahin-Onat, Sule; Ozel, Sumru

    2009-01-01

    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…

  20. Characterization of Potential Outcome Measures for Future Clinical Trials in Fragile X Syndrome

    ERIC Educational Resources Information Center

    Berry-Kravis, Elizabeth; Sumis, Allison; Kim, Ok-Kyung; Lara, Rebecca; Wuu, Joanne

    2008-01-01

    Clinical trials targeting recently elucidated synaptic defects in fragile X syndrome (FXS) will require outcome measures capable of assessing short-term changes in cognitive functioning. Potentially useful measures for FXS were evaluated here in a test-retest setting in males and females with FXS (N = 46). Good reproducibility, determined by an…

  1. Bayesian Nonparametric Estimation of Targeted Agent Effects on Biomarker Change to Predict Clinical Outcome

    PubMed Central

    Graziani, Rebecca; Guindani, Michele; Thall, Peter F.

    2015-01-01

    Summary The effect of a targeted agent on a cancer patient's clinical outcome putatively is mediated through the agent's effect on one or more early biological events. This is motivated by pre-clinical experiments with cells or animals that identify such events, represented by binary or quantitative biomarkers. When evaluating targeted agents in humans, central questions are whether the distribution of a targeted biomarker changes following treatment, the nature and magnitude of this change, and whether it is associated with clinical outcome. Major difficulties in estimating these effects are that a biomarker's distribution may be complex, vary substantially between patients, and have complicated relationships with clinical outcomes. We present a probabilistically coherent framework for modeling and estimation in this setting, including a hierarchical Bayesian nonparametric mixture model for biomarkers that we use to define a functional profile of pre-versus-post treatment biomarker distribution change. The functional is similar to the receiver operating characteristic used in diagnostic testing. The hierarchical model yields clusters of individual patient biomarker profile functionals, and we use the profile as a covariate in a regression model for clinical outcome. The methodology is illustrated by analysis of a dataset from a clinical trial in prostate cancer using imatinib to target platelet-derived growth factor, with the clinical aim to improve progression-free survival time. PMID:25319212

  2. Bayesian nonparametric estimation of targeted agent effects on biomarker change to predict clinical outcome.

    PubMed

    Graziani, Rebecca; Guindani, Michele; Thall, Peter F

    2015-03-01

    The effect of a targeted agent on a cancer patient's clinical outcome putatively is mediated through the agent's effect on one or more early biological events. This is motivated by pre-clinical experiments with cells or animals that identify such events, represented by binary or quantitative biomarkers. When evaluating targeted agents in humans, central questions are whether the distribution of a targeted biomarker changes following treatment, the nature and magnitude of this change, and whether it is associated with clinical outcome. Major difficulties in estimating these effects are that a biomarker's distribution may be complex, vary substantially between patients, and have complicated relationships with clinical outcomes. We present a probabilistically coherent framework for modeling and estimation in this setting, including a hierarchical Bayesian nonparametric mixture model for biomarkers that we use to define a functional profile of pre-versus-post-treatment biomarker distribution change. The functional is similar to the receiver operating characteristic used in diagnostic testing. The hierarchical model yields clusters of individual patient biomarker profile functionals, and we use the profile as a covariate in a regression model for clinical outcome. The methodology is illustrated by analysis of a dataset from a clinical trial in prostate cancer using imatinib to target platelet-derived growth factor, with the clinical aim to improve progression-free survival time. PMID:25319212

  3. Beyond the Basics of Clinical Outcomes Assessment: Selecting Appropriate Patient-Rated Outcomes Instruments for Patient Care

    ERIC Educational Resources Information Center

    Valier, Alison R.; Lam, Kenneth C.

    2015-01-01

    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…

  4. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report.

    PubMed

    Pimentel, Welson; Teixeira, Marcelo Lucchesi; Costa, Priscila Paganini; Jorge, Mônica Zacharias; Tiossi, Rodrigo

    2016-06-01

    This clinical report describes how to achieve predictable outcomes for anterior teeth esthetic restorations with porcelain laminate veneers by associating the digital planning and design of the restoration with interim restorations. The previous digital smile design of the restoration eliminates the communication barrier with the patient and assists the clinician throughout patient treatment. Interim restorations (diagnostic mock-ups) further enhance communication with the patient and prevent unnecessary tooth reduction for conservative tooth preparation. Adequate communication between patient and clinician contributes to successful definitive restorations and patient satisfaction with the final esthetic outcome. PMID:26633080

  5. Cerebellopontine angle epidermoid cysts: clinical presentations and surgical outcome.

    PubMed

    Hasegawa, Mitsuhiro; Nouri, Mohsen; Nagahisa, Shinya; Yoshida, Koichiro; Adachi, Kazuhide; Inamasu, Joji; Hirose, Yuichi; Fujisawa, Hironori

    2016-04-01

    Epidermoid cysts constitute less than 1 % of intracranial tumors with the majority of them involving cerebellopontine angle (CPA). Although several mechanisms for cranial nerve dysfunction due to these tumors have been proposed, no direct evaluation for hyper- or hypoactive dysfunction has been done. In this case series, pathophysiology of cranial nerve dysfunction in CPA epidermoid cysts was evaluated with special attention to a new mechanism of capsule strangulation caused by stratified tumor capsule. Twenty-two cases with epidermoid cysts of CPA micro-neurosurgically treated in our departments since 2005 were reviewed. Clinical status of the patients before the surgery and post-operative functional outcome were recorded. Available data from the English literature were summarized for comparison. Mass reduction of cyst contents in most cases was usually associated with prompt and marked improvement of the symptoms suggesting neuroapraxia caused by compression of the tumor content and/or mild ischemia. Among them, two cases showed strangulation of the affected nerves by the tumor capsule whose preoperative dysfunction did not improve after surgery in spite of meticulous microsurgical removal of the lesion. Involved facial and abducent nerves in these two cases showed distortion of nerve axis and nerve atrophy distal to the strangulation site. We report the first direct evidence of etiology of cranial nerve dysfunction caused by cerebellopontine angle epidermoid tumors. Young age and rapidly progressive neurological deficit might be the characteristics for strangulation of the affected nerves by the cyst capsule. Even though the number of cases might be limited, immediate decompression and release of the strangulating band might be urged in such patients to prevent irreversible deficits. PMID:26566990

  6. Scaphoid morphology and clinical outcomes in scaphoid reconstructions.

    PubMed

    Megerle, K; Harenberg, P S; Germann, G; Hellmich, S

    2012-03-01

    Scaphoid malunion and carpal malalignment can result after scaphoid reconstruction, if the two fragments are not properly reduced before fixation. However, currently there is no information about which degree of deformity or malalignment can be tolerated without impairing clinical function. The purpose of this study was to investigate the influence of the scaphoid morphology and carpal alignment on clinical outcomes after scaphoid reconstruction. A total of 65 patients with an average age of 29 years were followed-up after a mean period of 45 months. In all patients, osseous union after a first-time scaphoid reconstruction in the middle third had been confirmed. Scapholunate (SL) and radiolunate (RL) angles were obtained on plain radiographs as were intrascaphoid (ISA) and dorsal cortical (DCA) angles and the height/length (H/L) ratio of the reconstructed scaphoid on computed tomography (CT) scans. These parameters were correlated with clinical outcome measures. RL angles correlated significantly with wrist range of motion, grip strength and pain levels, whilst SL angles, ISA, DCA and H/L ratio failed to show significant correlations. Our data suggest that clinical outcome is correlated with correct restoration of bone morphology and carpal alignment. After reconstruction, the RL angle should not exceed 10°. PMID:21903213

  7. Evaluating Multimedia Interventions in Community-Based Clinics

    PubMed Central

    Sweeney, Mary Anne; Skiba, Diane; Lester, Jerry

    1993-01-01

    The Healthy Touch™ Series of multimedia programs has been developed, implemented, and evaluated in selected community clinics over the past year. A high-tech effort in carrying out the design and evaluation of the programs has resulted in a new intervention in clinical care with positive outcomes for both patients and staff. Utilization of the technology has opened up the opportunity to provide consistent, individualized, and enjoyable programs that invite easy patient participation.

  8. Clinical Outcomes of Medial Meniscus Posterior Root Tears

    PubMed Central

    Krych, Aaron John; Reardon, Patrick J.; Pareek, Ayoosh; Peter, Logan; Dahm, Diane L.; Levy, Bruce A.; Stuart, Michael J.

    2016-01-01

    Objectives: Medial meniscus posterior root tears (MMPRTs) present a unique challenge for both patients and surgeons as these tears have shown to be biomechanically equivalent to complete meniscectomy. However, little is known about the natural history of these lesions. Therefore, the purpose of this study is to describe the clinical course of MMPRTs with respect to subsequent operative and non-operative treatments, and associated comorbidities. Methods: Over 2600 MRIs were identified by searching radiologist reads for the terms “root” or “root tear” from 2005-2013. Presence or absence of MMPRTs and other associated boney, meniscal, or ligamentous injuries were identified and recorded. Of these MRIs, 102 MRIs from 102 patients who had unrepaired MMPRTs with minimum 2-year follow-up and no prior ligamentous surgery were followed. These MRIs were evaluated to confirm the presence of a meniscal root tear and the presence or absence of associated meniscal or ligamentous injuries, as well as meniscal extrusion, subchondral edema, or insufficiency fractures. Chart review was performed to obtain the treatment summary after diagnosis. Radiographs from before and after the diagnosis of MMPRT were reviewed and Kellgren-Lawrence scores were determined. Finally, the association between concomitant boney, ligamentous, or meniscal injuries, patient factors, and rate of arthroplasty, as well as final Kellgren-Lawrence scores were evaluated. Chi-square analysis was used for categorical variables, and Wilcoxon Rank-Sums was used for continuous variables. Kaplan-Meier analysis was used to evaluate the effect of meniscal extrusion on the time-dependant rate of arthroplasty. Results: 104 patients (43 M:61F) were diagnosed with MMPRTs at a mean age of 54±13. These patients were followed for a mean of 66±26 months. 75 (74%) patients had associated meniscal extrusion, 64 (62%) had associated subchondral edema, and 14 (13%) had associated insufficiency fractures at the time of

  9. Clinical outcomes and mortality in elderly peritoneal dialysis patients

    PubMed Central

    Sakacı, Tamer; Ahbap, Elbis; Koc, Yener; Basturk, Taner; Ucar, Zuhal Atan; Sınangıl, Ayse; Sevınc, Mustafa; Kara, Ekrem; Akgol, Cuneyt; Kayalar, Arzu Ozdemır; Caglayan, Feyza Bayraktar; Sahutoglu, Tuncay; Ünsal, Abdulkadir

    2015-01-01

    OBJECTIVES: To evaluate the clinical outcomes and identify the predictors of mortality in elderly patients undergoing peritoneal dialysis. METHODS: We conducted a retrospective study including all incident peritoneal dialysis cases in patients ≥65 years of age treated from 2001 to 2014. Demographic and clinical data on the initiation of peritoneal dialysis and the clinical events during the study period were collected. Infectious complications were recorded. Overall and technique survival rates were analyzed. RESULTS: Fifty-eight patients who began peritoneal dialysis during the study period were considered for analysis, and 50 of these patients were included in the final analysis. Peritoneal dialysis exchanges were performed by another person for 65% of the patients, whereas 79.9% of patients preferred to perform the peritoneal dialysis themselves. Peritonitis and catheter exit site/tunnel infection incidences were 20.4±16.3 and 24.6±17.4 patient-months, respectively. During the follow-up period, 40 patients were withdrawn from peritoneal dialysis. Causes of death included peritonitis and/or sepsis (50%) and cardiovascular events (30%). The mean patient survival time was 38.9±4.3 months, and the survival rates were 78.8%, 66.8%, 50.9% and 19.5% at 1, 2, 3 and 4 years after peritoneal dialysis initiation, respectively. Advanced age, the presence of additional diseases, increased episodes of peritonitis, the use of continuous ambulatory peritoneal dialysis, and low albumin levels and daily urine volumes (<100 ml) at the initiation of peritoneal dialysis were predictors of mortality. The mean technique survival duration was 61.7±5.2 months. The technique survival rates were 97.9%, 90.6%, 81.5% and 71% at 1, 2, 3 and 4 years, respectively. None of the factors analyzed were predictors of technique survival. CONCLUSIONS: Mortality was higher in elderly patients. Factors affecting mortality in elderly patients included advanced age, the presence of comorbid

  10. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

    PubMed Central

    Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

    2013-01-01

    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

  11. Functional outcome measures for NF1-associated optic pathway glioma clinical trials

    PubMed Central

    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.

    2013-01-01

    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

  12. Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

    PubMed

    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

    2016-07-01

    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

  13. Clinical Manifestations and Outcomes of West Nile Virus Infection

    PubMed Central

    Sejvar, James J.

    2014-01-01

    Since the emergence of West Nile virus (WNV) in North America in 1999, understanding of the clinical features, spectrum of illness and eventual functional outcomes of human illness has increased tremendously. Most human infections with WNV remain clinically silent. Among those persons developing symptomatic illness, most develop a self-limited febrile illness. More severe illness with WNV (West Nile neuroinvasive disease, WNND) is manifested as meningitis, encephalitis or an acute anterior (polio) myelitis. These manifestations are generally more prevalent in older persons or those with immunosuppression. In the future, a more thorough understanding of the long-term physical, cognitive and functional outcomes of persons recovering from WNV illness will be important in understanding the overall illness burden. PMID:24509812

  14. Predicting outcome in clinically isolated syndrome using machine learning

    PubMed Central

    Wottschel, V.; Alexander, D.C.; Kwok, P.P.; Chard, D.T.; Stromillo, M.L.; De Stefano, N.; Thompson, A.J.; Miller, D.H.; Ciccarelli, O.

    2014-01-01

    We aim to determine if machine learning techniques, such as support vector machines (SVMs), can predict the occurrence of a second clinical attack, which leads to the diagnosis of clinically-definite Multiple Sclerosis (CDMS) in patients with a clinically isolated syndrome (CIS), on the basis of single patient's lesion features and clinical/demographic characteristics. Seventy-four patients at onset of CIS were scanned and clinically reviewed after one and three years. CDMS was used as the gold standard against which SVM classification accuracy was tested. Radiological features related to lesional characteristics on conventional MRI were defined a priori and used in combination with clinical/demographic features in an SVM. Forward recursive feature elimination with 100 bootstraps and a leave-one-out cross-validation was used to find the most predictive feature combinations. 30 % and 44 % of patients developed CDMS within one and three years, respectively. The SVMs correctly predicted the presence (or the absence) of CDMS in 71.4 % of patients (sensitivity/specificity: 77 %/66 %) at 1 year, and in 68 % (60 %/76 %) at 3 years on average over all bootstraps. Combinations of features consistently gave a higher accuracy in predicting outcome than any single feature. Machine-learning-based classifications can be used to provide an “individualised” prediction of conversion to MS from subjects' baseline scans and clinical characteristics, with potential to be incorporated into routine clinical practice. PMID:25610791

  15. Clinical characteristics and outcomes of neonatal pertussis: a comparative study.

    PubMed

    Castagnini, Luis A; Munoz, Flor M

    2010-03-01

    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. PMID:20056236

  16. Candida Virulence Properties and Adverse Clinical Outcomes in Neonatal Candidiasis

    PubMed Central

    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.

    2012-01-01

    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

  17. Clinical Outcomes of Metabolic Surgery: Microvascular and Macrovascular Complications.

    PubMed

    Adams, Ted D; Arterburn, David E; Nathan, David M; Eckel, Robert H

    2016-06-01

    Understanding of the long-term clinical outcomes associated with bariatric surgery has recently been advanced. Research related to the sequelae of diabetes-in particular, long-term microvascular and macrovascular complications-in patients who undergo weight-loss surgery is imperative to this pursuit. While numerous randomized control trials have assessed glucose control with bariatric surgery compared with intensive medical therapy, bariatric surgery outcome data relating to microvascular and macrovascular complications have been limited to observational studies and nonrandomized clinical trials. As a result, whether bariatric surgery is associated with a long-term reduction in microvascular and macrovascular complications when compared with current intensive glycemic control therapy cannot be determined because the evidence is insufficient. However, the consistent salutary effects of bariatric surgery on diabetes remission and glycemic improvement support the opportunity (and need) to conduct high-quality studies of bariatric surgery versus intensive glucose control. This review provides relevant background information related to the treatment of diabetes, hyperglycemia, and long-term complications; reports clinical findings (to date) with bariatric surgery; and identifies ongoing research focusing on long-term vascular outcomes associated with bariatric surgery. PMID:27222549

  18. Monitoring and Evaluating Psychosocial Intervention Outcomes in Humanitarian Aid.

    PubMed

    de Jong, Kaz; Ariti, Cono; van der Kam, Saskia; Mooren, Trudy; Shanks, Leslie; Pintaldi, Giovanni; Kleber, Rolf

    2016-01-01

    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

  19. Monitoring and Evaluating Psychosocial Intervention Outcomes in Humanitarian Aid

    PubMed Central

    de Jong, Kaz; Ariti, Cono; van der Kam, Saskia; Mooren, Trudy; Shanks, Leslie; Pintaldi, Giovanni; Kleber, Rolf

    2016-01-01

    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

  20. Rehabilitation Predictors of Clinical Outcome following Revision ACL Reconstruction

    PubMed Central

    Wright, Rick W.; Group, Mars

    2016-01-01

    Objectives: Revision ACL reconstruction has been documented to have worse outcomes compared with primary ACL reconstructions. The reasons why remain unknown. The purpose of this study was to determine whether rehabilitation-related factors prescribed at the time of ACL revision reconstruction significantly influence two year outcomes, as well as the incidence of incurring a subsequent re-operation. Our hypothesis was that immediate versus passive, active range of motion (ROM) and weightbearing will result in improved outcomes without incidence of subsequent surgery. Use of postoperative and functional return to sport braces will not improve return to sports function. Methods: Revision ACL reconstruction patients were identified and prospectively enrolled between 2006 and 2011. Data collected included baseline demographics, surgical technique and pathology, prescribed post-op and rehabilitation instructions (ie. timing of weightbearing, timing of passive and active ROM, use of postoperative and return to sport braces) and a series of validated patient reported outcome instruments (IKDC, KOOS, and Marx activity rating score). Patients were followed up for 2 years, and asked to complete the identical set of outcome instruments. Because meniscal repair, meniscal transplants, HTOs, concurrent ligamentous reconstructions, and certain chondral treatments (ie. microfracture, abrasion arthroplasty, mosiacplasty, etc) are known to affect prescribed rehab treatments, patients with these pathologies were excluded from the analyses. Regression analysis was used to control for age, gender, activity level, baseline outcome scores, and the above-mentioned rehabilitation-related variables, in order to assess the risk factors for clinical outcomes 2 years after revision ACL reconstruction. Results: A total of 843 patients met the inclusion criteria and were successfully enrolled. 482 (57%) were males, with a median cohort age of 27 years. Baseline characteristics of the cohort are

  1. Gynecomastia: Clinical evaluation and management

    PubMed Central

    Cuhaci, Neslihan; Polat, Sefika Burcak; Evranos, Berna; Ersoy, Reyhan; Cakir, Bekir

    2014-01-01

    Gynecomastia is the benign enlargement of male breast glandular tissue and is the most common breast condition in males. At least 30% of males will be affected during their life. Since it causes anxiety, psychosocial discomfort and fear of breast cancer, early diagnostic evaluation is important and patients usually seek medical attention. Gynecomastia was reported to cause an imbalance between estrogen and androgen action or an increased estrogen to androgen ratio, due to increased estrogen production, decreased androgen production or both. Evaluation of gynecomastia must include a detailed medical history, clinical examination, specific blood tests, imaging and tissue sampling. Individual treatment requirements can range from simple reassurance to medical treatment or even surgery. The main aim of any intervention is to relieve the symptoms and exclude other etiological factors. PMID:24741509

  2. Individual-level outcomes from a national clinical leadership development programme.

    PubMed

    Patton, Declan; Fealy, Gerard; McNamara, Martin; Casey, Mary; Connor, Tom O; Doyle, Louise; Quinlan, Christina

    2013-08-01

    A national clinical leadership development programme was instituted for Irish nurses and midwives in 2010. Incorporating a development framework and leadership pathway and a range of bespoke interventions for leadership development, including workshops, action-learning sets, mentoring and coaching, the programme was introduced at seven pilot sites in the second half of 2011. The programme pilot was evaluated with reference to structure, process and outcomes elements, including individual-level programme outcomes. Evaluation data were generated through focus groups and group interviews, individual interviews and written submissions. The data provided evidence of nurses' and midwives' clinical leadership development through self and observer-reported behaviours and dispositions including accounts of how the programme participants developed and displayed particular clinical leadership competencies. A key strength of the new programme was that it involved interventions that focussed on specific leadership competencies to be developed within the practice context. PMID:24099226

  3. Outcomes evaluation of St Petersburg Russia Women's Wellness Center.

    PubMed

    Callister, Lynn Clark; Getmanenko, Natalia; Garvrish, Natalia; Marakova, Olga Eugenevna; Zotina, Nataliya Vladimirovna; Turkina, Natalia

    2009-03-01

    Researchers demonstrate that investing in women's health yields great social and economic dividends, yet the health of women often receives little attention throughout the world. Women's wellness centers (WWCs) were established in the former Soviet Union beginning in 1992 under the sponsorship of the American International Health Alliance (AIHA) in conjunction with the United States Association for International Development (USAID) to provide a women-centered approach to primary care, providing access to a wide range of clinical services and educational outreach programs. Because the St Petersburg Women's Wellness Center (WWC) is considered one of the more advanced centers and represents a microcosm of opportunities and challenges in women's health care delivery in the Russian Federation, a descriptive qualitative outcomes evaluation of the clinic was conducted. In the spirit of continuous quality improvement, interviews were conducted with childbearing women. Findings are categorized into the dimensions of access, privacy and comfort, communication with providers, comprehensiveness of care, and follow-up care. Strengths of the clinic include the "woman friendly" environment and educational offerings. Suggestions also were made by study participants for improvement of clinic services. Qualitative research can be translated into clinical practice guidelines for WWCs in Eastern Europe. PMID:19191120

  4. Surgical Treatment and Clinical Outcome of Nonfunctional Pancreatic Neuroendocrine Tumors

    PubMed Central

    Yang, Min; Zeng, Lin; Zhang, Yi; Su, An-ping; Yue, Peng-ju; Tian, Bo-le

    2014-01-01

    Abstract Our primary aim of the present study was to analyze the clinical characteristics and surgical outcome of nonfunctional pancreatic neuroendocrine tumors (non-F-P-NETs), with an emphasis on evaluating the prognostic value of the newly updated 2010 grading classification of the World Health Organization (WHO). Data of 55 consecutive patients who were surgically treated and pathologically diagnosed as non-F-P-NETs in our single institution from January 2000 to December 2013 were retrospectively collected. This entirety comprised of 55 patients (31 males and 24 females), with a mean age of 51.24 ± 12.95 years. Manifestations of non-F-P-NETs were nonspecific. Distal pancreatectomy, pancreaticoduodenectomy, and local resection of pancreatic tumor were the most frequent surgical procedures, while pancreatic fistula was the most common but acceptable complication (30.3%). The overall 5-year survival rate of this entire cohort was 41.0%, with a median survival time of 60.4 months. Patients who underwent R0 resections obtained a better survival than those who did not (P < 0.005). As for the prognostic analysis, tumor size and lymph invasion were only statistically significant in univariate analysis (P = 0.046 and P < 0.05, respectively), whereas the newly updated 2010 grading classification of WHO (G1 and G2 vs G3), distant metastasis, and surgical margin were all meaningful in both univariate and multivariate analysis (P = 0.045, 0.001, and 0.042, respectively). Non-F-P-NETs are a kind of rare neoplasm, with mostly indolent malignancy. Patients with non-F-P-NETs could benefit from the radical resections. The new WHO criteria, distant metastasis and surgical margin, might be independent predictors for the prognosis of non-F-P-NETs. PMID:25396335

  5. Clinical Outcomes of Percutaneous Endoscopic Surgery for Lumbar Discal Cyst

    PubMed Central

    Ha, Sang Woo; Kim, Seok Won; Lee, SeungMyung; Kim, Yong Hyun; Kim, Hyeun Sung

    2012-01-01

    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

  6. Aspergillus Osteomyelitis: Epidemiology, Clinical Manifestations, Management, and Outcome

    PubMed Central

    Gamaletsou, Maria N.; Rammaert, Blandine; Bueno, Marimelle A.; Moriyama, Brad; Sipsas, Nikolaos V.; Kontoyiannis, Dimitrios P.; Roilides, Emmanuel; Zeller, Valerie; Prinapori, Roberta; Tajaldeen, Saad Jaber; Brause, Barry; Lortholary, Olivier; Walsh, Thomas J.

    2014-01-01

    Background The epidemiology, pathogenesis, diagnosis, and management of Aspergillus osteomyelitis are not well understood. Methods Protocol-defined cases of Aspergillus osteomyelitis published in the English literature were reviewed for comorbidities, microbiology, mechanisms of infection, clinical manifestations, radiological findings, inflammatory biomarkers, antifungal therapy, and outcome. Results Among 180 evaluable patients, 127 (71%) were males. Possible predisposing medical conditions in 103 (57%) included pharmacological immunosuppression, primary immunodeficiency, and neutropenia. Seventy-three others (41%) had prior open fracture, trauma or surgery. Eighty (44%) followed a hematogenous mechanism, 58 (32%) contiguous infections, and 42 (23%) direct inoculation. Aspergillus osteomyelitis was the first manifestation of aspergillosis in 77%. Pain and tenderness were present in 80%. The most frequently infected sites were vertebrae (46%), cranium (23%), ribs (16%), and long bones (13%). Patients with vertebral Aspergillus osteomyelitis had more previous orthopedic surgery (19% vs 0%; P=0.02), while those with cranial osteomyelitis had more diabetes mellitus (32% vs 8%; P=0.002) and prior head/neck surgery (12% vs 0%; P=0.02). Radiologic findings included osteolysis, soft-tissue extension, and uptake on T2-weighted images. Vertebral body Aspergillus osteomyelitis was complicated by spinal-cord compression in 47% and neurological deficits in 41%. Forty-four patients (24%) received only antifungal therapy, while 121(67%) were managed with surgery and antifungal therapy. Overall mortality was 25%. Median duration of therapy was 90 days (range, 10–772 days). There were fewer relapses in patients managed with surgery plus antifungal therapy in comparison to those managed with antifungal therapy alone (8% vs 30%; P=0.006). Conclusions Aspergillus osteomyelitis is a debilitating infection affecting both immunocompromised and immunocompetent patients. The most

  7. Clinical outcomes following salvage Gamma Knife radiosurgery for recurrent glioblastoma

    PubMed Central

    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

    2014-01-01

    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

  8. ADCOMS: a composite clinical outcome for prodromal Alzheimer's disease trials

    PubMed Central

    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

    2016-01-01

    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

  9. Renal function trajectory over time and adverse clinical outcomes.

    PubMed

    Sohel, Badrul Munir; Rumana, Nahid; Ohsawa, Masaki; Turin, Tanvir Chowdhury; Kelly, Martina Ann; Al Mamun, Mohammad

    2016-06-01

    The growing burden of chronic kidney disease (CKD), with its associated morbidity and mortality, is recognized as a major public health problem globally and causing substantial load on health care systems. The current framework for the definition and staging of CKD, based on eGFR levels or presence of kidney damage, is useful for clinical classification of patients, but identifies a huge number of people as having CKD which is too many to target for intervention. The ability to identify a subset of patients, at high risk for adverse outcomes, would be useful to inform clinical management. The current staging system applies static definitions of kidney function that fail to capture the dynamic nature of the kidney disease over time. Now-a-days, it is possible to capture multiple measurements of different laboratory test results for an individual including eGFR values. A new possibility for identifying individuals at higher risk of adverse outcomes is being explored through assessment and consideration of the rate of change in kidney function over time, and this approach will be feasible in the current context of digitalization of health record keeping system. On the basis of the existing evidence, this paper summarizes important findings that support the concept of dynamic changes in kidney function over time, and discusses how the magnitude of these changes affect the future adverse outcomes of kidney disease, particularly the End Stage Renal Disease (ESRD), CVD and mortality. PMID:26728745

  10. Postoperative Clinical Outcome and Risk Factors for Poor Outcome of Foraminal and Extraforaminal Lumbar Disc Herniation

    PubMed Central

    Bae, Jung Sik; Kang, Kyung Hee; Park, Jeong Hyun; Lim, Jae Hyeon

    2016-01-01

    Objective We evaluated postoperative outcomes in patients who have lumbar foraminal or extraforaminal disc herniation (FELDH) and suggested the risk factors for poor outcomes. Methods A total of 234 patients were selected for this study. Pre- and post-operative Visual Analogue Scale (VAS) and Korean version Oswestry Disability Index (KODI) were evaluated and the changes of both score were calculated. Outcome was defined as excellent, good, fair, and poor based on Mcnab classification. The percentage of superior facetectomy was calculated by using the Maro-view 5.4 Picture Archiving Communication System (PACS). Results Paramedian lumbar discectomy was performed in 180 patients and combined lumbar discectomy was performed in 54 patients. Paramedian lumbar discectomy group showed better outcome compared with combined discectomy group. p value of VAS change was 0.009 and KODI was 0.013. The average percentage of superior facetectomy was 33% (range, 0–79%) and it showed negative correlation with VAS and KODI changes (Pearson coefficient : -0.446 and -0.498, respectively). Excellent or good outcome cases (Group I) were 136 (58.1%) and fair or poor outcome cases (Group II) were 98 (41.9%). The percentage of superior facetectomy was 26.5% at Group I and 42.5% at Group II. There was significant difference in superior facetectomy percentage between Group I and II (p=0.000). Conclusion This study demonstrated that paramedian lumbar discectomy with preservation of facet joints is an effective and good procedure for FELDH. At least 60% of facet should be preserved for excellent or good outcomes. PMID:26962420

  11. A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis

    PubMed Central

    Bhargava, Ramya; Kalra, Philip A.; Brenchley, Paul; Hurst, Helen; Hutchison, Alastair

    2015-01-01

    Background. Retrospective, observational studies link high phosphate with mortality in dialysis patients. This generates research hypotheses but does not establish “cause-and-effect.” A large randomised controlled trial (RCT) of about 3000 patients randomised 50 : 50 to lower or higher phosphate ranges is required to answer the key question: does reducing phosphate levels improve clinical outcomes? Whether such a trial is technically possible is unknown; therefore, a study is necessary to inform the design and conduct of a future, definitive trial. Methodology. Dual centre prospective parallel group study: 100 dialysis patients randomized to lower (phosphate target 0.8 to 1.4 mmol/L) or higher range group (1.8 to 2.4 mmol/L). Non-calcium-containing phosphate binders and questionnaires will be used to achieve target phosphate. Primary endpoint: percentage successfully titrated to required range and percentage maintained in these groups over the maintenance period. Secondary endpoints: consent rate, drop-out rates, and cardiovascular events. Discussion. This study will inform design of a large definitive trial of the effect of phosphate on mortality and cardiovascular events in dialysis patients. If phosphate lowering improves outcomes, we would be reassured of the validity of this clinical practice. If, on the other hand, there is no improvement, a reassessment of resource allocation to therapies proven to improve outcomes will result. Trial Registration Number. This trial is registered with ISRCTN registration number ISRCTN24741445. PMID:26366297

  12. RASCH ANALYSIS OF CLINICAL OUTCOME MEASURES IN SPINAL MUSCULAR ATROPHY

    PubMed Central

    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.

    2015-01-01

    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

  13. Clinical characteristics and outcome of cancer diagnosed during pregnancy

    PubMed Central

    Shim, Min Hee; Mok, Chi-Won; Chang, Kylie Hae-Jin; Sung, Ji-Hee; Oh, Soo-young; Roh, Cheong-Rae; Kim, Jong-Hwa

    2016-01-01

    Objective The aim of this study is to describe the clinical characteristics and outcome of cancer diagnosed during pregnancy. Methods This is a retrospective cohort study of women who were diagnosed with cancer during pregnancy at a tertiary academic hospital between 1995 and 2013. Maternal characteristics, gestational age at diagnosis, and type, stage, symptoms and signs of cancer for each patient were retrieved from the medical records. The cancer treatment, pregnancy management and the subsequent perinatal and maternal outcomes for each cancer were assessed. Results A total of 87 women were diagnosed with cancer during pregnancy (172.6 cases per 100,000 deliveries). The most common cancer was breast cancer (n=20), followed by gastrointestinal (n=17), hematologic (n=13), thyroid (n=11), central nervous system (n=7), cervical (n=7), ovarian (n=5), lung (n=3), and other cancers (n=4). Eighteen (20.7%) patients terminated their pregnancies. In the 69 (79.3%) patients who maintained their pregnancies, one patient miscarried and 34 patients delivered preterm. Of the preterm babies, 24 (70.6%) were admitted to the neonatal intensive care unit and 3 (8.8%) of those expired. The maternal mortality rate was 31.0%, with highest rate seen with lung cancers (66.7%), followed by gastrointestinal (50.0%), central nervous system (50.0%), hematologic (30.8%), breast (25.0%), ovarian (20.0%) cervical (14.3%), and thyroid cancers (0%). Conclusion The clinical characteristics and outcome of cancer during pregnancy were highly variable depending on the type of cancer. However, timely diagnosis and appropriate management of cancer during pregnancy may improve both maternal and neonatal outcome. PMID:26866029

  14. Clinical Outcomes Following Arthroscopic Micro Fracture of the Hip

    PubMed Central

    Begly, John P.; Ryan, Michael K.; Capogna, Brian; Youm, Thomas

    2016-01-01

    Objectives: Objective and clinical results of microfracture for treatment of chondral defects of the knee is well documented, yet outcomes for microfracture of the hip have not been extensively studied. Recently, several studies demonstrated clinical improvements in patients treated with microfracture of the hip. The purpose of this study is to examine clinical outcomes and survivorship in patients who underwent microfracture during arthroscopic hip surgery. Methods: A retrospective analysis of a prospectively collected database was performed. Thirty-eight patients with a mean age of 41 (range, 17-64) who underwent microfracture during arthroscopic hip surgery by a single surgeon (senior author) were identified. Demographic data, diagnosis, and details regarding operative procedures were collected. All patients were indicated for hip arthroscopy based on standard pre-operative examination as well as routine and advanced imaging. Baseline pre-operative modified Harris Hip Scores (mHHS) and Non-Arthritic Hip Scores (NAHS) were compared to mHHS and NAHS at two-year follow-up. Additionally, survivorship data was assessed to determine failure, defined as any subsequent revision arthroscopic surgery and/or hip arthroplasty of the same hip. Results: Thirty-four of the 38 (89.5%) patients were available for two-year clinical follow-up. Baseline mean mHHHS and NAHS for all patients improved from 50.6 (+/- 12.7) and 46.9 (+/-12.8) to 84.7 (+/- 12.5) and 85.6 (+/- 11.2) respectively. Both improvements were statistically significant (p < 0.05). Eight patients (23.5%) met failure criteria and underwent additional surgery at an average of 23.9 months. Two patients (5.8%) underwent revision arthroscopic surgery, and six patients (17.7%) underwent hip arthroplasty. Conclusion: Significant improvements in clinical outcomes are seen at two-year follow-up after microfracture treatment of chondral lesions of the hip. Despite overall success, failure rates are relatively high. As with

  15. The clinical outcomes of chronic hepatitis C in South Korea

    PubMed Central

    Ok, Kyeong Sam; Jeong, Sook-Hyang; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Kim, In Hee; Cho, Sung Bum; Bae, Si Hyun; Lee, Han Chu

    2016-01-01

    Abstract This prospective cohort study aimed to elucidate the clinical outcome and its related factors of chronic hepatitis C in a hepatitis B-dominant Asian region. From January 2007 to October 2012, 382 patients with chronic hepatitis C without liver cirrhosis were prospectively enrolled at 6 university hospitals, and regularly followed until Apr 2014 to identify the development of liver cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), and overall survival. During the median follow-up of 39.0 months (range 18.0–81.0 months), liver cirrhosis, hepatic decompensation, and HCC developed in 42 patients (11.0%), 4 patients (1.0%), and 12 patients (3.1%), respectively. The cumulative probability of development of cirrhosis at 3 years and at 5 years was 9.6% and 16.7%, respectively. That of HCC at 3 and 5 years was 1.6% and 4.5%, respectively. The 3-year and 5-year overall survival rate was 99.7% and 96.0%, respectively. Pegylated interferon-based antiviral therapy was undertaken in 237 patients (62.0%) with a sustained virologic response (SVR) rate of 74.3%. The factors related to the overall clinical outcomes were age ≥55 years (HR 2.924, P = 0.016), platelet counts <150  × 109/L (HR 3.195, P = 0.007), and the achievement of SVR (HR 0.254, P = 0.002). The clinical outcomes of this Korean chronic hepatitis C cohort were modest with minimal mortality, but significant disease progression occurred in the patients with old age, low platelet, and non-SVR after interferon-based antiviral treatment or no treatment, suggesting priority for direct acting antiviral therapy. PMID:27583874

  16. [Clinical Outcomes of Cardiovascular Surgery in Jehovah's Witness Patients].

    PubMed

    Mukaihara, Kosuke; Yamashita, Masafumi; Toyohira, Hitoshi; Yotsumoto, Goichi; Fukumoto, Yoshihiro; Ueno, Takayuki; Matsumoto, Kazuhisa; Moriyama, Yukinori; Imoto, Yutaka

    2016-03-01

    Cardiovascular surgery in Jehovah's Witness is challenging for surgeons on the ground that they refuse blood transfusion. We report 11 cases of cardiovascular surgery. All of the patients underwent elective surgery with cardiopulmonary bypass. Two cases underwent minimally invasive procedures. The mean preoperative hemoglobin level was 13.0 g/dl, and hematopoietic medicines were preoperatively administrated in 4 patients. Although 10 patients recovered satisfactory without blood transfusion, 1 surgical case was lost due to uncontrollable postoperative bleeding. The clinical outcomes of the Jehovah's Witness patients are considered to be satisfactory. However, careful indication is recommended in high risk cases. PMID:27075280

  17. Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic.

    PubMed

    Wright, Diane L; Afeiche, Myriam C; Ehrlich, Shelley; Smith, Kristen; Williams, Paige L; Chavarro, Jorge E; Batsis, Maria; Toth, Thomas L; Hauser, Russ

    2015-01-01

    Total hair mercury (Hg) was measured among 205 women undergoing in vitro fertilization (IVF) treatment and the association with prospectively collected IVF outcomes (229 IVF cycles) was evaluated. Hair Hg levels (median=0.62ppm, range: 0.03-5.66ppm) correlated with fish intake (r=0.59), and exceeded the recommended EPA reference of 1ppm in 33% of women. Generalized linear mixed models with random intercepts accounting for within-woman correlations across treatment cycles were used to evaluate the association of hair Hg with IVF outcomes adjusted for age, body mass index, race, smoking status, infertility diagnosis, and protocol type. Hair Hg levels were not related to ovarian stimulation outcomes (peak estradiol levels, total and mature oocyte yields) or to fertilization rate, embryo quality, clinical pregnancy rate or live birth rate. PMID:25601638

  18. Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic

    PubMed Central

    Ehrlich, Shelley; Smith, Kristen; Williams, Paige L.; Chavarro, Jorge E.; Batsis, Maria; Toth, Thomas L.; Hauser, Russ

    2015-01-01

    Total hair mercury (Hg) was measured among 205 women undergoing in vitro fertilization (IVF) treatment and the association with prospectively collected IVF outcomes (229 IVF cycles) was evaluated. Hair Hg levels (median=0.62 ppm, range: 0.03-5.66 ppm) correlated with fish intake (r=0.59), and exceeded the recommended EPA reference of 1ppm in 33% of women. Generalized linear mixed models with random intercepts accounting for within-woman correlations across treatment cycles were used to evaluate the association of hair Hg with IVF outcomes adjusted for age, body mass index, race, smoking status, infertility diagnosis, and protocol type. Hair Hg levels were not related to ovarian stimulation outcomes (peak estradiol levels, total and mature oocyte yields) or to fertilization rate, embryo quality, clinical pregnancy rate or live birth rate. PMID:25601638

  19. Two Years Later: Former Students' Perceptions of a Clinical Evaluation Course and Current Evaluation Practices

    ERIC Educational Resources Information Center

    Staudt, Marlys M.

    2007-01-01

    The Council on Social Work Education accreditation standards requires that the social work curricula include content on practice evaluation. To meet this requirement, many schools have a course devoted to clinical evaluation. The desired outcome of these courses is that students not only learn the content but also retain it and implement…

  20. Clinical Supervision in Treatment Transport: Effects on Adherence and Outcomes

    PubMed Central

    Schoenwald, Sonja K.; Sheidow, Ashli J.; Chapman, Jason E.

    2009-01-01

    This non-experimental study used Mixed-Effects Regression Models (MRMs) to examine relations among supervisor adherence to a clinical supervision protocol, therapist adherence, and changes in the behavior and functioning of youth with serious antisocial behavior treated with an empirically supported treatment (i.e., Multisystemic Therapy), one-year post treatment. Participants were 1979 youth and families treated by 429 clinicians across 45 provider organizations in North America. Four dimensions of clinical supervision were examined. MRM results showed one dimension, supervisor focus on adherence to treatment principles, predicted greater therapist adherence. Two supervision dimensions, adherence to the structure and process of supervision, and focus on clinician development, predicted changes in youth behavior. Conditions required to test hypothesized mediation by therapist adherence of supervisor adherence effects on youth outcomes were not met, and direct effects of each were observed in models including both supervisor and therapist adherence. PMID:19485583

  1. Clinical Problem Solving Exercises for Pre-Clinical Medical Education: A Design, Implementation and Preliminary Evaluation.

    ERIC Educational Resources Information Center

    Bordage, Georges

    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;…

  2. Evaluating stakeholder participation in water management: intermediary outcomes as potential indicators for future resource management outcomes

    NASA Astrophysics Data System (ADS)

    Carr, Gemma; Bloeschl, Guenter; Loucks, Daniel Pete

    2013-04-01

    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

  3. Correlation of Fluconazole MICs with Clinical Outcome in Cryptococcal Infection

    PubMed Central

    Aller, A. I.; Martin-Mazuelos, E.; Lozano, F.; Gomez-Mateos, J.; Steele-Moore, L.; Holloway, W. J.; Gutiérrez, M. J.; Recio, F. J.; Espinel-Ingroff, A.

    2000-01-01

    We have correlated the in vitro results of testing the susceptibility of Cryptococcus neoformans to fluconazole with the clinical outcome after fluconazole maintenance therapy in patients with AIDS-associated cryptococcal disease. A total of 28 isolates of C. neoformans from 25 patients (24 AIDS patients) were tested. The MICs were determined by the broth microdilution technique by following the modified guidelines described in National Committee for Clinical Standards (NCCLS) document M27-A, e.g., use of yeast nitrogen base medium and a final inoculum of 104 CFU/ml. The fluconazole MIC at which 50% of isolates are inhibited (MIC50) and MIC90, obtained spectrophotometrically after 48 h of incubation, were 4 and 16 μg/ml, respectively. Of the 25 patients studied, 4 died of active cryptococcal disease and 2 died of other causes. Therapeutic failure was observed in five patients who were infected with isolates for which fluconazole MICs were ≥16 μg/ml. Four of these patients had previously had oropharyngeal candidiasis (OPC); three had previously had episodes of cryptococcal infection, and all five treatment failure patients had high cryptococcal antigen titers in either serum or cerebrospinal fluid (titers, >1:4,000). Although 14 of the 18 patients who responded to fluconazole therapy had previously had OPC infections, they each had only a single episode of cryptococcal infection. It appears that the clinical outcome after fluconazole maintenance therapy may be better when the infecting C. neoformans strain is inhibited by lower concentrations of fluconazole for eradication (MICs, <16 μg/ml) than when the patients are infected with strains that require higher fluconazole concentrations (MICs, ≥16 μg/ml). These findings also suggest that the MICs determined by the modified NCCLS microdilution method can be potential predictors of the clinical response to fluconazole therapy and may aid in the identification of patients who will not respond to fluconazole

  4. CLINICAL OUTCOME AFTER INFECTED TOTAL KNEE AND TOTAL HIP ARTHROPLASTY

    PubMed Central

    Mittag, Falk; Leichtle, Carmen Ina; Schlumberger, Michael; Leichtle, Ulf Gunther; Wünschel, Markus

    2016-01-01

    ABSTRACT Objective: 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. Methods: 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. Results: 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. Conclusion: Thorough surgical technique leads to good clinical results independent of infection-type and treatment philosophy. Level of Evidence III, Case Control Study. PMID:26997914

  5. Clinical Outcomes Associated with Treatment Modalities for Gastrointestinal Bezoars

    PubMed Central

    Park, So-Eun; Ahn, Ji Yong; Jung, Hwoon-Yong; Na, Shin; Park, Se Jeong; Lim, Hyun; Choi, Kwi-Sook; Lee, Jeong Hoon; Kim, Do Hoon; Choi, Kee Don; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho

    2014-01-01

    Background/Aims With technical and instrumental advances, the endoscopic removal of bezoars is now more common than conventional surgical removal. We investigated the clinical outcomes in a patient cohort with gastrointestinal bezoars removed using different treatment modalities. Methods Between June 1989 and March 2012, 93 patients with gastrointestinal bezoars underwent endoscopic or surgical procedures at the Asan Medical Center. These patients were divided into endoscopic (n=39) and surgical (n=54) treatment groups in accordance with the initial treatment modality. The clinical feature and outcomes of these two groups were analyzed retrospectively. Results The median follow-up period was 13 months (interquartile range [IQR], 0 to 77 months) in 93 patients with a median age of 60 years (IQR, 50 to 73 years). Among the initial symptoms, abdominal pain was the most common chief complaint (72.1%). The bezoars were commonly located in the stomach (82.1%) in the endoscopic treatment group and in the small bowel (66.7%) in the surgical treatment group. The success rates of endoscopic and surgical treatment were 89.7% and 98.1%, and the complication rates were 12.8% and 33.3%, respectively. Conclusions Endoscopic removal of a gastrointestinal bezoar is an effective treatment modality; however, surgical removal is needed in some cases. PMID:25071905

  6. Clinical characteristics and post-surgical outcomes of focal cortical dysplasia subtypes.

    PubMed

    Xue, Hai; Cai, Lixin; Dong, Sheng; Li, Yongjie

    2016-01-01

    We retrospectively studied 105 patients with a focal cortical dysplasia (FCD) diagnosed on pathological examination, and investigated the long term postoperative seizure outcomes, different clinical characteristics of the three FCD subtypes, particularly type I and II, and surgical outcomes for each group. FCD is a common cause of drug-resistant epilepsy, which is divided into three different subtypes according to its involvement at different stages of brain development. Each of these groups may have different characteristics and may even have different surgical outcomes. After treatment, 55% of patients were completely seizure-free, with two significant predictive variables for poorer outcomes: focal MRI findings and electrode implantation. FCD type I had relatively poor surgical outcomes compared to FCD type II and type IIIa. Compared with FCD type I, type II, particularly IIb, had a higher frequency of seizure attacks, predominantly located in the extratemporal lobes, and was more readily detected and diagnosed via focal lesions on MRI and localized electroencephalogram abnormalities. FCD type II patients seem to show better surgical outcomes than FCD type I, but the difference was not significant. Larger cohort studies are needed for further evaluation of the seizure outcomes of different FCD subtypes. PMID:26314661

  7. Electronic patient-reported outcome systems in oncology clinical practice.

    PubMed

    Bennett, Antonia V; Jensen, Roxanne E; Basch, Ethan

    2012-01-01

    Patient-reported outcome (PRO) questionnaires assess topics a patient can report about his or her own health. This includes symptoms (eg, nausea, fatigue, diarrhea, pain, or frequent urination), physical functioning (eg, difficulty climbing stairs or difficulty fastening buttons), and mental health (eg, anxiety, fear, or worry). Electronic PRO (ePRO) systems are used in oncology clinical care because of 1) their ability to enhance clinical care by flagging important symptoms and saving clinicians time; 2) the availability of standardized methods for creating and implementing PROs in clinics; and 3) the existence of user-friendly platforms for patient self-reporting like tablet computers and automated telephone surveys. Many ePRO systems can provide actionable links to clinical care such as summary reports in a patient's electronic medical record and real-time e-mail alerts to providers when patients report acute needs. This review presents 5 examples of ePRO systems currently in use in oncology practice. These systems support multiple clinical activities, including assessment of symptoms and toxicities related to chemotherapy and radiation, postoperative surveillance, and symptom management during palliative care and hospice. Patient self-reporting is possible both at clinical visits and between visits over the Internet or by telephone. The implementation of an ePRO system requires significant resources and expertise, as well as user training. ePRO systems enable regular monitoring of patient symptoms, function, and needs, and can enhance the efficiency and quality of care as well as communication with patients. PMID:22811342

  8. Clinical outcomes of pars plicata anterior vitrectomy: 2-year results

    PubMed Central

    Narang, Priya; Agarwal, Amar

    2015-01-01

    Purpose: To demonstrate the safety and outcome of a surgical approach that uses pars plicata site for anterior vitrectomy during phacoemulsification procedure complicated by posterior capsule rupture and residual cortical matter. Design: Single center, retrospective, interventional, noncomparative study. Materials and Methods: Medical records of a consecutive series of 35 eyes of 35 patients who underwent pars plicata anterior vitrectomy (PPAV) were reviewed. The main outcome measures were corrected and uncorrected distance visual acuity (CDVA, UDVA), early and late postoperative complications and intraocular pressure (IOP). Ultrasound biomicroscopic (UBM) evaluation of sclerotomy site and spectral domain optical coherence tomography analysis for central macular thickness (CMT) was performed. The final visual outcome at 2 years was evaluated. Results: At 2 years follow-up, the mean postoperative UDVA (logarithm of the minimum angle of resolution [logMAR]) and CDVA (logMAR) was 0.49 ± 0.26 and 0.19 ± 0.14, respectively. There was no significant change in the IOP (P = 0.061) and the mean CMT at 2 years was 192.5 ± 5.54 μm. The postoperative UBM image of the sclerotomy site at 8 weeks demonstrated a clear wound without any vitreous adhesion or incarceration. Intraoperative hyphema was seen in 1 (2.8%) case and postoperative uveitis was seen in 2 (5.7%) cases, which resolved with medications. No case of an iatrogenic retinal break or retinal detachment was reported. Conclusions: PPAV enables a closed chamber approach, allows thorough cleanup of vitreous in the pupillary plane and anterior chamber and affords better access to the subincisional and retropupillary cortical remnant with a significant visual outcome and an acceptable complication rate. PMID:26632124

  9. A Program Evaluation Model: Using Bloom's Taxonomy to Identify Outcome Indicators in Outcomes-Based Program Evaluations

    ERIC Educational Resources Information Center

    McNeil, Rita C.

    2011-01-01

    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…

  10. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    PubMed

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    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. PMID:26184686

  11. Clinicopathologic Features and Clinical Outcomes of Esophageal Gastrointestinal Stromal Tumor

    PubMed Central

    Feng, Fan; Tian, Yangzi; Liu, Zhen; Xu, Guanghui; Liu, Shushang; Guo, Man; Lian, Xiao; Fan, Daiming; Zhang, Hongwei

    2016-01-01

    Abstract Clinicopathologic features and clinical outcomes of gastrointestinal stromal tumors (GISTs) in esophagus are limited, because of the relatively rare incidence of esophageal GISTs. Therefore, the aim of the current study was to investigate the clinicopathologic features and clinical outcomes of esophageal GISTs, and to investigate the potential factors that may predict prognosis. Esophageal GIST cases were obtained from our center and from case reports and clinical studies extracted from MEDLINE. Clinicopathologic features and survivals were analyzed and compared with gastric GISTs from our center. The most common location was lower esophagus (86.84%), followed by middle and upper esophagus (11.40% and 1.76%). The majority of esophageal GISTs were classified as high-risk category (70.83%). Mitotic index was correlated with histologic type, mutational status, and tumor size. The 5-year disease-free survival and disease-specific survival were 65.1% and 65.9%, respectively. Tumor size, mitotic index, and National Institutes of Health risk classification were associated with prognosis of esophageal GISTs. Only tumor size, however, was the independent risk factor for the prognosis of esophageal GISTs. In comparison to gastric GISTs, the distribution of tumor size, histologic type, and National Institutes of Health risk classification were significantly different between esophageal GISTs and gastric GISTs. The disease-free survival and disease-specific survival of esophageal GISTs were significantly lower than that of gastric GISTs. The most common location for esophageal GISTs was lower esophagus, and most of the esophageal GISTs are high-risk category. Tumor size was the independent risk factor for the prognosis of esophageal GISTs. Esophageal GISTs differ significantly from gastric GISTs in respect to clinicopathologic features. The prognosis of esophageal GISTs was worse than that of gastric GISTs. PMID:26765432

  12. Adverse outcome pathway (AOP) development and evaluation

    EPA Science Inventory

    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...

  13. Review of nutritional screening and assessment tools and clinical outcomes in heart failure.

    PubMed

    Lin, Hong; Zhang, Haifeng; Lin, Zheng; Li, Xinli; Kong, Xiangqin; Sun, Gouzhen

    2016-09-01

    Recent studies have suggested that undernutrition as defined using multidimensional nutritional evaluation tools may affect clinical outcomes in heart failure (HF). The evidence supporting this correlation is unclear. Therefore, we conducted this systematic review to critically appraise the use of multidimensional evaluation tools in the prediction of clinical outcomes in HF. We performed descriptive analyses of all identified articles involving qualitative analyses. We used STATA to conduct meta-analyses when at least three studies that tested the same type of nutritional assessment or screening tools and used the same outcome were identified. Sensitivity analyses were conducted to validate our positive results. We identified 17 articles with qualitative analyses and 11 with quantitative analysis after comprehensive literature searching and screening. We determined that the prevalence of malnutrition is high in HF (range 16-90 %), particularly in advanced and acute decompensated HF (approximate range 75-90 %). Undernutrition as identified by multidimensional evaluation tools may be significantly associated with hospitalization, length of stay and complications and is particularly strongly associated with high mortality. The meta-analysis revealed that compared with other tools, Mini Nutritional Assessment (MNA) scores were the strongest predictors of mortality in HF [HR (4.32, 95 % CI 2.30-8.11)]. Our results remained reliable after conducting sensitivity analyses. The prevalence of malnutrition is high in HF, particularly in advanced and acute decompensated HF. Moreover, undernutrition as identified by multidimensional evaluation tools is significantly associated with unfavourable prognoses and high mortality in HF. PMID:26920682

  14. Outcome Measures for Clinical Trials in Interstitial Lung Diseases

    PubMed Central

    Lammi, Matthew R.; Baughman, Robert P.; Birring, Surinder S.; Russell, Anne-Marie; Ryu, Jay H.; Scholand, Marybeth; Distler, Oliver; LeSage, Daphne; Sarver, Catherine; Antoniou, Katerina; Highland, Kristin B.; Kowal-Bielecka, Otylia; Lasky, Joseph A.; Wells, Athol U.; Saketkoo, Lesley Ann

    2015-01-01

    The chronic fibrosing idiopathic interstitial pneumonias (IIPs) are a group of heterogeneous pulmonary parenchymal disorders described by radiologic and histological patterns termed usual interstitial pneumonia (UIP) and non-specific interstitial pneumonia (NSIP). These include idiopathic pulmonary fibrosis (IPF) and those related to connective tissue disease (CTD) and are associated with substantial morbidity and mortality. Beyond the importance of establishing an appropriate diagnosis, designing optimal clinical trials for IIPs has been fraught with difficulties in consistency of clinical endpoints making power analyses, and the establishment of efficacy and interpretation of results across trials challenging. Preliminary recommendations, developed by rigorous consensus methods, proposed a minimum set of outcome measures, a ‘core set’, to be incorporated into future clinical trials (Saketkoo et al, THORAX. 2014.). This paper sets out to examine the candidate instruments for each domain (Dyspnea, Cough, Health Related Quality of Life, Imaging, Lung Physiology and Function, Mortality). Candidate measures that were not selected as well as measures that were not available for examination at the time of the consensus process will also be discussed. PMID:27019654

  15. In-patient rehabilitation: clinical outcomes and cost implications

    PubMed Central

    Bunyan, Mel; Ganeshalingam, Yogesh; Morgan, Ehab; Thompson-Boy, Donvé; Wigton, Rebekah; Holloway, Frank; Tracy, Derek K.

    2016-01-01

    Aims and method A retrospective evaluation was undertaken of the clinical and economic effectiveness of three in-patient rehabilitation units across one London National Health Service trust. Information on admission days and costs 2 years before and 2 years after the rehabilitation placement, length of rehabilitation placement and the discharge pathway was collected on 22 service users. Results There were statistically significant reductions in hospital admission days in the 2 years following rehabilitation compared with the 2 years before, further reflected in significantly lower bed costs. Longer length of rehabilitation placement was correlated with fewer admission days after the placement. A substantial proportion of the sample went into more independent living, some with no further admissions at follow-up. Clinical implications The findings suggest that in-patient rehabilitation is both clinically and cost effective: if benefits are sustained they will offset the cost of the rehabilitation placement. PMID:26958355

  16. Evaluating Clinical Teaching in Medicine.

    ERIC Educational Resources Information Center

    Irby, David; Rakestraw, Philip

    1981-01-01

    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)

  17. Aberrant Hedgehog Signaling and Clinical Outcome in Osteosarcoma

    PubMed Central

    Lo, Winnie W.; Pinnaduwage, Dushanthi; Gokgoz, Nalan; Wunder, Jay S.; Andrulis, Irene L.

    2014-01-01

    Despite the importance of Hedgehog signaling in bone development, the relationship between Hedgehog pathway expression and osteosarcoma clinical characteristics and outcome has not been investigated. In this study of 43 high-grade human osteosarcoma samples, we detected high expression levels of the Hedgehog ligand gene, IHH, and target genes, PTCH1 and GLI1, in most samples. Further analysis in tumors of patients with localized disease at diagnosis identified coexpression of IHH and PTCH1 exclusively in large tumors. Higher levels of IHH were observed more frequently in males and patients with higher levels of GLI1 were more responsive to chemotherapy. Subgroup analysis by tumor size and IHH expression indicated that the well-known association between survival and tumor size was further refined when IHH levels were taken into consideration. PMID:24799831

  18. Clinical outcomes of enjoying sexualization among lesbian women.

    PubMed

    Erchull, Mindy J; Liss, Miriam

    2015-01-01

    The Enjoyment of Sexualization Scale (ESS) was given to 150 lesbians in addition to measures of self-objectification, negative eating attitudes, and depression. The ESS was found to have acceptable levels of internal consistency reliability with a lesbian sample. Scores on the ESS were lower in this sample than in previously reported research with heterosexual women. Enjoying sexualization was found to moderate the relationship between body shame and both depressive symptomatology and negative eating attitudes. In contrast to findings from a heterosexual sample, lesbians who enjoyed sexualization had smaller relationships between these negative clinical outcomes and body shame than lesbians who did not. For lesbians, enjoying sexualization may serve a protective function against the negative effects of self-objectification. Findings are discussed in terms of body image and perceptions of ideal beauty among lesbians. PMID:25287134

  19. [Assessment of individual clinical outcomes: regarding an electroconvulsive therapy case].

    PubMed

    Iraurgi, Ioseba; Gorbeña, Susana; Martínez-Cubillos, Miren-Itxaso; Escribano, Margarita; Gómez-de-Maintenant, Pablo

    2015-01-01

    Evaluation of therapeutic results and of the efficacy and effectiveness of treatments is an area of interest both for clinicians and researchers. In general, randomized controlled trial designs have been used as the methodology of choice in which intergroup comparisons are made having a minimum of participants in each arm of treatment. However, these procedures are seldom used in daily clinical practice. Despite this fact, the evaluation of treatment results for a specific patient is important for the clinician in order to address if therapeutic goals have been accomplished both in terms of statistical significance and clinical meaningfulness. The methodology based on the reliable change index (Jacobson y Truax)1 provides an estimate of these two criteria. The goal of this article is to propose a procedure to apply the methodology with a single case study of a woman diagnosed with major depression and treated with electroconvulsive therapy. PMID:25282427

  20. Single momentary assessments are not reliable outcomes for clinical trials.

    PubMed

    Stone, Arthur A; Broderick, Joan E; Kaell, Alan T

    2010-09-01

    Patient reported outcomes (PROs) play an essential role in clinical trials, though questions have been raised about the accuracy of PROs using long recall periods. This paper examines the utility of a PRO employing a single momentary assessment of pain in a sample of community rheumatology patients. We explore the accuracy and reliability of a single assessment versus the average of multiple assessments taken over 1-week, which is considered a common outcome reporting period. A secondary analysis of 128 patients who monitored their pain intensity with momentary data collections several times a day for a week and 3 months later for another week allowed a comparison of randomly-selected single momentary assessments with the average of many assessments from the week. Results from cross-sectional analyses of the first week were that levels of pain measured by single points were not significantly different than the week average in 4 of 5 analyses, but these single-point assessments had much higher variance. Correlations of single-point and week averages were below 0.70. Longitudinal analysis of change scores across 3 months also demonstrated considerable unreliability of single-point measures, thus the statistical power generated by single-point assessments was considerably less than the more reliable week average. Our conclusion is that single momentary assessments, at least for representing an outcome over a period of a week, are not ideal measures. We discuss alternative measurement strategies for efficiently collecting PRO data for a 1-week period using end-of-day diaries or 7-day recall measures. PMID:20580945

  1. Obsessionality in eating-disorder patients: relationship to clinical presentation and two-year outcome.

    PubMed

    Zubieta, J K; Demitrack, M A; Fenick, A; Krahn, D D

    1995-01-01

    Obsessionality and obsessive-compulsive symptoms have been regarded as important characteristics in the clinical presentation of the eating disorders. In this report, we examined the relation between obsessionality and the clinical presentation and outcome of a sample of eating-disordered patients. Self-rated obsessional symptoms, defined by the obsessive-compulsive subscale of the Symptom Checklist 90 (revised version), were compared with presenting clinical symptomatology, and scores on the Eating Disorder Inventory (EDI) and Beck Depression Inventory (BDI) in a sample of 110 consecutively evaluated women who met DSM-IIIR criteria for eating disorders. Forty patients were contacted for a follow-up investigation, 2 years after the initial evaluation. Higher obsessive-compulsive subscale scores at presentation were associated with more severe dieting, a greater number of psychiatric hospitalizations, and higher EDI, SCL-90R and BDI scores. Initial obsessive-compulsive scores did not predict the subsequent outcome of a sample of these patients in the community. However, elevated obsessive-compulsive scores obtained at follow-up were associated with the presence of lower body weight and more severe eating-disorder symptoms at that time. These results support the hypothesis that elevated obsessionality is associated with more severe eating disorder symptomatology. In addition, obsessional symptoms change along with those of the eating disorder, and their persistence may be associated with a poorer outcome. PMID:8847659

  2. Clinical characteristics and outcome of hydronephrosis detected by prenatal ultrasonography.

    PubMed

    Lim, Dae Jung; Park, Jae-Young; Kim, Jeong Hyun; Paick, Sung Hyun; Oh, Seung-June; Choi, Hwang

    2003-12-01

    The widespread use of prenatal ultrasound results in an increased recognition of fetal hydronephrosis. To determine clinical characteristics and postnatal outcome of fetal hydronephrosis, we performed a retrospective study in children diagnosed as having fetal hydronephrosis between 1990 and 2001. 341 children with 427 dilated kidneys were included. Dilatation of the renal pelvis was caused by primary ureteropelvic junction obstruction in 65.6%, multicystic kidney in 9.4%, vesicoureteral reflux in 7.0%, duplex system in 5.4%, ureterovesical junction obstruction in 4.0%, and posterior urethral valves in 3.0%. Hydronephrosis resolved spontaneously in 126 (29.5%) kidneys, with 52.7% of mild hydronephrosis, and 2.6% of severe hydronephrosis. Mean interval to spontaneous resolution was 1.39 (+/- 1.41, SD) yr. Surgery was performed in 174 kidneys, including pyeloplasty in 105, ureteroneocystostomy in 23, transurethral incision in 11 and nephrectomy in 9. Most patients had initially high-grade hydronephrosis (p<0.05). Mild hydronephrosis appears to be relatively benign, and in most cases, dilatation improves with time, and thus surgical intervention is not required. On the other hand, moderate or severe hydronephrosis often results in a significantly poor outcome and requires surgical intervention, and therefore, requires closer follow-up both antenatally and postnatally. PMID:14676444

  3. Common Minor Histocompatibility Antigen Discovery Based upon Patient Clinical Outcomes and Genomic Data

    PubMed Central

    Armistead, Paul M.; Liang, Shoudan; Li, Hua; Lu, Sijie; Van Bergen, Cornelis A. M.; Alatrash, Gheath; St. John, Lisa; Hunsucker, Sally A.; Sarantopoulos, Stefanie; Falkenburg, J. H. Frederik; Molldrem, Jeffrey J.

    2011-01-01

    Background Minor histocompatibility antigens (mHA) mediate much of the graft vs. leukemia (GvL) effect and graft vs. host disease (GvHD) in patients who undergo allogeneic stem cell transplantation (SCT) [1], [2], [3], [4]. Therapeutic decision making and treatments [5] based upon mHAs will require the evaluation of multiple candidate mHAs and the selection of those with the potential to have the greatest impact on clinical outcomes. We hypothesized that common, immunodominant mHAs, which are presented by HLA-A, B, and C molecules, can mediate clinically significant GvL and/or GvHD, and that these mHAs can be identified through association of genomic data with clinical outcomes. Methodology/Principal Findings Because most mHAs result from donor/recipient cSNP disparities, we genotyped 57 myeloid leukemia patients and their donors at 13,917 cSNPs [6]. We correlated the frequency of genetically predicted mHA disparities with clinical evidence of an immune response and then computationally screened all peptides mapping to the highly associated cSNPs for their ability to bind to HLA molecules. As proof-of-concept, we analyzed one predicted antigen, T4A, whose mHA mismatch trended towards improved overall and disease free survival in our cohort. T4A mHA mismatches occurred at the maximum theoretical frequency for any given SCT. T4A-specific CD8+ T lymphocytes (CTLs) were detected in 3 of 4 evaluable post-transplant patients predicted to have a T4A mismatch. Conclusions/Significance Our method is the first to combine clinical outcomes data with genomics and bioinformatics methods to predict and confirm a mHA. Refinement of this method should enable the discovery of clinically relevant mHAs in the majority of transplant patients and possibly lead to novel immunotherapeutics [5]. PMID:21858034

  4. Clinical Manifestations and Treatment Outcomes of Eosinophilic Gastroenteritis in Children

    PubMed Central

    Choi, Jong Sub; Choi, Shin Jie; Lee, Kyung Jae; Kim, Ahlee; Yoo, Jung Kyung; Yang, Hye Ran; Moon, Jin Soo; Chang, Ju Young; Kang, Gyeong Hoon

    2015-01-01

    Purpose The aim of the present study was to investigate the clinical features and outcome of eosinophilic gastroenteritis (EGE) in children. Methods Our study enrolled 24 children who were diagnosed with EGE from 1993 to 2014 at the Department of Pediatrics, Seoul National University Children's Hospital. The patients' clinical manifestations, treatments, and outcomes were reviewed from the medical records. Results The mean age at diagnosis was 5.3 years. Most patients had gastrointestinal symptoms including diarrhea (54.2%) and abdominal pain (45.8%). Peripheral eosinophilia was present in 91.7% of the patients. Thirteen patients (54.2%) showed anemia, and 15 patients (62.5%) had hypoalbuminemia. EGE was classified as mucosal, subserosal, or muscular in 75.0%, 20.8%, and 4.2% of cases, respectively. Three patients showed gastroduodenal ulcers upon endoscopic analysis. A history of allergy was reported in 13 patients, including atopic dermatitis, allergic rhinitis, and asthma. Five patients (20.8%) improved with food restrictions. Among the 19 patients treated with steroids, 11 (57.9%) discontinued steroid treatment without subsequent relapse, 4 (21.1%) relapsed after ceasing steroid treatment, and 4 (21.1%) showed no response to steroids. Two patients who were resistant to steroids underwent therapeutic surgery. The presence of gastroduodenal ulcers was significantly associated with relapse and steroid resistance. Conclusion A high suspicion of EGE is warranted when children have nonspecific gastrointestinal symptoms and peripheral eosinophilia. Most patients improved with food restrictions or steroid treatment, although one-third of patients showed a relapse or steroid resistance. PMID:26770900

  5. Different Placebos, Different Mechanisms, Different Outcomes: Lessons for Clinical Trials

    PubMed Central

    Benedetti, Fabrizio; Dogue, Sara

    2015-01-01

    Clinical trials use placebos with the assumption that they are inert, thus all placebos are considered to be equal. Here we show that this assumption is wrong and that different placebo procedures are associated to different therapeutic rituals which, in turn, trigger different mechanisms and produce different therapeutic outcomes. We studied high altitude, or hypobaric hypoxia, headache, in which two different placebos were administered. The first was placebo oxygen inhaled through a mask, whereas the second was placebo aspirin swallowed with a pill. Both placebos were given after a conditioning procedure, whereby either real oxygen or real aspirin was administered for three consecutive sessions to reduce headache pain. We found that after real oxygen conditioning, placebo oxygen induced pain relief along with a reduction in ventilation, blood alkalosis and salivary prostaglandin (PG)E2, yet without any increase in blood oxygen saturation (SO2). By contrast, after real aspirin conditioning, placebo aspirin induced pain relief through the inhibition of all the products of cyclooxygenase, that is, PGD2, PGE2, PGF2, PGI2, thromboxane (TX)A2, without affecting ventilation and blood alkalosis. Therefore, two different placebos, associated to two different therapeutic rituals, used two different pathways to reduce headache pain. The analgesic effect following placebo oxygen was superior to placebo aspirin. These findings show that different placebos may use different mechanisms to reduce high altitude headache, depending on the therapeutic ritual and the route of administration. In clinical trials, placebos and outcome measures should be selected very carefully in order not to incur in wrong interpretations. PMID:26536471

  6. Clinical Features and Outcomes of Pasteurella multocida Infection

    PubMed Central

    Giordano, Antonio; Dincman, Toros; Clyburn, Benjamin E.; Steed, Lisa L.; Rockey, Don C.

    2015-01-01

    Abstract Pasteurella multocida, a zoonotic infectious organism, has most often been described in patients after an animal bite. Here, we characterize the clinical features and outcomes of P multocida infection in a large cohort of patients according to the presence or absence of an animal bite. We retrospectively searched MUSC's laboratory information system for all patients with positive P multocida cultures from 2000 to 2014. Extensive data were abstracted, including clinical and outcome data. The Charlson comorbidity index (CCI) was used to assess comorbidities among patients. We identified 44 patients with P multocida infections, including 25 with an animal bite. The average age was 64 years and the majority of patients were women (N = 30). There was no difference in age and sex distribution among those with and without a bite (P = 0.38 and 0.75, respectively). A CCI ≥1 was significantly associated with the absence of a bite (P = 0.006). Patients presenting without a bite were more frequently bacteremic (37% vs 4%, respectively, P = 0.001), and were hospitalized more often (84% vs 44%, respectively, P = 0.012). Of the 8 patients who required intensive care unit (ICU)-based care, 7 were non-bite-related. There were 4 deaths, all occurring in patients not bitten. P multocida infections not associated with an animal bite were often associated with bacteremia, severe comorbidity(ies), immune-incompetent states, the need for ICU management, and were associated with substantial mortality. PMID:26356688

  7. Clinical outcomes of the high-performance membrane dialyzer.

    PubMed

    Koda, Yutaka

    2011-01-01

    HPM (high-performance membrane or high-flux membrane) has better biocompatibility and higher capacity to remove retention solutes of large molecular weight, which has been proven to be toxic especially to cardiovascular and skeletal organs. To date, several non-randomized observational studies have shown a reduction in morbidity and mortality in HPM-treated patients compared with low-flux conventional membrane. Meanwhile, two randomized controlled trials were unable to reveal the superiority of high-flux membrane in survival of all-cause mortality, but suggested a significant benefit by subgroup analyses or post-hoc analyses in patients with diabetes, hypoalbuminemia and long duration of prior dialysis. Thus, the results of the published studies are conflicting and it still cannot be explained whether the effect is based on the biocompatibility of the membrane or on the differences in the clearance of middle molecules, or on the microbiological purity of dialysate which improved simultaneously with the flux increment. As survival outcome might be determined by additional multiple confounding factors, dialysis-related or non-dialysis-related, investigations to control them are difficult to perform. Although the clinical results are non-conclusive and it is still unanswered how much large molecule removal is required to improve outcomes in routine clinical practice, there is a considerable amount of biological plausibility for high-flux dialysis or middle molecule removal. Further trials will be required to confirm what patient group benefits the most, the magnitude of advantages and how large the molecules are and how much molecule removal is acceptable using advanced high-performance dialyzers. Dispersing hazardous effects by a low-quality therapy should be taken more seriously than practicing a high-quality therapy of uncertain superiority. PMID:21865777

  8. Association between susceptible genotypes to periodontitis and clinical outcomes of periodontal regenerative therapy: A systematic review

    PubMed Central

    Koidou, Vasiliki-Petros

    2016-01-01

    Background The aim of this review is to systematically investigate the effect of a susceptible genotype to periodontitis with the clinical outcomes of periodontal regeneration. Material and Methods Based on a focused question, an electronic search identified 155 unique citations. Three journals (Journal of Periodontology, Journal of Clinical Periodontology and Journal of Periodontal Research), references of relevant studies and review articles were hand-searched. Two independent reviewers implementing eligibility inclusion criteria selected the studies. Results Of the 155, four studies fulfilled the inclusion criteria. All studies were published between 2000 and 2004 and the samples’ size was 40 to 86 patients. Polymorphisms of Interleukin-1 (IL-1) gene were included in all. Three out of four studies failed to identify an association between susceptible genotypes to periodontitis and clinical outcomes of periodontal regeneration, while one found an association. The heterogeneity and small number of studies included prevented the conduct of a meta-analysis. No studies were identified evaluating the effect of other genotypes and as a result only IL-1 genotype studies were included. Conclusions Within the limits of the present review, no direct conclusion for the effect of a susceptible IL-1 genotype status to the clinical outcome after periodontal regeneration could be drawn. The need of more qualitative studies to explore a possible association emerges. Key words:Periodontitis, genotype, periodontal therapy, regeneration, susceptibility, systematic review. PMID:26946210

  9. Clinical Characteristics and Outcome of Cardiovascular Implantable Electronic Device Infections in Turkey.

    PubMed

    Aydin, Mesut; Yildiz, Abdulkadir; Kaya, Zeynettin; Kaya, Zekeriya; Basarir, Ahmet Ozgur; Cakmak, Nazmiye; Donmez, Ibrahim; Morrad, Baktash; Avci, Ahmet; Demir, Kenan; Cagliyan, Emre Caglar; Yuksel, Murat; Elbey, Mehmet Ali; Kayan, Fethullah; Ozaydogdu, Necdet; Islamoglu, Yahya; Cayli, Murat; Alan, Said; Ulgen, Mehmet Siddik; Ozhan, Hakan

    2016-07-01

    Infection is one of the most devastating outcomes of cardiovascular implantable electronic device (CIED) implantation and is related to significant morbidity and mortality. In our country, there is no evaluation about CIED infection. Therefore, our aim was to investigate clinical characteristics and outcome of patients who had infection related to CIED implantation or replacement. The study included 144 consecutive patients with CIED infection treated at 11 major hospitals in Turkey from 2005 to 2014 retrospectively. We analyzed the medical files of all patients hospitalized with the diagnosis of CIED infection. Inclusion criteria were definite infection related to CIED implantation, replacement, or revision. Generator pocket infection, with or without bacteremia, was the most common clinical presentation, followed by CIED-related endocarditis. Coagulase-negative staphylococci and Staphylococcus aureus were the leading causative agents of CIED infection. Multivariate analysis showed that infective endocarditis and ejection fraction were the strongest predictors of in-hospital mortality. PMID:25589093

  10. Using Quality of Life to Evaluate Outcomes and Measure Effectiveness

    ERIC Educational Resources Information Center

    Kober, Ralph; Eggleton, Ian R. C.

    2009-01-01

    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…